FrancophonIA/ELRC3.0 huggingface dataset:
English: What Bronchitol is and what it is used for What you need to know before you use Bronchitol How to use Bronchitol
Croatian: Što morate znati prije nego počnete primjenjivati Bronchitol Kako primjenjivati Bronchitol Moguće nuspojave
English: Cough was commonly reported with use of Bronchitol in clinical studies (see section 4.8).
Croatian: Kašalj Klinička ispitivanja pokazala su učestalu pojavu kašlja kod primjene Bronchitola (vidjeti dio 4.8).
English: No mutagenic or genotoxic effect has been revealed when mannitol was assayed in a standard battery of genotoxicity tests.
Croatian: U standardnom nizu testova genotoksičnosti nisu otkriveni mutageni ni genotoksični učinci manitola.
English: The 2-week treatment pack is for treatment use.
Croatian: Pakiranje za 2-tjedno liječenje namijenjeno je liječenju (nakon procjene početne doze).
English: Haemoptysis has been commonly reported with Bronchitol in clinical studies.
Croatian: Klinička ispitivanja pokazala su učestalu pojavu hemoptize kod primjene Bronchitola.
English: IMED Poland Sp. z o. o. Tel: +48 22 663 43 10
Croatian: Tel: +48 22 663 43 10
English: Patients must be monitored for bronchial hyperresponsiveness to inhaled mannitol during their initiation dose assessment before commencing the therapeutic dose regimen of Bronchitol.If the patient is unable to perform spirometry or complete the initiation dose assessment, they must not be prescribed Bronchitol.
Croatian: Pacijente se mora nadzirati zbog hiperreaktivnosti na inhalirani manitol tijekom procjenjivanja učinka početne doze, a prije nego se započne s uzimanjem terapijske doze Bronchitola.
English: EU/1/12/760/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/760/001
English: The treatment effect of Bronchitol on FEV1 was less evident in the subgroup of patients who were receiving concomitant rhDNase.In rhDNase users in study 301 the relative change in FEV1 % predicted from baseline across 26 weeks of treatment was 2.83 (95% CI -0.62, 6.27).
Croatian: Za osobe koje uzimaju rhDNase u ispitivanju 301, procijenjena relativna postotna promjena FEV1 % u odnosu na početnu vrijednost tijekom 26 tjedana iznosila je 2,83 (95% CI -0,62, 6,27).
English: Before you are started on Bronchitol, your doctor will check whether your airways are too sensitive to mannitol.
Croatian: Prije no što počnete uzimati Bronchitol, liječnik će provjeriti jesu li
English: EU/1/12/760/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/760/002
English: Animal reproduction studies have not been carried out with inhaled mannitol.
Croatian: Ispitivanja učinka inhalacije manitola na reprodukciju u životinja nisu provedena.
English: Once removed from the blister a capsule should be used immediately.
Croatian: Kapsula se mora upotrijebiti odmah nakon vađenja iz blistera.
English: For instructions on how to use the inhaler, see the end of the leaflet.
Croatian: Upute o uporabi inhalatora potražite na kraju Upute.
English: In study 302 the most frequent adverse reaction reported during the MTT was cough in seven patients (2.1%),and in study 303 the most frequently reported adverse reaction from the MTT was also cough in eight patients (1.6%).
Croatian: U ispitivanju 302, najučestalija nuspojava zabilježena tijekom MTT-a bio je kašalj u sedam pacijenata (2,1 %), a u ispitivanju 303
English: CARTON - 2-WEEK TREATMENT PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - PAKIRANJE ZA 2-TJEDNO LIJEČENJE
English: Renal or hepatic impairment
Croatian: - Prehlada i vrućica
English: Treatment dose (2-week packs) - You must use Bronchitol every day.
Croatian: - Bronchitol morate uzimati svaki dan.
English: Uncommon Bronchitis, Bronchopneumonia, Dysphonia, Hyperventilation, Sputum Discoloured, Throat irritation, Pharyngitis, Upper respiratory tract infection, Bronchospasm, Dyspnoea, Chest pain
Croatian: nadraženost grla, faringitis, infekcija gornjih dišnih putova, bronhospazam, dispneja, bol u prsištu
English: Post-tussive vomiting, Vomiting Uncommon Nausea, Diarrhoea, Eructation, Flatulence, Gastrooesophageal reflux disease, Glossodynia, Retching, Stomatitis, Abdominal pain upper, Aphthous Stomatitis, Odynophagia
Croatian: Poremećaji probavnog sustava Često povraćanje uzrokovano kašljem, povraćanje Manje često mučnina, proljev, podrigivanje, flatulencija, gastroezofagealna refluksna bolest, glosodinija,
English: Pharmaxis Europe Limited Tél/Tel: + 353 (0) 1431 9816
Croatian: PharmaxisEurope Limited Tél/Tel: + 353 (0) 1431 9816
English: Bronchitol 40 mg, inhalation powder, hard capsules mannitol
Croatian: Bronchitol 40 mg, prašak inhalata, tvrde kapsule manitol
English: Bronchitol 40 mg inhalation powder, hard capsules mannitol
Croatian: Bronchitol 40 mg prašak inhalata, tvrde kapsule manitol
English: Take off the cap - Using both hands, hold the inhaler upright and take off the cap.
Croatian: Skinite zatvarač - Držite inhalator u uspravnom položaju objema rukama i skinite zatvarač.
English: In study DPM-CF-303 (N=423) the baseline FEV1 percent predicted was 63.17 (SD: 15.15) and 62.98 (SD: 13.65).In study DPM-CF-301 64.4 % of the patient population were adults while in study DPM-CF302 this figure was 49.5%.
Croatian: U ispitivanju DPM-CF-301, 64,4 % populacije pacijenata činile su odrasle osobe, dok je ta brojka u ispitivanju DPM-CF-302 bila 49,5 %.
English: Oropharyngeal pain, Wheezing Uncommon Productive cough, Throat irritation, Asthma, Bronchospasm, Forced expiratory volume decreased, Rhinorrhoea, Dyspnoea Dysphonia, Hyperventilation, Obstructive airways disorder, Respiratory tract congestion, Sputum discoloured, Hypoxia
Croatian: bronhospazam, smanjen forsirani ekspiracijski volumen zraka, rinoreja, dispneja, disfonija,
English: Uncommon Initial insomnia, Morbid thoughts
Croatian: Manje često početna nesanica, morbidne misli Poremećaji živčanog sustava Često glavobolja
English: Cough, Haemoptysis,
Croatian: hiperventilacija, promjena boje sputuma,
English: Non-CF Bronchiectasis
Croatian: Bronhiektazije nepovezane s cističnom fibrozom
English: Cough
Croatian: - Kašalj
English: Refer to enclosed leaflet for inhaler device instructions.
Croatian: Upute o inhalatoru potražiti u priloženoj uputi o lijeku.
English: 4.7 Effects on ability to drive and use machines
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada na strojevima Bronchitol ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada na strojevima.
English: EXP
Croatian: FEV1
English: Repeat the rinsing operation once or twice.
Croatian: Postupak ispiranja ponovite jednom ili dvaput.
English: Protect from light.
Croatian: Zaštititi od svjetla
English: Do not re-freeze under any circumstances.
Croatian: Ne zamrzavati ponovo ni u kojim okolnostima.
English: Each dose of vaccine contains:
Croatian: Svaka doza cjepiva sadrži:
English: Date of first authorisation: 09/08/2002 Date of last renewal: 06/07/2012
Croatian: Datum prvog odobrenja: 09/08/2002 Datum posljednje obnove: 06/07/2012
English: Use immediately after preparation.
Croatian: Primijeniti odmah nakon pripremanja.
English: ATCvet code QI01AD15
Croatian: ATCvet kod QI01AD15
English: Proceed immediately to next step.
Croatian: Odmah prijeđite na slijedeći korak.
English: Vaccinate only healthy birds.
Croatian: Cijepiti samo zdrave ptice.
English: EXP {month/year}
Croatian: EXP{mjesec/godina}
English: The instructions for use of this device should be strictly followed.
Croatian: Treba se strogo pridržavati uputa za uporabu uređaja.
English: A single vaccination is sufficient to provide protection during the risk period.
Croatian: Jednokratno cijepljenje je dostatno za osiguravanje zaštite tijekom rizičnog razdoblja.
English: The device should be proven to safely and effectively deliver the appropriate dose.
Croatian: Naprava treba biti provjerena za sigurno i djelotvorno davanje odgovarajuće doze.
English: The onset of protection is from 2 weeks and the protection extends to 9 weeks.
Croatian: Početak zaštite je nakon 2 tjedna, a zaštita traje do 9 tjedana.
English: It should be used immediately after the preparation (all of the diluted vaccine should be used up within one hour).
Croatian: Mora se primijeniti odmah nakon pripreme (svo razrijeđeno cjepivo mora se upotrijebiti u roku od jednog sata).
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/EV i Europskog Parlamenta i Vijeća koja je dopunjena, država članica može, u skladu sa svojim nacionalnim zakonodavstvom, zabraniti proizvodnju, uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunološkog veterinarsko-medicinskog proizvoda na cijelom ili na jednom njenom dijelu ako je utvrđeno da:
English: Apply the usual aseptic precautions to all administration procedures.
Croatian: Primijenite uobičajene aseptičke mjere opreza u svim postupcima primjene.
English: Casein hydrolysate Phenol red 1% solution Salts
Croatian: Kazein hidrolizat Fenol crvena 1% solucija Soli
English: For active immunisation of chickens:
Croatian: Za aktivnu imunizaciju pilića:
English: 1 bottle of 200 ml
Croatian: 1 bočica od 200 ml
English: However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Croatian: Međutim, potrebno je poduzeti mjere opreza kako bi se izbjegao izravni ili neizravni kontakt cijepljenih pilića i purana.
English: 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 ili eradikacije bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živim životinjama ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
English: The onset of protection is from 4 days.
Croatian: Početak zaštite je nakon 4 dana.
English: Day-old chickens and 18 days embryonated eggs.
Croatian: Jednodnevni pilići i 18-dnevna embrionirana jaja.
English: 1000 doses 2000 doses
Croatian: 1000 doza: 2000 doza:
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: Do not re-use opened containers of diluted vaccine.
Croatian: Ne koristiti ponovo otvorene spremnike s razrijeđenim cjepivom.
English: Merial Laboratoire Lyon Gerland, 254 rue Marcel Merieux 69007 Lyon
Croatian: Merial, Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 Lyon
English: • Transfer the suspension into the diluent (Do not use if cloudy).
Croatian: • Prenesite suspenziju u razrjeđivač (Ne koristite ako je mutna).
English: Interaction with other medicinal products and other forms of interaction:
Croatian: Interakcija sa ostalim veterinarsko medicinskim preparatima i ostale vrste interakcija:
English: The active substance being a principle of biological origin intended to 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) 470/2009.
English: • Remove from the liquid nitrogen container only those ampoules which are to be used immediately.
Croatian: • Iz spremnika s tekućim dušikom izvadite samo one ampule koje će se odmah upotrijebiti.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above.
Croatian: Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom osim gore navedenim proizvodom.
English: As a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Croatian: Kao živo cjepivo, cjepni soj se izlučuje iz cijepljenih ptica i može se proširiti na purane.
English: For in ovo administration, an automated egg injection machine can be used.
Croatian: Za primjenu in ovo treba koristiti uređaj za automatsko injiciranje jaja.
English: 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 proizvod namijenjen da pruži imunost, odsutna s tog područja.
English: Use sterile and antiseptic-free and/or disinfectant-free equipment for injections purposes.
Croatian: Za davanje cjepiva koristite sterilne materijale bez antiseptičkog i/ili dezinfekcijskog sredstva.
English: Do not mix with any other veterinary medicinal product except those mentioned in section 4.8 and the diluent supplied for use with the product.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim onih navedenih u dijelu 4.8 i razrjeđivačem koji je isporučen s proizvodom.
English: The vaccine strain is a recombinant Herpesvirus of turkeys (HVT) expressing the protective antigen (VP2) of the Infectious Bursal Disease Virus (IBDV) strain Faragher 52/70.
Croatian: Cjepni soj je rekombinantni herpes virus purana (HVT) koji izražava zaštitni antigen (VP2) virusa zarazne bolesti burze (IBDV) soj Faragher 52/70.
English: • The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
Croatian: • Razrijeđeno cjepivo pripremljeno kako je opisano lagano se mućka kako bi bilo spremno za primjenu.
English: • As soon as they are thawed, open ampoules holding them at arm's length in order to prevent any risk of injury should an ampoule break.
Croatian: • Čim su otopljene, otvarajte ampule tako da ih držite na udaljenosti dužine ruke kako bi se spriječila opasnost od povrede ako se ampula slomi.
English: • Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe.
Croatian: • Nakon otvaranja ampule navucite sadržaj u sterilnu špricu od 5 ml.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Croatian: Svaki neiskorišteni veterinarski lijek ili otpadni materijal dobiven iz tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
English: Do not use if cloudy.
Croatian: Ne primjenjivati ako je mutno.
English: In the absence of specific studies, no other veterinary medicinal product should be administered concurrently with the product.
Croatian: U nedostatku određenih ispitivanja, nijedan drugi veterinarsko-medicinski proizvod se ne smije primjenjivati s ovim veterinarsko-medicinskim proizvodom.
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Merial attenuated vaccines against Newcastle disease and Infectious bronchitis.
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti primijenjeno istog dana, ali ne pomiješano s atenuiranim cjepivom tvrtke Merial protiv Newcastleske bolesti i zaraznog bronhitisa.
English: The vaccine induces an active immunity and a serological response against Infectious Bursal Disease and Marek's Disease in chickens.
Croatian: Cjepivo inducira aktivni imunitet i serološki odgovor protiv zarazne bolesti burze i Marekove bolesti u pilića.
English: OTHER INFORMATION
Croatian: 12. OSTALE INFORMACIJE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {AMPOULE 1000 and 2000 doses}
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA AMPULA s 1000 i 2000 doza
English: Name and address of the manufacturers of the biological active substance(s)
Croatian: Naziv i adresa proizvođača biološki djelatne(ih) tvari
English: • Transfer the suspension into the diluent.
Croatian: • Prenesite suspenziju u razrjeđivač.
English: This diluent may be used with the following products: Vaxxitek HVT+IBD (EU/2/02/032/001-002)
Croatian: Vaxxitek HVT+IBD (EU/2/02/032/001-002)
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Croatian: Ako zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo da javite veterinaru.
English: Open ampoules holding them at arm's length in order to prevent any risk of injury should an ampoule break.
Croatian: Otvarajte ampule tako da ih držite na udaljenosti dužine ruke kako bi se spriječila opasnost od povrede ako se ampula slomi.
English: Suspension and solvent for suspension for injection
Croatian: Suspenzija i razrjeđivač za suspenziju za injekcije.
English: Do not use after the expiry date stated on the ampoule.
Croatian: Ne koristiti poslije isteka roka valjanosti naznačenog na ampuli.
English: This is why the vaccine suspension should only be prepared as and when required.
Croatian: Zato suspenziju cjepiva treba pripremiti kako i kada je potrebno.
English: Shelf life of the non-reconstituted vaccine: 36 months at -196°C Shelf life of the reconstituted vaccine: up to 2 hours at a temperature below 25°C.
Croatian: Rok valjanosti nerekonstituiranog cjepiva: 36 mjeseci na -196 °C Rok valjanosti rekonstituiranog cjepiva: do 2 sata na temperaturi ispod 25 C.
English: This is why the vaccine suspension should only be prepared as and when required
Croatian: Zato suspenziju cjepiva treba pripremiti kako i kada je potrebna
English: Do not mix with any other veterinary medicinal product except those mentioned in the above paragraph and the diluent supplied for use with the product.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim onih navedenih u u gornjem odlomku i razrjeđivačem isporučenim s proizvodom.
English: STERILE DILUENT
Croatian: STERILNI RAZRJEĐIVAČ
English: Safety and reversion to virulence trials have shown that the strain is safe for turkeys.
Croatian: Ispitivanja neškodljivosti i povrata virulencije su pokazala da soj nije škodljiv za purane.
English: Store the vaccine in liquid nitrogen.
Croatian: Cjepivo čuvati u tekućem dušiku.
English: Live vHVT013-69 recombinant virus, at least ......................................................... 3.6 to 5.0 log10 PFU Excipient ...................................................................................................................................... qs 1 dose Diluent:
Croatian: Živi vHTV013-69 rekombinirani virus, najmanje ................................................. 3,6 do 5,0 log10 PFU* Pomoćne tvari ..............................................................................................................................qs 1 doza
English: • Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent.
Croatian: • Isperite ampulu s tih 2 ml, a zatim prebacite tekućinu za ispiranje u razrjeđivač.
English: Store the reconstituted vaccine at a temperature below 25°C.
Croatian: Rekonstituirano cjepivo čuvati na temperaturi ispod 25 °C.
English: Live recombinant vaccine against Infectious Bursal Disease and Marek's Disease.
Croatian: Živo rekombinantno cjepivo protiv zarazne bolesti burze i Marekove bolesti.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Croatian: NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I PROIZVOĐAČA ODGOVORNOG ZA PUŠTANJE PROIZVODNE SERIJE, AKO JE
English: Shelf life of the diluent in polyvinylchloride bags: 36 months at a temperature below 30°C.
Croatian: Rok valjanosti razrjeđivača u vrećicama iz polivinilklorida: 36 mjeseci na temperaturi ispod 30 C.
English: Dimethyl sulfoxide Dilution medium
Croatian: Suspenzija: Dimetil sulfoksid
English: Special precautions for use in animals:
Croatian: Posebna mjere opreza za primjenu kod životinja:
English: Read the package leaflet supplied with the vaccine vial before use.
Croatian: Pročitati uputu o VMP isporučenu s cjepivom, prije primjene.
English: Ampoule carriers are stored in canister, and in liquid nitrogen containers.
Croatian: Nosači ampula čuvaju se u kanistru, u spremnicima s tekućim dušikom. - (polipropilenska) bočica s 200 ml razrjeđivača.
English: • To reduce mortality, clinical signs and lesions of Marek's disease.
Croatian: • Za smanjenje smrtnosti, kliničkih znakova i lezija od Marekove bolesti.
English: Shelf life of the diluent in polypropylene bottles: 12 months at a temperature below 30°C.
Croatian: Rok valjanosti razrjeđivača u polipropilenskim bocama: 12 mjeseci na temperaturi ispod 30 C.
English: • To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.
Croatian: • Za sprječavanje smrtnosti i smanjenje kliničkih znakova i lezija od zarazne bolesti burze.
English: Subcutaneous route: one single injection of 0.2 ml per chicken at the age of one day.
Croatian: Subkutana primjena: jedna injekcija od 0,2 ml po jednodnevnom piletu..
English: One single injection of 0.2 ml per chicken at the age of one day, by subcutaneous route.
Croatian: Jedna injekcija od 0,2 ml po jednodnevnom piletu, subkutano.
English: In ovo route: one single injection of 0.05 ml per egg at 18 days of embryonation.
Croatian: Primjena in ovo: jedna injekcija od 0,05 ml po 18-dnevnom embrioniranom jajetu.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Croatian: Posebne mjere opreza za osobu koja primijenjuje veterinarsko medicinski proizvod na životinji:
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial attenuated vaccines against Marek's disease Rispens strain.
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti pomiješano atenuiranim cjepivom tvrtke Merial protiv Marekove bolesti, soj Rispens.
English: - (polyvinylchloride) bag of 200ml, 400ml, 600ml, 800ml, 1000ml, 1200ml, 1400ml, 1600ml,
Croatian: - (polivinilkloridska) vrećica s 200 ml, 400 ml, 600 ml, 800ml, 1000 ml, 1200 ml, 1400 ml, 1600 ml, 1800 ml ili 2400 ml razrjeđivača.
English: • Thaw the contents of the ampoules rapidly by agitation in water at 25°C-30°C.
Croatian: • Sadržaj ampula brzo otopite mućkanjem u vodi pri 25°C-30°C.
English: • Draw up 2 ml of the contents of the diluent into the syringe.
Croatian: • Navucite 2 ml sadržaja razrjeđivača u špricu.
English: • Wear protective gloves and spectacles during the ampoule thawing and opening operations.
Croatian: • Tijekom postupka odmrzavanja i otvaranja ampula nositi zaštitne rukavice i naočale.
English: - (glass) ampoule of 1,000 doses of vaccine, 5-ampoule carrier.
Croatian: - (staklena) ampula od 1,000 doza cjepiva, nosač s 5 ampula.
English: For subcutaneous route:
Croatian: Za subkutanu primjenu:
English: Wear protective gloves and spectacles during the ampoule thawing and opening operations.
Croatian: Tijekom postupka odmrzavanja i otvaranja ampula nositi zaštitne rukavice i naočale.
English: Vaxxitek HVT+IBD Suspension and solvent for suspension for injection
Croatian: Vaxxitek HVT+IBD suspenzija i razrjeđivač za suspenziju za injekcije
English: Shelf life of the reconstituted vaccine: up to 2 hours at a temperature below 25°C.
Croatian: Rok valjanosti rekonstituiranog cjepiva: do 2 sata na temperaturi ispod 25 °C.