FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 98 (2 packs of 49) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets Multipack: 90 (3 packs of 30) film-coated tablets
Maltese: U KONTENUT Pakkett b'ħafna: 98 (2 pakketti ta' 49) pillola miksija b'rita Pakkett b'ħafna: 280 (20 pakkett ta' 14) pillola miksija b'rita Pakkett b'ħafna: 90 (3 pakketti ta' 30) pillola miksija b'rita
English: Rasilez HCT should not be used in children aged 2 to less than 6 years because of safety concerns due to potential aliskiren overexposure (see sections 4.3, 4.4, 5.2, and 5.3).
Maltese: Raskilez HCT m'għandux jintuża fit-tfal minn sentejn sa inqas minn 6 snin minħabba tħassib ta' sigurtà dovut għal esponiment eċċessiv potenzjali għal aliskiren (ara sezzjonijiet 4.3, 4.4, 5.2 u 5.3).
English: Acute renal failurea,h, renal impairmenta
Maltese: Insuffiċjenza akuta tal-kliewia,h, indeboliment tal-kliewia
English: The adverse reactions listed in the table above, which are marked with the reference “h”, have been reported in patients treated with thiazide diuretics alone, including hydrochlorothiazide.
Maltese: Ir-reazzjonijiet avversi elenkati fit-tabella fuq, li huma mmarkati bir-referenza “ħ”, ġew irrappurtati f'pazjenti li ngħataw kura b'dijuretiċi thiazide biss, inkluż hydrochlorothiazide.
English: Single-packs (perforated unit dose blister) containing 56 x 1 tablets.
Maltese: Pakketti b'wieħed (folja mtaqqba b' doża waħda) li jkun fihom 56 x 1 pillola.
English: − Hereditary or idiopathic angioedema.
Maltese: − Anġjoedima ereditarja jew idjopatika.
English: Thrombocytopenia sometimes with purpurah
Maltese: Tromboċitopenija, xi kultant b'purpurah
English: Multi-packs containing 280 (20 packs of 14) tablets.
Maltese: Pakketti multipli li jkun fihom 280 (20 pakkett ta' 14) pillola.
English: Multi-packs (perforated unit dose blister) containing 98 (2 packs of 49 x 1) tablets.
Maltese: Pakketti multipli (folja mtaqqba b'doża waħda) li jkun fihom 98 (2 pakketti ta' 49 x 1) pillola.
English: The other ingredients are: Microcrystalline cellulose, crospovidone type A, lactose monohydrate and wheat starch (see section 2 under ‘Rasilez HCT contains lactose and wheat starch'), povidone K-30, magnesium stearate, silica colloidal anhydrous, talc, hypromellose substitution type 2910 (3 mPa s), macrogol 4000, titanium dioxide (E171).
Maltese: Issustanzi l-oħra huma Microcrystalline cellulose, crospovidone tip A, lactose monohydrate u wheat starch (ara sezzjoni 2 taħt ‘Rasilez HCT fih lactose u wheat starch'), povidone K-30, magnesium stearate, silica colloidal anhydrous, talc, hypromellose tip ta' sostitut 2910 (3 mPa s), macrogol 4000, titanium dioxide (E171).
English: Rasilez HCT 150 mg/12.5 mg film-coated tablets Rasilez HCT 150 mg/25 mg film-coated tablets Rasilez HCT 300 mg/12.5 mg film-coated tablets Rasilez HCT 300 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Maltese: Rasilez HCT 150 mg/12.5 mg pilloli miksijin b'rita Rasilez HCT 150 mg/25 mg pilloli miksijin b'rita Rasilez HCT 300 mg/12.5 mg pilloli miksijin b'rita Rasilez HCT 300 mg/25 mg pilloli miksijin b'rita Aliskiren/hydrochlorothiazide
English: Aliskiren was evaluated for cardiovascular and/or renal benefit in a double-blind placebo controlled randomised trial in 8,606 patients with type 2 diabetes and chronic kidney disease (evidenced by proteinuria and/or GFR < 60 ml/min/1.73 m2) with or without cardiovascular disease.
Maltese: Aliskiren kien evalwat għall-benefiċċju kardjovaskulari u/jew tal-kliewi fi studju randomised, doubleblind, kontrollat bi plaċebo f'8,606 pazjent b'dijabete tat-tip 2 u b'mard tal-kliewi kroniku (evidenzjat minn u proteinurja u/jew GFR < 60 ml/min/1.73 m2) bi jew mingħajr mard kardjovaskulari.
English: • Facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
Maltese: • Raxx fil-wiċċ, uġigħ fil-ġogi, disturb fil-mukskoli, deni (lupus erythematosus)
English: Increases in cholesterol and triglyceridesh
Maltese: Żieda fil-kolesterol u t-trigliċeridih
English: • Bruising and frequent infections (aplastic anaemia)
Maltese: • Tbenġil u infezzjonijiet frekwenti (anemija aplastika)
English: − History of angioedema with aliskiren.
Maltese: − Storja ta' anġjoedima b'aliskiren.
English: Not known (frequency cannot be estimated from the available data):
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi kkalkulata mid-dejta disponibbli)
English: Rasilez HCT 150 mg/12.5 mg film-coated tablets Rasilez HCT 150 mg/25 mg film-coated tablets Rasilez HCT 300 mg/12.5 mg film-coated tablets Rasilez HCT 300 mg/25 mg film-coated tablets
Maltese: Rasilez HCT 150 mg/12.5 mg pilloli miksijin b'rita Rasilez HCT 150 mg/25 mg pilloli miksija b'rita Rasilez HCT 300 mg/12.5 mg pilloli miksija b'rita Rasilez HCT 300 mg/25 mg pilloli miksija b'rita
English: Muscle spasmh
Maltese: Spażmu fil-muskolih
English: In a pharmacokinetic study of aliskiren treatment in 39 paediatric hypertensive patients aged 6 to 17 years given daily doses of 2 mg/kg or 6 mg/kg aliskiren administered as granules (3.125 mg/tablet), pharmacokinetic parameters were similar to those in adults.
Maltese: Fi studju farmakokinetiku ta' kura b'aliskiren f'39 pazjent pedjatriku bi pressjoni għolja, fl-età ta' bejn 6 snin sa 17-il sena, li ngħataw dożi ta' 2 mg/kg jew 6 mg/kg ta' aliskiren kuljum bħala bċejjeċ żgħar (3.125 mg/pillola), il-parametri farmakokinetiċi kienu jixbhu lil dawk fl-adulti.
English: 98 film-coated tablets (2 packs of 49x1)
Maltese: 98 pillola miksija b'rita (2 pakketti ta' 49x1)
English: In a study in 722 randomised patients not adequately responsive to hydrochlorothiazide 25 mg treatment, the combination of aliskiren/hydrochlorothiazide 300 mg/25 mg produced systolic/diastolic blood pressure reductions of 16.78/10.7 mmHg, which were significantly greater than hydrochlorothiazide 25 mg monotherapy.
Maltese: Fi studju b'722 pazjent randomised li ma wrewx rispons xieraq għal kura b'hydrochlorothiazide 25 mg, it-taħlita ta' aliskiren/hydrochlorothiazide 300 mg/25 mg ikkawżat tnaqqis fil pressjoni sistolika/dijastolika tad-demm ta' 16.78/10.7 mmHg, li kienu akbar b'mod sinifikanti mill-monoterapija b'hydrochlorothiazide waħdu.
English: However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, corticosteroids, laxatives, adrenocorticotropic hormone (ACTH), amphotericin, carbenoxolone, penicillin G, salicylic acid derivatives).
Maltese: Madankollu, dan l-effett ta' hydrochlorothiazide fuq il-potassium fis-serum ikun mistenni li jitqawwa minn prodotti mediċinali oħrajn assoċjati mat-telf ta' potassium u ipokalimja (eż. dijuretiċi kaljuretiċi oħrajn, kortikosterojdi, porog, ormon adrenokortikotropiku (ACTH), amphotericin, carbenoxolone, penicillin G, derivati ta' salicylic acid).
English: Whereas other agents that inhibit the RAAS (angiotensin converting enzyme inhibitors (ACEI) and angiotension II receptor blockers (ARB)) cause a compensatory rise in plasma renin activity (PRA), treatment with aliskiren decreases PRA in hypertensive patients by approximately 50 to 80%.
Maltese: Filwat li aġenti oħrajn li jinibixxu r-RAAS (inibituri tal-enzimi li jikkonvertu l-enzimi (ACEI) u imblukkaturi tar-riċetturi ta' angiotensin II (ARB)) jikkawżaw żieda ta' kumpens fl-attività ta' renin fil-plażma (PRA), il-kura b'aliskiren tnaqqas il-PRA f'pazjenti bil-pressjoni għolja b'madwar 50 sa 80%.
English: INFORMATION IN BRAILLE Rasilez HCT 300 mg/25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Rasilez HCT 300 mg/25 mg
English: • Joint pain (arthralgia)
Maltese: • Uġigħ fil-ġogi (artralġja)
English: In another clinical studies, the efficacy and safety of Rasilez HCT were also assessed in 489 obese hypertensive patients who did not respond to hydrochlorothiazide 25 mg (baseline systolic/diastolic blood pressure 149.4/96.8 mmHg).
Maltese: Fi studju kliniku ieħor, l-effikaċja u s-sigurtà ta' Rasilez HCT kienet evalwata f'489 pazjent obeż bi pressjoni għolja li ma wrewx rispons għal hudrochlorothiazide 25 mg (linja bażi tal-pressjoni sistolika/dijastolika tad-demm 149.4/96.8 mmHg).
English: A single dose interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold.
Maltese: Studju dwar interazzjoni tal-mediċina b'doża waħda f'individwi b'saħħithom wera li ciclosporin (200 u 600 mg) iżid is-Cmax ta' aliskiren 75 mg b'madwar 2.5 drabi u l-AUC b'madwar 5 darbiet.
English: Over 3,900 hypertensive patients received Rasilez HCT once daily in clinical study.
Maltese: 'L fuq minn 3,900 pazjent bil-pressjoni għolja irċievew Rasilez HCT darba kuljum fi studju kliniku.
English: In post-marketing experience, renal dysfunction, and cases of acute renal failure have been reported in patients at risk (see section 4.4).
Maltese: Fl-esperjenza ta' wara t-tqegħid fis-suq, disfunzjoni tal-kliewi u każijiet ta' insuffiċjenza akuta talkliewi kienu rrappurtati f'pazjenti li kienu f'riskju (ara sezzjoni 4.4).
English: Hyperuricaemiah, hypomagnesaemiah
Maltese: Iperuriċemijah, ipomanjesimijah
English: • Itchy rash (urticarial)
Maltese: • Raxx bil-ħakk (urtikarja)
English: Aliskiren was evaluated for cardiovascular mortality and morbidity benefit in a double-blind active controlled randomised study in 7,064 patients with chronic heart failure and reduced left ventricular ejection fraction, of which 62% had a history of hypertension.
Maltese: Aliskiren kien evalwat għall-benefiċċju fejn jidħlu l-mortalità u l-morbidità kardjovaskulari waqt studju randomizzat double-blind ikkontrollat bl-attiv fost 7,064 pazjent b'insuffiċjenza kardijaka kronika u frazzjoni ta' tfigħ 'il barra mil-ventrikolu xellugi mnaqqas, li 62% minnhom kellhom storja ta' pressjoni għolja.
English: INFORMATION IN BRAILLE Rasilez HCT 300 mg/12.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Rasilez HCT 300 mg/12.5 mg
English: Rasilez HCT 150 mg/25 mg film-coated tablets EU/1/08/491/021-040
Maltese: Rasilez HCT 150 mg/25 mg pilloli miksija b'rita EU/1/08/491/021-040
English: • Pale skin, tiredness, breathlessness, dark-coloured urine (haemolytic anaemia)
Maltese: • Ġilda ċassa, għeja, qtugħ ta' nifs, awrina ta' lewn skur (anemija emolitika)
English: Haemoglobin decreaseda, haematocrit decreaseda, blood creatinine increaseda, glycosuriah c Adverse reaction observed with Rasilez HCT a Adverse reaction observed with monotherapy with aliskiren h Adverse reaction observed with monotherapy with hydrochlorothiazide * Isolated cases of liver disorder with clinical symptoms and laboratory evidence of more marked hepatic dysfunction.
Maltese: Tnaqqis fl-emoglobinaa, tnaqqis fl-ematokrita, żieda fil kreatinina tad-demma, glikosurjah c Reazzjoni avversa osservata b'Rasilez HCT a Reazzjoni avversa osservata b'monoterapija ta' aliskiren h Reazzjoni avversa osservata b'monoterapija ta' hydrochlorothiazide * Każijiet iżolati ta' disturbi tal-fwied b'sintomi kliniċi u b'evidenza tal-laboratorju ta' disfunzjoni tal-kliewi aktar qawwija. ** Inklużi każ wieħed ta' ‘insuffiċjenza fulminanti tal-fwied' irrappurtat fl-esperjenza ta' wara ttqegħid fis-suq, li għalih ma jistax jiġi eskluż relazzjoni kawżali ma' aliskiren.
English: INFORMATION IN BRAILLE Rasilez HCT 150 mg/12.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Rasilez HCT 150 mg/12.5 mg
English: This medicine contains two active substances, called aliskiren and hydrochlorothiazide.
Maltese: Din il-mediċina fiha żewġ sustanzi attivi, li jisimhom aliskiren u hydrochlorothiazide.
English: Each tablet contains 50 mg lactose (as monohydrate) and 49 mg wheat starch.
Maltese: Kull pillola fiha 50 mg lactose (bħala monohydrate) u 49 mg lamtu tal-qamħ.
English: In general, dual blockade of the RAAS by combining aliskiren with an ACEI or an ARB is not recommended (see section “Dual blockade of the renin-angiotensin-aldosterone system (RAAS)” above and also sections 4.5 and 4.8).
Maltese: B'mod ġenerali, mhuwiex irrakkomandat imblokk doppju tar-RAAS billi aliskiren jingħata flimkien ma' xi ACEI jew xi ARB (ara s-sezzjoni “Imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS)” hawn fuq u wkoll sezzjonijiet 4.5 u 4.8).
English: Rasilez HCT 300 mg/25 mg film-coated tablets EU/1/08/491/061-080
Maltese: Rasilez HCT 300 mg/25 mg pilloli miksija b'rita EU/1/08/491/061-080
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 98 (2 packs of 49 x 1) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Maltese: U KONTENUT Pakkett b'ħafna: 98 (2 pakketti ta' 49 x 1) pillola miksija b'rita Pakkett b'ħafna: 280 (20 pakkett ta' 14) pillola miksija b'rita
English: INFORMATION IN BRAILLE Rasilez HCT 150 mg/25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Rasilez HCT 150 mg/25 mg
English: Contains lactose and wheat starch.
Maltese: TA' EĊĊIPJENTI Fih lactose u wheat starch.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) Hypotension, syncope, stroke, hyperkalaemia, and decreased renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system (see section 5.1).
Maltese: Imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS) Pressjoni baxxa, sinkope, puplesija, iperkalimja u tnaqqis fil-funzjoni tal-kliewi (li jinkludi insuffiċjenza akuta tal-kliewi) ġew irrappurtati f'individwi suxxettibbli, speċjalment jekk tkun qed tintuża kombinazzjoni ta' prodotti mediċinali li jaffettwaw lil din is-sistema (ara sezzjoni 5.1).
English: Rasilez HCT 300 mg/12.5 mg film-coated tablets EU/1/08/491/041-060
Maltese: Rasilez HCT 300 mg/12.5 mg pilloli miksija b'rita EU/1/08/491/041-060
English: Hypokalaemiah
Maltese: Ipokalimjah
English: There is therefore a potential for aliskiren overexposure in paediatric patients with immature MDR1 efflux system (see sections 4.2, 4.3 and 5.2).
Maltese: Għaldaqstant hemm il-potenzjal ta' espsożizzjoni eċċessiva għal aliskiren f'pazjenti pedjatriċi b'sistema immatura ta' effluss tal-MDR1 (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: After single dose administration in the dose range of 75 to 600 mg, a 2-fold increase in dose results in a ~2.3 and 2.6-fold increase in AUC and Cmax, respectively.
Maltese: Wara li tingħata doża waħda fil-medda ta' dożi bejn 75 u 600 mg, meta d-doża tiġi rduppjata jkun hemm żieda ta' ~2.3 u 2.6-il darba fl-AUC u s-Cmax rispettivament.
English: Intrahepatic cholestasish, jaundicea,h
Maltese: Kolestażi ġol-fwiedh, suffejraa,h
English: Other inducers of Pgp (St. John's wort) might decrease the bioavailability of aliskiren.
Maltese: Indutturi oħrajn ta' P-gp (St. John's Wort) jistgħu jnaqqsu l-bijodisponibbiltà ta' aliskiren.
English: The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
Maltese: Ilpotenzjal ta' interazzjonijiet fis-sit P-gp x'aktarx li jkun jiddependi mill-grad ta' inibizzjoni tattrasportatur.
English: Headacheh, paraesthesiah
Maltese: Skumdità fl-addomeh, stitikezzah
English: The starting doses for aliskiren were 37.5/75/150 mg in the low, mid and high weight groups, respectively.
Maltese: Id-dożi tal-bidu għal aliskiren kienu ta' 37.5/75/150 mg fil-gruppi ta' piż baxx, tan-nofs u għoli, rispettivament.
English: At steady state meals with low fat content reduce Cmax by 76% and AUC0tau by 67% in hypertensive patients.
Maltese: Fi stadju stabbli ikliet b'kontenut baxx ta' xaħam inaqqsu s-Cmax b'76% u l-AUC0-tau b'67% f'pazjenti bi pressjoni għolja.
English: However, there is an increased risk of renal insufficiency, including acute renal failure, when patients with renal artery stenosis are treated with aliskiren.
Maltese: Madankollu hemm żieda fir-riskju ta' insuffiċjenza tal-kliewi, inkluż indeboliment gravi tal-kiewi, meta l-pazjenti bi stenożi tal-arterja renali jiġu kkurati b'aliskiren.
English: Aliskiren was not teratogenic in rats or rabbits (see section 5.3).
Maltese: Aliskiren ma kienx teratoġeniku fi frien jew fniek (ara sezzjoni 5.3).
English: Safety pharmacology studies with aliskiren did not reveal any adverse effects on central nervous, respiratory or cardiovascular function.
Maltese: Studji b'aliskiren dwar is-sigurtà farmakoloġika ma wrew l-ebda effetti avversi fuq is-sistema nervuża ċentrali, respiratorja jew funzjoni kardjovaskulari.
English: Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association (NYHA) functional class III-IV) (see section 5.1).
Maltese: III-IV tal-Assoċjazzjoni Tal-Qalb ta' New York (NYHA)) (ara sezzjoni 5.1).
English: Medicinal products affected by serum potassium disturbances Periodic monitoring of serum potassium is recommended when Rasilez HCT is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Maltese: Prodotti mediċinali effettwati minn disturbi tal-potassium fis-serum Monitoraġġ perjodiku tal-potassium fis-serum huwa irrikkmandat meta Rasilez HCT jingħata ma' prodotti mediċinali effettwati minn disturbi tal-potassium fis-serum (eż. digitalis glycosides, antiarritmijaċi).
English: In the event of severe and perisistent diarrhoea, Rasilez HCT therapy should be stopped (see section 4.8).
Maltese: Ġenerali Fil-każ ta 'dijarea severa u persistenti, it-terapija b'Rasilez HCT għandha titwaqqaf (ara sezzjoni 4.8).
English: How to take Rasilez HCT
Maltese: X'inhu Rasilez HCT
English: See also section “Do not take Rasilez HCT”.
Maltese: Ara wkoll is-sezzjoni “Tiħux Rasilez HCT”.
English: Coadministration of grapefruit juice with aliskiren 150 mg resulted in a 61% decrease in aliskiren AUC and co-administration with aliskiren 300 mg resulted in a 38% decrease in aliskiren AUC.
Maltese: L-għoti talmeraq tal-grejpfrut flimkien ma' aliskiren 150 mg wassal għal tnaqqis ta' 61% fl-AUC ta' aliskiren u l-għoti flimkien ma' aliskiren 300 mg wassal għal tnaqqis ta' 38% fl-AUC ta' aliskiren.
English: Treatment with Rasilez HCT had an overall incidence of adverse experiences at doses up to 300 mg/25 mg similar to placebo.
Maltese: Kura b'Rasilez HCT kellha frekwenza globali ta' esperjenzi avversi b'dożi sa' 300 mg/25 mg simili għall-plaċebo.
English: When administered in hypertensive patients with markedly elevated blood pressure (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), Rasilez HCT in doses from 150 mg/12.5 mg to 300 mg/25 mg administered without up-titration from monotherapy demonstrated significantly greater systolic/diastolic blood pressure control rates (< 140/90 mmHg) as compared to the respective monotherapies.
Maltese: Meta tingħata f'pazjenti li jsofru minn pressjoni għolja u li għandhom pressjoni għolja ħafna (pressjoni sistolika ≥ 160 mmHg u/jew pressjoni dijastolika ≥ 100 mmHg), dożi ta' Rasilez HCT minn 150 mg/12.5 mg sa 300 mg/25 mg mogħtija mingħajr titrazzjoni tad-doża aktar minn monoterapija wrew rati ta' kontroll tal-pressjoni sistolika/dijastolika tad-demm (< 140/90 mmHg) meta imqabbla ma' monoterapiji rispettivi.
English: • Sad mood (depression)
Maltese: • Burdata ħażina (depressjoni)
English: In a pooled analysis of efficacy and safety data from clinical study up to 12 months duration, there was no statistically significant difference in blood pressure reduction between aliskiren 300 mg and aliskiren 150 mg in elderly patients (≥ 65 years).
Maltese: Skont analiżi miġbura tad-dejta dwar l-effikaċja u s-sigurtà waqt studji kliniċi li damu sa 12-il xahar, ma kienx hemm differenza qawwija statistikament fejn jidħol it-tnaqqis tal-pressjoni tad-demm bejn 300 mg aliskiren u 150 mg aliskiren f'pazjenti ta' età akbar (≥ 65 sena).
English: After the first 52 week extension study, eligible male and female paediatric patients aged 6 to 17 years with primary or secondary hypertension, were enrolled in a 52 to 104 week off-therapy noninterventional observational extension study designed to evaluate the LT growth and development, through height and weight measurement, with added neurocognitive and renal function evaluations as follow-up measures performed only in patients with secondary hypertension (19 patients: 9 previously treated with aliskiren and 10 previously treated with enalapril).
Maltese: Wara l-ewwel studju ta' estensjoni li dam 52 ġimgħa, pazjenti pedjatriċi rġiel u nisa eliġibbli li kellhom minn 6 sa 17-il sena bi pressjoni għolja primarja jew sekondarja, kienu rreġistrati fi studju osservazzjonali, ta' estensjoni, u mingħajr intervent, li dam 52 sa 104 ġimgħa u li fih ma kinux jieħdu terapija, imfassal biex jevalwa it-tkabbir u l-iżvilupp LT, permezz tal-kejl tat-tul u tal-piż tal-ġisem, u b'evalwazzjonijiet addizzjonali newrokonjittivi u tal-funzjoni renali bħala miżuri ta' segwitu, imwettqa biss f'pazjenti bi pressjoni għolja sekondarja (19-il pazjent: 9 li qabel kienu ttrattati b'aliskiren u 10 li qabel kienu ttrattati b'enalapril).
English: Increased cellular vacuolation of the adrenal gland zona glomerulosa was observed during the 13-week toxicity study in rats.
Maltese: Żieda fil-vakwolazzjoni ċellulari taż-żona glomerulosa tal-glandola adrenali kienet osservata waqt l-istudju ta' tossiċità ta' 13-il ġimgħa filfirien.
English: In this difficult-to-treat population, Rasilez HCT provided a blood pressure reduction (systolic/diastolic) of 15.8/11.9 mmHg compared to 15.4/11.3 mmHg for irbesartan/hydrochlorothiazide, 13.6/10.3 mmHg for amlodipine/hydrochlorothiazide and 8.6/7.9 mmHg for hydrochlorothiazide monotherapy, with similar safety to hydrochlorothiazide monotherapy.
Maltese: 3 mmHg għal amlodipine/hydrochlorothiazide u 8.6/7.9 mmHg għal monoterapija b'hydrochlorothiazide, b'sigurtà simili għal monoterapija b'hydrochlorothiazide.
English: The safety and efficacy of Rasilez HCT in children below 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Rasilez HCT fit-tfal minn età taħt it-18-il sena ma ġewx determinati s'issa.
English: Name and address of the manufacturer(s) responsible for batch release Noden Pharma DAC
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Noden Pharma DAC
English: The study also evaluated the combination of aliskiren and enalapril.
Maltese: L-istudju evalwa wkoll l-għoti flimkien ta' aliskiren u enalapril.
English: Rasilez HCT 300 mg/12.5 mg film-coated tablets - Each tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrocholorothiazide.
Maltese: Rasilez HCT 300 mg/12.5 mg pilloli miksija b'rita - Kull pillola fiha 300 mg aliskiren (bħala il-hemifumarate) u 12.5 mg hydrochlorothiazide.
English: Rasilez HCT 150 mg/25 mg film-coated tablets - Each tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide.
Maltese: Rasilez HCT 150 mg/25 mg pilloli miksija b'rita - Kull pillola fiha 150 mg aliskiren (bħala il-hemifumarate) u 25 mg hydrochlorothiazide.
English: Results from an in vitro MDR1 human tissue study suggested an age and tissue dependent pattern of MDR1 (P-gp) transporter maturation.
Maltese: MDR1 (P-gp) dipendenti fuq l-età u t-tessuti.
English: • Confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic alkalosis)
Maltese: • Konfużjoni, għeja, ġbid u spażi tal-muskoli, in-nifs jittieħed b'ħatf (alkalożi ipokloremika)
English: Haemoglobin and haematocrit
Maltese: Emoglobina u ematokrit
English: Rasilez HCT 300 mg/25 mg film-coated tablets - Each tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide.
Maltese: Rasilez HCT 300 mg/25 mg pilloli miksija b'rita - Kull pillola fiha 300 mg aliskiren (bħala il-hemifumarate) u 25 mg hydrochlorothiazide.
English: This study was extended with a 52-week double-blind, randomised study to evaluate the safety, tolerability and efficacy of aliskiren compared to enalapril in 208 paediatric hypertensive patients aged 6 to 17 years (at baseline in the previous study).
Maltese: L-istudju kien estiż bi studju ta' 52 ġimgħa double-blind, randomised għall-evalwazzjoni tas-sigurtà, it-tollerabilità u l-effikaċja ta' aliskiren meta mqabbla ma' enalapril f'208 pazjent pedjatriku bi pressjoni għolja fl-età ta' bejn 6 snin sa 17 il sena (fil-linja bażi fl-istudju preċedenti).