FrancophonIA/ELRC3.0 huggingface dataset:
English: Exceptional cases of a disulfiram-like reaction have been reported when ketoconazole was co-administered with alcohol, characterised by flushing, rash, peripheral oedema, nausea and headache, have been reported.
Maltese: Ġew irrappurtati każijiet eċċezzjonali ta' reazzjoni tixbah lil ta' disulfiram meta ketoconazole ngħata fl-istess ħin mal-alkoħol, ikkaratterizzata minn fwawar, raxx, edima periferali, dardir u wġigħ ta' ras.
English: ergotamine and methylergometrine (methylergonovine) - certain medicines used in cancers: irinotecan, everolimus - sirolimus: used to prevent your body from rejecting a kidney transplant - tolvaptan used for a specific disease called “syndrome of inappropriate antidiuretic hormone secretion” - vardenafil in men older than 75 years - medicine to treat erectile dysfunction in adults men - certain medicines for HIV: saquinavir/ritonavir, saquinavir - certain medicines to treat long-term (chronic) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus): Paritaprevir/Ombitasvir (ritonavir) - methadone: medicine to treat dependence to drugs - In patients with renal disorders:
Maltese: Paritaprevir/Ombitasvir (ritonavir) - methadone: mediċina għall-kura tad-dipendenza mid-drogi - F'pazjenti b'disturbi fil-kliewi: colchicine: mediċina għall-kura tal-gotta fesoterodine u solifenacin: mediċini għall-kura tas-sintomi ta' bużżieqa tal-awrina attiva żżejjed telithromycin u clarithromycin: mediċini użati għall-kura tal-infezzjonijiet
English: • Abdominal pain
Maltese: • Disturbi mestrwali
English: Not recommended due to the increased risk of QT prolongation and extrapyramidal symptoms.
Maltese: Mhux rakkomandat minħabba żżieda fir-riskju ta' titwil tal-QT u sintomi ekstrapiramidali.
English: Potential ↑in plasma concentrations of sildenafil
Maltese: ↑ potenzjali fil-konċentrazzjonijiet talmethadone fil-plażma
English: Salmeterol
Maltese: Nadolol
English: Interactions between ketoconazole and other medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, an no change as “↔”).
Maltese: L-interazzjonijiet bejn ketoconazole u prodotti mediċinali oħra huma elenkati fit-tabella ta' hawn taħt (żieda hija indikata bħala “↑”, tnaqqis bħala “↓”, u l-ebda bidla bħala “↔”).
English: AUC: ↑ 2-fold
Maltese: TAGĦRIF
English: Contraindicated due to the risk of serious cardiovascular events including QT prolongation (see section 4.3).
Maltese: Kontraindikat minħabba r-riskju ta' avvenimenti kardjovaskulari serji fosthom titwil tal-QT (ara sezzjoni 4.3).
English: Potential ↑in plasma concentrations of sertindole.
Maltese: Huma mistennija ↓ potenzjali filkonċentrazzjonijiet ta' ketoconazole filplażma.
English: Cmax: ↑ 6 fold
Maltese: AUC: ↑ 9 darbiet Cmax: ↑ 6 darbiet
English: Liver problems can rarely happen (may affect up to 1 in 1,000 people).
Maltese: Rarament jistgħu jseħħu problemi fil-fwied (jistgħu jaffettwaw sa persuna 1 minn kull 1,000).
English: Cmin: ↑ 1.3-fold
Maltese: Cmax: ↑ 1.3 darbiet
English: Post Authorisation safety study (PASS): Multi-country, observational registry to collect clinical information on patients with Cushing Syndrome patients exposed with Ketoconazole (preferably using the existing European Registry on Cushing's syndrome (ERCUSYN) registry where feasible ), to assess drug utilization patterns and to document the safety (eg hepatotoxicity, QT prolongation) and effectiveness of ketoconazole
Maltese: Reġistru li jinvolvi aktar minn pajjiż wieħed, ta' osservazzjoni sabiex jiġbor informazzjoni klinika dwar pazjenti bisSindromu ta' Cushing esposti b'Ketoconazole (preferibbilment bl-użu tar-Reġistru Ewropew eżistenti dwar is-sindromu ta' Cushing (ERCUSYN) fejn dan ikun fattibbli), sabiex jevalwa t-tendenzi tal-użu tal-mediċini u sabiex tiġi ddokumentata s-sigurtà (eż. epatotossiċità, titwil tal-QT) u l-effikaċja ta' ketoconazole.
English: The most frequent adverse reactions are adrenal insufficiency, nausea, vomiting, abdominal pain, diarrhoea, pruritus, rash and the hepatic enzymes increased.
Maltese: Ir-reazzjonijiet avversi l-aktar frekwenti huma insuffiċjenza adrenali, dardir, rimettar, uġigħ addominali, dijarea, ħakk, raxx u żieda fl-enzimi tal-fwied.
English: Due to the known hepatotoxicity of ketoconazole, the treatment must not be initiated in patients with liver enzymes levels above 2 times the upper limit of normal (see section 4.3).
Maltese: Minħabba l-epatotossiċità magħrufa ta' ketoconazole, il-kura m'għandhiex tinbeda f'pazjenti b'livelli ta' enzimi tal-fwied ogħla mid-doppju tal-limitu ta' fuq tan-normal (ara sezzjoni 4.3).
English: Contraindicated due to an increase risk of edema and congestive heart failure (see section 4.3).
Maltese: Kontraindikat f'pazjenti b'indeboliment tal-kliewi (ara sezzjoni 4.3).
English: MN = Multiples of Normal
Maltese: MN = Multipli tan-Normal
English: EU/1/14/974/001 56 capsules EU/1/14/974/002 196 capsules EU/1/14/974/003 14 capsules
Maltese: EU/1/14/974/001 56 kapsula EU/1/14/974/002 196 kapsula EU/1/14/974/003 14-il kapsula
English: Sanofi - Produtos Farmacêuticos, Lda.
Maltese: Portugal Sanofi - Produtos Farmacêuticos, Lda.
English: Capsule contents Microcrystalline cellulose Lactose monohydrate Hypromellose Glycerol dibehenate
Maltese: Kontenut tal-kapsula Microcrystalline cellulose Lactose monohydrate Hypromellose Glycerol dibehenate
English: The size of the capsule is ‘size 2' (dimensions 18.0 x 6.4 mm).
Maltese: Id-daqs tal-kapsula huwa ‘daqs 2' (dimensjonijiet 18.0 x 6.4 mm).
English: (N=47)**
Maltese: Cerezyme (N=47)**
English: Effects on skeletal pathology
Maltese: Effetti fuq il-patoloġija skeletali
English: MN = Multiples of Normal, CI = confidence interval * Excludes patients with a total splenectomy.
Maltese: MN = Multipli tan-Normal, CI = intervall ta' fiduċja * Esklużi pazjenti b'splenektomija totali.
English: Genzyme Ireland, Ltd IDA Industrial Park Old Kilmeaden Road, Waterford Ireland
Maltese: Genzyme Ireland, Ltd IDA Industrial Park Old Kilmeaden Road, Waterford
English: • The active substance is eliglustat (as tartrate).
Maltese: • Is-sustanza attiva hi eliglustat (bħala tartrate).
English: Genzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford
Maltese: Manifattur Genzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford
English: amiodarone or sotalol.
Maltese: amiodarone jew sotalol.
English: All patient number (N)= Per Protocol Population
Maltese: In-numru totali ta'pazjenti (N)=Il-Popolazzjoni skont il-Protokoll (Per Protocol Population)
English: Gender, body weight, age, and race
Maltese: Sess, piż tal-ġisem, età, u razza
English: Eliglustat is a substrate of the efflux transporter P-gp.
Maltese: Eliglustat huwa substrat tat-trasportatur tal-effluss P-gp.
English: 14 hard capsules 56 hard capsules 196 hard capsules
Maltese: 14-il kapsula iebsa 56 kapsula iebsa 196 kapsula iebsa
English: Table 1: Tabulated list of adverse reactions
Maltese: Tabella 1: Lista f'forma tabulari tar-reazzjonijiet avversi
English: o In the capsule shell: gelatin, potassium aluminium silicate (E555), titanium dioxide (E171), yellow iron oxide (E172) and indigotine (E132).
Maltese: o Fil-qoxra tal-kapsula: gelatin, potassium aluminium silicate (E555), titanium dioxide (E171), yellow iron oxide (E172) u indigotine (E132).
English: • isoniazid - used to treat tuberculosis.
Maltese: • isoniazid - użat fil-kura tat-tuberkulożi.
English: Cerdelga has not been tested in children and adolescents under 18 years of age.
Maltese: Cerdelga ma ġiex ittestjat fi tfal u adolexxenti li għandhom inqas minn 18-il sena.
English: After 30 months and 4.5 years of treatment, the T-score further increased to -0.722 (1.1250) (n=27) and -0.533 (0.8031) (n=9), respectively.
Maltese: 722 (1.1250) (n=27) u -0.533 (0.8031) (n=9), rispettivament.
English: Electrocardiographic evaluation
Maltese: Valutazzjoni elettrokardjografika
English: • dextromethorphan - cough medicine
Maltese: • dextromethorphan - mediċina kontra s-sogħla
English: • terbinafine, itraconazole, fluconazole, posaconazole, voriconazole - antifungals (used to treat fungal infections)
Maltese: • terbinafine, itraconazole, fluconazole, posaconazole, voriconazole - antifungali (użati biex jikkuraw infezzjonijiet fungali)
English: • paroxetine, fluoxetine, fluvoxamine, duloxetine, bupropion, moclobemide - antidepressants (used to treat depression)
Maltese: • paroxetine, fluoxetine, fluvoxamine, duloxetine, bupropion, moclobemide - antidipressanti
English: Black iron oxide (E172) Propylene glycol Ammonia solution, concentrated
Maltese: Black iron oxide (E172) Propylene glycol
English: Haemoglobin Level (g/dL) 16 11.33 Liver Volume (MN)
Maltese: Volum tal-Milsa (MN) Livell tal-Emoglobina (g/dL) 16 11.33 Volum tal-Fwied (MN)
English: Difference (CerdelgaPlacebo) [95% CI]
Maltese: Differenza (Cerdelga - Plaċebo) [95% CI]
English: Standard Deviation
Maltese: Devjazzjoni Standard
English: 5% (40.57%) [n=39], 74.6% (49.57%) [n=35], and 86.8% (54.20%) [n=12]; mean reduction in spleen volume (MN) 46.5% (9.75%) [n=38], 54.2% (9.51%) [n=32], and 65.6% (7.43%) [n=13]; and mean reduction in liver volume (MN) 13.7% (10.65%) [n=38], 18.5% (11.22%) [n=32], and 23.4% (10.59%) [n=13].
Maltese: Irriżultati (tibdil mil-linja bażi) wara 18-il xahar, 30 xahar u 4.5 snin ta' espożizzjoni għal Cerdelga għal dawn il-punti finali li ġejjin kienu: tibdil assolut fil-livell tal-emoglobina (g/dL) 1.1 (1.03) [n=39], 1.4 (0.93) [n=35], u 1.4 (1.31) [n=12]; iż-żieda medja fl-għadd tal-plejtlits (mm3) 58. 5% (40.57%) [n=39], 74.6% (49.57%) [n=35], u 86.8% (54.20%) [n=12]; it-tnaqqis medju fil-volum tal-milsa (MN) 46.5% (9.75%) [n=38], 54.2% (9.51%) [n=32], u 65.6% (7.43%) [n=13]; u t-tnaqqis medju fil-volum tal-fwied (MN) 13.7% (10.65%) [n=38], 18.5% (11.22%) [n=32], u 23.4% (10.59%) [n=13].
English: Dry skin, urticaria*
Maltese: Ġilda xotta, urtikarja*
English: • The other ingredients are: o In the capsule: microcrystalline cellulose, lactose monohydrate (see section 2 under ‘Cerdelga contains lactose'), hypromellose and glycerol dibehenate.
Maltese: • Is-sustanzi l-oħra huma: o Fil-kapsula: microcrystalline cellulose, lactose monohydrate (ara sezzjoni 2 taħt ‘Cerdelga fih lactose'), hypromellose u glycerol dibehenate.
English: Absolute Change in Haemoglobin Level (g/dL)
Maltese: Livell ta' Emoglobina (g/dL)
English: • nortryptyline, amitriptyline, imipramine, desipramine - antidepressants (used to treat depression)
Maltese: • nortryptyline, amitriptyline, imipramine, desipramine - antidipressanti (użati biex jikkuraw depressjoni)
English: At 2 and 24 hours post-dose, 0.034 % and 0.013 % of labelled dose was detected in foetal tissue, respectively.
Maltese: Wara sagħtejn u 24 siegħa mill-għoti tad-doża, 0.034% u 0.013% tad-doża ttikkettata dehru rispettivament fit-tessut tal-fetu.
English: Cerdelga 84 mg hard capsules
Maltese: Cerdelga 84 mg kapsuli ibsin
English: A limited number of patients aged 65 years (n=10) and over were enrolled in clinical trials.
Maltese: Numru limitat ta' anzjani ta' età minn 65 sena (n=10) u iżjed irreġistraw f'provi kliniċi.
English: Mean [95% CI]
Maltese: Medja [95% CI]
English: Cerdelga contains lactose
Maltese: Cerdelga fih lactose
English: Each capsule contains 106 mg lactose (as monohydrate).
Maltese: Kull kapsula fiha 106 mg ta' lattosju (bħala monoidrat).
English: • ciprofloxacin, clarithromycin, erythromycin, telithromycin - antibiotics (used to treat infections)
Maltese: • ciprofloxacin, clarithromycin, erythromycin, telithromycin - antibijotiċi (użati biex jikkuraw infezzjonijiet)
English: • boceprevir, telaprevir - antiviral (used to treat Hepatitis C)
Maltese: • boceprevir, telaprevir - antivirali (użat fil-kura tal-Epatite Ċ)
English: Eliglustat is moderately bound to human plasma proteins (76 to 83%) and is mainly distributed in plasma.
Maltese: Eliglustat jintrabat b'mod moderat mal-proteini tal-plasma tal-bniedem (76 sa 83%) u jiġi prinċipalment distribwit fil-plasma.
English: Pack sizes of 14 hard capsules in 1 blister wallet, 56 hard capsules in 4 blister wallets of 14 capsules each or 196 hard capsules in 14 blister wallets of 14 capsules each
Maltese: Daqsijiet tal-pakkett ta' 14-il kapsula iebsa f'kartiera waħda, 56 kapsula iebsa f'4 kartieri ta' folji ta' 14-il kapsula kull waħda jew 196 kapsula iebsa f'14-il kartiera ta' folji ta' 14-il kapsula kull waħda.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX10.
Maltese: Prodotti oħra tal-passaġġ alimentari u tal-metaboliżmu, diversi prodotti tal-passaġġ alimentari u tal-metaboliżmu, Kodiċi ATC:
English: This may cause mild increases in the PR, QRS, and QTc intervals.
Maltese: Dan jista' jikkawża żidiet ħfief fl-intervalli PR, QRS, u QTc.
English: • amlopidine, ranolazine - used to treat angina pectoris
Maltese: • amlopidine, ranolazine - użati fil-kura tal-anġina pectoris
English: • carbamazepine, phenobarbital, phenytoin -anti-epileptics (used to treat epilepsy and seizures)
Maltese: • carbamazepine, phenobarbital, phenytoin -anti epilettiċi (użati biex jikkuraw l-epilessija u konvulżjonijiet)
English: Each pack contains 14, 56 or 196 hard capsules.
Maltese: Kull pakkett fih 14, 56 jew 196 kapsula iebsa.
English: Mean haemoglobin levels were 12.8 and 12.1 g/dL, and platelet counts were 78.5 and 75.1 x 109/L, respectively.
Maltese: Illivelli medji tal-emoglobina kienu ta' 12.8 u 12.1 g/dL, u l-għadd tal-plejtlits kien ta' 78.5 u 75.1 x 109/L, rispettivament.
English: Each capsule contains 84 mg eliglustat.
Maltese: Kull kapsula fiha 84 mg eliglustat.
English: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Maltese: Genzyme Europe B.V., Paasheuvelweg 25, 1105
English: • atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, saquinavir, tipranavir antiretrovirals (used to treat HIV)
Maltese: • atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, saquinavir, tipranavirantiretrovirali (użati biex jikkuraw l-HIV) cobicistat - użat biex jgħin iżid l-effetti tal-antiretrovirali (użati biex jikkuraw l-HIV)
English: In the Cerdelga group 34 (32%) patients received a dose escalation to 84 mg eliglustat twice daily and 51 (48%) to 127 mg twice daily during the 12month primary analysis period , and 21 (20%) patients continued to receive 42 mg twice daily.
Maltese: Fil-grupp ta' Cerdelga 34 (32%) pazjent irċevew żieda fid-doża sa 84 mg eliglustat darbtejn kuljum u 51 (48%) sa 127 mg darbtejn kuljum matul il-perjodu tal-analiżi primarja ta' 12-il xahar, u 21 (20%) pazjent komplew jirċievu 42 mg darbtejn kuljum.
English: 1105 BP Amsterdam The Netherlands
Maltese: 1105 BP Amsterdam Il-Pajjiżi l-Baxxi
English: • Gas (flatulence)
Maltese: • Gass (gass fl-istonku)
English: Cerdelga 84 mg hard capsules eliglustat
Maltese: Cerdelga 84 mg kapsuli ibsin eliglustat
English: Strong CYP3A inducers
Maltese: Stimulaturi qawwija ta' CYP3A
English: In intermediate (IMs) and extensive metabolisers (EMs):
Maltese: F'metabolizzaturi intermedji (IMs) u metabolizzaturi estensivi (EMs):
English: • dronedarone, quinidine, verapamil - antiarrhythmic medicines (used to treat irregular heartbeat)
Maltese: • dronedarone, quinidine, verapamil - mediċini antiarritmiċi (użati biex jikkuraw taħbit tal-qalb irregolari)
English: • rifampicin, rifabutin - antibiotics (used to treat infections)
Maltese: • rifampicin, rifabutin - antibijotiċi (użati biex jikkuraw infezzjonijiet)
English: Year 2
Maltese: 2 Sena
English: CYP2D6 phenotype
Maltese: Fenotip ta' CYP2D6
English: Concentration-dependent cardiac effects were observed in nonclinical studies: inhibition of human cardiac ion channels, including potassium, sodium, and calcium, at concentrations ≥ 7-fold of predicted human Cmax; sodium ion channel-mediated effects in an ex-vivo electrophysiology study in dog Purkinje fibres (2-fold of predicted human unbound plasma Cmax); and increases in QRS and PR intervals in dog telemetry and cardiac conduction studies in anaesthesised dogs, with effects seen at concentrations 14-fold of predicted human total plasma Cmax, or 2-fold of predicted human unbound plasma Cmax.
Maltese: kienu osservati effetti kardijaċi dipendenti fuq il-konċentrazzjoni: inibizzjoni tal-kanali tal-joni kardijaċi fil-bniedem, inklużi tal-potassju, is-sodju, u l-kalċju, f'konċentrazzjonijiet ≥7 darbiet is-Cmax previst tal-bniedem; effetti kkawżati mill-kanal tal-joni tas-sodju fi studju ex-vivo tal-elettrofiżjoloġija f'fibri Purkinje tal-klieb (darbtejn is-Cmax previst fil-plasma tal-bniedem mingħajr irbit); u żidiet flintervalli tal-QRS u l-PR fit-telemetrija tal-klieb u fi studji dwar il-konduzzjoni kardijaka fi klieb anestetizzati, b'effetti li dehru f'konċentrazzjonijiet 14-il darba s-Cmax totali previst fil-plasma talbniedem, jew darbtejn is-Cmax previst fil-plasma tal-bniedem mingħajr irbit.
English: • are an extensive metaboliser and you have moderately reduced liver function.
Maltese: • metabolizzatur estensiv u għandek il-funzjoni tal-fwied li hija mnaqqsa b'mod moderat.
English: Pivotal study of Cerdelga in GD1 patients switching from ERT- Study 02607 (ENCORE) Study 02607 was a randomized, open-label, active-controlled, non-inferiority, multicenter clinical study in 159 patients previously stabilised with ERT.
Maltese: L-istudju prinċipali ta' Cerdelga f'pazjenti b'GD1 li qalbu minn ERT- Studju 02607 (ENCORE) L-istudju 02607 kien studju kliniku multiċentriku, b'tikketta mikxufa, ikkontrollat b'mod attiv, tat-tip non-inferiority, fuq 159 pazjent li qabel kienu stabilizzati b'ERT.
English: Dyspepsia, abdominal pain upper*, diarrhoea*, nausea, constipation, abdominal pain*, gastrooesophageal reflux disease, abdominal distension*, gastritis, dysphagia, vomiting*, dry mouth, flatulence
Maltese: dijarea*, dardir, stitikezza, uġigħ addominali*, mard ta' rifluss gastroesofagali, distensjoni addominali*, gastrite, disfaġja, rimettar*, ħalq xott, gass fl-istonku
English: • phenothiazines - antipsychotics (used to treat schizophrenia and psychosis)
Maltese: • phenothiazines - antipsikotiċi (użati biex jikkuraw skizofrenija u psikożi)
English: Information for healthcare professionals:
Maltese: Kategorija farmakoterapewtika:
English: • atomoxetine - used to treat attention deficit hyperactivity disorder (ADHD) • pravastatin - used to lower cholesterol and prevent heart disease
Maltese: • atomoxetine - użat fil-kura ta' disturb ta' iperattività u ta' nuqqas ta' attenzjoni (attention deficit hyperactivity disorder, ADHD)
English: Placebo* (n=20) a
Maltese: (N=20)a
English: Cerdelgab Mean [95% CI])
Maltese: Cerdelgab Medja [95% CI])
English: Hard capsule
Maltese: Kapsula iebsa.
English: 3 years
Maltese: 3 Sena
English: Fourteen (78%) continued on 84 mg Cerdelga twice daily.
Maltese: Erbatax (78%) baqgħu fuq 84 mg Cerdelga darbtejn kuljum.
English: Based on PK/PD modelling, eliglustat plasma concentrations 11-fold the predicted human Cmax are expected to cause mean (upper bound of the 95% confidence interval) increases in the PR, QRS, and QTcF intervals of 18.8 (20.4), 6.2 (7.1), and 12.3 (14.2) msec, respectively.
Maltese: 95%) fl-intervalli tal-PR, QRS, u l-QTcF ta' 18.8 (20.4), 6.2 (7.1), u 12.3 (14.2) msec, rispettivament.
English: After 18 months of Cerdelga treatment in the open-label extension phase, the mean (SD) lumbar spine Bone Mineral Density T-score increased from -1.14 (1.0118) at Baseline (n=34) to -0.918 (1.1601) (n=33) in the normal range.
Maltese: Wara 18-il xahar ta' trattament b'Cerdelga fil-fażi ta' estensjoni open-label, il-punteġġ-T medju (SD) tad-Densità Minerali tal-Għadam (bone mineral density, BMD) tal-ispina lumbari żdied minn -1.14 (1.0118) fil-Linjabażi (n=34) għal -0.918 (1.1601) (n=33) fil-marġni normali.
English: How to take Cerdelga
Maltese: Tiħux Cerdelga
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont is-sistema tal-klassifika tal-organi u l-frekwenza ([komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna(<1/10,000)]).
English: • digoxin -used to treat heart failure and atrial fibrillation
Maltese: • digoxin -użat għall-kura ta' insuffiċjenza tal-qalb u fibrillazzjoni atrijali
English: Food does not have a clinically relevant effect on eliglustat pharmacokinetics.
Maltese: L-ikel m'għandux effett klinikament rilevanti fuq il-farmakokinetika ta' eliglustat.
English: • Throat irritation
Maltese: • Palpitazzjonijiet • Irritazzjoni fil-gerżuma
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE Cerdelga
English: Cerdelga showed sustained improvements in organ volume and haematological parameters over the 8 year treatment period (see Table 3).
Maltese: Cerdelga wera titjib sostnut fil-volum tal-organi u fil-parametri ematoloġiċi matul il-perijodu ta' kura ta' 8 snin (ara t-Tabella 3).
English: CYP2D6 inhibitors In intermediate (IMs) and extensive metabolisers (EMs):
Maltese: Inibituri ta' CYP2D6 F'metabolizzaturi intermedji (IMs) u metabolizzaturi estensivi (EMs):
English: • Acid reflux disease (gastrooesophageal reflux disease)
Maltese: • Mard ta' rifluss tal-aċtu (mard ta' rifluss gastroesofagali)
English: Cerdelgab Mean [95% CI]
Maltese: Cerdelgab Medja [95% CI]
English: Primary metabolic pathways of eliglustat involve sequential oxidation of the octanoyl moiety followed by oxidation of the 2,3-dihydro-1,4-benzodioxane moiety, or a combination of the two pathways, resulting in multiple oxidative metabolites.
Maltese: Il-passaġġi metaboliċi primarji ta' eliglustat jinvolvu ossidazzjoni sekwenzjali tal-parti octanoyl segwita minn ossidazzjoni tal-parti 2,3-dihydro-1,4-benzodioxane, jew il-kombinazzjoni taż-żewġ passaġġi, li jwassal għal diversi metaboliti ossidattivi.
English: Each capsule contains 84.4 mg of eliglustat (as tartrate).
Maltese: Kull kapsula fiha 84.4 mg ta' eliglustat (bħala tartrat).
English: After a single 0.25 mg dose of digoxin, a P-gp substrate, concomitant administration of 127 mg twice daily doses of eliglustat resulted in a 1.7- and 1.5-fold increase in digoxin Cmax and AUClast, respectively.
Maltese: Wara doża unika ta' 0.25 mg ta' digoxin, substrat ta' P-gp, l-għoti fl-istess ħin ta' dożi ta' 127 mg ta' eliglustat darbtejn kuljum wassal għal żieda ta' 1.7 u 1.5 darbiet fis-Cmax u l-AUClast ta' digoxin, rispettivament.
English: Lower doses of substances which are P-gp substrates (e.g. digoxin, colchicine, dabigatran, phenytoin, pravastatin) may be required.
Maltese: Jistgħu jkunu meħtieġa dożi aktar baxxi ta' sustanzi li huma substrati ta' P-gp (eż. digoxin, colchicine, dabigatran, phenytoin, pravastatin).
English: • cimetidine, ranitidine - antacids (used to treat indigestion)
Maltese: • cimetidine, ranitidine - kontra l-aċtu (użati fil-kura tal-indiġestjoni)
English: The most frequently reported adverse reaction with Cerdelga is dyspepsia, in approximately 6% of the clinical trial patients.
Maltese: L-aktar reazzjoni avversa rrapportata b'mod frekwenti b'Cerdelga hija dispepsja, f'madwar 6 % talpazjenti fil-prova klinika.
English: Heart-rate corrected QT interval using Fridericia's correction (QTcF) was evaluated in a randomized, placebo and active (moxifloxacin 400 mg) controlled cross-over, single-dose study in 47 healthy subjects.
Maltese: L-intervall tal-QT ikkoreġut għar-rata tal-qalb bl-użu tal-korrezzjoni ta' Fridericia (QTcF) kien ivvalutat fi studju magħmul b'mod arbitrarju, cross-over, ikkontrollat b'mod attiv (moxifloxacin 400 mg) u bi plaċebo, b'doża unika f'47 individwu b'saħħithom.
English: Table 4: Changes from baseline to Month 12 (primary analysis period) in patients with GD1 switching to Cerdelga in study 02607
Maltese: Tabella 4: Bidliet mil-linja bażi sa Xahar 12 (perjodu tal-analiżi primarja) f'pazjenti b'GD1 li qalbu għal Cerdelga fl-istudju 02607
English: Use of a strong CYP3A inducer (e.g. rifampicin, carbamazepine, phenobarbital, phenytoin, rifabutin and St. John's wort) with eliglustat is not recommended in IMs, EMs and PMs.
Maltese: L-użu ta' stimulatur qawwi ta' CYP3A (eż. rifampicin, carbamazepine, phenobarbital, phenytoin, rifabutin u St.