FrancophonIA/ELRC3.0 huggingface dataset:
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1. Dodataka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se primjenjuju u tim veterinarsko-medicinskim proizvodima.
English: 4.7 Use during pregnancy, lactation or lay
Croatian: 4.7 Primjena tijekom gravidnosti, laktacije ili nesenja
English: Shelf life of the veterinary medicinal product as package for sale: 30 months.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kada je zapakiran za prodaju: 30 mjeseci.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: Nema dostupnih podataka o neškodljivost i učinkovitosti ove vakcine kada se koristi zajedno s bilo kojim drugim veterinarsko-medicinskim proizvodom.
English: Use cold and fresh non-chlorinated water that is free from metal-ions.
Croatian: Koristiti hladnu svježu vodu koja ne sadrži metalne ione.
English: Do not vaccinate animals undergoing antibacterial or immunosuppressive treatment.
Croatian: Ne vakcinirati jedinke koje primaju antibakterijsku ili imunosupresivnu terapiju.
English: Immunosuppressed people should not be present during administration of the vaccine.
Croatian: Osobe s imunosupresijom ne bi smjele biti prisutne za vrijeme primjene vakcine.
English: As a general rule, apply reconstituted vaccine to chlorine-free and fresh water at the rate of 1,000 doses of the vaccine to 1 litre of water per day of age for 1,000 chickens, e.g. 10 litres would be needed for 1,000 10-day old chickens.
Croatian: Generalno pravilo je primijeniti rekonstituirano cjepivo svježom vodom bez klora u omjeru od 1000 doza cjepiva na 1 litru vode po danu starosti na 1.000 pilića, npr. 10 litara će biti potrebno za 1.000 pilića starih 10 dana.
English: Do not split large vials to vaccinate more than 1 house or drinking system, as this may lead to mixing errors.
Croatian: Ne dijeliti velike bočice da bi cijepili više od jedne nastambe ili sustava za napajanje jer to može dovesti do greške.
English: Ideally, vaccine should be administered in the volume of water consumed by the birds in up to 3 hours.
Croatian: Idealno bi bilo cjepivo primijeniti u količini vode koju konzumira perad u roku 3 sata.
English: Allow water to be consumed so that levels of drinkers are minimal before vaccine is applied.
Croatian: Dopustiti da se voda konzumira tako da su razine pojilica minimalne prije nego što se primjeni cjepivo.
English: Use clean vaccination materials and turn off ventilation until 15 minutes after vaccination.
Croatian: Koristiti čisti pribor za vakcinaciju i ugasiti sustav ventilacije do 15 minuta nakon vakcinacije.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima
English: For these serotypes no onset of immunity or duration of immunity was established.
Croatian: Za ove serotipove nije ustanovljen ni početak ni trajanje imunosti.
English: Make sure that all conduit pipes, tubing, troughs, drinkers etc. are thoroughly clean and free of any trace of disinfectants, detergents, soap, etc. and antibiotics.
Croatian: Uvjeriti se da su sve dovodne cijevi, cijevi, žljebovi, pojilice itd., temeljito čisti, bez ikakvih dezinficijensa, deterdženata, sapuna, itd. ili antibiotika.
English: Shelf life after reconstitution according to directions: 2 hours.
Croatian: Rok valjanosti poslije razrjeđenja ili rekonstitucije prema uputi: 2 sata.
English: 12 weeks for the reduction of lesions and mortality (drinking water).
Croatian: 12 tjedna za smanjenje lezija i smrtnosti (vodom za piće).
English: The spraying distance should be between 30 and 80 cm above the animals in order to ensure an even distribution and the recommended droplet size is greater than 100 µm.
Croatian: Udaljenost prilikom raspršivanja bi trebala biti između 30 i 80 cm iznad peradi kako bi se osigurala ravnomjerna raspoređenost, a preporučena veličina kapljica su veće od 100 µm.
English: To stimulate active immunity to Escherichia coli serotype O78.
Croatian: Za stimulaciju aktivne imunosti prema Escherichi coli serotip O78.
English: Upon reconstitution, transparent to white-yellowish and opaque suspension (depending on the volume of diluent used).
Croatian: Nakon rekonstitucije, prozirna do bijelo žućkasta i neprozirna otopina (ovisno o količini iskorištenog diluenta).
English: Other precautions:
Croatian: Ostale mjere opreza:
English: All tubing should be emptied of plain water, so that the drinkers contain only vaccine water.
Croatian: Sve cijevi treba isprazniti od obične vode, tako da pojilice sadrže samo vodu sa cjepivom.
English: Avoid exposure of the vaccine suspension to sunlight.
Croatian: Izbjegavati izlaganje suspenzije cjepiva suncu.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Europske agencije za lijekove http://www.ema.europa.eu/.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: C. IZVJEŠĆE O MRL Djelatna tvar koja se sastoji od tvari biološkog podrijetla, namijenjena je za izazivanje aktivne imunosti, na koju se ne primjenjuju odredbe Uredbe (EZ) br. 470/2009.
English: Overdose (symptoms, emergency procedures, antidotes): No adverse reactions have been observed after the administration of a 10 fold overdose of the vaccine.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti): Nisu uočene nuspojave nakon primjene 10 puta veće doze cjepiva.
English: Chickens: 2 weeks after vaccination for the reduction of lesions.
Croatian: Pilići: 2 tjedna nakon vakcinacije za smanjenje lezija.
English: Half-fill the vial with chlorine-free water at room temperature.
Croatian: Napuniti bočicu do polovine s nekloriranom vodom sobne temperature.
English: Apply the usual aseptic precautions to all administration procedures.
Croatian: U svim procedurama primjene treba primijeniti uobičajene aseptičke postupke.
English: Chickens: 8 weeks for the reduction of lesions and 12 weeks for the reduction of mortality (spray).
Croatian: Pilići: 8 tjedana za smanjenje lezija i 12 tjedana za smanjenje smrtnosti (raspršivanje).
English: Personnel involved in attending vaccinated animals should follow general hygiene principals and take particular care in handling litter from recently vaccinated animals.
Croatian: Osoblje zaduženo za brigu o vakciniranim životinjama treba slijediti opća higijenska načela i posebno voditi brigu prilikom zbrinjavanja otpada (feces, stelja) vakcinirane peradi.
English: Do not use in birds in lay, or within 6 weeks of the start of the laying period.
Croatian: Ne primjenjivati na nesilicama za vrijeme nesenja ili unutar 6 tjedana od početka nesenja.
English: Open the vaccine vial under water and dissolve thoroughly in a container.
Croatian: Otvoriti bočicu cjepiva pod vodom i temeljito otopiti u posudi.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GLASS VIAL
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: The vaccine strain may spread to in-contact birds.
Croatian: Vakcinalni soj se može raširiti među pticama u kontaktu.
English: Cream coloured lyophilisate.
Croatian: Liofilizat bijelo žućkaste boje.
English: For active immunisation of broiler chickens, future layer/breeders and turkeys in order to reduce mortality and lesions (pericarditis, perihepatitis, airsacculitis) associated with Escherichia coli serotype O78.
Croatian: Za aktivnu imunizaciju brojlerskih pilića, budućih nesilica/roditelja i pura kako bi se smanjila smrtnost i lezije (perikarditis, perihepatitis, upala zračnih vrećica) povezane s E. coli, serotip O78.
English: The vaccine strain can be identified by its growth properties on biological growth media: it shows normal growth on MacConkey and trypticase soy agar, while no colonies are observed when plated without aromatic amino acids (minimum agar).
Croatian: pokazuje normalan rast na MacConkey i tripton soja agaru, dok kolonije nisu opažene kada je nasađen bez aromatskih aminokiselina (minimalni agar).
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Saharoza
English: It may be necessary to withhold water prior to vaccination in order to ensure that all birds drink during the vaccination period.
Croatian: Prije cijepljenja, peradi bi trebalo uskratiti vodu kako bi se osiguralo da sve ptice piju za vrijeme cijepljenja.
English: IMMUNOLOGICAL PROPERTIES
Croatian: 5 IMUNOLOŠKA SVOJSTVA
English: No disinfectants or other substances impairing the performance of the live vaccine should be used in the sprayer.
Croatian: Nikakva dezinfekcijska sredstva ili druge tvari koje mogu umanjiti učinkovitost žive vakcine ne smiju se upotrijebiti u uređaju za raspršivanje.
English: MARKETING AUTHORISATION HOLDER
Croatian: Nositelj odobrenja za stavljanje u promet
English: Live E. coli: 5.2 x 106 - 9.1 x 108 CFU/dose
Croatian: Živa E. coli: 5,2 x 106 - 9,1 x 108 CFU/doza
English: Therefore, it is recommended to clean and disinfect bird houses where the vaccine was applied after completion of the finishing or rearing period.
Croatian: preporuča se čišćenje i dezinfekcija peradnjaka, u kojima je primijenjena vakcina, nakon završetka uzgojnog ili proizvodnog ciklusa.
English: A cross protection study showed reduction of incidence and severity of airsacculitis caused by E. coli serotypes O1, O2 and O18 for spray application for chickens.
Croatian: Ispitivanje unakrižne zaštite je pokazalo smanjenje pojavnosti i težine upale zračnih vrećica uzrokovane s E. coli serotipovima O1, O2 i O18 za primjenu raspršivanjem za piliće.
English: EU/2/12/140/001-008
Croatian: BROJ ODOBRENJA ZA STAVLJANJE U PROMET EU/2/12/140/001-008
English: Do not use this veterinary medicinal product after the expiry date which is stated on the vial.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na bočici poslije EXP.
English: Live aroA gene deleted Escherichia coli, type O78,
Croatian: Živi aroA gen deletirane Escherichia coli, tip O78,
English: Vaccinate healthy birds only.
Croatian: Vakcinirati samo zdravu perad.
English: Do not use antibiotic treatment within 1 week before and after vaccination because antibiotic treatment might impair the efficacy of the vaccine.
Croatian: Jedan tjedan prije i jedan tjedan nakon vakcinacije ne smije se davati antibiotska terapija.
English: Pour the reconstituted vaccine into a clean container and add chlorine-free water to further dilute the vaccine in order to obtain an even distribution when sprayed onto the birds.
Croatian: Preliti rekonstituiranu vakcinu u čisti spremnik i doliti nekloriranu vodu kako bi se vakcina dalje razrijedila te dobila ravnomjerna rasprostranjenost prilikom raspršivanja po peradi.
English: Dilute and administer the reconstituted vaccine at a rate of one dose of reconstituted vaccine per bird, according to the directions of your specific coarse spray vaccination equipment.
Croatian: Razrijediti i aplicirati rekonstituiranu vakcinu u količini od jedne doze rekonstituirane vakcine po ptici i u skladu s uputom za upotrebu vaše specifične opreme za vakcinaciju raspršivanjem većim česticama
English: If in doubt, measure the water intake the day before administering vaccine.
Croatian: Ako ste u nedoumici, izmjerite unos vode dan prije davanja cjepiva.
English: 1 x 2,500 doses, 10 x 2,500 doses 1 x 5,000 doses, 10 x 5,000 doses 1 x 10,000 doses, 10 x 10,000 doses 1 x 20,000 doses, 10 x 20,000 doses
Croatian: 1 x 2500 doza, 10 x 2500 doza 1 x 5000 doza, 10 x 5000 doza 1 x 10000 doza, 10 x 10000 doza 1 x 20000 doza, 10 x 20000 doza
English: Ammonium sulphate Magnesium sulphate heptahydrate Potassium phosphate monobasic Sodium phosphate dibasic heptahydrate
Croatian: Amonijev sulfat Magnezijev sulfat heptahidrat
English: Care should be taken to empty the vial and its top completely by rinsing them in water.
Croatian: Pobrinuti se da se kompletno isprazni bočica i njezin vrh ispiranjem u vodi.
English: The onset of immunity has not been established for the mortality claim.
Croatian: Početak imunosti za tvrdnju smanjenja smrtnosti nije utvrđen.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere opreza prilikom odlaganje neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: Vaccinated birds may excrete the vaccine strain by faecal route for up to 5 weeks (chickens) or 7 days (turkeys) post vaccination and the vaccine may remain present in the environment until the end of the finishing or rearing period (chickens) or for 7 days (turkeys).
Croatian: Vakcinirani pilići mogu izlučivati vakcinalni soj putem fecesa do pet tjedana (pilići) ili 7 dana (pure) nakon vakcinacije, a vakcina može ostati prisutna u okolini do kraja uzgojnog ili proizvodnog ciklusa (pilići) ili 7 dana (pure).
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: 2,500 doses 5,000 doses 10,000 doses 20,000 doses
Croatian: 2500 doza 5000 doza 10000 doza 20000 doza
English: Turkeys: 3 weeks after second vaccination for the reduction of lesions and mortality.
Croatian: Pure: 3 tjedna nakon drugog cijepljenja za smanjenje lezija i smrtnosti.
English: 1348 Louvain-la-Neuve BELGIUM
Croatian: Rue Laid Burniat 1 1348 Louvain-la-Neuve
English: Administer the dissolved vaccine to birds immediately after reconstitution.
Croatian: Primijeniti otopljeno cjepivo za perad odmah nakon rekonstitucije.
English: Pharmacotherapeutic group: Immunologicals for aves, live bacterial vaccines for domestic fowl.
Croatian: Farmakoterapijska skupina: imunološki pripravci za ptice, žive bakterijske vakcine za domaće kokoši ATCvet kôd: QI01AE04
English: The vaccine strain can be detected in tissues (liver, heart) until 6 days (chickens) or in tissues (thoracic air sacs) 4 days (turkeys) post vaccination.
Croatian: Soj vakcine se može otkriti u tkivima (jetra, srce) do šest dana (pilići) ili u tkivima (zračne vrećice prsnog koša) do 4 dana (pure) nakon vakcinacije.
English: Withdrawal period: 0 days.
Croatian: KARENCIJA(E) Karencija: 0 dana.
English: Low-fat skimmed milk powder (i.e. < 1% fat) may be added to the water (2-4 grams per litre) or skimmed milk (20-40 ml per litre of water) to improve the water quality and to increase the stability of the bacteria.
Croatian: Mlijeko u prahu niske masnoće (tj. <1% masti) može biti dodatno u vodu (2 - 4 g/l).
English: EXP {month/year} Once reconstituted use within 2 hours.
Croatian: Upotrijebiti unutar 2 sata od rekonstitucije.
English: Chickens (broilers, future layers/breeders) and turkeys.
Croatian: Pilići (brojleri, buduće nesilice, budući roditelji) i pure.
English: Turkeys: duration of immunity has not been established.
Croatian: Pure: nije utvrđeno trajanje imunosti.
English: The use of eye-protection, gloves and a nose-mouth mask by the operator is advised during administration.
Croatian: Preporuča se upotreba zaštite za oči, rukavica i maske za lice (koja prekriva nos i usta) osobu koja provodi vakcinaciju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of one vial of 2,500 or 5,000 or 10,000 or 20,000 doses Cardboard box of ten vials of 2,500 or 5,000 or 10,000 or 20,000 doses
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija s jednom bočicom od 2500 ili 5000 ili 10000 ili 20000 doza Kartonska kutija s deset bočica od 2500 ili 5000 ili 10000 ili 20000 doza
English: The use of eye-protection, gloves and a nose-mouth mask by the operator is recommended during administration.
Croatian: Preporuča se upotreba zaštite za oči, rukavica i maske za lice (koja prekriva nos i usta) za osobu koja provodi vakcinaciju.
English: The vaccine strain can be detected in tissues (liver, heart) until 6 days (chickens) or in tissues (thoracic air sacs) until 4 days (turkeys) post vaccination.
Croatian: Soj vakcine se može otkriti u tkivima (jetra, srce) do šest dana (pilići) nakon vakcinacije ili (zračne vrećice prsnog koša) do 4 dana (pure) nakon vakcinacije.
English: Type I borosilicate glass vial of 10 ml for 2,500 and 5,000 dose-presentations and 50 ml for 10,000 and 20,000 dose-presentations with a bromobutyl rubber stopper sealed with aluminium crimp caps.
Croatian: Tip I borosilikatna staklena bočica od 10 ml za 2500 i 5000 doza i 50 ml za 10000 i 20000 doza s brombutilnim gumenim čepom i aluminijskom kapicom.
English: Only vaccinate healthy birds.
Croatian: Cijepiti samo zdrave životinje.
English: Replace the stopper and shake well until dissolved.
Croatian: Začepiti bočicu gumenim čepom i dobro protresti dok se sadržaj potpuno ne otopi.
English: Chickens: One dose of vaccine from 1 day of age by coarse spray or from 5 days of age by drinking water administration.
Croatian: Pilići: jedna doza vakcine od prvog dana starosti putem raspršivanja većim česticama (orošavanje) ili nakon 5 dana starosti vodom za piće.
English: Live aroA gene deleted Escherichia coli, type O78, strain EC34195
Croatian: tip O78, soj EC34195
English: STATEMENT OF ACTIVE SUBSTANCES Active substance:
Croatian: SASTAV DJELATNIH TVARI
English: Chickens: One dose of vaccine from 1 day of age by coarse spray administration or one dose of vaccine from 5 days of age by drinking water administration.
Croatian: Program vakcinacije Pilići: jedna doza vakcine, od prvog dana starosti putem raspršivanja većim česticama (orošavanje) ili jedna doza cjepiva od navršenih 5 dana starosti putem vode za piće.
English: Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1
Croatian: 7 NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET Zoetis Belgium SA
English: 1/10 x 2,500, 5,000, 10,000, 20,000 doses
Croatian: STAKLENA BOČICA 1/10 x 2500, 5000, 10000, 20000 doza
English: Coarse spray administration for chickens and turkeys or in drinking water use for chickens.
Croatian: Primjena putem raspršivanja za piliće i pure ili vodom za piće za piliće.
English: Cardboard box of ten vials of 2,500, 5,000, 10,000 or 20,000 doses.
Croatian: Kartonska kutija s deset bočica od 2500, 5000, 10000 ili 20000 doza.
English: Cardboard box of one vial of 2,500, 5,000, 10,000 or 20,000 doses.
Croatian: Kartonska kutija s jednom bočicom od 2500, 5000, 10000 ili 20000 doza.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nikakve nuspojave nisu primijećene nakon primjene deseterostruke preporučene doze vakcine.
English: Coarse spray administration for chickens / turkeys or in drinking water use for chickens.
Croatian: Primjena raspršivanjem za piliće/pure ili putem vode za piće, za piliće.
English: Spray vaccination or in drinking water use.
Croatian: Vakcinacija raspršivanjem ili vodom za piće.
English: Lyophilisate for suspension for spray vaccination or for use in drinking water.
Croatian: Liofilizat za suspenziju za vakcinaciju raspršivanjem ili vodom za piće.
English: The vaccine is supplied in type I borosilicate glass vial of 10 ml or 50 ml with a bromobutyl rubber stopper sealed with aluminium crimp caps.
Croatian: Vakcina je pakovana u Tip I (borosilikatne staklene bočice od 10 ml za 2500 i 5000 doza i 50 ml za 10000 i 20000 doza s brombutilnim gumenim čepom i aluminijskom kapicom.
English: Poulvac E. coli lyophilisate for suspension for spray vaccination or for use in drinking water
Croatian: Poulvac E. coli, liofilizat za suspenziju za vakcinaciju raspršivanjem ili vodom za piće
English: Name and address of the manufacturer of the biological active substance Zoetis Inc.
Croatian: Naziv i adresa proizvođača biološki djelatne tvari
English: Poulvac E. coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickens
Croatian: Poulvac E. coli liofilizat za suspenziju za vakcinaciju raspršivanjem za piliće i pure ili vodom za piće za piliće
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI (I) PROIZVOĐAČ(I) ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: Veterinary medicinal product subject to prescription.
Croatian: Izdaje se na veterinarski recept.
English: Chickens and turkeys
Croatian: CILJNE VRSTE ŽIVOTINJA Pilići i pure
English: PACKAGE LEAFLET Poulvac E. coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickens
Croatian: UPUTA O VMP Poulvac E. coli, liofilizat za suspenziju za vakcinaciju raspršivanjem za piliće i pure ili vodom za piće za piliće
English: Zoetis Belgium SA Rue Laid Burniat 1
Croatian: Zoetis Belgium SA
English: 5.2 x 106 - 9.1 x 108 CFU* * Colony forming units when grown on tryptic soy agar plates.
Croatian: tip O78, soj EC34195 *Jedinica tvorbe kolonija (colony forming units) kada se uzgaja na tripton soja agar podlogama
English: USA
Croatian: BELGIJA
English: Spray vaccination or for use in drinking water.
Croatian: Vakcinacija raspršivanjem ili primjena putem vode za piće.
English: Spray application:
Croatian: Primjena raspršivanjem:
English: BATCH NUMBER
Croatian: Zoetis Inc.
English: EU/1/16/1104/001
Croatian: EU/1/16/1104/001 Palonosetron Accord mikrogram a
English: (Invented) name Strength Pharmaceutical form
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik
English: Intravenous use vial (glass) 5 ml
Croatian: Za primjenu u venu bočica (staklo) 5 ml
English: EU/1/19/1367/001 Zynteglo cells/mL
Croatian: EU/1/19/1367/001 Zynteglo stanica/ml disperzija za infuziju
English: 1 bag (or more)
Croatian: 1 vrećica (ili više)
English: Intravenous use bag (FEP)
Croatian: Vrećica (FEP)
English: One capsule daily.
Croatian: Jedna kapsula dnevno.
English: The following indication should be deleted:
Croatian: Sljedeću je indikaciju potrebno izbrisati:
English: The usual dose is one capsule a day.
Croatian: Uobičajena doza je jedna kapsula dnevno.
English: Section 4.1: Therapeutic indications
Croatian: Dio 4.1: Terapijske indikacije
English: Adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, anti-platelet medicinal products, beta-blockers, ACE inhibitors).
Croatian: Adjuvantno liječenje u sekundarnoj prevenciji nakon infarkta miokarda, uz drugu standardnu terapiju (npr. statine, antitrombocitne lijekove, beta-blokatore, ACE inhibitore).
English: Section 5.1 Pharmacodynamic properties
Croatian: Dio 5.1. Farmakodinamička svojstva
English: B. Package Leaflet: Information for the patient
Croatian: Uputa o lijeku: Informacije za bolesnika
English: Section 3
Croatian: Dio 3.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela države članice mogu, prema potrebi, naknadno ažurirati informacije o lijeku u suradnji s referentnom državom članicom, u skladu s postupcima utvrđenima u poglavlju 4. glave III.
English: Section 1
Croatian: Dio 1.