FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1 Adverse reactions reported in patients who received linagliptin 5 mg daily as monotherapy or as add-on therapies in clinical trial and from post-marketing experience
Maltese: Tabella 1 Reazzjonijiet avversi rrappurtati f'pazjenti li rċivew linagliptin 5 mg kuljum bħala monoterapija jew bħala terapiji addizzjonali fi prova klinika u minn esperjenza wara ttqegħid fis-suq)
English: Linagliptin as add-on to a combination of metformin and sulphonylurea therapy A placebo-controlled study of 24 weeks in duration was conducted to evaluate the efficacy and safety of linagliptin 5 mg to placebo, in patients not sufficiently treated with a combination with metformin and a sulphonylurea.
Maltese: Linagliptin bħala terapija addizzjonali ma' kumbinazzjoni ta' terapija b'metformin u suphonylurea Sar studju bi plaċebo bħala kontroll li dam 24 ġimgħa biex jevalwa l-effikaċja u s-sigurtà ta' linagliptin 5 mg mal-plaċebo, f'pazjenti mhux ittrattati biżżejjed b'kumbinazzjoni ma' metformin u sulphonylurea.
English: Do not use Trajenta if the package is damaged or shows signs of tampering.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: In non-diabetic patients with mild moderate and severe hepatic insufficiency (according to the ChildPugh classification), mean AUC and Cmax of linagliptin were similar to healthy matched controls following administration of multiple 5 mg doses of linagliptin.
Maltese: F'pazjenti mhux dijabetiċi b'insuffiċjenza ħafifa, moderata u severa tal-fwied (skont il-klassifikazzjoni ta' Child-Pugh), il-medja tal-AUC u tas-Cmax ta' linagliptin kienu simili għal kontrolli mqabbla b'saħħithom wara l-għoti ta' dożi multipli ta' 5 mg ta' linagliptin.
English: If you forget to take Trajenta
Maltese: L-inċidenza osservata ta'
English: Creatinine clearance was measured by 24-hour urinary creatinine clearance measurements or estimated from serum creatinine based on the Cockcroft-Gault formula.
Maltese: It-tneħħija tal-krejatinina tkejlet minn kejl ta' 24 siegħa tat-tneħħija talkrejatinina fl-awrina, jew stmata minn krejatinina fis-serum ibbażat fuq il-formula ta' CockcroftGault.
English: There was no difference between groups in severe hypoglycaemic events.
Maltese: Ma kien hemm l-ebda differenza bejn il-gruppi f'każijiet ipoglikemiċi severi.
English: The NOAEL for fertility, early embryonic development and teratogenicity in rats was set at >900 times the human exposure.
Maltese: L-NOAEL għal fertilità, żvilupp bikri embrijoniku u teratoġeniċità fil-firien ġie deċiż li jkun ta' >900 darba tal-esponiment uman.
English: Linagliptin provided significant improvements in HbA1c (-0.59 % change compared to placebo after 12 weeks), from a mean baseline HbA1c of 8.2%.
Maltese: Linagliptin ipprovda titjib sinifikanti fl-HbA1c, (bidla ta' -0.59% meta mqabbel mal-plaċebo wara 12-il ġimgħa), minn medja ta' HbA1c fil-linja bażi ta' 8.2%.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim
Maltese: TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Boehringer Ingelheim
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti tossiċi diretti jew indiretti fuq is-sistema riproduttiva (ara 5.3). Bћala prekawzjoni hu preferribli li ma jintuzax linagliptin waqt it-tqala.
English: However, more frequent blood glucose testing might be recommended to minimise the risk for hypoglycaemia, especially when Trajenta is combined with sulphonylurea and/or insulin.
Maltese: Madankollu, jista' jkun irrakkomandat ittestjar aktar frekwenti tal-glucose fid-demm biex timminimizza r-riskju ta' ipogliċemija, b'mod speċjali meta Trajenta jiġi kkombinat ma' sulphonylurea u/jew mal-insulina.
English: Linagliptin as add-on therapy in patients with severe renal impairment, 12 week placebo-controlled data (stable background) and 40 week placebo-controlled extension (adjustable background) The efficacy and safety of linagliptin was also evaluated in type 2 diabetes patients with severe renal impairment in a double-blind study versus placebo for 12 weeks duration, during which background glycaemic therapies were kept stable.
Maltese: Linagliptin bħala terapija addizzjonali f'pazjenti b'indeboliment sever tal-kliewi, dejta ta' 12-il ġimgħa bi plaċebo bħala kontroll (sfond stabbli) u estensjoni ta' 40 ġimgħa bi plaċebo bħala kontroll (sfond aġġustabbli).
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620
Maltese: Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 600
English: The unbound concentrations, which are usually less than 1% at the therapeutic dose of linagliptin, were increased 4-5-fold after coadministration with ritonavir.
Maltese: Il-konċentrazzjonijiet mhux imwaħħla, li normalment ikunu inqas minn 1% tad-doża terapewtika ta' linagliptin, żdiedu b'4-5-darbiet wara l-għoti flimkien ma' ritonavir.
English: The observed incidence of hypoglycaemia in patients treated with linagliptin was similar to placebo.
Maltese: L-inċidenza osservata ta' ipogliċemija f'pazjenti ttrattati b'linagliptin kienet simili għal plaċebo.
English: Boehringer Ingelheim International GmbH Binger Strasse 173
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Boehringer Ingelheim International GmbH Binger Strasse 173
English: Linagliptin is a P-glycoprotein substrate, and inhibits P-glycoprotein mediated transport of digoxin with low potency.
Maltese: Linagliptin hu substrat ta' P-glikoproteina, u jinibixxi t-trasport ta' digoxin li jsir permezz ta' P-glikoproteina b'potenza baxxa.
English: Due to the concentration dependent binding of linagliptin to DPP-4, the pharmacokinetics of linagliptin based on total exposure is not linear; indeed total plasma AUC of linagliptin increased in a less than dose-proportional manner while unbound AUC increases in a roughly dose-proportional manner.
Maltese: Minħabba t-twaħħil dipendenti fuq il-konċentrazzjoni ta' linagliptin ma' DPP-4, il-farmakokinetika ta' linagliptin ibbażati fuq l-espożizzjoni totali mhijiex lineari; filfatt l-AUC tal-plażma totali ta' linagliptin żdiedet b'mod inqas minn dak proporzjonali għad-doża filwaqt li l-AUC mhux imwaħħla tiżdied bejn wieħed u ieħor b'mod proporzjonali għad-doża.
English: Your doctor may ask you to stop Trajenta.
Maltese: Ittabib tiegħek jista' jitolbok twaqqaf Trajenta.
English: Sulphonylureas and insulin are known to cause hypoglycaemia.
Maltese: Sulphonylureas u insulina huma magħrufa li jikkawżaw ipogliċemija.
English: Patients should be informed of the characteristic symptoms of acute pancreatitis.
Maltese: Ilpazjenti għandhom jiġu infurmati dwar is-sintomi karatteristiċi ta' pankreatite akuta.
English: - If you get any side effects talk to your doctor, pharmacist or nurse.
Maltese: - Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, infermiera, jew lill-ispiżjar tiegħek.
English: Respiratory, thoracic and mediastinal disorders Cough uncommon
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Sogħla mhux komuni
English: In clinical trials of linagliptin as part of combination therapy with medicinal products not known to cause hypoglycaemia (metformin), rates of hypoglycaemia reported with linagliptin were similar to rates in patients taking placebo.
Maltese: Fi provi kliniċi ta' linagliptin bħala parti minn terapija kkombinata ma' prodotti mediċinali li mhumiex magħrufa li jikkawżaw ipogliċemija (metformin), ir-rati ta' ipogliċemija rrappurtati b'linagliptin kienu simili għar-rati f'pazjenti li kienu qed jieħdu plaċebo.
English: Oral anti-diabetics are used to treat high blood sugar levels.
Maltese: Mediċini anti-dijabetiċi orali jintużaw għat-trattament ta' livelli għolja ta' zokkor fid-demm.
English: No teratogenic effects were observed in rabbits at >1,000 times human exposure.
Maltese: L-ebda effett teratoġeniku ma ġie osservat fil-fniek f' >1,000 darba tal-esponiment uman.
English: Infections and infestations Nasopharyngitis uncommon
Maltese: Infezzjonijiet u infestazzjonijiet Nażofarinġite mhux komuni
English: After a median follow up of 2.2 years, linagliptin, when added to usual care, did not increase the risk of major adverse cardiovascular events or renal outcome events.
Maltese: Wara segwitu medjan ta' 2.2 snin, linagliptin, meta miżjud mal-kura tas-soltu, ma żiedx ir-riskju ta' avvenimenti kardjovaskulari avversi maġġuri jew avvenimenti b'riżultat tal-kliewi.
English: Linagliptin also showed significant improvements in fasting plasma glucose (FPG) compared to placebo.
Maltese: Linagliptin wera wkoll titjib sinifikanti fil-livell tal-glucose fil-plażma (FPG) fl-istat sajjem meta mqabbel ma' plaċebo.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of linagliptin.
Maltese: Kull pillola fiha 5 mg ta' linagliptin.
English: when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Maltese: • f'kombinazzjoni ma' prodotti mediċinali oħrajn għall-kura tad-dijabete, inkluż l-insulina, meta dawn ma jipprovdux kontroll gliċemiku adegwat (ara s-sezzjonijiet 4.4, 4.5 u 5.1 għal data disponibbli fuq kombinazzjonijiet differenti).
English: Trajenta is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as: monotherapy
Maltese: Trajenta huwa indikat f'adulti b'dijabete mellitus tat-tip 2 bħala addizzjoni għad-dieta u l-eżerċizzju biex itejjeb il-kontroll gliċemiku bħala: monoterapija
English: EMA/851451/2018 EMEA/H/C/003822
Maltese: EMA/851451/2018 EMA/H/C/003822
English: This summary was last updated in 01-2019.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'01-2019.
English: Other information about Ravicti
Maltese: Informazzjoni oħra dwar Ravicti
English: Further information on the orphan designations can be found on the European Medicines Agency's website ema.europa.eu/en/medicines/ /ema_group_types/ema_orphan.
Maltese: Aktar informazzjoni fuq iddenominazzjonijiet orfni tista' tinstab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini ema.europa.eu/en/medicines/ /ema_group_types/ema_orphan..
English: Ravicti is used in patients who lack one or more of the following enzymes: carbamoyl phosphate synthase-I, ornithine carbamoyltransferase, argininosuccinate synthetase, argininosuccinate lyase, arginase I and ornithine translocase.
Maltese: Ravicti jintuża f'pazjenti li ma għandhomx wieħed jew iktar mill-enzimi li ġejjin: carbamoyl phosphate synthase-I, ornithine carbamoyltransferase, argininosuccinate synthetase, argininosuccinate lyase, arginase I u ornithine translocase.
English: Ravicti contains the active substance glycerol phenylbutyrate.
Maltese: Ravicti fih is-sustanza attiva glycerol phenylbutyrate.
English: The most common side effects with Ravicti (which may affect more than 1 in 20 people) are diarrhoea, flatulence (passing gas), headache, decreased appetite, vomiting, tiredness, feeling sick and abnormal skin smell.
Maltese: L-effetti sekondarji l-aktar komuni b'Ravicti (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 20) huma dijarea, gass, uġigħ ta' ras, nuqqas ta' aptit, rimettar, għeja, tħossok ma tiflaħx u riħa anormali tal-ġilda.
English: The study showed that Ravicti was at least as effective as the comparator in controlling the blood level of ammonia: the estimated average ammonia level was about 870 micromoles per litre in patients treated with Ravicti, compared with about 980 micromoles per litre in patients treated with sodium phenylbutyrate.
Maltese: L-istudju wera li Ravicti kien tal-inqas effikaċi daqs il-komparutur fil-kontroll tal-livell tal-ammonja fid-demm: il-livell medju stmat tal-ammonja kien madwar 870 mikromoli għal kull litru f'pazjenti kkurati b'Ravicti, meta mqabbel ma' madwar 980 mikromoli għal kull litru f'pazjenti kkurati b'sodium phenylbutyrate.
English: Urea cycle disorders are rare, and Ravicti was designated an ‘orphan medicine' (a medicine used in rare diseases) for several forms of the disease on 10 June 2010.
Maltese: Disturbi fiċ-ċiklu tal-urea huma rari, u Ravicti ġie denominat bħala “mediċina orfni” (mediċina li tintuża f'mard rari) għal diversi forom tal-marda fl-10 ta' Ġunju 2010.
English: Ravicti has been compared with sodium phenylbutyrate (another medicine used to treat urea cycle disorders) in a study involving 88 adults with urea cycle disorders.
Maltese: Ravicti tqabbel ma' sodium phenylbutyrate (mediċina oħra użata biex tikkura disturbi fiċ-ċiklu tal-urea) fi studju li kien jinvolvi 88 adult b'disturbi fiċ-ċiklu tal-urea.
English: What are the risks associated with Ravicti?
Maltese: X'inhuma r-riskji assoċjati ma' Ravicti?
English: Ravicti received a marketing authorisation valid throughout the EU on 27 November 2015 Further information on Ravicti can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ravicti
Maltese: ema.europa.eu/medicines/human/EPAR/ravicti
English: As for all medicines, data on the use of Ravicti are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ravicti hija ssorveljata kontinwament.
English: The active substance in Ravicti, glycerol phenylbutyrate, is converted to phenylacetate in the body.
Maltese: Is-sustanza attiva f'Ravicti, glycerol phenylbutyrate, tinbidel f'phenylacetate fil-ġisem.
English: For the full list of side effects and restrictions with Ravicti, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u tar-restrizzjonijiet irrappurtati b'Ravicti, ara l-fuljett ta' tagħrif.
English: Ravicti is a sustained-release medicine, meaning the active substance is released throughout the day.
Maltese: Ravicti huwa mediċina b'rilaxx sostnut, li jfisser li s-sustanza attiva tiġi rilaxxata matul il-jum.
English: Why is Ravicti authorised in the EU?
Maltese: Għaliex Ravicti huwa awtorizzat fl-UE?
English: Additionally, the Agency considered that since Ravicti is available as a liquid this could make the medicine more palatable especially for children, compared with other medicines available as granules to be added to food; the liquid formulation also facilitates giving it through a tube to patients unable to swallow.
Maltese: Barra minn hekk, l-Aġenzija kkunsidrat li peress Ravicti jiġi bħala likwidu, dan jista' jagħti togħma aħjar lill-mediċina speċjalment għat-tfal, meta mqabbel ma' mediċini oħrajn disponibbli bħala granuli li għandhom jiżdiedu mal-ikel; il-forma likwida tiffaċilita wkoll l-għoti tagħha permezz ta' tubu lillpazjenti li ma jistgħux jibilgħu.
English: The company that markets Ravicti will set up a registry of patients to obtain further information on the long-term benefits and safety of the medicine.
Maltese: Il-kumpanija li tqiegħed Ravicti fis-suq sejra toħloq reġistru ta' pazjenti biex tikseb iktar informazzjoni dwar il-benefiċċji u s-sigurtà fit-tul tal-mediċina.
English: Ravicti must not be used to treat acute hyperammonaemia (sudden rise of blood ammonia levels).
Maltese: Ravicti ma għandux jintuża biex jikkura iperammonemija akuta (żieda f'daqqa fil-livelli tal-ammonja fid-demm).
English: How does Ravicti work?
Maltese: Kif jaħdem Ravicti?
English: This removal of proteins decreases the levels of nitrogen in the body, reducing the amount of ammonia produced.
Maltese: Din it-tneħħija tal-proteini tnaqqas il-livelli tan-nitroġenu fil-ġisem, u tnaqqas lammont tal-ammonja prodott.
English: Ravicti is available as a liquid (1.1 g/ml) to be taken by mouth, or given through a tube that goes from the nose to the stomach or through the belly into the stomach.
Maltese: Ravicti jiġi bħala likwidu (1.1 g/ml) li għandu jittieħed mill-ħalq, jew jingħata permezz ta' tubu li jibda mill-imnieħer u jispiċċa fl-istonku jew miż-żaqq għall-istonku.
English: Data from additional studies showed a similar effect in children treated with Ravicti from birth.
Maltese: Data minn studji addizzjonali wriet effett simili fit-tfal ikkurati b'Ravicti mit-twelid.
English: Phenylacetate attaches to the amino acid glutamine found in proteins to form a substance that the kidneys can remove from the body.
Maltese: Phenylacetate jeħel mal-aċidu amminiku tal-glutamina li jinsab fil-proteini biex jifforma sustanza li l-kliewi jistgħu jneħħu mill-ġisem.
English: Since proteins are a source of nitrogen, Ravicti must be used together with a special low-protein diet, and sometimes with dietary supplements (depending on the daily protein intake needed for growth and development).
Maltese: Peress li l-proteini huma sors ta' nitroġenu, Ravicti għandu jintuża flimkien ma' dieta speċjali bi ftit proteini, u xi drabi b'supplimenti tad-dieta (skont it-teħid ta' kuljum ta' proteini meħtieġa għat-tkabbir u l-iżvilupp).
English: Side effects reported with Ravicti are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Ravicti huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: What measures are being taken to ensure the safe and effective use of Ravicti?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Ravicti?
English: Ravicti is a medicine used to manage urea cycle disorders in adults and children, when the diseases cannot be managed by changes in diet alone.
Maltese: Ravicti huwa mediċina li tintuża fit-tul biex timmaniġġja disturbi fiċ-ċiklu tal-urea fl-adulti u fit-tfal, meta l-mard ma jkunx jista' jiġi mmaniġġjat minn bidliet fid-dieta biss.
English: The full EPAR for Orphacol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 09-2013.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi'09-2013.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Orphacol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European public assessment report (EPAR) for Orphacol.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Orphacol.
English: Other information about Orphacol
Maltese: Informazzjoni oħra dwar Orphacol
English: The European Commission granted a marketing authorisation valid throughout the European Union for Orphacol on 12 September 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Orphacol fit-12 ta' Settembru 2013.
English: The applicant presented data on 49 patients with inborn errors in primary bile acid synthesis, taken from the scientific literature (38 patients with 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency and 11 patients with Δ4-3-Oxosteroid-5β-reductase deficiency).
Maltese: L-applikant ippreżenta dejta dwar 49 pazjent b'difetti preżenti fit-twelid fis-sintesi tal-aċidu biljari prinċipali, meħuda milletteratura xjentifika (38 pazjent b'defiċjenza ta' 3β-Hydroxy-Δ5-C27-steroid oxidoreductase u 11-il pazjent b'defiċjenza ta' Δ4-3-Oxosteroid-5β-reductase).
English: Why is Orphacol approved?
Maltese: Għal xiex ġiet approvat Orphacol?
English: Orphacol has been authorised under ‘exceptional circumstances'.
Maltese: Orphacol ġie awtorizzat taħt ‘ċirkustanzi ta' eċċezzjoni'.
English: Orphacol cholic acid
Maltese: Orphacol aċidu koliku
English: The side effects seen with Orphacol were diarrhoea, pruritus (itching), increases in transaminases (liver enzymes) and possibly gallstones, although their frequency could not be reliably estimated from the available limited data.
Maltese: L-effetti sekondarji li dehru b'Orphacol kienu dijarrea, prurite (ħakk), żidiet fit-transaminases (enzimi tal-fwied) u possibbilment ġebel fil-marrara, għalkemm il-frekwenza tagħhom ma setgħetx tiġi stabbilita b'mod affidabbli mid-dejta limitata disponibbli.
English: A risk management plan has been developed to ensure that Orphacol is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Orphacol jintuża bl-aktar mod sigur possibbli.
English: The daily dose is between 5 and 15 mg per kg body weight, adjusted for each patient according to the state of their bile acid, with a minimum daily dose of 50 mg and a maximum of
Maltese: Iddoża ta' kuljum hija bejn 5 u 15 mg għal kull kg tal-piż tal-ġisem, aġġustata għal kull pazjent skont listat tal-aċidu biljari tagħhom, b'doża minima kuljum ta' 50 mg u massima ta' 500 mg.
English: Orphacol is used in patients who do not have enough of two specific liver enzymes (3β-Hydroxy-Δ5-C27-steroid oxidoreductase or Δ4-3-Oxosteroid-5β-reductase).
Maltese: Orphacol jintuża f'pazjenti li ma jkollhomx biżżejjed minn żewġ enzimi speċifiċi tal-fwied (3β-Hydroxy-Δ5-C27-steroid oxidoreductase jew Δ4-3-Oxosteroid-5β-reductase).
English: What information is still awaited for Orphacol?
Maltese: Liema informazzjoni għadha mistennija għal Orphacol?
English: What measures are being taken to ensure the safe and effective use of Orphacol?
Maltese: X'miżuri qegħdin jitteħdu biex jassiguraw użu sigur u effettiv ta' Orphacol??
English: What are the risks associated with Orphacol?
Maltese: X'inhuma r-riskji assoċjati ma' Orphacol?
English: Because the number of patients with inborn errors in primary bile acid synthesis is low, the condition is considered ‘rare', and Orphacol was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 December 2002.
Maltese: Peress li n-numru ta' pazjenti b'difetti preżenti fit-twelid fis-sintesi tal-aċidu biljari primarju huwa baxx, il-marda hija kkunsidrata ‘rari', u Orphacol ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-18 ta' Diċembru 2002.
English: Since Orphacol has been approved under exceptional circumstances, the company that markets Orphacol will establish a database of patients treated with Orphacol to monitor the safety and effectiveness of the treatment, and will submit the results to the CHMP at regular, specified intervals.
Maltese: Minħabba li Orphacol ġie approvat taħt ċirkostanzi ta' eċċezzjoni, il-kumpanija li tikkumerċjalizza Orphacol se tistabbilixxi database tal-pazjenti kkurati b'Orphacol biex timmonitorja s-sigurtà u leffikaċja tal-kura, u se tissottometti r-riżultati lis-CHMP f'intervalli regolari, speċifikati.
English: The Committee for Medicinal Products for Human Use (CHMP) noted that the use of cholic acid to treat inborn errors in primary bile acid synthesis was well established in medical practice and documented in the scientific literature, although the number of documented cases was low due to the rarity of the condition.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) innota li l-użu tal-aċidu koliku għallkura ta' difetti preżenti fit-twelid fis-sintesi tal-aċidu biljari prinċipali kien stabbilit sewwa fil-prattika medika u dokumentat fil-letteratura xjentifika, għalkemm in-numru tal-każijiet dokumentati kien baxx minħabba r-rarità tal-kundizzjoni.
English: It is used to treat adults and children from one month of age who have a genetic abnormality that makes them unable to produce bile.
Maltese: Huwa jintuża għall-kura ta' adulti u tfal mill-età ta' xahar 'il fuq li jkollhom anormalità ġenetika li tagħmilhom mhux kapaċi jipproduċu l-bila.
English: Cholic acid is the main primary bile acid produced by the liver.
Maltese: L-aċidu koliku huwa l-aċidu biljari primarju ewlieni prodott mill-fwied.
English: It must not be taken by patients already taking phenobarbital, a medicine used to treat epilepsy.
Maltese: M'għandux jittieħed minn pazjenti li diġà jkunu qegħdin jieħdu phenobarbital, mediċina użata għall-kura tal-epilessija.