MX2014008113A

MX2014008113A - Kit for producing a vaccine.

Info

Publication number: MX2014008113A
Application number: MX2014008113A
Authority: MX
Inventors: Dirk Neven Rauleder; Gerald Behrens; Knut Elbers
Original assignee: Boehringer Ingelheim Vetmed
Priority date: 2012-01-13
Filing date: 2013-01-14
Publication date: 2014-09-22
Also published as: PH12014501599B1; HUE052963T2; PH12014501599A1; DK2802348T3; KR20190122268A; PT2802348T; MX363253B; ES2836828T3

Abstract

The invention relates to a kit, to a use, and to a method for producing a vaccine for immunizing against porcine circovirus disease and/or enzootic pneumonia of pigs, wherein a first container is filled only partially with a first vaccine and a second container is filled with a second component, wherein the second vaccine is transferred into the first container by means of an adapter device by penetrating a closing device for the first time and/or one time only and the vaccine is produced in the first container, which enables a simple, less error-prone and more hygienic operation with reduced material use.

Description

KIT FOR THE PRODUCTION OF AN INOCULANT The present invention relates to a kit for the production of an inoculant, a use of the kit for the production of an inoculant, a use of at least two precursors for the production of an inoculant and a method for making an inoculant available .

The present invention relates, in particular, to the production and making available of inoculants, also called vaccines, in particular for the veterinary medical sector. First, the present invention relates to inoculants for immunization against porcine diseases by Porcine Circovirus, in particular of type 2, also called Porcine Circovirus-associated disease or PCVD (for its acronym in English), and / or with bacteria of strain Mycoplasma hyopneumoniae, also called enzootic pneumonia or EP (for its acronym in English).

It is known that a prevention against the aforementioned diseases is possible by immunization with vaccines. The inoculants are most often intended to be injected and must be correspondingly sterile. In addition, each individual injection means stress for the treated living being, so the number of inoculation processes must be kept as small as possible.

A known option for reducing the number of inoculation processes are the so-called combined inoculations that allow an immunization against different diseases in only a few sessions and even in a single session. Frequently, however, a combined inoculation is not possible because of the incompatibility of different vaccines or constituents of the same. Even if it were possible to achieve at least a short-term compatibility, it is necessary to produce these combined inoculants in situ. In particular in the field of veterinary medicine, the inoculants must be prepared and / or applied outdoors. In this case, the problem is that contaminations of the combined inoculant can occur, for example a contamination with pathogenic germs and, in particular, when a mixing bottle must be punctured multiple times.

The present invention has the objective of indicating a kit for the production of an inoculant, a use of this kit for the production of an inoculant, a use of at least two precursors for the production of an inoculant and a method for making available of an inoculant, it being possible to produce an inoculant in a simple manner, which is not very susceptible to faults and, at the same time, in a hygienic manner, also from precursors that are only stable for a short time.

The aforementioned objective is achieved by means of a kit for the production of an inoculant according to claim 1, by using such a kit for the production of an inoculant according to claim 55, by using at least two precursors for the production of an inoculant according to claim 56 or a method for making an inoculant available according to claim 1. Advantageous improvements are the subject of the secondary claims.

A first aspect of the present invention relates to a kit for the production of an inoculant, in particular for the production of an inoculant for immunization against the disease associated with the Porcine Circovirus "PCVD" and / or "EP" or "enzootic" pneumonia. infections with Circovirus Porcine, in particular type 2, and / or Mycoplasma hyopneumoniae.

The kit according to the invention has a first precursor and a second precursor different from the first precursor. A precursor in the sense of the present invention is preferably any starting substance, in particular a vaccine, a starting substance that presents a vaccine and / or a component or a starting substance for an inoculant, preferably an antigen or a compound that contains an antigen. In addition, the kit has a first receptacle filled only in part with a first precursor and a second receptacle with the second precursor.

A receptacle in the sense of the present invention is preferably a structure enclosing a volume, preferably configured to receive a liquid, in particular a container, a bottle, a bag or the like.

The kit also has an adapter device for the creation of a fluid connection, the fluid connection between the first and the second receptacles being able to be created. Therefore, it is preferred that the adapter device be configured to produce a fluidic connection between the interior spaces of the first receptacle and the second receptacle.

Furthermore, in the kit according to the proposal, at least one of the receptacles is closed at the factory by means of a closing device. Preferably, both receptacles are closed at the factory by means of a closing device. It is preferred that an air and / or sterile seal is provided. In particular it must be a seal, a rubber stopper or the like, the closing device being preferably penetrable and / or pierceable, in particular from reversible way. In this way, the receptacles, therefore at least one of the receptacles, can be closed in sterile conditions.

It is provided that the second receptacle can be connected to the first receptacle by the adapter device by means of a first and / or only single perforation of the closing device, in such a way that the second precursor arrives, in particular is transported, to the first receptacle, and with the first precursor form the inoculant there. That is, the closing device or the closing devices are preferably configured to be penetrated or pierced by the adapter device. The adapter device is preferably configured in such a way that it can penetrate and / or pierce the closing device or the closing devices. In this way it is possible to provide a fluid connection between the first and the second receptacles.

Therefore, with the kit according to the invention it is possible, with only two receptacles and an adapter device, to produce an inoculant based on two precursors, in particular for use in immunization against diseases caused by infections with Porcine Circovirus and / or Mycoplasma hyopneumoniae, preferably for use in immunization against diseases caused by infection with Porcine Circovirus and Mycoplasma hyopneumoniae. In addition, the kit prevents the use of other incompatible precursors, in particular by the administration of precursors and receptacles as a kit.

Advantageously, the inoculant can be formed in the first receptacle only partially filled, which prevents additional receptacles and / or additional adapter devices from being used. This allows a simple application if possible. Additionally, the use of materials is minimized because the number of necessary components is reduced to a minimum.

Furthermore, it is particularly advantageous if a single or first penetration or perforation of the closing device is sufficient to produce the inoculant. Specifically, in this way it is prevented that when piercing or penetrating the closure device multiple times, foreign bodies or pathogenic microorganisms can reach the vaccine.

In the present invention, for reasons of clarity, one differentiates between vaccines as possible components of one or more precursors and the inoculant as a product produced from the precursors.

Therefore, with the kit according to the invention it is possible, with only two receptacles and an adapter device, to produce an inoculant of two precursors, in particular for use in immunization against diseases caused by infection with Porcine Circovirus and / or Mycoplasma hyopneumoniae, preferably for use in immunization against diseases caused by infection with Porcine Circovirus and Mycoplasma hyopneumoniae. In addition, the kit prevents the use of other incompatible precursors, in particular by the administration of precursors and receptacles as a kit.

Furthermore, it is particularly advantageous that a single or first penetration or perforation of the closure device is sufficient to produce the inoculant. Specifically, in this way it is prevented that when piercing or penetrating the closure device multiple times, foreign bodies or pathogenic microorganisms can reach the inoculant.

Therefore, preferably with the term "inoculant", even when it is here also a vaccine, the final product is designated, which is preferably produced or manufactured from the two precursors and / or is used for the treatment. Particularly preferably, the inoculant is a combined inoculant, preferably containing at least two vaccines different from each other or at least two antigens different from each other or compositions containing two antigens, the compositions containing the antigens differing at least in their antigens. By "vaccines", even if in this case they are inoculants, they are preferably understood as precursors or components thereof, in particular antigens or compositions containing antigens. An "antigen" or a "compound containing antigen" is preferably understood to be a substance or a composition containing the substance, which in an animal can, after administration, provoke an immune reaction or reinforce an already existing immune reaction. . Therefore, the differentiation between the concepts "inoculant" and "vaccine" serves, in particular, only as a clarification or distinction of the product of possible components of one or more of the precursors. Consequently, it is possible to replace the term "inoculant" with the term "vaccine" or vice versa.

A kit in the sense of the present invention is, in particular, an assembly and / or a system with the first receptacle, the second receptacle and, preferably, the adapter device, forming components of the kit. Preferably, the components of the kit are marketed as a whole, in particular in a common package or the like. However, it is also possible that the named components form a loose set for common use. In this case, a common component or connection former may be provided, for example instructions for use, handling recommendations, references on the labels of one or more components of the kit or the like.

Another feasible aspect, also independently, of the present invention relates to the use of a kit preferably in accordance with that proposed for the production and / or making available an inoculant, in particular for immunization against the disease or diseases associated with the Circovirus. Porcine "PCVD" and / or "EP" enzootic pneumonia or Porcine Circovirus infections and / or infection with bacteria of Mycoplasma strain, in particular Mycoplasma hyopneumoniae, preferably for immunization against diseases associated with Porcine Circovirus "PCVD" and / or "EP" enzootic pneumonia or against Porcine Circovirus infections, in particular Porcine Circovirus type 2 and infection with bacteria of the Mycoplasma strain, in particular Mycoplasma hyopneumoniae.

Another feasible aspect, also independently, of the present invention relates to the use of at least two precursors for the production of an inoculant, in particular for immunization particularly treatment against the disease or diseases associated with Porcine Circovirus "PCVD" and / or "EP" enzootic pneumonia, preferably for particularly simultaneous immunization against diseases associated with Porcine Circovirus "PCVD" and / or "EP" enzootic pneumonia, or against infections with Porcine Circovirus, in particular Porcine Circovirus type 2 and infection with bacteria of the strain Mycoplasma, in particular Mycoplasma hyopneumoniae, in which for the production of the inoculant the precursors are implanted in receptacles and with an adapter device. In this case it is possible to apply the proposed kit. It is further provided that in a first receptacle partially filled with a first precursor and in a second receptacle containing a second precursor different from the first precursor and an adapter device are used configured to produce fluid binding between the first and second receptacles. At least one of the receptacles is closed at the factory with a closing device. A fluid connection between the first and second receptacles is produced by the adapter device by means of a first and / or only single piercing of the closure device, for transferring the second precursor to the first receptacle through the adapter device and the delivery device. close and produce the inoculant in the first receptacle.

Another aspect of the present invention, also independently realizable, relates to a method for making available an inoculant of a first precursor and a second precursor different from the first precursor, in particular for immunization, in particular simultaneous, against the disease associated with Porcine Circovirus "PCVD" and / or "EP" enzootic pneumonia, preferably for immunization, particularly simultaneous, against the disease associated with Porcine Circovirus "PCVD" and / or pneumonia enzootic "EP". For the production of the inoculant a kit according to the proposal can be used.

Between a first receptacle filled only partially with the first precursor and a second receptacle presenting the second precursor, a fluid connection is produced by means of an adapter device in such a way that by means of the adapter device, by means of a first and / or only one rupture and / or perforation of a closure device provided at the factory, which preferably closes at least one of the receptacles, a fluid connection is established between the first and second receptacles. The second precursor is transferred or transported to the first receptacle through the adapter device and the closure device. In the first receptacle the inoculant is formed from the first precursor and the second precursor.

It is preferred that the first and / or second precursor be or present a vaccine, an antigen and / or a compound containing an antigen. In addition, the first precursor can be differentiated from the second precursor. That is, the first precursor may be or present a first vaccine, a first antigen and / or a compound containing a first antigen and the second precursor a second vaccine different from the first vaccine, a second antigen different from the first antigen and / or a compound that contains an antigen, whose antigen differs from the compound that contains the first antigen. Preferably, the first vaccine and the second vaccine either the first antigen and the second antigen or the compounds containing the different antigens for, in particular, simultaneous immunization against different diseases or pathogenic germs, for example against the disease associated with the Circovirus. Porcine "PCVD" and "EP" enzootic pneumonia, or for immunization against Porcine Circovirus, preferably Porcine Circovirus type 2 and against Mycoplasmas, preferably against Mycoplasma hyopneumoniae. In this way it is possible to produce a combined inoculant. The precursors can present, in addition to vaccines, other substances, in particular water, adjuvants and / or adjuvants.

It is particularly preferred that the first precursor has only one of the vaccine components against Mycoplasma or Mycoplasma antigen and vaccine against the Circovirus or Circovirus antigen (and optionally other substances). Therefore, the first precursor may present the Mycoplasma vaccine or one or more Mycoplasma antigens or, alternatively, the vaccine against the Circovirus or one or more Circovirus antigens. Preferably, the first precursor is stored separately from the second precursor, especially when the precursors together are not stable in the long term. The second precursor preferably has only the other component of the Mycoplasma vaccine or one or more Mycoplasma antigens and a vaccine against the Circovirus or one or more antigens of the Circovirus (and optionally other substances). Therefore, when the first precursor presents the vaccine against Mycoplasma or one or more antigens of Mycoplasma, the second precursor presents the vaccine against the Circovirus or one or more antigens of the Circovirus.

The vaccine against Mycoplasma can present attenuated and / or inactivated bacteria, fragments of bacteria or recombinant parts of Mycoplasma hyopneumoniae, but at least one or more antigens of Mycoplasma hyopneumoniae. Preferably, the antigen of Mycoplasma hyopneumoniae comes from the J strain of Mycoplasma hyopneumoniae or in the Mycoplasma hyopneumoniae inactivated are bacteria of strain J. Otherwise, the vaccine against Mycoplasma can be one of the following vaccines or the antigen of Mycoplasma hyopneumoniae can be the antigen (s) contained in one of the following vaccines: lngelvac®MycoFlex (Boehringer Ingelheim Vetmedica Inc., St. Joseph, MO, USA), Porcilis M. hyo, Myco Silencer® BPM, Myco Silencer® BPME, Myco Silencer® ME, Myco Silencer® M, Myco Silencer® Once, Myco Silencer® MEH (all from Intervet Inc., Millsboro, USA) Stellamune Mycoplasma (Pfizer Inc., New York, NY, USA), Suvaxyn Mycoplasma, Suvaxyn M. hyo, Suvaxyn MH-One (all former Fort Dodge Animal Health, Overland Park, KS, USA (now Pfizer Animal Health).

The vaccine against the Circovirus may have attenuated and / or inactivated Porcine Circovirus, preferably type 2, in particular the ORF2 type 2 protein. Particularly preferred is the use of the recombinant expressed type 2 porcine Circovirus protein ORF2, preferably expressed in y obtained from in vitro cell culture. Among others, the international patent application WO2006-072065 describes examples of porcine Circovirus type 2 ORF2 proteins. They have proved to be particularly advantageous for effective vaccination. Otherwise, the vaccine against the Circovirus can be one of the following inoculants, or the antigen of the Circovirus can be the antigen (s) contained in one of the following vaccines: lngelvac®CircoFLEX, (Boehringer Ingelheim Vetmedica Inc, St Joseph, MO, USA), CircoVac® (Merial SAS, Lyon, France), CircoVent (Intervet Inc., Millsboro, DE, USA), or Suvaxyn PCV-2 One Dose® (Fort Dodge Animal Health, Kansas City, KA, USA).

The vaccine against the Circovirus, as long as it contains the ORF2 protein, preferably contains between 2 pg and 150 pg, preferably between 2 pg and 60 pg, more preferably between 2 pg and 50 pg, more preferably between 2 pg and 40 pg, more preferably between 2 pg and 30 pg, more preferably between 2 pg and 25 pg, more preferably between 2 pg and 20 pg, more preferably between 4 pg and 20 pg, more preferably between 4 pg and 16 pg of ORF2 protein per dose to be administered. The vaccine against the Circovirus is preferably produced in such a way that 1 ml of the vaccine is equivalent to a dose of 1. In particular, the vaccine against the Circovirus can present the ORF2 protein in amounts greater than 2 pg / ml, preferably larger at 4 pg / ml and / or less than 150 pg / ml, preferably less than 60 pg / ml, 50 pg / ml, 40 pg / ml, 30 pg / ml or 25 pg / ml, in particular less than 20 pg / ml ml. This is conducive to reliable applicability. The vaccine against Mycoplasma, insofar as it contains Mycoplasma inactivated bacteria, preferably inactivated bacteria of Mycoplasma hyopneumoniae, preferably contains between 104 and 108 colony forming units (CFU), preferably between 04 and 108 (CFU) , more preferably between 105 and 106 (CFU). The vaccine against Mycoplasma is produced, preferably, in such a way that 1 ml of the vaccine is equivalent to a dose of 1. In particular, the vaccine against Mycoplasma can present, in particular before the inactivation of bacteria, more than 103 CFU / ml, preferably more than 10 4 CFU / ml, particularly more than 10 5 CFU / ml and / or less than 10 9 CFU / ml, preferably less than 10 8 CFU / ml, particularly less than 10 7 CFU / ml or 10 6 CFU / ml inactivated Mycoplasma bacteria, preferably inactivated Mycoplasma hyopneumoniae bacteria.

At least one of the precursors and / or the inoculant may present an adjuvant, preferably a polymer adjuvant, in particular carbomer. Preferably, at least one or exactly one of both precursors, preferably both precursors, contains an adjuvant amount of 500 pg to 5 mg, preferably 750 pg to 2.5 mg, more preferably more or less 1 mg of adjuvant per dose to be administered . The precursors are preferably produced and / or prepared in such a way that 1 ml of the respective precursor equals a dose of 1. The use of an adjuvant, preferably a polymeric adjuvant, for example carbomer, has been found advantageous with respect to the efficiency of the immunization or of the active period. However, the use of alternative and / or additional adjuvants is not excluded.

Furthermore, it has turned out to be advantageous that the total volume of the first receptacle exceeds the volume of the first precursor at least in the volume of the second precursor, in particular by more than 2%, preferably by more than 5%, in particular by more than 8%. In this way it is possible to ensure that sufficient volume for the second precursor is available in the first receptacle. In addition, due to the volume of the first receptacle, which exceeds the volumes of the first and second precursors, an effective mixture of the precursors is ensured, in particular when the first receptacle is moved, after the transfer of the second precursor, to the first receptacle .

Therefore, on the one hand it is preferable that the total volume of the first receptacle exceeds the sum of the volumes of the precursors. On the other hand, in order to achieve or accelerate a homogenous mixture and / or a reaction, the first receptacle is moved, during and / or after the transfer of the second precursor to the first receptacle.

According to another aspect of the present invention, the first receptacle can be used for application in or with an injection device. In particular, it is a reusable injection device multiple times, for example an injection gun, a needleless injector and / or a self-refilling syringe, such as are used, for example, in vaccinations of large batches of animals. In this way the number of perforations of the closing device of the first receptacle can be minimized again. In particular, the number of perforations can be reduced to two, namely a perforation for the preparation and a second perforation for the extraction of the inoculant. In a particularly advantageous manner, the adaptation device for the connection can be used with the injection device, whereby the number of perforations is reduced to one.

The kit according to the invention may have an injection device or be assigned to one. In particular, the opening, a flange or any connecting or closing element of the first receptacle and / or adapter device can be configured in such a way that a direct application on or with an injection device is possible. In addition, the opening, flange or other connecting and / or closing element can be configured specifically for connection to a particular injection device. In this way it is possible to reduce again the probability of an incorrect use, in particular the erroneous quantity of active agents or application processes.

One or more of the receptacles can have, in addition to the respective precursor, a gas, in particular a protective gas, with which the long-term stability of the respective precursor can be improved. In addition, the adapter device may be configured to transfer the gas from the first receptacle to the second receptacle, when the first precursor of the second receptacle is transferred to the first receptacle, in particular to the exclusion of the ambient atmosphere. In this way it is possible to ensure that influencing one or more of the precursors and / or the inoculant is impossible, in particular by oxidation or the like, and / or pressure compensation is possible.

Other aspects, details, characteristics, properties and advantages of the present invention result from the claims and the drawings and from the following description of a preferred embodiment of the proposed kit for the production of an inoculant. They show: Figure 1, a first receptacle, partly filled with a first precursor; Figure 2, a second receptacle with a second precursor; Figure 3, an adapter device for fluid binding of the receptacles; Figure 4, a second receptacle with adapter device applied; Figure 5, a first and a second receptacles connected by means of an adapter device; Figure 6, a first receptacle with inoculant; Figure 7, an injection device with the first receptacle spliced.

In the figures, the same references are used for identical or similar parts with which corresponding or comparable properties and advantages can be achieved, even if a repeated description has been dispensed with.

Figure 1 shows a first receptacle 1 with a wall 2 limiting the volume. The receptacle 1 has an opening sector 3 which can have a flange 4, for example an annular collar. Preferably, the receptacle 1 is closed by a closing device 5, in particular sterile and / or air-tight. For this purpose it can be provided that the closing device 5 is in firm contact with the flange 4, in particular under pressure against it.

For example, a clamping element 6, in particular a clamping ring, can be provided which presses the closing device 5 against the flange 4. The clamping element 6 can be made of metal and in particular have aluminum or stainless steel. Alternatively or additionally it is possible for the clamping element 6 to be plastic or made of plastic. The clamping element 6 is preferably configured in such a way that the closing device 5 presses against the flange 4 and, thus, allows a sealing of the first receptacle 1, in particular against the environment and / or the atmosphere.

In the exemplary embodiment, the closing device 5 closes or seals the first receptacle 1. The closing device 5 is preferably pierceable or penetrable, for example by means of a prong, a needle, a hollow needle, a double prong or Similary. Particularly preferably, the closure device 5 is designed to be pierceable or penetrable in such a way that a reversible closure is achieved. Therefore, the closure device 5 again permits a particularly air-tight and / or sterile closure, in particular also after perforation, penetration and extraction of the corresponding medium. The closure device 5 may have rubber, in particular type 1 halobutyl rubber and / or be shaped as a rubber stopper. Do not However, the closure device 5 can also be composed of other materials, in particular of materials that are also applied to the wall 2, or present such materials.

The wall 2 of the first receptacle 1 preferably has a sterile material, preferably glass, polyethylene, high density polyethylene (HDPE), ethylene and vinyl acetate (EVA), halobutyl rubber type 1 and / or silicone chlorobutyl. The wall 2 can be rigid or flexible. The first receptacle 1 can be shaped, in particular, as a bottle, bag, can or the like. In particular, the first receptacle 1 can be a cartridge, an insert or a connection or application device for an injection device 22 (FIG. 7) which will be explained in detail below.

In the embodiment of FIG. 1, the receptacle 1 is only partially filled with the first precursor 7. The receptacle 1 is filled with the first precursor by less than 70%, preferably by less than 50%, in particular by less than 45% and / or more than 10%, preferably more than 20%, particularly more than 30%.

In addition to the first precursor, the first receptacle 1 may have a gas 8, in particular a protective gas, noble gas, inert gas or the like. In this way, the preservability of the first precursor can be improved 7.

Preferably, the sum of the volumes of the first precursor 7 and the gas 8 expresses the total volume of the first receptacle 1, for example the volume enclosed by the wall 2 of the first receptacle 1, in particular with the closing device 5, or a volume less.

Figure 2 shows a second receptacle 9 with a second precursor 10. The second receptacle 9 can have a wall 11, a sector opening 12, a flange 13, a closing device 14 and / or a tightening element 15, which can preferably have the same or similar characteristics as the respective elements of the first receptacle 1, so that it is dispensed with at this point of a reiterative description. Therefore, reference will now be made only to possible differences of the second receptacle 9 with respect to the first receptacle.

The second receptacle 11 is preferably configured with a wall 11 at least partially flexible, in particular so that by pressing on the wall 11 pressure can be exerted on the second precursor 10. This may favor the yield or the transfer of the second precursor 10 Preferably, the volume of the gas 8 equals or exceeds the volume of the second precursor 10. In particular, the volume of the gas 8 in the first receptacle 1 exceeds the volume of the second precursor 0 by more than 2%, preferably by more than 5% by volume. particular more than 8% and / or less than 80%, preferably less than 50%, in particular less than 40% or 30%. In this way it is possible to achieve a minimum space requirement of the first receptacle 1 with a simultaneous homogeneous production of the inoculant 21 (compare figure 5) in the first receptacle 1. In particular, a sufficient volume of gas 8 remains in the first receptacle 1 , whereby it is possible to achieve a homogeneous mixture by moving the first receptacle 1.

In the exemplary embodiment according to FIG. 2, the second receptacle 9 is, essentially, filled with the second precursor 10. However, alternatively or additionally it is also possible that the second receptacle 9 is completely filled with the second precursor 10 or only partly with the second precursor 10. When only partial filling of the second receptacle 9 with the second precursor 10 is provided, a gas 16, in particular a protective gas, can be provided. that, preferably, together with the second precursor 10, fill the volume of the second receptacle 9 enclosed by the wall 11, in particular by the closing device 14.

It is particularly preferred that the total volume of the first receptacle 1 exceeds the volume of the first precursor 7 at least in the volume of the second precursor 10. Therefore, the volume of the first receptacle 1 preferably exceeds the sum of the volumes of the first precursor 7 and of the second precursor 10.

Figure 3 shows an adapter device 17 for the production of a fluidic connection between the first receptacle 1 and the second receptacle 9. The adapter device 17 may have at least one, preferably two, but also more than two adapter elements 18, in particular needles, hollow needles, barbs, wedges or the like.

The adapter device 17 preferably has a fluid channel 19, in particular for the fluid connection of the interior spaces of the receptacles 1 and 9. In the exemplary embodiment, the adapter device 17 is designed as a double spike or hollow needle.

The adapter device 17 can be configured in such a way that during transport of the second precursor 10 to the first receptacle 1, the gas 8 or protective gas of the first receptacle 1 reaches the second receptacle 9, in particular in a transported manner. To do this, the adapter device 17 it has an aeration and / or ventilation device 20. The aeration and / or ventilation device 20 is preferably configured as a channel, especially at least substantially parallel to the fluid channel 19. However, other solutions are also possible.

Preferably, the adapter device 17 has a channel as an aeration and / or ventilation device 20, the openings of which are arranged in such a way that, when flowing, the second precursor 10 of the receptacle 9 is made possible under the influence of gravity by a return of the gas 8. from the first receptacle 1 to the second receptacle 9. In particular, the ventilation and / or vent opening 20 facing the first receptacle 1 can jump back from the opening of the fluid channel 19 facing the first receptacle 1 in the direction of extension longitudinal of the adapter device 17 or be arranged on the side of the opening of the fluid channel 19 away from the open end of the adapter device 17. Consequently, the ventilation and / or vent opening 20 facing the second receptacle 9 is preferably located closer to the open end of the adapter device 17 with respect to the opening of the fluid channel 19 orient to the second receptacle 9.

In the exemplary embodiment, the adapter device 17 is formed in one piece according to FIG. 3. However, it is also possible, alternatively or additionally, between the adapter elements 18 to be arranged a hose, a tube, any other flexible passage or rigid or similar. In this case, it is preferred that the fluid channel 19 and / or the aeration and / or ventilation device 20 continuously connect the adapter elements 18. In particular it is possible for a hose to be provided between the adapter elements 18, in particular formed , a tube or similar.

This enables flexible manipulation and / or lengthening of the adapter device 17.

The adapter device 17, in particular one or more of the adapter elements 18 can or can be configured specifically with respect to the first receptacle 1 and / or the second receptacle 9. This can be realized, in particular, because at least one of the adapter elements 18 is specifically configured mechanically with respect to one of the receptacles 1, 9, in particular with respect to one of the receptacles 1, 9 assigned to the respective adapter element 18, for example by means of a specific thread 3, 12, a specific projection, undercut, a specific peak or any other structure. In this way it is possible to prevent other substances that the first precursor 7 and / or the second precursor 10 from infiltrating into the first receptacle 1 and / or the second receptacle 9. Furthermore, it is preferable that the opening sector of at least one or both receptacles 1, 9 are specifically configured for the adapter device 17, in particular for an adapter element 18.

Furthermore, it is preferable that a connection between the receptacles 1, 9 is only established, preferably, excluding the ambient atmosphere. In the sense of the present invention, the atmosphere is preferably considered already excluded, even when in the adapter device 17 there remains a small remaining volume of atmospheric origin, for example less than 10 ml or 5 ml.

The first precursor 7 and / or the second precursor 10 preferably have a vaccine. Furthermore, it is preferred that the precursors 7, 10 be different, in particular present different vaccines.

As can be seen in figures 4 and 5, it is possible to establish with the adapter device 17 a fluid connection between the first receptacle 1 and the second receptacle 9, the second precursor 10 being able to be transported, preferably with the collaboration of gravity and / or exerting pressure on the second precursor 10 by means of the wall 11 of the second receptacle 9, to the first receptacle 1 to form there with the first precursor 7 the inoculant 2. Inoculant 21 is preferably formed for the prevention of swine disease by infections with Mycoplasma hyopneumoniae and / or Porcine Circovirus, in particular type 2, preferably for the prevention of porcine diseases by infections with Mycoplasma hyopneumoniae and Porcine Circovirus. type 2 Therefore, in the exemplary embodiment represents a combined inoculant.

The first receptacle 1, the second receptacle 9 and, preferably, the adapter device 17 preferably form a kit or assembly. Therefore, they have in the sense of the present invention preferably at least one feature in common binding. This common feature may be that the first receptacle 1, the second receptacle 9 and / or the adapter device 17 are packaged together. Alternatively or additionally it is possible that the first receptacle 1, the second receptacle 9 and / or the adapter device 17 present joint handling instructions, a common instruction sheet, a joint production recommendation or the like. It is also possible that the labels, labels, markings, symbols or any other denominations of the receptacles 1, 9 refer to each other or the like.

Optionally, the kit can also present other components. Examples of this are one or more injection devices 22, adapters for the connection of the first receptacle 1 to an injection device 22, any other device or other receptacle.

The kit is preferably provided for producing an inoculant 21 for prevention of diseases caused by infections with the Porcine Circovirus type 2 and / or Mycoplasma hyopneumoniae, preferably for the prevention of diseases caused in pigs by infections diseases with Porcine Circovirus diseases type 2 and / or Mycoplasma hyopneumoniae. However, different applications are not excluded. In particular, it may alternatively be envisaged to use other vaccines than the named ones or other substances or mixture of substances as precursors 7, 10 and / or to achieve similar advantages with respect to the simple handling and the reduced probability of a contamination of foreign bodies, pathogenic or similar germs. In particular, the two alternative precursors may be one or more antigens of the following pathogens: Actinobacillus pleuropneumonia (A1) Adenovirus (A2); Alphaviruses, for example Eastern Equine Encephalomyelitis Virus (A3); Bordetella bronchiseptica (A4); Brachyspira spp. (A5), preferably B. hyodyentheriae (A6); B. piosicoli (A7), Brucella suis, preferably Biovaren 1, 2, and 3 (A8); Classical Swine Fever Virus (A9); Clostridium spp. (A10), preferably Cl difficile (A11), Cl perfringens types A, B, and C (A12), Cl novyi (A13), Cl septicum (A14), Cl tetani (A15).....; Coronavirus (A16), preferably Porcine Respiratory Coronavirus (A17); Eperythrozoonosis suis (A18); Erysipelothrix rhusiopathiae (A 9) Escherichia coli (A20); Haemophilus parasuis, preferably of subtypes 1, 7 and 14 (A21) Haemagglutinating Encephalomyelitis Virus (A22); Japanese Encephalitis Virus (A23); Lawsonia intracellularis (A24) Leptospira spp. (A25), preferably Leptospira australis (A26), Leptospira canicola (A27), Leptospira grippotyphosa (A28), Leptospira icterohaemorrhagicae (A29), Leptospira interrogans (A30), Leptospira pomona (A3 1), Leptospira hardjo (A32) and Leptospira tarassovi (A33); Mycobacterium spp. (A34) preferably M. avium (A35) and M. intracellulare (A36); Pasteurella multocida (A37); Porcine Cytomegalovirus (A38); Porcine Parvovirus (A39); Porcine Reproductive and Respiratory Syndrome Virus (PRRS) (A40); Pseudorabies virus (A41); Rotavirus (A42); Salmonella spp. (A43), preferably S. thyphimurium (A44) and S. choleraesuis (A45); Staphylococcus spp. (A46) preferably Staph. hicus (A47); Streptococcus spp. (A48), preferably Strep. suis (A49); Porcine Herpes Virus (A50); Swine Influenza Virus (A51); Porcine Poxvirus (A52); Vesicular stomatitis virus (A53); Swine Vesicular Exanthem Virus (A54); and Mycoplasma hyosynoviae (A55). Preferably, the precursors 7 and 10 are different antigens mentioned herein pathogens, so that the inoculant 21 after mixing of the different precursors can be used for prevention of diseases caused by at least two of pathogens diseases mentioned herein .

For the production of the inoculant 21, in particular as shown in Figure 4, the adapter device 17 with an adapter element 18 can be introduced through the closing device 14 of the second receptacle 9 into its interior space. Therefore, the closing device 14 is traversed, preferably, by the adapter device 17, in particular by an adapter element 18 thereof.

In addition, in particular, as shown in FIG. 5, the connection of the second receptacle 9 and adapter device 17, in particular with another adapter element 18 of the adapter device 17, can be introduced into its interior space through the closing device 5 of the first receptacle 1. In this case it is preferred that the adapter device 17 or the adapter element 18 passes through the closure device 5 of the first receptacle 1. In this way it is possible to achieve that through the adapter device 17 a fluidic connection 20 is established between the interior spaces of the first receptacle 1 and the second receptacle 9.

For reasons of clarity, no details of the opening sectors 3, 12 of the receptacles 1, 9 or of the adapter device 17 are shown in FIGS. 4 and 5. For this, reference is made to FIGS. 1 to 3.

As shown in Figure 5, the second precursor 10 can be transferred to the first receptacle 1 by means of the adapter device 17, preferably using the gravity force and / or by compressing the second, preferably flexible, shaped receptacle 9. Alternative and / or additional procedures or procedures for transporting the second precursor 10 to the first receptacle 1 are also possible.

In another example, not shown, the adapter device 17 is first used to pierce the closing device 5 of the first receptacle 1. Then, in a second step, the second receptacle 9 is inserted into the adapter device 17 already applied to the first receptacle 1 or otherwise connected to the adapter device 17 so that a fluidic connection 20 is established between the first receptacle 1 and the second receptacle 9.

In any case, after the introduction of the adapter device 17 into a first of the receptacles 1, 9, it is preferable that that of the receptacles 1, 9 still not connected with the adapter device 17 be plugged on the vertical connection of adapter device 17 and the other of containers 1, 9. In this way, spillage of one of the precursors 7, 10 can be prevented.

One aspect of the present invention relates to the first and / or only perforation of at least one of the closing devices 5, 14 by the adapter device 17. Particularly preferably, both receptacles 1, 9 have closing devices 5, 14 that, in each case, are pierced, penetrated or perforated. In the exemplary embodiment, this is possible because the first receptacle 1 is only partially filled with the first precursor 7. Thus, advantageously, it is possible to produce the inoculant 21, in particular the combined inoculant, without working with multiple adapter devices 17 or with more than two receptacles 1, 9. This results in a simple, safe and univocal handling in which for the production of the inoculant 21 only an adapter device 17 should be used, with which they are effectively prevented confusions with other precursors and contamination with dirt or pathogenic germs.

These positive characteristics can be reinforced because the first receptacle 1, optionally with the adapter device 17, is configured to be used directly in or applied by the injection device 22, in particular with an injection gun, a needleless injector and / or a self-filling syringe (see figure 7). In this way, the first receptacle 1 can be used in or with a reusable injection device 22, preferably several times. In this way it is possible to achieve that each closing device 5, 14 is pierced or pierced for the first and only time. This allows a maximum of application security, manipulation simple and hygiene.

It can be provided that the first receptacle 1 is configured for placement in or with an injection device 22 in a sector of neck or orifice, in particular in the sector of opening 3, for connection with an injection device 22, particularly reusable multiple times The injection device 22 can have a housing 23 for the first receptacle 1. This can be provided so that the longitudinal extension and / or the diameter of the first receptacle 1 is configured for use in an injection device 22, particularly reusable several times . For example, the first receptacle 1 may have a diameter greater than 1 cm, preferably greater than 2 cm, in particular greater than 3 cm and / or less than 10 cm, preferably less than 8 cm, particularly less than 6 cm. Alternatively or additionally it is possible that the first receptacle 1 may have a longitudinal extension that is greater than 3 cm, preferably greater than 5 cm, in particular greater than 6 cm and / or less than 30 cm, preferably less than 25 cm, particularly minor that 20 cm.

As soon as the second precursor 10 has passed through the adapter device 17 to the first receptacle 1, the inoculant 21 can be formed. In this case, it is possible that the inoculant 21 is produced by mixing the precursors 7, 10, dissolving the precursors 7, 10 to each other and / or by reaction of the precursors 7, 10 or parts thereof to each other. It is preferred, as indicated by an arrow in Figure 6, that the first receptacle 1 with the precursors 7, 10 be set in motion, in particular shaken, agitated, put into rotation or the like. In this way, a homogenous and / or accelerated mixing, reaction and / or dissolution is achieved or favored.

In the exemplary embodiment, the first precursor 7 and / or the second precursor 10 present vaccines preferably in amounts greater than 30 weight percent, preferably greater than 40 weight percent, in particular greater than 50 weight percent; and / or less than 90 percent by weight, preferably less than 80 percent by weight, particularly less than 70 percent by weight. In addition, the first precursor 7, the second precursor 10 and / or the inoculant 21 thus produced may be a suspension, preferably with vaccines and / or indissoluble proteins, preferably in amounts greater than 30 weight percent, preferably greater than 40 weight percent. by weight, in particular greater than 50 weight percent; and / or less than 90 percent by weight, preferably less than 80 percent by weight, particularly less than 70 percent by weight. In this way, an effectiveness is achieved with reduced amounts of inoculant and, at the same time, a sufficiently low viscosity, which favors the applicability.

The second precursor 10 preferably has only the other components, Mycoplasma vaccine, Mycoplasma antigen and vaccine against the Circovirus vaccine or Circovirus antigen. Therefore, it is preferred that when the first precursor 7 presents the vaccine against Mycoplasma or one or more Mycoplasma antigens, the first precursor 7 does not present the vaccine against the Circovirus or the antigen of the Circovirus, however, instead , the second precursor 10 presents the vaccine against the Circovirus or one or more antigens of the Circovirus, but not the vaccine against the Mycoplasma or the Mycoplasma antigen. However, for none of the precursors 7, 10 it is possible to exclude the possibility that the corresponding precursor presents additional substances. These can be water, adjuvants, adjuvants, preservatives or the like.

In one example, the volume ratio of the first precursor 7 to the second precursor 10 is from 3: 1 to 1: 3, preferably 2: 1 to 1: 2, in particular more or less 1: 1. The first precursor 7 and / or the second precursor 10 and / or the inoculant 21 may have a viscosity that is less than 10,000 mPa-s, preferably less than 1000 mPa-s, in particular less than 500 mPa-s; and / or more than 5 mPa-s, preferably more than 10 mPa-s, in particular more than 20 mPa-s and, specifically, measured with a Brookfield viscometer according to EN ISO 2555 at 5 ° C. Preferably the first precursor 7 and / or the second precursor 10 become liquid at 2 ° C to 8 ° C and have a melting point that is less than 1 ° C, preferably less than 0 ° C, in particular less than -0.2 ° C and / or greater than -1.5 ° C, preferably greater than -1 ° C, in particular greater than -0.8 ° C.

According to another aspect of the present invention, it is preferable that the inoculant 21 has a characteristic and different color of the two precursors 7, 10. The specific color of the inoculant can arise, for example, from the mixture of precursors 7 and 10 of different coloration. For example, the mixture of a precursor 7 colored yellow with a precursor 10 colored red produces an orange coloration of the inoculant 21. It is possible that upon producing the inoculant 21 the coloring components of the precursors 7, 10 generate the characteristic color by means of of reaction or any other interactions. Alternatively or additionally it can be provided that the inoculant 21 presents, unlike at least one of the precursors 7, 10, one or no color. In this way it is possible to ensure by the characteristic color that inoculant 21 has been successfully produced. Correspondingly, it is also possible when at least one of the precursors has a color, however the inoculant 21 no longer after its production.

As already mentioned above, the vaccine against Mycoplasma can present attenuated and / or inactivated bacteria, fragments of bacteria or recombinant parts of Mycoplasma hyopneumoniae, but at least one or more antigens of Mycoplasma hyopneumoniae. Preferably, the antigen of Mycoplasma hyopneumoniae comes from strain J of Mycoplasma hyopneumoniae or inactivated Mycoplasma hyopneumoniae are bacteria of strain J. Otherwise, the vaccine against Mycoplasma can be one of the following vaccines or the Mycoplasma antigen hyopneumoniae can be the antigen (s) contained in one of the following vaccines: lngelvac® MycoFlex (Boehringer Ingelheim Vetmedica Inc., St Joseph, MO, USA), Porcilis M. hyo, Myco Silencer® BPM, Myco Silencer® BPME, Myco Silencer® ME, Myco Silencer® M, Myco Silencer® Once, Myco Silencer® MEH (all from Intervet Inc., Millsboro, USA) Stellamune Mycoplasma (Pfizer Inc., New York, NY, USA) .), Suvaxyn Mycoplasma, Suvaxyn M. hyo, Suvaxyn MH-One (all former Fort Dodge Animal Health, Overland Park, KS, USA (now Pfizer Animal Health).

The vaccine against the Circovirus may have attenuated and / or inactivated Porcine Circovirus, preferably type 2, in particular the type 2 ORF2 protein. Particularly preferred is the use of the ORF2 protein of recombinant expressed type 2 porcine circovirus, preferably expressed in and / u obtained from cell culture in vitro. Examples of porcine Circovirus type 2 ORF2 proteins are described, inter alia, in the international patent application WO2006-072065. They have turned out to be particularly advantageous for an effective vaccination. Otherwise, the vaccine against the Circovirus may be one of the following inoculants or the antigen of the Circovirus may be the antigen / s contained in one of the following vaccines: lngelvac®CrcoFLEX, (Boehringer Ingelheim Vetmedica Inc, St Joseph, MO, USA), CircoVac® (Merial SAS, Lyon, France), Circo Vent (Intervet Inc., Millsboro, DE, USA), or Suvaxyn PCV-2 One Dose® (Fort Dodge Animal Health, Kansas City, KA, USA).

The vaccine against the Circovirus, insofar as it is the ORF2 protein, preferably contains between 2 pg and 150 pg, preferably between 2 pg and 60 pg, also preferably between 2 pg and 50 pg, also preferably between 2 pg and 40 pg, more preferably between 2 pg and 30 pg, more preferably between 2 pg and 25 pg, more preferably between 2 pg and 20 pg, more preferably between 4 pg and 20 pg, more preferably between 4 pg and 16 pg of ORF2 protein per dose a manage. The vaccine against the Cyclovirus is preferably produced in such a way that 1 ml of the vaccine is equivalent to a dose of 1.

The vaccine against Mycoplasma, insofar as it contains Mycoplasma inactivated bacteria, preferably inactivated bacteria of Mycoplasma hyopneumoniae, preferably contains between 103 and 109 colony forming units (CFU), preferably between 104 and 108 (CFU), more preferably between 105 and 106 (CFU). The vaccine against Mycoplasma is produced, preferably, in such a way that 1 ml of the vaccine equals a dose of 1.

The vaccine against Mycoplasma can present attenuated and / or inactive bacteria or fragments of bacteria of the Mycoplasma strain hyopneumoniae or corresponding antigens, preferably in amounts greater than 30 percent by weight, preferably greater than 40 percent by weight, in particular greater than 50 percent by weight; and / or less than 90 percent by weight, preferably less than 80 percent by weight, particularly less than 70 percent by weight.

The vaccine against the Circovirus may preferably have porcine Circovirus, preferably type 2, attenuated and / or inactivated, in particular Porcine Circovirus type 2 ORF2 protein or corresponding antigens, preferably in amounts greater than 30 weight percent, preferably higher that 40 percent by weight, in particular greater than 50 percent by weight; and / or less than 90 percent by weight, preferably less than 80 percent by weight, particularly less than 70 percent by weight.

In addition, at least one of the precursors 7, 10 and / or the inoculant 21 can have an adjuvant, preferably polymer, in particular carbomer. Preferably, one of the two precursors, preferably both precursors, contains an adjuvant amount of 500 pg to 5 mg, preferably 750 pg to 2.5 mg, more preferably of plus or minus 1 mg per dose to be administered. The precursors are preferably produced or prepared in such a way that 1 ml of the respective precursor equals a dose of 1. Therefore, in particular, at least one of the precursors 7, 10 may have one or more adjuvants of one total amount of more than 500 g / ml, preferably greater than 750 pg / ml and / or less than 5 mg / ml, preferably less than 2.5 mg / ml.

It is also possible that at least one of the precursors 7, 10 and / or Inoculant 21 present an adjuvant in amounts greater than 0.1 weight percent, preferably greater than 1 weight percent, particularly greater than 2 weight percent; and / or less than 20 weight percent, preferably less than 10 weight percent, particularly less than 5 weight percent. It is also possible that an adjuvant, preferably polymer, in particular carbomer, is formed in the inoculant 21.

The vaccine against Mycoplasma and / or the vaccine against the Circovirus or at least one of the precursors 7, 10, and / or the inoculant 21 may present formaldehyde, preferably with a concentration of less than 2.5 mg / m3, preferably less than 1.5 mg / m3, in particular 0.74 mg / m3 or less. Alternatively or additionally, at least one of the precursors 7, 10, preferably both precursors 7, 10 may have water in a concentration of at least 20 weight percent, preferably at least 30 weight percent, in particular at least 40 weight cent in weight; and / or a maximum of 80 weight percent, preferably a maximum of 70 weight percent, in particular a maximum of 60 weight percent.

The first precursor 7, the second precursor 10 and / or the inoculant 21 may have one or more adjuvants, in particular a preservative, an antioxidant and / or an emulsifier, more preferably in each case, in a concentration of at least 0.1. percent by weight, preferably at least 0.2 percent by weight, in particular less than 0.3 percent by weight; and / or a maximum of 10 weight percent, preferably a maximum of 5 weight percent, in particular a maximum of 3 weight percent.

The preferred use of the present invention relates to the production of the inoculant 21 of two vaccines, particularly preferred to the production of an inoculant 21 for use in the immunization, preferably simultaneously, against the disease associated with the Porcine Circovirus "PCVD" and / or "EP" enzootic pneumonia or against the infection with Porcine Circovirus and / or with Mycoplasma bacteria, preferably for the use in immunization against the disease associated with Porcine Circovirus "PCVD" and "EP" enzootic pneumonia or against infection with Porcine Circovirus, in particular type 2 and with Mycoplasma bacteria, in particular Mycoplasma hyopneumoniae. In addition, the present invention relates primarily to inoculants for veterinary medicine, in particular for its application in pigs.

However, the present invention is not limited to this combination. In particular it is possible to use the kit according to the proposal also with other precursors, in particular vaccine or antigen, for example with antigens of the pathogenic germs described above. Also in this case it may be possible to achieve similar advantages, at least with respect to the simple and particularly hygienic applicability. Something similar is also valid for the aspect of the present invention in which the inoculant 21 produced has a different coloration from that of the precursors 7, 10, thereby enabling an effective, simple and effective control over the successful production of the inoculant. 21. The specific color of the inoculant may arise, for example, of the mixture of precursors 7 and 10 of different coloration. For example, the mixture of a yellow precursor 7 with a red precursor 10 produces an orange coloration of the inoculant 21. Also the applicability of the first receptacle 1 with an injection device 22 can also be successful and advantageous in other fields, in particular, similar advantages being possible with reference to improved hygiene and / or less use of materials.

Particularly preferred, however, is at least one combination of the kit according to the invention with a characteristic coloration of the inoculant 21 produced, which is different from the colors of the precursors 7, 10. This produces a manifestly high degree of safety of use. However, the various aspects of the present invention can also be combined in any other way.

List of references: 1 first receptacle 2 wall 3 opening sector 4 flange 5 closing device 6 tightening element 7 first precursor 8 gas 9 second receptacle 10 second precursor 1 1 wall 12 opening sector 13 flange 14 closing device 15 tightening element 16 gas 17 adapter device 18 adapter element fluid channel aeration device and / or inoculant ventilation injection device accommodation Living being

Claims

1. - Kit for the production of an inoculant, in particular kit for the production of an inoculant for use in immunization against the disease associated with the Porcine Circovirus "PCVD" and / or "EP" enzootic pneumonia, the kit presenting a first precursor, a second precursor different from the first, a first receptacle filled only partially with the first precursor, a second receptacle having the second precursor and, preferably, an adapter device for the creation of a fluid junction between the first and second receptacles, being less one of the receptacles closed at the factory with a closing device and the second receptacle can be connected to the first receptacle by means of the adapter device by means of a first and / or only single perforation of the closing device, in such a way that the second precursor reaches the first receptacle, and with the first precursor forms the inoculant there.

2. - Kit according to claim 1, characterized in that the first and / or second precursor is or presents a vaccine.

3. - Kit according to claims 1 or 2, characterized in that the first precursor differs from the second precursor.

4. Kit according to one of the preceding claims, characterized in that the first precursor has a first vaccine and the second precursor has a second vaccine different from the first vaccine.

5. Kit according to one of the preceding claims, characterized in that the first precursor has only one of the vaccines against Mycoplasma and the vaccine against the Circovirus, preferably in amounts greater than 30 percent by weight, preferably greater than 40 percent by weight, in particular greater than 50 percent by weight; and / or less than 90 percent by weight, preferably less than 80 percent by weight, particularly less than 70 percent by weight.

6. - Kit according to claim 5, characterized in that the second precursor has only the other component vaccine against Mycoplasma and vaccine against the Circovirus.

7. Kit according to one of the preceding claims, characterized in that the second precursor has only one of the vaccines against Mycoplasma and the vaccine against the Circovirus, preferably in amounts greater than 30 weight percent, preferably greater than 40 weight percent, in particular greater than 50 weight percent; and / or less than 90 percent by weight, preferably less than 80 percent by weight, particularly less than 70 percent by weight.

8. Kit according to one of the preceding claims, characterized in that the first precursor, the second precursor and / or the inoculant is a suspension, preferably with vaccines and / or indissoluble proteins, preferably in amounts greater than 30 weight percent, preferably greater than 40 percent by weight, in particular greater than 50 percent by weight; and / or less than 90 percent by weight, preferably less than 80 percent by weight, particularly less than 70 percent by weight.

9. Kit according to one of the preceding claims, characterized in that the volumetric ratio of the first to the second precursor is from 3: 1 to 1: 3, preferably 2: 1 to 1: 2, in particular more or less 1: 1.

10. Kit according to one of the preceding claims, characterized in that the first precursor and / or the second precursor and / or the inoculant has a viscosity that is less than 10000 mPa-s, preferably less than 1000 mPa-s, in particular less than 500 mPa-s; and / or greater than 5 mPa-s, preferably greater than 10 mPa-s, in particular greater than 20 mPa-s, measured with a Brookfield viscometer according to EN ISO 2555 at 5 ° C.

11. Kit according to one of the preceding claims, characterized in that the first precursor and / or the second precursor are liquids at 2 ° C to 8 ° C and / or have a melting point lower than 1 ° C, preferably lower than 0 ° C , in particular less than -0.2 ° C and / or greater than -1.5 ° C, preferably greater than -1.0 ° C, in particular greater than -0.8 ° C.

12. Kit according to one of the preceding claims, characterized in that the inoculant has a characteristic color and different from that of the two precursors; and / or because the inoculant, unlike at least one of the precursors, has one or no color.

13. Kit according to one of the preceding claims, characterized in that a mixture of one of the precursors with a third precursor different from the two precursors produces no color or a different color than the characteristic color for the inoculant.

14. Kit according to one of the preceding claims, characterized in that the inoculant is designed for the prevention of swine disease with Mycoplasma hyopneumoniae and / or Porcine Circovirus type 2.

15. Kit according to one of the preceding claims, characterized because the vaccine against Mycoplasma has one or more antigens of Mycoplasma hyopneumoniae, preferably in amounts greater than 30 weight percent, preferably greater than 40 weight percent, in particular greater than 50 weight percent; and / or less than 90 percent by weight, preferably less than 80 percent by weight, particularly less than 70 percent by weight.

16. Kit according to one of the preceding claims, characterized in that the vaccine against the Circovirus has one or more Porcine Circovirus antigens, preferably type 2, particularly the Porcine Circovirus type 2 ORF2 protein, preferably in amounts greater than 30 percent in weight, preferably greater than 40 weight percent, in particular greater than 50 weight percent; and / or less than 90 percent by weight, preferably less than 80 percent by weight, particularly less than 70 percent by weight.

17. Kit according to one of the preceding claims, characterized in that at least one of the precursors and / or the inoculant has an adjuvant, preferably polymer, in particular carbomer.

18 -. 18 - Kit according to claim 17, characterized in that at least one of the precursors and / or the inoculant has the adjuvant in amounts greater than 0.1 percent by weight and / or less than 20 percent by weight, preferably greater than 1 percent in weight and / or less than 10 weight percent, in particular greater than 2 weight percent and / or less than 5 weight percent.

19. Kit according to one of the preceding claims, characterized in that an adjuvant is formed in the inoculant, preferably polymer, in particular carbomer.

20. Kit according to one of the preceding claims, characterized in that the vaccine against Mycoplasma and / or the vaccine against the Circovirus contains formaldehyde with a concentration of less than 2.5 mg / m3, preferably less than 1.5 mg / m3, in particular 0.74 mg / m3 or less.

21. Kit according to one of the preceding claims, characterized in that the first precursor has water in a concentration of at least 20 percent by weight, preferably at least 30 percent by weight, in particular at least 40 percent by weight; and / or a maximum of 80 weight percent, preferably a maximum of 70 weight percent, in particular a maximum of 60 weight percent.

22. Kit according to one of the preceding claims, characterized in that the first precursor has one or more adjuvants, in particular preservatives, antioxidants and / or emulsifiers, in each case, preferably in a concentration of at least 0.1 percent by weight, preferably at least 0.2 percent by weight, in particular at least 0.3 percent by weight; and / or a maximum of 10 weight percent, preferably a maximum of 5 weight percent, in particular a maximum of 3 weight percent.

23. Kit according to one of the preceding claims, characterized in that the total volume of the first receptacle exceeds the volume of the first precursor by at least the volume of the second precursor.

24. Kit according to one of the preceding claims, characterized in that the first receptacle with the first precursor is filled in less than 70%, preferably less than 50%, in particular less 45%

25. Kit according to one of the preceding claims, characterized in that the first receptacle contains gas, preferably protective gas.

26. Kit according to claim 25, characterized in that the volume of the gas is at least equal to the volume of the second precursor in the second receptacle.

27. Kit according to claim 25 or 26, characterized in that the volume of the gas in the first receptacle exceeds the volume of the second precursor by more than 2%, preferably by more than 5%, in particular by more than 8% and / or by less than 80%. %, preferably less than 50%, in particular less than 40% or 30%.

28. Kit according to one of claims 25 to 27, characterized in that the adapter device can be configured in such a way that during transport of the second precursor to the first receptacle, the protective gas or gas of the first receptacle reaches the second receptacle, in particular in a manner transported.

29. Kit according to one of the preceding claims, characterized in that the adapter device is designed for a preferably fluid connection of the interior spaces formed by the receptacles.

30. Kit according to one of the preceding claims, characterized in that the adapter device has a fluid channel for establishing a fluid connection between the interior spaces formed by the receptacles.

31. Kit according to one of the preceding claims, characterized in that the adapter device has an aeration or ventilation device.

32. - Kit according to claim 31, characterized in that the adapter device has a channel for aeration or ventilation.

33. - Kit according to claim 30 and according to claims 31 or 32, characterized in that the aeration or ventilation device, in particular the channel for aeration or ventilation, is provided, in addition to the fluid channel of the adapter device, in particular parallel thereto.

34. - Kit according to claim 30 and one of claims 31 to 33, characterized in that an opening of the channel for aeration or ventilation is withdrawn with respect to the outlet opening of the fluid channel on the side facing the first receptacle in the direction of the main extension of the adapter device, and / or because a second one. opening of the channel for aeration or ventilation oriented to the second receptacle is arranged at the open end of the side facing the adapter device facing the side of the outlet opening of the fluid channel facing the second receptacle.

35 -. 35 - Kit according to one of claims 31 to 34, characterized in that the aeration or ventilation device is designed for the particularly fluid connection of the interior spaces formed by the receptacles

36. Kit according to one of the preceding claims, characterized in that the adapter device has two adapter elements that form a fluid channel and / or aeration or ventilation device assigned to the receptacles, preferably configured as Transfer needle, hollow needle and / or barb.

37. Kit according to claim 36, characterized in that between the adapter elements a hose or tube is arranged, in particular shaped, preferably to extend the fluid channel.

38. Kit according to one of the preceding claims, characterized in that the adapter device is configured specifically for the first receptacle and / or the second receptacle.

39. Kit according to claim 38, characterized in that at least one adapter element is configured in a mechanically specific manner for one of the receptacles.

40. Kit according to claim 38 or 39, characterized in that the incorporation into the first and / or second receptacle of other substances than the first and / or second precursor is prevented.

41. Kit according to one of the preceding claims, characterized in that the adapter device is configured to establish a connection only between the first and second receptacles, in particular excluding the ambient atmosphere.

42 -. 42. Kit according to one of the preceding claims, characterized in that the second precursor reaches the first receptacle by the force of gravity.

43. Kit according to one of the preceding claims, characterized in that at least one of the receptacles, in particular the second receptacle, is flexible deformable.

44. Kit according to one of the preceding claims, characterized in that the first receptacle, the second receptacle, the device of closure and / or connecting device are composed, at least essentially, of HDPE, EVA, halobutyl rubber type 1 and / or silicone chlorobutyl.

45. Kit according to one of the preceding claims, characterized in that the closing device has a rubber stopper or 5 composes of it.

46. Kit according to claim 45, characterized in that the rubber stopper has halobutyl rubber of type 1 or is composed at least essentially of halobutyl rubber of type 1.

47. Kit according to one of the preceding claims, characterized in that for the administration form, the first receptacle, the second receptacle as well as the adapter device form a closed component, preferably with a container in common.

48. Kit according to one of the preceding claims, characterized in that the inoculant is designed for the prevention of the porcine diseases by an infection with porcine Circovirus type 2 and / or Mycoplasma hyopneumoniae.

49. Kit according to one of the preceding claims, characterized in that the first receptacle is preferably usable multiple times in or with an injection device, in particular injection or injection gun, needleless injector and / or self-polling syringe.

50. Kit according to one of the preceding claims, characterized in that the first receptacle is connectable air-tight with a housing of the injection device for use in or with an injection device, particularly usable multiple times, in particular 5-injection gun, injector without needle and / or self-pollinating syringe.

51. Kit according to one of the preceding claims, characterized in that the first receptacle is connectable in a sector of neck or orifice, in particular by means of a closing device for connection with an injection device, particularly usable multiple times, in particular injection gun , needleless injector and / or self-refilling syringe.

52. Kit according to one of the preceding claims, characterized in that the longitudinal extension and / or the diameter of the first receptacle is designed for use in an injection device, particularly usable multiple times, in particular injection gun, needleless injector and / or self-refillable syringe.

53. Kit according to one of the preceding claims, characterized in that the first receptacle has a diameter greater than 1 cm, preferably greater than 2 cm, in particular greater than 3 cm and / or less than 10 cm, preferably less than 8 cm, particularly smaller that 6 cm.

54 -. 54 - Kit according to one of the preceding claims, characterized in that the first receptacle has a longitudinal extension that is greater than 3 cm, preferably greater than 5 cm, in particular greater than 6 cm and / or less than 30 cm, preferably less than 25 cm. cm, particularly less than 20 cm.

55 -. 55 - Use of a kit, in particular according to one of the preceding claims, for the production and / or provision of an inoculant, preferably for immunization, in particular simultaneous, against the disease associated with the Porcine Circovirus "PCVD" and / or enzootic pneumonia "EP".

56. - Use of at least two precursors for the production of an inoculant, preferably for immunization, in particular simultaneous, against the disease associated with the Porcine Circovirus "PCVD" and / or "EP" enzootic pneumonia of the pig, in which for the production of the inoculant the precursors are implanted in receptacles and with an adapter device, in particular using a kit according to one of claims 1 to 54, a first receptacle being partly filled with a first precursor and a second receptacle containing a second precursor different from the first precursor in a second receptacle having the second precursor and an adapter device configured to produce a fluid connection between the first and second receptacles, at least one of the receptacles being closed at the factory with a closing device and producing, by means of the adapter device, by means of a first and / or only single piercing of the closure device, a fluid connection between the first and second receptacle, for transferring the second precursor to the first receptacle through the adapter device and the closure device and producing the inoculant in the first receptacle.

57. - Use according to claim 56, characterized in that the adapter device is used to pierce the closing device.

58. - Use according to claims 56 or 57, characterized in that the adapter device is used to pierce closure device of both receptacles, preferably for the first time and / or only once.

59. - Use according to one of claims 56 to 58, characterized in that the adapter device is used first to perforate the closing device of the second receptacle and then the closing device of the first receptacle, preferably for the first time and / or only time.

60. - Use according to one of claims 56 to 59, characterized because the adapter device is used to manufacture in such a way a fluid connection between the receptacles so that the precursor arrives from the second receptacle to the first receptacle by the force of gravity.

61. Use according to one of claims 56 to 60, characterized in that the first receptacle is moved, during and / or after the transfer of the second precursor to the first receptacle, in order to achieve and / or accelerate a homogeneous mixture.

62. - Use according to one of claims 56 to 61, characterized in that the first receptacle is used with an injection device, particularly connected to it.

63. Use according to one of Claims 56 to 62, characterized in that the first receptacle is used in or with an injection device preferably useable multiple times, in particular injection gun, needleless injector and / or self-refilling syringe.

64. Use according to one of claims 56 to 63, characterized in that the first receptacle is designed for application in or with an injection device particularly usable multiple times, in particular injection gun, needleless injector and / or self-refilling syringe.

65. - Use according to one of claims 56 to 64, characterized in that the first receptacle is designed in a sector of neck or orifice for connection with an injection device particularly usable multiple times, in particular injection gun, needleless injector and / or self-refillable syringe.

66. - Use according to one of claims 56 to 65, characterized in that the longitudinal extension and / or the diameter of the first receptacle are designed for use in an injection device particularly usable multiple times, in particular injection gun, needleless injector and / or self-refilling syringe.

67. - Use according to one of claims 56 to 66, characterized in that the first receptacle has a diameter greater than 1 cm, preferably greater than 2 cm, in particular greater than 3 cm and / or less than 10 cm, preferably less than 8 cm, particularly less than 6 cm.

68. - Use according to one of claims 56 to 67, characterized in that the first receptacle has a longitudinal extension that is greater than 3 cm, preferably greater than 5 cm, in particular greater than 6 cm and / or less than 30 cm, preferably smaller than 25 cm, particularly less than 20 cm.

69. - Use according to one of claims 56 to 68, characterized in that the first and / or second precursor is or presents a vaccine.

70. - Use according to one of claims 56 to 69, characterized in that the first precursor differs from the second precursor.

71 -. 71 - Use according to one of claims 56 to 70, characterized in that the first precursor has a first vaccine and the second precursor has a second vaccine different from the first vaccine.

72 -. 72 - Use according to one of claims 56 to 71, characterized in that the first precursor has only one of the first vaccines against Mycoplasma and the vaccine against the Circovirus, preferably in amounts greater than 30 weight percent, preferably greater than 40 per 100 percent by weight, particularly greater than 50 percent by weight; and / or less than 90 percent by weight, preferably less than 80 percent by weight, particularly less than 70 weight percent.

73. - Use according to one of claims 56 to 72, characterized in that the second precursor has only the other component vaccine against Mycoplasma and vaccine against the Circovirus.

74. Use according to one of claims 56 to 73, characterized in that the second precursor has only one of the first vaccines against Mycoplasma and the vaccine against the Circovirus, preferably in amounts greater than 30 weight percent, preferably greater than 40 percent by weight, in particular greater than 50 weight percent; and / or less than 90 percent by weight, preferably less than 80 percent by weight, particularly less than 70 percent by weight.

75. Use according to one of claims 56 to 74, characterized in that the first precursor, the second precursor and / or the inoculant is a suspension, preferably with vaccines and / or indissoluble proteins, preferably in amounts greater than 30 weight percent, preferably greater than 40 percent by weight, in particular greater than 50 percent by weight; and / or less than 90 percent by weight, preferably less than 80 percent by weight, particularly less than 70 percent by weight.

76. Use according to one of claims 56 to 75, characterized in that the volumetric ratio of the first precursor to the second precursor is from 3: 1 to 1: 3, preferably from 2: 1 to 1: 2, in particular more or less 1: 1 .

77. - Use according to one of claims 56 to 76, characterized in that the first precursor and / or the second precursor and / or the inoculant has a viscosity that is less than 10000 mPa-s, preferably lower than 1000 mPa-s, in particular less than 500 mPa-s; and / or greater than 5 mPa-s, preferably greater than 10 mPa-s, in particular greater than 20 mPa-s, measured with a Brookfield viscometer according to EN ISO 2555 at 5 ° C.

78. - Use according to one of claims 56 to 77, characterized in that the first precursor and / or the second precursor are liquids at 2 ° C to 8 ° C; and / or have a melting point lower than 1 ° C, preferably lower than 0 ° C, in particular lower than -0.2 ° C and / or higher than -1.5 ° C, preferably higher than -1.0 ° C, particularly higher -0.8 ° C.

79. - Use according to one of claims 56 to 78, characterized in that the inoculant has a characteristic color and different from that of the two precursors; and / or because the inoculant, unlike at least one of the precursors, has one or no color.

80. Use according to one of claims 56 to 79, characterized in that a mixture of one of the precursors with a third precursor different from the two precursors does not produce any color or a different color than the characteristic color for the inoculant.

81 -. 81 - Use according to one of claims 56 to 80, characterized in that the inoculant is designed for the prevention of swine diseases by an infection with Mycoplasma hyopneumoniae and / or porcine Circovirus type 2.

82. Use according to one of claims 56 to 81, characterized in that the vaccine against Mycoplasma has one or more Mycoplasma hyopneumoniae antigens, preferably in amounts greater than 30 weight percent, preferably greater than 40 weight percent, in particular higher that 50 percent by weight; and / or less than 90 percent in weight, preferably less than 80 weight percent, particularly less than 70 weight percent.

83. Use according to one of claims 56 to 82, characterized in that the vaccine against the Circovirus has one or more Porcine Circovirus antigens, preferably type 2, particularly the Porcine Circovirus type 2 ORF2 protein, preferably in amounts greater than 30% by weight, preferably greater than 40 percent by weight, in particular greater than 50 percent by weight; and / or less than 90 percent by weight, preferably less than 80 percent by weight, particularly less than 70 percent by weight.

84. Use according to one of claims 56 to 83, characterized in that at least one of the precursors and / or the inoculant has an adjuvant, preferably polymer, in particular carbomer.

85. - Use according to claim 84, characterized in that at least one of the precursors and / or the inoculant has the adjuvant in amounts greater than 0.1 percent by weight and / or less than 20 percent by weight, preferably less than 1 percent by weight. weight and / or less than 10 weight percent, particularly greater than 2 weight percent and / or less than 5 weight percent.

86 -. 86 - Use according to one of claims 56 to 85, characterized in that an adjuvant, preferably polymer, in particular carbomer, is formed in the inoculant.

87 -. 87 - Use according to one of claims 56 to 86, characterized in that the vaccine against Mycoplasma and / or the vaccine against the Circovirus contains formaldehyde with a concentration of less than 2.5 mg / m3, preferably less than 1.5 mg / m3, in particular 0.74 mg / m3 or less.

88. Use according to one of claims 56 to 87, characterized in that the first precursor has water in a concentration of at least 20 weight percent, preferably at least 30 weight percent, in particular at least 40 weight percent; and / or a maximum of 80 weight percent, preferably a maximum of 70 weight percent, in particular a maximum of 60 weight percent.

89. Use according to one of Claims 56 to 88, characterized in that the first precursor has one or more adjuvants, in particular preservatives, antioxidants and / or emulsifiers, in each case, preferably at a concentration of at least 0.1 percent by weight, preferably at least 0.2 percent by weight, in particular at least 0.3 percent by weight; and / or a maximum of 10 weight percent, preferably a maximum of 5 weight percent, in particular a maximum of 3 weight percent.

90. - Use according to one of claims 56 to 89, characterized in that the total volume of the first receptacle exceeds the volume of the first precursor in at least the volume of the second precursor.

91 -. 91 - Use according to one of claims 56 to 90, characterized in that the first receptacle with the first precursor is filled at less than 70%, preferably less than 50%, in particular less than 45%.

92. - Use according to one of claims 56 to 91, characterized in that the first receptacle contains gas, preferably protective gas.

93 -. 93 - Use according to claim 92, characterized in that the volume of the gas is at least equal to the volume of the second precursor in the second receptacle.

94. - Use according to claims 92 or 93, characterized in that the volume of the gas in the first receptacle exceeds the volume of the second precursor by more than 2%, preferably by more than 5%, in particular by more than 8% and / or by less 80%, preferably less than 50%, in particular less than 40% or 30%.

95. - Use according to one of claims 92 to 94, characterized in that the adapter device is configured in such a way that during the transport of the second precursor to the first receptacle, the protective gas or gas of the first receptacle reaches the second receptacle, in particular transported .

96. - Use according to one of claims 56 to 95, characterized in that the adapter device is designed for a preferably fluid connection of the interior spaces formed by the receptacles.

97. - Use according to one of claims 56 to 96, characterized in that the adapter device has a fluid channel to establish a fluid connection between the interior spaces formed by the receptacles.

98. - Use according to claim 98, characterized in that the adapter device has an aeration or ventilation device.

99. - Use according to one of claims 56 to 98, characterized in that the adapter device has a channel for aeration and / or ventilation.

100. - Use according to claim 97 and claims 98 or 99, characterized in that the aeration and / or ventilation device, in particular the channel for aeration and / or ventilation, is provided additional to the fluid channel of the adapter device, in particular parallel to the same.

101. - Use according to claim 97 and claims 98 or 100, characterized in that an opening of the channel for aeration or ventilation is withdrawn with respect to the outlet opening of the fluid channel in the direction of the main extension of the adapter device.

102. - Use according to one of claims 97 to 101, characterized in that the aeration or ventilation device is designed for the particular union of fluids of the interior spaces formed by the receptacles.

103. Use according to one of claims 97 to 102, characterized in that the adapter device has two adapter elements, which form a fluid channel and / or aeration or ventilation device, assigned to the receptacles, preferably configured as transfer needle, hollow needle and / or prong.

104. - Use according to claim 103, characterized in that between the adapter elements a hose or tube is arranged, in particular shaped, preferably to extend the fluid channel.

105. - Use according to one of claims 56 to 104, characterized in that the adapter device, in particular an adapter element, is configured specifically for the first receptacle and / or the second receptacle.

106. - Use according to claims 104 or 105, characterized in that at least one adapter element is configured in a mechanically specific manner for one of the receptacles.

07. - Use according to one of claims 56 to 106, characterized in that the incorporation into the first and / or second receptacle of substances different from the first and / or second precursor.

108. - Use according to one of claims 56 to 107, characterized in that the adapter device is configured to establish a connection only between the receptacles, in particular excluding the ambient atmosphere.

109. - Use according to one of claims 56 to 108, characterized in that the second precursor reaches the first receptacle by the force of gravity.

110. - Use according to one of claims 56 to 109, characterized in that at least one of the receptacles, in particular the second receptacle, is flexible deformable.

111. - Use according to one of claims 56 to 110, characterized in that the first receptacle, the second receptacle, the closing device and / or the connecting device are composed, at least essentially, of HDPE, EVA, halobutyl rubber of type 1 and / or siliconized chlorobutyl.

12. - Use according to one of claims 56 to 11, characterized in that the closure device has a rubber stopper or consists of it.

13. Use according to claim 12, characterized in that the rubber stopper has halobutyl rubber of type 1 or is composed at least essentially of halobutyl rubber of type 1.

14. Use according to one of claims 56 to 13, characterized in that for the form of administration, the first receptacle, the second receptacle as well as the adapter device form a closed component, preferably with a container in common.

115. - Use according to one of claims 56 to 114, characterized in that the inoculant is designed for the prevention of swine diseases by infections with Porcine Circovirus type 2 and / or Mycoplasma hyopneumoniae.

116. - Process for the provision of an inoculant composed of a first precursor and a second precursor different from the first, preferably for immunization, particularly simultaneous, against the disease associated with Porcine Circovirus "PCVD" and / or "EP" enzootic pneumonia, in particular by means of a kit according to one of claims 1 to 54, in which, between a first receptacle filled only partially with the first precursor and a second receptacle presenting the second precursor, a fluid connection is produced by an adapter device. in such a way that by means of the adapter device, by means of a first and / or only single breakage and / or perforation of a factory-fitted closure device that closes at least one of the receptacles, a fluid connection is established between the first and the second receptacle, wherein the second precursor is transported to the first receptacle through the adapter device and the closure device, and wherein the inoculant is formed in the first receptacle from the first and second precursors.

117. - Method according to claim 116, characterized in that the closure device of both receptacles is perforated with the adapter device, preferably for the first time and / or only once.

118. Method according to one of claims 116 or 117, characterized in that firstly the closing device of the second receptacle and then the closing device of the first receptacle are crossed with the adapter device, preferably for the first time and / or only once, or vice versa.

119. - Method according to one of claims 116 to 118, characterized in that a fluid connection is created between the receptacles so that the second precursor accesses the second receptacle from the second receptacle by the force of gravity.

120. - Process according to one of claims 116 to 119, characterized in that the first receptacle is moved, during and / or after the transfer of the second precursor to the first receptacle, to achieve and / or accelerate a homogeneous reaction, in particular solution or mixture.

121. - Method according to one of claims 116 to 120, characterized in that the first receptacle is incorporated or applied to an injection device

122. - Method according to one of claims 116 to 121, characterized in that the first receptacle is incorporated or applied to an injection device preferably useable multiple times, in particular injection gun, needleless injector and / or self-refilling syringe.