FrancophonIA/ELRC3.0 huggingface dataset:
English: • Veltassa 8.4 g powder for oral suspension: each sachet contains 8.4 g of patiromer
Croatian: • Veltassa 8,4 g prašak za oralnu suspenziju: svaka vrećica sadrži 8,4 g patiromera.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Veltassa 25.2 g
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE - Veltassa 25,2 g
English: INFORMATION IN BRAILLE VELTASSA 8.4 G
Croatian: 16. PODACI NA BRAILLEOVOM PISMU VELTASSA 8,4 G
English: Mix Veltassa with water and stir until it is thoroughly mixed, as follows:
Croatian: Pomiješajte lijek Veltassa s vodom i dobro promiješajte, na sljedeći način:
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za primjenu kroz usta.
English: (CKD) on stable doses of at least one RAAS inhibitor (i.e. angiotensin converting enzyme inhibitor [ACEI], angiotensin II receptor blocker [ARB] or aldosterone antagonist [AA]).
Croatian: Sigurnost i djelotvornost patiromera dokazana je u dvodijelnom, jednostruko slijepom, randomiziranom ispitivanju ukidanja terapije kojim se ocjenjivalo ovo liječenje u bolesnika s kroničnom bolešću bubrega (KBB) i hiperkalemijom na stabilnim dozama barem jednog inihibitora RAAS-a (tj. inhibitora angiotenzin-konvertirajućeg enzima [ACE inhibitor], blokatora receptora angiotenzina II [ARB] ili antagonista aldosterona [AA]).
English: • quinidine: a medicine to treat irregular heart rhythm.
Croatian: • kinidin: lijek za liječenje aritmije.
English: NAME OF THE MEDICINAL PRODUCT Veltassa 25.2 g powder for oral suspension patiromer
Croatian: NAZIV LIJEKA Veltassa 25,2 g prašak za oralnu suspenziju patiromer
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Veltassa 16.8 g
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE - Veltassa 16,8 g
English: No special dose and administration guidelines are recommended for this population.
Croatian: Starija populacija (≥65 godina) Za tu populaciju ne preporučuju se nikakve posebne smjernice doziranja i primjene.
English: 5.5 to <6.5 mEq/L (n=147) Serum Potassium (mEq/L)
Croatian: 5,5 do <6,5 mEq/l (n=147)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Veltassa 8.4 g
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE - Veltassa 8,4 g
English: Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in the clinical studies.
Croatian: U klinička ispitivanja nisu bili uključeni bolesnici s anamnezom opstrukcije crijeva ili bolesnici koji su imali veći operativni zahvat na probavnom sustavu, teške poremećaje probavnog sustava ili poremećaje gutanja.
English: NAME OF THE MEDICINAL PRODUCT Veltassa 8.4 g powder for oral suspension patiromer
Croatian: NAZIV LIJEKA Veltassa 8,4 g prašak za oralnu suspenziju patiromer
English: Nausea Vomiting
Croatian: • povraćanje
English: NAME OF THE MEDICINAL PRODUCT Veltassa 16.8 g powder for oral suspension patiromer
Croatian: NAZIV LIJEKA Veltassa 16,8 g prašak za oralnu suspenziju patiromer
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium)
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka vrećica sadrži 25,2 g patiromera (u obliku patiromer-sorbiteks-kalcija)
English: Low blood magnesium can occur when taking Veltassa.
Croatian: Pri uzimanju lijeka Veltassa može doći do snižavanja razine magnezija u krvi.
English: Patients with end-stage renal disease (ESRD)
Croatian: Bolesnici sa završnim stadijem bubrežne bolesti
English: NAME OF THE MEDICINAL PRODUCT Veltassa 8.4 g powder for oral suspension Veltassa 16.8 g powder for oral suspension Veltassa 25.2 g powder for oral suspension
Croatian: Veltassa 8,4 g prašak za oralnu suspenziju Veltassa 16,8 g prašak za oralnu suspenziju Veltassa 25,2 g prašak za oralnu suspenziju
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium)
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka vrećica sadrži 16,8 g patiromera (u obliku patiromer-sorbiteks-kalcija)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium)
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka vrećica sadrži 8,4 g patiromera (u obliku patiromer-sorbiteks-kalcija)
English: More placebo patients (60% [95% CI: 47%, 74%]) developed a serum potassium ≥5.5 mEq/L at any time during
Croatian: Više bolesnika na placebu (60 % [95 % CI: 47 %, 74 %]) razvilo je razinu kalija u serumu ≥5,5 mEq/l u bilo kojem trenutku tijekom dijela B nego bolesnika koji su primali patiromer (15 % [95 % CI: 6 %, 24 %]), p<0,001.
English: The primary efficacy endpoint, change from baseline in serum potassium to the end of the 28-day treatment period, was significantly lower (p<0.001) in the patiromer group (LS mean [SEM]: −0.
Croatian: Mjera primarnog ishoda djelotvornosti, promjena razine kalija u serumu od početka ispitivanja do kraja razdoblja ispitivanja od 28 dana, bila je značajno niža (p<0,001) u skupini koja je primala patiromer (srednja vrijednost procijenjena metodom najmanjih kvadrata [standardna pogreška srednje vrijednosti]: −0,21 [0,07] mEq/l) u usporedbi sa skupinom koja je primala placebo (srednja vrijednost procijenjena metodom najmanjih kvadrata [standardna pogreška srednje vrijednosti]: +0,23 [0,07] mEq/l).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1179/004 30 sachets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1179/004 30 vrećica
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1179/007 30 sachets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1179/007 30 vrećica
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1179/001 30 sachets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1179/001 30 vrećica
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET of Veltassa 25.2 g
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU VREĆICA s 25,2 g lijeka Veltassa
English: EU/1/17/1179/008 60 sachets
Croatian: EU/1/17/1179/008 60 vrećica
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Početna vrijednost, srednja vrijednost (SD)
English: • problems swallowing
Croatian: • imate poteškoća s gutanjem
English: EU/1/17/1179/005 60 sachets
Croatian: EU/1/17/1179/005 60 vrećica
English: EU/1/17/1179/006 90 sachets
Croatian: EU/1/17/1179/006 90 vrećica
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET of Veltassa 16.8 g
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU VREĆICA s 16,8 g lijeka Veltassa
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET of Veltassa 8.4 g
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU VREĆICA s 8,4 g lijeka Veltassa
English: EU/1/17/1179/002 60 sachets
Croatian: EU/1/17/1179/002 60 vrećica
English: Figure 1: Mean (95% CI) serum potassium over time Baseline Serum K+ > 5.0 to 5.5 mEq/L
Croatian: Početni K+ u serumu > 5,0 do 5,5 mEq/l
English: EU/1/17/1179/009 90 sachets
Croatian: EU/1/17/1179/009 90 vrećica
English: EU/1/17/1179/003 90 sachets
Croatian: EU/1/17/1179/003 90 vrećica
English: Gastrointestinal Disorders
Croatian: Poremećaji probavnog sustava
English: • wind
Croatian: • vjetrovi
English: Pack size bottle (HDPE) 30 tablets bottle (HDPE) 90 (3 x 30) tablets (multipack)
Croatian: Veličina pakiranja boca (HDPE) 30 tableta boca (HDPE) 90 (3 x 30) tableta (višestruko pakiranje)
English: MA (EU) Numbers Invented name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: Intravenous use vial (glass)
Croatian: Intravenska primjena bočica (staklena) 20 ml
English: The absolute bioavailability was 74 %.
Croatian: Apsolutna bioraspoloživost bila je 74 %.
English: NexGard kills fleas within 8 hours and ticks within 48h.
Croatian: NexGard ubija buhe unutar 8 sati i krpelje unutar 48h.
English: Each chewable tablet contains: NexGard
Croatian: Svaka tableta za žvakanje sadrži: NexGard
English: For each strength, the chewable tablets are available in the following pack sizes:
Croatian: Za svaku jačinu, dostupne su tablete za žvakanje, u sljedećim veličinama pakovanja:
English: Date of first authorisation: 11/02/2014 Date of last renewal:
Croatian: Datum prvog odobrenja: Datum posljednjeg produljenja odobrenja: 19/12/2018
English: NexGard tablets are chewable and palatable to most dogs.
Croatian: NexGard tablete za žvakanje ukusne su za većinu pasa.
English: − very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: Carton with 1 blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Croatian: Kutija s 1 blisterom, s 1, 3 ili 6 tableta za žvakanje ili 15 blistera s 1 tabletom za žvakanje.
English: Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus).
Croatian: Liječenje i prevencija infestacije krpeljima u pasa (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus).
English: − rare (more than 1 but less than 10 animals in 10,000 animals treated)
Croatian: - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja)
English: Marketing authorisation holder: MERIAL
Croatian: Nositelj odobrenja za stavljanje u promet MERIAL
English: Afoxolaner is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum and Haemaphysalis longicornis.
Croatian: D. variabilis, Ixodes ricinus, Ixodes hexagonus i I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum i Haemaphysalis longicornis.
English: - 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: - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja)
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)).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja)
English: NexGard 11 mg dogs 2-4 kg NexGard 28 mg dogs >4-10 kg NexGard 68 mg dogs >10-25 kg NexGard 136 mg dogs >25-50 kg afoxolaner
Croatian: NexGard 11 mg psi 2-4 kg NexGard 28 mg psi >4-10 kg NexGard 68 mg psi >10-25 kg NexGard 136 mg psi >25-50 kg afoxolaner
English: NexGard 11 mg chewable tablets for dogs (2-4 kg) NexGard 28 mg chewable tablets for dogs (>4-10 kg) NexGard 68 mg chewable tablets for dogs (>10-25 kg) NexGard 136 mg chewable tablets for dogs (>25-50 kg) afoxolaner
Croatian: NexGard 11 mg tableta za žvakanje za pse (2-4 kg) NexGard 28 mg tableta za žvakanje za pse (>4-10 kg) NexGard 68 mg tableta za žvakanje za pse (>10-25 kg) NexGard 136 mg tableta za žvakanje za pse (>25-50 kg) afoksolaner
English: NexGard 11 mg chewable tablets for dogs 2-4 kg NexGard 28 mg chewable tablets for dogs >4-10 kg NexGard 68 mg chewable tablets for dogs >10-25 kg NexGard 136 mg chewable tablets for dogs >25-50 kg afoxolaner
Croatian: NexGard 11 mg tablete za žvakanje za pse od 2-4 kg NexGard 28 mg tablete za žvakanje za pse >4-10 kg NexGard 68 mg tablete za žvakanje za pse >10-25 kg NexGard 136 mg tablete za žvakanje za pse >25-50 kg afoxolaner
English: PACKAGE LEAFLET: NexGard 11 mg chewable tablets for dogs 2-4 kg NexGard 28 mg chewable tablets for dogs >4-10 kg NexGard 68 mg chewable tablets for dogs >10-25 kg NexGard 136 mg chewable tablets for dogs >25-50 kg
Croatian: UPUTA O VMP : NexGard 11 mg tableta za žvakanje za pse 2-4 kg NexGard 28 mg tableta za žvakanje za pse >4-10 kg NexGard 68 mg tableta za žvakanje za pse >10-25 kg NexGard 136 mg tableta za žvakanje za pse >25-50 kg
English: NexGard 11 mg chewable tablets for dogs 2-4 kg NexGard 28 mg chewable tablets for dogs >4-10 kg NexGard 68 mg chewable tablets for dogs >10-25 kg NexGard 136 mg chewable tablets for dogs >25-50 kg
Croatian: NexGard 11 mg tablete za žvakanje za pse 2-4 kg NexGard 28 mg tablete za žvakanje za pse >4-10 kg NexGard 68 mg tablete za žvakanje za pse >10-25 kg NexGard 136 mg tablete za žvakanje za pse >25-50 kg
English: ATCvet code: QI01AN01.
Croatian: ATCvet kod: QI01AN01.
English: The device should be cleaned after each use.
Croatian: Uređaj treba očistiti nakon svake uporabe.
English: Date of first authorisation: 18/04/2016
Croatian: Datum prvog odobrenja: 18/04/2016
English: Severe overdose (10-fold) may result in a temporary reduction in daily live weight gain within the first week without any consequences on the final performances.
Croatian: Teško predoziranje (10-struko) može dovesti do privremenog smanjenja dnevnog porasta težine unutar prvog tjedna bez bilo kakvih posljedica na konačni učinak.
English: Montanide IMS
Croatian: montanid IMS
English: 10,000 doses
Croatian: 10 000 doza
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorization holder.
Croatian: Za bilo koju informaciju o ovom veterinarsko-medicinskom proizvodu molimo kontaktirajte lokalnog predstavnika nositelja odobrenja za stavljanje u promet.
English: See the manufacturer's instructions to ensure proper disinfection and maintenance of the device.
Croatian: Pogledajte upute proizvođača kako bi osigurali ispravnu dezinfekciju i održavanje uređaja.
English: Generally the number is higher the first weeks post-vaccination and lower once the flock has achieved a proper protection.
Croatian: Obično je broj veći prvih tjedana nakon cijepljenja, a niži, jednom kad je jato postiglo odgovarajuću zaštitu.
English: Dilute the vaccine with the corresponding volumes:
Croatian: Razrijedite cjepivo u odgovarajućim volumenima:
English: Duration of immunity: 60 weeks post-vaccination in an environment that permits oocysts recycling.
Croatian: Trajanje imunosti: 60 tjedana nakon cijepljenja u okolišu koji omogućuje recikliranje oocista.
English: Suspension: White turbid suspension.
Croatian: Suspenzija: bijela neprozirna suspenzija.
English: A copy of example certificates of analysis should be provided to confirm compliance.
Croatian: Potrebno je predati kopiju primjera certifikata analize kako bi se potvrdila sukladnost.
English: It is recommended that litter should be removed and facilities and material cleaned between production cycles to reduce field infections.
Croatian: Preporučuje se ukloniti stelju te očistiti nastambe i materijal između proizvodnih ciklusa kako bi smanjili infekcije u okolišu.
English: * Number of sporulated oocysts derived from precocious attenuated lines of coccidia, according to in vitro procedures of the manufacturer at the time of blending.
Croatian: * Broj sporuliranih oocista dobivenih iz prekocijalnih atenuiranih linija kokcidija, prema in vitro postupku proizvođača u trenutku miješanja.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara ili farmaceuta kako odlagati veterinarsko-medicinske proizvode koji vam više nisu potrebni.
English: To improve the uniformity of the vaccination maintain the chicks inside the transportation box for at least 1 hour in order to let them ingest all the vaccine droplets.
Croatian: Kako bi se poboljšala ujednačenost cijepljenja, držite piliće u transportnim kavezima najmanje 1 sat kako bi mogli probaviti sve kapljice cjepiva.
English: The vaccine will not protect species other than chickens against coccidiosis and is only effective against the Eimeria species indicated.
Croatian: Cjepivo, osim kokoši, ne štiti druge vrste protiv kokcidioze i učinkovito je samo protiv naznačenih vrsta Eimeria.
English: 1,000 doses 5,000 doses
Croatian: 1 000 doza 5 000 doza
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonske kutije
English: The method of administration is by coarse spray by using a suitable device (volume delivered: 28 ml/100 chicks, droplet size: 200-250 µm and working pressure: 2 to 3 bars).
Croatian: Način primjene je raspršivanje velikim kapljicama koristeći odgovarajući uređaj (isporučeni volumen: 28 ml/100 pilića, veličina kapi: 200-250 µm i radni tlak: 2 do 3 bara).
English: Pharmacotherapeutic group: Immunological for Aves, live parasitic vaccines for domestic fowl.
Croatian: Farmakoterapijska grupa: imunološki proizvodi za Aves (ptice), živa parazitska cjepiva za domaću perad.
English: EXP {month/year} Once diluted use within 10 hours.
Croatian: ROK VALJANOSTI EXP {mjesec/godina} Jednom načeto upotrijebiti unutar 10 sati.
English: Królowej Marysieńki, 9 - 1
Croatian: HIPRA POLSKA Sp.z.o.o. Ul. Królowej Marysieńki, 9 - 1
English: Wash and disinfect hands and equipment after use.
Croatian: Nakon uporabe operite i dezinficirajte ruke i opremu.
English: la Selva 135
Croatian: Avda. la Selva 135
English: Within 6 months of Commission Decision.
Croatian: mjeseci od odluke
English: Shelf life after first opening the immediate packaging: use immediately.
Croatian: Rok valjanosti poslije prvog otvaranja spremnika: upotrijebiti odmah.
English: To stimulate active immunity against coccidiosis caused by Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Croatian: Za stimulaciju aktivne imunosti protiv kokcidioze uzrokovane vrstama Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix i Eimeria tenella.
English: The active substances being principles of biological origin intended to produce active immunity are not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna tvar koja se sastoji od tvari biološkog podrijetla, namijenjena je za stvaranje aktivne imunosti i na koje se ne primjenjuju odredbe Uredbe (EZ) br. 470/2009.
English: HIPRAMUNE T, solvent for Evalon
Croatian: HIPRAMUNE T, otapalo za Evalon
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kartonskoj kutiji i oznaci poslije EXP.
English: Additionally, the enhancement of protection produced by oocyst re-infections would also be limited.
Croatian: Nadalje, to može ograničiti pojačavanje zaštite koja nastaje uslijed ponovljenih infekcija oocistama.
English: Onset of immunity: 3 weeks post-vaccination.
Croatian: Nastup imunosti: 3 tjedna nakon cijepljenja.
English: Dilute the content of the vial with clean room temperature water into an appropriate container.
Croatian: Razrijedite sadržaj bočice u čistoj vodi sobne temperature u odgovarajućem spremniku.
English: After this time, place the chicks carefully in the litter and continue with regular management practices.
Croatian: Potom pažljivo premjestite piliće na stelju i nastavite s uobičajenim načinima postupanja.
English: Shake the vaccine vial and dilute the content into the previous solution.
Croatian: Protresite bočicu cjepiva i razrijedite sadržaj u prethodnoj otopini.
English: Brilliant Blue (E133) Red AC (E129) Vanillin
Croatian: Pomoćne tvari: briljantno modra (E133) alurno crvena AC (E129)
English: It is normal to find vaccinal oocysts in the intestine or litter of vaccinated flocks.
Croatian: Normalno je naći vakcinalne oociste u probavnom sustavu ili stelji cijepljenog jata pilića.
English: 10 ml, 50 ml or 100 ml type I colourless glass vials containing 7 ml, 35 ml or 70 ml of suspension (1,000, 5,000 and 10,000 doses) closed with type I polymeric elastomer closures and aluminium caps.
Croatian: I od 10 ml, 50 ml ili 100 ml koje sadrže 7 ml, 35 ml ili 70 ml suspenzije (1 000, 5 000 i 10 000 doza) zatvorene čepovima od polimerskog elastomera tipa
English: Evalon (vaccine)
Croatian: Evalon (cjepivo)
English: The correct replication of the vaccine oocysts and consequently, the development of a solid immunity could be hindered.
Croatian: To može spriječiti ispravno umnažanje vakcinalnih oocista i razvitak učinkovite imunosti.
English: ARBUSET, Produtos Farmacêuticos e Sanitários De Uso Animal, Lda
Croatian: Portugal ARBUSET, Produtos Farmacêuticos e Sanitários
English: Before starting the preparation, make certain to have a clean container available with sufficient capacity for preparing the diluted vaccine suspension.
Croatian: Prije početka pripreme, provjerite da je dostupan čisti spremnik dovoljne zapremnine za pripremu suspenzije razrijeđenog cjepiva.
English: Chickens must be strictly floor-reared in the first 3weeks after vaccination.
Croatian: Pilići se prva 3 tjedna nakon cijepljenja moraju uzgajati isključivo podnim načinom.
English: HIPRA EΛΛAΣ A.E. Ψuχάρη 3 / 184 53 Níκαια Tηλ: 210 4978660 - Fax: 210 4978661 e-mail: greece@hipra.com
Croatian: Ψuχάρη 3 / 184 53 Níκαια Tηλ: 210 4978660 - Fax: 210 4978661
English: HIPRAMUNE T (solvent):
Croatian: HIPRAMUNE T (otapalo):
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vaccine vial of 10,000 doses
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Bočica cjepiva od 10 000 doza.
English: Shelf life after dilution according to directions: 10 hours.
Croatian: Rok valjanosti poslije razrjeđenja prema uputi: 10 sati.
English: One dose of vaccine (0.007 ml) from 1 day of age.
Croatian: Jedna doza cjepiva (0,007 ml) nakon 1 dana starosti.
English: Evalon (vaccine):
Croatian: Evalon (cjepivo):
English: Innovation Center BioCity Nottingham Pennyfoot Street
Croatian: BioCity Nottingham
English: Marketing authorisation holder and manufacturer responsible for batch release: Laboratorios Hipra, S.A.
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet: Laboratorios Hipra, S.A.
English: Vaccination schedule: One dose of vaccine (0.007 ml) from 1 day of age.
Croatian: Raspored cijepljenja: Jedna doza cjepiva (0,007 ml) nakon 1 dana starosti.
English: Fill the reservoir of the spraying device with all the vaccine suspension prepared.
Croatian: Napunite spremnik uređaja za raspršivanje cijelim pripremljenim sadržajem otopine za cijepljenje.
English: Each dose (0.007 ml) of undiluted vaccine contains:
Croatian: Svaka doza (0,007 ml) nerazrijeđenog cjepiva sadrži:
English: To be mixed with the solvent.
Croatian: Pomiješati s otapalom.
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim s diluentom priloženim za primjenu s proizvodom.
English: HIPRAMUNE T (solvent) - Brilliant blue (E 133) - Red AC (E 129) - Vanillin - Montanide IMS
Croatian: - boja briljantno modra (E 133) - boja alurno crvena AC (E 129)
English: Alignment of the supplier's specifications for Foetal Bovine Serum (FBS) with the applicant's internal specifications for FBS, ensuring Ph. Eur.
Croatian: Foetal Bovine Serum, FBS) dobavljača s internim specifikacijama podnositelja zahtjeva za FBS, koje osigurava sukladnost s Europskom farmakopejom.
English: Polypropylene (PP) vials containing 50 ml, 250 ml and 500 ml of solvent closed with type I polymeric elastomer closures and aluminium caps.
Croatian: Bočice od polipropilena (PP) koje sadrže 50 ml, 250 ml i 500 ml otapala zatvorene čepovima od polimerskog elastomera tipa
English: Do not use in birds in lay and within 2 weeks before the onset of the laying period
Croatian: Ne primjenjivati na nesilicama za vrijeme nesenja i 2 tjedna prije početka razdoblja nesenja.