HRP20200073T1 - Vrećica za sterilne otopine - Google Patents

Vrećica za sterilne otopine Download PDF

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Publication number
HRP20200073T1
HRP20200073T1 HRP20200073TT HRP20200073T HRP20200073T1 HR P20200073 T1 HRP20200073 T1 HR P20200073T1 HR P20200073T T HRP20200073T T HR P20200073TT HR P20200073 T HRP20200073 T HR P20200073T HR P20200073 T1 HRP20200073 T1 HR P20200073T1
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Croatia
Prior art keywords
bag
filter
approximately
sterile solutions
bladders
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HRP20200073TT
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English (en)
Inventor
Grant Anthony BOMGAARS
Bernd Krause
Mark Edward Pasmore
Michael Joseph Sadowski
Yuanpang Samuel Ding
Ying-Cheng Lo
Joseph Vincent Ranalletta
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Baxter International Inc
Baxter Healthcare Sa
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Application filed by Baxter International Inc, Baxter Healthcare Sa filed Critical Baxter International Inc
Publication of HRP20200073T1 publication Critical patent/HRP20200073T1/hr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1443—Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters
    • A61J1/1456—Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters using liquid filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/0209—Multiple bag systems for separating or storing blood components
    • A61M1/0218—Multiple bag systems for separating or storing blood components with filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/105—Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/24—Dialysis ; Membrane extraction
    • B01D61/243—Dialysis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • B01D63/02—Hollow fibre modules
    • B01D63/024—Hollow fibre modules with a single potted end
    • B01D63/0241—Hollow fibre modules with a single potted end being U-shaped
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    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • B01D63/02—Hollow fibre modules
    • B01D63/033—Specific distribution of fibres within one potting or tube-sheet
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
    • B01D69/08—Hollow fibre membranes
    • B01D69/081—Hollow fibre membranes characterised by the fibre diameter
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/26—Polyalkenes
    • B01D71/261—Polyethylene
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/40—Polymers of unsaturated acids or derivatives thereof, e.g. salts, amides, imides, nitriles, anhydrides, esters
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/40—Polymers of unsaturated acids or derivatives thereof, e.g. salts, amides, imides, nitriles, anhydrides, esters
    • B01D71/401—Polymers based on the polymerisation of acrylic acid, e.g. polyacrylate
    • B01D71/4011—Polymethylmethacrylate
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/40—Polymers of unsaturated acids or derivatives thereof, e.g. salts, amides, imides, nitriles, anhydrides, esters
    • B01D71/42—Polymers of nitriles, e.g. polyacrylonitrile
    • B01D71/421—Polyacrylonitrile
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/44—Polymers obtained by reactions only involving carbon-to-carbon unsaturated bonds, not provided for in a single one of groups B01D71/26-B01D71/42
    • B01D71/441—Polyvinylpyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1066—Tube connectors; Tube couplings having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2319/00—Membrane assemblies within one housing
    • B01D2319/04—Elements in parallel
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2325/00—Details relating to properties of membranes
    • B01D2325/18—Membrane materials having mixed charged functional groups
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B01D—SEPARATION
    • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02—Hollow fibre modules
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02—Hollow fibre modules
    • B01D63/025—Bobbin units
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
    • B01D69/02—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
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    • B01D71/06—Organic material
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/30—Polyalkenyl halides
    • B01D71/32—Polyalkenyl halides containing fluorine atoms
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    • B01D71/66—Polymers having sulfur in the main chain, with or without nitrogen, oxygen or carbon only
    • B01D71/68—Polysulfones; Polyethersulfones

Claims (15)

1. Vrećica za sterilne otopine (150) koja sadržava: mjehur (152); držak (156) ima ulazni i izlazni kraj, izlazni kraj drška (156) povezan s mjehurom tako da omogućuje protok tekućine (152); i filtar (155) smješten uzdužno s drškom (156), pri čemu filtar ima membranu filtra (170) s nominalnom veličinom pora u rasponu od približno 0,1 mm do približno 0,5 mm, pri čemu je membrana filtra oblikovana kao šuplje vlakno s porama koje se nalaze u stijenci vlakana, naznačena time, da se vrećica za sterilne otopine odlikuje time da je izlazni kraj (158) šupljeg vlakna membrane filtra (170) zatvoren, a ulazni kraj otvoren (160).
2. Vrećica za sterilne otopine (150) u skladu s patentnim zahtjevom 1, naznačena time, da je membrana filtra (170) smještena unutar drška (156) između ulaznog i izlaznog kraja.
3. Vrećica za sterilne otopine (150) u skladu s bilo kojim od patentnih zahtjeva 1 ili 2, naznačena time, da filter (155) sadrži mnoštvo filtarskih membrana (422, 502).
4. Vrećica za sterilne otopine (150) u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačena time, da membrana filtra (170) ima debljinu stijenke u rasponu od približno 150 mm do otprilike 500 mm.
5. Vrećica za sterilne otopine (150) u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačena time, da je uzdužna dimenzija membrana filtra (170) u rasponu od približno 3 cm do oko 20 cm, unutarnji promjer u rasponu od približno 2 mm do približno 4 mm, a vanjski promjer u rasponu od približno 2,3 mm do otprilike 5 mm.
6. Vrećica za sterilne otopine (150) u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačena time, da je membrana filtra (170) izrađena od najmanje jednog od sljedećih materijala: poliolefina, polivinililiden fluorida, polimetilmetakrilata, poliakrilonitrila, polisulfona, polietersulfona i polimera koji sadrži kationski naboj.
7. Vrećica za sterilne otopine (150) u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačena time, da je držak (156) fleksibilan ili kruti držak.
8. Vrećica za sterilne otopine (150) u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačena time, da je držak (156) izrađen od najmanje jednog od sljedećih materijala: PVC, PET, poli(met)akrilat, polikarbonat, poliolefin, cikloolefinski kopolimer, polistiren ili silikonski polimer.
9. Vrećica za sterilne otopine (150) u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačene time, da filter (155) sadrži barem jednu filtarsku membranu (402) od šupljih vlakana u obliku slova U, učvršćenu u obliku slova U u kućištu membrane filtra (406), koja se nalazi tijelu filtra (404).
10. Vrećica za sterilne otopine (150) u skladu s patentnim zahtjevom 9, naznačena time, da filtar (155) sadržava mnoštvo filtarskih membrana od šupljih vlakana (402) u obliku slova U.
11. Vrećica za sterilne otopine (150) u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačena time, da filtar (155) sadržava mnoštvo paralelnih filtarskih membrana od šupljih vlakana (502) postavljenih u paralelnu konfiguraciju.
12. Vrećica za sterilne otopine (150) u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačena time, da filtar (155) sadržava mnoštvo paralelnih membranskih filtera od šupljih vlakana (502) postavljenih u kružnu konfiguraciju.
13. Vrećica za sterilne otopine (150) u skladu s bilo kojim od prethodnih patentnih zahtjeva , naznačena time, da membrana filtra (170) ima nazivnu veličinu pora u rasponu od približno 0,1 mm do približno 0,22 mm.
14. Vrećica za sterilne otopine (150) u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačena time, da sadržava mnoštvo mjehura (202a, 202b, 202c) koji su izravno međusobno povezani tako da kroz njih prolazi tekućina, a držak(156) i filtar (155) spojeni su s mnoštvom mjehura (202a, 202b, 202c) radi punjenja vrećice proizvodom (150), pri čemu je svaki mjehur (202a, 202b, 202c) na kraju povezan barem s jednim drugim mjehurom (202a, 202b, 202c) (206a, 206b) između mjehura (202a, 202b, 202c) i svakog kraja (206a, 206b) nalazi se otvor (208a, 208b) koji omogućuje prolazak tekućine među mjehurima (202a, 202b, 202c) i gdje je jednostruki filter (206) povezan s jednim mjehurima (202a, 202b, 202c) s pomoću ulaznog dijela.
15. Vrećica za sterilne otopine (150) u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačena time, da sadržava mnoštvo mjehura (316) koji su međusobno povezani brtvenim cijevima (302) tako da je omogućen prolaz tekućine, držak (302) i filtar ( 304) spojeni su s mnoštvom mjehura (316) za punjenje vrećice proizvodom (150), pri čemu se brtvene cijevi sastoji od prvog dijela (306) koji se proteže do spoja (308) i mnoštva drugih dijelova (310) koji se protežu od spoja (308) do mnoštva mjehura (316), pri čemu se svaki drugi dio (310) proteže do jednog mjehura (316).
HRP20200073TT 2016-01-22 2020-01-17 Vrećica za sterilne otopine HRP20200073T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662281799P 2016-01-22 2016-01-22
PCT/US2017/014253 WO2017127625A1 (en) 2016-01-22 2017-01-20 Sterile solutions product bag
EP17703550.8A EP3405161B1 (en) 2016-01-22 2017-01-20 Sterile solutions product bag

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HRP20200073T1 true HRP20200073T1 (hr) 2020-04-03

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US (2) US10617603B2 (hr)
EP (2) EP3405161B1 (hr)
JP (2) JP6637606B2 (hr)
KR (1) KR101964576B1 (hr)
CN (1) CN108495610B (hr)
AU (2) AU2017210313B2 (hr)
BR (1) BR112018013901B1 (hr)
CA (1) CA3011511C (hr)
CO (1) CO2018006818A2 (hr)
DE (1) DE112017000470T5 (hr)
DK (1) DK3405161T3 (hr)
ES (1) ES2767743T3 (hr)
GB (1) GB2562959A (hr)
HR (1) HRP20200073T1 (hr)
HU (1) HUE047651T2 (hr)
IL (1) IL260097B (hr)
MX (1) MX2018008877A (hr)
MY (1) MY191758A (hr)
NZ (1) NZ743293A (hr)
PH (2) PH12018501561B1 (hr)
PL (1) PL3405161T3 (hr)
PT (1) PT3405161T (hr)
RU (1) RU2732111C2 (hr)
SI (1) SI3405161T1 (hr)
TR (1) TR201809267T2 (hr)
WO (1) WO2017127625A1 (hr)

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