FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean levels of 7α-hydroxy-4-cholesten-3one significantly decreased from baseline to post-baseline Visits 1 and 2.
Maltese: Il-livelli medji ta' 7α-hydroxy-4-cholesten-3one tnaqqsu b'mod sinjifikanti mil-linja bażi għal Viżti 1 u 2 ta'
English: In CTX, deficiency of chenodeoxycholic acid causes a lack of feedback of cholesterol 7 alpha hydroxylase (CYP7A1) and HMG CoA reductase, causing increased production of atypical bile acids, bile alcohols and cholestanol that lead to the pathological consequences of the condition.
Maltese: F'CTX, id-defiċjenza ta' chenodeoxycholic acid jikkaġuna nuqqas ta' rispons għal cholesterol 7 alpha hydroxylase (CYP7A1) u HMG Co A reductase, li jwassal għal żieda fil-produzzjoni ta' aċidi biljari atipiċi, alkoħols biljari u cholestanol li jikkaġunaw konsegwenzi patoloġiċi tal-kondizzjoni.
English: Chenodeoxycholic acid Leadiant 250 mg hard capsules
Maltese: Chenodeoxycholic acid Leadiant 250 mg kapsuli ibsin
English: There was a statistically significant (p = 0.04) improvement (decrease) of -0.31 ± 0.48 in the mean Rankin score for the < 21 years of age subgroup.
Maltese: 31 ± 0.48 fil-punteġġ medju ta' Rankin fis-sottogrupp ta' < 21 sena.
English: Chenodeoxycholic acid Leadiant 250 mg hard capsules chenodeoxycholic acid
Maltese: Chenodeoxycholic acid Leadiant 250 mg kapsuli ibsin chenodeoxycholic acid
English: The corresponding amount of suspension to give = (5 mg x 1 ml) = 1 ml
Maltese: (5 mg x 1 ml) = 1 ml 5 mg
English: Mean Rankin and EDSS scores showed a very small increase (worsening) from baseline to clinical current visit at 0.08 ± 0.74 and 0.27 ± 1.24 in the overall population and this increase was not statistically significant.
Maltese: Punteġġi medji ta' Rankin u EDSS urew żieda żgħira ħafna (aggravament) mil-linja bażi għall-viżita klinika attwali f'0.08 ± 0.74 u 0.27 ± 1.24 fil-popolazzjoni globali u din iż-żieda ma kinetx statistikament sinjifikanti.
English: Size 0 capsule, 21.7 mm in length with a yellow body and orange cap, containing a white, compressed powder.
Maltese: Kapsula ta' daqs 0, 21.7 mm twila b'korp safrani u għatu oranġju, li fih trab bajdani kkompressat.
English: There was a resolution, improvement or stabilisation in 88.9% (16/18) of patients with cognitive impairment.
Maltese: Kien hemm riżoluzzjoni, titjib jew stabilizzazzjoni fi 88.9% (16/18) tal-pazjenti b'indeboliment konjittiv.
English: Chenodeoxycholic acid Leadiant is unlikely to cause serious side effects.
Maltese: Mhux probabbli li Chenodeoxycholic acid Leadiant ser jikkaġuna effetti sekondarji serji.
English: Babies
Maltese: Trabi
English: In the supportive study CDCA-STRCH-CR-14-001 treatment of CTX patients with chenodeoxycholic acid 750 mg/day given for a median duration of 5.75 years was associated with statistically significant decreases in mean serum levels of cholestanol from baseline to any post-baseline visit.
Maltese: Fl-istudju t'appoġġ CDCA-STRCH-CR-14-001 it-trattament ta' pazjenti b'CTX b'chenodeoxycholic acid 750 mg/jum mogħti għal żmien medjan ta' 5.75 snin kien assoċjat ma' tnaqqis statistikament sinjifikanti fil-livelli ta' kolestanol fis-serum mil-linja bażi għal kull viżita wara l-linja bażi.
English: In rhesus monkey and baboon studies it was demonstrated that chenodeoxycholic acid dose to pregnant animals (at 5-120 mg/kg/day for rhesus monkey; at 18-38 mg/kg/day for baboons) produced liver pathology in the developing foetus.
Maltese: Fi studji fuq xadini reżu u babwini ġie muri li doża ta' chenodeoxycholic acid f'annimali tqal (b'5120 mg/kg/jum għal xadini reżu; b'18-38 mg/kg/jum għal babwini) ikkawżat patoloġija tal-fwied fil feti li qed jiżviluppaw.
English: In the pivotal study CDCA-STUK-15-001 treatment of CTX patients with chenodeoxycholic acid 7501000 mg/day in adults or 5-15 mg/kg/day in infants and children was associated with statistically significant decreases in mean serum levels of cholestanol from baseline to post-baseline in the overall population and in the two subgroups of patients aged < 21 years or ≥ 21 years at first treatment.
Maltese: 1000 mg/jum f'adulti jew 5-15 mg/kg/jum fi trabi u tfal kien assoċjat ma' tnaqqis statistikament sinjifikanti fil-livelli medji ta' kolestanol fis-serum mil-linja bażi għal wara l-linja bażi fil-popolazzjoni globali u fiż-żewġ sottogruppi ta' pazjenti ta' < 21 sena jew ≥ 21 sena fl-ewwel trattament.
English: Additional or more frequent investigations may need to be undertaken to monitor therapy during periods of fast growth, concomitant disease and pregnancy (see section 4.6).
Maltese: Jista' jkun li jrid isir stħarriġ addizzjonali u aktar frekwenti sabiex tiġi monitorata tterapija waqt perijodi ta' żvilupp mgħaġġel, mard fl-istess waqt u tqala (ara sezzjoni 4.6).
English: 10 kg patient on a dose of 15 mg/kg of chenodeoxycholic acid.
Maltese: Pazjent ta' 10 kg fuq doża ta' 15 mg/kg ta' chenodeoxycholic acid.
English: 3 kg patient on a dose of 5 mg/kg of chenodeoxycholic acid.
Maltese: Pazjent ta' 3 kg fuq doża ta' 5 mg/kg ta' chenodeoxycholic acid.
English: A similar effect on CYP27A1, albeit at higher doses, is also seen with sirolimus.
Maltese: Effett simili fuq CYP27A1, anke jekk f'dożi ogħla, ġie osservat ukoll b'sirolimus.
English: Chenodeoxycholic acid Leadiant capsules contain a substance called chenodeoxycholic acid.
Maltese: Il-kapsuli ta' Chenodeoxycholic acid Leadiant fihom sustanza msejħa chenodeoxycholic acid.
English: Dose calculation (Infants 1month-1yr) chenodeoxycholic acid 5 mg/mL suspension Daily dose:
Maltese: Kalkolazzjoni tad-doża (Trabi xahar - sena) sospensjoni ta' chenodeoxycholix acid 5 mg/mL Doża ta' kuljum:
English: The primary pharmacodynamic effects of chenodeoxycholic acid are: 1.
Maltese: L-effetti farmakodinamiċi primarji ta' chenodeoxycholic acid huma:
English: After treatment with chenodeoxycholic acid, the endogenous synthesis of the primary bile acids, cholic acid and chenodeoxycholic acid, is inhibited.
Maltese: Wara trattament b'chenodeoxycholic acid, is-sintesi endoġena tal-aċidi biljari primarji, aċidu koliku u chenodeoxycholic acid, tiġi impeduta.
English: Reduced production of atypical bile alcohols and bile acids: through restoration of feedback inhibition of primary bile acid synthesis (action on CYP7A1)
Maltese: 3. Produzzjoni mnaqqsa ta' alkoħols biljari atipiċi u aċidi biljari: permezz ta' restorazzjoni tarrispons għall-impediment tas-sintesi ta' aċidu biljari prinċipali (azzjoni fuq CYP7A1).
English: Maternal effects in the rhesus monkeys, but not baboons, included diarrhoea, emesis, weight loss and reduction in food consumption.
Maltese: Effetti maternali fix-xadini reżu, imma mhux fil-babwini, kienu jinkludu dijarea, remettar, telf fil-piż u tnaqqis fil-konsum tal-ikel.
English: (Weight in kg) x (Dose in mg/kg) = Daily dose in mg
Maltese: (Toqol f'kg) x (Doża f'mg/kg) - Doża ta' kuljum f'mg
English: Ciclosporin has been shown to reduce the synthesis of chenodeoxycholic acid by inhibition of CYP27A1 and increasing the activity of HMG CoA reductase.
Maltese: Intwera li ciclosporin inaqqas is-sintesi ta' chenodeoxycholic acid billi jimpedixxi CYP27A1 u jżid lattività ta' HMG CoA reductase.
English: • Constipation • Abnormal liver test values
Maltese: • Valuri abnormali għat-testijiet tal-fwied
English: Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults.
Maltese: Chenodeoxycholic acid huwa indikat għat-trattament ta' erruri mit-twelid fis-sintesi ta' aċidu biljari prinċipali minħabba nuqqas ta' sterol 27 hydroxylase ( ippreżentat bħala ksantomatosi ċerebrotendinus
English: Chenodeoxycholic acid Leadiant is available in blister packs containing 100 hard capsules.
Maltese: Chenodeoxycholic acid Leadiant jiġi f'pakketti ta' folji li fihom 100 kapsula iebsa.
English: Capsules are packed in polyvinyl chloride (PVC) blisters sealed with aluminium foil and packed in cardboard boxes.
Maltese: Il-kapsuli huma ppakkjati f'folji ta' polyvinyl chloride (PVC) issiġillati b'folja tal-aluminju u ppakkjati f'kaxxi tal-kartun.
English: Chenodeoxycholic acid is an endogenous bile acid used for replacement therapy and it is anticipated to have no effects on fertility at therapeutic doses.
Maltese: Chenodeoxycholic acid huwa aċidu biljari endoġenu għal terapija sostittutiva u mhux previst li jkun hemm effetti fuq il-fertilità f'dożi terapewtiċi.
English: In patients with CTX, no interaction studies with chenodeoxycholic acid and concomitantly administered medicinal products have been performed.
Maltese: F'pazjenti b'CTX, ma twettaq l-ebda studju ta' interazzjoni bejn chenodeoxycholic acid u prodotti mediċinali amministrati fl-istess waqt.
English: Chenodeoxycholic acid Leadiant should be used under medical supervision.
Maltese: Chenodeoxycholic acid Leadiant għandu jintuża taħt superviżjoni medika.
English: Diarrhoea disappeared in 100% (23/23 patients) of the patients who had this symptom at baseline.
Maltese: Id-dijarea sparixxiet f'100% (23/23 pazjent) tal-pazjenti li kellhom is-sintomu fil-linja bażi.
English: Please discuss suitable contraceptive methods with your doctor.
Maltese: Jekk jogħġbok iddiskuti metodi kontraċettivi adattati mat-tabib tiegħek.
English: Capsule shell Gelatine
Maltese: Il-qoxra tal-kapsula
English: No formal preclinical safety studies have been conducted however data in the literature reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Maltese: Ma sarux studji formali dwar is-sigurtà qabel l-użu kliniku, madanakollu tagħrif fil-letteratura medika ma tirrilevax periklu speċjali għall-bniedem abbażi ta' studji konvenzjonali dwar tossiċità b'doża unika, tossiċità b'doża ripetuta u potenzjal karċinoġeniku.
English: Chenodeoxycholic acid is an endogenous bile acid in humans, which is tightly regulated by its secretion into bile via exporter pumps and detoxification by sulfation.
Maltese: Chenodeoxycholic acid huwa aċidu biljari endoġenu fil-bniedem, li hu regolat b'mod strett bit-tnixxija tiegħu fil-bilja permezz ta' pompi esportaturi u detossifikazzjoni b'sulfazzjoni.
English: Increases in bone mineral density (Z-score) were observed at lumbar spine at both post-treatment visits and at total hip at post-treatment at post-treatment Visit 2.
Maltese: (punteġġ Z) kienu osservati fl-ispina lumbari fiż-żewġ viżti ta' wara t-trattament u fil-ġenbejn totali wara t-trattament f'Viżta 2.
English: For children, adolescents and adults who cannot swallow capsules and/or need to take a dose below 250 mg, the capsules may be opened and the contents added to 25 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) to produce a suspension containing chenodeoxycholic acid 10 mg/mL.
Maltese: Għal tfal adolexxenti u adulti li ma jistgħux jibilgħu kapsuli u/jew li jeħtieġu doża ta' inqas minn 250 mg, il-kapsuli jistgħu jinfetħu u l-kontenut jiġi magħdud ma' 25 mL f'soluzzjoni ta' 8.4% sodium bicarbonate (1 mmol/mL) biex tiġi prodotta suspensjoni li fiha 10 mg/mL chenodeoxycholic acid.
English: Developmental toxicity studies in rats, hamsters and primates showed an absence of teratogenic effects.
Maltese: Studji ta' tossiċità tal-iżvilupp fil-firien, fniek tal-indi u primati wrew nuqqas ta' effetti teratoġeniċi.
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 webportal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal web Ewropew tal-mediċini.
English: Due to the rarity of CTX, the available literature is not sufficient to detect a difference in the safety of chenodeoxycholic acid within paediatric age groups or between paediatric patients and adults.
Maltese: Minħabba r-rarità ta' CTX, il-letteratura disponibbli mhix biżżejjed biex tiżvela differenza fis-sikurezza ta' chenodeoxycholic acid fi ħdan gruppi ta' età pedjatrika jew bejn pazjenti pedjatriċi u adulti.
English: The dose range in children is 5-15 mg/kg per day.
Maltese: Il-firxa tad-dożi fi tfal hi ta' bejn 5-15 mg/kg kuljum.
English: However, cholic acid is still formed via an alternate microsomal pathway.
Maltese: Madanakollu, cholic acid xorta jiġi fformat permezz tal-passaġġ mikrosomali alternattiv.
English: • phenobarbital (a medicine used for epilepsy)
Maltese: TWISSIJ(A/IET) SPEĊJALI
English: For infants the capsules may be opened, the contents added to 50 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) and mixed to produce a suspension containing chenodeoxycholic acid 5 mg/mL.
Maltese: 250 mg, il-kapsula tista' tinfetaħ, l-kontenut jiġi magħdud ma' 25 mL ta' soluzzjoni ta' 8.4% ta' sodium bicarbonate (1 mmol/mL) u mħallat biex tiġi prodottta suspensjoni li fiha 10 mg/mL
English: In the intestine Chenodeoxycholic acid and its glycine or taurine conjugate are decomposed by bacteria.
Maltese: Fl-imsaren chenodeoxycholic acid u l-konjugati tiegħu glycine u taurine jiġu dekomposti minn batterji.
English: • medicines to treat heartburn (antacids) containing aluminium hydroxide and/or smectite
Maltese: • colestyramine, colestipol (hekk imsejħa sekwestranti tal-aċidu biljari) • mediċini għat-trattament ta' ħruq fl-istonku (antaċidi) li fihom aluminium hydroxide u/jew smectite (aluminium oxide)
English: Exogenous chenodeoxycholic acid is used as replacement therapy to restore the feedback inhibition lost due to the deficiency/absence of endogenous chenodeoxycholic acid.
Maltese: Chenodeoxycholic acid esoġenu jintuża bħala terapija ta' sostituzzjoni biex jirrestawra l-impediment risponsiv mitluf għan-nuqqas/l-assenza ta' chenodeoxycholic acid endoġenu.
English: Concomitant administration of chenodeoxycholic acid with phenobarbital increases HMG CoA reductase and thus counteracts one of the pharmacodynamics effects of chenodeoxycholic acid in CTX.
Maltese: L-għoti fl-istess waqt ta' chenodeoxycholic acid ma' phenobarbital iżżid l-HMG CoA reductase u b'hekk tikkontrabilanċja wieħed mill-effetti farmakodinamiċi ta' chenodeoxycholic acid f'CTX.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: NUMR(U/I)
English: This instance of hepatic adverse reactions in an infant presented with multiple confounders, such as concomitant parechovirus infection, co-administration of medicinal products known to affect liver function (acyclovir and phenobarbital) and presence of hyperbilirubinemia at birth.
Maltese: Dan il-każ ta' reazzjonijiet avversi tal-fwied f'tarbija ppreżenta tħassib multiplu, bħal infezzjoni talparechovirus konkomitanti, l-għoti fl-istess waqt ta' prodotti mediċinali magħrufa li jaffettwaw il funzjoni tal-fwied (acyclovir u phenobarbital) u l-preżenza ta' iperbilirubinemija fit-twelid.
English: Effects of chenodeoxycholic acid with other medicinal products Co-administration with ciclosporin, sirolimus, phenobarital is not recommended, see section 4.5 for further details.
Maltese: L-għoti fl-istess waqt ta' ciclosporin, sirolimus, phenobarbital mhux rakkomandat, ara sezzjoni 4.5
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Maltese: Peress li din hi approvazzjoni taħt ċirkustanzi eċċezzjonali u skont l-Artikolu 14(8) tar-Regolament (KE) 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li ġejjin:
English: Pathological effects on adrenals and kidneys were also seen in rhesus monkey foetuses.
Maltese: Effetti patoloġiċi fl-adrenali u l-kliewi kienu osservati wkoll fil-feti ta' xadini reżu.
English: After reabsorption in the intestine, the bile acid is nearly completely conjugated to the amino acids glycine and taurine and then excreted again in the bile.
Maltese: Wara riassorbiment fl-imsaren, l-aċidu biljari jiġi kważi kompletament konjugat għall-aċidi amminiċi glycine u taurine u mbagħad jiġi eliminat għal darb' oħra fil-bilja.
English: The infant's liver function normalised upon temporarily stopping treatment with Chenodeoxycholic acid.
Maltese: Il-funzjoni tal-fwied tat-tarbija nnormalizzat malli twaqqaf b'mod temporanju t-trattament b'Chenodeoxycholic acid.
English: Diarrhoea improved or disappeared in 64.3% of the patients who had this symptom present at baseline.
Maltese: Id dijarea tjiebet u sparixxiet f'64.3% tal-pazjenti li kellhom is-sintomu preżenti fil-linja bażi.
English: This substance is normally produced by the liver from cholesterol.
Maltese: Din is sustanza ġeneralment tiġi prodotta fil-fwied mill-kolesterol.
English: Whereas 7-keto-lithocholic acid can be formed partially in the colon and also in the liver to chenodeoxycholic acid and ursodeoxycholic acid (3α-, 7ß-di-hydroxycholanic acid), lithocholic acid is absorbed to a small extent only and is thus largely lost with faeces.
Maltese: Filwaqt li 7-keto-lithocholic acid jista' jiġi fformat parzjalment fil-musrana l-kbira u wkoll fil-fwied f'chenodeoxycholic acid u ursodeoxycholic acid (3α-,7ß-di-hydroxycholanic acid), lithocholic acid jiġi assorbit f'ammonti żgħar u b'hekk jiġi eliminat prinċipalment mal-ippurgar.
English: It is not recommended to take oral contraceptives whilst taking Chenodeoxycholic acid Leadiant.
Maltese: Mhux rakkomandat li tieħu kontraċettivi orali waqt li tkun qed tieħu Chenodeoxycholic acid Leadiant.
English: (Daily dose in mg) = Divided dose in mg (Dose frequency) Volume to administer: (Divided dose in mg) x 1 ml = Amount of suspension to give
Maltese: (Doża diviża f'mg x 1 ml) = Ammont ta' sospensjoni li trid tingħata
English: Colestipol or antacid medicinal products containing aluminium hydroxide and/or smectite should be taken either 2 hours before or after taking chenodeoxycholic acid.
Maltese: Colestipol jew prodotti mediċinali antaċidi li fihom aluminium hydroxide u/jew smectite għandhom jittieħdu jew sagħtejn qabel jew wara li jittieħed chenodeoxycholic acid.
English: In two-non interventional studies with chenodeoxycholic acid, a total of 14 paediatric patients with CTX were treated with Chenodeoxycholic acid: 1 infant (0 to < 2 years), 6 children (2 to < 12 years) and 7 adolescents (12 to < 18 years).
Maltese: Tarbija 1 (0 sa < sentejn), 6 itfal (2 sa <12-il sena) u 7 adolexxenti
English: Chenodeoxycholic acid should not be administered together with colestipol or antacid medicinal products containing aluminium hydroxide and/or smectite (aluminium oxide) since these preparations bind the active substance of chenodeoxycholic acid in the intestine and thus prevent its reabsorption and efficacy.
Maltese: Chenodeoxycholic acid m'għandux jingħata flimkien ma' colestipol jew prodotti mediċinali antaċidi li fihom aluminium hydroxide u/jew smectite (aluminium oxide) peress li dawn it-taħlitiet jingħaqdu mas-sustanza attiva ta'' chenodeoxycholic acid fl-imsaren u b'hekk jevitaw l-assorbiment mill-ġdid u l effikaċja.
English: Each hard capsule contains 250 mg of chenodeoxycholic acid.
Maltese: Kull kapsula iebsa fiha 250 mg ta' chenodeoxycholic acid.
English: This deficiency blocks the synthesis of primary bile acids via the classical (neutral pathway) and the alternative (acidic) pathway.
Maltese: Dan in-nuqqas jimpedixxi s-sintesi tal-aċidi biljari ewlenien permezz tal-passaġġ klassiku (passaġġ newtrali) u dak alternattiv (aċiduż).
English: Oral contraceptives are not recommended.
Maltese: Kontraċettivi orali mhumiex rakkomandati.
English: How to store Chenodeoxycholic acid Leadiant 6.
Maltese: Kif taħżen Chenodeoxycholic acid Leadiant 6.
English: Adverse reactions in patients (both adults and children) receiving Chenodeoxycholic acid are generally mild to moderate in severity; the main reactions observed are given in the table below.
Maltese: Reazzjonijiet avversi f'pazjenti (kemm adulti u tfal) li jirċievu Chenodeoxycholic acid huma ġeneralment ħfief għal moderati fis-severità tagħhom: ir-reazzjonijiet prinċipali osservati huma mogħtija fit-tabella t'hawn taħt.
English: - Each capsule contains 250 mg of chenodeoxycholic acid.
Maltese: - Kull kapsula fiha 250 mg ta' chenodeoxycholic acid.
English: The suspension produced contains 22.9 mg of sodium per mL, which needs to be taken into consideration by patients on a controlled sodium diet.
Maltese: Is-sospensjoni tipproduċi 22.9 mg ta' sodju kull mL, li teħtieġ li tittieħed inkonsiderazzjoni minn pazjenti fuq dieta b'sodju kkontrollat.
English: The administration of oral contraceptives reduces the pool size of chenodeoxycholic acid.
Maltese: L-għoti ta' kontraċettivi orali jnaqqas id-daqs miġbur ta' chenodeoxycholic acid.
English: However, parkinsonian symptoms, a rare disease manifestation/association that occurred in only 2 patients during the course of the study, did not respond.
Maltese: Madanakollu, għas-sintomi ta' Parkinson, manifestazzjoni/assoċjazzjoni ta' marda rari li seħħet f'żewġ pazjenti biss waqt il-kors tal-istudju, ma kienx hemm rispons.
English: Chenodeoxycholic acid Leadiant capsules treats CTX by replacing the chenodeoxycholic acid, which prevents the build-up of the fatty deposits.
Maltese: Porzjoni żgħira ta' chenodeoxycholic acid jiġi eliminat mal-ippurgar.
English: How to take Chenodeoxycholic acid Leadiant 4.
Maltese: Chenodeoxycholic acid Leadiant.
English: Each capsule contains 250 mg chenodeoxycholic acid.
Maltese: Kull kapsula fiha 250 mg ta' chenodeoxycholic acid.
English: Two pregnancies in mothers with CTX resulted in premature infants with evidence of intrauterine growth retardation also reported in the literature.
Maltese: Żewġ tqalat f'ommijiet b'CTX irriżultaw fi trabi prematuri b'evidenza ta' żvilupp ritardat ġol-utru rrapportati wkoll fil-letteratura medika.
English: One instance of mild intermittent constipation occurred in an adult and another instance occurred in a child. One instance of hepatic adverse reactions occurred in a two week old infant diagnosed with CTX and is discussed in the section below.
Maltese: Waqt it-trattament tiegħek, it-tabib tiegħek ser iwettaq testijiet tad-demm u tal-awrina biex jimmonitorja r-rispons tiegħek għal din il-mediċina, u jaġġusta d-doża tiegħek, jekk ikun meħtieġ.
English: Patients with a rare condition known as cerebrotendinous xanthomatosis (CTX) cannot produce chenodeoxycholic acid and this causes a buildup of fatty deposits in various areas of the body.
Maltese: Pazjenti b'kundizzjoni rari magħrufa bħala ksantomatosi ċerebrotendinus (CTX - cerebrotendinous xanthomethosis) ma jistgħux jipproduċu chenodeoxycholic acid u dan jikkawża akkumulazzjoni ta' depożiti ta' grass f'diversi partijiet tal-ġisem Dan jista'
English: Chenodeoxycholic acid has no or negligible influence on the ability to drive and use machines.
Maltese: Chenodeoxycholic acid m'għandu l-ebda influwenza jew influwenza neġliġibbli fuq il-kapaċità ta' sewqan u tħaddim ta' magni.
English: The daily dose can be subsequently increased in 250 mg increments to a maximum of 1000 mg/ day if the serum cholestanol and/or urine bile alcohols remain elevated.
Maltese: sussegwentement tiżdied b'inkrementi ta' 250 mg għal massimu ta' 1000 mg/jum jekk il-cholestanol fis-serum u/jew l-alkoħols tal-bilja fl-awrina jibgħu għoljien.
English: Breast-feeding It is unknown whether chenodeoxycholic acid/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk chenodeoxycholic acid/metaboliti jiġux eliminati fil-ħalib tal-bniedem.
English: • Nephrotic syndrome (NS)
Maltese: • Sindromu nefrotiku (NS)
English: The agreed Core Safety profile (CSP) from the last PSUR 13 work sharing procedure (EE/H/PSUR/0007/001) and the public AR from the paediatric article 45 procedure (CZ/W/04/pdWS/01, 2010) were also used.
Maltese: Intużaw ukoll il-profil tas-Sigurtà Ewlenija (CSP) maqbul mill-aħħar proċedura ta' kondiviżjoni tax-xogħol 13 tal-PSUR (EE/H/PSUR/0007/001) u l-AR pubbliku mill-proċedura pedjatrika skont l-artikolu 45 (CZ/W/04/pdWS/01, 2010).