FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipient(s) with known effect: Lactose monohydrate (145.79 mg per capsule).
Maltese: Eċċipjent(i) b'effett magħruf: Lactose monohydrate (145.79 mg kull kapsula).
English: Excipient(s) with known effect: Lactose monohydrate (66.98 mg per capsule).
Maltese: Eċċipjent(i) b'effett magħruf: Lactose monohydrate (66.98 mg kull kapsula).
English: Content of capsules: Lactose monohydrate (see section 2 under ‘Orphacol contains lactose' for more information), colloidal anhydrous silica, magnesium stearate Capsule shell:
Maltese: Kontenut tal-kapsuli: Lactose monohydrate (ara sezzjoni 2 ‘Orphacol fih lattosju' għal aktar tagħrif), colloidal anhydrous silica, magnesium stearate Qoxra tal-kapsuli:
English: Orphacol contains a certain sugar (lactose monohydrate).
Maltese: Orphacol fih zokkor partikolari (lactose monohydrate).
English: Laboratoires CTRS 63, rue de l'Est 92100 Boulogne-Billancourt France
Maltese: Laboratoires CTRS 63, rue de l'Est 92100
English: Laboratory tests showed elevation of serum gamma glutamyltransferase (GGT) transaminases and serum bile acid concentrations.
Maltese: Testijiet fil-laboratorju wrew żieda fis-serum gamma glutamyltransferase (GGT) transaminasi u fil-konċentrazzjonijiet tal-aċidu biljari fis-serum.
English: Pack sizes are available in 30, 60 and 120 capsules.
Maltese: Id-daqsijiet tal-pakkett huma disponibbli f'pakketti ta' 30, 60 u 120 kapsula.
English: Elderly population (≥65 years old)
Maltese: Popolazzjoni anzjana (≥65 sena)
English: Laboratoires CTRS Teл.
Maltese: Laboratoires CTRS Tél/Tel:
English: Concurrent elevation of serum gamma glutamyltransferase (GGT), alanine aminotransferase (ALT) and/or serum bile acids above normal levels may indicate overdose.
Maltese: Żieda fl-istess ħin ta' gamma glutamyltransferase (GGT) tasserum, alanine aminotransferase (ALT) u/jew aċidi biljari tas-serum ogħla mil-livelli normali tista' tindika doża eċċessiva.
English: Gelatin (bovine origin), Titanium dioxide (E171), Carmine blue (E132).
Maltese: Titanium dioxide (E171), Blu carmine (E132).
English: The oral LD50 in mice is 1520 mg/kg.
Maltese: L-LD50 orali fil-ġrieden hija ta' 1520 mg/kg.
English: Orphacol 250 mg: gelatin, titanium dioxide (E171), carmine blue (E132), yellow iron oxide (E172).
Maltese: Orphacol 50 mg: ġelatina, dijossidu tat-titanju (E171), blu carmine (E132); Orphacol 250 mg: ġelatina, dijossidu tat-titanju (E171), blu carmine (E132), ossidu tal-ħadid isfar (E172).
English: EU/1/13/870/004 EU/1/13/870/005 EU/1/13/870/006
Maltese: EU/1/13/870/005 EU/1/13/870/006
English: Other medicines and Orphacol
Maltese: Mediċini oħra u Orphacol
English: EU/1/13/870/004 [30 hard capsules] EU/1/13/870/005 [60 hard capsules] EU/1/13/870/006 [120 hard capsules]
Maltese: EU/1/13/870/004 [30 kapsula iebsa] EU/1/13/870/005 [60 kapsula iebsa] EU/1/13/870/006 [120 kapsula iebsa]
English: See also section 4.2.
Maltese: Ara wkoll is-sezzjoni 4.2.
English: EXPIRY DATE
Maltese: Data ta' għeluq
English: The rational basis for treatment consists of restoration of the bile aciddependent component of bile flow enabling restoration of biliary secretion and biliary elimination of toxic metabolites; inhibition of the production of the toxic bile acid metabolites by negative feedback on cholesterol 7α-hydroxylase, which is the rate-limiting enzyme in bile acid synthesis; and improvement of the patient's nutritional status by correcting intestinal malabsorption of fats and fat-soluble vitamins.
Maltese: Il-bażi razzjonali għall-kura tikkonsisti fir-restituzzjoni talkomponent li jiddependi mill-aċidu biljari tal-fluss biljari li jippermetti r-restituzzjoni tas-sekrezzjoni biljari u t-tneħħija biljari ta' metaboliti tossiċi; l-inibizzjoni tal-produzzjoni ta' metaboliti tossiċi tal-aċidu biljari permezz ta' rispons negattiv fuq il-cholesterol 7α-hydroxylase, li hija l-enzima li tillimita r-rata fissintesi tal-aċidu biljari; u t-titjib tal-istat nutrittiv tal-pazjent billi jiġi korrett l-assorbiment ħażin intestinali tax-xaħmijiet u tal-vitamini li jinħallu fix-xaħam.
English: Episodes of symptomatic overdose have been reported, including accidental overdose.
Maltese: Ġew irrappurtati episodji ta' doża eċċessiva sintomatika, inkluża doża eċċessiva aċċidentali.
English: EU/1/13/870/001 [30 hard capsules] EU/1/13/870/002 [60 hard capsules] EU/1/13/870/003 [120 hard capsules]
Maltese: EU/1/13/870/001 [30 kapsula iebsa] EU/1/13/870/002 [60 kapsula iebsa] EU/1/13/870/003 [120 kapsula iebsa]
English: Bile acid sequestrants (cholestyramine, colestipol, colesevelam) and certain antacids (e.g. aluminium hydroxide) bind bile acids and lead to their elimination.
Maltese: Is-sekwestranti tal-aċidu biljari (cholestyramine, colestipol, colesevelam) u ċerti antaċidi (eż. aluminium hydroxide) jorbtu l-aċidi biljari u jwasslu għall-eliminazzjoni tagħhom.
English: The remaining part is transformed by reduction of the 7α-hydroxy group to deoxycholic acid (3α, 12α-dihydroxy) by intestinal bacteria.
Maltese: Il-parti li jifdal tinbidel permezz tat tnaqqis tal-grupp 7α-hydroxy għal aċidu deoxycholic (3α, 12α-dihydroxy) permezz tal-batterji intestinali.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Il-pazjenti bi problemi ereditarji rari ta' nuqqas ta' tolleranza għall-galactose, b'defiċjenza totali ta' lactase jew b'nuqqas ta' assorbiment ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Oblong, opaque, blue and white capsule.
Maltese: Kapsula bajda u blu, opaka u tawwalija.
English: Date of first authorisation: 12 September 2013 Date of latest renewal: 24 April 2019
Maltese: 12 Settembru 2013 Data tal-aħħar tiġdid: 24
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar ilMediċini http://www.ema.europa.eu/.
English: Cholic acid This medicine is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Concomitant use of phenobarbital with cholic acid (see section 4.5).
Maltese: Użu fl-istess ħin ta' fenobarbital mal-aċidu koliku (ara sezzjoni 4.5).
English: Orphacol 250 mg: Each hard capsule contains 250 mg of cholic acid.
Maltese: Orphacol 250 mg: Kull kapsula iebsa fiha 250 mg ta' aċidu koliku.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinstab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu
English: Ciclosporin alters the pharmacokinetics of cholic acid by inhibition of the hepatic uptake and hepatobiliary secretion of bile acids, as well as its pharmacodynamics by inhibition of cholesterol 7α-hydroxylase.
Maltese: Iċ-Ciclosporin jibdel il-farmakokinetika tal-aċidu koliku permezz tal-inibizzjoni tat-teħid epatiku u ssekrezzjoni epatobiljari tal-aċidi biljari, kif ukoll il-farmakodinamika tiegħu permezz tal-inibizzjoni tal kolesterol 7α-hydroxylase.
English: This rarity also made the conduct of controlled clinical studies impossible.
Maltese: Din ir-rarità għamlet impossibbli wkoll it-twettiq ta' studji kliniċi kkontrollati.
English: Treatment must be initiated and monitored by an experienced gastroenterologist/hepatologist or a paediatric gastroenterologist/hepatologist in the case of paediatric patients.
Maltese: It-trattament għandu jinbeda u jkun issorveljat minn gastroenterologista/epatoloġista tal-esperjenza jew gastroenterologista/epatoloġista pedjatriku fil-każ ta' pazjenti pedjatriċi.
English: Adverse reaction
Maltese: Disturbi epatobiljari
English: 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency The daily dose ranges from 5 to 15 mg/kg in infants, children, adolescents and adults.
Maltese: Defiċjenza tat-3β-Hydroxy-Δ5-C27-steroid oxidoreductase Id-doża ta' kuljum għandha tvarja minn 5 sa 15 mg/kg fit-trabi, it-tfal, l-adoloxxenti u l-adulti.
English: Orphacol 250 mg hard capsules
Maltese: Orphacol 250 mg kapsuli
English: Orphacol 50 mg: Each hard capsule contains 50 mg of cholic acid.
Maltese: Orphacol 50 mg: Kull kapsula iebsa fiha 50 mg ta' aċidu koliku.
English: In adults, the daily dose should not exceed 500 mg.
Maltese: Fl adulti, id-doża ta' kuljum m'għandhiex taqbeż il-500 mg.
English: Orphacol 50 mg hard capsules
Maltese: Orphacol 50 mg kapsuli
English: Detailed long-term data on treatment with cholic acid monotherapy are available for 14 patients observed for up to 12.9 years.
Maltese: Dejta dettaljata fit-tul dwar it-trattament permezz ta' monoterapija bl-aċidu koliku hija disponibbli għal 14-il pazjent osservati sa 12.9 snin.
English: Reduction of the dose led to resolution of the clinical signs and correction of abnormal laboratory parameters.
Maltese: Ittnaqqis tad-doża wassal għas-soluzzjoni tas-sinjali kliniċi u l-korrezzjoni tal-parametri anormali tallaboratorju.
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.
Maltese: Dan ifisser li minħabba li din il-marda hija rari, u għal raġunijiet ta' etika kien impossibbli li tinkiseb informazzjoni kompleta dwar din il-mediċina.
English: 3β, 7α, 12α-trihydroxy-5-cholenoic acids) or in Δ4-3-Oxosteroid-5β-reductase deficiency (3-oxo-7α-hydroxy- and 3-oxo-7α, l2α-dihydroxy-4-cholenoic acids) should be determined.
Maltese: 3β-Hydroxy-Δ5-C27-steroid oxidoreductase (3β, 7α-dihydroxy- u 3β, 7α, 12α-trihydroxy-5-cholenoic acids) jew f'defiċjenza ta' Δ4-3-Oxosteroid-5β-reductase (3-oxo-7α-hydroxy- u
English: There is a limited amount of data (less than 20 pregnancy outcomes) from the use of cholic acid in pregnant women.
Maltese: Hemm dejta limitata (inqas minn 20 eżiti ta' tqala) dwar l-użu ta' aċidu koliku f'nisa tqal.
English: How to store Orphacol
Maltese: X'fih Orphacol
English: - PSUR - Annual Reassessment
Maltese: - PSUR - Valutazzjoni mill-ġdid annwali
English: • Risk of gallstones
Maltese: • Riskju ta' ġebel fil-marrara
English: OTHER CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR
English: Pharmacotherapeutic group: Bile and liver therapy, bile acid and derivatives, ATC code: A05AA03
Maltese: Kura tal-fwied u bili tal-fwied, aċidu biljari u derivati, Kodiċi ATC:
English: Use of phenobarbital in patients with 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency treated with cholic acid is contraindicated (see section 4.3).
Maltese: Hydroxy-Δ5-C27-steroid oxidoreductase jew b'defiċjenza ta' Δ4-3-Oxosteroid-5β-reductase ikkurati bl aċidu koliku huwa kontra-indikat (ara sezzjoni 4.3).
English: Limited data are available for patients with minor to severe hepatic impairment related to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency.
Maltese: Id-dejta għal pazjenti b'indeboliment epatiku minuri sa sever relatat mad-defiċjenza tat-3β-Hydroxy-Δ5C27-steroid oxidoreductase jew defiċjenza ta' Δ4-3-Oxosteroid-5β-reductase hija limitata.
English: For additional information, see section 6.6.
Maltese: Għal aktar tagħrif ara sezzjoni 6.6.
English: The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to provide educational material on correct diagnosis and therapeutic managements of the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency and to inform on expected and potential risks associated with the treatment.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu, bi qbil mal-awtoritajiet kompetenti fl-Istati Membri, jimplimenta, qabel it-tnedija, programm edukattiv għat-tobba bil-għan li jipprovdi materjal edukattiv dwar dijanjożi korretta u ġestjoni terapewtika tal-kura ta' żbalji inerenti fis-sinteżi tal-aċidu biljari primarju dovuti għal defiċjenza ta' 3β-Hydroxy-Δ5-C27-steroid oxidoreductase jew għal defiċjenza ta' Δ4-3-Oxosteroid-5β-reductase u biex iwassal tagħrif dwar riskji mistennija u potenzjali assoċjati mal kura.
English: Capsules of 50 mg cholic acid are blue and white and capsules of 250 mg cholic acid are green and white.
Maltese: Il-kapsuli ta' 50 mg aċidu koliku huma blu u bojod, u l-kapsuli ta' 250 mg aċidu koliku huma ħodor u bojod.
English: Cholic acid showed non-significant mutagenic activity in a battery of genotoxicity tests performed in vitro.
Maltese: L-aċidu koliku wera nuqqas ta' attività mutaġenika sinifikanti f'sensiela ta' testijiet ta' ġenotossiċità li saru in vitro.
English: Orphacol is indicated for the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency in infants, children and adolescents aged 1 month to 18 years and adults.
Maltese: Orphacol huwa indikat għall-kura ta' difetti preżenti fit-twelid fis-sintesi primarja tal-aċidu tal-marrara minħabba defiċjenza tat-3β-Hydroxy-Δ5-C27-steroid oxidoreductase jew defiċjenza ta' Δ4-3-Oxosteroid5β-reductase fi trabi, tfal u adoloxxenti minn xahar sa 18-il sena u adulti.
English: Some medicines used to lower cholesterol levels, so-called bile acid sequestrants (cholestyramine, colestipol, colesevelam), and medicines to treat heartburn that contain aluminium may lessen the effect of Orphacol.
Maltese: Xi mediċini li jintużaw sabiex ibaxxu l-livelli tal-kolesterol, imsejħa sekwestranti tal-aċidu biljari (cholestyramine, colestipol, colesevelam), u mediċini għall-kura tal-ħruq fl-istonku li fihom l-aluminju jistgħu jnaqqsu l-effett ta' Orphacol.
English: Each hard capsule contains 250 mg of cholic acid.
Maltese: Kull kapsula iebsa fiha 250 mg ta' aċidu koliku.
English: The objectives of this surveillance programme is to monitor accumulating data on efficacy and safety in the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency with Orphacol in infants, children, adolescents and adults.
Maltese: L-objettivi ta' dan il-programm ta' sorveljanza huwa li jimmonitorja d-dejta li qiegħda takkumula dwar l-effikaċja u s-sigurtà fil-kura ta' żbalji inerenti fis-sinteżi tal-aċidu biljari primarja dovuta għal defiċjenza ta' 3β-Hydroxy-Δ5-C27-steroid oxidoreductase jew defiċjenza ta' Δ4-3-Oxosteroid-5β-reductase b'Orphacol fi trabi, tfal, adoloxxenti u adulti.
English: 3β, 7α, 12α-trihydroxy-5-cholenoic acids) or in Δ4-3-Oxosteroid-5β-reductase deficiency (3-oxo-7α-hydroxy- and 3-oxo-7α, 12α-dihydroxy-4-cholenoic acids) should be determined.
Maltese: Għandhom jiġu stabbiliti l-konċentrazzjonijiet tal-metaboliti tal-aċidu biljari anormali sintetizzati f'defiċjenza ta' 3β-Hydroxy-Δ5-C27-steroid oxidoreductase (3β, 7α-dihydroxy- u 3β, 7α, 12α-trihydroxy-5-cholenoic acids) jew f'defiċjenza ta' Δ4-3-Oxosteroid-5β-reductase (3-oxo-7α-hydroxy- u 3-oxo-7α, 12α-dihydroxy-4-cholenoic acids).
English: No data are available for patients with renal impairment.
Maltese: M'hemmx dejta disponibbli għal pazjenti b'indeboliment renali.
English: Deoxycholic acid is a secondary bile acid.
Maltese: steroid oxidoreductase.
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).
Maltese: Għal bosta pazjenti ġiet irrappurtata żieda fl-enzimi tal-fwied (transaminases fis-serum) matul ittrattament b'Orphacol (il-frekwenza ma tistax tiġi stmata mid-data disponibbli).
English: Orphacol 250 mg capsules Cholic acid
Maltese: Orphacol 250 mg kapsuli iebsin
English: Orphacol capsules contain lactose.
Maltese: Il-kapsuli ta' Orphacol fihom il-lattosju.
English: The intravenous LD50 of cholic acid in mice is 350 mg/kg body weight.
Maltese: L-LD50 ġol-vina tal-aċidu koliku fil-ġrieden huwa ta' 350 mg/kg piż tal-ġisem.
English: What Orphacol looks like and contents of the pack
Maltese: Id-Dehra ta' Orphacol u l-kontenuti tal-pakkett
English: Each hard capsule contains 50 mg of cholic acid.
Maltese: Kull kapsula iebsa fiha 50 mg ta' aċidu koliku.
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).
Maltese: Għandhom isiru investigazzjonijiet addizzjonali jew aktar frekwenti biex jimmonitorjaw it-terapija matul il-perijodi ta' tkabbir mgħaġġel (fit-tfulija), mard konkomitanti u tqala (ara sezzjoni 4.6).
English: - The active substance is cholic acid.
Maltese: - Is-sustanza attiva hija l-aċidu koliku.
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.
Maltese: Illetteratura disponibbli m'hijiex biżżejjed sabiex tinstab differenza bejn is-sigurtà tal-aċidu koliku bejn il gruppi tal-età pedjatrika jew bejn il-pazjenti pedjatriċi u l-adulti.
English: In patients with inborn deficiency of 3β-Hydroxy-Δ5-C27-steroid oxidoreductase and Δ4-3-Oxosteroid-5β-reductase, the biosynthesis of primary bile acids is reduced or absent.
Maltese: F'pazjenti li jkollhom defiċjenza mittwelid tat-3β-Hydroxy-Δ5-C27-steroid oxidoreductase u Δ4-3-Oxosteroid-5β-reductase, il-bijosintesi tal aċidi biljari primarji tonqos jew tkun nieqsa għal kollox.
English: Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency and no dose recommendation can be given.
Maltese: Hydroxy-Δ5-C27-steroid oxidoreductase jew defiċjenza ta' Δ4-3-Oxosteroid-5β-reductase u ma tistax tingħata rakkomandazzjoni għad-dożi.
English: Alternative treatments should be used.
Maltese: Għandhom jintużaw kuri alternattivi.
English: Orphacol contains lactose
Maltese: Orphacol jista' jintuża waqt ittreddigħ.
English: Patients presenting with pruritus and/or persistent diarrhoea should be investigated for a potential overdose by a serum and/or urine bile acid assay (see section 4.9).
Maltese: Il-pazjenti li jippreżentaw ħakk u/jew dijarea persistenti għandhom jiġu eżaminati għall-possibbiltà ta' doża eċċessiva permezz ta' analiżi tal-aċidu biljari fis-serum u/jew fl-awrina (ara sezzjoni 4.9).
English: Both inborn diseases are extremely rare, with a prevalence in Europe of about 3 to 5 patients with 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency per 10 million inhabitants, and an estimated ten-fold lower prevalence for Δ4-3-Oxosteroid-5β-reductase deficiency.
Maltese: Iż-żewġ mardiet huma ferm rari, bi prevalenza flEwropa ta' madwar 3 sa 5 pazjenti b'defiċjenza tat-3β-Hydroxy-Δ5-C27-steroid oxidoreductase għal kull 10 miljun abitant, u prevalenza ta' madwar għaxar darbiet inqas għad-defiċjenza ta' Δ4-3-Oxosteroid-5β reductase.
English: The clinical experience reported in the literature is from a patient population with inborn deficiency of 3β-Hydroxy-Δ5-C27-steroid oxidoreductase or Δ4-3-Oxosteroid-5β-reductase that includes principally infants from the age of one month, children and adolescents.
Maltese: L-esperjenza klinika rrappurtata fil-letteratura hija minn popolazzjoni ta' pazjenti b'defiċjenza mit-twelid ta' 3β-Hydroxy-Δ5-C27-steroid oxidoreductase jew Δ4-3-Oxosteroid-5β-reductase li tinkludi prinċipalment trabi mill-età ta' xahar, tfal u adoloxxenti.
English: Laboratoires CTRS Tél/Tel: +352 278 62 329 ctrs@ctrs.fr
Maltese: +352 278 62 329 ctrs@ctrs.fr
English: Δ4-3-Oxosteroid-5β-reductase deficiency
Maltese: C27-steroid oxidoreductase jew defiċjenza ta' Δ4-3-Oxosteroid-5β-reductase hija limitata.
English: How to take Orphacol
Maltese: Orphacol.
English: A concomitant decrease of urine total bile acids should be observed.
Maltese: Tnaqqis konkomitanti tal-aċidi biljari totali fl-awrina għandha tkun osservata.
English: Laboratoires CTRS Tél/Tel: +32 (0)2 40 11 442 ctrs@ctrs.fr
Maltese: +32 (0)2 40 11 442 ctrs@ctrs.fr
English: Ciclosporin (a medicine used to suppress the immune system) may also change the effect of Orphacol.
Maltese: Iċ-Ciclosporin (mediċina użata biex trażżan is-sistemi immunitarja) tista' wkoll tibdel l-effett ta'
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Orphacol 50 mg hard capsules Orphacol 250 mg hard capsules
Maltese: Orphacol 50 mg kapsuli iebsin Orphacol 250 mg kapsuli iebsin
English: The available non-clinical data in the literature reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Maltese: Informazzjoni mhux klinika disponibbli fil-letteratura magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, u effett tossiku fuq is-sistema riproduttiva, ma turi l-ebda periklu speċjali għall-bniedem.
English: More than 90% of the primary and secondary bile acids are reabsorbed in the ileum by a specific active transporter and are recycled to the liver by the portal vein; the remainder is excreted in the faeces.
Maltese: Aktar minn 90% tal-aċidi biljari primarji u sekondarji jiġu assorbiti mill-ġdid fl-ileu permezz ta' trasportatur attiv speċifiku u jiġu riċiklati għall-fwied permezz tal-vina portali; il-bqija jitneħħa mal-ippurgar. Frazzjoni żgħira tal-aċidi biljari titneħħa fl-awrina.
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.
Maltese: Analiżi permezz talispettrometrija tal-massa tal-awrina waqt it-terapija bl-aċidu koliku turi l-preżenza ta' aċidu koliku u tnaqqis sostanzjali, jew saħansitra l-eliminazzjoni sħiħa tal-metaboliti tossiċi tal-aċidu biljari.
English: Orphacol is not expected to have an effect on the ability to drive and use machines.
Maltese: Orphacol jista' jintuża waqt it-treddigħ.
English: Orphacol 50 mg capsules Cholic acid
Maltese: Orphacol 50 mg kapsuli iebsin Aċidu koliku
English: Orphacol is available as hard capsules (capsules) of oblong shape.
Maltese: Orphacol huwa disponibbli f'kapsuli iebsin (kapsuli) ta' għamla tawwalija.
English: Immedica Pharma AB Tlf: +46 (0)8 533 39 500 info@immedica.com
Maltese: Tlf: +46 (0)8 533 39 500 info@immedica.com
English: No data on the effects of cholic acid on fertility are available.
Maltese: Fertilità M'hemmx dejta disponibbli dwar l-effetti tal-aċidu koliku fuq il-fertilità.
English: Tell your doctor or pharmacist if you are taking, have recently taken any or might take other medicines.
Maltese: Bħala prekawzjoni, inti u t-tarbija tiegħek għandkom tkunu ssorveljati mill-qrib waqt it-tqala.
English: : + 33 (0)1 707 60 637 ctrs@ctrs.fr
Maltese: Laboratoires CTRS Teл.: + 33 (0)1 707 60 637 ctrs@ctrs.fr
English: Transaminases increased Gallstones
Maltese: Sustanzi mhux attivi
English: This reflects restoration of an effective feedback control of bile acid synthesis and a metabolic equilibrium.
Maltese: Dan jirrifletti r-restituzzjoni tal-kontroll ta' rispons effettiv tas-sintesi tal-aċidu biljari u bilanċ metaboliku.
English: It is a suspension for injection and contains the active substances F4ab, F4ac, F5, F6, and LT toxoid.
Maltese: Jiġi f'sospensjoni għal injezzjoni li fih is-sustanzi attivi F4ab, F4ac, F5, F6, u LT toxoid.
English: Porcilis Porcoli Diluvac Forte is used to immunise against E. coli which have the adhesins (surface components) F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P).
Maltese: Porcilis Porcoli Diluvac Forte jintuża biex jimmunizza kontra l-E. coli li għandhom l-adeżini (komponenti tal-wiċċ) F4ab (K88ab), F4ac (K88ac), F5 (K99) u F6 (987P).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis Porcoli Diluvac Forte to Intervet International B.V. on 2 May 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Porcilis Porcoli Diluvac Forte lil Intervet International B.V. fit-2 ta' Mejju 2002.