FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/2/99/014/003 (30 mg - 3 pipettes) EU/2/99/014/007 (30 mg - 6 pipettes) EU/2/99/014/004 (60 mg - 3 pipettes) EU/2/99/014/009 (60 mg - 6 pipettes) EU/2/99/014/005 (120 mg - 3 pipettes) EU/2/99/014/010 (120 mg - 6 pipettes) EU/2/99/014/006 (240 mg - 3 pipettes) EU/2/99/014/011 (240 mg - 6 pipettes) EU/2/99/014/015 (360 mg - 3 pipettes) EU/2/99/014/016 (360 mg - 6 pipettes)
Croatian: EU/2/99/014/007 (30 mg - 6 pipeta) EU/2/99/014/004 (60 mg - 3 pipete) EU/2/99/014/009 (60 mg - 6 pipeta) EU/2/99/014/005 (120 mg - 3 pipete) EU/2/99/014/010 (120 mg - 6 pipeta) EU/2/99/014/006 (240 mg - 3 pipete) EU/2/99/014/011 (240 mg - 6 pipeta) EU/2/99/014/015 (360 mg - 3 pipete) EU/2/99/014/016 (360 mg - 6 pipete)
English: For the prevention of flea infestations, the veterinary medicinal product should be administered at monthly intervals throughout the flea season, starting one month before fleas become active.
Croatian: Za prevenciju infestacije buhama veterinarsko-medicinski proizvod treba primjenjivati u mjesečnim intervalima za vrijeme sezone buha, počevši mjesec dana prije nego što buhe postanu aktivne.
English: Stronghold is available in packs of three pipettes (all pipette sizes), six pipettes (all pipette sizes except 15 mg selamectin), or fifteen pipettes (15 mg selamectin pipette size only).
Croatian: Stronghold je dostupan u pakovanjima od tri pipete (sve veličine pipeta), šest pipeta (sve veličine pipeta osim 15 mg selamektina) ili petnaest pipeta (samo veličina pipete od 15 mg selamektina).
English: When concurrent infestations or infections in the same animal are to be treated with the veterinary medicinal product, only one application of the recommended 6 mg/kg dose should be administered at any one time.
Croatian: Ukoliko treba tretirati više istovremenih infestacija ili invazija kod iste životinje ovim veterinarsko-medicinskim proizvodom, treba samo jednom primijeniti preporučenu dozu od 6 mg/kg u isto vrijeme.
English: For use as part of a treatment strategy for flea allergy dermatitis the veterinary medicinal product should be administered at monthly intervals.
Croatian: Ako se primjenjuje kao dio strategije liječenja alergijskog dermatitisa uzrokovanog buhama, veterinarsko-medicinski proizvod treba primjenjivati u mjesečnim intervalima.
English: Store in the unopened foil package in a dry place.
Croatian: Čuvati u originalnom pakovanju, na suhom mjestu.
English: In extensive field testing no interactions between Stronghold and routinely used veterinary medicinal products or medical or surgical procedures were observed.
Croatian: U opsežnom terenskom ispitivanju nisu uočene interakcije između Strongholda i veterinarskomedicinskih proizvoda koji se uobičajeno koriste te medicinskih ili kirurških postupaka.
English: Medicines should not be disposed of via wastewater.
Croatian: Veterinarsko-medicinski proizvodi se ne smiju odlagati u otpadne vode ili kućni otpad.
English: Each single-dose (pipette) delivers: Stronghold 15 mg for cats and dogs
Croatian: Svaka pojedinačna doza (pipeta) sadrži: Stronghold 15 mg za mačke i pse
English: EU/2/99/014/002 (3 pipettes) EU/2/99/014/008 (6 pipettes) EU/2/99/014/013 (3 pipettes) EU/2/99/014/014 (6 pipettes)
Croatian: EU/2/99/014/002 (3 pipete) EU/2/99/014/008 (6 pipeta) EU/2/99/014/013 (3 pipete) EU/2/99/014/014 (6 pipete)
English: However, shampooing or soaking the animal 2 or more hours after treatment will not reduce the efficacy of the veterinary medicinal product.
Croatian: Međutim, šamponiranje ili namakanje životinje najmanje 2 sata nakon primjene terapije neće smanjiti djelotvornost veterinarsko-medicinskog proizvoda.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Butilhidroksitoluen
English: 3 pipettes 6 pipettes
Croatian: 6 pipeta
English: Treatment of biting lice infestations (Trichodectes canis) Treatment of sarcoptic mange (caused by Sarcoptes scabiei) Treatment of adult intestinal roundworms (Toxocara canis).
Croatian: Liječenje infestacije paušima (Trichodectes canis) Liječenje sarkoptoze-šuge (uzrokovane Sarcoptes scabiei) Liječenje invazije odraslim intestinalnim nematodima (Toxocara canis).
English: 0.75 ml 1.0 ml
Croatian: 6 pipeta 0,75 ml 1,0 ml
English: This is as a result of the adulticidal, larvicidal and ovicidal properties of the veterinary medicinal product.
Croatian: To je rezultat adulticidnog, larvicidnog i ovicidnog djelovanja veterinarsko-medicinskog proizvoda.
English: Following administration of the veterinary medicinal product to the animal, adult fleas and larvae are killed and no viable eggs are produced.
Croatian: Nakon primjene veterinarsko-medicinskog proizvoda na životinji odrasle buhe i larve ugibaju i ne proizvode se larve sposobne za život.
English: When replacing another heartworm preventive veterinary medicinal product in a heartworm disease prevention programme, the first dose of the veterinary medicinal product must be given within a month of the last dose of the former medication.
Croatian: U slučaju zamjene nekim drugim veterinarsko-medicinskim proizvodom za prevenciju bolesti srčanog crva u okviru programa prevencije te bolesti, prva doza veterinarsko-medicinskog proizvoda mora se dati unutar mjesec dana od posljednje doze prethodnog lijeka.
English: • Treatment of sarcoptic mange (caused by Sarcoptes scabiei)
Croatian: • Liječenje sarkoptoze-šuge (uzrokovane sa S. scabiei)
English: Cats and dogs weighing 2.5 kg or less
Croatian: CILJNE VRSTA ŽIVOTINJA Mačke i psi tjelesne mase 2,5 kg ili manje
English: Holding the pipette upright, firmly depress the cap to puncture the applicator seal, then remove the cap
Croatian: Držeći pipetu uspravno, čvrsto pritisnite zatvarač da biste probušili pečat aplikatora, a zatim uklonite zatvarač
English: The veterinary medicinal product was also administered at 3 times the recommended dose to breeding male and female cats and dogs, including pregnant and lactating females nursing their litters and at 5 times the recommended dose to ivermectin-sensitive Collies, and no undesirable effects were observed.
Croatian: Veterinarsko-medicinski proizvod je također primijenjen u trostrukoj preporučenoj dozi u rasplodnih mužjaka i ženki mačaka i pasa, uključujući skotne ženke i ženke u laktaciji, te u peterostrukoj preporučenoj dozi u škotskih ovčara koji su osjetljivi na ivermektin, a štetne reakcije nisu uočene.
English: For complete elimination of the mites, a single dose of the veterinary medicinal product should be administered for two consecutive months.
Croatian: Za potpunu eliminaciju šugaraca propisanu dozu veterinarsko-medicinskog proizvoda treba primijeniti dva mjeseca uzastopce.
English: Treatment of ear mites (Otodectes cynotis).
Croatian: Liječenje ušne šuge (Otodectes cynotis).
English: selamectin 30 mg selamectin 60 mg selamectin 120 mg selamectin 240 mg selamectin 360 mg
Croatian: selamektin 30 mg selamektin 60 mg selamektin 120 mg selamektin 240 mg selamektin 360 mg
English: for one month following a single administration.
Croatian: tjedna nakon primjene.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON LABEL, 45 mg, 60 mg (3 and 6 pipettes)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KARTONSKA ETIKETA, 45 mg, 60 mg (3 i 6 pipeta)
English: A single dose of the veterinary medicinal product should be administered.
Croatian: Treba jednokratno primijeniti preporučenu dozu veterinarsko-medicinskog proizvoda.
English: For the full list of excipients, see section 6.1.
Croatian: Butilhidroksitoluen 0,08 % Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: Part the hair at the base of your animal's neck in front of the shoulder blades to expose a small area of skin
Croatian: Razmaknite dlaku pri bazi vrata ispred lopatica životinje da se vidi koža
English: • Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.
Croatian: • Prevencija bolesti srčanog crva uzrokovane Dirofilaria immitis primjenom jedanput mjesečno.
English: Apply to the skin at the base of the neck in front of the shoulder blades.
Croatian: Primijeniti na kožu u bazu vrata ispred lopatica.
English: Cats (kg) Pipette cap colour mg of selamectin dispensed
Croatian: Boja zatvarača pipete mg doziranog selamektina
English: The veterinary medicinal product was administered at 3 times the recommended dose to cats and dogs infected with adult heartworms and no undesirable effects were observed.
Croatian: Veterinarskomedicinski proizvod je primijenjen u trostrukoj preporučenoj dozi u mačaka i pasa koji su invadirani odraslim srčanim dirofilarijama bez opažanja štetnih reakcija.
English: Part the hair at the base of your animal's neck in front of the shoulder blades to expose a small area of skin.
Croatian: Razmaknite dlaku pri bazi vrata ispred lopatica životinje da se vidi koža.
English: Treatment of sarcoptic mange (dogs)
Croatian: Liječenje sarkoptes-šuge (kod pasa)
English: EU/2/99/014/001 (3 pipettes) EU/2/99/014/012 (15 pipettes)
Croatian: EU/2/99/014/012 (15 pipeta)
English: selamectin 45 mg selamectin 60 mg
Croatian: SASTAV DJELATNIH TVARI selamektin 45 mg selamektin 60 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON LABEL, 30 mg, 60 mg, 120 mg, 240 mg, 360 mg (3 and 6 pipettes)
Croatian: KARTONSKA ETIKETA, 30 mg, 60 mg, 120 mg, 240 mg, 360 mg (3 i 6 pipeta)
English: • Treatment of ear mites (Otodectes cynotis).
Croatian: • Liječenje infestacije ušnim šugaracem (Otodectes cynotis).
English: This stops flea reproduction, breaks the flea lifecycle and may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Croatian: To zaustavlja reprodukciju buha, prekida njihov životni ciklus i može pomoći u kontroli postojećih infestacija buhama iz okoliša u područjima u koja životinja ima pristup.
English: Stronghold 15 mg for cats and dogs
Croatian: Stronghold 15 mg za mačke i pse
English: This ensures that fleas infesting the animal are killed, no viable flea eggs are produced by these fleas, and larvae (found only in the environment) are also killed.
Croatian: Time se osigurava ugibanje buha kojima je životinja infestirana, osigurava se da te buhe ne proizvode jajašca sposobna za život, a ugibaju i larve (pronađene samo u okolišu).
English: Do not use in cats that are suffering from concomitant disease, or are debilitated and underweight (for size and age).
Croatian: Ne primjenjivati u bolesnih, slabih i neuhranjenih (primjereno pasmini i dobi) mačaka i mačaka koje pate od popratnih bolesti.
English: Stronghold 45 mg for cats
Croatian: Stronghold 45 mg za mačke
English: Pipettes with rose caps contain 0.25 ml of 6% w/v solution and deliver 15 mg of selamectin Pipettes with blue caps contain 0.75 ml of 6% w/v solution and deliver 45 mg of selamectin Pipettes with taupe caps contain 1.0 ml of 6% w/v solution and deliver 60 mg of selamectin Pipettes with violet caps contain 0.25 ml of 12% w/v solution and deliver 30 mg of selamectin Pipettes with brown caps contain 0.5 ml of 12% w/v solution and deliver 60 mg of selamectin Pipettes with red caps contain 1.0 ml of 12% w/v solution and deliver 120 mg of selamectin Pipettes with green caps contain 2.0 ml of 12% w/v solution and deliver 240 mg of selamectin Pipettes with plum caps contain 3.0 ml of 12% w/v solution and deliver 360 mg of selamectin.
Croatian: Pipete s ružičastim zatvaračem sadrže 0,25 ml 6 % w/v otopine i primjenjuju 15 mg selamektina Pipete s plavim zatvaračem sadrže 0,75 ml 6 % w/v otopine i primjenjuju 45 mg selamektina Pipete sa zatvaračem „taupe“ boje (mješavina sivkaste i smećkaste, u hrvatskom jeziku nema točnog prijevoda ovog izraza) sadrže 1,0 ml 6% w/v otopine i primjenjuju 60 mg selamektina Pipete s ljubičastim zatvaračem sadrže 0,25 ml 12% w/v otopine i primjenjuju 30 mg selamektina Pipete sa smeđim zatvaračem sadrže 0,5 ml 12% w/v otopine i primjenjuju 60 mg selamektina Pipete s crvenim zatvaračem sadrže 1,0 ml 12% w/v otopine i primjenjuju 120 mg selamektina Pipete sa zelenim zatvaračem sadrže 2,0 ml 12% w/v otopine i primjenjuju 240 mg selamektina Pipete sa zatvaračem boje šljive sadrže 3,0 ml 12% w/v otopine i primjenjuju 360 mg selamektina
English: How to apply: Remove the Stronghold pipette from its protective package
Croatian: Izvadite pipetu Strongholda iz zaštitnog pakovanja
English: • Treatment of adult roundworms (Toxocara cati)
Croatian: • Liječenje odraslih crijevnih oblica (Toxocara cati)
English: • Treatment of biting lice infestations (Trichodectes canis)
Croatian: • Liječenje infestacije paušima (Trichodectes canis)
English: Other information
Croatian: 15. OSTALE INFORMACIJE
English: Following administration of the veterinary medicinal product, the adult fleas on the animal are killed, no viable eggs are produced, and larvae (found only in the environment) are also killed.
Croatian: Nakon primjene veterinarsko-medicinskog proizvoda odrasle buhe na životinji ugibaju, ne proizvode jajašca koja su sposobna za život, a ugibaju i larve (koje se nalaze samo u okolišu).
English: This stops flea reproduction and may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Croatian: To zaustavlja reprodukciju buha i može pomoći u kontroli postojećih infestacija buhama u okolišu životinja.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: Način i put(evi) primjene:
English: Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.
Croatian: Prevencija invazije srčanim crvom uzrokovane Dirofilarijom immitis primjenom jedanput mjesečno.
English: • Treatment of adult intestinal hookworms (Ancylostoma tubaeforme).
Croatian: • Liječenje invazija odraslim crijevnim oblićima (Ancylostoma tubaeform).
English: selamectin 15 mg
Croatian: SASTAV DJELATNIH TVARI selamektin 15 mg
English: Stronghold 60 mg for cats
Croatian: Stronghold 60 mg za mačke
English: Stronghold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg selamectin
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Stronghold 15 mg otopina za nakapavanje na kožu za mačke i pse ≤ 2,5 kg selamektin
English: Flea treatment and prevention (cats and dogs)
Croatian: Terapija protiv buha i prevencija buha (u mačaka i pasa)
English: 12% w/v solution selamectin 120 mg
Croatian: 12 % w/v otopina selamektin 120 mg
English: Treatment of biting lice infestations (Felicola subrostratus) Treatment of adult roundworms (Toxocara cati) Treatment of adult intestinal hookworms (Ancylostoma tubaeforme).
Croatian: Liječenje invazije intestinalnim nematodima (Toxocara cati) Liječenje invazije odraslim intestinalnim ankilostomima (Ancylostoma tubaeforme).
English: Stronghold 240 mg for dogs
Croatian: Stronghold 240 mg za pse
English: 12% w/v solution selamectin 240 mg
Croatian: 12 % w/v otopina selamektin 240 mg
English: Prevention of heartworm disease (cats and dogs)
Croatian: Prevencija bolesti dilofilarioze (u mačaka i pasa)
English: Stronghold 360 mg for dogs
Croatian: Stronghold 360 mg za pse
English: Stronghold 45 mg spot-on solution for cats 2.6-7.5 kg Stronghold 60 mg spot-on solution for cats 7.6-10.0 kg selamectin
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Stronghold 45 mg otopina za nakapavanje na kožu za mačke 2,6 - 7,5 kg Stronghold 60 mg otopina za nakapavanje na kožu za mačke 7,6 - 10,00 kg selamektin
English: 6% w/v solution selamectin 45 mg
Croatian: 6 % w/v otopina selamektin 45 mg
English: Stronghold 120 mg for dogs
Croatian: Stronghold 120 mg za pse
English: Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will aid prevention of flea infestation in the litter up to seven weeks of age.
Croatian: Primjena otopine jednom mjesečno u skotnih životinja ili životinja u laktaciji može kroz smanjenje populacije buha pomoći u prevenciji infestacije buhama u leglu do sedam tjedana starosti.
English: EU/2/99/014/001-016
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/99/014/001-016
English: 6% w/v solution selamectin 15 mg
Croatian: 6 % w/v otopina selamektin 15 mg
English: 12% w/v solution selamectin 360 mg
Croatian: 12 % w/v otopina selamektin 360 mg
English: Stronghold 30 mg for dogs
Croatian: Stronghold 30 mg za pse
English: Treatment of hookworm infections (cats)
Croatian: Liječenje invazije ankilostomima (u mačaka)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOIL LABEL, 15 mg, 30 mg, 45 mg, 60 mg, 120 mg, 240 mg, 360 mg
Croatian: ETIKETA NA FOLIJI, 15 mg, 30 mg, 45 mg, 60 mg, 120 mg, 240 mg, 360 mg NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
English: 12% w/v solution selamectin 30 mg
Croatian: 12 % w/v otopina selamektin 30 mg
English: Stronghold should be administered topically as a single application of a single-dose delivering a minimum of 6 mg/kg selamectin.
Croatian: Stronghold treba primijeniti jednokratno na kožu u pojedinačnoj dozi koja osigurava min.
English: 6% w/v solution selamectin 60 mg
Croatian: 6 % w/v otopina selamektin 60 mg
English: Treatment of biting lice (cats and dogs)
Croatian: Liječenje infekcije oblićima (kod mačaka i pasa)
English: The veterinary medicinal product is ovicidal for 3 weeks after administration.
Croatian: Veterinarsko - medicinski proizvod djeluje ovicidno 3
English: 12% w/v solution selamectin 60 mg
Croatian: 12 % w/v otopina selamektin 60 mg
English: Stronghold 30 mg spot-on solution for dogs 2.6-5.0 kg Stronghold 60 mg spot-on solution for dogs 5.1-10.0 kg Stronghold 120 mg spot-on solution for dogs 10.1-20.0 kg Stronghold 240 mg spot-on solution for dogs 20.1-40.0 kg Stronghold 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin
Croatian: Stronghold 30 mg otopina za nakapavanje na kožu za pse 2,6 - 5,0 kg Stronghold 60 mg otopina za nakapavanje na kožu za pse 5,1 - 10,0 kg Stronghold 120 mg otopina za nakapavanje na kožu za pse 10,1 - 20,0 kg Stronghold 240 mg otopina za nakapavanje na kožu za pse 20,1 - 40,0 kg Stronghold 360 mg otopina za nakapavanje na kožu za pse 40,1 - 60,0 kg selamektin
English: Stronghold 15 mg spot-on for cats and dogs ≤ 2.5 kg Stronghold 30 mg spot-on for dogs 2.6-5.0 kg Stronghold 45 mg spot-on for cats 2.6-7.5 kg Stronghold 60 mg spot-on for cats 7.6-10.0 kg Stronghold 60 mg spot-on for dogs 5.1-10.0 kg Stronghold 120 mg spot-on for dogs 10.1-20.0 kg Stronghold 240 mg spot-on for dogs 20.1-40.0 kg Stronghold 360 mg spot-on for dogs 40.1-60.0 kg selamectin
Croatian: Stronghold 15 mg otopina za nakapavanje na kožu za mačke i pse ≤ 2,5 kg Stronghold 30 mg otopina za nakapavanje na kožu za pse 2,6 - 5,0 kg Stronghold 45 mg otopina za nakapavanje na kožu za mačke 2,6 - 7,5 kg Stronghold 60 mg otopina za nakapavanje na kožu za mačke 7,6 - 10,0 kg Stronghold 60 mg otopina za nakapavanje na kožu za pse 5,1 - 10,0 kg Stronghold 120 mg otopina za nakapavanje na kožu za pse 10,1 - 20,0 kg Stronghold 240 mg otopina za nakapavanje na kožu za pse 20,1 - 40,0 kg Stronghold 360 mg otopina za nakapavanje na kožu za pse 40,1 - 60,0 kg selamektin
English: Stronghold 60 mg for dogs
Croatian: Stronghold 60 mg za pse
English: Cats weighing 2.6-7.5 kg. Cats weighing 7.6-10.0 kg.
Croatian: CILJNE VRSTA ŽIVOTINJA Mačke tjelesne mase 2,6 - 7,5 kg.
English: Treatment of pregnant and lactating animals to prevent flea infestations in puppies and kittens:
Croatian: Liječenje i prevencija infestacije buhama (kod mačaka i pasa)
English: 2.6-7.5 Blue 7.6-10.0 Taupe
Croatian: ružičasta 2,6 - 7,5 plava 7,5 - 10,0 sivkasto smeđa odgovarajuća kombinacija pipeta odgovarajuća kombinacija pipeta
English: Cats and dogs weighing 2.5 kg or less (Stronghold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg) Dogs weighing 2.6 kg-5.0 kg (Stronghold 30 mg spot-on solution for dogs 2.6-5.0 kg) Cats weighing 2.6 kg-7.5 kg (Stronghold 45 mg spot-on solution for cats 2.6-7.5 kg) Cats weighing 7.6 kg-10.0 kg (Stronghold 60 mg spot-on solution for cats 7.6-10.0 kg) Dogs weighing 5.1 kg-10.0 kg (Stronghold 60 mg spot-on solution for dogs 5.1-10.0 kg) Dogs weighing 10.1 kg-20.0 kg (Stronghold 120 mg spot-on solution for dogs 10.1-20.0 kg) Dogs weighing 20.1 kg-40.0kg (Stronghold 240 mg spot-on solution for dogs 20.1-40.0 kg) Dogs weighing 40.1 kg-60.0 kg (Stronghold 360 mg spot-on solution for dogs 40.1-60.0 kg)
Croatian: Stronghold 15 mg otopina za nakapavanje na kožu za mačke i pse ≤ 2,5 kg Stronghold 30 mg otopina za nakapavanje na kožu za pse 2,6 - 5,0 kg Stronghold 45 mg otopina za nakapavanje na kožu za mačke 2,6 - 7,5 kg Stronghold 60 mg otopina za nakapavanje na kožu za mačke 7,6 - 10,0 kg Stronghold 60 mg otopina za nakapavanje na kožu za pse 5,1 - 10,0 kg Stronghold 120 mg otopina za nakapavanje na kožu za pse 10,1 - 20,0 kg Stronghold 240 mg otopina za nakapavanje na kožu za pse 20,1 - 40,0 kg Stronghold 360 mg otopina za nakapavanje na kožu za pse 40,1 - 60,0 kg
English: BATCH NUMBER
Croatian: Koncentr acija
English: The full EPAR for Zostavax is available on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Zostavax nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It must also not be used in patients with active untreated tuberculosis or in pregnant women.
Croatian: Također se ne smije koristiti u bolesnika s aktivnom neliječenom tuberkulozom ili u trudnica.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zostavax on 19 May 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Zostavax na snazi u Europskoj uniji od 19. svibnja 2006.
English: In patients who have bleeding problems, the vaccine should be given under the skin.
Croatian: Bolesnicima koji imaju problema s krvarenjem cjepivo se treba dati pod kožu.
English: The study was a double-blind trial, which means that neither the doctor nor the patient knew what treatment the patient was receiving.
Croatian: Ispitivanje je bilo dvostruko slijepo ispitivanje, što znači da ni liječnik ni bolesnik nisu znali koji oblik liječenja bolesnik prima.
English: What measures are being taken to ensure the safe and effective use of Zostavax?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zostavax?
English: The patients were followed for 2 to 4.5 years after vaccination.
Croatian: Bolesnici su praćeni od 2 godine do 4,5 godina nakon cijepljenja.
English: The main measure of effectiveness was based on the number of people who developed shingles and post-herpetic pain.
Croatian: Glavno mjerilo djelotvornosti temeljilo se na broju osoba u kojih su se razvili herpes zoster i postherpetična bol.
English: The effect was seen both in patients aged between 50 and 59 years and in those aged 60 years and older.
Croatian: Taj je učinak uočen u bolesnika u dobi od 50 do 59 godina kao i onih u dobi od 60 godina i starijih.
English: What is the risk associated with Zostavax?
Croatian: Koji su rizici povezani s lijekom Zostavax?
English: Most of these side effects were mild.
Croatian: Većina tih nuspojava bila je blagog intenziteta.
English: This is a summary of the European public assessment report (EPAR) for Zostavax.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Zostavax.
English: Zostavax was more effective than placebo in preventing shingles.
Croatian: Zostavax je bio djelotvorniji od placeba u sprečavanju herpes zostera.
English: Other information about Zostavax
Croatian: Ostale informacije o lijeku Zostavax
English: In studies, the most common side effects with Zostavax are reactions at the site of the injection (redness, pain, swelling, itching, warmth and bruising), headache and pain in the arm or leg.
Croatian: Najčešće nuspojave lijeka Zostavax utvrđene ispitivanjima jesu reakcije na mjestu injekcije (crvenilo, bol, oticanje, svrbež, toplina i stvaranje modrica), glavobolja i bol u ruci ili nozi.