FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you are allergic to cholic acid or any of the other ingredients of this medicine (listed in section - if you are taking phenobarbital, a medicine to treat epilepsy.
Croatian: - ako ste alergični na kolatnu kiselinu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako uzimate fenobarbital, lijek za liječenje epilepsije.
English: Reports on recruitment progress of the patient surveillance database will be analysed and reported to the CHMP at the time of PSURs (for safety) and of the Annual Reassessments (for efficacy and safety).
Croatian: Izvješća o napretku popunjavanja baze podataka za nadzor bolesnika analizirat će se i podnositi CHMP-u istovremeno sa PSUR-evima (za sigurnost) i Godišnjim ponovnim izvješćem o lijeku (za djelotvornost i sigurnost).
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 s ciljem praćenja terapije tijekom razdoblja brzoga rasta, istodobne bolesti i trudnoće (vidjeti dio 4.6).
English: 30 hard capsules 60 hard capsules 120 hard capsules
Croatian: 30 tvrdih kapsula 60 tvrdih kapsula 120 tvrdih kapsula
English: As a precaution, you and your unborn child should be closely monitored during pregnancy.
Croatian: Kao mjera opreza potrebno je pažljivo pratiti Vas i Vaše nerođeno dijete tijekom trudnoće.
English: Co-administration should be avoided.
Croatian: Treba izbjegavati istodobnu primjenu.
English: What Orphacol looks like and contents of the pack
Croatian: Kako Orphacol izgleda i sadržaj pakiranja
English: In all age groups, the minimum dose is 50 mg and the dose is adjusted in 50 mg steps.
Croatian: Za sve starosne grupe minimalna doza iznosi 50 mg te se prilagođava u koracima od po 50 mg.
English: The available literature is not sufficient to detect a difference in the safety of cholic acid within paediatric age groups or between paediatric patients and adults.
Croatian: Dostupna literatura nije dostatna za otkrivanje razlika u sigurnosti kolatne kiseline unutar različitih pedijatrijskih dobnih skupina ili između pedijatrijskih bolesnika i odraslih osoba.
English: Orphacol capsules are taken by mouth with a meal at approximately the same time each day, in the morning and/or evening.
Croatian: Orphacol kapsule uzimaju se kroz usta uz obrok, i to svaki dan otprilike u isto vrijeme, odnosno ujutro i/ili uvečer.
English: Development of gallstones associated with long-term treatment have been reported in very limited number of patients.
Croatian: Razvoj žučnih kamenaca povezan s dugoročnim liječenjem prijavljen je na ograničenom broju bolesnika.
English: 92100 Boulogne-Billancourt France
Croatian: 92100 Boulogne-Billancourt Francuska
English: What Orphacol is and what it is used for What you need to know before you take Orphacol How to take Orphacol
Croatian: Što je Orphacol i za što se koristi Što morate znati prije nego počnete uzimati Orphacol
English: Take a pregnancy test as soon as you suspect you may be pregnant.
Croatian: Napravite test na trudnoću čim posumnjate na trudnoću.
English: Detailed long-term data on treatment with cholic acid monotherapy are available for 14 patients observed for up to 12.9 years.
Croatian: Detaljni dugoročni podaci o liječenju monoterapijom kolatnom kiselinom dostupni su za 14 bolesnika koji su praćeni do 12,9 godina.
English: Date of first authorisation: 12 September 2013 Date of latest renewal: 24 April 2019
Croatian: Datum posljednje obnove odobrenja: 24. travnja 2019.
English: Capsules must be swallowed whole with water, without chewing.
Croatian: Kapsule se moraju progutati cijele s vodom i ne smiju se žvakati.
English: Orphacol capsules must be taken with food at approximately the same time each day, in the morning and/or evening.
Croatian: Orphacol kapsule uzimaju se sa hranom otprilike u isto vrijeme svaki dan, i to ujutro i/ili uvečer.
English: Administered orally, bile acids and salts generally have only a minor toxic potential.
Croatian: Ako se primjenjuju oralno, žučne kiseline i soli imaju samo manji toksični potencijal.
English: Orphacol is available as hard capsules (capsules) of oblong shape.
Croatian: Orphacol je dostupan kao tvrde kapsule (kapsule) duguljastog oblika.
English: Pack sizes are available in 30, 60 and 120 capsules.
Croatian: Dostupna su pakiranja po 30, 60 i 120 kapsula.
English: He will assess your laboratory test results and advise you when you should resume your treatment with your normal dose.
Croatian: Liječnik će procijeniti rezultate Vaših laboratorijskih pretraga i savjetovat će Vam kada da nastavite liječenje Vašom normalnom dozom.
English: Other special populations Please refer to section 4.2 for use of Orphacol in special populations.
Croatian: Proučite dio 4.2 za primjenu Orphacola u posebnim populacijama.
English: The exposed pregnancies showed no adverse reactions to cholic acid and resulted in normal, healthy children.
Croatian: U trudnoćama izloženim lijeku nisu se pojavile nuspojave na kolatnu kiselinu i rezultirale su normalnom, zdravom djecom.
English: No pharmacokinetic study data for Orphacol are available.
Croatian: Nema dostupnih farmakokinetičkih ispitivanja za Orphacol.
English: The studies have however not been conducted to the same level of detail as for a pharmaceutical agent, as cholic acid is a physiological substance in animals and humans.
Croatian: No, ispitivanja nisu završena s istom količinom detaljnih podataka kao u slučaju farmaceutskog sredstva, s obzirom da je kolna kiselina fiziološka tvar u životinjama i ljudima.
English: This rarity also made the conduct of controlled clinical studies impossible.
Croatian: Zbog ove male učestalosti stanja nemoguće je provođenje kontroliranih kliničkih ispitivanja.
English: Orphacol can be used during breast-feeding.
Croatian: Orphacol se može koristiti tijekom dojenja.
English: As a precautionary measure, pregnant women and their unborn children should be closely monitored.
Croatian: Kao mjera opreza preporučuje se pažljivo pratiti trudnice i njihovu nerođenu djecu.
English: Patients that have previously been treated with other bile acids or other cholic acid preparations should be closely monitored in the same manner during the initiation of treatment with Orphacol.
Croatian: Bolesnici koji su prethodno liječeni drugim žučnim kiselinama ili drugim pripravcima kolatne kiseline trebaju se pažljivo pratiti na isti način tijekom početne faze liječenja lijekom Orphacol.
English: Paediatric population The presented safety information is derived principally from paediatric patients.
Croatian: Navedene sigurnosne informacije izvedene su načelno od pedijatrijskih bolesnika.
English: This means that because of the rarity of this disease and for ethical reasons it has been impossible to get complete information on this medicine.
Croatian: To znači da zbog male učestalosti ove bolesti i zbog etičkih razloga nije bilo moguće dobiti potpune informacije o ovom lijeku.
English: For several patients an increase of liver enzymes (serum transaminases) have been reported during the treatment with Orphacol (frequency cannot be estimated from the available data).
Croatian: Za nekoliko bolesnika porast jetrenih enzima (serumskih transaminaza) prijavljen je tijekom liječenja lijekom Orphacol (učestalost se ne može procijeniti iz dostupnih podataka).
English: The lowest dose of cholic acid that effectively reduces the bile acid metabolites to as close to zero as possible should be chosen.
Croatian: Treba odabrati najmanju dozu kolatne kiseline koja djelotvorno smanjuje metabolite žučne kiseline na vrijednost što je moguće bliže nuli.
English: The daily dose may be divided if it consists of more than one capsule in order to mimic the continuous production of cholic acid in the body and to reduce the number of capsules that need to be taken per administration.
Croatian: Dnevna doza može se rasporediti tijekom dana, ako se sastoji od više od jedne kapsule, kako bi se oponašalo kontinuirano stvaranje kolatne kiseline u tijelu te se smanjio broj kapsula koji se mora uzeti prilikom svake primjene lijeka.
English: CTRS commits to monitor the safety and efficacy in patients treated with Orphacol from a patient surveillance database for which the protocol has been endorsed by the CHMP and is documented in the Orphacol RMP.
Croatian: Proizvođač CTRS obvezuje se pratiti sigurnost i djelotvornost u bolesnika liječenih lijekom Orphacol pomoću baze podataka za praćenje bolesnika, za koju je CHMP odobrio protokol, a koja je dokumentirana u RMP za Orphacol.
English: Cholic acid showed non-significant mutagenic activity in a battery of genotoxicity tests performed in vitro.
Croatian: Kolna kiselina nije pokazala nikakvu značajnu mutagenu aktivnost u nizu genotoksičnih testova provedenih in vitro.
English: The dose of bile acid sequestrants or antacids must be separated from the dose of cholic acid by an interval of 5 hours, regardless of which medicinal product is administered first.
Croatian: Doza sekvestranta žučne kiseline ili antacida mora se uzimati odvojeno od doze kolatne kiseline u intervalima od 5 sati, bez obzira koji se lijek uzima prvi.
English: Mass spectrometry analysis of urine during cholic acid therapy shows the presence of cholic acid and a marked reduction, or even complete elimination of the toxic bile acid metabolites.
Croatian: Analiza masene spektrometrije urina tijekom terapije kolatnom kiselinom pokazuje prisutnost kolatne kiseline i znatno smanjivanje ili čak potpunu eliminaciju toksičnih metabolita žučne kiseline.
English: The daily dose in infants from 1 month to 2 years of age, children and adolescents ranges from 5 to 15 mg/kg and must be adjusted individually for each patient.
Croatian: Dnevna doza u dojenčadi starosti od 1 mjeseca do 2 godine, djece i adolescenata iznosi od 5 do 15 mg/kg i mora se individualno prilagoditi za svakog bolesnika.
English: Animal studies showed that cholic acid did not induce any teratogenic effect or foetal toxicity.
Croatian: Ispitivanja provedena na životinjama pokazala su da kolna kiselina nije inducirala teratogenu posljedicu ili fetalnu toksičnost.
English: Women of childbearing potential should conduct a pregnancy test as soon as a pregnancy is suspected.
Croatian: Žene reproduktivne dobi trebaju napraviti test trudnoće čim posumnjaju na trudnoću.
English: Diarrhoea, increased transaminases and pruritus have been associated with overdosage and disappeared after dose reduction.
Croatian: Proljev, povišene transaminaze i pruritus povezani su s predoziranjem te nestaju nakon smanjenja doze.
English: Orphacol contains a certain sugar (lactose monohydrate).
Croatian: Orphacol sadrži određeni šećer (laktozu hidrat).
English: If you take more Orphacol than you should
Croatian: Ako uzmete više lijeka Orphacol nego što ste trebali
English: In case of persistent lack of therapeutic response to cholic acid monotherapy, other treatment options should be considered (see section 4.4).
Croatian: U slučaju dugotrajnog izostanka terapijskog odgovora na monoterapiju kolatnom kiselinom treba uzeti u obzir druge opcije liječenja (vidjeti dio 4.4).
English: This reflects restoration of an effective feedback control of bile acid synthesis and a metabolic equilibrium.
Croatian: Ovo se očituje u obnavljanju učinkovite povratne sprege kontrole sinteze žučne kiseline i metaboličke ravnoteže.
English: The dose must be adjusted for each patient in a specialised unit according to blood and/or urine chromatographic bile acid profiles.
Croatian: Doziranje Doza se mora prilagoditi svakom bolesniku u specijaliziranim jedinicama u skladu s kromatografskim profilima žučne kiseline u krvi i/ili urinu.
English: • Risk of gallstones
Croatian: • rizik od žučnih kamenaca
English: Your doctor will prescribe laboratory tests on your blood, urine and liver for you when you start treatment and regularly thereafter.
Croatian: Liječnik će propisati laboratorijske pretrage krvi, mokraće i jetre prilikom početka liječenja te redovito tijekom liječenja.
English: This means that due to the rarity of the disease and for ethical reasons it has not been possible to obtain complete information on this medicinal product.
Croatian: To znači da s obzirom na malu učestalost bolesti i zbog etičkih razloga nije bilo moguće doći do potpunih informacija o ovom lijeku.
English: Treatment must be initiated and monitored by an experienced gastroenterologist/hepatologist or a paediatric gastroenterologist/hepatologist in the case of paediatric patients.
Croatian: Liječenje mora započeti i pratiti iskusan gastroenterolog/hepatolog ili pedijatar gastroenterolog/hepatolog u slučaju pedijatrijskih bolesnika.
English: - PSUR - Annual Reassessment
Croatian: - PSUR - Godišnje ponovno izvješće o dokumentaciji o lijeku
English: Several patients have experienced itching and/or diarrhoea, however, it is not known how likely this is to occur (frequency cannot be estimated from the available data).
Croatian: Kod nekoliko bolesnika pojavili su se svrbež i/ili proljev, no nije poznato koliko je izgledno da će se ove nuspojave pojaviti (učestalost se ne može procijeniti na temelju dostupnih podataka).
English: Tell your doctor if you plan to breast-feed or are breastfeeding before you take Orphacol.
Croatian: Obavijestite svojeg liječnika ako planirate dojiti ili ako dojite prije uzimanja lijeka Orphacol.
English: In repeated-dose studies, frequently reported effects of cholic acid have included decreased body weight, diarrhoea and liver damage with elevated transaminases.
Croatian: U ispitivanjima ponovljene doze, često prijavljivani učinci kolatne kiseline uključivali su smanjenje tjelesne mase, proljev i oštećenje jetre s povišenim transaminazama.
English: Treatment with cholic acid should be stopped if abnormal hepatocellular function, as measured by prothrombin time, does not improve within 3 months of the initiation of cholic acid treatment.
Croatian: Liječenje kolatnom kiselinom mora se prekinuti, ako se abnormalna funkcija jetrenih stanica izmjerena protrombinskim vremenom ne poboljša u roku od 3 mjeseca od početka liječenja kolatnom kiselinom.
English: Orphacol is not expected to have an effect on the ability to drive and use machines.
Croatian: Ne očekuje se utjecaj lijeka Orphacol na sposobnost upravljanja vozilima i strojevima.
English: Content of capsules: Lactose monohydrate (see section 2 under ‘Orphacol contains lactose' for more information), colloidal anhydrous silica, magnesium stearate Capsule shell:
Croatian: Sadržaj kapsule: laktoza hidrat (vidjeti dio 2 „Orphacol sadrži laktozu“ za više informacija), koloidni bezvodni silicijev dioksid, magnezijev stearat Ovojnica kapsule:
English: The oral LD50 in mice is 1520 mg/kg.
Croatian: Oralni LD50 u miševa iznosi 1520 mg/kg.
English: Orphacol capsules contain lactose.
Croatian: Orphacol kapsule sadrže laktozu.
English: Transient elevations of transaminases at the initiation of cholic acid treatment have been observed and do not indicate the need for a dose reduction if GGT is not elevated and if serum bile acid levels are falling or in the normal range.
Croatian: Uočena su prolazna povišenja vrijednosti transaminaza u početnoj fazi liječenja kolatnom kiselinom, ali to nije indikacija za smanjivanje doze ako razina GGT-a nije povišena i ako se razine žučne kiseline u serumu smanjuju ili se nalaze u rasponu normalnih vrijednosti.
English: Orphacol contains cholic acid, a bile acid which is normally produced by the liver.
Croatian: Orphacol sadrži kolatnu kiselinu, žučnu kiselinu koju normalno stvara jetra.
English: • Prescription of a supratherapeutic dose (MedDRA term: drug toxicity)
Croatian: • propisivanje supraterapijske doze (MedDRA pojam: toksičnost lijeka [engl.
English: Concomitant use of phenobarbital with cholic acid (see section 4.5).
Croatian: Istodobna primjena fenobarbitala s kolatnom kiselinom (vidjeti dio 4.5).
English: Cholic acid is the predominant primary bile acid in man.
Croatian: Kolna kiselina je predominantna primarna žučna kiselina u ljudi.
English: In addition, blood cholic acid concentration was normal and fat-soluble vitamins were restored to their normal range.
Croatian: Nadalje, koncentracija kolatne kiseline u krvi bila je normalna, a vrijednosti vitamina topivih u masti ponovno su se vratile unutar normalnih raspona.
English: Capsules of 50 mg cholic acid are blue and white and capsules of 250 mg cholic acid are green and white.
Croatian: Kapsule koje sadrže 50 mg kolatne kiseline su plavo-bijele boje, a kapsule koje sadrže 250 mg kolatne kiseline su zeleno-bijele boje.
English: Pharmacotherapeutic group: Bile and liver therapy, bile acid and derivatives, ATC code: A05AA03
Croatian: Farmakoterapijska skupina: terapija žuči i jetre, pripravci žučne kiseline i derivati, ATK oznaka: A05AA03
English: Excipient(s) with known effect: Lactose monohydrate (145.79 mg per capsule).
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom: laktoza hidrat (145,79 mg po kapsuli).
English: Oral cholic acid therapy has been shown to: postpone or obviate the need for liver transplantation; restore normal laboratory parameters; improve histological lesions of the liver, and significantly improve all of the patient's symptoms.
Croatian: Oralna terapija kolatnom kiselinom dokazano: odgađa ili eliminira potrebu za transplantacijom jetre, uspostavlja normalne laboratorijske parametre poboljšava lezije jetre praćene histološkom metodom i značajno poboljšava sve simptome bolesnika.
English: Phenobarbital antagonises the effect of cholic acid.
Croatian: Fenobarbital je antagonist djelovanja kolatne kiseline.
English: Gallstones have been reported after long-term therapy.
Croatian: Žučni kamenci prijavljeni su nakon dugotrajne terapije.
English: Excipient(s) with known effect: Lactose monohydrate (66.98 mg per capsule).
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom: laktoza hidrat (66,98 mg po kapsuli).
English: Oblong, opaque, green and white capsule.
Croatian: Duguljasta, neprozirna, zeleno-bijela kapsula.
English: Gallstones have been reported after long-term therapy with Orphacol.
Croatian: Žučni kamenci prijavljeni su nakon dugotrajne terapije lijekom Orphacol.
English: Increased liver weight and gallstones have been reported in repeated dose studies in which cholic acid was co-administered with cholesterol.
Croatian: Povećana masa jetre i žučni kamenci prijavljivani su u ispitivanjima ponovljene doze, u kojima je kolna kiselina primijenjena zajedno s kolesterolom.
English: Oblong, opaque, blue and white capsule.
Croatian: Duguljasta, neprozirna, plavo-bijela kapsula.
English: Laboratory tests showed elevation of serum gamma glutamyltransferase (GGT) transaminases and serum bile acid concentrations.
Croatian: Laboratorijski testovi pokazali su povećanje serumske gama glutamiltransferaze (GGT), transaminaza i koncentracija žučne kiseline u serumu.
English: During the initiation of therapy and dose adjustment, serum and/or urine bile acid levels should be monitored intensively (at least every three months during the first year of treatment, every six months during the second year) using suitable analytical techniques.
Croatian: U početnoj fazi terapije i fazi prilagođavanja terapije razine žučne kiseline u serumu i/ili urinu moraju se intenzivno pratiti (najmanje svaka tri mjeseca tijekom prve godine liječenja te svakih šest mjeseci tijekom druge godine).
English: Concurrent elevation of serum gamma glutamyltransferase (GGT), alanine aminotransferase (ALT) and/or serum bile acids above normal levels may indicate overdose.
Croatian: Istodobno povišene vrijednosti serumske gama glutamiltransferaze (GGT), alanin aminotransferaze (ALT) i/ili žučnih kiselina u serumu iznad normalnih razina može biti indikacija predoziranja.
English: There is no need for contraceptive measures in women of childbearing potential treated with cholic acid or their partners.
Croatian: Ne postoji potreba za mjerama kontracepcije u žena reproduktivne dobi, a koje su liječene kolatnom kiselinom, ili u njihovih partnera.
English: A small fraction of bile acids is excreted in urine.
Croatian: Mali dio žučnih kiselina izlučuje se u urinu.
English: If you stop taking Orphacol
Croatian: Ako prestanete uzimati Orphacol
English: There is a theoretical possibility that administration with food may increase cholic acid bioavailability and improve tolerability.
Croatian: Postoji teorijska mogućnost da primjena lijeka s hranom može povećati bioraspoloživost kolatne kiseline te poboljšati toleranciju.
English: Parenteral administration may cause haemolysis and cardiac arrest.
Croatian: Parenteralna primjena može uzrokovati hemolizu i srčani zastoj.
English: The cholic acid contained in Orphacol replaces the bile acids that are missing due to the defect in bile acid production.
Croatian: Kolna kiselina sadržana u lijeku Orphacol zamjenjuje žučne kiseline koje nedostaju zbog poremećaja u stvaranju žučne kiseline.
English: After the initiation period, serum and/or urine bile acids (using suitable analytical techniques) and liver parameters should be determined annually, at a minimum, and the dose adjusted accordingly.
Croatian: Po završetku početnog vremenskog razdoblja parametri žučnih kiselina u serumu i/ili urinu (pomoću odgovarajućih analitičkih metoda) i jetreni parametri trebaju se određivati najmanje jednom godišnje, te se doze moraju primjereno uskladiti.
English: Do not use Orphacol after the expiry date which is stated on the carton and blister after EXP.
Croatian: Orphacol se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti“.
English: No data on the effects of cholic acid on fertility are available.
Croatian: Nisu dostupni podaci o utjecaju kolatne kiseline na plodnost.
English: Cholic acid and its metabolites are excreted in human milk, but at therapeutic doses of Orphacol, no effects on the breastfed newborns/infants are anticipated.
Croatian: Kolatna kiselina i njezini metaboliti se izlučuju u majčino mlijeko, ali se pri terapijskoj dozi lijeka Orphacol ne očekuju učinci na dojenu novorođenčad/dojenčad.
English: Administration of these medicinal products is expected to reduce the effect of cholic acid.
Croatian: Primjena ovih lijekova može smanjiti djelovanje kolatne kiseline.
English: Administration with food may increase cholic acid bioavailability and improve tolerability.
Croatian: Uzimanje lijeka s hranom može povećati bioraspoloživost i poboljšati toleranciju.
English: Bile acid sequestrants (cholestyramine, colestipol, colesevelam) and certain antacids (e.g. aluminium hydroxide) bind bile acids and lead to their elimination.
Croatian: Sekvestranti žučne kiseline (kolestiramin, kolestipol, kolesevelam) i određeni antacidi (primjerice aluminijev hidroksid) vežu žučne kiseline i uzrokuju njihovu eliminaciju iz tijela.
English: Progress and results from the database will form the basis of the annual reassessments of the benefit/risk profile of Orphacol.
Croatian: Napredak i rezultati baze podataka tvore osnovu za godišnju ponovnu ocjenu omjera koristi i rizika lijeka Orphacol.
English: If you forget to take Orphacol
Croatian: Ako zaboravite uzeti Orphacol
English: The following table lists adverse reactions reported in the literature under treatment with cholic acid.
Croatian: Sljedeća tablica navodi nuspojave prijavljene u literaturi za liječenje kolatnom kiselinom.
English: What you need to know before you take Orphacol Do not take Orphacol
Croatian: Što morate znati prije nego počnete uzimati Orphacol
English: Regular and fixed times of administration support the patient's or caregiver's compliance.
Croatian: Redovita i utvrđena vremena za uzimanje lijeka potiču suradljivost bolesnika i pružatelja skrbi.
English: The intravenous LD50 of cholic acid in mice is 350 mg/kg body weight.
Croatian: Intravenozni LD50 kolatne kiseline u miševa iznosi 350 mg/kg tjelesne mase.
English: Liver parameters should also be monitored, preferentially more frequently than serum and/or urine bile acid levels.
Croatian: Potrebno je pratiti i parametre jetre, i to po mogućnosti češće od razina žučne kiseline u serumu i/ili urinu.