FrancophonIA/ELRC3.0 huggingface dataset:
English: Lenalidomide works in a number of different ways: it blocks the development of abnormal cells, prevents the growth of blood vessels within tumours and also stimulates specialised cells of the immune system to attack the abnormal cells.
Croatian: Lenalidomid djeluje na niz različitih načina: inhibira razvoj abnormalnih stanica, sprječava rast krvnih žila u tumorima te također potiče posebne stanice imunosnog sustava da napadaju abnormalne stanice.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Revlimid, and do not need to be repeated for Lenalidomide Accord.
Croatian: Ispitivanja koristi i rizika djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Revlimid i stoga ih nije potrebno ponavljati za Lenalidomide Accord.
English: Lenalidomide Accord is a medicine used for the treatment of multiple myeloma, a cancer of a type of white blood cells called plasma cells.
Croatian: Lenalidomide Accord je lijek za liječenje multiplih mijeloma, raka jedne vrste bijelih krvnih stanica naziva stanice plazme.
English: This means that Lenalidomide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Revlimid.
Croatian: To znači da Lenalidomide Accord sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Revlimid.
English: What measures are being taken to ensure the safe and effective use of Lenalidomide Accord?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Lenalidomide Accord?
English: It will also supply cards for patients to ensure that they are informed about appropriate safety measures to be taken by each patient.
Croatian: Bolesnicima također treba dostaviti kartice da se osigura pružanje informacija o odgovarajućim mjerama opreza kojih se bolesnici trebaju pridržavati.
English: Because Lenalidomide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Lenalidomide Accord generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: The company that markets Lenalidomide Accord will provide a letter and educational kits for healthcare professionals, and brochures for patients, explaining that the medicine can be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely.
Croatian: Tvrtka koja stavlja na tržište lijek Lenalidomide Accord zdravstvenim radnicima mora dostaviti pismo i edukativni komplet, te bolesnicima brošure u kojima se objašnjava da lijek može štetiti nerođenom djetetu te detaljno navode mjere koje treba poduzeti za sigurnu primjenu lijeka.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Lenalidomide Accord has been shown to have comparable quality and to be bioequivalent to Revlimid.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, lijek Lenalidomide Accord dokazao usporedivu kakvoću te da je bioekvivalentan s lijekom Revlimid.
English: Lenalidomide Accord is used:
Croatian: Lenalidomide Accord se primjenjuje:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenalidomide Accord have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Lenalidomide Accord nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: An overview of Lenalidomide Accord and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Lenalidomide Accord i zašto je odobren u EU-u
English: For more information about using Lenalidomide Accord, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Lenalidomide Accord pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Lenalidomide Accord contains the active substance lenalidomide and is a ‘generic medicine'.
Croatian: Lenalidomide Accord sadržava djelatnu tvar lenalidomid te je „generički lijek”.
English: • in combination with melphalan (a cancer medicine) and prednisone (an anti-inflammatory medicine) for the treatment of adults with previously untreated multiple myeloma, who cannot have a stem cell transplant;
Croatian: • u kombinaciji s melfalanom (lijekom protiv raka) i prednizonom (protuupalnim lijekom) za liječenje odraslih s prethodno neliječenim multiplim mijelomima, koji ne mogu ići na transplantaciju matičnih stanica;
English: The active substance in Lenalidomide Accord, lenalidomide, is an immunomodulating agent.
Croatian: Djelatna tvar u lijeku Lenalidomide Accord, lenalidomid, imunomodulatorni je agens.
English: The dose depends on the situation in which Lenalidomide Accord is used.
Croatian: Doza ovisi o vrsti bolesti za koju se primjenjuje lijek Lenalidomide Accord.
English: Other information about Lenalidomide Accord
Croatian: Ostale informacije o lijeku Lenalidomide Accord
English: As for all medicines, data on the use of Lenalidomide Accord are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Lenalidomide Accord kontinuirano se prate.
English: • in combination with dexamethasone (an anti-inflammatory medicine), for the treatment of adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have a stem cell transplant;
Croatian: • u kombinaciji s deksametazonom (protuupalnim lijekom) za liječenje odraslih s prethodno neliječenim (novodijagnosticiranim) multiplim mijelomima, koji ne mogu ići na transplantaciju matičnih stanica;
English: As for every medicine, the company provided studies on the quality of Lenalidomide Accord.
Croatian: Kao i za svaki lijek, tvrtka je dostavila podatke o ispitivanjima kakvoće za lijek Lenalidomide Accord.
English: What is Lenalidomide Accord and what is it used for?
Croatian: Što je Lenalidomide Accord i za što se primjenjuje?
English: Therefore, the Agency's view was that, as for Revlimid, the benefit of Lenalidomide Accord outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist kod lijeka Lenalidomide Accord, kao i kod lijeka Revlimid, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: What are the benefits and risks of Lenalidomide Accord?
Croatian: Koje su koristi i rizici lijeka Lenalidomide Accord?
English: Why is Lenalidomide Accord authorised in the EU?
Croatian: Zašto je lijek Lenalidomide Accord odobren u EU-u?
English: How does Lenalidomide Accord work?
Croatian: Kako djeluje Lenalidomide Accord?
English: How is Lenalidomide Accord used?
Croatian: Kako se Lenalidomide Accord primjenjuje?
English: How has Lenalidomide Accord been studied?
Croatian: Kako je Lenalidomide Accord ispitivan?
English: Immediate packaging
Croatian: Unutarnje pakiranje
English: These measures should help protect the environment.
Croatian: Te mjere pomažu u zaštiti okoliša
English: Vaccinate only healthy animals.
Croatian: Smiju se vakcinirati samo zdrave životinje.
English: Apply usual aseptic procedures.
Croatian: Primijenite uobičajene aseptične postupke.
English: Date of latest renewal: 13/12/2016
Croatian: Datum zadnje obnove: 13/12/2016
English: These resolved within a maximum of 25 days.
Croatian: One nestaju najviše nakon 25 dana.
English: Official control authority batch release is required for this product.
Croatian: „Official control authority batch release“ certifikat je potreban za ovaj proizvod.
English: The entire content of the bottle should be used immediately after broaching and during the same procedure.
Croatian: Cijeli sadržaj bočice treba iskoristiti odmah nakon otvaranja i tijekom istog postupka.
English: The level of efficacy for other species may differ from that observed in cattle.
Croatian: Razina učinkovitosti kod drugih vrsta može se razlikovati od one dokazane kod goveda.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u dijelu 6.1 SPC su dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno.
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
Croatian: *(Ciklička vrijednost (Ct) ≥ 36 prema validiranoj RT-PCR metodi, bez indicirane prisutnosti viralnog genoma).
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 veterinarsko-medicinskog proizvoda na životinjama interferirati s provedbom nacionalnih programa za otkrivanje, kontrolu i iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
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 samo pod posebnim uvjetima određenim zakonima Europske zajednice o kontroli bolesti plavog jezika.
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle.
Croatian: *Relativni potencijal prema testu potencije provedenom na miševima u usporedbi sa referentnom vakcinom koja je pokazala učinkovitost kod goveda.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Croatian: Nositelj odobrenja za stavljanje u promet mora obavijestiti Europsku Komisiju o planovima za stavljanje u promet veterinarsko-medicinskog proizvoda odobrenog prema ovoj odluci.
English: Avoid multiple vial broaching.
Croatian: Izbjegavati višestruko otvaranje.
English: 2nd injection: after 3 weeks.
Croatian: Druga injekcija: nakon 3 tjedna.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/03/2012.
Croatian: Datum prvog odobrenja: 08/03/2012.
English: Store and transport refrigerated (2 °C - 8 °C).
Croatian: Čuvati i prevoziti rashlađeno (2 ⁰C - 8 ⁰C).
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 sastoje od tvari biološkog podrijetla, namijenjene za stvaranje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies.
Croatian: Nema dostupnih podataka o primjeni vakcine kod seropozitivnih životinja uključujući one s maternalno dobivenim antitijelima.
English: Local reactions may increase slightly following the second dose in this case lasting up to 15 days.
Croatian: Lokalne reakcije se mogu malo povećati nakon primjene druge doze i tada traju do 15 dana.
English: Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Croatian: Svaka shema revakcinacije treba biti odobrena od nadležnog tijela ili odgovornog veterinara uzimajući u obzir lokalnu epidemiološku situaciju.
English: Shake gently immediately before use.
Croatian: Nježno protresti prije uporabe.
English: 17813 Vall de Bianya
Croatian: 17813 Vall de Bianya Girona
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: Nema dostupnih podataka o sigurnosti i učinkovitosti ove vakcine kada se koristi zajedno sa bilo kojim drugim veterinarsko-medicinskim pripravkom.
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: Kod ovih vrsta životinja cjepivo treba koristiti samo u skladu s procjenom koristi / rizika od strane odgovornog veterinara i / ili nacionalnog nadležnog tijela prema važećim smjernicama cijepljenja protiv virusa bolesti plavog jezika (BPJ).
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 primjenjuje kod drugih domaćih ili divljih vrsta preživača koje se smatra rizičnim prema infekciji, treba pažljivo procijeniti primjenu, te se preporuča testiranje vakcine na manjem broju grla prije masovne primjene.
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 davanju ove vakcine prije ili poslije bilo kojeg drugog veterinarsko-medicinskog proizvoda treba pojedinačno donijeti ovisno od slučaja do slučaja.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 tretiranih životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 tretiranih životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 3 months of age.
Croatian: Daje se jedna doza od 2 ml prema slijedećoj shemi vakcinacije: Prva injekcija: nakon navršena 3 mjeseca starosti.
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 odnosni veterinarsko-medicinski proizvod namijenjen da pruži imunost, u velikoj mjeri odsutna s tog područja.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove (EMA) (/) http://www.ema.europa.eu.
English: High density polyethylene (HDPE) vials of 20, 100 or 240 ml with chlorobutyl elastomer rubber stopper and aluminium seal containing 10, 50 or 120 doses of vaccine.
Croatian: Polietilenska bočica visoke gustoće (HDPE) od 20, 100 ili 240 ml, začepljena klorbutilnim elastomernim čepom i aluminijskom kapicom, sadrži 10, 50 ili 120 doza vakcine.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo da se javite veterinaru.
English: Pregnancy: Can be used during pregnancy.
Croatian: Može se primijeniti tijekom graviditeta.
English: Shelf life of the veterinary medicinal product as packaged for sale: 1 year.
Croatian: 6.3 Rok valjanosti Rok valjanosti veterinarsko-medicinskog proizvoda kada je zapakiran za prodaju: 1 godina.
English: Off-white or pink liquid
Croatian: Sivkasto bijela ili ružičasta tekućina.
English: 2nd injection: 3 weeks after 1st injection.
Croatian: Druga injekcija: tri tjedna nakon prve injekcije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20 ml, 1 x 100 ml or 240 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija s 1 x 20 ml, 1 x 100 ml ili 240 ml
English: A. LABELLING
Croatian: A.OZNAČAVANJE
English: PACKAGE LEAFLET: Zulvac 1+8 Bovis Suspension for injection for cattle
Croatian: UPUTA O VMP : Zulvac 1+8 Bovis Suspenzija za injekciju za goveda
English: Per dose of 2 ml:
Croatian: Po dozi od 2 ml:
English: Avoid bubble formation, as this can be irritating at the site of injection.
Croatian: Prilikom protresanja treba izbjeći stvaranje mjehurića, koji mogu izazvati iritaciju na mjestu davanja injekcije.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Croatian: POSEBNO(A) UPOZORENJE(A), UKOLIKO JE POTREBNO Pažljivo pročitati uputu o VMP prije primjene.
English: 4.7 Use during pregnancy, lactation or lay
Croatian: 4.7 Primjena tijekom graviditeta, laktacije ili nesenja Može se primijeniti tijekom graviditeta i laktacije.
English: Pack sizes
Croatian: VELIČINA PAKOVANJA
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNIH TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: EU/2/12/139/002 (100 ml) EU/2/12/139/003 (240 ml)
Croatian: EU/2/12/139/001 (20 ml) EU/2/12/139/002 (100 ml) EU/2/12/139/003 (240 ml)
English: The safety and the efficacy of the vaccine have not been established in breeding males.
Croatian: Neškodljivost i učinkovitost cjepiva nije utvrđena kod rasplodnih mužjaka.
English: A transient increase in rectal temperature, not exceeding 2.7 C, was commonly observed during the 48 hours following vaccination in field safety studies.
Croatian: Prolazno povećanje rektalne temperature koje ne prelazi 2,7 ⁰C, često je zamijećeno u terenskim ispitivanjima neškodljivosti te može trajati i do 48 sati nakon vakcinacije.
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate dihydrate Sodium chloride
Croatian: Natrijevhidrogenfosfat dihidrat Natrij klorid
English: Duration of immunity: 12 months after completion of the primary vaccination course.
Croatian: Trajanje imunosti: 12 mjeseci nakon završetka primarnog cijepljenja.
English: Adjuvant(s): Aluminium hydroxide
Croatian: Adjuvans(i): Aluminijev hidroksid
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml (10 doses)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA
English: To stimulate active immunity against bluetongue virus, serotypes 1 and 8 in cattle.
Croatian: Stimulacija aktivne imunosti protiv virusa bolesti plavog jezika (BPJ), serotipovi 1 i 8, kod goveda.
English: Pack of 1 bottle of 10 doses (20 ml).
Croatian: Pakovanje od jedne bočice od 10 doza (20 ml).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Intramuskularna upotreba.
English: Local reactions of up to 5 cm diameter were very commonly observed and reactions > 5 cm diameter were commonly observed after repeated administration of a single dose in field safety studies.
Croatian: Lokalne reakcije promjera do 5 cm se mogu javiti vrlo često, a reakcije promjera > 5 cm javile su se često nakon ponovne primjene jedne doze, u terenskim ispitivanjima neškodljivosti.
English: Aluminium hydroxide, saponin and thiomersal.
Croatian: Aluminijev hidroksid, saponin i tiomersal.
English: In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used.
Croatian: Kako bi se izbjegla slučajna kontaminacija vakcine, prilikom upotrebe se preporuča upotreba više doznih injekcijskih aplikatora u slučaju korištenja većih oblika pakovanja.
English: Pack of 1 bottle of 120 doses (240 ml).
Croatian: Pakovanje od jedne bočice od 120 doza (240 ml).
English: Adjuvants: Aluminium hydroxide
Croatian: Adjuvansi: Aluminijev hidroksid
English: Excipient(s): Thiomersal
Croatian: Pomoćna(e) tvar(i): Tiomersal
English: PACKAGE SIZE 20 ml (10 doses) 100 ml (50 doses) 240 ml (120 doses)
Croatian: 20 ml (10 doza) 100 ml (50 doza) 240 ml (120 doza)
English: Pack of 1 bottle of 50 doses (100 ml).
Croatian: Pakovanje od jedne bočice od 50 doza (100 ml).
English: CONTRAINDICATIONS
Croatian: INDIKACIJE
English: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1, Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02.
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 1, soj BTV-1/ALG2006/01 E1, Inaktivirani virus bolesti plavog jezika, serotip 8, soj BTV-8/BEL2006/02.
English: For active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus (BTV), serotypes 1 and 8.
Croatian: Za aktivnu imunizaciju goveda starijih od 3 mjeseca, za prevenciju* viremija uzrokovanih virusom bolesti plavog jezika (BPJ), serotipovi 1 i 8.
English: PACKAGE SIZE 100 ml (50 doses) 240 ml (120 doses)
Croatian: 100 ml (50 doza) 240 ml (120 doza)
English: EU/2/12/139/003
Croatian: EU/2/12/139/002 EU/2/12/139/003
English: Onset of immunity: 21 days after completion of the primary vaccination course.
Croatian: Početak imunosti: 21 dan nakon završetka primarnog cijepljenja.
English: Fertility:
Croatian: Laktacija:
English: A transient increase in rectal temperature, not exceeding 2 °C, may occur in 10% of the animals during the 24 hours following administration of two-fold overdose.
Croatian: Prolazno povišenje rektalne temperature, ne veće od 2 ⁰C, može se pojaviti kod 10% životinja unutar
English: Name and address of the manufacturer of the biological active substance Zoetis Manufacturing & Research Spain, S.L.
Croatian: Naziv i adresa proizvođača biološki djelatne tvari Zoetis Manufacturing & Research Spain, S.L. Ctra.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml or 240 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Etiketa za bočicu od 100 ml ili 240 ml
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove (EMA) (/). http://www.ema.europa.eu.
English: Do not use after the expiry date which is stated on the carton and label after EXP. Once broached use immediately.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi i kutiji poslije EXP.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Per dose of 2 ml:
Croatian: KOLIČINA DJELATNE(IH) TVARI Po dozi od 2 ml:
English: Lactation: Can be used during lactation.
Croatian: Može se primijeniti tijekom laktacije.
English: Shelf life after first opening the immediate packaging: use immediately after broaching.
Croatian: Rok valjanosti poslije razrjeđenja ili rekonstitucije prema uputi: iskoristiti odmah nakon probijanja gumenog čepa.
English: Name and address of the manufacturer responsible for batch release Zoetis Manufacturing & Research Spain, S.L.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet Zoetis Manufacturing & Research Spain, S.L.
English: WITHDRAWAL PERIOD(S) Zero days.
Croatian: KARENCIJA(E) Nula dana.