FrancophonIA/ELRC3.0 huggingface dataset:
English: Fidaxomicin had no effects on fertility when evaluated in rats (see section 5.3).
Croatian: U ispitivanjima na štakorima, fidaksomicin nije imao utjecaja na plodnost (vidjeti dio 5.3).
English: Inflammatory bowel disease
Croatian: Upalna bolest crijeva
English: If you use one of these medicines, please ask your doctor for advice before taking this medicine.
Croatian: Ako uzimate neki od ovih lijekova, molimo obratite se svom liječniku za savjet prije nego što uzmete ovaj lijek.
English: It interferes with RNA polymerase at a distinct site from that of rifamycins.
Croatian: Fidaksomicin ometa RNK-polimerazu na različitom mjestu od rifamicina.
English: Fidaxomicin does not have a clinically significant effect on the exposure of rosuvastatin, a substrate for the transporters OATP2B1 and BCRP.
Croatian: Fidaksomicin nema klinički značajan učinak na izloženost rosuvastatinu, supstratu za prijenosnike OATP2B1 i BCRP.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Na zahtjev Europske agencije za lijekove; • Prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG} Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: − The active substance is fidaxomicin.
Croatian: Djelatna tvar je fidaksomicin.
English: Data from an open label, single arm study in CDI patients with concomitant inflammatory bowel disease (IBD) indicated no major difference in plasma concentrations of fidaxomicin or its main metabolite OP-1118 in patients with IBD as compared with patients without IBD in other studies.
Croatian: Podaci iz otvorenog ispitivanja s jednom skupinom, provedenog u bolesnika s infekcijom uzrokovanom bakterijom C. difficile i istodobnom upalnom bolešću crijeva, nisu ukazali na značajnu razliku u koncentracijama fidaksomicina ili njegova glavnog metabolita OP-1118 u plazmi bolesnika s upalnom bolešću crijeva u usporedbi s bolesnicima bez upalne bolesti crijeva u drugim ispitivanjima.
English: No extensive analysis of metabolites in plasma has been performed, due to low levels of systemic absorption of fidaxomicin.
Croatian: Zbog niske razine sistemske apsorpcije fidaksomicina, nije provedena opsežna analiza metabolita u plazmi.
English: Fidaxomicin has been shown to inhibit C. difficile sporulation in vitro.
Croatian: Pokazalo se da fidaksomicin in vitro inhibira stvaranje spora C. difficile.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Astellas Pharma Europe B.V.
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Astellas Pharma Europe B.V.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of fidaxomicin.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 200 mg fidaksomicina.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Učinak P-gp inhibitora na fidaksomicin
English: Hypersensitivity reactions including severe angioedema have been reported (see section 4.8).
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Prijavljene su reakcije preosjetljivosti koje uključuju teški angioedem (vidjeti dio 4.8).
English: Gastrointestinal disorders vomiting, nausea, constipation abdominal distention, flatulence, dry mouth
Croatian: zatvor distenzija trbuha, flatulencija, suha usta
English: Fidaxomicin may be a mild to moderate inhibitor of intestinal P-gp.
Croatian: Fidaksomicin može blago do umjereno inhibirati crijevni P-gp.
English: Limited data from patients with an active history of chronic hepatic cirrhosis in the Phase 3 studies showed that median plasma levels of fidaxomicin and OP-1118 may be approximately 2- and 3-fold higher, respectively, than in non-cirrhotic patients.
Croatian: Ograničeni podaci prikupljeni u ispitivanjima faze III u bolesnika koji su imali aktivnu kroničnu cirozu jetre pokazali su da medijan koncentracija fidaksomicina u plazmi može biti približno dvaput, a metabolita OP-1118 približno triput veći nego u bolesnika bez ciroze.
English: Co-administration of potent P-glycoprotein inhibitors such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see sections 4.5 and 5.2).
Croatian: ketokonazol, eritromicin, klaritromicin, verapamil, dronedaron i amiodaron (vidjeti dijelove 4.5 i 5.2).
English: In CDI patients, average peak plasma levels of fidaxomicin and its main metabolite OP-1118 tend to be 2- to 6-fold higher than in healthy adults.
Croatian: U bolesnika s infekcijom uzrokovanom C. difficile, prosječne vršne koncentracije fidaksomicina i njegovog metabolita OP-1118 u plazmi znaju biti dvostruko do šesterostruko više nego u zdravih odraslih osoba.
English: NN:
Croatian: Tel.:
English: Due to limited clinical data, fidaxomicin should be used with caution in patients with severe renal impairment or moderate to severe hepatic impairment (see section 5.2).
Croatian: Zbog ograničenih kliničkih podataka, fidaksomicin treba primjenjivati s oprezom u bolesnika s teškim oštećenjem funkcije bubrega ili umjerenim do teškim oštećenjem funkcije jetre (vidjeti dio 5.2).
English: If you have kidney or liver problems, ask your doctor for advice before using this medicine.
Croatian: Ako imate tegobe s bubrezima ili jetrom, potražite savjet svog liječnika prije uzimanja ovog lijeka.
English: 100 x 1 film-coated tablet in alu/alu perforated unit dose blisters.
Croatian: 100 x 1 filmom obložena tableta u Al/Al perforiranim blisterima djeljivima na jedinične doze.
English: Due to the limited clinical data in this population, DIFICLIR should be used with caution in patients with severe renal impairment (see sections 4.4 and
Croatian: Zbog ograničenih kliničkih podataka u ove populacije, DIFICLIR treba primjenjivati s oprezom u bolesnika s teškim oštećenjem funkcije bubrega (vidjeti dijelove 4.4 i 5.2).
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U
English: DIFICLIR 200 mg film-coated tablets Fidaxomicin
Croatian: DIFICLIR 200 mg filmom obložene tablete fidaksomicin
English: 20 x 1 film-coated tablet in alu/alu perforated unit dose blisters.
Croatian: 20 x 1 filmom obložena tableta u Al/Al perforiranim blisterima djeljivima na jedinične doze.
English: Each film-coated tablet contains 200 mg of fidaxomicin.
Croatian: Jedna filmom obložena tableta sadrži 200 mg fidaksomicina.
English: − The other ingredients are: Tablet core: microcrystalline cellulose, pregelatinised starch, hydroxypropyl cellulose, butylated hydroxytoluene, sodium starch glycolate and magnesium stearate Coating: polyvinyl alcohol, titanium dioxide (E171), talc, polyethylene glycol and lecithin (soy)
Croatian: Drugi sastojci su: Jezgra tablete: mikrokristalična celuloza, prethodno gelirani škrob, hidroksipropilceluloza, butilhidroksitoluen, natrijev škroboglikolat i magnezijev stearat.
English: If such reaction occurs, stop taking DIFICLIR and seek medical advice urgently from your doctor, pharmacist or at your local hospital emergency department.
Croatian: Ukoliko se pojave ovakve reakcije, prekinite uzimanje DIFICLIR-a i potražite hitni medicinski savjet od Vašeg liječnika,
English: Due to limited clinical data, fidaxomicin should be used with caution in patients with pseudomembranous colitis, fulminant or life threatening CDI.
Croatian: Zbog ograničenih kliničkih podataka, fidaksomicin treba primjenjivati s oprezom u bolesnika s pseudomembranoznim kolitisom, fulminantnom ili životno opasnom infekcijom uzrokovanom bakterijom C. difficile.
English: − clarithromycin (a medicine used to treat chest infections, throat and sinus infections, skin and tissue infections and Helicobacter pylori infections associated with duodenal or stomach ulcer)
Croatian: infekcija kože i tkiva i infekcija bakterijom Helicobacter pylori povezanih s vrijedom na dvanaesniku ili želucu)
English: Warnings and precautions Talk to your doctor or pharmacist before taking DIFICLIR.
Croatian: Razgovarajte sa svojim liječnikom ili ljekarnikom prije nego što počnete uzimati DIFICLIR.
English: As the clinical relevance of this increase in exposure is unclear, co-administration of potent inhibitors of P-gp, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see section 4.4 and 5.2).
Croatian: Budući da klinička važnost ovog povećanja izloženosti nije jasna, ne preporučuje se istovremena primjena jakih inhibitora P-gp-a, kao što su ciklosporin, ketokonazol,
English: Fidaxomicin is a substrate of P-gp.
Croatian: Fidaksomicin je supstrat P-gp-a.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Croatian: Kako čuvati DIFICLIR Lijek čuvajte izvan pogleda i dohvata djece.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA
English: If you are breastfeeding ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako dojite, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: Method of administration DIFICLIR is intended for oral use.
Croatian: DIFICLIR je namijenjen za peroralnu primjenu.
English: The maximum fidaxomicin and OP-1118 plasma levels in CDI patients with concomitant IBD were within the range of levels found in CDI patients without IBD.
Croatian: Maksimalne koncentracije fidaksomicina i OP-1118 u plazmi bolesnika s infekcijom uzrokovanom bakterijom C. difficile i istodobnom upalnom bolešću crijeva bile su unutar raspona vrijednosti zabilježenih u bolesnika s infekcijom uzrokovanom bakterijom C. difficile koji nisu imali upalnu bolest crijeva.
English: DIFICLIR is indicated in adults for the treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) (see section 5.1).
Croatian: također poznate pod nazivom proljev uzrokovan C. difficile (vidjeti dio 5.1).
English: Fidaxomicin and the metabolite OP-1118 are substrates of P-gp.
Croatian: OP-1118 supstrati su P-gp.
English: NAME OF THE MEDICINAL PRODUCT DIFICLIR 200 mg film-coated tablets fidaxomicin
Croatian: NAZIV LIJEKA DIFICLIR 200 mg filmom obložene tablete
English: How to store DIFICLIR
Croatian: Moguće nuspojave Kako čuvati DIFICLIR
English: DIFICLIR is an antibiotic which contains the active substance fidaxomicin.
Croatian: Sadržaj pakiranja i druge informacije Što je DIFICLIR i za što se koristi DIFICLIR je antibiotik koji sadrži djelatnu tvar fidaksomicin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 200 mg of fidaxomicin.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 200 mg fidaksomicina.
English: − rash, itching (pruritus)
Croatian: (alanin aminotransferaza) − osip, svrbež (pruritus)
English: What DIFICLIR is and what it is used for What you need to know before you take DIFICLIR How to take DIFICLIR
Croatian: Što se nalazi u ovoj uputi: Što je DIFICLIR i za što se koristi
English: Tel: +386 (0) 1 401 1400
Croatian: Astellas Pharma d.o.o. Tel: +386 (0) 1 401 1400
English: Tel: +420 236 080300
Croatian: Astellas Pharma s.r.o. Tel: +420 236 080300
English: Astellas Pharma B.V. Tel: +31 (0)71 5455745
Croatian: Tel: +31 (0)71 5455745
English: Astellas Pharma s.r.o.
Croatian: Astellas Pharma S.p.A.
English: Only very low levels of OP-1118 and no fidaxomicin was detectable in human urine.
Croatian: Fidaksomicin nije utvrđen u ljudskoj mokraći, dok je OP-1118 utvrđen samo u vrlo niskim koncentracijama.
English: Astellas Pharma Ges.m.b.H.
Croatian: Astellas Pharma B.V.
English: Astellas Pharma S.p.A. Tel: +39 02 921381
Croatian: Tel: +39 02 921381
English: Marketing Authorisation Holder Astellas Pharma Europe B.V. Sylviusweg 62
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Astellas Pharma Europe B.V.
English: Astellas Pharma Co. Ltd. Tel: +353 (0)1 4671555
Croatian: Astellas Pharma Ges.m.b.H. Tel: +43 (0)1 8772668
English: Tel.: +48 225451 111
Croatian: Astellas Pharma Sp. z o.o. Tel.: +48 225451 111
English: Slovenská republika Astellas Pharma s.r.o.
Croatian: Magyarország Astellas Pharma Kft.
English: E.J.
Croatian: {MM/GGGG}
English: This will help protect them against the disease.
Croatian: To će im pomoći pri njihovoj zaštiti od bolesti.
English: This summary was last updated in September 2015.
Croatian: Ovaj sažetak je posljednji put ažuriran u rujnu 2015.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Croatian: Cjepiva djeluju „učeći“ imunosni sustav (prirodnu obranu tijela) kako se obraniti protiv bolesti.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Croatian: Cjepivo sadrži i „adjuvans“ (aluminij hidroksid i saponin) kako bi se pojačao imunosni odgovor.
English: The full EPAR for Zulvac SBV can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za Zulvac SBV nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: In the future if the animals are exposed to Schmallenberg virus, the immune system will be able to produce antibodies more quickly.
Croatian: Kad životinja ubuduće bude izložena Schmallenberg virusu, imunosni će sustav brže moći proizvesti antitijela.
English: When it is given to cattle or sheep, the animals' immune system recognises the virus as foreign and makes antibodies against it.
Croatian: Kada se cjepivo daje govedima ili ovcama, imunosni sustav životinje prepoznaje virus kao „strano tijelo“ i proizvodi antitijela protiv njega.
English: Zulvac SBV is a veterinary vaccine used to protect cattle and sheep from 3.5 months of age against Schmallenberg virus by reducing viraemia (presence of virus in the blood).
Croatian: Zulvac SBV je veterinarsko cjepivo koje se koristi za zaštitu goveda i ovaca od 3,5 mjeseca starosti od Schmallenberg virusa, smanjujući viremiju (prisutnost virusa u krvi).
English: Schmallenberg virus vaccine (inactivated)
Croatian: Cjepivo protiv Schmallenberg virusa (inaktivirano)
English: The withdrawal period for meat from cattle and sheep treated with Zulvac SBV is ‘zero' days, which means there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso goveda i ovaca liječenih VMP-om Zulvac SBV iznosi „nula” dana, drugim riječima, nema obaveznog razdoblja čekanja.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zulvac SBV on 6 February 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Zulvac SBV na snazi u Europskoj uniji od 6. veljače 2015.
English: In pregnant ewes vaccination reduced viraemia and infection of the embryo.
Croatian: U gravidnih ovaca cijepljenje je smanjilo viremiju i infekciju embrija.
English: Zulvac SBV contains Schmallenberg virus that has been inactivated so that it cannot cause disease.
Croatian: Zulvac SBV sadrži Schmallenberg virus koji je inaktiviran tako da ne može uzrokovati bolest.
English: Zulvac SBV is available as a suspension for injection and can only be obtained with a prescription.
Croatian: Zulvac SBV dostupan je kao suspenzija za injekciju i izdaje se samo na recept.
English: The effectiveness of Zulvac SBV has been investigated in laboratory studies in cattle and sheep.
Croatian: Djelotvornost cjepiva Zulvac SBV ispitana je u laboratorijskim ispitivanjima u goveda i ovaca.
English: Schmallenberg virus is transmitted by midges and causes stillbirths and birth defects in cattle and sheep.
Croatian: Schmallenberg virus prenosi se mušicama i uzrokuje mrtvorođenja i porođajne anomalije u mladunčadi goveda i ovaca.
English: The animals were vaccinated according to the vaccination schedule and were then exposed to the Schmallenberg virus.
Croatian: Životinje su cijepljene sukladno rasporedu za cijepljenje i potom izložene Schmallenberg virusu.
English: Zulvac SBV contains the active substance inactivated (killed) Schmallenberg virus strain BH80/11-4.
Croatian: Zulvac SBV sadrži aktivnu tvar koja se sastoji od inaktiviranog (ubijenog) soja Schmallenberg virusa BH80/11-4.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: U slučaju nehotičnog samoinjektiranja potrebno je odmah potražiti liječnički savjet te liječniku pokazati uputu o proizvodu ili etiketu VMP-a.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Zulvac SBV's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od veterinarsko-medicinskog proizvoda Zulvac SBV nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: The vaccine is given to cattle as two injections of 2 ml into the neck muscle three weeks apart and to sheep as a single injection of 1 ml under the skin behind the elbow.
Croatian: Cjepivo se primjenjuje u goveda kao dvije injekcije od 2 ml u mišić vrata u razmaku od 3 tjedna, a u ovaca kao jedna injekcija od 1°ml pod kožu iza zgloba.
English: For female sheep vaccination should be at least two weeks before breeding to reduce viraemia (virus in the blood) and infection of the embryo during the first trimester of pregnancy.
Croatian: U slučaju ženskih ovaca cijepljenje treba završiti najmanje dva tjedna prije rasploda kako bi se smanjila viremija (virus u krvi) te infekcija embrija tijekom prvog trimestra gravidnosti.
English: It is not intended to provide practical advice on how to use Zulvac SBV.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Zulvac SBV.
English: This is a summary of the European public assessment report (EPAR) for Zulvac SBV.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni (EPAR) veterinarsko-medicinskog proizvoda Zulvac SBV.
English: What is Zulvac SBV and what is it used for?
Croatian: Što je Zulvac SBV i za što se koristi?
English: Zulvac SBV is a vaccine.
Croatian: Zulvac SBV je cjepivo.
English: Other information about Zulvac SBV:
Croatian: Ostale informacije o VPM-u Zulvac SBV:
English: For booster vaccination in cattle two injections of 2 ml should be given three weeks apart every 12 months.
Croatian: Kod dodatnih cjepiva u goveda trebaju se primijeniti dvije injekcije od 2 ml u razmaku od tri tjedna svakih 12 mjeseci.
English: For booster vaccination in non-breeding sheep a single injection of 1 ml should be given every six months whilst in female breeding sheep a single injection of 1 ml should be given at least two weeks before breeding.
Croatian: U slučaju dodatnih cjepiva u ovaca koje se ne koriste za rasplod treba primijeniti jednu injekciju od 1 ml svakih šest mjeseci, dok u ženki ovaca koje se koriste za rasplod treba primijeniti jednu injekciju od 1°ml najmanje dva tjedna prije rasploda.
English: In pregnant ewes more than one in ten animals may have an increase in body temperature of up to 0.8 °C during 4 hours after vaccination.
Croatian: U gravidnih ovaca više od jedne u deset životinja mogu imati povišenje tjelesne temperature do 0,8 °C tijekom 4 sata nakon cijepljenja.
English: Why is Zulvac SBV approved?
Croatian: Zašto je Zulvac SBV odobren?
English: In sheep protection starts three weeks after vaccination and lasts six months.
Croatian: Imunizacija ovaca nastupa tri tjedna nakon cijepljenja i traje šest mjeseci.
English: What are the risks associated with Zulvac SBV?
Croatian: Koji su rizici povezani s lijekom Zulvac SBV?
English: More than one in ten animals may show swellings or lumps of up to 8 cm in diameter under the skin at the injection site, which may last for at least 97 days as granules less than 0.5 cm in diameter.
Croatian: Više od jedne na deset životinja mogu pokazivati otoke ili kvržice promjera do 8 cm ispod kože u mjestu injekcije, koji mogu trajati najmanje 97 dana kao granule manje od 0,5 cm u promjeru.
English: In cattle protection starts two weeks after vaccination and lasts 12 months.
Croatian: Imunizacija goveda nastupa dva tjedna nakon cijepljenja i traje 12 mjeseci.
English: In sheep more than one in ten animals may have an increase in body temperature of up to 1.5 °C during the 24 hours after vaccination.
Croatian: U slučaju ovaca, više od jedne na deset životinja može imati povišenje tjelesne temperature do 1,5 °C tijekom 24 sata nakon cijepljenja.
English: For more information about treatment with Zulvac SBV, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Zulvac SBV vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: For practical information about using Zulvac SBV, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Zulvac SBV vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svom veterinaru ili ljekarniku.
English: More than one in ten animals may show swellings or lumps of up to 8 cm in diameter under the skin at the injection site, and swellings less than 2 cm in diameter may last for at least 47 days.
Croatian: Više od jedne na deset životinja mogu pokazivati otoke ili kvržice promjera do 8 cm ispod kože u mjestu injekcije te otoke manje od 2 cm u promjeru, koji mogu trajati najmanje 47 dana.
English: How does Zulvac SBV work?
Croatian: Kako djeluje Zulvac SBV?
English: In cattle, an increase in body temperature of up to 1.5°C during the 48 hours after vaccination and the appearance of small lumps of up to 0.7 cm in diameter at the vaccination site that resolve within 10 days are very common (seen in more than 1 animal in 10).
Croatian: U goveda je vrlo često (uočeno u više od 1 na 10 životinja) povišenje tjelesne temperature za do 1,5°C tijekom 48 sati nakon cijepljenja kao i pojavljivanje malih kvržica promijera do 0,7 cm na mjestu cijepljenja koje nestaju nakon 10 dana.
English: What benefits of Zulvac SBV have been shown in studies?
Croatian: Koje su koristi VMP-a Zulvac SBV utvrđene u ispitivanjima?
English: The main measure of effectiveness was absence of viraemia following exposure to the virus.The studies showed that Zulvac SBV protects cattle two weeks and sheep three weeks after vaccination.
Croatian: Ispitivanja su utvrdila da Zulvac SBV stvara imunizaciju u goveda nakon dva tjedna, tj. u ovaca tri tjedna nakon cijepljenja.
English: How is Zulvac SBV used?
Croatian: Kako se Zulvac SBV koristi?
English: EU/1/09/600/001
Croatian: EMEA/H/C/001089/0000/001 Zutectra
English: 500 IU Solution for injection
Croatian: 500 IU Otopina za injekciju
English: Invented name Strength Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik Put primjene
English: 5 pre-filled syringes
Croatian: 5 štrcaljki s uloškom
English: Pre-filled syringe (glass) 1 ml
Croatian: Potkožna primjena Štrcaljka s uloškom (staklo)
English: No specific measures are usually required.
Croatian: Obično nisu potrebne specifične mjere.
English: Before you start
Croatian: Prije nego počnete
English: Your doctor will tell you the exact date and time.
Croatian: Liječnik će Vam reći točan datum i vrijeme.
English: If blood appears:
Croatian: Ako se pojavi krv: