FrancophonIA/ELRC3.0 huggingface dataset:
English: o The need to explain to and ensure understanding of by patients: o the risk of treatment with ravulizumab (including potential risks of serious infections and malignancies and haematologic abnormalities) o the signs and symptoms of meningococcal infection and what action to take o the patient's guides and their contents o the need to carry the patient safety card and to tell any healthcare practitioner that he/she is receiving treatment with ravulizumab o the requirement for pre-treatment vaccinations/antibiotic prophylaxis o the enrolment in the PNH registry o Details of the PNH registry and how to enter patients
Croatian: maligniteta i hematoloških abnormalnosti) o znakove i simptome meningokokne infekcije i što poduzeti o vodič za bolesnike i sadržaj vodiča o potrebu da bolesnik sa sobom nosi karticu s upozorenjima za bolesnika i da obavijesti svakog zdravstvenog radnika da prima terapiju ravulizumabom o zahtjev da budu cijepljeni/da uzimaju antibiotsku profilaksu prije liječenja o upis u registar bolesnika s PNH-om o Detalji o registru oboljelih od PNH-a i kako upisati bolesnike
English: Meningococcal infections in patients treated with ravulizumab presented as meningococcal sepsis.
Croatian: Meningokokne infekcije u bolesnika liječenih ravulizumabom prezentirale su se kao meningokokna sepsa.
English: How to store Ultomiris
Croatian: Kako primjenjivati Ultomiris
English: Units of pRBC/whole blood transfused within 12 months prior to first dose
Croatian: Broj jedinica koncentrata eritrocita / pune krvi primljenih transfuzijom u 12 mjeseci prije prve doze
English: Table 7: Maintenance dose administration reference table Body weight range (kg)
Croatian: Tablica 7: Tablica referentnih vrijednosti kod primjene doza održavanja Raspon tjelesne težine (kg)
English: There were no noteworthy differences in the demographic or baseline characteristics between the ravulizumab and eculizumab treatment groups in either of the Phase 3 studies.
Croatian: U oba ispitivanja faze III, između skupine liječene ravulizumabom i one liječene ekulizumabom nije bilo značajnih razlika u demografskim ili početnim karakteristikama.
English: Talk to your doctor before using Ultomiris.
Croatian: Upozorenja i mjere opreza Obratite se liječniku prije nego što primite Ultomiris.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: 30 mL of sterile concentrate in a vial (Type I glass) with a stopper and a seal.
Croatian: Bočica (staklo tipa I) s 30 ml sterilnog koncentrata s čepom i zaštitnim zatvaračem.
English: After dilution, the medicinal product should be used immediately.
Croatian: Lijek treba primijeniti odmah nakon razrjeđivanja.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ultomiris 300 mg concentrate for solution for infusion.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ultomiris 300 mg koncentrat za otopinu za infuziju ravulizumab
English: Nonclinical reproductive toxicology studies conducted in mice with the murine surrogate molecule BB5.1 identified no adverse effect to pups resulting from consuming milk from treated dams.
Croatian: Neklinička ispitivanja reproduktivne toksičnosti provedena u miševa pomoću mišje surogatne molekule BB5.1 pokazala su da unos mlijeka liječenih ženki nema štetni učinak na mladunčad.
English: Vomiting, Nausea, Diarrhoea, Abdominal pain, Dyspepsia
Croatian: Poremećaji probavnog sustava povraćanje mučnina proljev bol u abdomenu dispepsija
English: See the leaflet for further information.
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: Table 4 presents the baseline characteristics of the PNH patients enrolled in the complement-inhibitor naïve study, with no apparent clinically meaningful differences observed between the treatment arms.
Croatian: U tablici 4 prikazane su početne karakteristike bolesnika s PNH-om uključenih u ispitivanje u kojem bolesnici prethodno nisu primali inhibitor sustava komplementa.
English: Consult your doctor before you start Ultomiris to be sure that you receive vaccination against Neisseria meningitidis at least 2 weeks before beginning therapy.
Croatian: Neisseria meningitidis najmanje 2 tjedna prije početka terapije.
English: Table 5 presents the baseline characteristics of the PNH patients enrolled in the eculizumabexperienced study, with no apparent clinically meaningful differences observed between the treatment arms.
Croatian: U tablici 5 prikazane su početne karakteristike bolesnika s PNH-om uključenih u ispitivanje primjene u bolesnika koji su prethodno primali ekulizumab.
English: Adverse reactions MedDRA System Organ Class
Croatian: MedDRAklasifikacija organskih sustava
English: Meningococcal infection*
Croatian: Simptomi meningokokne infekcije
English: Maintenance doses should be administered at a once every 8-week interval, starting 2 weeks after loading dose administration.
Croatian: Doze koje treba primijeniti temelje se na tjelesnoj težini bolesnika kako je prikazano u tablici 1. Doze održavanja primjenjuju se jednom svakih 8 tjedana, s početkom primjene 2 tjedna nakon udarne doze.
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride
Croatian: 6.1 Popis pomoćnih tvari natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dihidrat natrijev klorid polisorbat 80 voda za injekcije
English: Table 2: Dose administration rate Body weight range (kg)
Croatian: Tablica 6: Tablica referentnih vrijednosti kod primjene udarnih doza Raspon tjelesne težine (kg)
English: Patients with unresolved Neisseria meningitidis infection at treatment initiation (see section Patients who are not currently vaccinated against Neisseria meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination (see section
Croatian: Neisseria meningitidis, osim ako primaju profilaktičku terapiju odgovarajućim antibioticima do 2 tjedna nakon cijepljenja (vidjeti dio 4.4).
English: Units of pRBC transfused within 12 months prior to first dose
Croatian: Broj jedinica koncentrata eritrocita primljenih transfuzijom u 12 mjeseci prije prve doze
English: Table 5: Baseline characteristics in the eculizumab-experienced study Parameter
Croatian: Tablica 5: Početne karakteristike u ispitivanju primjene u bolesnika koji su prethodno primali ekulizumab
English: The prepared solution should be administered immediately following preparation unless it is stored at 2-8°C.
Croatian: Pripremljenu otopinu, ako nije bila čuvana na temperaturi 2°C-8°C, treba primijeniti odmah nakon pripreme.
English: Patients should be provided with information from the Package Leaflet to increase their awareness of potential serious infections and their signs and symptoms.
Croatian: Kako bi bolesnici znali više o mogućim ozbiljnim infekcijama i njihovim znakovima i simptomima, potrebno ih je upoznati s informacijama iz upute o lijeku.
English: What is Ultomiris used for
Croatian: Za što se Ultomiris koristi
English: Pregnancy/ Breast-feeding
Croatian: Trudnoća/dojenje
English: Table 1: Ultomiris weight-based dosing regimen
Croatian: Tablica 1: Režim doziranja lijeka Ultomiris na temelju tjelesne težine Raspon tjelesne težine (kg)
English: Table 4: Baseline characteristics in the complement-inhibitor naïve study Parameter
Croatian: Tablica 4: Početne karakteristike u ispitivanju u kojem bolesnici prethodno nisu primali inhibitor sustava komplementa
English: Visually inspect Ultomiris solution for particulate matter and discolouration.
Croatian: Vizualno pregledajte jesu li u otopini lijeka Ultomiris prisutne čestice i je li otopina promijenila boju.
English: Total PNH RBC clone size
Croatian: Ukupno Srednja vrijednost (SD) Medijan Ukupni broj klonalnih eritrocita PNH Medijan Ukupni broj klonalnih granulocita PNH
English: Ultomiris should only be diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection.
Croatian: Ultomiris se smije razrjeđivati samo 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za injekciju.
English: The need for effective contraception in women of childbearing potential during and up to eight months after treatment.
Croatian: Žene reproduktivne dobi moraju primjenjivati učinkovitu kontracepciju tijekom liječenja i do osam mjeseci nakon toga.
English: Dilution should only use sodium chloride 9 mg/mL (0.9 %) solution for injection as diluent.
Croatian: Za razrjeđivanje se kao otapalo smije upotrijebiti samo 0,9%-tna (9 mg/ml) otopina natrijeva klorida za injekciju.
English: Reporting of side effects
Croatian: Promjena rezultata za FACIT-umor
English: Cases of serious meningococcal infections/sepsis have been reported in patients treated with ravulizumab.
Croatian: U bolesnika liječenih ravulizumabom zabilježeni su slučajevi ozbiljnih meningokoknih infekcija/sepse.
English: Refer to the administration reference tables below.
Croatian: Pogledajte tablice s referentnim vrijednostima u nastavku.
English: Withdraw the required amount of Ultomiris from the vial(s) using a sterile syringe.
Croatian: Sterilnom štrcaljkom izvucite iz bočice/bočica potrebnu količinu lijeka Ultomiris.
English: Pyrexia, Influenza like illness, Fatigue, Chills, Asthenia
Croatian: Opći poremećaji i reakcije na mjestu primjene pireksija bolest slična gripi umor zimica astenija
English: Study in complement-inhibitor naïve patients with PNH
Croatian: Ispitivanje u bolesnika s PNH-om koji prethodno nisu primali inhibitor sustava komplementa
English: Haematuria or haemoglobinuria Aplastic anaemia Renal failure
Croatian: anemija hematurija ili hemoglobinurija aplastična anemija zatajenje bubrega mijelodisplastični sindrom komplikacije trudnoće drugo a a
English: Table 1: Loading dose administration reference table
Croatian: Tablica 1: Tablica referentnih vrijednosti kod primjene udarnih doza
English: No clear treatment-related effects or adverse effects were observed in the murine surrogate reproductive toxicology studies in mice.
Croatian: U ispitivanjima reproduktivne toksičnosti mišjeg surogata u miševa nisu opaženi očiti učinci povezani s liječenjem ili štetni učinci.
English: Ensure that your current meningococcal vaccination is up to date.
Croatian: Provjerite traje li Vam još uvijek zaštita nakon cijepljenja protiv meningokoka.
English: Refer to the administration reference tables below for minimum infusion duration.
Croatian: Najmanje trajanje infuzije pogledajte u tablicama s referentnim vrijednostima u nastavku.
English: Therefore, effective contraception during treatment and up to 8 months after treatment should be used in women who are able to get pregnant.
Croatian: Stoga žene koje mogu zatrudnjeti moraju primjenjivati učinkovitu kontracepciju tijekom liječenja i do 8 mjeseci nakon toga.
English: Cases of serious or fatal meningococcal infections/sepsis have been reported in patients treated with other terminal complement inhibitors.
Croatian: U bolesnika liječenih drugim inhibitorima završne aktivacije sustava komplementa zabilježeni su slučajevi ozbiljnih ili smrtonosnih meningokoknih infekcija/sepse.
English: Back pain, Arthralgia, Myalgia, Muscle spasms
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u leđima artralgija mialgija spazam mišića
English: ANNEX I
Croatian: 3 - Primjena
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: OZNAČIVANJE I UPUTA O LIJEKU
English: PNH medical history was similar between ravulizumab and eculizumab treatment groups.
Croatian: Skupine liječene ravulizumabom i ekulizumabom imale su sličnu anamnezu u pogledu PNH-a.
English: Do not use chemical disinfectants.
Croatian: Ne upotrebljavati kemijske dezinficijense.
English: Do not thaw in hot or ice cold water.
Croatian: Ne otapati u vrućoj ili ledeno hladnoj vodi.
English: UNITED STATES OF AMERICA
Croatian: SJEDINJENE AMERIČKE DRŽAVE
English: 800 ml
Croatian: 400 ml 800 ml
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03/07/2015
Croatian: Datum prvog odobrenja: 03/07/2015
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 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 naznačeno 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: MARKETING AUTHORISATION NUMBER(S) EU/2/15/182/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/15/182/001
English: Suspension: - Type I glass ampoules containing 2,000 or 4,000 doses.
Croatian: Suspenzija: - Staklene ampule tipa I, koje sadrže 2000 ili 4000 doza.
English: The vaccine is administered by subcutaneous injection in the neck.
Croatian: Cjepivo se primjenjuje subkutanom injekcijom u vrat.
English: 1 PFU: plaque forming units.
Croatian: 1PFU: Jedinice koje tvore plak.
English: Overdose (symptoms, emergency procedures, antidotes): No symptoms were observed after the administration of a 10-fold dose of vaccine.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti): Nisu primijećeni simptomi ni nakon primjene 10 puta veće doze cjepiva.
English: After adding the content of the ampoule to the solvent, the ready to use product is a clear, red coloured suspension for injection.
Croatian: Nakon dodavanja sadržaja ampule u otapalo, proizvod spreman za upotrebu je bistra, crveno obojena suspenzija za injekciju.
English: (number of doses per ampoule is presented on the colour coded clip attached to each cane containing the ampoule)
Croatian: (broj doza po ampuli je navedena na obojanoj oznaci priloženoj na svakoj kutiji koja sadrži ampule
English: CAUTION: Ampoules have been known to explode on sudden temperature changes.
Croatian: UPOZORENJE: ampule mogu eksplodirati prilikom naglih promjena temperature.
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 izazivanje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
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 zabranjuju ili mogu zabraniti proizvodnju, uvoz, prodaju, opskrbu i/ili primjenu veterinarskomedicinskog proizvoda na cijelom ili na dijelu svog teritorija ako je utvrđeno da:
English: Do not mix with any other veterinary medicinal product except Nobilis Rismavac and the solvent supplied for use with the veterinary medicinal product.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim Nobilis Rismavacom i otapalom priloženim za primjenu s proizvodom.
English: Care should be exercised to prevent contaminating your hands, eyes and clothing with the suspension.
Croatian: Posebno obratiti pozornost sprečavanju zagađenja ruku, očiju i odjeće suspenzijom.
English: Duration of immunity: ILT: 60 weeks, MD: entire risk period.
Croatian: Trajanje imuniteta: ILT: 60 tjedana, MB: cijelo rizično razdoblje.
English: However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Croatian: Svejedno bi trebalo slijediti mjere predostrožnosti da bi se izbjegao izravan ili neizravan dodir cijepljenih pilića i pura.
English: Fertility: No information is available on use in future breeding birds.
Croatian: Plodnost: Nema dostupnih informacija za upotrebu kod budućeg rasplodnog jata.
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day, but not mixed with, Nobilis ND Clone 30 or Nobilis ND C2.
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni i dokazuju da ovo cjepivo može biti primijenjeno istog dana ali ne i pomiješano s Nobilis ND Clone 30 ili Nobilis ND C2.
English: Remove the syringe and invert the bag (6-8 times) to mix the vaccine.
Croatian: Maknuti injekciju i preokrenuti vrećicu (6-8 puta) radi miješanja cjepiva.
English: Disinfect vaccinating equipment by boiling in water for 20 minutes or by autoclaving (15 minutes at 121 °C).
Croatian: Dezinficirati opremu za cijepljenje kuhanjem u vodi kroz 20 min ili u autoklavu (15 min na 121°C).
English: When this product is mixed with Nobilis Rismavac, both should be diluted in the same solvent bag in the same way (400 ml of solvent for each 2,000 doses of both products or 800 ml of solvent for each 4,000 doses of both products).
Croatian: Kada se ovaj proizvod miješa s Nobilis Rismavac oboje treba rastopiti u istoj vrećici otapala na isti način (400 ml otapala za svakih 2000 doza oba proizvoda ili 800 ml otapala za svakih 4000 doza oba proizvoda).
English: When Innovax-ILT is mixed with Nobilis Rismavac the development of immunity towards ILT may be delayed in animals with maternally derived antibodies.
Croatian: Kada se Innovax ILT miješa s Nobilis Rismavacom razvoj imuniteta protiv ILT može biti odgođen kod životinja s materalnim protutijelima.
English: Cell suspension:
Croatian: Stanična suspenzija:
English: Dry the ampoule, then break the ampoule at its neck and immediately proceed as described below.
Croatian: Osušiti ampulu, zatim prelomiti je na vratu i odmah postupiti prema ranije navedenom.
English: It is important that the suspension, after being thawed, is mixed immediately into the solvent to protect the cells.
Croatian: Važno je da se suspenzija nakon odmrzavanja odmah pomiješa s otapalom kako bi se zaštitilo stanice.
English: Vaccinate healthy one-day-old chicks only.
Croatian: Cijepiti samo zdrave jednodnevne piliće.
English: For this mixed use, an onset of immunity of 5 days has been demonstrated for MD.
Croatian: Kod kombinirane upotrebe, za MB dokazan je početak imuniteta nakon 5 dana.
English: If frozen suspension is situated in the tip of the ampoule this indicates that the suspension has been thawed and must not be used.
Croatian: Ako je suspenzija smrznuta na vrhu ampule znači da treba biti uklonjena i ne smije se upotrijebiti.
English: ROUTE(S) OF ADMINISTRATION Read package leaflet before use.
Croatian: PUT(EVI) PRIMJENE Pročitati uputu prije primjene.
English: Pancreatic digest of casein Phenolsulfonphthalein (Phenol red) Potassium dihydrogen phosphate Water for injections
Croatian: Fenolsulfoftalin (fenol crveni) Kalijev dihidrogen fosfat Voda za injekciju
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Croatian: Ako zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo se javite veterinaru.
English: There is no information available on the number of doses on the ampoules once they are removed from the cane, so special care has to be taken to ensure that the mix-ups of ampoules with different number of doses is avoided and the correct solvent is used.
Croatian: Nema dostupnih informacija o broju doza po ampuli nakon što je izvađena iz kontejnera te treba obratiti posebnu pozornost da se ne pomiješaju ampule sa različitim brojevima doza te da se upotrebljava ispravno otapalo.
English: No symptoms were observed after the administration of a 10-fold dose of vaccine.
Croatian: Nisu primijećeni simptomi ni nakon primjene 10 puta veće doze cjepiva.
English: The vaccine induces active immunity against infectious laryngotracheitis and Marek's disease in chickens.
Croatian: Cjepivo potiče aktivni imunitet protiv zaraznog laringotraheitisa i Marekove bolesti u pilića.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) HVT/ILT-138
Croatian: HVT/ILT-138
English: During subcutaneous vaccination, care should be taken to prevent damage of the blood vessels in the neck of the chickens.
Croatian: Tijekom subkutanog cijepljenja, posebno obratiti pažnju da se ne ozlijede krvne žile na vratu pilića.
English: Shelf life after reconstitution according to directions: 2 hours at a temperature below 25 °C.
Croatian: Rok valjanosti nakon rekonstitucije prema uputama: 2 sata na temperaturi ispod 25 °C.
English: As a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Croatian: Kao živo cjepivo, vakcinalni soj izlučen iz cijepljenih ptica može se proširiti na pure.
English: The solvent must be clear, red coloured, without sediment and at room temperature (15-25 °C) at the time of mixing.
Croatian: Otapalo treba biti bistro, crveno obojeno, bez taloga i na sobnoj temperaturi (15-25 °C) u vrijeme miješanja.
English: Pharmacotherapeutic group: immunologicals for Aves, live viral vaccines for domestic fowls.
Croatian: Farmakoterapijska grupa: za imunizaciju ptice, živo virusno cjepivo za domaću perad.
English: Innovax-ILT is a virus suspension packed in glass ampoules and stored in liquid nitrogen.
Croatian: Innovax-ILT je virusna suspenzija pakirana u staklene ampule koje se čuvaju u tekućem dušiku.
English: Any person intending to manufacture, import, possess, sell, supply and/or use Innovax-ILT must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Croatian: Tko namjerava proizvoditi, uvesti, prodavati, opskrbljivati i/ili primjenjivati Inovax-ILT mora konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju prije proizvodnje, uvoza, prodaje, opskrbe i/ili primjene.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose (0.2 ml) of reconstituted vaccine contains:
Croatian: NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA Svaka doza (0,2 ml) rekonstituirane vakcine sadrži:
English: Use 400 ml of solvent for each 2,000 doses of cell suspension or 800 ml of solvent for each 4,000 doses of cell suspension.
Croatian: Upotrijebiti 400 ml otapala za svakih 2000 doza stanične otopine ili 800 ml otapala za svakih 4000 doza stanične otopine.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Croatian: For animal treatment only.
English: To allow a check on correct storage and transport the ampoules are placed upside down in the liquid nitrogen containers.
Croatian: Da bi se osigurala provjera ispravnosti uvjeta čuvanja i transportiranja ampule su položene uspravno u kontejnerima s tekućim dušikom.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Innovax-ILT
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
English: For this reason, thaw the ampoules in clean water at 25-27 °C.
Croatian: Iz tog razloga, uroniti ampulu u čistu vodu na temperaturi od 25-27ºC.
English: ILT: 4 weeks, MD: 9 days.
Croatian: Početak imuniteta: ILT: 4 tjedna, MB: 9 dana.
English: 5 bags of 400 ml solvent or 5 bags of 800 ml solvent.
Croatian: 5 vrećica od 400 ml otapala ili 5 vrećica od 800 ml otapala.