FrancophonIA/ELRC3.0 huggingface dataset:
English: Ifirmasta is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Croatian: Ifirmasta se također koristi za liječenje bolesti bubrega u odraslih s hipertenzijom i šećernom bolešću tipa 2.
English: What is Ifirmasta?
Croatian: Što je Ifirmasta?
English: Ifirmasta is a medicine that contains the active substance irbesartan.
Croatian: Ifirmasta je lijek koji sadrži djelatnu tvar irbesartan.
English: Because Ifirmasta is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Croatian: Budući da je Ifirmasta generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Because Ifirmasta is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine.
Croatian: Budući da je Ifirmasta generički lijek, ispitivanja na bolesnicima bile su ograničena na utvrđivanje činjenice je li riječ o bioekvivalentu referentnom lijeku.
English: The full EPAR for Ifirmasta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Ifirmasta nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Ifirmasta pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: What is Ifirmasta used for?
Croatian: Za što se Ifirmasta koristi?
English: The CHMP concluded that, in accordance with EU requirements, Ifirmasta has been shown to have comparable quality and to be bioequivalent to Aprovel.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu s preduvjetima EU-a, lijek Ifirmasta posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Aprovel.
English: How is Ifirmasta used?
Croatian: Kako se Ifirmasta koristi?
English: ‘Essential' means that the hypertension has no obvious cause.
Croatian: Ifirmasta se koristi za liječenje esencijalne hipertenzije (visokog krvnog tlaka) u odraslih osoba. „Esencijalno” znači da ne postoji očiti uzrok hipertenzije.
English: Therefore, the CHMP's view was that, as for Aprovel, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi nadmašuju utvrđene rizike, kao i kod lijeka Aprovel.
English: How does Ifirmasta work?
Croatian: Kako djeluje Ifirmasta?
English: How has Ifirmasta been studied?
Croatian: Kako je Ifirmasta ispitivan?
English: België/Belgique/Belgien, Luxembourg/Luxemburg, Република България, Magyarország, Česká republika, Malta, Danmark, Norge, Eesti, Österreich, Ελλάδα, Polska, Portugal, France, România, Slovenija, Ísland, Slovenská republika, Italia, Suomi/Finland, Κύπρος, Sverige, Latvija, Lietuva, Hrvatska
Croatian: België/Belgique/Belgien, Luxembourg/Luxemburg, Република България, Magyarország, Česká republika, Malta, Danmark, Norge, Eesti, Österreich, Ελλάδα, Polska, Portugal, France, România, Slovenija, Ísland, Slovenská republika, Italia, Suomi/Finland, Κύπρος, Sverige, Latvija,
English: Do not freeze.
Croatian: Ne zamrzavajte.
English: Protect from light.
Croatian: Zaštitite od svjetla.
English: Date of first authorisation: 14/04/2011 Date of last renewal: 15/03/2016
Croatian: Datum prvog odobrenja: 14/04/2011. Datum zadnje obnove odobrenja: 15/03/2016
English: Each ml of vaccine contains:
Croatian: Svaki ml cjepiva sadržava:
English: The current annual reporting cycle for periodic safety update reports (PSURs) should be maintained.
Croatian: Redovito treba održavati sadašnji godišnji ciklus dostave periodičkih izvješća o neškodljivosti (PSUR).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA/OBNOVE ODOBRENJA
English: PROHIBITION OF SALE, SUPPLY AND/OR USE
Croatian: ZABRANA PRODAJE, OPSKRBE I/ILI UPOTREBE
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Croatian: SADRŽAJ IZRAŽEN MASOM, VOLUMENOM ILI BROJEM DOZA
English: ADVICE ON CORRECT ADMINISTRATION
Croatian: SAVJET ZA PRAVILNU PRIMJENU
English: Pregnancy and lactation:
Croatian: Gravidnosti i laktacije:
English: For the full list of excipients, see section 6.1.
Croatian: Potpuni popis pomoćnih tvari pogledajte u poglavlju 6.1.
English: EXP {month/year} Once opened, use within 10 hours.
Croatian: EXP {mjesec/godina} Jednom otvoren upotrijebiti u roku od 10 sati.
English: Shake well before use.
Croatian: Prije upotrebe dobro protresite.
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Podrobne informacije o ovom proizvodu dostupne su na internetskim stranicama Europske agencije za lijekove (http://www.ema.europa.eu/).
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kada je zapakiran za prodaju: 2 godine.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Croatian: 4.8 Međusobno djelovanje s drugim medicinskim proizvodima i drugi oblici međusobnog djelovanja
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: Na djelatnu tvar koja se sastoje od tvari biološkog podrijetla, namijenjenu za stvaranje aktivne imunosti ne primjenjuju se odredbe Uredbe (EZ) br. 470/2009.
English: Avoid introduction of contamination.
Croatian: Pazite da ne dođe do kontaminacije.
English: SPECIAL WARNING(S), IF NECESSARY
Croatian: POSEBNO(A) UPOZORENJE(A) UKOLIKO JE POTREBNO
English: OTHER INFORMATION Immunological properties
Croatian: 15. DRUGE INFORMACIJE Imunološka svojstva
English: Occasionally, the presence of maternally derived antibodies in ovines of minimum recommended age might interfere with the protection induced by the vaccine.
Croatian: Ponekad prisutnost majčinskih protutijela u ovaca minimalne preporučene dobi može nepovoljno utjecati na zaštitu koju stvara cjepivo.
English: It lasts not longer than 24 to 48 hours.
Croatian: Povećana tjelesna temperatura traje od 24 do 48 sati.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Croatian: Podrobne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na internetskim stranicama Europske agencije za lijekove (http://www.ema.europa.eu).
English: (*) equivalent to titre prior to inactivation (log10)
Croatian: (*) istovrijedno titru prije inaktivacije (log10)
English: The level of efficacy for other species may differ from that observed in sheep and cattle.
Croatian: Razina djelotvornosti u drugih vrsta može se razlikovati u odnosu na dokazanu djelotvornost u ovaca i goveda.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Croatian: Posebne mjere opreza koje treba poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama
English: ATCvet codes: QI04AA02 (sheep) and QI02AA08 (cattle).
Croatian: ATCvet kodovi: QI04AA02 (ovce) i QI02AA08 (goveda).
English: Any unused product or waste materials derived from such veterinary medicinal products 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: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNE VRSTU ŽIVOTINJA, PUT(OVI) I NAČIN PRIMJENE
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Croatian: Informacije o ovom veterinarsko-medicinskom proizvodu potražite od mjesnog predstavnika nositelja odobrenja za stavljanje u promet.
English: Not all pack sizes may be marketed.
Croatian: Neke od navedenih veličina pakovanja možda nisu dostupne na tržištu.
English: EU/2/11/122/001 bottle of 52 ml EU/2/11/122/002 bottle of 100 ml EU/2/11/122/003 bottle of 252 ml
Croatian: EU/2/11/122/001 bočica od 52 ml EU/2/11/122/002 bočica od 100 ml EU/2/11/122/003 bočica od 252 ml
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Croatian: Pri upotrebi cjepiva u drugih domaćih i divljih vrsta preživača, kod kojih se smatra da postoji opasnost od infekcije, potreban je oprez te se prije masovnog cijepljenja preporučuje ispitivanje cjepiva na manjem broju životinja.
English: In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or National competent authorities on the current vaccination policies against bluetongue virus (BTV).
Croatian: U ovoj kategoriji životinja cjepivo je potrebno upotrijebiti samo u skladu s procjenom koristi-rizika koju je napravio odgovorni veterinar i/ili nadležno nacionalno tijelo ovisno o trenutnoj politici cijepljenja protiv bolesti plavog jezika (engl. bluetongue virus, BTV).
English: Intervet Nederland B.V. Wim de Körverstraat 35 5831 AN Boxmeer Tel: +31.485.587652
Croatian: Wim de Körverstraat 35 5831 AN Boxmeer Tel: +31.485.587652
English: Store and transport refrigerated.
Croatian: Skladištite i prevozite u hladnjaku.
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: Odluku o upotrebi ovog cjepiva prije ili nakon upotrebe nekog drugog veterinarsko-medicinskog proizvoda potrebno je donijeti od slučaja do slučaja.
English: Any revaccination scheme should be agreed by the competent authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Croatian: Svaki program ponovnog cijepljenja mora odobriti nadležno tijelo ili odgovorni veterinar uzimajući u obzir lokalnu epidemiološku situaciju.
English: 4.4 Special warnings for each target species
Croatian: 4.4 Posebna upozorenja za svaku ciljnu životinjsku vrstu
English: 1 year after the second dose.
Croatian: 1 godinu nakon druge doze.
English: Store and transport refrigerated (2 °C - 8 °C).
Croatian: Skladištite i prevozite u hladnjaku (na temperaturi od 2 °C do 8 °C).
English: Each ml of vaccine contains: BTV8 antigen 106.5 CCID50
Croatian: Svaki ml cjepiva sadržava: Antigen BTV8 106,5 CCID50
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: Nisu dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva pri upotrebi s drugim veterinarskomedicinskim proizvodima.
English: 4.2 Indications for use, specifying the target species Sheep
Croatian: 4.2 Indikacije za upotrebu, navesti ciljne vrste životinja
English: Phosphate buffered saline (sodium chloride, disodium phosphate and potassium phosphate, water for injections)
Croatian: Tiomersal Fosfatna puferska fiziološka otopina (natrijev klorid, dinatrijev fosfat i kalijev fosfat, voda za injekcije)
English: Box of 1 bottle of 52 ml Box of 1 bottle of 100 ml Box of 1 bottle of 252 ml.
Croatian: Kutija s 1 bočicom od 52 ml Kutija s 1 bočicom od 100 ml Kutija s 1 bočicom od 252 ml.
English: The safety and efficacy of the vaccine has not been established in breeding males (sheep and cattle).
Croatian: Neškodljivost i djelotvornost cjepiva u rasplodnih mužjaka (u ovaca i goveda) nije utvrđena.
English: 31 days after the second dose.
Croatian: 31 dan nakon druge doze.
English: 20 days after the second dose.
Croatian: 20 dana nakon druge doze.
English: Avoid multiple vial broaching.
Croatian: Izbjegavajte višekratno probijanje bočice.
English: TARGET SPECIES
Croatian: CILJNE ŽIVOTINJSKE VRSTE
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 pri zbrinjavanju neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala nastalih primjenom takvog proizvoda
English: BLUEVAC BTV8 stimulates active immunity against bluetongue virus, serotype 8.
Croatian: BLUEVAC BTV8 potiče aktivni imunitet protiv virusa bolesti plavog jezika, serotip 8.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (52 ml, 100 ml and 252 ml)
Croatian: PODACI NA VANJSKOM PAKOVANJU Kartonska kutija (52 ml,100 ml i 252 ml)
English: Batch: {number}
Croatian: Lot: {broj}
English: Temporary local reactions can occur very rarely at the injection site in the form of a nodule of 0.5 to 1 cm in sheep and of 0.5 to 3 cm in cattle which disappears within 14 days, at the latest and which may be painful.
Croatian: U vrlo rijetkim slučajevima, se na mjestu injiciranja javljaju se privremene lokalne reakcije u obliku čvorića promjera od 0,5 do 1 cm u ovaca, odnosno od 0,5 do 3 cm u goveda, koji nestaje najkasnije u roku od 14 dana i koja može biti bolna.
English: High density polyethylene (HDPE) bottles of 52 ml, 100 ml or 252 ml with bromobutyl stoppers and aluminium seals.
Croatian: Bočice od polietilena visoke gustoće ( engl. high density polyethylene, HDPE) od 52 ml, 100 ml ili 252 ml s čepom od bromobutila i aluminijskim zatvaračem.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Croatian: 13. OZNAKA „SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U VEZI S OPSKRBOM I UPOTREBOM, ako je primjenjivo
English: Pregnancy: Can be used during pregnancy in ewes and cows.
Croatian: Graviditet: Dopuštena je primjena tijekom gravidnosti ovaca i krava.
English: Duration of immunity: 1 year after the second dose.
Croatian: Početak imuniteta: 20 dana nakon druge doze.
English: 4.5 Special precautions for use
Croatian: 4.5 Posebne mjere opreza pri upotrebi
English: Suspension for injection White or pinkish-white.
Croatian: Bijeli ili ružičast-bijelo.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: NAČIN I PUT(OVI) PRIMJENE
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Croatian: OZNAKA „SAMO ZA PRIMJENU NA ŽIVOTINJAMA”
English: Can be used during pregnancy in ewes and cows.
Croatian: Dopuštena je upotreba tijekom gravidnosti ovaca i krava.
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,
English: a) the administration of the product to animals will interfere with the implementation of a national programmes for the diagnosis, control and/or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Croatian: kontrolu ili iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja. b) je bolest, za koju je proizvod namijenjen da pruži imunost, u velikoj mjeri odsutna s odnosnog područja.
English: No information is available on the use of the vaccine in seropositive bovines, including those with maternally derived antibodies.
Croatian: Nisu dostupni podatci o upotrebi cjepiva u seropozitivnih goveda ni goveda s majčinskim protutijelima.
English: Each ml of vaccine contains: Bluetongue virus inactivated, serotype 8
Croatian: Svaki ml cjepiva sadržava: Inaktivirani virus bolesti plavog jezika, serotip 8
English: Store and transport refrigerated (2 ºC - 8 ºC).
Croatian: Skladištite i prevozite u hladnjaku (na temperaturi od 2ºC do 8ºC).
English: Sheep from 2.5 months of age: Administer two doses of 2 ml subcutaneously with a 3 week interval.
Croatian: Ovce u dobi od 2,5 mjeseci i više: Primijenite dvije doze po 2 ml potkožno u intervalu od 3 tjedna.
English: CLINICAL PARTICULARS 4.1 Target species
Croatian: 4.1 Ciljne životinjske vrste
English: 4.9 Amounts to be administered and administration route
Croatian: 4.9 Doziranje i put primjene
English: Special precautions for use in animals
Croatian: Posebne mjere opreza pri primjeni na životinjama
English: Tel.: + 34 986 33 04 00 Fax: + 34 986 33 65 77 czv@czveterinaria.com
Croatian: CZ Veterinaria, S.A. La Relva s/n, 36400 Porriño ŠPANJOLSKA Tel.: + 34 986 33 04 00 Faks: + 34 986 33 65 77 czv@czveterinaria.com
English: Bluetongue virus inactivated, serotype 8:
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 8:
English: BLUEVAC BTV8 suspension for injection for cattle and sheep
Croatian: BLUEVAC BTV8 suspenzija za injekcije za goveda i ovce
English: Cattle from 2.5 months of age: Administer two doses of 4 ml subcutaneously with a 3 week interval.
Croatian: Goveda u dobi od 2,5 mjeseci i više: Primijenite dvije doze po 4 ml potkožno u intervalu od 3 tjedna.
English: SPECIAL STORAGE CONDITIONS
Croatian: 11. POSEBNI UVJETI SKLADIŠTENJA
English: Occasionally a slight increase of the temperature (0.5 ºC - 1.0 ºC) is observed for 24-48 hours after the administration of a double dose of the vaccine.
Croatian: Ponekad se može primijetiti malo povećanje tjelesne temperature (od 0,5 ºC do1,0 ºC) u razdoblju od 24
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Croatian: 13. POSEBNE MJERE OPREZA PRI ZBRINJAVANJU NEUPOTREBLJENOG PROIZVODA ILI OTPADNIH TVARI, AKO POSTOJE
English: 6.5 Nature and composition of immediate packaging
Croatian: Vrsta i sastav unutarnjeg pakovanja
English: Pharmacotherapeutic group: Bluetongue virus vaccines, inactivated.
Croatian: Farmakoterapijska skupina: cjepiva protiv virusa bolesti plavog jezika, inaktivirana.
English: Special precautions for storage
Croatian: Posebne mjere opreza pri skladištenju
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVAR I PROIZVOĐAČ ODGOVORAN ZA
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: DODATAK I. SAŽETAK SVOJSTAVA PROIZVODA
English: PACKAGE LEAFLET: BLUEVAC BTV8 suspension for injection for cattle and sheep
Croatian: UPUTA O VMP: BLUEVAC BTV8 suspenzija za injekcije za goveda i ovce
English: Painless swellings occur occasionally with a size up to 2 cm in sheep and up to 4.5 cm in cattle after a double dose.
Croatian: Nakon primjene dvostruke doze ponekad se javljaju bezbolne otekline veličine do 2 cm u ovaca, odnosno do 4,5 cm u goveda.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Croatian: 14. DATUM ZADNJEG ODOBRENJA UPUTE O VMP
English: Cardboard box with 1 bottle containing either 126 sheep doses or 63 cattle doses (252 ml).
Croatian: kartonska kutija s 1 bočicom koja sadržava ili 26 doza za ovce ili 13 doza za goveda (52 ml). kartonska kutija s 1 bočicom koja sadržava ili 50 doza za ovce ili 25 doza za goveda (100 ml). kartonska kutija s 1 bočicom koja sadržava ili 126 doza za ovce ili 63 doze za goveda (252 ml).
English: ATCvet code: QI04AA02 (sheep) and QI02AA08 (cattle).
Croatian: Farmakoterapijska skupina: cjepivo protiv virusa bolesti plavog jezika, inaktivirano ATC vet kodovi: QI04AA02 (ovce) i QI02AA08 (goveda).
English: Primary vaccination:
Croatian: Osnovno cijepljenje
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za stavljanje serije u promet
English: Lactation: There is no negative impact on the milk yield using the vaccine in lactating ewes and cows.
Croatian: Primjena cjepiva ne utječe nepovoljno na mliječnost ovaca i krava tijekom laktacije.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 52 ml
Croatian: PODACI KOJI MORAJU BITI NAVEDENI NA MALIM UNUTARNJIM PAKIRANJIMA
English: For the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
Croatian: Za aktivnu imunizaciju ovaca u dobi od 2,5 mjeseci i više u cilju sprječavanja viremije* i smanjenja kliničkih znakova izazvanih virusom bolesti plavog jezika, serotip 8. *(ciklična vrijednost (Ct) ≥ 36 pri potvrdnoj metodi RT-PCR, pokazuje da virusni genom nije prisutan).
English: There is no negative impact on the milk yield using the vaccine in lactating ewes and cows.
Croatian: Upotreba cjepiva ne utječe nepovoljno na mliječnost ovaca i krava tijekom laktacije.
English: Excipients:
Croatian: Laktacija:
English: Read the package leaflet before use.
Croatian: Prije upotrebe pročitajte uputu o VMP.
English: For the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8.
Croatian: Za aktivnu imunizaciju goveda u dobi od 2,5 mjeseci i više u cilju sprječavanja viremije* izazvane virusom bolesti plavog jezika, serotip 8. *(ciklična vrijednost (Ct) ≥ 36 pri potvrdnoj metodi RT-PCR, pokazuje da virusni genom nije prisutan)
English: CZ Veterinaria, S.A. 36400 Porriño SPAIN
Croatian: CZ Veterinaria, S.A. 36400 Porriño ŠPANJOLSKA
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml and 252 ml
Croatian: Bočica od 100 ml i 252 ml
English: CZ Veterinaria, S.A. La Relva s/n, 36400 Porriño SPAIN
Croatian: CZ Veterinaria, S.A. La Relva s/n, 36400 Porriño ŠPANJOLSKA
English: 1 bottle + 1 syringe
Croatian: 1 bočica + 1 štrcaljka
English: Oral solution bottle (HDPE) 180 ml
Croatian: Oralna otopina bočica (HDPE) 180 ml
English: Package size
Croatian: Sastav Veličina pakiranja
English: Data, however, were not controlled.
Croatian: Međutim, podatci nisu bili kontrolirani.
English: Jatros Gastroenterol, 1993” (Study S2)”, and
Croatian: Jatros Gastroenterol, 1993” (ispitivanje S2), te
English: It is not life threatening but can significantly impact the quality of life of patients.
Croatian: Nije opasan po život, ali može značajno utjecati na kvalitetu života bolesnika.
English: Symbioflor 2 is currently used for the indications:
Croatian: Lijek Symbioflor 2 trenutačno se primjenjuje za indikacije:
English: The marketing authorisations were granted in Austria in 2000 (renewed on 12 February 2014) and in 2003 in Hungary (HU) respectively.
Croatian: Odobrenja za stavljanje lijeka u promet izdana su u Austriji 2000. (obnovljeno 12. veljače 2014.) i u Mađarskoj 2003.
English: Following the rejection of the application, the Marketing Authorisation Holder (MAH) requested to be granted a German National Marketing Authorisation on the basis that an authorisation had already been granted in another country of the European Union (Austria).
Croatian: Nakon odbijanja zahtjeva, nositelj odobrenja za stavljanje u promet zatražio je da mu se dodijeli nacionalno odobrenje za stavljanje lijeka u promet u Njemačkoj na osnovi odobrenja koje mu je već dodijeljeno u drugoj zemlji Europske unije (Austrija).
English: While several centres did not report any responder, the overall results were driven by one centre.
Croatian: Iako nekoliko centara nije prijavilo bolesnike s reakcijom, ukupni rezultati temeljili su se na jednom centru.
English: Symbioflor 2 has been marketed in Germany since 1954 and in Austria since 1975.
Croatian: Lijek Symbioflor 2 prisutan je na tržištu u Njemačkoj od 1954., a u Austriji od 1975.
English: The analyses showed statistical significant superiority of the active treatment over placebo in almost all endpoints evaluated.
Croatian: Analiza je pokazala statistički značajnu superiornost aktivnog liječenja u odnosu na placebo u gotovo svim ocijenjenim ishodima.