FrancophonIA/ELRC3.0 huggingface dataset:
English: Vaccination of FeLV positive cats is of no benefit.
Croatian: Cijepljenje FeLV pozitivnih mačaka nije od koristi.
English: This vaccine should not be handled by persons who are immunodeficient or taking immunosuppressive medicinal products.
Croatian: Ovim cjepivom ne smiju rukovati imunodeficijentne osobe ili osobe koje uzimaju imunosupresivne lijekove.
English: Use in healthy animals only.
Croatian: Upotrijebiti samo na zdravim životinjama.
English: * less than 1 animal in 10,000 animals displaying adverse reaction(s) during the course of one treatment, including isolated reports.
Croatian: * manje od 1 životinje na 10.000 životinja pokazalo je nuspojave tijekom jedne primjene , uključujući izolirane slučajeve.
English: EU/2/04/047/001 lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/047/002 lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Croatian: EU/2/04/047/001 Liofilizat (10 bočica s 1 dozom) + otapalo (10 bočica od 1 ml) EU/2/04/047/002 Liofilizat (50 bočica s 1 dozom) + otapalo (50 bočica od 1 ml)
English: Per dose of 1 ml: Lyophilisate:
Croatian: Po dozi od 1 ml: Liofilizat :
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti primijenjeno istog dana, ali ne pomiješano s cjepivom protiv bjesnoće tvrtke MERIAL.
English: In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
Croatian: U normalnim uvjetima primjene, povremeno se mogu javiti apatija i anoreksija, kao i hipertermija (u trajanju obično 1 ili 2 dana).
English: Manufacturer responsible for the batch release: MERIAL
Croatian: Nositelj odobrenja za proizvodnju odgovoran za puštanje proizvodne serije: MERIAL
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim otapalom za primjenu s proizvodom.
English: If self-injection occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydial vaccine has occurred.
Croatian: Ako dođe do samoinjiciranja, mora se odmah potražiti savjet liječnika, a liječnik mora biti obaviješten da je došlo do samoinjiciranja živim cjepivom protiv klamidije.
English: 4.5 Special precautions for use Special precautions for use in animals
Croatian: 4.5 Posebne mjere za primjenu Posebne mjere predostrožnost za primjenu na životinjama
English: The feline leukaemia vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A.
Croatian: Soj cjepiva protiv mačje leukemije je rekombinant virusa boginja kanarinca koji izražava env i gag gene virusa FeLV-A.
English: No effect other than those already mentioned in section on “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.
Croatian: Nisu primijećene nikakve druge nuspojave osim onih spomenutih u odjeljku “Nuspojave” nakon primjene nekoliko doza, te hipertermije koja može izuzetno trajati 5 dana.
English: It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
Croatian: Preporučuje se provesti testiranje na virus FeLV prije cijepljenja.
English: Where high levels of maternal antibodies against rhinotracheitis, calicivirosis, panleucopenia or Chlamydophila components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Croatian: kaliciviroze, panleukopenije ili Chlamydophila (npr. kod mačića u dobi 9-12 tjedana porijeklom od mačaka cijepljenih prije graviditeta i/ili s poznatim ili suspektnim prethodnim izlaganjem patogenima), prvo cijepljenje treba odgoditi do dobi od 12 tjedana.
English: Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme:
Croatian: Nakon rekonstitucije liofilizata s otapalom, injicirajte subkutano jednu dozu (1 ml) cjepiva, prema slijedećem rasporedu cijepljenja:
English: In very rare* cases, hyperthermia and lethargy sometimes associated with lameness has been observed one to three weeks following booster vaccination in adult cats.
Croatian: U vrlo rijetkim slučajevima* primijećena je hipertermija i letargija ponekad povezana sa šepanjem jedan do tri tjedna nakon revakcinacije u odraslih mačaka.
English: In very rare cases, hyperthermia and lethargy sometimes associated with lameness has been observed one to three weeks following booster vaccination in adult cats.
Croatian: U vrlo rijetkim slučajevima primijećena je hipertermija i letargija, ponekad povezana sa šepanjem jedan do tri tjedna nakon revakcinacije u odraslih mačaka.
English: Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the chlamydiosis and feline leukaemia components and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Croatian: Docjepljivanje: - prva revakcinacija mora se provesti za sve komponente jednu godinu nakon prvog cijepljenja, - naknadne revakcinacije moraju biti provedene svake godine za komponente klamidiozu i mačju leukemiju i u intervalima od najviše tri godine za komponente rinotraheitis, kalicivirozu, i panleukopeniju.
English: Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml of solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
Croatian: I staklena bočica s 1 ml otapala, obje zatvorene gumenim čepom i zapečaćeni aluminijskom kapicom.
English: Per dose of 1 ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
Croatian: Po dozi od 1 ml: FHV (soj F2) .................................................................................................................... ≥ 104,9 CCID50
English: The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis, calicivirosis and panleucopenia components, and 1 year for the Chlamydophila felis and feline leukaemia components.
Croatian: Trajnost imuniteta nakon zadnje re-vakcinacije je 3 godine za komponente rinotraheitisa, kaliciviroze i panleukopenije i 1 godinu za komponente Chlamydophila felis i leukemiju mačaka.
English: Excipient:
Croatian: Liofilizat :
English: Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection
Croatian: Purevax RCPCh FeLV liofilizat i otapalo za suspenziju za injekcije
English: Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection.
Croatian: Purevax RCPCh FeLV liofilizat i otapalo za suspenziju za injekcije.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate bottle
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Bočica s liofilizatom
English: FeLV recombinant canarypox virus (vCP97)................................................................... ≥ 107.2 CCID50.
Croatian: FeLV rekombiniran s virusom boginja kanarinca (vCP97) ............................................. ≥ 107,2 CCID50
English: Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus, Chlamydophila felis, feline panleucopenia virus and feline leukaemia virus.
Croatian: Potiče aktivni imunitet protiv virusnog rinotraheitisa mačaka uzrokovanog herpes virusom, kaliciviroze mačaka, Chlamydophilia felis, panleukopenije mačaka i virusa mačje leukemije.
English: Gentamicin, at most .......................................................................................................................... 34 µg Solvent:
Croatian: Gentamicin, najviše ......................................................................................................................... 34 µg Otapalo:
English: 2 egg infective dose 50%.
Croatian: 1 količina virusa koja zarazi 50 posto stanica kulture u koju je dodan virus 2 količina virusa koja zarazi 50 posto oplođenih jaja u koja se virus ucijepi
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja)
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) ...................................................................... ≥ 103.0 EID502 Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Croatian: Atenuirana Chlamydophila felis (soj 905) ......................................................................... ≥ 103,0 EID502 Atenuirani virus panleukopenije mačaka (PLI IV) ......................................................... ≥ 103,5 CCID501
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.
Croatian: Pokazalo se da imunitet nastupa 1 tjedan nakon prvog cijepljenja protiv rinotraheitisa, kalicivirusa, Chlamydophila felis i panleukopenije,te 2 tjedna nakon prvog cijepljenja protiv leukemije mačaka.
English: Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate
Croatian: Dinatrij hidrogen ortofosfat Monokalij fosfat anhidrid Natrijev klorid Dinatrij fosfat dihidrat Magnezij klorid heksahidrat Kacij klorid dihidrat
English: FeLV recombinant canarypox virus (vCP97) .................................................................. ≥ 107.2 CCID501 1 cell culture infective dose 50%
Croatian: FeLV rekombiniran s virusom boginja kanarinca (vCP97) ............................................ ≥ 107,2 CCID501
English: Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent.
Croatian: Pakovanje sadrži 10 bočica s 1 dozom liofilizata i 10 bočica s 1 ml otapala Pakovanje sadrži 50 bočica s 1 dozom liofilizata i 50 bočica s 1 ml otapala
English: Gentamicin, at most .......................................................................................................................... 34 µg
Croatian: Gentamicin, najviše .......................................................................................................................... 34 µg
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against Chlamydophila felis infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs, - against leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Croatian: - protiv panleukopenije mačaka za sprječavanje smrtnosti i kliničkih znakova.protiv leukemije mačaka za sprječavanje trajne viremije i kliničkih simptoma bolesti.
English: Casein hydrolysate Collagen hydrolysate Dipotassium phosphate Potassium dihydrogen phosphate Potassium hydroxide Sodium chloride
Croatian: Kalij dihidrogen fosfat Kalij hidroksid Natrij klorid
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) ...................................................................... ≥ 103.0 EID502 Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Croatian: Inaktivirani antigeni kalicivirus mačaka (soj FCV 431 i FCV G1) ................................
English: Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous Potassium chloride
Croatian: Kazein hidrolizat Kolagen hidrolizat Dikalij fosfat
English: SPECIAL STORAGE CONDITIONS
Croatian: Popis pomoćnih tvari
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis, chlamydiosis, feline panleucopenia and feline leukaemia.
Croatian: Cjepivo protiv virusnog rinotraheitisa mačaka, kaliciviroze mačaka, klamidioze mačaka, panleukopenije i mačje leukemije.
English: The second injection is given three to four weeks later.
Croatian: Druga se injekcija daje tri do četiri tjedna kasnije.
English: As the company had supplied additional information requested, the ‘exceptional circumstances' ended on 6 May 2013.
Croatian: Budući da je tvrtka dostavila dodatne zatražene informacije, „iznimne okolnosti” su prestale 6. svibnja 2013.
English: Further information on BTVPUR can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Više informacija o VMP-u BTVPUR nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The vaccine is given to young animals as two injections under the skin.
Croatian: Cjepivo se daje mladim životinjama tako da im se ubrizgaju dvije injekcije pod kožu.
English: There can also be a slight rise in body temperature, usually of no more than 1 °C, in the 24 hours following vaccination.
Croatian: Može doći i do blagog povišenja tjelesne temperature, obično ne za više od 1°C, 24 sata nakon cijepljenja.
English: BTVPUR is a vaccine.
Croatian: BTVPUR je cjepivo.
English: What is BTVPUR and what is it used for?
Croatian: Što je BTVPUR i za što se primjenjuje?
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) that enhance the response of the immune system.
Croatian: Cjepivo također sadržava „adjuvanse” (aluminijev hidroksid i saponin) kako bi se pojačao odgovor imunosnog sustava.
English: Vaccination may be followed by a small local swelling at the injection site, which normally resolves within five weeks.
Croatian: Nakon cijepljenja može se pojaviti mali otok na mjestu injekcije, koji se obično povlači u roku od pet tjedana.
English: This overview was last updated in June 2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 6. 2018.
English: BTVPUR is developed using data from the vaccine BTVPUR AlSap 1-8 originally authorised under ‘exceptional circumstances' on 17 December 2010 because limited information was available at the time of approval.
Croatian: VMP BTVPUR razvijen je iz cjepiva BTVPUR AlSap 1 - 8, koji je izvorno odobren u „iznimnim okolnostima” 17. prosinca 2010. jer su u trenutku izdavanja odobrenja bile dostupne ograničene informacije.
English: The withdrawal period for meat and milk from sheep and cattle treated with BTVPUR is ‘zero' days, which means that there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso i mlijeko goveda liječenih VMPom BTVPUR iznosi „nula” dana, odnosno nema obveznog razdoblja čekanja.
English: In 2018 a fourth possible serotype was added still with one or two serotypes selected depending on the need.
Croatian: U 2018. dodan je četvrti mogući serotip još uvijek s jednim ili dva moguća serotipa odabrana prema potrebi.
English: Previously known as BTVPUR AlSap 1-8 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: Prethodno poznat kao BTVPUR AlSap 1 - 8 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom plavog jezika, njihov će imunosni sustav brže moći proizvesti protutijela.
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease.
Croatian: Cjepivo se primjenjuje radi sprječavanja viremije (prisutnosti virusa u krvi) i ublažavanja znakova bolesti.
English: Why is BTVPUR authorised in the EU?
Croatian: Zašto je BTVPUR odobren u EU-u?
English: The studies also showed that the vaccine can be used in pregnant and lactating sheep and cattle.
Croatian: Ispitivanja su također pokazala da se cjepivo može primjenjivati tijekom graviditeta i dojenja u ovaca i goveda.
English: Other information about BTVPUR:
Croatian: Ostale informacije o VMP-u BTVPUR
English: When it is given to sheep and cattle, the animals' immune systems recognise the viruses as ‘foreign' and make antibodies against them.
Croatian: Kada se cjepivo daje ovcama ili govedima, imunosni sustav životinje prepoznaje virus kao „strano tijelo” i proizvodi protutijela za njega.
English: BTVPUR contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Croatian: BTVPUR sadržava viruse bolesti plavog jezika koji su inaktivirani kako ne bi mogli uzrokovati bolest.
English: The vaccine contains inactivated (killed) bluetongue virus.
Croatian: Cjepivo sadrži inaktivirani (umrtvljeni) virus bolesti plavog jezika.
English: What are the risks associated with BTVPUR?
Croatian: Koji su rizici povezani s VMP-om BTVPUR?
English: For a vaccine containing only bluetongue virus serotype 2 or 4 (or both together) in sheep, one injection is sufficient.
Croatian: Za cjepivo koje sadržava samo serotipove 2 ili 4 (ili oba zajedno) virusa bolesti plavog jezika koje se primjenjuje u ovaca dovoljna je jedna injekcija.
English: The company also presented results from a series of studies conducted with vaccines of similar composition but including different serotypes from the ones in BTVPUR to provide supportive information that could be used to calculate the effectiveness of the vaccine.
Croatian: 4. Tvrtka je također predočila rezultate niza ispitivanja provedenih uz primjenu cjepiva sličnog sastava, koja su uključivala različite serotipove od onih sadržanih u VMP-u BTVPUR kako bi se osigurale dodatne informacije koje se mogu upotrebljavati za određivanje djelotvornosti cjepiva.
English: An overview of BTVPUR and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u BTVPUR i zašto je odobren u EU-u
English: The European Medicines Agency decided that BTVPUR's benefits are greater that its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od VMP-a BTVPUR nadmašuju s njim povezane rizike te da se VMP može odobriti za primjenu u Europskoj uniji.
English: BTVPUR received a marketing authorisation valid throughout the EU on 12 April 2016.
Croatian: VMP BTVPUR je dobio odobrenje za stavljanje u promet koje vrijedi na prostoru EU-a od 12. travnja
English: For more information about using BTVPUR see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a BTVPUR pogledajte uputu o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: BTVPUR is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Croatian: BTVPUR je cjepivo koje se primjenjuje u ovaca i goveda radi zaštite od bolesti plavog jezika, infekcije koju uzrokuje virus bolesti plavog jezika koji prenose mušice.
English: In 2016 the CVMP considered that data submitted allowed BTVPUR AlSap 1-8 to convert to a BTVPUR vaccine based on three possible serotypes with one or two serotypes selected depending on the need.
Croatian: CVMP je smatrao da su podneseni podatci dovoljni da se dopusti da se BTVPUR AlSap 1 - 8 pretvori u cjepivo BTVPUR na osnovi triju mogućih serotipova od kojih se, prema potrebi, odabire jedan serotip ili dva.
English: The first injection is given from one month of age in animals that have never been exposed to the disease, and from two-and-a-half months if the animal's mother is already immune to the disease and has bluetongue virus antibodies.
Croatian: U životinja koje nikada nisu bile izložene bolesti prva se injekcija daje u dobi od mjesec dana, a ako im je majka već imuna na bolest i ima protutijela virusa bolesti plavog jezika daje se u dobi od najmanje dva i pol mjeseca.
English: BTVPUR contains bluetongue virus of one or two types selected from serotypes 1, 2, 4 and 8.
Croatian: BTVPUR sadržava virus bolesti plavog jezika jednog ili dvaju serotipova odabranih među serotipovima 1, 2, 4 i 8.
English: How does BTVPUR work?
Croatian: Kako djeluje BTVPUR?
English: The variety (serotype) of the virus in the vaccine is selected depending on which serotypes are circulating and causing disease at the time of manufacture, so it may contain serotype 1, 2, 4 or 8 or a combination of any two of these.
Croatian: Odabir serotipa virusa u cjepivu ovisi o tome koji serotipovi cirkuliraju i uzrokuju bolest u vrijeme proizvodnje lijeka i stoga cjepivo može sadržavati serotipove 1, 2, 4 ili 8 ili kombinaciju bilo koja dva od tih serotipova.
English: What benefits of BTVPUR have been shown in studies?
Croatian: Koje su koristi od VMP-a BTVPUR utvrđene u ispitivanjima?
English: The studies showed that the vaccine is safe for sheep and cattle and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotypes 1, 4 and 8.
Croatian: Ispitivanja su pokazala da je cjepivo sigurno za ovce i goveda te da ublažuje znakove bolesti i sprječava viremiju u životinja u dobi od mjesec dana koje su zaražene virusom bolesti plavog jezika serotipova 1, 4 i 8.
English: The studies also showed that the vaccine reduces the signs of the disease in sheep and prevents viraemia in sheep and cattle from one month of age that are infected with bluetongue virus serotype 2.
Croatian: Ispitivanja su također pokazala da cjepivo ublažuje znakove bolesti u ovaca i sprječava viremiju u ovaca i goveda u dobi od mjesec dana koje su zaražene virusom bolesti plavog jezika serotipa 2.
English: (Bluetongue virus inactivated vaccine containing either serotype 1, 2, 4 or 8 or a combination of any two)
Croatian: BTVPUR1 (inaktivirano cjepivo protiv virusa bolesti plavog jezika koje sadržava serotipove 1, 2, 4 ili 8 ili kombinaciju bilo koja dva)
English: Further laboratory studies were conducted in calves using a vaccine containing bluetongue serotype 2 and in sheep and calves using a vaccine containing bluetongue serotype 4.
Croatian: Dodatna laboratorijska ispitivanja provedena su na teladi primjenom cjepiva koje sadržava virus bolesti plavog jezika serotipa 2 te na ovcama i teladi primjenom cjepiva koje sadržava virus bolesti plavog jezika serotipa
English: How is BTVPUR used?
Croatian: Kako se BTVPUR primjenjuje?
English: The effectiveness of the vaccine was studied in laboratory studies using vaccines containing bluetongue serotype 1, bluetongue serotype 8, or both, in sheep and cattle of young age.
Croatian: Djelotvornost cjepiva ispitivana je u okviru laboratorijskih ispitivanja na mladim ovcama i govedima u kojima su se primjenjivala cjepiva koja sadržavaju virus bolesti plavog jezika serotipa 1, virus bolesti plavog jezika serotipa 8 ili oba.
English: In the future, if the animals are exposed to the bluetongue virus, their immune system will be able to produce antibodies more quickly.
Croatian: Kad životinje ubuduće budu izložene virusu bolesti
English: It spreads rapidly around the world.
Croatian: Brzo se širi svijetom.
English: Adults from the age of 18 years:
Croatian: Odrasle osobe starije od 18 godina:
English: - This vaccine has been prescribed for you only.
Croatian: Ovo cjepivo propisano je samo Vama.