FrancophonIA/ELRC3.0 huggingface dataset:
English: Elimination is principally in the excreta (primarily the urine), with some biliary excretion also observed.
Croatian: Eliminira se uglavnom izlučivanjem (prvenstveno urinom), a uočena je i eliminacija putem žući.
English: Salivation and labial and tongue oedema have been uncommonly associated with the oral lesions in a field study.
Croatian: Slinjenje i edem usnica i jezika manje često su bili povezani s oralnim lezijama tijekom terenskih ispitivanja.
English: Firocoxib 20 mg
Croatian: Firokoksib 20 mg
English: The oral paste is available in the following pack sizes: - 1 carton box containing 1 syringe - 1 carton box containing 7 syringes - 1 carton box containing 14 syringes
Croatian: Peroralna pasta dostupna je u sljedećim veličinama pakovanja: - 1 kartonska kutija sadrži 1 štrcaljku - 1 kartonska kutija sadrži 7 štrcaljki - 1 kartonska kutija sadrži 14 štrcaljki
English: Withdrawal period: Meat and offal: 26 days Do not use in mares producing milk for human consumption.
Croatian: Karencija: meso i iznutrice: 26 dana Ne upotrebljavati u kobila koje proizvode mlijeko za ljudsku uporabu.
English: If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Croatian: Ako se pojave nuspojave primjena se treba prekinuti te se treba potražiti savjet veterinara.
English: Do not use in mares producing milk for human consumption.
Croatian: Ne upotrebljavati u kobila koje proizvode mlijeko za ljudsku uporabu.
English: TARGET SPECIES For horses (450-600 kg)
Croatian: CILJNE VRSTE ŽIVOTINJA Za konje (450-600 kg)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each syringe contains 7.32 g of paste and delivers: Firocoxib 8.2 mg/g
Croatian: Svaka brizgaljka od 7,32 g paste sadrži: Firokoksib 8,2 mg/g
English: Administer one tablet once daily for horses weighing 450-600 kg bodyweight.
Croatian: Primijeniti jednu tabletu jednom dnevno konjima težine 450-600 kg.
English: For safe and effective use, this product should only be administered to horses in the weight range 450-600 kg. For horses weighing under 450 kg or over 600 kg, and where firocoxib is the treatment of choice, use of other firocoxib-containing formulations that allow for accurate dosing is advised.
Croatian: Kod konja težine ispod 450 kg ili iznad 600 kg i kad je firokoksib djelatna tvar izbora preporuča se koristiti neki drugi VMP koji sadrži firokoksib kod kojeg se može preciznije odrediti potrebna doza.
English: SPECIAL STORAGE CONDITIONS Replace cap after use.
Croatian: 11. POSEBNI UVJETI ČUVANJA Nakon upotrebe ponovo stavite kapicu.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Ceva Santé Animale
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET Ceva Santé Animale
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Croatian: Pomoćne tvari navedene u odjeljku 6.1 Sažetka opisa svojstava su dozvoljene tvari, za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential risk of increased renal toxicity.
Croatian: Izbjegavajte primjenu kod dehidrirane, hipovolemične ili hipotenzivne životinje, budući da postoji potencijalna opasnost od povećane toksičnosti za bubrege.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Croatian: NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE PROIZVODNE SERIJE
English: To administer EQUIOXX at the dose of 0.1 mg firocoxib/kg, set the syringe plunger to the appropriate dose division for the horse's weight.
Croatian: Za primjenu EQUIOXXA u dozi od 0,1 mg firokoksib/kg, postavite klip brizgaljke na oznaku doze koja odgovara težini konja.
English: Manufacturer responsible for batch release: MERIAL
Croatian: Nositelj odobrenja za proizvodnju odgovoran za puštanje proizvodne serije: Merial
English: - 1 cardboard box containing 60 tablets in a 30 ml high density polyethylene bottle.
Croatian: - 1 kartonska kutija sadrži 60 tableta u bočici od 30 mL od polietilena visoke gustoće.
English: Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic, cardiac or renal function and bleeding disorders.
Croatian: Ne primjenjivati na životinje koje pate od gastrointestinalnih poremećaja i krvarenja, oštećenja funkcije jetre, srca ili bubrega i poremećaja krvarenja.
English: The safety of the product for use in breeding, pregnant or lactating horses has not been evaluated.
Croatian: Neškodljivost upotrebe proizvoda u rasplodnih, gravidnih ili kobila u laktaciji nije ocjenjivana.
English: Do not use after the expiry date stated on the label.
Croatian: Ne primjenjivati nakon isteka roka valjanosti naznačenog na naljepnici.
English: Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, ATC vet code: QM01AH90.
Croatian: Farmakoterapijska grupa: Protuupalni i protureumatski proizvodi, nesteroidi, ATC vet kod:
English: Other NSAIDs, diuretics and substances that have a high degree of protein binding may compete for binding and lead to toxic effects.
Croatian: Drugi nesteroidni protuupalni lijekovi, diuretici i tvari s visokim stupnjem vezanja proteina mogu dovesti do kompetitivnosti u vezanju i time do toksičnih učinaka.
English: However, studies with laboratory animals have shown embryo-foetotoxicity, malformations, delayed parturition and decreased pup survival.
Croatian: Međutim, ispitivanja na laboratorijskim životinjama su pokazala embrio-fetotoksičnost, malformacije, odgođeni porod i povećano ugibanje mladunčadi.
English: Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Croatian: Ne upotrebljavati istovremeno s kortikosteroidima ili drugim nesteroidnim protuupalnim lijekovima (NSAID).
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION Oral use.
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT PRIMJENE Peroralna primjena.
English: In in-vitro equine whole blood assays, firocoxib exhibited 222 to 643 fold selectivity for COX-2 over COX-1.
Croatian: U in-vitro testiranjima krvi konja, firokoksib pokazuje približno 222 do 643 puta veću selektivnost za COX-2 nego za COX-1.
English: PHARMACEUTICAL FORM Solution for injection
Croatian: Otopina za injekciju.
English: The recommended dose is 0.09 mg firocoxib per kg bodyweight (equivalent to 1 ml of the solution per 225 kg bodyweight) once daily by intravenous injection.
Croatian: Preporučena doza je 0,09 mg firokoksiba na kg tjelesne mase (što odgovara 1 ml otopine na 225 kg tjelesne mase), jednom dnevno intravenskom injekcijom.
English: PHARMACEUTICAL FORM Chewable tablet
Croatian: OBLIK Tablete za žvakanje
English: The recommended dose is 0.09 mg firocoxib per kg bodyweight (equivalent to 1ml of the solution per 225 kg bodyweight) once daily by intravenous injection.
Croatian: Preporučena doza je 0,09 mg firokoksiba na kg tjelesne mase (što odgovara 1ml otopine na 225 kg tjelesne mase), jednom dnevno intravenskom injekcijom.
English: Laboratory studies in laboratory animals have shown evidence of embryofoetotoxicity, malformations, delayed parturition and decreased pup survival.
Croatian: Ispitivanja na laboratorijskim životinjama su pokazala embrio-fetotoksičnost, malformacije, odgođeni porod i povećano ugibanje mladunčadi.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Glycerol formal
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari
English: After administration, it is recommended to examine the buccal cavity to ensure that the tablet has been adequately swallowed.
Croatian: Nakon primjene preporuča se provjera da tableta nije ostala u usnoj šupljini, tj. da se potvrdi da je konj progutao tabletu.
English: No entry Antiinflammatory agents/
Croatian: Protuupalna sredstva/ nesteroidna protuupalna sredstva/
English: • EQUIOXX 57 mg chewable tablets for horses The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Croatian: • EQUIOXX 57 mg tablete za žvakanje za konje Pomoćne tvari navedene u odjeljku 6.1 Sažetka opisa svojstava su dozvoljene tvari, za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Ceva Santé Animale
Croatian: 15. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Ceva Santé Animale
English: No data on use during pregnancy is available in horses.
Croatian: Graviditet i laktacija: Podaci o primjeni tijekom graviditeta nisu dostupni za konje.
English: Meat and offal: 26 days.
Croatian: Meso i iznutrice: 26 dana.
English: Not authorized for use in animals producing milk for human consumption.
Croatian: Ovaj veterinarsko-medicinski proizvod nije odobren za korištenje u životinja koje proizvode mlijeko za ljudsku uporabu.
English: Meat and offal: 26 days Not authorized for use in animals producing milk for human consumption.
Croatian: Karencija: Meso i iznutrice: 26 dana Ne upotrebljavati u kobila koje proizvode mlijeko za ljudsku uporabu.
English: Macrogol 400
Croatian: Tiodipropionska kiselina Makrogol 400
English: Disodium edetate n-Propyl gallate
Croatian: Glicerolov formal Dinatrijev edeat n-Propil galat
English: - 1 cardboard box containing 180 tablets in transparent PVC /aluminium foil blisters.
Croatian: - 1 kartonska kutija sadrži 180 tableta u prozirnim PVC/aluminijskim blisterima.
English: ADVERSE REACTIONS Mild injection site swellings associated with perivascular inflammation and pain.
Croatian: Prolazne otekline na mjestu injiciranja povezuju se s perivaskularnom upalom i boli.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Firocoxib 57 mg
Croatian: NAVOĐENJE DJELATNIH I DRUGIH TVARI Firokoksib 57 mg
English: Shelflife after first opening the container : 1 month.
Croatian: Rok valjanosti poslije prvog otvaranja spremnika: 1 mjesec.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 20 mg/ml
Croatian: KOLIČINA DJELATNE(IH) TVARI Firokoksib 20 mg/ml
English: TARGET SPECIES For horses
Croatian: CILJNE VRSTE ŽIVOTINJA
English: TARGET SPECIES Horses (450-600 kg).
Croatian: CILJNE VRSTE ŽIVOTINJA Konji (450-600 kg).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Syringe labelling
Croatian: OSNOVNI DIJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Oznaka na brizgalici
English: - 1 cardboard box containing 30 tablets in transparent PVC /aluminium foil blisters.
Croatian: - 1 kartonska kutija sadrži 30 tableta u prozirnim PVC/aluminijskim blisterima.
English: Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be observed in treated animals when administered the recommended treatment dose.
Croatian: U liječenih životinja ponekad se mogu primijetiti lezije (erozija/ulceracija) na usnoj sluznici i koži oko usta kod primjene preporučenih doza.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 57 mg
Croatian: KOLIČINA DJELATNE(IH) TVARI Firokoksib 57 mg
English: The injection vials are available in the following pack sizes: - carton containing one vial of 25 ml.
Croatian: Injekcijske bočice dostupne su u sljedećim veličinama pakovanja: - kutija sadrži jednu bočicu od 25 ml. - kutija sadrži 6 bočica od 25 ml.
English: IV
Croatian: I
English: Mild reactions at the injection site characterised by swelling and associated with perivascular inflammation have been reported in clinical studies following administration of the product at the recommended dose.
Croatian: U kliničkim ispitivanjima nakon primjene proizvoda u preporučenoj dozi, uočene su blage reakcije na mjestu injiciranja koje karakterizira otok i povezuju se s perivaskularnom upalom.
English: • EQUIOXX 8.2 mg/g oral paste for horses
Croatian: • EQUIOXX 8.2 mg/g peroralna pasta za konje
English: • EQUIOXX 20 mg/ml solution for injection for horses The excipients listed in section 6.1 of the SPC (Glycerol formal and Macrogol 400) are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Croatian: • EQUIOXX 20 mg/ml otopini za injekcije za konje Pomoćne tvari navedene u odjeljku 6.1 Sažetka opisa svojstava su dozvoljene tvari, za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno.
English: Administer 0.1 mg firocoxib per kg bodyweight, once daily.
Croatian: Primijenite 0,1 mg firokoksiba na kg tjelesne mase, jednom dnevno.
English: Thiodipropionic acid
Croatian: Hidroksipropilna celuloza
English: Do not use concomitantly with corticosteroids or other NSAIDs.
Croatian: Ne upotrebljavati istovremeno s kortikosteroidima ili drugim nesteroidnim protuupalnim lijekovima
English: Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Croatian: Uklanjanje bolova i upala povezanih s osteoartrozom i smanjenje s time povezane hromosti konja.
English: Shelf-life after first opening the syringe: 3 months.
Croatian: Rok valjanosti poslije prvog otvaranja štrcaljke: 3 mjeseca.
English: EXP Once broached use within 1 month.
Croatian: Jednom otvoreno, upotrijebiti u roku 1 mjeseca.
English: 6.5 Nature and composition of immediate packaging Pre-filled oral syringe made of polypropylene, with a polyethylene cap, a rubber rod tip, and a polypropylene plunger rod.
Croatian: Napunjena brizgaljka za usta od polipropilena, s polipropilenskom kapicom, gumenim vrhom i polipropilenskim klipom.
English: firocoxib
Croatian: Firokoksib
English: The contents of one syringe will treat horses weighing up to 600 kg. To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid overdosing.
Croatian: Za pravilno doziranje, tjelesnu masu treba utvrditi što je moguće točnije kako bi se izbjeglo predoziranje.
English: EQUIOXX 20 mg/ml solution for injection for horses.
Croatian: EQUIOXX 20 mg/ml otopina za injekcije za konje.
English: EQUIOXX 57 mg chewable tablets for horses.
Croatian: EQUIOXX 57 mg tablete za žvakanje za konje
English: Silica, colloidal anhydrous
Croatian: Silicijev dioksid, koloidni, bezvodni
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Firocoxib 20 mg/ml
Croatian: NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA Firokoksib 20 mg/ml.
English: MARKETING AUTHORISATION NUMBER EU/2/08/083/001
Croatian: BROJ ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/083/001
English: Shelf life after first opening the immediate packaging: 1 month.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 1 mjesec.
English: - 1 cardboard box containing 10 tablets in blisters - 1 cardboard box containing 30 tablets in blisters - 1 cardboard box containing 180 tablets in blisters - 1 cardboard box containing 60 tablets in a 30 ml bottle
Croatian: Peroralna pasta dostupna je u sljedećim veličinama pakovanja: - 1 kartonska kutija sadrži 1 brizgaljku - 1 kartonska kutija sadrži 7 brizgaljki - 1 kartonska kutija sadrži 14 brizgaljki
English: Excipients:
Croatian: Djelatna tvar:
English: Do not use in breeding, pregnant or lactating animals.
Croatian: Ne primjenjivati na rasplodnim, gravidnim ili životinjama u laktaciji.
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2)-mediated prostaglandin synthesis.
Croatian: Firokoksib je nesteroidni protuupalni lijek (NSAID) koji pripada skupini koksiba, koja djeluje selektivnom inhibicijom ciklooksigenaze-2 (COX-2) - u sintezi prostaglandina.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Firocoxib 20 mg/ml
Croatian: NAVOĐENJE DJELATNIH I DRUGIH TVARI Firokoksib 20 mg/ml.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 8.2 mg/g oral paste for horses.
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA EQUIOXX 8,2 mg/g peroralna pasta za konje.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 20 mg/ml solution for injection for horses
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA EQUIOXX 20 mg/ml otopina za injekcije za konje
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2) mediated prostaglandin synthesis.
Croatian: Firokoksib je nesteroidni protuupalni lijek (NSAID) koji pripada skupini koksiba, koja djeluje selektivnom inhibicijom ciklooksigenaze-2 (COX-2) u sintezi prostaglandina.
English: Muscle Fat
Croatian: Kroskarmelozni natrij
English: 4.2 Indications for use, specifying the target species Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Croatian: INDIKACIJE Uklanjanje bolova i upala povezanih s osteoartrozom i smanjenje s time povezane hromosti u konja.
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) mediated prostaglandin synthesis.
Croatian: Firokoksib je nesteroidni protuupalni lijek (NSAID) koji djeluje selektivnom inhibicijom ciklooksigenaze-2 (COX-2) u sintezi prostaglandina.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 8.2 mg/g
Croatian: Firokoksib 8,2 mg/g
English: Concurrent administration of potentially nephrotoxic medicinal products should be avoided as there might be an increased risk of renal toxicity.
Croatian: Istovremenu primjenu potencijalno nefrotoksičnih medicinskih proizvoda treba izbjegavati zbog mogućeg povećanja opasnosti od nefrotoksičnosti.
English: Therefore, do not use in breeding, pregnant or lactating animals.
Croatian: Stoga se ne smije primjenjivati na rasplodnim, gravidnim ili životinjama u laktaciji.
English: 6.5 Nature and composition of immediate packaging Multi-dose amber-coloured glass injection vials closed with rubber stopper and sealed with an aluminium crimped top.
Croatian: Višedozne, jantarne staklene bočice za injekciju, s gumenim čepom i aluminijskim prstenom.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/006-009
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/083/006-009
English: Withdrawal period: Meat and offal: 26 days.
Croatian: Karencija: meso i iznutrice: 26 dana.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/002-003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/083/002-003
English: EXPIRY DATE
Croatian: EXP { }
English: Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be observed in treated animals.
Croatian: U liječenih životinja ponekad se mogu primijetiti lezije (erozija/ulceracija) na usnoj sluznici i koži oko usta.
English: Other NSAIDs, diuretic and substances with high protein binding may compete for binding and lead to toxic effects.
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija: Drugi nesteroidni protuupalni lijekovi, diuretici i tvari s visokim stupnjem vezanja proteina mogu dovesti do kompetitivnosti u vezanju i time do toksičnih učinaka.
English: Concurrent administration of potentially nephrotoxic medicinal drugs should be avoided.
Croatian: Istovremenu primjenu potencijalno nefrotoksičnih medicinskih proizvoda treba izbjegavati.
English: Animal species
Croatian: Životin jska vrsta
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION 0.1 mg firocoxib per kg bodyweight, once daily for up to 14 days.
Croatian: 0,1 mg firokoksiba na kg tjelesne mase, jednom dnevno do 14 dana.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 57 mg chewable tablets for horses firocoxib
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA EQUIOXX 57 mg tablete za žvakanje za konje firokoksib
English: Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth were very commonly observed in treated animals during tolerance studies.
Croatian: U liječenih životinja tijekom ispitivanja podnošljivosti vrlo često su primijećene lezije (erozija/ulceracija) na usnoj sluznici i koži oko usta.
English: Macrogol 300
Croatian: Makrogol 300 6.2 Inkompatibilnosti
English: PACKAGE LEAFLET EQUIOXX 20 mg/ml solution for injection for horses
Croatian: EQUIOXX 20 mg/ml otopina za injekcije za konje
English: PACKAGE LEAFLET EQUIOXX 8.2 mg/g oral paste for horses
Croatian: EQUIOXX 8,2 mg/g peroralna pasta za konje
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Croatian: 13. POSEBNE MJERE OPREZA PRILIKOM ODLAGANJE NEUPOTREBLJENOG PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: SPECIAL STORAGE PRECAUTIONS
Croatian: 11. POSEBNE MJERE OPREZA PRI ČUVANJU
English: Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such medicinal products should therefore be observed.
Croatian: Prethodno liječenje bilo kojim protuupalnim tvarima može za posljedicu imati dodatne ili pojačane štetne učinke pa je stoga potrebno provesti razdoblje bez takvih lijekova.
English: The safety of the veterinary medicinal product for use in breeding, pregnant or lactating horses has not been evaluated.
Croatian: 4.7 Primjena tijekom graviditeta, laktacije ili nesenja Neškodljivost upotrebe ovog VMP u rasplodnih, gravidnih ili kobila u laktaciji nije ocjenjivana.
English: SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Croatian: 13. POSEBNE MJERE OPREZA PRILIKOM ODLAGANJA NEUPOTREBLJENOG PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: MANUFACTURER'S BATCH NUMBER Lot
Croatian: BROJ PROIZVODNE SERIJE
English: Name and address of the manufacturer responsible for batch release:
Croatian: Nositelj odobrenja za proizvodnju odgovoran za puštanje proizvodne serije:
English: Withdrawal period : Meat and offal: 26 days.
Croatian: KARENCIJA Karencija: Meso i iznutrice: 26 dana.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/002
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/083/002
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/001
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/083/001
English: If you are also taking other medicines:
Croatian: Ako također uzimate i druge lijekove:
English: Clinical monitoring is recommended.
Croatian: Preporučuje se klinički nadzor.
English: • Do not give this medicine to children and adolescents under 18 years of age.
Croatian: • Nemojte davati ovaj lijek djeci i adolescentima mlađima od 18 godina.
English: If you have hepatitis B infection, your doctor will carefully consider the best treatment for you.
Croatian: Ako imate infekciju hepatitisom B, Vaš će liječnik pažljivo razmisliti o najboljem liječenju za Vas.
English: See section 3, How to take
Croatian: Pogledajte dio 3, Kako
English: Elvitegravir has a relatively low genetic barrier to resistance.
Croatian: Elvitegravir ima relativno nisku genetsku barijeru za rezistenciju.
English: (may affect 1 to 10 in every 100 patients treated)
Croatian: (mogu se javiti u 1 do 10 osoba na svakih 100 liječenih bolesnika)
English: No data are available for children below 18 years of age.
Croatian: Nema dostupnih podataka za djecu mlađu od 18 godina.
English: What Vitekta is and what it is used for
Croatian: Što je Vitekta i za što se koristi
English: The safety and efficacy of elvitegravir in children aged 0 to less than 18 years have not yet been established (see section 5.1).
Croatian: Sigurnost i djelotvornost elvitegravira u djece u dobi od 0 do manje od 18 godina nisu još ustanovljene (vidjeti dio 5.1).