FrancophonIA/ELRC3.0 huggingface dataset:
English: Episodes of symptomatic overdose (or excessive dosing regimen) have been reported, including accidental overdose.
Croatian: Prijavljene su epizode simptomatskog predoziranja (ili prekomjernog režima doziranja), uključujući i slučajno predoziranje.
English: The limited data from animal studies do not indicate direct reproductive toxicity (see section 5.3).
Croatian: Ograničeni podaci ispitivanja na životinjama ne upućuju na izravnu reproduktivnu toksičnost (vidjeti dio 5.3).
English: In the liver, cholic acid is extracted from portal blood by multiple mechanisms, including passive diffusion and transporters.
Croatian: U jetri se kolatna kiselina izdvaja iz portalne krvi višestrukim mehanizmima, uključujući pasivnu difuziju i transportere.
English: If you have a condition called familial hypertriglyceridaemia, your doctor may have to increase your dose of cholic acid.
Croatian: Ako bolujete od stanja koje se naziva obiteljska hipertrigliceridemija, Vaš liječnik će možda morati povećati Vašu dozu kolatne kiseline.
English: Reduction of the dose led to resolution of the clinical signs and correction of abnormal laboratory parameters.
Croatian: Smanjenje doze rezultiralo je povlačenjem kliničkih znakova i normalizacijom poremećenih laboratorijskih parametara.
English: In the absence of clinical experience in such patients, no recommendations on dosage adjustment can be made.
Croatian: Zbog nedostatka kliničkog iskustva u liječenju ovih bolesnika nije moguće dati preporuke za prilagodbu doziranja.
English: The MAH shall ensure that at launch all physicians expected to prescribe the product are provided with information on the correct and safe use of the product.
Croatian: Nositelj odobrenja treba osigurati da u trenutku stavljanja lijeka u promet svi liječnici za koje se očekuje da će propisivati lijek imaju sve informacije o ispravnoj i sigurnoj primjeni lijeka.
English: See above under ‘Do not take Kolbam'.
Croatian: Pogledajte prethodni dio „Nemojte uzimati Kolbam“.
English: This leaflet was last revised in DDmonthYYYY.
Croatian: Ova uputa je zadnji puta revidirana u DD mjesec GGGG.
English: The relevance of animal data with regards to cholic acid therapy safety is uncertain due to the known high inter-animal variability of bile acid homeostasis.
Croatian: Relevantnost životinjskih podataka na sigurnost terapije kolatnom kiselinom je nepouzdana zbog poznate visoke varijabilnosti među životinjama u homeostazi žučne kiseline.
English: The capsule contents will remain as fine granules in the milk or food.
Croatian: Sadržaj kapsula ostaje u obliku finih granula u mlijeku ili hrani.
English: Co-administration should be avoided.
Croatian: Treba izbjegavati njihovu istodobnu primjenu.
English: Mild peripheral neuropathy
Croatian: Blaga periferna neuropatija Često
English: The remaining 5 patients were treatment naïve.
Croatian: Preostalih 5 bolesnika nisu ranije primili to liječenje.
English: • AMACR deficiency (n=1)
Croatian: • deficijencija AMACR-a (n=1)
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 Kolbam.
Croatian: Bolesnike koji su prethodno liječeni drugim žučnim kiselinama ili drugim pripravcima kolatne kiseline treba pažljivo kontrolirati na isti način tijekom početne faze liječenja s lijekom Kolbam.
English: • Information on: o Calculation of the correct dose and the need to instruct caregivers on how to administer the product correctly o Symptoms and signs of an overdose and the management of this
Croatian: o izračunu ispravne doze i potrebi davanja upute njegovateljima o načinu ispravne primjene lijeka o simptomima i znakovima predoziranja i liječenju istih
English: Other medicines and Kolbam
Croatian: Drugi lijekovi i Kolbam
English: Treatment must be initiated and monitored by physicians, including paediatricians, experienced in the management of the specific deficiencies.
Croatian: 4.2 Doziranje i način primjene Liječenje moraju započeti i nadzirati liječnici, uključujući pedijatre, iskusni u liječenju konkretnih deficijencija.
English: • CYP7A1 deficiency
Croatian: • deficijenciju CYP7A1-a
English: The clinical experience reported is from a patient population with disorders in primary bile acid synthesis that includes principally infants from the age of one month, children and adolescents.
Croatian: Prijavljeno kliničko iskustvo prikupljeno je iz populacije bolesnika s poremećajem primarne sinteze žuči, koja obuhvaća uglavnom dojenčad u dobi od jednog mjeseca, djecu i adolescente.
English: Do not take Kolbam - If you are allergic to cholic acid or to any of the other ingredients of this medicine (listed in section 6).
Croatian: - Ako ste alergični na kolatnu kiselinu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Each capsule contains a white powder.
Croatian: Svaka kapsula sadrži bijeli prašak.
English: • Increase liver enzymes (serum transaminases)
Croatian: • povišeni enzimi jetre (transaminaze u serumu)
English: You can continue to breastfeed your baby whilst being treated with cholic acid, as levels in breast milk are considered too low to harm your baby.
Croatian: Možete nastaviti dojiti svoje dijete tijekom liječenja kolatnom kiselinom s obzirom na to da se razine u majčinom mlijeku smatraju preniskima da bi mogle naškoditi djetetu.
English: The capsules contain a white powder.
Croatian: Kapsule sadrže bijeli prašak.
English: If you forget to take Kolbam
Croatian: Ako ste zaboravili uzeti Kolbam
English: There is a theoretical possibility that administration of 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 podnošljivost.
English: Where the dose calculated is not a multiple of 50, the nearest dose below the maximum of 15 mg/kg/day should be selected, provided that is sufficient to suppress urinary bile acids.
Croatian: U slučaju kada izračunata doza nije višekratnik od 50, treba odabrati najbližu dozu manju od maksimalnih 15 mg/kg/dan, koja će omogućiti dostatnu supresiju žučne kiseline u urinu.
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 učinkovito smanjuje metabolite žučne kiseline na vrijednost što je moguće bliže nuli.
English: It is recommended that cholic acid is taken with food (see section 4.2).
Croatian: Preporučuje se uzimanje kolatne kiseline s hranom (vidjeti dio 4.2).
English: Skin and subcutaneous tissue disorders Skin lesion Pruritus
Croatian: Poremećaji kože i potkožnog tkiva Lezija kože
English: • lipid-lowering medicines such as clofibrate
Croatian: • lijekovi za snižavanje lipida poput klofibrata.
English: There are a limited number of studies that have demonstrated that cholic acid administered orally for up to 26 weeks at doses significantly greater than the therapeutic dose, was well tolerated in animals with no mortalities, no effects on bodyweight or food consumption and no evidence of significant macroscopic or microscopic findings in the liver.
Croatian: Postoji ograničeni broj ispitivanja na životinjama kojima je utvrđeno da je kolatna kiselina primijenjena peroralno u trajanju do 26 tjedana u dozama značajno većima od terapijskih doza dobro podnošena bez mortaliteta, bez učinaka na tjelesnu težinu ili unos hrane i bez dokaza značajnih makroskopskih ili mikroskopskih nalaza u jetri.
English: By replacing the missing cholic acid it stimulates the production of normal bile and helps prevent the build-up of the abnormal substances in the liver.
Croatian: Zamjenjujući kolatnu kiselinu koja nedostaje, Kolbam stimulira stvaranje normalne žuči i pomaže spriječiti nakupljanje abnormalnih tvari u jetri.
English: However, these patients should be carefully monitored and the dose of cholic acid titrated individually.
Croatian: No, ove bolesnike treba pažljivo kontrolirati te se doza kolatne kiseline treba individualno titrirati.
English: A total of 79 patients received cholic acid treatment, 49 of these suffered from a primary enzyme defect.
Croatian: Ukupno 79 bolesnika primilo je liječenje kolatnom kiselinom, od kojih je 49 imalo primarni defekt enzima.
English: Cholic acid will pass to the liver in the portal blood, in which it is moderately bound to albumin.
Croatian: Kolatna kiselina prelazi u jetru u portalnoj krvi, u kojoj je umjereno vezana na albumin.
English: Slightly increased blood pressure was evident in rats after 30 days of cholic acid at approximately 4-fold therapeutic dose with increased vasoconstrictor responses to noradrenaline, together with decreased levels of aldosterone and increased corticosterone, but no adverse clinical signs were observed.
Croatian: Blago povišen krvni tlak uočen je u štakora nakon 30-dnevne primjene kolatne kiseline u otprilike četverostrukoj terapijskoj dozi s povišenim vazokonstrikcijskim odgovorima na noradrenalin istovremeno sa smanjenim razinama aldosterona i povišenim kortikosteronom, no štetni klinički znakovi nisu uočeni.
English: Ciclosporin may affect the levels of cholic acid.
Croatian: Ciklosporin može utjecati na razine kolatne kiseline.
English: Among the subgroup of patients with CTX (n=8), 3 transitioned from CAC-91-10-10 and were on cholic acid treatment at study start.
Croatian: Unutar podskupine bolesnika s CTX-om (n=8), 3 su prešla iz ispitivanja CAC-91-10-10 i primali su liječenje kolatnom kiselinom na početku ispitivanja.
English: General improvements in the degree of atypical urine bile acids were also seen in individual defect groups.
Croatian: Općenita poboljšanja u stupnju razina atipičnih žučnih kiselina u urinu uočene su također u grupama s pojedinačnim defektom.
English: The concentrations of the abnormal bile acid metabolites synthesised subsequently should be determined.
Croatian: Treba utvrditi koncentracije abnormalnih metabolita žučne kiseline koji se naknadno sintetiziraju.
English: A total of 53 patients took part in the clinical study and received at least one dose of cholic acid; 22 (42%) were treatment naive, i.e., received their first dose of cholic acid during study CAC002-01.
Croatian: Ukupno je 53 bolesnika sudjelovalo u kliničkom ispitivanju i primilo je najmanje jednu dozu kolatne kiseline; za njih 22 (42%) je ovo liječenje bilo novo, tj. primili su svoju prvu dozu kolatne kiseline tijekom ispitivanja CAC-002-01.
English: Patients with certain types of conditions known as inborn errors of bile synthesis cannot produce cholic acid and bile normally, which leads to the production and build-up of abnormal substances that are potentially damaging to the liver.
Croatian: Bolesnici s određenim stanjima poznatima kao prirođene greške sinteze žuči ne mogu normalno proizvoditi kolatnu kiselinu i žuč, što uzrokuje stvaranje i nakupljanje abnormalnih tvari koje mogu oštetiti jetru.
English: This has led to the identification of cholic acid as a tumour promoter, considered to be via the hyperproliferation of colorectal epithelium in the presence of secondary bile acids.
Croatian: Ovo je rezultiralo identifikacijom kolatne kiseline kao promotora tumora, smatra se putem hiperproliferacije kolorektalnog epitela u prisutnosti sekundarnih žučnih kiselina.
English: In growing infants, treatment with cholic acid helps with the normal development of the liver and bile circulation system.
Croatian: Kod dojenčadi u razvoju, liječenje kolatnom kiselinom pomaže pri normalnom razvoju jetre i sustava za cirkulaciju žuči.
English: The recommended dosage for cholic acid in the treatment of inborn errors of primary bile acid synthesis is 10-15 mg/kg per day, either as a single daily dose or in divided doses, for both adult and paediatric patients.
Croatian: Preporučena doza kolatne kiseline za liječenje prirođenih grešaka u sintezi primarne žučne kiseline iznosi 10-15 mg/kg na dan, bilo kao jedna dnevna doza ili podijeljeno u nekoliko doza kako kod odraslih bolesnika tako i kod pedijatrijskih bolesnika.
English: Clinical features were limited to pruritus and diarrhoea.
Croatian: Kliničke karakteristike ograničene su na svrbež i proljev.
English: Familial hypertriglyceridaemia
Croatian: Obiteljska hipertrigliceridemija
English: In repeated dose studies, frequently reported effects of cholic acid have included decreased body weight, diarrhoea and liver damage with elevated transaminases although are considered to be associated with the pharmacological effects of bile acid metabolism.
Croatian: U ispitivanju ponovljenih doza, često prijavljeni učinci kolatne kiseline uključivali su smanjenje tjelesne težine, proljev i oštećenje jetre s povišenim transaminazama iako se smatra da su povezani s farmakološkim učincima metabolizma žučne kiseline.
English: Medicines for lowering cholesterol levels in the blood, such as cholestyramine, colestipol or colesevelam, and certain antacids which contain aluminium (e.g. indigestion relief products) may affect the absorption of cholic acid.
Croatian: Lijekovi koji snižavaju razine kolesterola u krvi, poput kolestiramina, kolestipola ili kolesevelama, i određeni antacidi koji sadrže aluminij (primjerice lijekovi za ublažavanje probavnih tegoba) mogu utjecati na apsorpciju kolatne kiseline.
English: Pack sizes: 90 capsules.
Croatian: Veličina pakiranja: 90 kapsula.
English: After the initiation period, serum and 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 početne faze liječenja žučne kiseline u serumu i urinu (korištenjem prikladnih analitičkih tehnika) i jetreni parametri trebaju se određivati najmanje jednom godišnje, te se doze moraju prema tome i uskladiti.
English: There is insufficient information on the excretion of cholic acid and its metabolites in human milk.
Croatian: Ne postoji dovoljno podataka o izlučivanju kolatne kiseline i njezinih metabolita u majčino mlijeko u ljudi.
English: If your doctor considers it necessary that you keep taking ciclosporin, he will closely monitor the levels of bile acids in your blood and urine and adjust the dose of cholic acid accordingly.
Croatian: Ako liječnik smatra da je potrebno nastaviti s uzimanjem ciklosporina, on će pažljivo kontrolirati razine žučnih kiselina u Vašoj krvi i mokraći, te će prilagoditi dozu kolatne kiseline prema potrebi.
English: Return any unused medicine to your pharmacist for disposal
Croatian: Neiskorišteni lijek vratite ljekarniku kako bi ga zbrinuo.
English: Cholic acid is not mutagenic; however, co-administration of cholic acid with known carcinogens has shown increased tumour formation compared to the known carcinogen alone.
Croatian: Kolatna kiselina nije mutagena, no utvrđeno je da istovremena primjena kolatne kiseline s poznatim karcinogenima povećava nastanak tumora u usporedbi sa samim poznatim karcinogenom.
English: Concomitant use with phenobarbital (see section 4.5).
Croatian: Istodobna uporaba s fenobarbitalom (vidjeti dio 4.5).
English: Available data in animals have shown excretion of cholic acid in milk (see section 5.3).
Croatian: Dostupni podaci iz ispitivanja na životinjama dokazuju izlučivanje kolatne kiseline u mlijeko (vidjeti dio 5.3).
English: Concurrent elevation of serum gamma glutamyltransferase (Gamma GT), 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 pokazatelj predoziranja.
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 mogućnosti liječenja, vidjeti dio 4.4.
English: Treatment with cholic acid in patients with pre-existing hepatic impairment should be given under close monitoring and, for all patients should be stopped in case of abnormal hepatocellular function, as measured by prothrombin time, if hepatocellular function does not improve within 3 months of the initiation of cholic acid treatment.
Croatian: Liječenje kolatnom kiselinom u bolesnika s postojećim oštećenjem funkcije jetre mora se provoditi uz pažljivo praćenje, te ga je u svih bolesnika potrebno prekinuti u slučaju abnormalne hepatocelularne funkcije, mjerene protrombinskim vremenom, ako se hepatocelularna funkcija ne poboljša unutar 3 mjeseca od početka liječenja kolatnom kiselinom.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Slijedom navedenog, nositelj odobrenja će ta izvješća podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.
English: Any cholic acid not absorbed will be excreted in the faeces, either unchanged or following dehydroxylation via bacterial metabolism.
Croatian: Sva kolatna kiselina koja se ne apsorbira, izlučuje se u feces, bilo u nepromijenjenom obliku ili nakon dehidroksilacije putem bakterijskog metaboliziranja.
English: DATE OF REVISION OF THE TEXT
Croatian: DATUM REVIZIJE TEKSTA <{DD mjesec GGGG}>
English: Orally administered cholic acid is absorbed by passive diffusion along the length of the gastrointestinal tract.
Croatian: Peroralno primijenjena kolatna kiselina apsorbira se pasivnom difuzijom cijelom dužinom gastrointestinalnog trakta.
English: Of all the patients treated in Study CAC-91-10-10, 49 patients presented with a single enzyme defect.
Croatian: Od svih bolesnika liječenih u ispitivanju CAC-91-10-10, 49 bolesnika imalo je defekte na jednom enzimu.
English: Study CAC-91-10-10, (Investigation in the pathogenesis of liver disease in patients with inborn errors of bile acid metabolism) was conducted from 1992-2009 to evaluate the therapeutic efficacy and safety of cholic acid to treat patients with identified inborn errors of bile acid metabolism.
Croatian: Ispitivanje CAC-91-10-10 (istraživanje u patogenezi bolesti jetre kod bolesnika s prirođenim greškama metabolizma žučne kiseline) provedeno je od 1992.-2009. sa ciljem evaluacije terapijske djelotvornosti i sigurnosti kolatne kiseline za liječenje bolesnika s identificiranim prirođenim greškama metabolizma žučne kiseline.
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 Gamma GT 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: Affected patients often present with significant comorbidities, including CNS impairment, which would not be treated by addressing the bile defect effects.
Croatian: Zahvaćeni bolesnici često su imali značajne komorbiditete, uključujući oštećenje CNS-a, koje nije bilo liječeno uklanjanjem učinaka manjka žučne kiseline.
English: Laboratory tests showed elevation of serum gamma glutamyltransferase (Gamma GT) transaminases and serum bile acid concentrations.
Croatian: Laboratorijski testovi pokazali su povećanje serumske gama glutamiltransferaze (GGT), transaminaza i koncentracija žučne kiseline u serumu.
English: Reflux esophagitis
Croatian: Refluksni ezofagitis
English: In this manner the vast majority of the bile acid pool is conserved and will cycle multiple times during feeding.
Croatian: Na ovaj način većina se rezervoara žučne kiseline sačuva i cirkulira više puta tijekom hranjenja.
English: Cholic acid has no or negligible influence on the ability to drive and use machines.
Croatian: Kolatna kiselina ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: During the initiation of therapy and dose adjustment, serum and urine bile acid levels should be monitored intensively by using suitable analytical techniques.
Croatian: U početnoj fazi liječenja i fazi prilagodbe doze, koncentracije žučne kiseline u serumu i urinu treba intenzivno kontrolirati pomoću prikladnih analitičkih tehnika.
English: In Study CAC-002-01 for patients overall with single-enzyme defects, urinary bile acids and serum transaminases did not change significantly from baseline to worst post-baseline value.
Croatian: U ispitivanju CAC-002-01 za bolesnike s ukupnim defektima pojedinačnog enzima, žučne kiseline u urinu i transaminaze u serumu nisu se značajno promijenile od početne vrijednosti u usporedbi s najlošijom vrijednosti nakon početne vrijednosti.
English: Within the liver, cholic acid is amidated in species-specific proportions, with glycine and/or taurine, into a more hydrophilic, conjugated form.
Croatian: Unutar jetre, kolatna kiselina se amidira u omjerima specifičnim za pojedinu vrstu, s glicinom i/ili taurinom, u hidrofilniji, konjugirani oblik.
English: Try to ensure that if any of the dose is spat out or refused, it is given again.
Croatian: Pokušajte osigurati da dijete ponovno uzme istu količinu lijeka, ako ispljune ili odbije uzeti bilo koju količinu doze.
English: Reports on recruitment progress of the registry will be submitted with PSURs and Annual Re-assessments.
Croatian: Izvješća o napretku popunjavanja registra dostavljaju se istovremeno s PSUR-ovima i godišnjim ponovnim izvješćima o dokumentaciji o lijeku.
English: Progress and results from the registry will form the basis of the annual reassessments of the benefit/risk profile of Kolbam.
Croatian: Napredak i rezultati ovog registra tvore bazu godišnjih ponovnih ocjena omjera koristi i rizika za Kolbam.
English: Kolbam is used to treat these ‘inborn errors of bile acid synthesis'.
Croatian: Kolbam se primjenjuje za liječenje ovih „prirođenih grešaka sinteze žučne kiseline“.
English: Distribution and pharmacological effects of bile acids such as cholic acid are mainly limited to the enterohepatic circulation, which includes the intestine, portal vein, liver and biliary tract.
Croatian: Distribucija i farmakološko djelovanje žučnih kiselina, poput kolatne kiseline, ograničeno je većinom na enterohepatičku cirkulaciju, što uključuje crijevo, portalnu venu, jetru i žučni trakt.
English: Administration of a single dose of cholic acid intravenously to pregnant ewes in late gestation demonstrated systemic exposure of cholic acid in the foetus with no effect on either the mother or the foetuses other than an increase in early deliveries.
Croatian: Primjena jedne doze kolatne kiseline intravenozno kod gravidnih ovaca u kasnoj gestaciji pokazala je sistemsku izloženost kolatnoj kiselini u fetusa bez drugih učinka na majku ili fetus, izuzev povećanja broja ranih poroda.
English: In the body cholic acid is naturally produced in the liver and is part of the bile, a fluid that helps digestion and absorbs fat and vitamins from the food.
Croatian: U tijelu se kolatna kiselina prirodno stvara u jetri i sastavni je dio žuči, tekućine koja pomaže pri probavi i apsorpciji masti i vitamina iz hrane.
English: • Sterol 27-hydroxylase deficiency (presenting as CTX)
Croatian: • deficijenciju sterol 27-hidroksilaze (manifestira se kao CTX)
English: Phenobarbital has been shown to increase the pool size and turnover of cholic acid and therefore has an antagonistic effect to the desired action of cholic acid in patients.
Croatian: Utvrđeno je da fenobarbital povećava veličinu rezervoara i metaboličku izmjenu kolatne kiseline te stoga ima antagonistički učinak na željeno djelovanje kolatne kiseline kod bolesnika.
English: There are no data on the effects of cholic acid on fertility.
Croatian: Nisu dostupni podaci o utjecaju kolatne kiseline na plodnost.
English: Packs containing 90 capsules.
Croatian: Pakiranje sadrži 90 kapsula.