FrancophonIA/ELRC3.0 huggingface dataset:
English: In in vivo models the no effect levels for QTc prolongation in dogs and induction of arrhythmias in a rabbit model sensitized for torsade de pointes exceeded the free plasma concentrations in humans at maximum daily dose (10 mg administered 3 times a day) by more than 22-fold and 435-fold, respectively.
Croatian: U in vivo modelima, razine na kojima nema učinka na produljenje QTc intervala u pasa, i induciranja aritmija u modelu kunića senzibiliziranog na torsade de pointes, prelazile su više od 22 puta, odnosno 435 puta koncentracije slobodnog lijeka u humanoj plazmi pri maksimalnoj dnevnoj dozi (10 mg 3 puta na dan).
English: Breast-feeding
Croatian: Dojenje
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Croatian: Izmjene odgovarajućih dijelova Sažetka opisa svojstava lijeka i Upute o lijeku
English: One sachet (containing 10 mg domperidone per sachet) up to three times per day with a maximum dose of 3 sachets per day.
Croatian: Jedna vrećica (koja sadrži 10mg domperidona po vrećici) do tri puta na dan sa maksimalnom dozom od 3 vrećice na dan.
English: Do not take more than three sachets per day.
Croatian: Nemojte uzeti više od tri vrećice na dan.
English: Safety margins in in vitro proarrhythmic models (isolated Langendorff perfused heart) exceeded the free plasma concentrations in humans at maximum daily dose (10 mg administered 3 times a day) by 9- up to 45-fold.
Croatian: U in vitro proaritmijskim modelima (izolirano perfundirano srce po Langendorffu) sigurnosne granice su bile 9 do 45 puta veće od koncentracija slobodnog lijeka u plazmi ljudi pri maksimalnoj dnevnoj dozi (10 mg 3 puta na dan).
English: The 2-sided 90 % CI (1.0 to 5.9 msec) did not exceed 10 msec. No clinically relevant QTc effects were observed in this study when domperidone was administered at up to 80 mg/day (i.e., more than twice the maximum recommended dosing).
Croatian: U ovom ispitivanju, nisu primijećeni klinički značajni učincina QTc kod primjene domperidona do 80 mg/dan (što je npr. više nego dvostruka maksimalna preporučena doza).
English: Oral bioavailability is decreased by prior concomitant administration of cimetidine and sodium bicarbonate.
Croatian: Prethodna istodobna primjena cimetidina i sode bikarbone smanjuje oralnu bioraspoloživost.
English: Suppositories 30 mg [Instructions for use must be included]
Croatian: [Upute za uporabu moraju biti uključene]
English: [This following wording should be reflected in this section]
Croatian: [U ovaj dio treba uključiti s ljedeći tekst]
English: Concomitant use of the following substances is contraindicated QTc-prolonging medicinal products o anti-arrhythmics class IA (e.g., disopyramide, hydroquinidine, quinidine)
Croatian: Istodobna primjena sljedećih tvari je kontraindicirana lijekovi koji produljuju QTc interval o antiaritmici klase IA (npr. dizopiramid, hidrokinidin, kinidin) o antiaritmici klase III (npr. amiodaron, dofetilid, dronedaron, ibutilid, sotalol) određeni antipsihotici (npr. haloperidol, pimozid, sertindol)
English: Do not use more than two suppositories per day.
Croatian: Nemojte uzeti više od dva čepića na dan.
English: Safety margins for prolongation of action potential duration in in vitro experiments on isolated cardiac tissues exceeded the free plasma concentrations in humans at maximum daily dose (10 mg administered 3 times a day) by 45-fold.
Croatian: U eksperimentima in vitro na izoliranim srčanim tkivima, sigurnosne granice za produljenje trajanja akcijskog potencijala bile su 45 puta veće od koncentracija slobodnog lijeka u plazmi ljudi pri maksimalnoj dnevnoj dozi (10 mg 3 puta na dan).
English: Oral suspension [Appropriate measure device such as dosing cup must be provided with the product, and instructions for use must be included]
Croatian: [Uz lijek mora biti priložena graduirana štrcaljka za usta i upute za uporabu]
English: ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
Croatian: Zbog mogućeg produljenja QT intervala treba provoditi pračenje EKG -a.
English: Section 5.2 Pharmacokinetic properties [This section should be amended to include the following wording]
Croatian: Dio 4.9 Predoziranje [U ovaj dio treba uključiti sljedeći tekst]
English: • cancer (e.g., toremifene, vandetanib, vincamine) Tell your doctor or pharmacist if you are taking drugs to treat infection, heart problems or AIDS/HIV.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate lijekove za liječenje infekcije, srčanih tegoba ili AIDS/HIV.
English: Section 2 ‘What you need to know before you take X ‘ [This section should be amended to include the below wording] Do not take <X>:- if you have a moderate or severe liver disease - if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval” - if you have or had a problem where your heart cannot pump the blood round your body as well as it should (condition called heart failure).
Croatian: - ako imate ili ste imali stanje kad Vaše srce ne može pumpati krv u cijelo tijelo tako dobro kao što bi trebalo (stanje koje se naziva zatajenje srca).
English: Orodispersible tablets 10 mg [Instructions for use must be included]
Croatian: Raspadljive tablete za usta 10 mg
English: PACKAGE LEAFLET
Croatian: Oralna suspenzija
English: These measures should help protect the environment.
Croatian: Ove bi mjere trebale pomoći u zaštiti okoliša.
English: * (for details see section 4.4)
Croatian: * (za detalje vidi odjeljak 4.4)
English: DATE OF REVISION OF THE TEXT
Croatian: 10 DATUM REVIZIJE TEKSTA
English: 3 weeks after vaccination.
Croatian: 3 tjedna nakon cijepljenja.
English: Shake the bottle before use and periodically during use.
Croatian: Protresite bočicu prije upotrebe i povremeno za vrijeme upotrebe.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control 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: a) će primjena proizvoda na životinjama interferirati s provedbom nacionalnog programa otkrivanja, kontrole i eradikacije bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živim životinjama ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
English: Use clean and sterile vaccination equipment and avoid the introduction of contamination.
Croatian: Koristite čistu i sterilnu opremu za cijepljenje i izbjegavajte kontaminaciju.
English: The CVMP also agreed that the periodic safety update report (PSUR) cycle for would be re-started for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at three-yearly intervals.
Croatian: CVMP se također slaže da se ponovno pokrene ciklus PSUR-a podnošenjem 6 mjesečnih izvještaja (koji uključuje sva odobrena pakovanja proizvoda) u slijedeće 2 godine, a potom godišnjim izvještajima u slijedeće dvije godine i nakon toga, u trogodišnjim intervalima.
English: Opalescent pink with resuspendable sediment.
Croatian: Opalescentno ružičasta s resuspendiranim talogom.
English: It is recommended to use a multiject vaccination system.
Croatian: Preporuča se koristiti multiject sustav za cijepljenje.
English: After administration of a double dose in cattle and sheep no other reactions were observed.
Croatian: Nakon primjene dvostruke doze u goveda i ovaca nema drugih zabilježenih reakcija.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Croatian: Pitajte veterinara kako odlagati proizvode koji vam više nisu potrebni.
English: EU/2/10/106/003 EU/2/10/106/004 EU/2/10/106/005 EU/2/10/106/006 EU/2/10/106/007 EU/2/10/106/008 EU/2/10/106/009 EU/2/10/106/010 EU/2/10/106/011 EU/2/10/106/012 EU/2/10/106/013 EU/2/10/106/014
Croatian: EU/2/10/106/005 EU/2/10/106/006 EU/2/10/106/007 EU/2/10/106/008 EU/2/10/106/009 EU/2/10/106/010 EU/2/10/106/011 EU/2/10/106/012 EU/2/10/106/013 EU/2/10/106/014
English: Medicines should not be disposed of via wastewater or household waste.
Croatian: Lijekovi ne bi trebali biti odlagani u otpadne vode ili kućni otpad.
English: Pregnancy and lactation: The vaccine can be used during pregnancy and lactation.
Croatian: Graviditet i laktacija: Cjepivo se može koristiti tijekom graviditeta i laktacije.
English: A post inactivation antigen quantification test should be developed after the production of 10 commercial batches
Croatian: Testiranje količine antigena nakon inaktiviranja razvit će se nakon proizvodnje 10 komercijalnih serija
English: Before using the vaccine allow it to reach ambient temperature (15-25 °C).
Croatian: Prije uporabe cjepivo treba biti na sobnoj temperaturi (15 - 25 °C).
English: No adverse reactions other than those described in section 4.6 were observed following administration of a double dose in cattle and sheep.
Croatian: Nema drugih nuspojava osim opisanih u poglavlju 4.6 nakon aplikacije dvostruke doze u goveda i ovce.
English: Do not mix with any other veterinary medicinal product.
Croatian: Ne miješati s bilo kojim drugim veterinarsko medicinskim proizvodom.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
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 korištenju ove vakcine prije ili nakon bilo kojeg drugog veterinarsko medicinskog proizvoda, treba donositi od slučaja do slučaja.
English: 0.31 mg. For the full list of excipients, see section 6.1.
Croatian: 0,31 mg Za potpuni popis pomoćnih tvari vidi 6.1.
English: The level of efficacy for other species may differ from that observed in sheep and cattle.
Croatian: Djelotvornost u drugih vrsta može se razlikovati od onoga u ovaca i goveda.
English: The extent of this reduction has been shown by epidemiological modelling studies to be likely to reduce virus transmission to an extent that can limit the spread of an outbreak in a vaccinated population.
Croatian: Opseg ovog smanjenja je prikazan ispitivanjem epidemiološkog modeliranja te se vjerojatno smanjuje prijenos virusa u mjeri koja može ograničiti širenje epidemije u cijepljene populacije.
English: *(cycling value (Ct) > 30 by a validated rRT-PCR method, indicating absence of infectious virus)
Croatian: * (ciklička vrijednost (Ct) > 30 provjerenom rRT-PCR metodom, ukazuje na odsutnost infektivnog virusa)
English: Pack size: cardboard box with 1 or 10 vials.
Croatian: Veličina pakovanja: kartonska kutija s 1 ili 10 bočica.
English: However, the temperature rise may be 0.5 °C higher and the swellings may be more pronounced and palpable for a longer period.
Croatian: Međutim, porast temperature može biti 0.5 °C viši i otekline mogu biti izraženije i opipljivije duži period.
English: Sodium chloride Maleic acid Simeticone emulsion Aluminium hydroxide Saponin
Croatian: Trometamol Natrijev klorid Maleinska kiselina Simetikon emulzija Aluminij hidroksid
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 su dostupne na web stranici Europske agencije za lijekove (EMA) ( http://www.ema.europa.eu/.)
English: Store and transport refrigerated (2 °C - 8 °C).
Croatian: Čuvati i transportirati u hladnjaku (2 °C - 8 °C).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/09/2010.
Croatian: Datum prvog odobrenja: 06/09/2010.
English: Can be used during pregnancy and lactation.
Croatian: Može se koristiti tijekom graviditeta i laktacije.
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 i proizvod namijenjen da pruži imunost, odsutna s odnosnog područja.
English: This vaccine has been shown to reduce but not prevent viraemia in cattle.
Croatian: Ovim cjepivom se smanjuje, ali ne i sprječava viremija u goveda.
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 cjepiva kada se koristi s bilo kojim drugim veterinarsko medicinskim proizvodom.
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 koja se sastoji od tvari biološkog podrijetla, namijenjene za stvaranje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: Store and transport refrigerated (2 °C - 8 °C), protect from light, do not freeze.
Croatian: Čuvati i prevoziti u rashlađeno (2 °C - 8 °C), zaštititi od svjetla, čuvati od zamrzavanja.
English: Date of last renewal:
Croatian: Datum zadnjeg produženja odobrenja:
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: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve.
English: In sheep these swellings typically last for up to three weeks.
Croatian: U ovaca te otekline obično traju do tri tjedna.
English: In very rare cases hypersensitivity reactions may occur.
Croatian: U vrlo rijetkim slučajevima mogu se pojaviti povremene reakcije preosjetljivosti.
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Croatian: Upotreba ovog veterinarsko-medicinskog proizvoda je dozvoljena jedino pod posebnim uvjetima propisanim zakonodavstvom Europske Komisije u vezi kontrole bolesti plavog jezika.
English: EXP {month/year} Once broached, use within 8 hours.
Croatian: Jednom otvoren, upotrijebiti u roku od 8 dana.
English: This vaccine has been tested for safety in sheep and cattle.
Croatian: Ovo cjepivo je testirano na neškodljivost u ovaca i goveda.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Croatian: Svaki neupotrebljeni veterinarsko medicinski proizvod ili otpadni materijal dobiven iz tih VMP mora se odlagati u skladu s lokalnim propisima.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose (1 ml) contains:
Croatian: NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA Jedna doza (1 ml) sadržava:
English: No information is available on the use of the vaccine in seropositive animals, including those with maternally derived antibodies.
Croatian: Nema podataka o korištenju cjepiva u seropozitivnih životinja, uključujući i one s majčinskim antitijelima.
English: Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adresa proizvođača biološke djelatne tvari:
English: Shelf life after first opening the immediate packaging: 8 hours, provided the product is not subject to temperatures above 37 °C or contaminated.
Croatian: Rok valjanosti nakon prvog otvaranja pakovanja: 8 sati, pod uvjetom da proizvod nije bio na temperaturama iznad 37 °C ili kontaminiran.
English: Water for injection
Croatian: Saponini Voda za injekcije
English: The manufacture, import, possession, sale, supply and/or use of Bovilis BTV8 is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Croatian: Proizvodnja, uvoz, posjedovanje, prodaja, nabava i/ili korištenja Bovilis BTV8 je dopuštena samo pod posebnim uvjetima utvrđenim zakonodavstvom Europske zajednice o kontroli bolesti plavog jezika.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju samoinjiciranja odmah potražite savjet liječnika i pokažite uputu o proizvodu.
English: Cattle and sheep.
Croatian: Goveda i ovce.
English: 4.3 Contraindications None.
Croatian: 4.3 Kontraindikacije
English: Primary vaccination:
Croatian: Primarno cijepljenje:
English: Revaccination:
Croatian: Revakcinacija:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/106/001-014
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/10/106/001 - 014
English: In cattle small palpable swellings may still be present up to six weeks after vaccination in approximately one third of the vaccinated animals.
Croatian: U goveda male opipljive otekline još uvijek mogu biti prisutne i do šest tjedana nakon cijepljenja, u oko jedne trećine cijepljenih životinja.
English: For animal treatment only.
Croatian: Samo za liječenje životinja.
English: In these categories of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or the national Competent Authorities, depending on the current vaccination policies against bluetongue virus.
Croatian: U ovih kategorija životinja cjepivo treba koristiti samo prema procjeni koristi/rizika od strane nadležnog veterinara i/ili nacionalnih nadležnih tijela, ovisno o važećim odredbama cijepljenja protiv bolesti plavog jezika.
English: Active ingredient: bluetongue virus serotype 8: 500 antigenic units* (* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log2) Adjuvants: aluminium hydroxide, saponin.
Croatian: Djelatni sastojak: virus bolesti plavog jezika serotip 8: 500 antigenske jedinice * (* izaziva odgovor virus neutralizirajućih antitijela u pilića od ≥ 5,0 log2) Adjuvansi: aluminij hidroksid, saponin.
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: Ako se koristi kod drugih vrsta domaćih i divljih preživača, ako kod njih postoji rizik od infekcije, primjenu cjepiva u tih vrsta treba provoditi pažljivo i to je poželjno testirati na malom broju životinja prije masovnog cijepljenja.
English: In sheep, these swellings typically last for up to three weeks, while in cattle small palpable swellings may still be present up to six weeks after vaccination in approximately one third of vaccinates.
Croatian: U ovaca, te otekline obično traju do tri tjedna, dok u goveda male opipljive otekline mogu biti prisutne i do šest tjedana nakon cijepljenja, u oko jedne trećine cijepljenih životinja.
English: Aluminium hydroxide (as 100%) 16.7 mg Saponin
Croatian: Aluminij hidroksid (kao 100%)
English: In sheep, swellings may still be palpable after six weeks.
Croatian: U ovaca, otekline mogu biti opipljive i nakon šest tjedana.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Trometamol
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari
English: Sheep
Croatian: Ovca
English: * (for details see section 12)
Croatian: kako bi se smanjila viremija*. *(za detalje vidi odjeljak 12)
English: Bovilis BTV8 is an inactivated viral vaccine, to stimulate active immunity against bluetongue virus serotype 8.
Croatian: 15. OSTALE INFORMACIJE Bovilis BTV8 je inaktivirana virusna vakcina, za poticanje aktivnog imuniteta protiv virusa plavog jezika serotipa 8.
English: Fertility:
Croatian: Plodnost:
English: Onset of immunity:
Croatian: Trajanje imunosti:
English: PET vials of 10, 20, 50, 100, 200, 250 or 500 ml, with a rubber stopper and aluminium cap.
Croatian: PET bočica 10, 20, 50, 100, 200, 250 ili 500 ml, s gumenim čepom i aluminijskom kapicom.
English: MANUFACTURER'S BATCH NUMBER Lot{number}
Croatian: 17. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
English: The safety and efficacy of the vaccine has not been established in breeding males.
Croatian: Neškodljivost i djelotvornosti cjepiva nije utvrđena u rasplodnih mužjaka.
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 koja je dopunjena, države članice, u skladu s nacionalnim zakonodavstvom mogu zabraniti proizvodnju, uvoz, posjedovanje,
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis BTV8 suspension for injection for cattle and sheep
Croatian: UPUTA O VMP Bovilis BTV8 suspenzija za injekcije za goveda i ovce
English: EU/2/10/106/002
Croatian: EU/2/10/106/001 EU/2/10/106/002 EU/2/10/106/003 EU/2/10/106/004
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis BTV8
Croatian: Bovilis BTV8
English: PACKAGE LEAFLET FOR: Bovilis BTV8 suspension for injection for cattle and sheep
Croatian: Bovilis BTV8 suspenzija za injekcije za goveda i ovce
English: The vaccine is presented in cardboard boxes with 1 or 10 PET vials containing 10, 20, 50, 100, 200, 250 or 500 ml, closed with a rubber stopper and aluminium cap.
Croatian: Cjepivo je u kartonskoj kutiji s 1 ili 10 PET bočica koje sadrže 10, 20, 50, 100, 200, 250 ili 500 ml, zatvorene gumenim čepom i aluminijskom kapicom.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Croatian: Posebne mjere opreza za osobe koje primjenjuju ovaj veterinarsko medicinski proizvod na životinjama:
English: In very rare cases vaccination may result in a slight rise in temperature (usually not more than 0.5 °C, in individual cases up to about 2 °C) for up to three days after vaccination, and temporary swellings at the injection site.
Croatian: 0,5 °C, u pojedinim slučajevima do oko 2 °C) do tri dana nakon cijepljenja i privremenih otekline na mjestu uboda.
English: IMMUNOLOGICAL PROPERTIES ATCvet code: Sheep: QI04AA02 Cattle: QI02AA08 Inactivated viral vaccine, to stimulate active immunity against bluetongue virus serotype 8.
Croatian: IMUNOLOŠKA SVOJSTVA ATCvet broj: Ovce: QI04AA02 Goveda: QI02AA08
English: Special warnings for each target species:
Croatian: 12. POSEBNO(A) UPOZORENJE(A) Posebne mjere za svaku ciljnu vrstu:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (1 ml) contains:
Croatian: Jedna doza (1 ml) sadrži: Djelatna tvar:
English: Vials: 100 ml 200 ml 250 ml 500 ml
Croatian: Bočice: 100 ml 200 ml 250 ml 500 ml
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije:
English: Sheep from 1 month of age: injection of a single dose of 1 ml.
Croatian: Ovce od 1 mjeseca starosti: injekcija jedne doze od 1 ml.