FrancophonIA/ELRC3.0 huggingface dataset:
English: Cavoley is a medicine that contains the active substance pegfilgrastim, which stimulates the production of neutrophils (a type of white blood cell that fights infections).
Croatian: Cavoley je lijek koji sadrži djelatnu tvar pegfilgrastim, koja potiče stvaranje neutrofila (vrsta bijelih krvnih stanica koje se bore protiv infekcija).
English: The active substance in Cavoley, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Croatian: Djelatna tvar lijeka Cavoley, pegfilgrastim, sastoji se od filgrastima koji je „pegiliran” (spojen s kemijskom tvari pod nazivom polietilen glikol).
English: Cavoley was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Croatian: Cavoley se trebao primjenjivati za smanjenje trajanja neutropenije i pojave febrilne neutropenije (neutropenija praćena vrućicom).
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for Cavoley.
Croatian: Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja ni programa milosrdnog davanja lijeka Cavoley koji su u tijeku.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that having considered the CHMP's conclusion, it has decided to withdraw the application but to continue developing the product and follow the CHMP's advice to eliminate the remaining uncertainty.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da je nakon razmatranja zaključka CHMP-a donijela odluku o povlačenju zahtjeva i daljnjem razvijanju lijeka u cilju uklanjanja preostalih nejasnoća, sukladno savjetu CHMP-a.
English: The CHMP was concerned that study results had not shown that Cavoley was handled by the body in the same way as the reference medicine Neulasta.
Croatian: CHMP je izrazio zabrinutost da rezultati ispitivanja nisu pokazali da tijelo podnosi lijek Cavoley na isti način kao i referentni lijek Neulasta.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Cavoley could not have been approved for reducing neutropenia.
Croatian: Na temelju pregleda podataka te odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Cavoley za liječenje neutropenije.
English: Cavoley was to be used in cancer patients to reduce neutropenia (low levels of neutrophils).
Croatian: Lijek Cavoley trebao se primjenjivati u bolesnika oboljelih od raka za smanjenje neutropenije (niske razine neutrofila).
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not demonstrated that Cavoley is highly similar to Neulasta.
Croatian: Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao da tvrtka nije dostavila dostatne podatke kojima bi potkrijepili tvrdnju da je Cavoley vrlo sličan lijeku Neulasta.
English: Filgrastim is very similar to a human protein called
Croatian: Filgrastim je vrlo sličan ljudskom proteinu pod nazivom faktor stimulacije kolonije granulocita (G-CSF).
English: Withdrawal of the marketing authorisation application for Cavoley (pegfilgrastim) EMA/822769/2016
Croatian: EMA/822769/2016
English: ATCvet code: QI01BD03.
Croatian: ATC vet kod: QI01BD03.
English: The vaccine is then ready to use.
Croatian: Cjepivo je spremno za korištenje.
English: Do not use in birds in lay (see section 4.3).
Croatian: Ne primjenjivati pticama kad nesu (vidi odjeljak 4.3).
English: Store and transport refrigerated (2° C - 8° C).
Croatian: Čuvati i prevoziti na hladnom (2 °C - 8 °C).
English: Date of last renewal:
Croatian: Datum zadnjeg produljenja:
English: Concentrate:
Croatian: Koncentrat:
English: ANNEX IV GROUNDS FOR ONE ADDITIONAL RENEWAL
Croatian: DODATAK IV RAZLOZI ZA JEDNO DODATNO PRODULJENJE
English: Due to the limited period the veterinary medicinal product Parvoduk has been placed on the market and the consequently limited post-marketing safety information, the CVMP at their meeting on 6-8 November 2018 decided that one five-year renewal is required.
Croatian: Zbog ograničenog razdoblja u kojem je veterinarska-medicinski proizvod Parvoduk stavljen u promet i stoga ograničenih informacije o neškodljivosti , na sastanku CVMP dana 6.-8. studenoga 2018. odlučeno je da je potrebna petogodišnja obnova odobrenja.
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question
Croatian: b) je bolest, za koju je proizvod namijenjen da pruži imunost, u velikoj mjeri odsutna s odnosnog područja.
English: The concentrate is opalescent and homogeneous.
Croatian: Koncentrat je opalescentan i homogen.
English: Then remove the trocar from both containers.
Croatian: Potom izvucite trokar iz oba spremnika.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Croatian: Sukladno članku 71. Direktive 2001/82/EZ i Europskog Parlamenta i Vijeća s izmjenama i dopunama, države članice, u skladu s nacionalnim zakonodavstvom mogu zabraniti proizvodnju, uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunoloških veterinarsko-medicinskih proizvoda na cijelom ili na dijelu svog teritorija ako je utvrđeno da:
English: The excipients 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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari navedene u odjeljku 6.1 su dopuštene tvari za koje je u tablici 1. Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da se za njih ne zahtijeva određivanje DNK (MRL) ili nisu obuhvaćene odredbama Uredbe (EK) br. 470/2009, kada se koriste u ovom veterinarskom medicinskom proizvodu.
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: Djelatna tvar je biološkog podrijetla namijenjena za poticanje aktivne imunosti na koju se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 500 doses
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA 500 doza
English: Casein hydrolysate Aluminium hydroxide
Croatian: Kazein hidrolizat Aluminij hidroksid
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/04/2014
Croatian: Datum prvog odobrenja: 11/04/2014
English: SPECIAL STORAGE CONDITIONS Store below 25° C.
Croatian: 11. POSEBNI UVJETI ČUVANJA Čuvati na temperaturi ispod 25°C.
English: Eleven genetic markers (nucleotides) in the VP1 gene allow differentiation of the Parvoduk vaccine strain from the field strains of duck and goose parvovirus, as shown below:
Croatian: Jedanaest genetskih markera (nukleotida) u VP1 genu omogućavaju diferencijaciju Parvoduk vakcinalnog soja od terenskog soja parvovirusa pataka i gusaka, kako je niže prikazano:
English: Overdose (symptoms, emergency procedures, antidotes): No adverse reactions were observed after the administration of an overdose (10x the dose).
Croatian: Predoziranje (simptomi, hitni postupci, antidoti): Nisu zabilježene nuspojave nakon primjene uvećane doze (10 x veće doze).
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove http://www.emea.europa.eu/.
English: EXP Once diluted, use within 4 hours.
Croatian: EXP Jednom pripremljen upotrijebiti unutar 4 sata.
English: - First vaccination: at 1 day of age.
Croatian: - Primarno cijepljenje: na 1. dan starosti.
English: In ducklings free of maternally derived antibodies a single vaccination at day 1 will lead to an onset of immunity after 14 days.
Croatian: U pačića slobodnih od protutijela prenesenih od majke, jednokratno cijepljenje prvog dana starosti potiče stvaranje imuniteta nakon 14 dana.
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 otpadne materijale dobivene primjenom tih veterinarsko-medicinskih proizvoda treba odlagati u skladu s lokalnim propisima.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Croatian: U nedostatku ispitivanja kompatibilnosti, ovaj veterinarsko-medicinski proizvod ne smije se miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Croatian: ODGOVORAN ZA PUŠTANJE SERIJE U PROMET B. UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Croatian: Odluka o korištenju ovog cjepiva prije ili nakon bilo kojeg drugog veterinarsko-medicinskog proizvoda stoga treba biti donesena od slučaja do slučaja.
English: After mixing, connect the bag to a high-speed, automated or semi-automated injection system.
Croatian: Nakon toga, spojite vrećicu na automatsku ili poluautomatsku brizgalicu.
English: Duration of immunity: 26 days after the primary vaccination course
Croatian: Trajanje imunosti: 26 dana nakon prve injekcije.
English: Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dehydrate Water for injections.
Croatian: Kalij dihidrogen fosfat Dinatrijev fosfat dehidrat Voda za injekcije
English: No adverse reactions were observed after the administration of an overdose (10 x the dose).
Croatian: Nisu zabilježene nuspojave nakon primjene uvećane doze (10x veće doze).
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Croatian: Veterinarsko-medicinski proizvod se ne smije koristiti poslije isteka roka valjanosti naznačenog na etiketi poslije EXP.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako se zamijeti bilo koja ozbiljna nuspojava, čak i one koje nisu navedene u ovoj uputi o VMP-u, ili se posumnja u učinkovitost VMP-a, treba obavijestiti veterinara.
English: Shelf life after dilution according to directions: 4 hours
Croatian: Rok valjanosti nakon razrjeđenja prema uputama: 4 sata
English: The entire flock should be vaccinated to lower the risk of any circulation of the vaccine strain and virus recombination.
Croatian: Cijelo jato treba biti procijepljeno kako bi se smanjio rizik cirkulacije vakcinalnog i rekombinantnog soja virusa.
English: Administer one dose of 0.2 ml by subcutaneous injection according to the following vaccination scheme: - First vaccination: at 1 day of age.
Croatian: Primjena jedne doze od 0,2 ml potkožno, sukladno sljedećoj shemi cijepljenja: - Prvo cijepljenje: na 1. dan starosti.
English: Manufacturer responsible for batch release: MERIAL
Croatian: Proizvođač odgovoran za puštanje serije u promet: MERIAL
English: Duck Parvovirus
Croatian: Pačji parvovirus
English: Muscovy ducks.
Croatian: Mošusne patke.
English: C T C G C C C A A T A The vaccine strain can be found in the spleen for at least 35 days.
Croatian: Vakcinalni soj može biti prisutan u slezeni kroz najmanje 35 dana.
English: Goose Parvovirus
Croatian: Guščji parvovirus
English: - Second vaccination: at 17 days of age.
Croatian: - Docjepljivanje: 17. dana starosti.
English: A small occasional impact on growth cannot be excluded upon vaccination of day-old ducklings free of maternally derived antibodies.
Croatian: Neznatan povremeni utjecaj na rast se ne može isključiti nakon cijepljenja jednodnevnih pačića bez antitijela dobivenih od majke.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each reconstituted dose of 0.2 ml contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka pripremljena doza od 0,2 ml sadrži:
English: Antigen Concentrate:
Croatian: Koncentrat antigena:
English: CONTRAINDICATIONS Do not use in birds in lay.
Croatian: KONTRAINDIKACIJE Ne primjenjivati pticama kad nesu.
English: The demonstrated duration of immunity protects the birds during the period when they are most susceptible to Muscovy duck parvovirosis and Derzsy's disease.
Croatian: Potvrđeno trajanje imunosti štiti ptice u razdoblju kada su najosjetljivije na parvovirus mošusne patke i Derszy bolest.
English: 2,500 doses
Croatian: 2.500 doza
English: 2,500 doses.
Croatian: 2.500 doza.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out the sight and reach of children.
Croatian: I DOSEGA DJECE” Čuvati izvan pogleda i dosega djece.
English: PACKAGE SIZE 500 doses.
Croatian: VELIČINA PAKOVANJA 500 doza.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: Nema podataka o neškodljivosti i djelotvornosti ovog cjepiva kada se koristiti s bilo kojim drugim veterinarsko-medicinskim proizvodom.
English: Polypropylene bags with butyl elastomer closure and trocar.
Croatian: Polipropilenska vrećice s butil elastomerskim zatvaračem i troakarom.
English: The vaccine contains a live attenuated Muscovy duck parvovirus.
Croatian: Cjepivo sadrži živi atenuirani parvovirus mošusne patke.
English: Onset of immunity: 11 days after the primary vaccination course
Croatian: Početak imunosti: 11 dana nakon prve injekcije.
English: Shake the vial of antigen concentrate.
Croatian: Protresite bočicu koncentrata antigena.
English: One reconstituted dose of 0.2 ml contains:
Croatian: Jedna pripremljena doza od 0,2 ml sadrži:
English: Active immunisation of Muscovy ducks to reduce weight loss and lesions of Muscovy duck parvovirosis and Derzsy's disease and, in the absence of maternally derived antibodies, to also prevent mortality.
Croatian: Aktivna imunizacija mošusnih pataka radi smanjenja gubitka tjelesne težine i lezija nastalih od parvovirusa mošusne patke i Derzsy bolesti, u nedostatku majčinskih protutijela, kako bi se spriječilo uginuće.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of concentrate
Croatian: PODATCI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kutija s koncentratom
English: Transfer the content of the glass vial into the bag of diluent.
Croatian: Prebacite sadržaj staklene bočice u vrećicu s otapalom.
English: Shelf life of the veterinary medicinal product as packaged for sale : 2 years Shelf life after dilution according to directions: 4 hours.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 2 godine.
English: Special precaution for use in animals:
Croatian: Posebne mjere opreza prilikom primjene na životinjama:
English: TARGET SPECIES Muscovy ducks.
Croatian: CILJNE VRSTE ŽIVOTINJA Mošusne patke.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
Croatian: PROIZVOĐAČ BIOLOŠKI(H) DJELATNIH TVARI I PROIZVOĐAČ
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: DODATAK III OZNAČAVANJE I UPUTA O VMP-u
English: Administer one dose of 0.2 ml by subcutaneous injection according to the following vaccination scheme:
Croatian: Primjena jedne doze od 0,2 ml potkožno, sukladno sljedećoj shemi cijepljenja:
English: Concentrate and solvent for suspension for injection.
Croatian: Koncentrat i otapalo za suspenziju za injekciju.
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: live viral vaccines, duck parvovirus.
Croatian: Farmakoterapijska skupina: živo virusno cjepivo, parvovirus pataka.
English: It induces an active and specific immunity against Muscovy duck parvovirosis and Derzsy's disease in the vaccinated birds.
Croatian: On potiče aktivnu i specifičnu imunost mošusne patke protiv parvovirusa i Derszy bolesti u cijepljenih ptica.
English: Do not use in birds in lay.
Croatian: Ne primjenjivati pticama kad nesu.
English: MARKETING AUTHORISATION NUMBERS EU/2/14/162/001-002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/14/162/001-002
English: PHARMACEUTICAL FORM Concentrate for suspension for injection.
Croatian: OBLIK Koncentrat za suspenziju za injekciju.
English: Gently shake the bag to mix the antigen concentrate with the solvent.
Croatian: Lagano protresite vrećicu da se umiješa antigen iz koncentrata u otapalu.
English: Insert the trocar provided with the bag of diluent through the closures of both the glass vial and the diluent bag to connect them.
Croatian: Umetnite trokar koji ste dobili s vrećicom otapala kroz zatvarače spremnika staklene bočice i vrećicom s otapala, da bi ih povezali.
English: Live attenuated Muscovy duck parvovirus strain GM 199 ............................... 2.6-4.8 log10 CCID50* * Cell culture infectious dose 50%.
Croatian: Živi atenuirani parvovirus mošusne patke soj GM 199 ....................................... 2,6 - 4,8 log10 CCID50* * Infektivna doza 50% kultura stanica.
English: Parvoduk
Croatian: NUSPOJAVE
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/162/001
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/14/162/001
English: Name and address of the manufacturer(s) of the biological active substance(s)
Croatian: Naziv i adresa proizvođača bioloških djelatnih tvari
English: Live attenuated Muscovy duck parvovirus strain GM 199 ...................... 2.6-4.8 log10 CCID50* * Cell culture infectious dose 50%.
Croatian: Živi atenuirani parvovirus mošusne patke, parvovirus soj GM 199 ..................... 2,6 - 4,8 log10 CCID50* * Infektivna doza 50% kultura stanica
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For subcutaneous use.
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
English: Live attenuated Muscovy duck parvovirus strain GM 199 .................................... 2.6-4.8 log10 CCID50.
Croatian: Živi atenuirani parvovirus mošusnih pataka soj GM 199 ...................................... 2,6 - 4,8 log10 CCDI50
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Live attenuated Muscovy duck parvovirus.
Croatian: KOLIČINA DJELATNE(IH) TVARI Živi atenuirani parvovirus mošusnih pataka
English: PACKAGE SIZE 10 x 500 doses 1x 2,500 doses
Croatian: VELIČINA PAKOVANJA 10 x 500 doza
English: WITHDRAWAL PERIOD(S) Withdrawal period(s): zero days.
Croatian: KARENCIJA(E) Karencija: nula dana.
English: Lay: Do not use in birds in lay.
Croatian: Nesenje: Ne primjenjivati pticama kad nesu..
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Solvent for Parvoduk concentrate
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Otapalo za Parvoduk koncentrat
English: Cardboard box of 1 bag of 2,500 doses.
Croatian: Kartonska kutija s 1 vrećicom s 2.500 doza.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of solvent
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kutija sa otapalom
English: Cardboard box of 10 bags of 500 doses.
Croatian: Kartonska kutija s 10 vrećica s 500 doza.
English: STATEMENT OF ACTIVE SUBSTANCES Saline buffer
Croatian: SASTAV DJELATNIH TVARI Puferska sol.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials of concentrate
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: Type I glass vials with butyl elastomer closure.
Croatian: I s kružnim elastomerskim zatvaračem.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKIH DJELATNIH TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: Cardboard box of 10 vials of 500 doses.
Croatian: Kartonska kutija s 10 bočica s 500 doza.
English: Position on VP1 gene
Croatian: UPUTA O VMP
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk solvent for suspension for injection for Muscovy ducks
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Parvoduk otapalo za injekcijsku suspenziju za mošusne patke.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bags of solvent
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJIM PAKOVANJIMA Vrećica s otapalom
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk concentrate for suspension for injection for Muscovy ducks
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Parvoduk koncentrat za injekcijsku suspenziju za mošusne patke.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk concentrate and solvent for suspension for injection for Muscovy ducks
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Parvoduk koncentrat i otapalo za injekcijsku suspenziju za mošusne patke.
English: PACKAGE LEAFLET: Parvoduk concentrate and solvent for suspension for injection for Muscovy ducks
Croatian: Parvoduk koncentrat i otapalo za injekcijsku suspenziju za mošusne patke.
English: BATCH NUMBER
Croatian: BROJ PROIZVODNE SERIJE]
English: ADVERSE REACTIONS
Croatian: DODATAK
English: * Tissue culture infectious dose 50%
Croatian: * 50% infektivne doze kulture tkiva
English: --1 Lyophilisate (live attenuated) Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15
Croatian: --1 Liofilizat (živi atenuirani) Pseći parainfluenca virus tip 2, soj CPiV-2-Bio 15 103,1 -05,1 TCID50*
English: Lyophlilisate: vial (glass)
Croatian: Liofilizat: Staklena bočica
English: Package size
Croatian: Put primjene Pakovanje Sastav Veličina pakovanja
English: Lyophilisate: vial (glass)
Croatian: I Otapalo: staklena bočica
English: Ucedane with food and drink
Croatian: Ucedane s hranom i pićem
English: Date of first authorisation: 23 June 2017
Croatian: Datum prvog odobrenja: 23. lipanj 2017.
English: The tablet can be divided into four equal doses.
Croatian: Tableta se može podijeliti u četiri jednake doze.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100) 100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao: vrlo često (≥1/10), često (≥1/100 i <1/10) i manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzimali ili biste mogli uzimati bilo koje druge lijekove.
English: Consult your doctor for advice if you are pregnant or planning to become pregnant.
Croatian: Molimo Vas da se savjetujete s Vašim liječnikom ako ste trudni ili planirate trudnoću.
English: What Ucedane is and what it is used for
Croatian: Što je Ucedane i za što se koristi
English: Based on pharmacokinetic data and clinical experience, it is recommended to divide the total daily dose into two to four intakes to be given before meals or feedings.
Croatian: Na temelju farmakokinetičkih podataka i kliničkog iskustva preporučuje se podijeliti ukupnu dnevnu dozu na dva do četiri unosa koji se daju prije obroka ili hranjenja.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve infromacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet :