FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of darunavir in combination with ritonavir taken twice daily in 14 treatmentexperienced paediatric patients, aged 3 to < 6 years and weighing at least 15 kg to < 20 kg, showed that weight-based dosages resulted in darunavir exposure that was comparable to that achieved in adults receiving darunavir/ritonavir 600/100 mg twice daily (see section 4.2).
Croatian: Farmakokinetika darunavira u kombinaciji s ritonavirom uzetih dva puta na dan, kod 14 prethodno liječenih pedijatrijskih bolesnika u dobi 3 do < 6 godina s težinom najmanje 15 kg do < 20 kg, pokazala je da doziranje ovisno o tjelesnoj težini rezultira izloženošću darunaviru koja je usporediva s onom kod odraslih koji primaju darunavir/ritonavir od 600/100 mg dva puta na dan (vidjeti dio 4.2).
English: problems with your balance - difficulty breathing, cough, nosebleed, throat irritation - inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching - kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night
Croatian: problemi s ravnotežom - otežano disanje, kašalj, krvarenje iz nosa, nadraženost grla - upala želuca ili ustiju, žgaravica, dizanje želuca, suha usta, nelagoda u trbuhu, zatvor,
English: Co-administration with darunavir coadministered with cobicistat is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena s darunavirom istodobno primijenjenim s kobicistatom (vidjeti dio 4.4).
English: darunavir/ ritonavir 800/100 mg once daily N=294
Croatian: Darunavir/ ritonavir 800/100 mg jedanput na dan n=294
English: Concomitant use of darunavir with low dose ritonavir and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids)
Croatian: Istodobna upotreba darunavira s niskom dozom ritonavira i kortikosteroida koje metabolizira CYP3A (npr. flutikazon propionat ili ostali inhalacijski ili nazalni kortikosteroidi) može povećati opasnost od razvoja sistemskih učinaka kortikosteroida uključujući Cushingov sindrom i adrenalnu supresiju.
English: When administration of rosuvastatin and boosted darunavir is required, it is recommended to start with the lowest possible dose of rosuvastatin and titrate up to the desired clinical effect while monitoring for safety.
Croatian: Kada je potrebno primijeniti rosuvastatin i pojačani darunavir, preporučuje se početi s najnižom mogućom dozom rosuvastatina te dozu titrirati do željenog kliničkog učinka i pri tome pratiti sigurnost primjene.
English: When administration of rosuvastatin and darunavir coadministered with low dose ritonavir is required, it is recommended to start with the lowest possible dose of rosuvastatin and titrate up to the desired clinical effect while monitoring for safety.
Croatian: Kada je potrebno primijeniti rosuvastatin i darunavir primijenjen istodobno s niskom dozom ritonavira, preporučuje se početi s najnižom mogućom dozom rosuvastatina te dozu titrirati do željenog kliničkog učinka i pri tome pratiti sigurnost primjene.
English: Indinavir: comparison of indinavir/ritonavir 800/100 mg twice daily vs. indinavir/darunavir/ritonavir 800/400/100 mg twice daily.
Croatian: Indinavir: usporedba indinavir/ritonavir 800/100 mg dva puta na dan vs. indinavir/darunavir/ritonavir 800/400/100 mg dva puta na dan Darunavir: usporedba darunavir/ritonavir 400/100 mg dva puta na dan vs. darunavir/ritonavir 400/100 mg u kombinaciji s indinavirom 800 mg dva puta na dan.
English: White to off-white, oval shaped, biconvex film coated tablets approximately 16.5 mm by 8.2 mm, debossed with 'M' on one side of the tablet and 'DV3' on other side.
Croatian: Bijela do gotovo bijela, ovalna, bikonveksna filmom obložena tableta približne veličine 16,5 mm × 8,2 mm s utisnutom oznakom „M” na jednoj strani i „DV3” na drugoj strani.
English: darunavir/ ritonavir 600/100 mg twice daily N=298
Croatian: Darunavir/ ritonavir 600/100 mg dva puta na dan n=298
English: Darunavir Mylan 400 mg film-coated tablets are available blister packs containing 30 and 60 tablets and in the HDPE bottles of 60 and 100 tablets.
Croatian: Darunavir Mylan 400 mg filmom obložene tablete dostupne su u blister pakiranjima koja sadržavaju 30 i 60 tableta i plastičnim bocama koje sadržavaju 60 i 100 tableta.
English: Darunavir Mylan 800 mg film-coated tablets darunavir
Croatian: Darunavir Mylan 800 mg filmom obložene tablete darunavir
English: Name and address of the manufacturers responsible for batch release
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet Mylan Hungary Kft
English: - In the evening, take one 600 milligram darunavir tablet together with 100 milligram ritonavir.
Croatian: - Navečer uzmite jednu tabletu darunavira od 600 miligrama zajedno sa 100 miligrama ritonavira.
English: - In the morning, take one 600 milligram darunavir tablet together with 100 milligram ritonavir.
Croatian: - Ujutro uzmite jednu tabletu darunavira od 600 miligrama zajedno sa 100 miligrama ritonavira.
English: Darunavir/ ritonavir 600/100 mg twice daily N=296
Croatian: Darunavir/ ritonavir 600/100 mg dva puta na dan n=296
English: Darunavir Mylan 400 mg film-coated tablets darunavir
Croatian: Darunavir Mylan 400 mg filmom obložene tablete darunavir
English: Ciclosporin Sirolimus Tacrolimus Everolimus
Croatian: Ciklosporin Sirolimus
English: Darunavir Mylan 600 mg film-coated tablets darunavir
Croatian: Darunavir Mylan 600 mg filmom obložene tablete darunavir
English: Darunavir Mylan 600 mg film-coated tablets are white to off-white, oval shaped, with two curved sides, marked with M on one side and DV5 on the other side.
Croatian: Darunavir Mylan 600 mg filmom obložene tablete bijele su do gotovo bijele boje, ovalnog oblika s dvije zaobljene stranice i označene su s M na jednoj strani i DV5 na drugoj strani.
English: Darunavir/ritonavir 600/100 mg twice daily + OBR N=296
Croatian: Darunavir/ritonavir 600/100 mg dva puta na dan + OOR n=296
English: Boosted darunavir and didanosine can be used without dose adjustments.
Croatian: Pojačani darunavir se može primijeniti s didanozinom bez prilagodbe doze.
English: Darunavir Mylan 300 mg film-coated tablets are white to off-white, oval shaped, with two curved sides, marked with M on one side and DV3 on the other side.
Croatian: Darunavir Mylan 300 mg filmom obložene tablete bijele su do gotovo bijele boje, ovalnog oblika s dvije zaobljene stranice i označene su s M na jednoj strani i DV3 na drugoj strani.
English: When administration of pravastatin and boosted darunavir is required, it is recommended to start with the lowest possible dose of pravastatin and titrate up to the desired clinical effect while monitoring for safety.
Croatian: Kada je potrebno primijeniti pravastatin i pojačani darunavir, preporučuje se početi s najnižom mogućom dozom pravastatina te dozu titrirati do željenog kliničkog učinka i pri tome pratiti sigurnost primjene.
English: (drug) hypersensitivity immune reconstitution inflammatory syndrome
Croatian: Upalni sindrom imunološke rekonstitucije
English: Darunavir Mylan 300 mg film-coated tablets darunavir
Croatian: Darunavir Mylan 300 mg filmom obložene tablete darunavir
English: pravastatin Cmin ND pravastatin Cmax ↑ 63% an up to five-fold increase was seen in a limited subset of subjects
Croatian: ¶ kod limitirane podskupine ispitanika primijećeno je povišenje do pet puta
English: Darunavir co-administered with low dose ritonavir and raltegravir can be used without dose adjustments.
Croatian: Darunavir istodobno primijenjen s niskom dozom ritonavira i raltegravirom može se primijeniti bez prilagodbe doze.
English: Efavirenz in combination with darunavir once daily may result in sub-optimal darunavir Cmin.
Croatian: Efavirenz u kombinaciji s darunavirom može rezultirati suboptimalnom vrijednošću Cmin darunavira.
English: Darunavir Mylan 400 mg film-coated tablets are white to off-white, oval shaped with two curved sides, marked with M on one side and DV4 on the other side.
Croatian: Darunavir Mylan 400 mg filmom obložene tablete bijele su do gotovo bijele boje, ovalnog oblika s dvije zaobljene stranice i označene su s M na jednoj strani i DV4 na drugoj strani.
English: Boosted darunavir is expected to increase these β-blocker plasma concentrations.
Croatian: Očekuje se da će pojačani darunavir povećati koncentracije tih β-blokatora u plazmi. (CYP2D6 inhibicija)
English: The recommended dose regimen is 600 mg twice daily taken with ritonavir 100 mg twice daily taken with food.
Croatian: Odrasli bolesnici prethodno liječeni antiretrovirusnom terapijom (ART-om) Preporučeni režim doziranja je 600 mg dva puta na dan uz 100 mg ritonavira dva puta na dan uzeto s hranom.
English: Dose for children 3 years of age and above, weighing more than 40 kilograms who have taken antiretroviral medicines before (your child's doctor will determine this) The dose is either: - 800 milligram darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing
Croatian: Doza za djecu u dobi od 3 godine i više, težine najmanje 40 kilograma koja su prethodno uzimala antiretrovirusne lijekove (to će odrediti liječnik Vašeg djeteta) Doza može biti: - 800 miligrama darunavira (2 tablete koje sadrže 400 miligrama darunavira ili 1 tableta koja sadrži 800 miligrama darunavira) zajedno sa 100 miligrama ritonavira jedanput na dan.
English: Darunavir/ritonavir 600/100 mg twice daily + OBR N=298
Croatian: Darunavir/ritonavir 600/100 mg dva puta na dan + OOR n=298
English: 375 milligram darunavir + 50 milligram ritonavir twice a day between 30 and 40 kilograms
Croatian: Jedna doza je između 15 i 30 kilograma 375 miligrama darunavira + 50 miligrama ritonavira, dva puta na dan između 30 i 40 kilograma 450 miligrama darunavira + 60 miligrama ritonavira, dva puta na dan više od 40 kilograma*
English: 44.1%)c c
Croatian: (57; 114)c
English: If you notice within 12 hours, you must take the tablets immediately.
Croatian: Ako primijetite da niste uzeli lijek unutar 12 sati, tablete morate uzeti odmah, uvijek s kobicistatom ili ritonavirom i hranom.
English: - Take your other HIV medicines used in combination with darunavir and ritonavir as recommended by your doctor.
Croatian: - Ostale lijekove protiv HIV-a koje primjenjujete istodobno s darunavirom i ritonavirom,
English: When administration of pravastatin and darunavir co-administered with low dose ritonavir is required, it is recommended to start with the lowest possible dose of pravastatin and titrate up to the desired clinical effect while monitoring for safety.
Croatian: Kada je potrebno primijeniti pravastatin i darunavir primijenjen istodobno s niskom dozom ritonavira, preporučuje se početi s najnižom mogućom dozom pravastatina te dozu titrirati do željenog kliničkog učinka i pri tome pratiti sigurnost primjene.
English: Recommended dose for treatment-experienced paediatric patients (3 to 17 years) with darunavir tablets and ritonavir a
Croatian: Preporučena doza tableta darunavira i ritonavira a za liječenje pedijatrijskih bolesnika (3 do 17 godina) koji nisu prethodno liječeni ART-om Tjelesna težina (kg)
English: Darunavir Mylan 75 mg film-coated tablets
Croatian: Darunavir Mylan 75 mg filmom obložene tablete Filmom obložena tableta.
English: Not known rash (including macular, maculopapular, papular, erythematous, pruritic rash, generalised rash, and allergic dermatitis)
Croatian: Poremećaji kože i potkožnog tkiva vrlo često često rijetko nepoznato osip (uključujući makularni, makulopapularni, papularni, eritematozni, pruritički osip, generalizirani osip i alergijski dermatitis)
English: The combination of avanafil and boosted darunavir is contraindicated (see section 4.3).
Croatian: Kombinacija avanafila i pojačanog darunavira je kontraindicirana (vidjeti dio
English: Concomitant use of boosted darunavir with lovastatin and simvastatin is therefore contraindicated (see section
Croatian: Istodobna primjena pojačanog darunavira s lovastatinom i simvastatinom je zbog toga kontraindicirana (vidjeti dio 4.3).
English: Boosted darunavir is expected to increase these antineoplastic plasma concentrations.
Croatian: Očekuje se da će pojačani darunavir povećati koncentracije tih antineoplastika u plazmi. (CYP3A inhibicija)
English: ART-experienced paediatric patients (3 to 17 years of age and weighing at least 40 kg) In ART-experienced patients without DRV-RAMs* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Croatian: U bolesnika prethodno liječenih ART-om koji nemaju DRV RAM*, a imaju plazmatsku HIV 1 RNK < 100 000 kopija/ml i broj CD4+ stanica ≥ 100 stanica x 10
English: Hepatic impairment
Croatian: Mišićno-koštani poremećaji
English: V.J.
Croatian: ili C.
English: Darunavir/ritonavir
Croatian: na temelju objavljenih podataka s darunavirom/ritonavirom
English: You will require a different dose of darunavir which cannot be administered with these 75 milligram tablets.
Croatian: Doza za odrasle koji prije nisu uzimali antiretrovirusne lijekove (to će odrediti Vaš liječnik) Trebat ćete drugačiju dozu darunavira koja se ne može primijeniti tabletama od 75 miligrama.
English: 35 μg/1 mg once daily ethinylestradiol Cmax ↓ 32% β norethindrone AUC ↓ 14% β norethindrone Cmin ↓ 30% β norethindrone Cmax ↔ β β with darunavir/ritonavir based contraceptives are coadministered with darunavir and low dose ritonavir.
Croatian: etinilestradiol AUC ↓ 44% β etinilestradiol Cmin ↓ 62% β etinilestradiol Cmax ↓ 32% β noretindron AUC ↓ 14% β noretindron Cmin ↓ 30% β noretindron Cmax ↔ β β s darunavirom/ritonavirom
English: Darunavir co-administered with low dose ritonavir can be co
Croatian: Darunavir primijenjen istodobno s niskom dozom ritonavira može se istodobno primijeniti s antagonistima
English: problems with your balance - difficulty breathing, cough, nosebleed, throat irritation - inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching - kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night - urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema,
Croatian: podrigivanje - zatajenje bubrega, bubrežni kamenci, otežano mokrenje, često ili prekomjerno mokrenje, katkad i noću - koprivnjača, teško oticanje kože i drugih tkiva (najčešće usnica ili očiju), ekcem, prekomjerno znojenje, noćno znojenje, gubitak kose, akne, ljuskasta koža, obojenje noktiju - bolovi u mišićima, grčevi u mišićima ili slabost, bolovi u udovima, osteoporoza - usporavanje funkcije štitnjače, može se vidjeti iz rezultata krvnih pretraga - povišeni krvni tlak, navale crvenila - crvene ili suhe oči - vrućica, oticanje nogu zbog nakupljanja tekućine, opća slabost, razdražljivost, bol - simptomi infekcije, herpes simpleks - erektilna disfunkcija, povećanje dojki - teškoće sa spavanjem, pospanost, depresija, tjeskoba, abnormalni snovi, smanjeni spolni nagon.
English: Driving and using machines Do not operate machines or drive if you feel dizzy after taking darunavir.
Croatian: Ako osjetite omaglicu nakon uzimanja darunavira, nemojte upravljati strojevima i ne vozite.
English: Boosted darunavir is expected to increase these antipsychotic plasma concentrations.
Croatian: Očekuje se da će pojačani darunavir povećati koncentracije tih antipsihotika u plazmi. (CYP3A inhibicija)
English: The Summary of Product Characteristics of cobicistat or ritonavir as appropriate, must therefore be consulted prior to initiation of therapy with darunavir.
Croatian: Stoga se, prije početka terapije darunavirom, mora pročitati odgovarajući Sažetak opisa svojstava lijeka za kobicistat ili ritonavir.
English: Applicable to darunavir boosted with either ritonavir or cobicistat: - The combination product lopinavir/ritonavir (see section 4.5).
Croatian: Primjenjivo na darunavir pojačan bilo ritonavirom bilo s kobicistatom: - kombinacija lijekova lopinavir/ritonavir (vidjeti dio 4.5). - snaži CYP3A induktori, rifampicin i biljni pripravci koji sadrže gospinu travu (Hypericum perforatum).
English: Date of first authorisation: 13/04/2000 Date of last renewal: 22/03/2010
Croatian: Datum prvog odobrenja: 13/04/2000 Datum posljednje obnove: 22/03/2010
English: In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Croatian: U izuzetnim okolnostima može se javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajući simptomatski tretman.
English: first injection: from 8 weeks of age, second injection: 3 to 5 weeks later.
Croatian: prva injekcija: od 8 tjedana starosti, druga injekcija: 3 do 5 tjedna kasnije.
English: ATC vet code: QI06AD
Croatian: ATCvet kod: QI06AD
English: Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections.
Croatian: Kalijdihidrogen fosfat Dinatrij fosfat dihidrat Magnezij klorid heksahidrat Kalcij klorid dihidrat Voda za injekcije
English: EU/2/00/019/005 10 doses: 1-ml suspension (10 bottles) EU/2/00/019/006 20 doses: 1-ml suspension (20 bottles) EU/2/00/019/007 50 doses: 1-ml suspension (50 bottles)
Croatian: EU/2/00/019/005 10 doza: 1 ml suspenzije (10 bočica) EU/2/00/019/006 20 doza: 1 ml suspenzije (20 bočica) EU/2/00/019/007 50 doza: 1 ml suspenzije (50 bočica)
English: 10 x 1-ml suspension (10 doses) 20 x 1-ml suspension (20 doses) 50 x 1-ml suspension (50 doses)
Croatian: 10 x 1 ml suspenzije (10 doza) 20 x 1 ml suspenzije (20 doza) 50 x 1 ml suspenzije (50 doza)
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years Use immediately after broaching.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 2 godine Primijeniti odmah nakon otvaranja.
English: Vaccination of FeLV positive cats is of no benefit.
Croatian: Cijepljenje mačaka pozitivnih na FeLV nema korisnog učinka.
English: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST FRANCE
Croatian: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST FRANCUSKA
English: Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant or by appropriate channels approved for use by the competent authorities.
Croatian: Odlagati otpadne materijale uranjanjem u kipuću vodu, spaljivati, uranjati u prikladno dezinfekcijsko sredstvo ili odgovarajuće kanale, odobreno za upotrebu od strane nadležnog tijela.
English: It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
Croatian: Preporučuje se provesti testiranje na FeLV antigenemiju prije cijepljenja.
English: EXP (mm/yy) Use immediately after broaching
Croatian: EXP (mm/gg) Primijeniti odmah nakon otvaranja.
English: Laboratoire Lyon Gerland 254, rue Marcel Mérieux F-69007 Lyon FRANCE
Croatian: Laboratoire Lyon Gerland 254, rue Marcel Mérieux F-69007 Lyon FRANCUSKA
English: Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.
Croatian: Aktivna imunizacija mačaka starih 8 tjedana i starijih protiv leukemije mačaka za sprječavanje trajne viremije i kliničkih znakova bolesti.
English: Plastic box containing 10, 20 or 50 type I glass bottle with a Butyl elastomer closure and sealed with an aluminium cap.
Croatian: Plastična kutija koja sadrži 10, 20 ili 50 bočica vrste 1 zatvorene gumenim čepom i zapečaćene aluminijskom kapicom.
English: Duration of immunity:1 year after the last vaccination.
Croatian: Trajanje imuniteta: 1 godinu nakon posljednjeg cijepljenja.
English: The use is not recommended during lactation.
Croatian: Primjena se ne preporučuje tijekom laktacije.
English: Use immediately after broaching.
Croatian: Primijeniti odmah nakon otvaranja.
English: Keep out of the reach and sight of children.
Croatian: I POGLEDA DJECE” Čuvati izvan dosega i pogleda djece.
English: 4.2 Indications for use,specifying the target species
Croatian: 4.2 Indikacije za primjenu, navesti ciljne vrste životinja
English: Do not mix with any other vaccine or immunological product except Merial non-adjuvanted vaccine range.
Croatian: Ne miješati s drugim cjepivima ili imunološkim proizvodima osim s paletom neadjuviranih cjepiva tvrtke Merial.
English: annual
Croatian: godišnje
English: Purevax FeLV suspension for injection
Croatian: Purevax FeLV suspenzija za injekcije
English: A temporary small (< 2 cm) nodule may appear at the site of injection which regresses within 1 to 4 weeks
Croatian: Privremeni mali (< 2 cm) čvorić se može pojaviti na mjestu injiciranja koji se povlači tijekom 1 do 4
English: The vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A.
Croatian: Soj cjepiva je rekombinant virusa boginja kanarinca koji izražava env i gag gene virusa FeLV-A.
English: Transient lethargy and hyperthermia may occur for 1 day, exceptionally 2 days.
Croatian: Može se javiti prolazna letargija i hipertermija koja traje 1, iznimno 2 dana.
English: Store and transport refrigerated (2°C - 8°C), Protect from light.
Croatian: Čuvati i prevoziti rashlađeno (2 C - 8 C),
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog samo-injiciranja, odmah potražiti pomoć liječnika i pokazati mu uputu o VMP
English: No undesirable effect has been observed after the administration of several doses except those mentioned in the “Adverse reactions” section.
Croatian: Nisu primijećene nikakve druge nuspojave osim onih spomenutih u odjeljku “Nuspojave” nakon primjene nekoliko doza.
English: As a consequence, the vaccine induces an immune status against feline leukaemia virus.
Croatian: Posljedica toga je da cjepivo inducira aktivni imunitet na virus leukemije mačaka.
English: Plastic box containing 10, 20 or 50 bottles Not all pack sizes may be marketed.
Croatian: Plastična kutija koja sadrži 10, 20 ili 50 bočica
English: Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Croatian: Nositelj odobrenja za stavljanje u promet Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Administer one dose of 1ml according to the following schedule: Basic vaccination:
Croatian: Injicirajte jednu dozu 1ml cjepiva u skladu sa slijedećim rasporedom cijepljenja:
English: FeLV recombinant Canarypox virus (vCP97) ........ ≥ 10 7.2 CCID50
Croatian: FeLV rekombinantni virus boginja kanarinca (vCP97) ≥ 10 7.2 CCID50
English: Potassium chloride Sodium chloride
Croatian: Kalij klorid
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE {NATURE/TYPE}
Croatian: PODACI NA VANJSKOM PAKOVANJU {OSOBINE/TIP}
English: Manufacturing authorisation holder responsible for batch release MERIAL
Croatian: Nositelj odobrenja za proizvodnju odgovoran za puštanje proizvodne serije MERIAL
English: Onset of immunity:2 weeks after primary vaccination course.
Croatian: Početak imuniteta: 2 tjedna nakon prvog cijepljenja.
English: FeLV recombinant Canarypox virus (vCP97) ........ ≥ 10 7.2 CCID50 (cell culture infective dose 50%)
Croatian: FeLV rekombinantni virus boginja kanarinca (vCP97) ≥ 10 7.2 CCID50 (količina virusa koja zarazi 50 % stanica kulture u koju je dodan virus)
English: Revaccination:
Croatian: Docjepljivanje:
English: Subcutaneous use
Croatian: Subkutana primjena
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Croatian: UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U