FrancophonIA/ELRC3.0 huggingface dataset:
English: This rarity also made the conduct of controlled clinical studies impossible.
Slovenian: Redkost bolezni tudi onemogoča izvedbo kontroliranih kliničnih študij.
English: Detailed medium- to long-term data are available for 5 of these patients, of whom 1 has been treated with cholic acid monotherapy.
Slovenian: Podrobni srednje- do dolgoročni podatki so na voljo za 5 od teh bolnikov, od katerih je 1 prejemal monoterapijo s holno kislino.
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.
Slovenian: Vendar študije niso bile opravljene tako podrobno kot za zdravilo, saj je holna kislina fiziološka snov pri živalih in človeku.
English: Before treatment your doctor will make an assessment from your laboratory tests to determine the correct dose for you.
Slovenian: Pred začetkom zdravljenje bo vaš zdravnik pregledal vaše rezultate laboratorijskih preiskav in določil pravilni odmerek za vas.
English: PC: {number}
Slovenian: PC: {številka}
English: Administered orally, bile acids and salts generally have only a minor toxic potential.
Slovenian: Pri peroralnem dajanju imajo žolčne kisline in soli na splošno le manjši toksični potencial.
English: Other food such as fruit compote or yoghurt may be suitable for administration, but no data on the compatibility or palatability are available.
Slovenian: Za dajanje so lahko primerna tudi druga živila, kot so sadni kompot ali jogurt, vendar podatkov o združljivosti in okusnosti ni.
English: There is a limited amount of data (less than 20 pregnancy outcomes) from the use of cholic acid in pregnant women.
Slovenian: Podatkov o uporabi holne kisline pri nosečnicah je malo (manj kot 20 izidov nosečnosti).
English: E-mail: ctrs@ctrs.fr
Slovenian: E-pošta: ctrs@ctrs.fr
English: In all age groups, the minimum dose is 50 mg and the dose is adjusted in 50 mg steps.
Slovenian: V vseh starostnih skupinah je najmanjši odmerek 50 mg, odmerek pa se prilagaja v korakih po 50 mg.
English: Pack sizes are available in 30, 60 and 120 capsules.
Slovenian: Na voljo so pakiranja s 30, 60 in 120 kapsulami.
English: Taking Orphacol at regular times with a meal will help you remember to take this medicine, and may help your body to better take it up.
Slovenian: Jemanje zdravila Orphacol ob isti uri z obrokom vam bo pomagalo, da se boste spomnili vzeti zdravilo, hkrati pa ga bo telo morda bolje privzelo.
English: No pharmacokinetic study data for Orphacol are available.
Slovenian: Podatki farmakokinetičnih študij za zdravilo Orphacol niso na voljo.
English: Orphacol capsules must be taken with food at approximately the same time each day, in the morning and/or evening.
Slovenian: Kapsule Orphacol je treba jemati s hrano ob približno isti uri vsak dan, zjutraj in/ali zvečer.
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.
Slovenian: CTRS se obveže spremljati varnost in učinkovitost pri bolnikih, zdravljenih z zdravilom Orphacol v zbirki podatkov spremljanja bolnikov, katere protokol je potrdil CHMP in je zapisan v RMP zdravila Orphacol.
English: What Orphacol is and what it is used for
Slovenian: Kaj je zdravilo Orphacol in za kaj ga uporabljamo
English: The dose must be adjusted for each patient in a specialised unit according to blood and/or urine chromatographic bile acid profiles.
Slovenian: Odmerek je treba prilagoditi za vsakega bolnika v specializirani enoti glede na kromatografske profile žolčnih kislin v krvi in/ali urinu.
English: If your doctor has prescribed a dose which requires you to take more than one capsule per day, you and your doctor can decide how this will be taken during the day.
Slovenian: Če vam je zdravnik predpisal odmerek, za katerega morate vzeti več kot eno kapsulo dnevno, se lahko skupaj z zdravnikom odločite, kako ga boste jemali čez dan. Lahko na primer vzamete eno kapsulo zjutraj in eno zvečer.
English: Ciclosporin (a medicine used to suppress the immune system) may also change the effect of Orphacol.
Slovenian: Ciklosporin (zdravilo, ki zavira odziv imunskega sistema) lahko tudi spremeni učinek zdravila Orphacol.
English: Orphacol contains a certain sugar (lactose monohydrate).
Slovenian: Zdravilo Orphacol vsebuje določen sladkor (laktoza monohidrat).
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.
Slovenian: Bolnike, ki so se predhodno zdravili z drugimi žolčnimi kislinami ali drugimi pripravki holne kisline, je treba med uvajanjem zdravljenja z zdravilom Orphacol skrbno spremljati na enak način.
English: Treatment must be initiated and monitored by an experienced gastroenterologist/hepatologist or a paediatric gastroenterologist/hepatologist in the case of paediatric patients.
Slovenian: Zdravljenje mora uvesti in spremljati izkušen gastroenterolog/hepatolog, v primeru pediatričnih bolnikov pa pediatrični gastroenterolog/hepatolog.
English: Animal studies showed that cholic acid did not induce any teratogenic effect or foetal toxicity.
Slovenian: Študije na živalih so pokazale, da holna kislina ni povzročila teratogenih učinkov ali toksičnosti za plod.
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.
Slovenian: Dokazali so, da peroralno zdravljenje s holno kislino: odloži ali odpravi potrebo po presaditvi jeter; obnovi normalne laboratorijske parametre; izboljša histološke lezije jeter in bistveno izboljša vse bolnikove simptome.
English: Paediatric population The presented safety information is derived principally from paediatric patients.
Slovenian: Predstavljeni varnostni podatki so bili v glavnem zbrani na podlagi pediatričnih bolnikov.
English: Medicines should not be disposed of via wasterwater or household waste.
Slovenian: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: Administration of these medicinal products is expected to reduce the effect of cholic acid.
Slovenian: Uporaba teh zdravil naj bi zmanjšala učinek holne kisline.
English: Capsules must be swallowed whole with water, without chewing.
Slovenian: Kapsule je treba pogoltniti cele z vodo, brez žvečenja.
English: If you have taken more Orphacol than you should, contact your doctor as soon as possible.
Slovenian: Če ste vzeli večji odmerek zdravila Orphacol, kot bi smeli, čim prej obvestite svojega zdravnika.
English: He will assess your laboratory test results and advise you when you should resume your treatment with your normal dose.
Slovenian: Zdravnik bo pregledal vaše rezultate laboratorijskih preiskav ter vam svetoval, kdaj lahko nadaljujete zdravljenje z običajnim odmerkom.
English: Capsules of 50 mg cholic acid are blue and white and capsules of 250 mg cholic acid are green and white.
Slovenian: Kapsule s 50 mg holne kisline so modre in bele, kapsule z 250 mg holne kisline pa so zelene in bele.
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).
Slovenian: Pri več bolnikih so med zdravljenjem z zdravilom Orphacol poročali o zvišanju ravni jetrnih encimov (serumskih transaminaz) (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
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).
Slovenian: Dodatne ali pogostejše preiskave je treba opraviti za spremljanje zdravljenja v obdobju hitre rasti, sočasne bolezni ali nosečnosti
English: Other medicines and Orphacol
Slovenian: Druga zdravila in zdravilo Orphacol
English: Clinical features were limited to pruritus and diarrhoea.
Slovenian: Klinični znaki so bili omejeni na pruritus in drisko.
English: Marketing Authorisation Holder Laboratoires CTRS 63, rue de l'Est
Slovenian: Imetnik dovoljenja za promet Laboratoires CTRS 63 rue de l'Est
English: Orphacol capsules contain lactose.
Slovenian: Kapsule Orphacol vsebujejo laktozo.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive
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.
Slovenian: Dnevni odmerek se lahko razdeli, če je sestavljen iz več kapsul, da se posnema stalno nastajanje holne kisline v telesu in da se zmanjša število kapsul, ki jih je treba vzeti pri vsakem odmerjanju.
English: The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto ponovno pregledala nove podatke o zdravilu in posodobila navodilo za uporabo, če bo potrebno.
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.
Slovenian: Zdravljenje s holno kislino je treba prekiniti, če se nenormalna hepatocelična funkcija, ki se izmeri s protrombinskim časom, ne izboljša v 3 mesecih po uvedbi zdravljenja s holno kislino.
English: Orphacol capsules are taken by mouth with a meal at approximately the same time each day, in the morning and/or evening.
Slovenian: Kapsule Orphacol je treba jemati peroralno z obrokom ob približno isti uri vsak dan, zjutraj in/ali zvečer.
English: Phenobarbital antagonises the effect of cholic acid.
Slovenian: Fenobarbital antagonistično deluje na učinek holne kisline.
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.
Slovenian: Dnevni odmerek za dojenčke, stare od 1 meseca do 2 let, otroke in mladostnike je od 5 do 15 mg/kg in se mora prilagoditi posameznemu bolniku.
English: Detailed long-term data on treatment with cholic acid monotherapy are available for 14 patients observed for up to 12.9 years.
Slovenian: Podrobni dolgoročni podatki o monoterapiji s holno kislino so na voljo za 14 bolnikov, ki so bili spremljani do 12,9 let.
English: Cholic acid has no or negligible influence on the ability to drive and use machines.
Slovenian: Holna kislina nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: In case of persistent lack of therapeutic response to cholic acid monotherapy, other treatment options should be considered (see section 4.4).
Slovenian: V primeru perzistentnega neodzivanja na monoterapijo s holno kislino je treba preučiti druge možnosti zdravljenja (glejte poglavje 4.4).
English: Liver parameters should also be monitored, preferentially more frequently than serum and/or urine bile acid levels.
Slovenian: Spremljati je treba tudi jetrne parametre, po možnosti pogosteje kot ravni žolčnih kislin v serumu in/ali urinu.
English: SN: {number} NN: {number}
Slovenian: SN: {številka} NN: {številka}
English: Cholic acid, a primary bile acid, is partially absorbed in the ileum.
Slovenian: Holna kislina, primarna žolčna kislina, se delno absorbira v ileumu.
English: In addition, blood cholic acid concentration was normal and fat-soluble vitamins were restored to their normal range.
Slovenian: Poleg tega je bila koncentracija holne kisline v krvi normalna, koncentracije vitaminov, topnih v maščobah, pa so se vrnile v normalno območje.
English: This reflects restoration of an effective feedback control of bile acid synthesis and a metabolic equilibrium.
Slovenian: To je odraz obnovitve učinkovite povratne zanke sinteze žolčnih kislin in presnovnega ravnovesja.
English: As a precaution, you and your unborn child should be closely monitored during pregnancy.
Slovenian: Iz previdnostnih razlogov je treba vas in vaš plod med nosečnostjo skrbno spremljati.
English: Orphacol can be used during breast-feeding.
Slovenian: Zdravilo Orphacol se lahko uporablja v obdobju dojenja.
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.
Slovenian: Odmerek adsorbentov žolčnih kislin ali antacidov mora biti ločen od odmerka holne kisline s presledkom 5 ur, ne glede na to, katero zdravilo se jemlje prvo.
English: Contents of the pack and other information What Orphacol contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Orphacol
English: What you need to know before you take Orphacol Do not take Orphacol
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Orphacol Ne jemljite zdravila Orphacol
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, odsotnost aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Tell your doctor if you plan to breast-feed or are breastfeeding before you take Orphacol.
Slovenian: Obvestite svojega zdravnika, če načrtujete dojenje ali dojite, preden vzamete zdravilo Orphacol.
English: If you take more Orphacol than you should
Slovenian: Če ste vzeli večji odmerek zdravila Orphacol, kot bi smeli
English: There is no need for contraceptive measures in women of childbearing potential treated with cholic acid or their partners.
Slovenian: Ženske v rodni dobi Pri ženskah v rodni dobi, ki se zdravijo s holno kislino, ali njihovih partnerjih ni potrebna kontracepcija.
English: The effect of food on the bioavailability of cholic acid has not been studied.
Slovenian: Učinka hrane na biološko razpoložljivost holne kisline niso proučili.
English: What Orphacol is and what it is used for What you need to know before you take Orphacol How to take Orphacol
Slovenian: Kaj je zdravilo Orphacol in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Orphacol Kako jemati zdravilo Orphacol Možni neželeni učinki
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.
Slovenian: Opazili so prehodno povečanje vrednosti transaminaz med uvajanjem zdravljenja s holno kislino, kar pa ne pomeni, da je treba zmanjšati odmerek, če ravni GGT niso zvišane in če ravni žolčnih kislin v serumu padajo oz. so v normalnem območju.
English: Cholic acid is the predominant primary bile acid in man.
Slovenian: Holna kislina je prevladujoča primarna žolčna kislina pri človeku.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Orphacol.
Slovenian: Če vam je zdravnik povedal, da ne prenašate določenih sladkorjev, obvestite svojega zdravnika, preden vzamete zdravilo Orphacol.
English: Laboratory tests showed elevation of serum gamma glutamyltransferase (GGT) transaminases and serum bile acid concentrations.
Slovenian: Laboratorijske preiskave so pokazale zvišane serumske vrednosti gama-glutamiltransferaze (GGT), transaminaz in koncentracij žolčnih kislin v serumu.
English: Excipient(s) with known effect: Lactose monohydrate (66.98 mg per capsule).
Slovenian: Pomožne snovi z znanim učinkom: laktoza monohidrat (66,98 mg na kapsulo).
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.
Slovenian: Analiza z masno spektrometrijo urina med zdravljenje s holno kislino je pokazala prisotnost holne kisline in bistveno zmanjšanje ali celo popolno odstranitev toksičnih presnovkov žolčnih kislin.
English: Episodes of symptomatic overdose have been reported, including accidental overdose.
Slovenian: Opisane so epizode simptomatičnega prevelikega odmerjanja, vključno z nenamernim prevelikim odmerjanjem.
English: Concomitant use of phenobarbital with cholic acid (see section 4.5).
Slovenian: Sočasna uporaba fenobarbitala in holne kisline (glejte poglavje 4.5).
English: Patients with hepatic impairment should be monitored closely.
Slovenian: Bolnike z okvarjenim delovanjem jeter je treba skrbno spremljati.
English: As a precautionary measure, pregnant women and their unborn children should be closely monitored.
Slovenian: Iz previdnostnih razlogov je treba nosečnice in njihove plodove skrbno spremljati.
English: Women of childbearing potential should conduct a pregnancy test as soon as a pregnancy is suspected.
Slovenian: Ženske v rodni dobi morajo čim prej opraviti nosečnostni test, če menijo, da so noseče.
English: Excipient(s) with known effect: Lactose monohydrate (145.79 mg per capsule).
Slovenian: Pomožne snovi z znanim učinkom: laktoza monohidrat (145,79 mg na kapsulo).
English: Content of capsules: Lactose monohydrate (see section 2 under ‘Orphacol contains lactose' for more information), colloidal anhydrous silica, magnesium stearate Capsule shell:
Slovenian: Vsebina kapsul: laktoza monohidrat (za več informacij glejte razdelek „Zdravilo Orphacol vsebuje laktozo“ v poglavju 2), koloidni brezvodni silicijev dioksid, magnezijev stearat Ovoj kapsule:
English: Orphacol contains cholic acid, a bile acid which is normally produced by the liver.
Slovenian: Zdravilo Orphacol vsebuje holno kislino, žolčno kislino, ki jo običajno tvorijo jetra.
English: 30 hard capsules 60 hard capsules 120 hard capsules
Slovenian: 30 trdih kapsul 60 trdih kapsul 120 trdih kapsul
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.
Slovenian: Holna kislina in njeni presnovki se izločajo v materinem mleku, vendar se pri terapevtskih odmerkih zdravila Orphacol ne pričakujejo učinki na dojene novorojenčke/dojenčke.
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.
Slovenian: Med uvajanjem zdravljenja in prilagajanjem odmerka je treba intenzivno spremljati (vsaj vsake tri mesece v prvem letu, vsakih 6 mesecev v drugem letu) ravni žolčnih kislin v serumu in/ali urinu s plinsko kromatografijo z ustreznimi analitičnimi metodami.
English: Bile acid sequestrants (cholestyramine, colestipol, colesevelam) and certain antacids (e.g. aluminium hydroxide) bind bile acids and lead to their elimination.
Slovenian: Adsorbenti žolčnih kislin (holestiramin, kolestipol, holesevelam) in določeni antacidi (npr. aluminijev hidroksid) vežejo žolčne kisline, kar povzroči njihovo izločanje.
English: The following table lists adverse reactions reported in the literature under treatment with cholic acid.
Slovenian: V spodnji preglednici so navedeni neželeni učinki, objavljeni v literaturi o zdravljenju s holno kislino.
English: These reactions abated after dose reduction and are suggestive of overdose.
Slovenian: Ti reakciji sta pojenjali po zmanjšanju odmerka in kažeta na možnost prevelikega odmerjanja.
English: Diarrhoea, increased transaminases and pruritus have been associated with overdosage and disappeared after dose reduction.
Slovenian: Drisko, zvečane ravni transaminaz in pruritus so povezali s prevelikim odmerjanjem in po zmanjšanju odmerka izginejo.
English: A small fraction of bile acids is excreted in urine.
Slovenian: Majhen del žolčnih kislin se izloči z urinom.
English: There is a theoretical possibility that administration with food may increase cholic acid bioavailability and improve tolerability.
Slovenian: Obstaja teoretična možnost, da lahko jemanje s hrano poveča biološko razpoložljivost holne kisline in izboljša prenašanje zdravila.
English: The lowest dose of cholic acid that effectively reduces the bile acid metabolites to as close to zero as possible should be chosen.
Slovenian: Izbrati je treba najmanjši odmerek holne kisline, ki učinkovito zmanjša presnovke žolčnih kislin čim bližje ničli.
English: They are contained in blisters of 10 capsules each.
Slovenian: Pakirane so v pretisne omote po 10 kapsul.
English: Orphacol is not expected to have an effect on the ability to drive and use machines.
Slovenian: Učinek zdravila Orphacol na sposobnost vožnje in upravljanja s stroji se ne pričakuje.
English: Parenteral administration may cause haemolysis and cardiac arrest.
Slovenian: Parenteralno dajanje lahko povzroči hemolizo in zastoj srca.
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).
Slovenian: Pri več bolnikih se je pojavilo srbenje ali driska ali oboje, vendar verjetnost pojava teh učinkov ni znana (pogostnosti teh učinkov ni mogoče oceniti iz razpoložljivih podatkov).
English: The cholic acid contained in Orphacol replaces the bile acids that are missing due to the defect in bile acid production.
Slovenian: Holna kislina v zdravilu Orphacol nadomesti žolčne kisline, ki manjkajo zaradi nepravilnosti pri nastajanju žolčnih kislin.
English: If you become pregnant during treatment with Orphacol, your doctor will decide which treatment and dose is best in your situation.
Slovenian: Če zanosite med zdravljenjem z zdravilom Orphacol, bo vaš zdravnik presodil, kakšno zdravljenje oz.
English: Reduction of the dose led to resolution of the clinical signs and correction of abnormal laboratory parameters.
Slovenian: Po zmanjšanju odmerka so klinični znaki izginili, laboratorijski parametri pa so se popravili.
English: Certain medical conditions are caused by defects in bile acid production and Orphacol is used to treat infants from one month to 2 years of age, children, adolescents and adults with these medical conditions.
Slovenian: Določene bolezni so posledica nepravilnosti pri nastajanju žolčnih kislin in zdravilo Orphacol se uporablja za zdravljenje dojenčkov, starih od 1 meseca do 2 let, otrok, mladostnikov in odraslih bolnikov s temi boleznimi.
English: Your doctor will decide what to do if this happens to you.
Slovenian: Če se to zgodi pri vas, bo o tem, kaj storiti, presodil zdravnik.
English: If you stop taking Orphacol
Slovenian: Če ste prenehali jemati zdravilo Orphacol
English: Other special populations Please refer to section 4.2 for use of Orphacol in special populations.
Slovenian: Druge posebne populacije Za informacije o uporabi zdravila Orphacol pri posebnih populacijah glejte poglavje 4.2.
English: • Risk of gallstones
Slovenian: • tveganje za nastanek žolčnih kamnov.
English: No data on the effects of cholic acid on fertility are available.
Slovenian: Podatkov o učinkih holne kisline na plodnost ni.
English: If you forget to take Orphacol
Slovenian: Če ste pozabili vzeti zdravilo Orphacol
English: See the package leaflet for further information.
Slovenian: Za več informacij glejte priloženo navodilo za uporabo.
English: If administration of ciclosporin is considered necessary, serum and urine bile acid levels should be closely monitored and the cholic acid dose adjusted accordingly.
Slovenian: Če menite, da je uporaba ciklosporina potrebna, morate skrbno spremljati ravni žolčnih kislin v serumu in urinu ter ustrezno prilagoditi odmerek holne kisline.