FrancophonIA/ELRC3.0 huggingface dataset:
English: Major incompatibilities:
Croatian: Inkompatibilnosti:
English: Fill the reservoir of the spraying device with all the vaccine suspension prepared.
Croatian: Napunite spremnik uređaja za prskanje cijelim pripremljenim sadržajem otopine za cijepljenje.
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: 1.5 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: 1,5 do 3 bara).
English: No anticoccidial substances or other agents having anticoccidial activity via feed or water should be used for at least 3 weeks following the vaccination of chickens with this product otherwise the correct replication of the vaccine oocysts, and consequently the development of a solid immunity, could be hindered.
Croatian: Ne smiju se upotrebljavati antikokcidijske tvari ili druge tvari koje imaju antikokcidijsku aktivnost putem hrane ili vode tijekom najmanje 3 tjedna nakon cijepljenja pilića ovim proizvodom jer će inače doći do problema s pravilnom replikacijom oocista cjepiva i posljedičnim razvojem učinkovite imunosti.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vaccine vial of 10,000 doses
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Bočica cjepiva od 10,000 doza
English: HIPRA FRANCE Tél: (+33) 02 51 80 77 91
Croatian: Tél: (+33) 02 51 80 77 91
English: HIPRAMUNE T solvent for oral spray for chickens
Croatian: HIPRAMUNE T, otapalo za oralni sprej za piliće
English: LABORATORIOS HIPRA, S.A. Carretera C-63, Km 48.300 Polígono Industrial El Rieral Amer
Croatian: LABORATORIOS HIPRA, S.A. Carretera C-63, Km 48.300
English: Vaccination schedule: One dose of vaccine (0.007 ml) from 1 day of age.
Croatian: Raspored cijepljenja: Jedna doza cjepiva (0,007 ml) od 1 dana starosti.
English: Suspension for oral spray.
Croatian: Suspenzija za oralni sprej.
English: Before starting to prepare the spray solution, ensure there is a clean container with sufficient capacity for preparing the diluted vaccine suspension available.
Croatian: Prije početka pripreme otopine spreja provjerite je li dostupan čisti spremnik dovoljnog volumena za pripremu suspenzije razrijeđenog cjepiva.
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 (otapalom) priloženim za primjenu s proizvodom.
English: 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 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: Shake the vaccine (EVANT) vial and dilute the contents of it into the solvent and water solution.
Croatian: Protresite bočicu cjepiva (EVANT) i razrijedite sadržaj u otapalu i vodenoj otopini.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
Croatian: PROIZVOĐAČ<I> BIOLOŠKI DJELATNE<IH>
English: Brilliant Blue (E133) Red AC (E129) Vanillin
Croatian: Boja, briljantno modra (E133) Boja, alurno crvena AC (E129) Vanilin
English: Fax: +34 972 430661
Croatian: Fa x: +34 972 430661
English: Eimeria praecox and Eimeria tenella and to reduce clinical signs (diarrhoea) associated with Eimeria acervulina, Eimeria maxima and Eimeria tenella.
Croatian: Eimeria praecox te Eimeria tenella te za smanjenja kliničkih znakova (proljev) povezanih s Eimeria acervulina, Eimeria maxima i Eimeria tenella.
English: For the active immunisation of chicks from 1 day of age to reduce intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria maxima, Eimeria mitis,
Croatian: Za aktivnu imunizaciju pilića od 1. dana života kako bi se smanjile lezije na crijevima i izlučivanja oocista povezanih s kokcidiozom uzrokovanom s Eimeria acervulina, Eimeria maxima, Eimeria mitis,
English: Tel.: +34 972 430660
Croatian: Te l.: +34 972 430660
English: To stimulate active immunity against coccidiosis caused by Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox and Eimeria tenella.
Croatian: Za stimulaciju aktivne imunosti protiv kokciodioze koje uzrokuju vrste Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox i Eimeria tenella.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari EVANT (cjepivo):
English: Polypropylene vials containing 50 ml, 250 ml or 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: Maintain the diluted vaccine suspension in continuous homogenisation by using a magnetic stirrer while the vaccine is being administered via coarse spray to the chicks.
Croatian: Za vrijeme raspršivanja velikim kapljicama na pilićima, neka razrijeđena suspenzija cjepiva bude uvijek homogena pomoću magnetske mješalice.
English: Batch {number}
Croatian: (otapalo).
English: To be mixed with HIPRAMUNE T (solvent).
Croatian: Pomiješati s HIPRAMUNE T (otapalo).
English: HIPRAMUNE T (solvent): Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kada je zapakiran za prodaju: 2 godine.
English: For the active immunisation of chicks from 1 day of age to reduce intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox and Eimeria tenella and to reduce clinical signs (diarrhoea) associated with Eimeria acervulina, Eimeria maxima and Eimeria tenella.
Croatian: INDIKACIJE Za aktivnu imunizaciju pilića od 1. dana života kako bi se smanjile lezije na crijevima i izlučivanje oocista povezanih s kokcidiozom uzrokovanom s Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox te Eimeria tenella te za smanjenje kliničkih znakova (proljev) povezanih s Eimeria acervulina, Eimeria mxima i Eimeria tenella.
English: HIPRAMUNE T (solvent): Brilliant blue (E 133) Red AC (E 129) Vanillin
Croatian: Boja briljantno modra (E 133) Boja alurno crvena AC (E 129)
English: Each dose (0.007 ml) of undiluted vaccine contains:
Croatian: Svaka doza (0,007 ml) nerazrjeđenog cjepiva sadrži
English: PACKAGE LEAFLET: EVANT suspension and solvent for oral spray for chickens
Croatian: UPUTA O VMP: EVANT suspenzija i otapalo za oralni sprej za piliće
English: EVANT suspension and solvent for oral spray for chickens.
Croatian: EVANT suspenzija i otapalo za oralni sprej za piliće.
English: Suspension and solvent for oral spray.
Croatian: Suspenzija i otapalo za oralni sprej.
English: MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING Solvent vial of 50 ml, 250 ml or 500 ml
Croatian: Bočice otapala od 50 ml, 250 ml ili 500 ml
English: Each dose (0.007 ml) of undiluted vaccine contains: EVANT:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka doza (0,007 ml) nerazrijeđenog cjepiva sadrži: EVANT:
English: EVANT suspension and solvent for oral spray for chickens
Croatian: EVANT suspenzija i otapalo za oralni sprej za piliće
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVO G O DO BRENJA/PRODULJENJA O DOBRENJ
English: HIPRA BENELUX NV Tél/Tel: (+32) 09 2964464
Croatian: Tél/Tel: (+32) 09 2964464
English: Water Vaccine HIPRAMUNE T (solvent)
Croatian: Doze Voda Cjepivo HIPRAMUNE T (otapalo)
English: Cardboard box with one vial of EVANT containing 35 ml (5,000 doses) and one vial of HIPRAMUNE T containing 250 ml.
Croatian: Kartonska kutija s jednom bočicom cjepiva EVANT koja sadrži 35 ml (5.000 doza) i jedna bočica otapala HIPRAMUNE T koja sadrži 250 ml.
English: 17170 Amer (Girona)
Croatian: 17170 Ame r (Girona ) SP AIN
English: Solvent: Dark brownish solution.
Croatian: Otapalo: Tamna smećkasta otopina.
English: Coarse spray
Croatian: Kalijev klorid
English: Lay:
Croatian: Primjena:
English: One vial of 7 ml (1,000 doses) of EVANT and one vial of 50 ml of HIPRAMUNE T (solvent).
Croatian: Jedna bočica od 7 ml (1.000 doza) cjepiva EVANT i jedna bočica s 50 ml HIPRAMUNE T (otapalo).
English: One vial of 35 ml (5,000 doses) of EVANT and one vial of 250 ml of HIPRAMUNE T (solvent).
Croatian: Jedna bočica od 35 ml (5.000 doza) cjepiva EVANT i jedna bočica s 250 ml HIPRAMUNE T
English: Cardboard box with one vial of EVANT containing 70 ml (10,000 doses) and one vial of HIPRAMUNE T containing 500 ml.
Croatian: Kartonska kutija s jednom bočicom cjepiva EVANT koja sadrži 70 ml (10.000 doza) i jedna bočica otapala HIPRAMUNE T koja sadrži 500 ml.
English: Cardboard box with one vial of EVANT containing 7 ml (1,000 doses) and one vial of HIPRAMUNE T containing 50 ml.
Croatian: Kartonska kutija s jednom bočicom cjepiva EVANT koja sadrži 7 ml (1000 doza) i jedna bočica otapala HIPRAMUNE T koja sadrži 50 ml.
English: Coarse spray.
Croatian: I i aluminijskim poklopcima.
English: LABORATORIOS HIPRA, S.A. Paratge Lloret
Croatian: LABORATORIOS HIPRA, S.A. Avda. la Selva 135
English: One vial of 70 ml (10,000 doses) of EVANT and one vial of 500 ml of HIPRAMUNE T (solvent).
Croatian: Jedna bočica od 70 ml (10.000 doza) cjepiva EVANT i jedna bočica s 500 ml HIPRAMUNE T
English: Shake the solvent vial (HIPRAMUNE T).
Croatian: Protresite bočicu s otapalom (HIPRAMUNE T).
English: Withdrawal period: Zero days.
Croatian: KARENCIJA(E) Karencija: Nula dana.
English: Polysorbate 80
Croatian: Polígono Industrial El Rieral
English: HIPRA UK AND IRELAND, Ltd. Tel: (+44) 0115 845 6486
Croatian: Tel: (+44) 0115 845 6486
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE Veterinarsko-medicinski proizvod se izdaje na veterinarski recept.
English: Elderly patients (older than 65 years)
Croatian: Stariji bolesnici (stariji od 65 godina)
English: Height and weight showed similar improvements.
Croatian: Visina i težina pokazale su slična poboljšanja.
English: DATE OF FIRST AUTHORISATION 20 November 2015
Croatian: DATUM PRVOG ODOBRENJA 20. studenog 2015
English: The physician's educational material should contain the following key elements:
Croatian: Edukacijski materijal liječnika treba sadržavati sljedeće ključne elemente:
English: Some of the primary defects include but are not limited to:
Croatian: Neki od primarnih defekata uključuju ali nisu ograničeni na:
English: The study was completed on 31 July 2016.
Croatian: Ispitivanje je završeno 31. srpnja 2016.
English: Use within 3 months of opening.
Croatian: Upotrijebiti u roku od 3 mjeseca nakon otvaranja.
English: Once the bottle is opened, the medicinal product must be used within 3 months.
Croatian: Nakon što se boca otvori, lijek se mora iskoristiti u roku od 3 mjeseca.
English: Never take a double dose to make up for a forgotten dose.
Croatian: Nikad nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Do not take more capsules than your doctor has advised you.
Croatian: Ne uzimajte više kapsula nego što Vam je liječnik savjetovao.
English: • oral contraceptives,
Croatian: • oralni kontraceptivi,
English: Your doctor will tell you how many capsules you need to take, and when you should take the capsules.
Croatian: Liječnik će Vas obavijestiti koliko kapsula morate uzeti, te kada morate uzeti kapsule.
English: If not, the next higher dose should be selected.
Croatian: Ako se to nije postiglo, treba odabrati prvu sljedeću veću dozu.
English: Take the next dose as soon as you remember, as long as it is more than 12 hours until the next dose.
Croatian: Uzmite sljedeću dozu čim se sjetite samo ukoliko do sljedeće doze preostaje više od 12 sati.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Croatian: Budući je ovo odobrenje u iznimnim okolnostima, a temeljem članka 14(8) Uredbe (EZ) br. 726/2004, nositelj odobrenja će, unutar navedenog vremenskog okvira, provoditi sljedeće mjere:
English: Dublin 2, Ireland Tel: +353 86 803 8014 info@retrophin.com
Croatian: Tel: +353 86 803 8014 info@ retrophin.com
English: <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Do not chew the capsule.
Croatian: Ne žvačite kapsulu.
English: You should check with your doctor or pharmacist if you are unsure.
Croatian: Provjerite s liječnikom ili ljekarnikom, ako niste sigurni.
English: The dose should be adjusted accordingly, as described above.
Croatian: Doza se mora prilagoditi, kako je opisano ranije u tekstu.
English: The capsules should be swallowed whole with water.
Croatian: Kapsule se moraju progutati cijele s vodom.
English: No data available.
Croatian: Nema dostupnih podataka.
English: More frequent tests will be needed if you are growing fast, if you are ill (e.g., if you have liver problems) or if you are pregnant.
Croatian: Češće pretrage su potrebne ako brzo rastete, ako ste bolesni (npr. ako imate problema s jetrom) ili ako ste trudni.
English: Patients should be monitored initially every 3 months during the first year then 6 monthly during the subsequent three years and annually thereafter.
Croatian: Na početku bolesnike treba kontrolirati svaka 3 mjeseca tijekom prve godine, zatim svakih 6 mjeseci iduće tri godine, zatim jednom godišnje.
English: Your doctor will advise you to take cholic acid at least 5 hours before or after taking the other medicine.
Croatian: Vaš liječnik će Vam savjetovati da uzimate kolatnu kiselinu najmanje 5 sati prije ili nakon uzimanja drugog lijeka.
English: For additional information, see section 6.6.
Croatian: Za dodatne informacije vidjeti dio 6.6.
English: Your doctor will advise you if for any reason you have to stop treatment with cholic acid.
Croatian: Vaš će Vam liječnik savjetovati ako iz bilo kojeg razloga morate prekinuti liječenje kolatnom kiselinom.
English: • oestrogen,
Croatian: • estrogen,
English: A total of 85 patients took part in the clinical study.
Croatian: Ukupno je 85 bolesnika sudjelovalo u kliničkom ispitivanju.
English: These are some of the medicines that may affect the way in which Kolbam works:
Croatian: Ovo su samo neki od lijekova koji mogu utjecati na način na koji Kolbam djeluje:
English: It is important to give the full content of the capsule to the baby or young child where whole capsules cannot be given.
Croatian: Važno je dati cjelokupan sadržaj kapsule dojenčetu ili malom djetetu, u slučaju kada se ne mogu dati cijele kapsule.
English: If you take more Kolbam than you should
Croatian: Ako uzmete više lijeka Kolbam nego što ste trebali
English: Liver parameters should also be monitored.
Croatian: Potrebno je kontrolirati i jetrene parametre.
English: In this set of patients, about one quarter were below or at most 6 months of age at diagnosis, and about one third were between 7 and 36 months.
Croatian: U ovoj skupini bolesnika, otprilike jedna četvrtina bila je mlađa ili najviše u dobi od 6 mjeseci u trenutku dijagnoze, a otprilike jedna trećina je bila u dobi između 7 i 36 mjeseci.
English: In the event of overdose the patient should be monitored and treated symptomatically.
Croatian: U slučaju predoziranja, bolesnik se mora nadzirati i simptomatski liječiti.
English: Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State.
Croatian: Prije stavljanja u promet u svakoj državi članici, nositelj odobrenja usuglasit će konačan edukacijski materijal s nadležnim tijelom u državi članici.
English: The mixture should be given immediately after preparation.
Croatian: Mješavina se mora konzumirati odmah nakon pripreme.
English: Kolbam can be used from the age of one month and patients affected by these conditions will need treatment for the rest of their life.
Croatian: Kolbam se može primjenjivati u dobi od jednog mjeseca života, a bolesnici koji boluju od ovih stanja trebat će liječenje do kraja svog života.
English: Treatment should be stopped earlier if there are clear indicators of severe hepatic failure.
Croatian: Liječenje treba prekinuti ranije ako postoje jasni indikatori teškog zatajenja jetre.
English: Cholic acid is unlikely to cause serious side effects but you should contact your doctor for advice if you or your child have taken more than the amount prescribed.
Croatian: Nije izgledno da će kolatna kiselina uzrokovati ozbiljne nuspojave no trebate se obratiti svom liječniku za savjet ako ste Vi ili Vaše dijete uzeli količinu koja je veća od propisane.
English: The events were transitory and generally did not interfere with the therapy.
Croatian: Nuspojave su bile prolazne i općenito nisu interferirale s terapijom.
English: - If you are taking phenobarbital (a medicine used for epilepsy).
Croatian: Ako uzimate fenobarbital (lijek koji se koristi u liječenju epilepsije).
English: Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu France
Croatian: Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu Francuska
English: Do not take any phenobarbital while you are on cholic acid.
Croatian: Ne uzimajte nikakav fenobarbital dok uzimate kolatnu kiselinu.
English: It is recommended that cholic acid is taken with food (see section 4.5) at approximately the same time each day, in the morning and/or evening.
Croatian: Preporučuje se uzimanje kolatne kiseline s hranom (vidjeti dio 4.5) otprilike u isto vrijeme svaki dan, ujutro i/ili navečer.
English: Common Not known
Croatian: Nije poznato Nije poznato
English: There are several enzyme defects described in the literature.
Croatian: U literaturi su opisani defekti nekoliko enzima.
English: Swallow each capsule whole with water, either just before or just after food.
Croatian: Primjena u odraslih Progutajte svaku kapsulu cijelu s vodom, bilo neposredno prije ili odmah nakon konzumiranja hrane.
English: Cholic acid also promotes normal growth of children.
Croatian: Kolatna kiselina također pospješuje normalan rast u djece.
English: On average, patients in this subgroup were 3 years at treatment start, minimum and maximum ages were 0 and 14 years, respectively.
Croatian: Prosječno, bolesnici u ovoj podgrupi imali su 3 godine u trenutku započinjanja liječenja, a minimalna i maksimalna dob iznosile su 0 odnosno 14 godina.
English: No formal preclinical safety studies have been conducted; however, data in the literature reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Croatian: Nisu provedena formalna neklinička ispitivanja o sigurnosti primjene, no podaci u literaturi ne ukazuju na poseban rizik za ljude na temelju ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne toksičnosti.
English: If you stop taking Kolbam
Croatian: Ako prestanete uzimati Kolbam
English: WHAT YOU NEED TO KNOW BEFORE YOU TAKE KOLBAM
Croatian: Što morate znati prije nego počnete primjenjivati Kolbam
English: Biliary bile alcohols and bile acids show remarkable structural diversity across animal species.
Croatian: Bilijarni žučni alkoholi i žučne kiseline pokazuju značajnu strukturalnu raznolikost diljem životinjskih vrsta.
English: The dose should be subsequently titrated to the desired effect but should not exceed a maximum of 15 mg/kg/day.
Croatian: Naknadno se doza treba titrirati do željenog učinka, no ne smije se premašiti maksimalna doza od 15 mg/kg/dan.
English: Side effects of unknown frequency (cannot be estimated from the available data):
Croatian: Nuspojave nepoznate učestalosti (ne mogu se procijeniti na temelju dostupnih podataka):
English: Should the use of a preparation containing one of these substances be necessary, it must be taken at least 5 hours before or after cholic acid.
Croatian: Ako će primjena pripravka koji sadrži jednu od ovih tvari biti neophodna, isti se mora uzeti najmanje 5 sati prije ili nakon kolatne kiseline.
English: This mixing of the capsule contents with food should mask any unpleasant taste of the medicine.
Croatian: Miješanje sadržaja kapsule s hranom trebalo bi prikriti neugodan okus lijeka.
English: This medicine is intended for long-term use.
Croatian: Ovaj je lijek namijenjen za dugotrajnu primjenu.
English: Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava primjenom sljedeće konvencije: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i
English: The recommended dose is based on your body weight (10-15 mg per kg) taken either as a single dose, once a day, or divided into two doses, one in the morning and one in the evening.
Croatian: Preporučena doza se temelji na Vašoj tjelesnoj težini (10 - 15 mg po kg) koja se uzima kao jedna doza jedanput dnevno ili podijeljeno u dvije doze, i to jedna ujutro i jedna navečer.
English: Additional or more frequent investigations should be undertaken to monitor therapy during periods of fast growth, concomitant disease and pregnancy (see section 4.6).
Croatian: Dodatne ili češće pretrage trebaju se provoditi tijekom razdoblja brzoga rasta, istodobne bolesti i trudnoće (vidjeti dio 4.6).
English: Cholic acid is one of the primary bile acids in man on which essential physiological functions depend.
Croatian: Kolatna kiselina je jedna od primarnih žučnih kiselina u čovjeka, o kojoj ovise esencijalne fiziološke funkcije.
English: • AMACR deficiency
Croatian: • deficijenciju AMACR-a
English: 90 capsules.
Croatian: 90 kapsula.
English: During your treatment, your doctor will carry out various blood and urine tests at different times to see how your body is handling this medicine and to help work out the dose that you need.
Croatian: Vaš će liječnik obaviti različite pretrage krvi i mokraće u različitim razdobljima kako bi provjerio kako Vaše tijelo prihvaća lijek te utvrdio dozu koja Vam je potrebna.
English: In Study CAC-002-01, the mean age of patients at baseline was 9.0 years, with ages ranging from 0.1 to 35.6 years.
Croatian: U ispitivanju CAC-002-01, prosječna dob bolesnika na početku iznosila je 9,0 godina, pri čemu je raspon godina iznosio od 0,1 do 35,6 godina.
English: Of these 85 patients, 52 presented with disorders in primary bile acid synthesis including the following 3 single enzymes:
Croatian: Od ovih 85 bolesnika, 52 bolesnika imalo je poremećaje u sintezi primarne žučne kiseline uključujući sljedeća 3 pojedinačna enzima:
English: In all studies, a dose of 10-15 mg/kg/day was administered.
Croatian: U svim ispitivanjima primijenjena je doza od 10-15 mg/kg/dan.
English: The adverse reactions reported in the literature with an unknown frequency are also reported in the following table.
Croatian: Nuspojave prijavljene u literaturi s nepoznatom učestalošću također su navedene u tablici.
English: Mixing of the capsule contents is designed to mask any unpleasant taste which results from the capsules being opened but no data on the compatibility or palatability are available.
Croatian: Miješanje sadržaja kapsule osmišljeno je kako bi se prikrio neugodan okus sadržaja kapsule nakon što se otvori, no nisu dostupni podaci o kompatibilnosti ili palatabilnosti.
English: The dose of cholic acid should be adjusted individually.
Croatian: Doza kolatne kiseline treba se individualno prilagoditi.