FrancophonIA/ELRC3.0 huggingface dataset:
English: The joint database drug utilisation final study report submitted by the MAHs, together with the joint survey drug utilisation final study report submitted by the MAHs as a separate procedure (EMEA/H/N/PSR/J/0005), complies with their obligation to conduct a database drug utilisation study to characterise prescribing practices for the medicinal product during typical and clinical use in representative groups of prescribers and to assess the main reason for prescription as imposed during the Article 107i procedure EMA/H/A-107i/1357 for cyproterone/ethinylestradiol containing products.
Croatian: Završno izvješće ispitivanja potrošnje lijekova na temelju zajedničke baze podataka koje su podnijeli nositelji odobrenja za stavljanje lijeka u promet, uz završno izvješće ispitivanja potrošnje lijekova na temelju zajedničkog pregleda koje su podnijeli nositelji odobrenja za stavljanje lijeka u promet u zasebnom postupku (EMEA/H/N/PSR/J/0005), u skladu je s njihovom obvezom provođenja ispitivanja potrošnje lijekova na temelju baze podataka kako bi se opisale prakse propisivanja lijeka u uobičajenoj i kliničkoj upotrebi u reprezentativnoj skupini liječnika koji propisuju lijek te radi procjene glavnih razloga propisivanja kako je zadano tijekom postupka EMA/H/A-107i/1357 po članku 107i za lijekove koji sadrže ciproteron/etinilestradiol.
English: Therefore, in view of available data regarding the joint database drug utilisation final study report, together with the joint database drug utilisation final study report submitted as a separate procedure (EMEA/H/N/PSR/J/0005), the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Croatian: Stoga, s obzirom na dostupne podatke o završnom izvješću o ispitivanju potrošnje lijekova na temelju zajedničke baze podataka, uz završno izvješće ispitivanja potrošnje lijekova na temelju zajedničke baze podataka podnesenog u zasebnom postupku (EMEA/H/N/PSR/J/0005), PRAC smatra da su izmjene uvjeta odobrenja za stavljanje lijeka u promet opravdane.
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance cyproterone/ethinylestradiol concerned by the non-interventional imposed PASS final report The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through)
Croatian: Izmjene koje je potrebno unijeti u uvjete odobrenja za stavljanje lijeka u promet za lijek(ove) koji sadrži(e) djelatnu tvar ciproteron/etinilestradiol na koje se odnosi završno izvješće neintervencijskog zadanog PASS ispitivanja Nositelj(i) odobrenja za stavljanje lijeka u promet uklonit će sljedeći(e) uvjet(e) (novi tekst je podcrtan i podebljan, obrisani tekst je precrtan)
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance cyproterone/ethinylestradiol and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka o rezultatima ispitivanja lijeka(ova) koji sadrži(e) djelatnu tvar ciproteron/etinilestradiol i na koje se odnosi završno izvješće PASS ispitivanja, CMDh smatra da je omjer koristi i rizika lijeka(ova) spomenutog(ih) gore nepromijenjen, uz predložene izmjene informacija o lijeku.
English: The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied.
Croatian: Stajalište je CMDh-a da je potrebna izmjena odobrenja za stavljanje lijeka u promet za lijekove na koje se odnosi ovo završno izvješće PASS ispitivanja.
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance cyproterone/ethinylestradiol and concerned by the PASS final report , the scientific conclusions are as follows:
Croatian: Uzimajući u obzir PRAC-ovo Izvješće o ocjeni završnog izvješća neintervencijskog zadanog ispitivanja sigurnosti primjene lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet (PASS) za lijek(ove) koji sadrži(e) djelatnu tvar ciproteron/etinilestradiol i na koje se odnosi završno izvješće PASS ispitivanja, znanstveni zaključci su sljedeći:
English: MA (EU) number
Croatian: Broj (EU) oborenja
English: Strength Pharmaceutical Form
Croatian: Farmaceut ski oblik
English: _ _ 1 25 mg rilpivirine (as hydrochloride) / 200 mg emtricitabine / 245 mg tenofovir disoproxil (as fumarate)
Croatian: 25 mg rilpivirina (u obliku klorida) / 200 mg emtricitabina / 245 mg tenofovirdizoproksila (u obliku fumarata)
English: 3 x 30 tablets
Croatian: Bočica (HDPE) 3 x 30 tableta
English: 30 tablets
Croatian: Bočica (HDPE) 30 tableta
English: (Invented) name
Croatian: (Zaštićeno)
English: Packaging
Croatian: ime
English: Date of first authorisation: 12/11/2019
Croatian: Datum prvog odobrenja:12/11/2019
English: The final concentrations of the vaccines will therefore also differ.
Croatian: Konačne koncentracije cjepiva također će se razlikovati.
English: Chickens and embryonated chicken eggs.
Croatian: Pilići i embrionirana kokošja jaja.
English: Do not use in flocks without MDAs against IBDV.
Croatian: Nemojte koristiti u jatima bez MDA protiv IBDV.
English: Duration of immunity: up to 43 days of age.
Croatian: Trajanje imunosti: do 43 dana starosti.
English: In practice, studies in commercial broiler chickens have shown an onset of immunity from between 24 days of age and 28 days of age.
Croatian: U praksi, istraživanje kod komercijalnih pilića-brojlera pokazale su početak imunosti između 24 dana starosti i 28 dana starosti.
English: ATCvet code: QI01AD09
Croatian: ATCvet kod: QI01AD09
English: It is recommended to vaccinate all chickens on a site at the same time.
Croatian: Preporučuje se cijepljenje svih pilića na istoj farmi u isto vrijeme.
English: The instructions for the calibration and use of the equipment should be strictly followed in order to deliver the appropriate dose.
Croatian: Treba strogo slijediti upute za umjeravanje i uporabu opreme kako bi se isporučila odgovarajuća doza.
English: Wash and disinfect hands and equipment after use.
Croatian: Nakon upotrebe operite i dezinficirajte ruke i opremu.
English: Ελλάδα HIPRA EΛΛAΣ A.E.
Croatian: HIPRA EΛΛAΣ A.E.
English: This depletion does not cause immunosuppression in chickens.
Croatian: Ova deplecija ne uzrokuje imunosupresiju kod pilića.
English: EU/2/19/245/001 (10 x 1,000 doses) EU/2/19/245/002 (10 x 2,000 doses) EU/2/19/245/003 (10 x 2,500 doses) EU/2/19/245/004 (10 x 4,000 doses) EU/2/19/245/005 (10 x 5,000 doses)
Croatian: EU/2/19/245/001 (10 x 1000 doza) EU/2/19/245/002 (10 x 2000 doza) EU/2/19/245/003 (10 x 2500 doza) EU/2/19/245/004 (10 x 4000 doza) EU/2/19/245/005 (10 x 5000 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 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: During this time, contact between the vaccinated chickens and any immunosuppressed or unvaccinated birds should be avoided.
Croatian: Tijekom tog vremena treba izbjegavati kontakt između cijepljenih pilića i imunosupresiranih ili necijepljenih ptica.
English: In ovo or SC use.
Croatian: In ovo ili s.c.
English: For the reconstitution and administration of the vaccine, use sterile equipment free from any residues of chemical disinfectants.
Croatian: Za rekonstituciju i primjenu cjepiva koristite sterilnu opremu bez ostataka kemijskih dezinfekcijskih sredstava.
English: Onset of immunity: from 24 days of age.
Croatian: Početak imunosti: od 24 dana starosti.
English: Solvent for GUMBOHATCH
Croatian: Otapalo za GUMBOHATCH
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: Djelatne tvari koje se sastoje od tvari biološkog podrijetla, namijenjene za stvaranje aktivne imunosti i na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: Calculate and prepare the required volume of the vaccine as per the table below:
Croatian: Izračunajte i pripremite potreban volumen cjepiva prema tabeli u nastavku:
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara farmaceuta kako odlagati veterinarsko-medicinske proizvode koji vam više nisu potrebni.
English: Shelf life after reconstitution according to directions: 2 hours.
Croatian: Rok valjanosti nakon rekonstitucije prema uputi: 2 sata.
English: Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija: Ne postoje dostupni podaci o neškodljivosti i učinkovitosti ovog cjepiva kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom.
English: In case of adverse reactions following accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nuspojava nakon slučajnog samo-injiciranja, odmah potražite savjet liječnika i pokažite mu uputu o VMP ili etiketu.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label.
Croatian: Ovaj veterinarsko-medicinski proizvod nemojte koristiti nakon isteka roka valjanosti navedenog na kutiji i etiketi.
English: The onset of immunity depends on the initial maternally derived antibodies (MDA) level of the batch of chickens and even then will be different for individual chickens.
Croatian: Početak imunosti ovisi o početnom titru majčinskih protutijela (MDA) serije pilića, a čak će i tada biti različiti za pojedinačne piliće.
English: Shelf life of the lyophilisate as packaged for sale: 21 months.
Croatian: Rok valjanosti liofilizata zapakiranog za prodaju: 21 mjeseci.
English: This product should only be used after it has been demonstrated that very virulent IBDV strains are epidemiologically relevant in the area of vaccination.
Croatian: Ovaj se proizvod smije upotrebljavati isključivo nakon što je utvrđeno da su vrlo virulentni sojevi IBDV-a (virusa zarazne bolesti burze) epidemiološki relevantni u području cijepljenja.
English: The vaccine contains an intermediate-plus IBDV strain bound to specific IBDV immunoglobulins, forming an immune-complex which is administered through vaccination.
Croatian: Cjepivo sadrži intermedijarni IBDV soj vezan na specifične IBDV imunoglobuline, formirajući imunološki kompleks koji se primjenjuje cijepljenjem.
English: Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible wild and domestic birds.
Croatian: Treba poduzeti odgovarajuće veterinarske i uzgojne mjere kako bi se izbjeglo širenje cjepnog soja na podložne divlje i domaće ptice.
English: It is important to note that the volumes of solvent which must be used to reconstitute the vaccine are different depending on whether the vaccine will be administered in ovo to embryonated eggs, or by subcutaneous injection to 1-day-old chicks.
Croatian: Važno je napomenuti da su volumeni otapala koji se moraju upotrijebiti za rekonstituciju cjepiva različiti ovisno o tome da li će se cjepivo davati in ovo embrioniranim jajima, ili subkutanom injekcijom jednodnevnim pilićima.
English: The reconstituted vaccine is a slightly reddish homogeneous suspension which should be used within 2 hours after reconstitution.
Croatian: Rekonstituirano cjepivo je blago crvenkasta homogena suspenzija koju treba upotrijebiti unutar 2 sata nakon pripreme.
English: An automated egg injection machine can be used.
Croatian: Može se koristiti automatizirani injektor za ubrizgavanje jaja.
English: Wash and disinfect hands after handling vaccinated birds or their litter because the virus is excreted by vaccinated birds for up to 3 weeks.
Croatian: Operite i dezinficirajte ruke nakon rukovanja s cijepljenim pticama ili njihovim leglom jer cijepljene ptice izlučuju virus do 3 tjedna.
English: Vaccinated birds may excrete the vaccine strain up to 3 weeks following vaccine take.
Croatian: Cijepljene ptice mogu izlučivati cjepni soj do 3 tjedna nakon uzimanja cjepiva.
English: EXP {month/year} Once reconstituted use within 2 hours.
Croatian: EXP {mjesec/godina} Nakon rekonstitucije upotrijebite unutar 2 sata.
English: Pharmacotherapeutic group: Immunologicals for aves, domestic fowl, live viral vaccines, avian infectious bursal disease virus (Gumboro disease).
Croatian: Farmakoterapijska grupa: Imunološki proizvodi za ptice, domaću perad, živa virusna cjepiva, virus zarazne bolesti burze (gumborska bolest).
English: Solvent volume to be used:
Croatian: Volumen otapala koji se koristi:
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with this veterinary medicinal product.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim otapalom priloženim za primjenu s ovim veterinarsko-medicinskim proizvodom.
English: Mix the contents of the vial by gentle agitation until the contents are completely resuspended, then withdraw the suspension obtained and inject it into the solvent bag.
Croatian: Miješajte sadržaj bočice laganim miješanjem dok se sadržaj potpuno ne suspendira, zatim izvucite dobivenu suspenziju i ubrizgajte je u vrećicu s otapalom.
English: Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Potassium chloride Sodium chloride
Croatian: Dinatrij fosfat dodekahidrat Kalijev dihidrogen fosfat Kalijev klorid Natrijev klorid
English: Do not store above 25 °C.
Croatian: Nemojte čuvati pri temperaturi iznad 25 °C.
English: To stimulate active immunity against very virulent bursal disease viruses (Gumboro disease) in broiler chickens.
Croatian: Stimulirati aktivnu imunost protiv virulentnih virusa burze (gumborska bolest) kod pilića brojlera.
English: Shelf life of the solvent as packaged for sale: 3 years.
Croatian: Rok valjanosti otapala zapakiranog za prodaju: 3 godine.
English: 1,000 doses 2,000 doses 2,500 doses 4,000 doses 5,000 doses
Croatian: 1000 doza 2000 doza 2500 doza 4000 doza 5000 doza
English: Solvent: Polypropylene bags containing 200 ml, 400 ml, 800 ml or 1,000 ml.
Croatian: Polipropilenske vrećice koje sadrže 200 ml, 400 ml, 800 ml ili 1000 ml.
English: The vaccine (0.05 ml dose) must be injected into the amniotic sac of 18-day-old embryonated broiler chicken eggs.
Croatian: Cjepivo (0,05 ml doza) mora se ubrizgati u amnionsku vrećicu 18-dnevnih embrioniranih kokošjih jaja brojlera.
English: For active immunisation of 1-day-old broiler chicks and embryonated broiler chicken eggs to reduce clinical signs and lesions of the bursa of Fabricius caused by very virulent avian infectious bursal disease virus infection.
Croatian: Za aktivnu imunizaciju jednodnevnih pilića i embrioniranih jaja brojlera za smanjivanje kliničkih znakova i lezija Fabricijeve burze uzrokovane vrlo virulentnom infekcijom virusom zarazne bolesti burze.
English: The efficacy of the vaccine has been demonstrated in broilers having an average MDA level from 4,500 to 5,100 ELISA units at hatching.
Croatian: Učinkovitost cjepiva pokazana je kod brojlera koji imaju prosječni titar MDA od 4,500 do 5,100
English: An automated syringe can be used.
Croatian: Može se koristiti automatski injektor.
English: Do not use in birds in lay or breeding birds, or within 4 weeks before the start of the laying period.
Croatian: Ne primjenjivati na nesilicama za vrijeme nesenja ili pticama za rasplod ili 4 tjedna prije početka nesenja.
English: Solvent: clear colourless solution.
Croatian: Otapalo: bistra bezbojna otopina.
English: The vaccine (0.2 ml dose) must be injected under the skin of the neck of the 1-day-old broiler chicks.
Croatian: Cjepivo (doza od 0,2 ml) mora se ubrizgati pod kožu vrata jednodnevnih tovnih pilića.
English: Repeat step 2 to ensure that all the lyophilisate has been transferred into the solvent bag.
Croatian: Ponovite korak 2 kako biste bili sigurni da je sav liofilizat prenesen u vrećicu s otapalom.
English: Type I glass vials closed with Type I bromobutyl stoppers and sealed with aluminium caps containing 1,000 doses, 2,000 doses, 2,500 doses, 4,000 doses or 5,000 doses of the freeze-dried vaccine.
Croatian: I i zapečaćene aluminijskim kapicama koje sadrže 1000 doza, 2000 doza, 2500 doza, 4000 doza ili 5000 doza liofiliziranog cjepiva.
English: The safety of the veterinary medicinal product has not been established during lay.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme nesenja.
English: In laboratory studies, lymphocyte depletion was very common after vaccine take, which was followed by a lymphocyte repopulation and regeneration of the bursa of Fabricius.
Croatian: U laboratorijskim ispitivanjima limfocitna deplecija bila je vrlo česta nakon uzimanja cjepiva, nakon čega je uslijedila repopulacija limfocita i regeneracija Fabricijeve burze.
English: Withdraw 2 ml of the solvent and inject into the vial containing the lyophilisate.
Croatian: Izvucite 2 ml otapala i ubrizgajte u bočicu koja sadrži liofilizat.
English: Solvent: Do not store above 25 ºC.
Croatian: Otapalo: Nemojte čuvati pri temperaturi iznad 25 °C.
English: 10 x 1,000 doses 10 x 2,000 doses 10 x 2,500 doses 10 x 4,000 doses 10 x 5,000 doses
Croatian: 10 x 1000 doza 10 x 2000 doza 10 x 2500 doza 10 x 4000 doza 10 x 5000 doza
English: In laboratory studies, lymphocyte depletion was very common, followed by a lymphocyte repopulation and regeneration of the bursa of Fabricius.
Croatian: U laboratorijskim ispitivanjima, limfocitna deplecija bila je vrlo česta, nakon čega je uslijedila repopulacija limfocita i regeneracija Fabricijeve burze.
English: Each dose of reconstituted vaccine (0.05 ml for an in ovo dose or 0.2 ml for a subcutaneous dose) contains:
Croatian: Svaka doza rekonstituiranog cjepiva (0,05 ml za dozu in ovo ili 0,2 ml za potkožnu dozu) sadrži:
English: Live attenuated infectious bursal disease virus (IBDV), strain 1052……….. 101.48 - 102.63 PU* * PU: Potency Units
Croatian: Živi atenuirani virus zarazne bolesti burze (IBDV), soj 1052 …............… 101,48 - 102,63 PU* * PU: Jedinice potencije
English: * PU: Potency Units
Croatian: ** VNU: Jedinice neutralizacije virusa
English: Live attenuated infectious bursal disease virus (IBDV), strain 1052….. 10
Croatian: Živi atenuirani virus zarazne bolesti burze (IBDV), soj 1052………..
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vial
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
English: Lyophilisate: brown reddish colour.
Croatian: Liofilizat: smeđe crvenkasta boja.
English: Rinse the vial with another 2 ml of the solvent/lyophilisate suspension obtained in step 1, and inject it back into the solvent bag.
Croatian: Isperite bočicu s još 2 ml otapala/suspenzije liofilizata dobivenih u koraku 1 i ubrizgajte je natrag u vrećicu s otapalom.
English: Laboratorios Hipra, S.A. Avda.
Croatian: LABORATORIOS HIPRA, S.A.
English: By the subcutaneous route: Administer one single injection of 0.2 ml of the reconstituted vaccine to each chick at 1 day of age.
Croatian: Primjena pod kožu: Primijenite jednu injekciju od 0,2 ml rekonstituiranog cjepiva svakom jednodnevnom piliću.
English: After the administration of a 10-fold overdose, a mild exudate and slight congestion in the bursa of Fabricius were very commonly observed.
Croatian: Nakon primjene 10-strukog predoziranja, vrlo često su zabilježeni blagi eksudat i lagana kongestija u
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes (lyophilisate vials)
Croatian: Kartonske kutije (bočice liofilizata)
English: By the in ovo route: Administer one single injection of 0.05 ml of the reconstituted vaccine into each chicken egg at 18 days of embryonation.
Croatian: Primjena in ovo: Primijenite jednu injekciju od 0,05 ml rekonstituiranog cjepiva u svako 18 dana staro embrionirano jaje.
English: Disposal: read package leaflet supplied with the lyophilisate vial.
Croatian: Prije uporabe pročitajte uputu o lijeku dostavljenu s bočicom za liofilizat.
English: In ovo or subcutaneous use.
Croatian: In ovo ili primjena pod kožu.
English: la Selva, 135 Amer, 17170 Girona Spain
Croatian: Laboratorios Hipra, S.A. Avda. la Selva, 135 Amer, 17170 Girona Spain
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ
English: Lyophilisate for suspension for injection.
Croatian: Liofilizat za suspenziju za injekciju.
English: PU
Croatian: B.
English: Lyophilisate:
Croatian: Doziranje:
English: GUMBOHATCH lyophilisate for suspension for injection for chickens
Croatian: GUMBOHATCH liofilizat za suspenziju za injekcije za piliće
English: PACKAGE LEAFLET: GUMBOHATCH lyophilisate and solvent for suspension for injection for chickens
Croatian: UPUTA O VMP: GUMBOHATCH liofilizat i otapalo za suspenziju za injekciju za piliće
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Solvent bag
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU
English: Each dose (0.05 ml for in ovo or 0.2 ml for SC) contains: Live attenuated IBDV, strain 1052…………….. 101.48 - 102.63 PU* * PU: Potency Units
Croatian: Svaka doza (0,05 ml za in ovo ili 0,2 ml za SC) sadrži: Živi atenuirani IBDV, soj 1052……………..
English: Dilutions for subcutaneous administration (0.2 ml per dose) Number and content of vaccine vials:
Croatian: Razrjeđenja za supkutanu primjenu (0,2 ml po dozi):
English: Solvent for suspension for injection.
Croatian: Otapalo za suspenziju za injekciju.
English: Cardboard box with 10 bags containing 1,000 ml solvent.
Croatian: Kartonska kutija s 10 vrećica koje sadrže 1000 ml otapala.
English: Reconstitution of the vaccine:
Croatian: Rekonstitucija cjepiva:
English: la Selva, 135 Amer, 17170 (Girona) Spain
Croatian: Laboratorios Hipra, S.A. Avda. la Selva, 135 Amer, 17170 (Girona) Spain
English: Cardboard box with 10 lyophilisate vials containing 2,500 doses.
Croatian: Kartonska kutija s 10 liofiliziranih bočica koje sadrže 2500 doza.
English: For in ovo administration:
Croatian: Za primjenu pod kožu:
English: Cardboard box with 10 bags containing 200 ml solvent.
Croatian: Kartonska kutija s 10 vrećica koje sadrže 200 ml otapala.
English: GUMBOHATCH lyophilisate and solvent for suspension for injection for chickens
Croatian: GUMBOHATCH liofilizat i otapalo za suspenziju za injekciju za piliće
English: Cardboard box with 10 bags containing 400 ml solvent.
Croatian: Kartonska kutija s 10 vrećica koje sadrže 400 ml otapala.
English: Cardboard box with 10 bags containing 800 ml solvent.
Croatian: Kartonska kutija s 10 vrećica koje sadrže 800 ml otapala.
English: Tel: +39 030 7241821
Croatian: Hipra Italia S.r.l. Tel: +39 030 7241821
English: HIPRA UK AND IRELAND, Ltd. Tel: +44-(0)11 5845 6486
Croatian: Tel: +44-(0)11 5845 6486
English: Dilutions for subcutaneous administration (0.2 ml per dose): Number and content of vaccine vials:
Croatian: Izračunajte i pripremite potreban volumen cjepiva prema tabeli u nastavku: Razrjeđenja za supkutanu primjenu (0,2 ml po dozi): Broj i sadržaj bočica cjepiva: