FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients with severe renal impairment (CLcr <30 mL/min) the recommended dose is one 50 mg film-coated tablet once weekly.
Croatian: Za bolesnike s umjerenim oštećenjem bubrega (klirens kreatinina ≥30 i <50 ml/min) preporučena je prilagodba doze na jednu 50 mg filmom obloženu tabletu svaki drugi dan (vidjeti dio 5.2).
English: A statistically significant improvement in bone pain score was shown for Ibandronate 50 mg compared to placebo.
Croatian: Podaci prikupljeni tijekom ovog ispitivanja pokazali su znatnu prednost ibandronata 50 mg peroralno u odnosu na placebo u pogledu smanjivanja SRE,
English: System Organ Class
Croatian: Organsk i sustav
English: Pruritus
Croatian: Dojenje
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment
Croatian: Za bolesnike s rakom dojke i koštanim metastazama koji se liječe radi sprječavanja koštanih poremećaja te s umjerenim (CLcr ≥30 i <50 ml/min) ili teškim oštećenjem bubrega (CLcr <30 ml/min)
English: Talk to your doctor, pharmacist or nurse before receiving Iasibon:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Iasibon:
English: One ampoule with 1 ml of a concentrate for solution for infusion contains 1 mg ibandronic acid (as sodium monohydrate)
Croatian: Jedna ampula sa 1 ml koncentrata za otopinu za infuziju sadrži 1 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata)
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: This is because it can cause irritation, inflammation or ulcers in your food pipe/gullet (oesophagus).
Croatian: Važno je da Iasibon uzimate u pravo vrijeme i na pravi način jer može izazvati iritaciju, upalu ili vrijed jednjaka (ezofagusa).
English: Concentrate for solution for infusion 1 vial
Croatian: Koncentrat za otopinu za infuziju 1 ampula
English: • being unable to pass water (urine), cystitis (bladder inflammation)
Croatian: • poteškoće s mokrenjem, upala mokraćnog mjehura (cistitis)
English: Pyrexia, influenza-like illness**, oedema peripheral, asthenia, thirst
Croatian: Opći poremećaji i reakcije na mjestu primjene vrućica, bolest nalik gripi**, periferni edemi,
English: Benign skin neoplasm
Croatian: • žučni kamenci
English: Ocular inflammati on†**
Croatian: osteonekroza čeljusti†**,
English: Overdose
Croatian: Doza
English: Neoplasms benign, malignant, and unspecified
Croatian: zloćudne i nespecificirane novotvorine dobroćudne novotvorine kože
English: One ampoule with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate).
Croatian: Jedna ampula s 2 ml koncentrata za otopinu za infuziju sadrži 2 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
English: NAME OF THE MEDICINAL PRODUCT Iasibon 1 mg concentrate for solution for infusion
Croatian: NAZIV LIJEKA Iasibon 1 mg koncentrat za otopinu za infuziju
English: How to receive Iasibon
Croatian: Kako ćete primati Iasibon
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna ampula sa 6 ml koncentrata za otopinu za infuziju sadrži 6 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intravenous use, for infusion after dilution
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati Uputu o lijeku
English: NAME OF THE MEDICINAL PRODUCT Iasibon 2 mg concentrate for solution for infusion
Croatian: NAZIV LIJEKA Iasibon 2 mg koncentrat za otopinu za infuziju
English: How to store Iasibon
Croatian: Kako čuvati Iasibon
English: A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
Croatian: U bolesnika s pridruženim faktorima rizika (npr. rak, kemoterapija, radioterapija, kortikosteroidi, loša zubna higijena) preporučuje se pregled zuba i odgovarajući preventivni zubarski zahvati prije liječenja bisfosfonatima.
English: What Iasibon is and what it is used for What you need to know before you receive Iasibon How to receive Iasibon
Croatian: Što morate znati prije nego počnete primati Iasibon Kako ćete primati Iasibon Moguće nuspojave
English: Hypersensitivity bronchospasm†, angioedema†, Anaphylactic reaction/shock†
Croatian: Poremećaji imunološkog sustava preosjetljivost†, bronhospazam†, angioedem†,
English: Patients with hepatic impairment (see section 4.2)
Croatian: Pedijatrijska populacija (vidjeti dijelove 4.2 i 5.2)
English: Pharmathen S.A. 6, Dervenakion str 15351 Pallini, Attiki Greece
Croatian: 6, Dervenakion str 15351 Pallini, Attiki
English: • problems with your parathyroid gland
Croatian: • problemi s paratireoidnom žlijezdom
English: Paraesthesia, dysgeusia (taste perversion)
Croatian: Poremećaj i živčanog sustava parestezija, disgeuzija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/659/005
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/659/005
English: NAME OF THE MEDICINAL PRODUCT Iasibon 50 mg film-coated tablets ibandronic acid
Croatian: Uputa o lijeku: Informacija za bolesnika Iasibon 50 mg filmom obložene tablete ibandronatna kiselina
English: Atypical subtrocha nteric and diaphysea l femoral fractures†
Croatian: poremećaj zglobova, bol u kostima atipične suptrohan terične i dijafizealne frakture femura†
English: Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid.
Croatian: U bolesnika koji primaju ibandronatnu kiselinu intravenski prijavljeni su slučajevi ozbiljnih alergijskih reakcija, ponekad sa smrtnim ishodom.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Iasibon 6 mg concentrate for solution for infusion ibandronic acid
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Iasibon 6 mg koncentrat za otopinu za infuziju ibandronatna kiselina i.v. primjena
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/659/004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/659/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/659/003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/659/003
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Iasibon 1 mg concentrate for solution for infusion ibandronic acid
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Iasibon 1 mg koncentrat za otopinu za infuziju ibandronatna kiselina i.v. primjena
English: Atypical subtrochant eric and diaphyseal femoral fractures†
Croatian: Poremećaj i mišićno koštano g sustava i vezivnog tkiva atipične suptrohanterične i dijafizealne frakture femura†
English: One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Croatian: Jedna bočica sa 6 ml koncentrata za otopinu za infuziju sadrži 6 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata)
English: Pegnancy
Croatian: palpitacije
English: Pharmathen S.A. 6, Dervenakion str. 15351 Pallini, Attiki Greece
Croatian: 6, Dervenakion str. 15351 Pallini, Attiki
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Iasibon 2 mg concentrate for solution for infusion ibandronic acid
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Iasibon 2 mg koncentrat za otopinu za infuziju ibandronatna kiselina i.v. primjena
English: At the time of granting the marketing authorisation, the submission of periodic safety update reports is not required for this medicinal product.
Croatian: Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
English: Nervous system disorders
Croatian: Endokrini poremećaji poremećaj paratireoidnih žlijezda
English: Acetic acid, glacial
Croatian: astenija, žeđ hipotermija
English: One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Croatian: TVARI Jedna bočica sa 6 ml koncentrata za otopinu za infuziju sadrži 6 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
English: A statistically significant improvement in bone pain score was shown for intravenous Ibandronate 6 mg compared to placebo.
Croatian: Ibandronat 6 mg dan intravenski pokazao je u usporedbi s placebom statistički značajno poboljšanje rezultata kod boli u kostima.
English: Store in the original package in order to protect from moisture.
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvati u originalnom pakovanju radi zaštite od vlage.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu .
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Sodium acetate trihydrate
Croatian: egzacerbacija astme
English: One ampoule with 2 ml of a concentrate for solution for infusion contains2 mg ibandronic acid (as sodium monohydrate)
Croatian: Jedna ampula sa 2 ml koncentrata za otopinu za infuziju sadrži 2 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata)
English: NAME OF THE MEDICINAL PRODUCT Iasibon 6 mg concentrate for solution for infusion ibandronic acid
Croatian: Uputa o lijeku: Informacija za bolesnika Iasibon 6 mg koncentrat za otopinu za infuziju ibandronatna kiselina
English: The following information is intended for healthcare professionals only Dose: Prevention of skeletal events in patients with breast cancer and bone metastases The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenously given every 3-4 weeks.
Croatian: Preporučena doza za prevenciju koštanih događaja u bolesnika s rakom dojke i koštanim metastazama iznosi 6 mg intravenski svaka 3 - 4 tjedna.
English: Rare
Croatian: TVARI
English: NAME OF THE MEDICINAL PRODUCT Iasibon 1 mg concentrate for solution for infusion ibandronic acid
Croatian: Uputa o lijeku: Informacija za bolesnika Iasibon 1 mg koncentrat za otopinu za infuziju ibandronatna kiselina
English: How to store Iasibon.
Croatian: “Kako čuvati Iasibon”).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 50 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
English: Gastrointestinal irritation
Croatian: Prijavljivanje nuspojava
English: And
Croatian: Stoga se
English: Infusion Volume 1 and Time 2
Croatian: Volumen infuzije1 i vrijeme2
English: There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Croatian: Bolesnici s oštećeniem jetre (vidjeti dio 4.2) Ne postoje farmakokinetički podaci za ibandronatnu kiselinu u bolesnika s oštećenjem jetre.
English: **See further information below
Croatian: ** Vidjeti dodatne informacije niže † Identificirano u razdoblju nakon stavljanja lijeka na tržište
English: ATCvet code: QI09AD03.
Croatian: ATKvet kod: QI09AD03
English: Date of first authorization: 24/08/2017.
Croatian: Datum prvog odobrenja : 24/08/2017.
English: These resolve without treatment within few hours.
Croatian: One se povlače bez liječenja u roku od nekoliko sati.
English: 25 doses 50 doses 125 doses
Croatian: 25 doza 50 doza 125 doza
English: 6.2 Major incompatibilities
Croatian: 6.2 Važne inkompatibilnosti
English: The most common spreading route is via direct contact but spreading via contaminated objects or via the air cannot be excluded.
Croatian: Najčešći način širenja je izravnim kontaktom, ali ne može se isključiti ni širenje putem kontaminiranih predmeta ili zraka.
English: Use vaccination devices according to the manufacturer's instructions.
Croatian: Koristite uređaje za cijepljenje u skladu s uputama proizvođača.
English: Fattening pigs:
Croatian: Tovne svinje:
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju nuspojavu, čak i one koje nisu opisane u ovoj uputi o VMP ili mislite da VMP ne djeluje, molimo obavijestite svog veterinara.
English: A single booster dose is given every 6 months.
Croatian: Jedna doza za docjepljivanje daje se svakih 6 mjeseci.
English: Intramuscular injection: 2 ml in the neck.
Croatian: Intramuskularna injekcija: 2 ml u vrat.
English: Use sterile syringes and needles.
Croatian: Koristite sterilne štrcaljke i igle.
English: Do not use in herds where European PRRS virus has not been detected by reliable diagnostic methods.
Croatian: Ne primjenjivati u uzgojima u kojima europski virus PRRS nije otkriven pouzdanim dijagnostičkim metodama.
English: Duration of immunity: 26 weeks after vaccination.
Croatian: Trajanje imuniteta: 26 tjedana nakon cijepljenja.
English: The reaction evolved to form hard tissue and formation of a scab, which very commonly lasted up to more than 44 days.
Croatian: Reakcija se razvijala u tvrdo tkivo i formirala krastu, a vrlo je često trajala i više do 44 dana.
English: Each dose (2 ml) contains: Lyophilisate:
Croatian: Jedna doza (2 ml) sadrži: Liofilizat:
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Croatian: Uvjete čuvanja rekonstituiranog proizvoda, vidjeti u odjeljku 6.3.
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: Osoba koja namjerava proizvoditi, uvesti, posjedovati, prodavati, opskrbljivati i primjenjivati ovaj veterinarsko-medicinski proizvod mora se prethodno savjetovati s nadležnim tijelom odnosne države članice u pogledu važećih pravila o cijepljenju jer te aktivnosti mogu biti zabranjene u određenoj državi članici na cijelom ili samo na djelu njezinog teritorija , u skladu s nacionalnim zakonodavstvom.
English: Needles for administration should be appropriate for the size of the pig.
Croatian: Igle za primjenu trebaju biti primjerene veličini svinje.
English: It is advised to vaccinate all target pigs within a herd from the earliest recommended age onwards.
Croatian: Savjetuje se cijepiti sve ciljne svinje unutar određenog uzgoja počevši od najranije preporučene dobi nadalje.
English: It stimulates active immunity against PRRS virus.
Croatian: Cjepivo stimulira aktivni imunitet na virus PRRS.
English: Onset of immunity: 21 days after vaccination.
Croatian: Početak imuniteta: 21 dana nakon cijepljenja.
English: The solvent may be stored outside a refrigerator at 15 °C - 25 °C.
Croatian: Otapalo se može čuvati izvan hladnjaka na temperaturi od 15 °C - 25 °C.
English: The use of a multi-dosing syringe is recommended.
Croatian: Preporučuje se upotreba višedozne štrcaljke.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with the local requirements.
Croatian: Sav neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda treba odlagati u skladu s lokalnim propisima.
English: Shelf life after reconstitution: use immediately.
Croatian: Rok valjanosti poslije rekonstitucije: odmah upotrijebiti.
English: Transfer approximately 5 ml of solvent to the vial containing the lyophilisate and ensure complete reconstitution.
Croatian: Prenesite približno 5 ml otapala u bočicu koja sadrži liofilizat i provjerite da je rekonstitucija potpuna.
English: Special warnings for use in animals:
Croatian: Posebna upozorenja prilikom primjene na životinjama:
English: The vaccine contains a modified live PRRS virus (genotype 1, subtype 1).
Croatian: Cjepivo sadrži modificirani živi virus PRRS (genotip 1, podtip 1).
English: Store and transport refrigerated (2 °C - 8 °C).
Croatian: Čuvati i prevoziti na hladnom (2°C - 8°C).
English: Gilts and sows: A single dose of 2 ml is given prior to introduction into the sow herd, approximately 4 weeks prior to breeding.
Croatian: Nazimice i krmače: jedna doza od 2 ml daje se prije uvođenja u uzgoj krmača, približno 4 tjedna prije rasploda.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (25, 50 and 125 doses)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija (25, 50 i 125 doza)
English: Do not mix with any other veterinary medicinal product.
Croatian: Ne miješati ni sa kojim drugim veterinarsko-medicinskim proizvodom.
English: Do not use in boars producing semen, as PRRS virus can be shed in semen.
Croatian: Ne primjenjivati na nerastima za proizvodnju sjemena jer se virus PRRS može izlučiti u sjeme.
English: In cases where the vials containing the solvent and the lyophilisate are stored separately, verify prior to reconstituting the lyophilisate that the lot number mentioned on the vial containing the solvent is identical to the lot number mentioned on the vial containing the lyophilisate.
Croatian: U slučajevima kada se bočice koje sadrže otapalo i bočice koje sadrže liofilizat pohranjuju odvojeno, prije rekonstituiranja liofilizata provjeriti da je broj serije naveden na bočici koja sadrži otapalo isti kao i broj serije naveden na bočici koja sadrži liofilizat.
English: A local reaction involving transiently the whole neck region was very commonly observed (red-purple dark, erythematous swelling, causing itching, vesicle formation, increased local temperature, and, occasionally, pain).
Croatian: Vrlo često je zabilježena lokalna reakcija, koja je prolazno zahvaćala cijelo područje vrata (crvenoljubičaste, tamne, eritematozne otekline praćene svrbežom, nastanak vezikula, povišena lokalna temperatura te povremeno i bol).
English: EXP {month/year} Once reconstituted use immediately.
Croatian: Jednom rekonstituiran odmah upotrijebiti.
English: Transfer back the reconstituted solution into the solvent vial (containing the remaining solvent): 25 doses are reconstituted into 50 ml solvent, 50 doses are reconstituted into 100 ml solvent, and 125 doses are reconstituted into 250 ml solvent.
Croatian: Prenesite rekonstituiranu otopinu natrag u bočicu s otapalom (koja sadrži preostalo otapalo): 25 doza rekonstituira se u 50 ml otapala, 50 doza rekonstituira se u 100 ml otapala, a 125 doza rekonstituira se u 250 ml otapala.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Croatian: Odluku o primjeni ovog cjepiva prije ili poslije primjene bilo kojeg drugog veterinarsko medicinskog proizvoda treba donositi od slučaja do slučaja.
English: Mass vaccination can be used in herds in which the prevalence of European PRRS virus has been established.
Croatian: Može se koristiti masovno cijepljenje uzgoja u kojima je utvrđena prevalencija europskog virusa
English: Sodium chloride 0.9% solution
Croatian: Natrijev klorid 0,9% otopina
English: * Porcine respiratory and reproductive syndrome virus ** Cell culture infectious dose 50%
Croatian: * Virus respiratornog i reproduktivnog sindroma svinja ** Doza virusa koja inficira 50% uzoraka stanične kulture
English: Dextran 40
Croatian: Liofilizat: dekstran 40
English: The excipients 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: Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
English: Pharmacotherapeutic group: immunologicals for Suidae, live viral vaccines.
Croatian: Farmakoterapijska skupina: imunološki pripravci za svinje, živa virusna cjepiva.
English: Sodium chloride Water for injections
Croatian: Otapalo: natrijev klorid voda za injekcije
English: The vaccine strain can spread to in contact pigs.
Croatian: Cjepni soj se može proširiti na druge svinje u kontaktu s cijepljenima.
English: EXP {month/year} Once broached use immediately.
Croatian: Jednom otvoren odmah upotrijebiti.
English: Vaccinated animals may excrete the vaccine strain for more than 16 weeks following vaccination.
Croatian: Cijepljene životinje mogu izlučivati cjepni soj i dulje od 16 tjedana nakon cijepljenja.
English: 2 ml in the neck.
Croatian: Doziranje: 2 ml u vrat.
English: Special precautions should be taken to avoid spreading of the vaccine strain to unvaccinated animals (e.g. PRRS virus-naïve pregnant gilts and sows in second half of gestation) that should remain free from PRRS virus.
Croatian: Potrebno je primijeniti posebne mjere opreza da bi se izbjeglo širenje cjepnog soja na necijepljene životinje (npr.: gravidne nazimice i krmače koje nemaju antitijela protiv PRRS virusa u drugoj polovici gestacije) koje bi trebale ostati nezaražene virusom PRRS.
English: Medicines should not be disposed of via wastewater or household waste.
Croatian: Ovaj VMP se ne smiju odlagati u otvorene vode ili kućni otpad.
English: Solvent: clear, colourless solution.
Croatian: Otapalo: bistra, bezbojna otopina.
English: The safety of the vaccine has not been established during lactation.
Croatian: Nije utvrđena neškodljivost cjepiva tijekom laktacije.
English: Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adresa proizvođača biološki djelatne(ih) tvari:
English: Care should be taken to avoid the introduction of the vaccine strain into an area where PRRS virus is not already present.
Croatian: Treba paziti da se ne uvede cjepni soj u područje u kojem virus PRRS nije već prije prisutan.
English: Reconstitute the lyophilisate with the supplied solvent.
Croatian: Rekonstituirajte liofilizat s priloženim otapalom.
English: Pigs for fattening: A single dose of 2 ml is given to pigs from 1 day of age onwards.
Croatian: Tovne svinje: jedna doza od 2 ml daje se prasadi počevši od prvog dana života nadalje.
English: Casein hydrolysate Lactose monohydrate Sorbitol 70% (solution) Sodium hydroxide Water for injections Dilution medium
Croatian: kazein hidrolizat laktoza monohidrat sorbitol 70% (otopina)
English: Lyophilisate: off-white freeze-dried pellet.
Croatian: Liofilizat: liofilizirana peleta krem boje.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i bočici poslije skraćenice EXP, korištene za rok valjanosti.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE HDPE vials (100 ml or 250 ml)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJIM PAKOVANJIMA HDPE bočice (100 ml ili 250 ml)
English: Solvent: Sodium chloride 0.9% solution: qs 1 dose.
Croatian: Otapalo: Natrijev klorid 0,9% otopina za injekciju, voda za injekcije: q.s. 1 doza.