CA2129919C - Pharmaceutical composition having antiviral and antibacterial activity and method of administration - Google Patents
Pharmaceutical composition having antiviral and antibacterial activity and method of administrationInfo
- Publication number
- CA2129919C CA2129919C CA002129919A CA2129919A CA2129919C CA 2129919 C CA2129919 C CA 2129919C CA 002129919 A CA002129919 A CA 002129919A CA 2129919 A CA2129919 A CA 2129919A CA 2129919 C CA2129919 C CA 2129919C
- Authority
- CA
- Canada
- Prior art keywords
- component
- composition
- hours
- melphalan
- chlorambucil
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
A novel pharmaceutical composition having antibacterial and antiviral activity and method of treating diseases caused by bacterial and viral patho-gens through stimulation of the immunologic system. The composition comprises selected amounts of chlorambucil, procarbazine and cyclophosphamide. Melphalan and liothyronine are primary options. Calcium may also be included as a desirable supplement. The method includes administering these components to a patient in an ordered, time-released manner.
Description
PHARMACEUTICAL COMPOSITION HAVING
ANTmRAL AND ANTIBACTERIAL ACTIVITY
AND METHOD OF ADMINISTRATION
Technic~l Field The present invention relates to a composition of matter for general immunostimulation. More particu-larly, the present invention relates to a novel composi-tion that is particularly adapted for the treatment of a variety of selected amounts of chlorambucil, procarb-azine and cyclophosphamide. Melphalan and liothyronine are principal options. Calcium may be included as a supplement.
Back~round Art A method of stimulating the body's immunologic system in response to various pathogens has been sought by researches for some time. While various pharmaceuti-cal drugs have proven effective against bacteria, ideal responses to such pathogens are wanting. Effective responses to viral infection are even less available.
Particularly, those bacterial and viral infections that manifest themselves in diseases such as pneumonia, pneumonitis, chronic purulent bronchitis, bronchiectasis, different viremias, and other diseases of bacterial or viral etiology are ideal targets for such immunostimulation.
The common strand giving strength to these various diseases is a compromised immune system. In response, and to overcome the effects of these patho--z ~ ~99 ~ 9 gens, two possible routes can be taken. The first is to introduce antibacterial and antiviral agents into the blood of the afflicted person, thereby bypassing the person's own immune system. This course has the com-bined advantages of directness and efficiency, butsuffers from negative side effects to the body of the host.
The second method is directed to stimulating the host's immunological system to fight the pathogen.
This method is desired because it minimizes the risk of side effects. This method is also preferred because it allows the host's natural processes to act against the pathogen, thereby eliminating the need to fight the toxin directly and rendering unnecessary the introduc-tion of chemical agents that may secondarily harm thebody while fighting the disease.
However, the processes involved in immuno-stimulation have not been as well-studied as agents to directly disable bacteria and viruses, and methods of stimulating the body's own defense system are not well known. Accordingly, effective immunostimulating compo-sitions do not exist for overcoming the above-noted dlseases .
S-lmm~ry Of The Invention The present invention is directed to a compo-sition of matter useful for general immunostimu-lation. More particularly, the present invention relates to a novel composition that is particularly adapted for the treatment of a variety of bacterial and viral diseases.
ANTmRAL AND ANTIBACTERIAL ACTIVITY
AND METHOD OF ADMINISTRATION
Technic~l Field The present invention relates to a composition of matter for general immunostimulation. More particu-larly, the present invention relates to a novel composi-tion that is particularly adapted for the treatment of a variety of selected amounts of chlorambucil, procarb-azine and cyclophosphamide. Melphalan and liothyronine are principal options. Calcium may be included as a supplement.
Back~round Art A method of stimulating the body's immunologic system in response to various pathogens has been sought by researches for some time. While various pharmaceuti-cal drugs have proven effective against bacteria, ideal responses to such pathogens are wanting. Effective responses to viral infection are even less available.
Particularly, those bacterial and viral infections that manifest themselves in diseases such as pneumonia, pneumonitis, chronic purulent bronchitis, bronchiectasis, different viremias, and other diseases of bacterial or viral etiology are ideal targets for such immunostimulation.
The common strand giving strength to these various diseases is a compromised immune system. In response, and to overcome the effects of these patho--z ~ ~99 ~ 9 gens, two possible routes can be taken. The first is to introduce antibacterial and antiviral agents into the blood of the afflicted person, thereby bypassing the person's own immune system. This course has the com-bined advantages of directness and efficiency, butsuffers from negative side effects to the body of the host.
The second method is directed to stimulating the host's immunological system to fight the pathogen.
This method is desired because it minimizes the risk of side effects. This method is also preferred because it allows the host's natural processes to act against the pathogen, thereby eliminating the need to fight the toxin directly and rendering unnecessary the introduc-tion of chemical agents that may secondarily harm thebody while fighting the disease.
However, the processes involved in immuno-stimulation have not been as well-studied as agents to directly disable bacteria and viruses, and methods of stimulating the body's own defense system are not well known. Accordingly, effective immunostimulating compo-sitions do not exist for overcoming the above-noted dlseases .
S-lmm~ry Of The Invention The present invention is directed to a compo-sition of matter useful for general immunostimu-lation. More particularly, the present invention relates to a novel composition that is particularly adapted for the treatment of a variety of bacterial and viral diseases.
2 ~ 2 ~ 9 ~
The immunostimulating composition of the present invention comprises a multi-component formula. The result is a pharmaceutical product that includes quantities of chlorambucil, procarbazine and cyclophosphamide. Preferably, the active components are contained in a non-homogeneous pharmaceutically acceptable matrix. Two other components, melphalan and liothyronine, are principal options. Calcium is a preferred part of the product as a supplement.
When the components are in the non-homogeneous matrix, each component is released from the matrix separately by means of a time release mechanism one by one with proper timing and according to a selected sequence.
Normally, chlorambucil, melphalan, procarbazine and cyclophosphamide are indicated as being cyto-toxic and immunosuppressing. However, the observed positive results of the composition according to the present invention contradict the conventional wisdom regarding these chemicals. In the combination according to the quantity ranges specified and in the prescription of the present invention, these chemicals have the opposite effect.
- Administration of the formula is followed by and coupled with a specific dietary and work regimen comprising, for the most part, rest. While not a vaccine in the traditional sense, the effects of the administration of the composition according to the prescribed plan appear to mimic a vaccine.
Detailed Description of the Preferred Embodiments As briefly noted, two options are principally available in fighting bacteria or viruses. The patho-gens can be attacked directly by antibacterial or antiviral drugs, or the body's immune system can be stimulated to respond by producing antibodies to attack the foreign bodies.
The present invention is directed to a pharma-ceutical composition that follows the latter course by stimulating the production and proliferation of antibod-ies from lymphocytes and other components of the immune system.
The composition of the present invention is directed to the activation of deficient immune systems to overcome difficult or poorly managed diseases. The composition of the present invention includes, as its basic ingredients, chlorambucil, procàrbazine HCL and cyclophosphamide. Melphalan and liothyronine Na are principal options and, when included, assure optimum results and hastened improvement. Calcium is a pre-ferred supplement as it provides many known advantages.
The components are known and are readily available. Particularly, chlorambucil is a nitrogen mustard derivative that is slightly soluble water and is often used in medicines. Procarbazine is well-known by oncologists as an anti-cancer drug.
Cyclophosphamide is an alkylating agent. It is also a known anti-cancer drug. Melphalan (the generic name for the hydrochloride) is also a nitrogen mustard and is similarly used in medicines. Like '-- 2129919 cyclophosphamide, melphalan is an alkylating agent.
Liothyronine is an iodothyronine hormone.
Calcium is an essential component of bones and teeth. It is provided as a optional component, although it is noted that too much of this component (beyond the amounts recommended herein) results in a compromise of the effects of the present composition.
In its preferred embodiment, the pharmaceuti-cal composition of the present invention includes the above-described components according to the following approximate ranges:
Chlorambucil - 0.1 - 1.0 mg Procarbazine HCL - 2.0 - 25.0 mg Cyclophosphamide - 2.0 - 25.0 mg Melphalan - 0.1 - 1.0 mg Liothyronine Na - 1.5 ~g - 25.0 ~g Calcium - 200.0 mg - 2000.0 mg Preferably provided in a capsule, the individ-ual components are mixed, but are provided in a matrix whereby there is no chemical interaction between them.
An inert bonding agent may be used to maintain the separation of the components.
For optimum effect, the components of the present composition are released by conventional time-release means according to a preselected schedule even though the components are combined in the capsule.
Following ingestion, the following release schedule is preferred:
Chlorambucil - within 2-4 hours after ingestion Melphalan - after 6-8 hours Procarbazine HCL - after 9-12 hours Cyclophosphamide - after 12 hours Liothyronine and calcium are released at any time after ingestion. As noted, the release of the components according to the preferred schedule is made by conventional time-release mechanisms.
The preferred dosage is one treatment per day.
If all the ingredients are provided in one capsule or tablet, then the dosage is once a day. Conversely, if, for example, chlorambucil and melphalan are provided in one capsule and procarbazine and cyclophosphamide are provided in another, one dose of each per day is the appropriate regimen. This latter procedure requires the user to take the second dose at an appropriate time interval after the first in accord with the preferred release schedule. The conventional time release mecha-nism is altered accordingly. The forms of the dosages (that is, capsule, tablet, pill) are differentiated by numerical or alphabetical markings, size or color.
This preferred dosage is administered between eight and ten days. ~mi ni stration should begin at the earliest sign of disease. During administration, alcohol, cigarettes, corticosteroids and anti-flammatory agents are avoid. Spicy foods are also avoided during the treatment period. Other antibacterial or antiviral medications may be taken concurrently unless contraindi-cated by known undesirable interactions.
After the composition of the present invention begins to stimulate the immunologic system, tolerance to alcohol improves. Results vary according to the age of the patient and the stage of the disease.
~ q ~9 ~ ~
Once properly administered, the pharmaceutical composition of the present invention typically provides the patient with three to six months' protection against infectious diseases. Unless otherwise indicated, failure of the composition to produce the desired results can be corrected by the readministration of the composition in the same dosage and according to the same schedule as set forth above. Care should be taken on subsequent administration to verify that no agents are taken that would compromise the effectiveness of the composition as noted above.
The pharmaceutical composition of the present invention embodies the unique ability to stimulate in vivo the production and proliferation of antibodies. Application of this composition either alone or in conjunction with other antibiotic or antiviral therapy appears likely to markedly reduce morbidity and mortality rates due to infectious agents and prevent complications due to chronic intractable infections.
As well known in the art, the pharmaceutical composition of the present invention may be put in commercial packages for practical use. Such commercial packages usually carry instructions or indications that the pharmaceutical composition should or can be used for the purposes disclosed in this specification.
Example As discussed, the pharmaceutical composition of the present invention includes, as its base ingredients, chlorambucil, melphalan, procarbazine HCL and cyclophosphamide.
According to the present and preferred example, the composition 2 ~ 2 9 9 ~ ~ 7a 71087-374 included 0.4 mg chlorambucil, 0.4 mg melphalan, 10.0 mg procarbazine HCL and 10.0 mg cyclophosphamide. The primary optional component liothyronine Na was provided in the amount of 10.0 ~g. Calcium was provided in the amount of 800.0 mg.
The invention thus being described, it will be obvious that the same may be varied in many ways. Such _ variations are not regarded as a departure from the spirit and scope of the invention, and all such modifi-cations are intended to be included within the scope of the following claims.
When the components are in the non-homogeneous matrix, each component is released from the matrix separately by means of a time release mechanism one by one with proper timing and according to a selected sequence.
Normally, chlorambucil, melphalan, procarbazine and cyclophosphamide are indicated as being cyto-toxic and immunosuppressing. However, the observed positive results of the composition according to the present invention contradict the conventional wisdom regarding these chemicals. In the combination according to the quantity ranges specified and in the prescription of the present invention, these chemicals have the opposite effect.
- Administration of the formula is followed by and coupled with a specific dietary and work regimen comprising, for the most part, rest. While not a vaccine in the traditional sense, the effects of the administration of the composition according to the prescribed plan appear to mimic a vaccine.
Detailed Description of the Preferred Embodiments As briefly noted, two options are principally available in fighting bacteria or viruses. The patho-gens can be attacked directly by antibacterial or antiviral drugs, or the body's immune system can be stimulated to respond by producing antibodies to attack the foreign bodies.
The present invention is directed to a pharma-ceutical composition that follows the latter course by stimulating the production and proliferation of antibod-ies from lymphocytes and other components of the immune system.
The composition of the present invention is directed to the activation of deficient immune systems to overcome difficult or poorly managed diseases. The composition of the present invention includes, as its basic ingredients, chlorambucil, procàrbazine HCL and cyclophosphamide. Melphalan and liothyronine Na are principal options and, when included, assure optimum results and hastened improvement. Calcium is a pre-ferred supplement as it provides many known advantages.
The components are known and are readily available. Particularly, chlorambucil is a nitrogen mustard derivative that is slightly soluble water and is often used in medicines. Procarbazine is well-known by oncologists as an anti-cancer drug.
Cyclophosphamide is an alkylating agent. It is also a known anti-cancer drug. Melphalan (the generic name for the hydrochloride) is also a nitrogen mustard and is similarly used in medicines. Like '-- 2129919 cyclophosphamide, melphalan is an alkylating agent.
Liothyronine is an iodothyronine hormone.
Calcium is an essential component of bones and teeth. It is provided as a optional component, although it is noted that too much of this component (beyond the amounts recommended herein) results in a compromise of the effects of the present composition.
In its preferred embodiment, the pharmaceuti-cal composition of the present invention includes the above-described components according to the following approximate ranges:
Chlorambucil - 0.1 - 1.0 mg Procarbazine HCL - 2.0 - 25.0 mg Cyclophosphamide - 2.0 - 25.0 mg Melphalan - 0.1 - 1.0 mg Liothyronine Na - 1.5 ~g - 25.0 ~g Calcium - 200.0 mg - 2000.0 mg Preferably provided in a capsule, the individ-ual components are mixed, but are provided in a matrix whereby there is no chemical interaction between them.
An inert bonding agent may be used to maintain the separation of the components.
For optimum effect, the components of the present composition are released by conventional time-release means according to a preselected schedule even though the components are combined in the capsule.
Following ingestion, the following release schedule is preferred:
Chlorambucil - within 2-4 hours after ingestion Melphalan - after 6-8 hours Procarbazine HCL - after 9-12 hours Cyclophosphamide - after 12 hours Liothyronine and calcium are released at any time after ingestion. As noted, the release of the components according to the preferred schedule is made by conventional time-release mechanisms.
The preferred dosage is one treatment per day.
If all the ingredients are provided in one capsule or tablet, then the dosage is once a day. Conversely, if, for example, chlorambucil and melphalan are provided in one capsule and procarbazine and cyclophosphamide are provided in another, one dose of each per day is the appropriate regimen. This latter procedure requires the user to take the second dose at an appropriate time interval after the first in accord with the preferred release schedule. The conventional time release mecha-nism is altered accordingly. The forms of the dosages (that is, capsule, tablet, pill) are differentiated by numerical or alphabetical markings, size or color.
This preferred dosage is administered between eight and ten days. ~mi ni stration should begin at the earliest sign of disease. During administration, alcohol, cigarettes, corticosteroids and anti-flammatory agents are avoid. Spicy foods are also avoided during the treatment period. Other antibacterial or antiviral medications may be taken concurrently unless contraindi-cated by known undesirable interactions.
After the composition of the present invention begins to stimulate the immunologic system, tolerance to alcohol improves. Results vary according to the age of the patient and the stage of the disease.
~ q ~9 ~ ~
Once properly administered, the pharmaceutical composition of the present invention typically provides the patient with three to six months' protection against infectious diseases. Unless otherwise indicated, failure of the composition to produce the desired results can be corrected by the readministration of the composition in the same dosage and according to the same schedule as set forth above. Care should be taken on subsequent administration to verify that no agents are taken that would compromise the effectiveness of the composition as noted above.
The pharmaceutical composition of the present invention embodies the unique ability to stimulate in vivo the production and proliferation of antibodies. Application of this composition either alone or in conjunction with other antibiotic or antiviral therapy appears likely to markedly reduce morbidity and mortality rates due to infectious agents and prevent complications due to chronic intractable infections.
As well known in the art, the pharmaceutical composition of the present invention may be put in commercial packages for practical use. Such commercial packages usually carry instructions or indications that the pharmaceutical composition should or can be used for the purposes disclosed in this specification.
Example As discussed, the pharmaceutical composition of the present invention includes, as its base ingredients, chlorambucil, melphalan, procarbazine HCL and cyclophosphamide.
According to the present and preferred example, the composition 2 ~ 2 9 9 ~ ~ 7a 71087-374 included 0.4 mg chlorambucil, 0.4 mg melphalan, 10.0 mg procarbazine HCL and 10.0 mg cyclophosphamide. The primary optional component liothyronine Na was provided in the amount of 10.0 ~g. Calcium was provided in the amount of 800.0 mg.
The invention thus being described, it will be obvious that the same may be varied in many ways. Such _ variations are not regarded as a departure from the spirit and scope of the invention, and all such modifi-cations are intended to be included within the scope of the following claims.
Claims (19)
1. A pharmaceutical composition which comprises:
a chlorambucil component in an amount of from about 0.1 mg to about 1.0 mg;
a procarbazine component in an amount of from about
a chlorambucil component in an amount of from about 0.1 mg to about 1.0 mg;
a procarbazine component in an amount of from about
2.0 mg to about 25.0 mg; and a cylcophosphamide component in an amount of from about 2.0 mg to about 25.0 mg.
2. The composition of claim 1 further including a melphalan component.
2. The composition of claim 1 further including a melphalan component.
3. The composition of claim 1 or 2 further including a liothyronine component.
4. The composition of claim 3 further including a calcium component.
5. The composition of claim 2 wherein the melphalan component is contained in an amount of from 0.1 mg to 1.0 mg.
6. The composition of claim 3 wherein the liothyronine component is contained in an amount of from 1.5 µg to 25.0 µg.
7. The composition of claim 4 wherein the calcium component is contained in an amount of from 200.0 mg to 2000.0 mg.
8. A pharmaceutical composition which comprises:
a chlorambucil component in the range of 0.1 mg and 1.0 mg;
a melphalan component in the range of 0.1 mg and 1.0 mg;
a procarbazine component in the range of 2.0 mg and 25.0 mg; and a cyclophosphamide component in the range of 2.0 mg and 25.0 mg.
a chlorambucil component in the range of 0.1 mg and 1.0 mg;
a melphalan component in the range of 0.1 mg and 1.0 mg;
a procarbazine component in the range of 2.0 mg and 25.0 mg; and a cyclophosphamide component in the range of 2.0 mg and 25.0 mg.
9. A pharmaceutical composition of claim 8, which comprises:
0.4 mg of chlorambucil;
0.4 mg of melphalan;
0.4 mg of chlorambucil;
0.4 mg of melphalan;
10.0 mg of procarbazine HCl; and 10.0 mg of cyclophosphamide.
10. The composition of claim 8 or 9 further including a liothyronine component in the range of 1.5 µg and 25.0 µg.
10. The composition of claim 8 or 9 further including a liothyronine component in the range of 1.5 µg and 25.0 µg.
11. The composition of claim 8 or 9 further including a calcium component in the range of 200.0 mg and 2000.0 mg.
12. The composition according to claim 1, 3, 4, 6 or 7, wherein the components are contained in a non-homogeneous pharmaceutically acceptable matrix that acts as a time-release means so that the chlorambucil component, the procarbazine component and the cyclophosphamide component are released within 2-4 hours, after 9-12 hours and after 12 hours, respectively, after ingestion of the composition.
13. The composition according to claim 2 or 5, wherein the components are contained in a non-homogeneous pharmaceutically acceptable matrix that acts as a time-release means so that the chlorambucil component, the melphalan component, the procarbazine component and the cyclophosphamide components are released within 2-4 hours, after 6-8 hours, after 9-12 hours and after 12 hours, respectively, after ingestion of the composition.
14. The composition according to claim 8, 9, 10 or 11, wherein the components are contained in a non-homogeneous pharmaceutically acceptable matrix that acts as a time-release means so that the chlorambucil component, the melphalan component, the procarbazine component and the cyclophosphamide components are released within 2-4 hours, after 6-8 hours, after 9-12 hours and after 12 hours, respectively, after ingestion of the composition.
15. The composition according to any one of claims 1 through 11, which is in the form of a capsule or tablet adapted to be administered once a day.
16. The composition according to any one of claims 12 to 14 which is in the form of a capsule or tablet adapted to be administered once a day.
17. A commercial package which contains therein the pharmaceutical composition according to any one of claims 1 through 11 and carries instructions that the composition is to be used for stimulating a person's immunological system.
18. A commercial package according to claim 17, wherein the instructions state that the composition is to be used for the treatment of bacterial or viral disease.
19. A commercial package which contains therein the pharmaceutical composition according to claim 12, 13 or 14 and carries instructions that the composition is to be used for stimulating a person's immunological system.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002129919A CA2129919C (en) | 1994-08-11 | 1994-08-11 | Pharmaceutical composition having antiviral and antibacterial activity and method of administration |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002129919A CA2129919C (en) | 1994-08-11 | 1994-08-11 | Pharmaceutical composition having antiviral and antibacterial activity and method of administration |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2129919A1 CA2129919A1 (en) | 1996-02-12 |
| CA2129919C true CA2129919C (en) | 1999-02-23 |
Family
ID=4154152
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002129919A Expired - Fee Related CA2129919C (en) | 1994-08-11 | 1994-08-11 | Pharmaceutical composition having antiviral and antibacterial activity and method of administration |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2129919C (en) |
-
1994
- 1994-08-11 CA CA002129919A patent/CA2129919C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CA2129919A1 (en) | 1996-02-12 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |