FrancophonIA/ELRC3.0 huggingface dataset:
English: However, since aliskiren has been shown to be a substrate for the organic anion-transporting polypeptide 1A2 (OATP1A2) (see section “Organic anion transporting polypeptide (OATP” below) inhibitors), there is a potential for aliskiren to reduce plasma torasemide exposure by an interference with the absorption process.
Maltese: Madankollu, peress li aliskiren intwera li huwa sottostrat għall-polipeptid 1A2 li jittrasporta l anjoni organiċi (OATP1A2) (ara s-sezzjoni “Inibituri tal-polipeptid li jittrasporta l-anjoni organiċi
English: Co-administration of Rasilez had no significant impact on atorvastatin, metformin or amlodipine pharmacokinetics.
Maltese: Meta Rasilez ingħata ma' atorvastatin, metformin jew amlodipine dan ma kellux impatt sinifikanti fuq il-farmakokinetika tagħhom.
English: Aliskiren is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2).
Maltese: Aliskiren mhux irrakkomandat għall-użu f'pazjenti b'indeboliment renali sever (GFR < 30 ml/min/1.73 m2).
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 56 pillola miksija b'rita 56 x 1 pillola miksija b'rita 90 pillola miksija b'rita 98 pillola miksija b'rita
English: The starting doses for aliskiren were 37.5/75/150 mg in the low, mid and high weight groups, respectively.
Maltese: Id-dożi inizjali għal aliskiren kienu ta' 37.5/75/150 mg mogħtija lill-gruppi bl-inqas piż, b'piż medju u bl-ogħla piż, rispettivament.
English: Unit packs containing 7, 14, 28, 30, 50 or 56 tablets.
Maltese: Pakketti uniċi li jkun fihom 7, 14, 28, 30, 50 jew 56 pillola.
English: It is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min/1.73 m2).
Maltese: Mhux irrakkomandat għall-użu f'pazjenti b'indeboliment renali sever (rata tal-filtrazzjoni fil glomeruli (GFR) < 30 ml/min/1.73 m2).
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 tal kliewi kienu rrappurtati f'pazjenti li kienu f'riskju (ara sezzjoni 4.4).
English: Unit packs containing 7, 14, 28, 30, 50, 56 or 90 tablets.
Maltese: Pakketti uniċi li jkun fihom 7, 14, 28, 30, 50, 56 jew 90 pillola.
English: Dual blockade of the RAAS with aliskiren, ARBs or ACEIs Clinical trial data has shown that dual blockade of the RAAS through the combined use of ACEIs, ARBs or aliskiren is associated with a higher frequency of adverse events such as hypotension, stroke, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 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: Aliskiren is an effective once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Maltese: Aliskiren huwa kura effettiva kontra l-pressjoni għolja f'pazjenti aduti, ikun x'ikun is-sess, l-età, l indiċi tal-massa tal-ġisem u l-etniċità.
English: One colonic adenoma and one caecal adenocarcinoma recorded in rats at the dose of 1500 mg/kg/day were not statistically significant.
Maltese: Każ ta' adenoma fil-kolon u każ ta' adenokarċinoma filmusrana l-għamja li kien reġistrat f'firien b'doża ta' 1,500 mg/kg/jum ma kienux statistikament sinifikanti.
English: The AUC is 50% higher in elderly (> 65 years) than in young subjects.
Maltese: L-AUC huwa 50% ogħla fl-anzjani (> 65 sena) milli f'individwi żgħażagħ.
English: In another juvenile toxicity study in 14-day-old rats, aliskiren administration at 300 mg/kg/day (8.5-fold the maximum recommended human dose) was associated with delayed mortality.
Maltese: Fi studju ieħor dwar it-tossiċità fuq annimali mhux adulti fost firien ta' 14-il jum, l-għoti ta' aliskiren f'doża ta' 300 mg/kg/jum (8.5 drabi d-doża umana massima rrakkomandata) kien assoċjat ma' mortalità tardiva.
English: 9 l/h.
Maltese: 150 mg/jum.
English: 98 film-coated tablets (2x49)
Maltese: 98 pillola miksija b'rita (2 pakketti ta' 49)
English: Overall, the mean age of the patients was 11.8 years with 48.6% of patients being in the 6-11 years age group and 51.4% in the 12-17 years age group.
Maltese: Kollox ma' kollox, l-età medja tal-pazjenti kienet ta' 11.8 snin bi 48.6% tal-pazjenti kienu fil-grupp li kellhom bejn 6-11-il sena u 51.4% li kienu fil-grupp ta' bejn 12-17-il sena.
English: Rasilez 300 mg film-coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side.
Maltese: Rasilez 300 mg pilloli miksija b'rita huma pilloli ta' lewn aħmar ċar, konvessi miż-żewġ naħat, ovali, ittimbrati ‘IU' fuq naħa u ‘NVR' fuq in-naħa l-oħra.
English: Treatment effects were similar in patients with diabetes and with renal insufficiency.
Maltese: L-effetti tat trattament kienu simili f'pazjenti b'dijabete u b'insuffiċjenza renali.
English: Hypotension Respiratory, thoracic and mediastinal disorders Uncommon:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: In experimental animals, it has been shown that P-gp is a major determinant of Rasilez bioavailability.
Maltese: F'annimali esperimentali, intwera li P-gp jiddetermina bil-kbir il-biodisponibilità ta' Rasilez.
English: Contraindicated (see section 4.3)
Maltese: (ara sezzjoni 4.4).
English: Multipack: 84 (3 packs of 28) film-coated tablets Multipack: 90 (3 packs of 30) film-coated tablets Multipack: 98 (2 packs of 49) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Maltese: Pakkett b'ħafna: 84 (3 pakketti ta' 28) pillola miksija b'rita Pakkett b'ħafna: 90 (3 pakketti ta' 30) pillola miksija b'rita Pakkett b'ħafna: 98 (2 pakketti ta' 49) pillola miksija b'rita Pakkett b'ħafna: 280 (20 pakkett ta' 14) pillola miksija b'rita.
English: In the event of severe and persistent diarrhoea, Rasilez therapy should be stopped (see section 4.8).
Maltese: Fil-każ ta 'dijarea severa u persistenti, it-terapija b'Rasilez għandha titwaqqaf (ara sezzjoni 4.8).
English: Rasilez 150 mg film-coated tablets - Each tablet contains 150 mg aliskiren (as hemifumarate).
Maltese: Kull pillola fiha 150 mg aliskiren (bħala hemifumarate).
English: The usual recommended starting dose of aliskiren in elderly patients aged 65 years or older is 150 mg.
Maltese: Id-doża tal-bidu normalment rakkomandata ta' aliskiren għal pazjenti anzjani li jkollhom minn 65 sena 'l fuq hija ta' 150 mg.
English: Optional titration of the respective study drug doses to the next highest weight-based dose level was available by doubling the dose with each of the two allowed dose titrations, up to 600 mg (highest studied dose in adults) for aliskiren and 40 mg for enalapril in the ≥80 to ≤150 kg weight group, if medically necessary to control the mean sitting systolic blood pressure (i.e. msSBP should be less than the 90th percentile for age, gender and height).
Maltese: Wieħed seta' jagħżel li ssir titrazzjoni taddożi tal-mediċini studjati rispettivament għall-ogħla livell tad-doża li jmiss u dan skont il-piż billi tkun irduppjata d-doża b'kull waħda miż-żewġ titrazzjonijiet permessi tad-doża, sa 600 mg (l-ogħla doża studjata fost l-adulti) għal aliskiren u sa 40 mg għal enalapril fost il-grupp b'piż ta' bejn ≥80 sa ≤150 kg, jekk meħtieġ medikament sabiex ikun hemm kontroll tal-pressjoni sistolika medja tad-demm waqt li l-pazjent ikun bilqiegħda (i.e. l-msSBP għandha tkun anqas mid-90 perċentwali skont l-età, is sess u t-tul).
English: There were no statistically significant differences in the mean changes in weight, height, or BMI between the treatment groups from Baseline to LT Visit 18 (Week 104) (primary analysis).
Maltese: (indiċi tal-massa tal-ġisem) bejn il-gruppi ta' trattament mil-Linja Bażi sat-18-il Viżta LT (Ġimgħa 104) (analiżi primarja).
English: Rasilez 300 mg film-coated tablets
Maltese: Rasilez 300 mg pilloli miksija b'rita
English: - The concomitant use of Rasilez with an angiotensin converting enzyme inhibitor(ACEI) or an angiotensin II receptor blocker (ARB) is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Maltese: - L-użu fl-istess ħin ta' Rasilez ma' inibitur tal-enzimi li jikkonvertu angiotensin (ACEI) jew imblokkatur tar-riċetturi ta' angiotensin II (ARB) hu kontraindikat f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (GFR ta' < 60 ml/min/1.73m2) (ara sezzjonijiet 4.5 u 5.1).
English: What Rasilez looks like and contents of the pack Rasilez 150 mg film-coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Maltese: Rasilez 150 mg pilloli miksijin b'rita huma pilloli roża ċar, konvessi miż-żewġ naħat, tondi, ittimbrati ‘IL' fuq naħa u ‘NVR' fuq in-naħa l-oħra.
English: Rasilez 150 mg film-coated tablets
Maltese: Rasilez 150 mg pilloli miksija b'rita
English: However, in the subsequent 4 week randomised withdrawal phase of the study (Phase 2), the effect of aliskiren overlapped with the effects observed in patients switched to placebo in all dose groups (low, p=0.8894; mid, p=0.9511; high, p=0.0563).
Maltese: Madankollu, fil-fażi sussegwenti, randomised, ta' 4 ġimgħat, ta' waqfien tal-istudju (Fażi 2), l-effett ta' aliskiren ikkoinċida mal-effetti osservati f'pazjenti li nqalbu għall-plaċebo fil-gruppi tad-dożi kollha (baxxa, p=0.8894; medja, p=0.9511; għolja, p=0.0563). Iddifferenzi medji bejn aliskiren u l-plaċebo għall-gruppi ta' doża baxxa u medju kienu <0.2 mmHg.
English: Dyspnoea
Maltese: Iponatremja
English: MDR1/Mdr1a/1b (P-gp) was found to be the major efflux system involved in intestinal absorption and biliary excretion of aliskiren in preclinical studies (see section 5.2).
Maltese: Fi studji ta' qabel l-użu kliniku instab li MDR1/Mdr1a/1b (P-gp) hija s-sistema ta' effluss li hi l-aktar involuta fl-assorbiment mill-imsaren u tneħħija mill-marrara ta' aliskiren (ara sezzjoni 5.2).
English: NAME OF THE MEDICINAL PRODUCT Rasilez 300 mg film-coated tablets aliskiren
Maltese: Rasilez 300 mg pilloli miksijin b'rita aliskiren
English: At the end of this extension study, changes in msSBP from baseline were similar with aliskiren compared to enalapril (-7.63 mmHg vs. -7.94 mmHg) in the full analysis set.
Maltese: Fi tmien dan l-istudju ta' estensjoni, it-tibdiliet fl-msSBP mil-linja bażi kienu jixbhu lil dawk b'aliskiren meta mqabbel ma' enalapril (-7.63 mmHg vs. -7.94 mmHg) fis-sett sħiħ analizzat.
English: The starting doses for enalapril were 2.5/5/10 mg in the low, mid and high weight groups, respectively.
Maltese: Id-dożi inizjali għal enalapril kienu ta' 2.5/5/10 mg mogħtija lill-gruppi bl-inqas piż, b'piż medju u bl-ogħla piż, rispettivament.
English: In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of aliskiren 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
Maltese: (aliskiren 150 mg/amlodipine 5 mg 2.1% vs amlodipine 10 mg 11.2%).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX FOR UNIT PACK CONTAINING PCTFE/PVC BLISTERS
Maltese: KARTUNA LI JKUN FIHA FOLJI PCTFE/PVC
English: Rasilez 300 mg film-coated tablets Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
Maltese: Rasilez 300 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 300 mg aliskiren (bħala hemifumarate).
English: It is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2).
Maltese: Mhux irrakkomandat għall-użu f'pazjenti b'indeboliment renali sever (GFR < 30 ml/min/1.73 m2).
English: This decrease is likely due to an inhibition of organic anion transporting polypeptide-mediated uptake of aliskiren by components of fruit juice in the gastrointestinal tract.
Maltese: Dan it-tnaqqis x'aktarx jiġri minħabba l-inibizzjoni, medjata minn polipeptajd organiku li jittrasporta il-joni, tal-assorbiment ta' aliskiren permezz ta' komponenti tal-meraq tal-frott mill-passaġġ gastrointestinali.
English: Although aliskiren has known local (gastrointestinal tract) irritation potential, safety margins obtained in humans at the dose of 300 mg during a study in healthy volunteers were considered to be appropriate at 9-11-fold based on faecal concentrations or 6-fold based on mucosa concentrations in comparison with 250 mg/kg/day in the rat carcinogenicity study.
Maltese: Għalkemm huwa magħruf li aliskiren jista' jikkawża irritazzjoni lokali (passaġġ gastrointestinali), il marġini ta' sigurtà miksuba fil-bniedem b'doża ta' 300 mg waqt studju f'voluntiera b'saħħithom kienu meqjusa xierqa b'9-11-il darba ibbażat fuq konċentrazzjonijiet fl-ippurgar jew 6 darbiet fuq konċentrazzjonijiet fil-mukuża meta mqabbla ma' 250 mg/kg/jum fl-istudju dwar il-karċinoġeniċità fil-far.
English: 280 film-coated tablets (20x14)
Maltese: 280 pillola miksija b'rita (20 pakkett ta' x14)
English: In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with aliskiren 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
Maltese: F'pazjenti obeżi li għandhom il-pressjoni għolja li ma wrewx rispons xieraq għal HCTZ 25 mg, kura bl-inklużjoni ta' aliskiren 300 mg ipprovdiet tnaqqis addizzjonali fil-pressjoni tad-demm li seta' jitqabbel ma' kura bl-inklużjoni ta' irbesartan 300 mg jew amlodipine 10 mg.
English: Anaphylactic reactions, hypersensitivity reactions
Maltese: Reazzjonijiet anafilattiċi, reazzjonijiet ta' sensittività eċċessiva Disturbi fis-sistema nervuża
English: The efficacy and safety of aliskiren-based therapy were compared to ramipril-based therapy in a 9-month non-inferiority study in 901 elderly patients (≥ 65 years) with essential systolic hypertension.
Maltese: L-effikaċja u s-sigurtà tat-terapija b'aliskiren tqabblu mat-terapija b'ramipril waqt studju mhux inferjuri li dam għaddej 9 xhur fost 901 pazjent anzjan (≥ 65 sena) bi pressjoni għolja sistolika essenzjali.
English: No overall clinically relevant adverse impact on paediatric patients aged 6 to 17 years was observed after treatment with aliskiren for up to one year based on physical development, assessed in patients with primary or secondary hypertension, and neurocognitive development assessed only in patients with secondary hypertension (19 patients: 9 previously treated with aliskiren and 10 previously treated with enalapril) (see section 4.2, 4.8, 5.1 and 5.2).
Maltese: Kollox ma' kollox, ma deher l-ebda impatt avvers relevanti klinikament f'pazjenti pedjatriċi ta' bejn is-6 u s-17-il sena wara trattament b'aliskiren sa sena skont l iżvilupp fiżiku, evalwat f'pazjenti bi pressjoni għolja primarja jew sekondarja, u l-iżvilupp newrokonjittiv evalwat 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 (ara sezzjoni 4.2, 4.8, 5.1 u 5.2).
English: NAME OF THE MEDICINAL PRODUCT Rasilez 150 mg film-coated tablets aliskiren
Maltese: Rasilez 150 mg pilloli miksijin b'rita aliskiren
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR UNIT PACK CONTAINING PA/ALU/PVC BLISTERS
Maltese: KARTUNA LI JKUN FIHA FOLJI PA/ALU/PVC
English: Preclinical studies indicate that aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion.
Maltese: aliskiren minħabba dan l-effett addittiv ma ġiex studjat u għaldaqstant ma jistax jiġi eskluż.
English: 49 x 1 film-coated tablets.
Maltese: 84 pillola miksija b'rita.
English: These combinations were well tolerated.
Maltese: Dawn il kombinazzjonijiet kienu tollerati sew.
English: Findings during repeat-dose toxicity studies in animals were consistent with the known local (gastrointestinal tract) irritation potential or the expected pharmacological effects of aliskiren.
Maltese: Is-sejbiet waqt studji ta' tossiċità f'annimali minn dożi ripetuti kienu konsistenti mal-potenzjal ta' irritazzjoni lokali (passaġġ gastrointestinali) li hi magħrufa jew mal-effetti farmakoloġiċi mistennija ta' aliskiren.
English: In a 36-week study involving 820 patients with ischaemic left ventricular dysfunction, no changes in ventricular re-modelling as assessed by left ventricular end systolic volume were detected with aliskiren compared to placebo on top of background therapy.
Maltese: Waqt studju li dam għaddej 36 ġimgħa fost 820 pazjent b'disfunzjoni iskemika tal-ventrikolu xellugi, ma deher l-ebda tibdil fl-immudellar mill-ġdid tal-ventrikolu li kien evalwat permezz tal-volum sistoliku aħħari tal-ventrikolu xellugi b'aliskiren meta mqabbel mal-plaċebo fil-quċċata tat-terapija ta'
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 84 (3 packs of 28) film-coated tablets Multipack: 98 (2 packs of 49) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Maltese: Pakkett b'ħafna: 84 (3 pakketti ta' 28) pillola miksija b'rita Pakkett b'ħafna: 98 (2 pakketti ta' 49) pillola miksija b'rita Pakkett b'ħafna: 280 (20 pakkett ta' 14) pillola miksija b'rita.
English: Over the 12 week period, aliskiren monotherapy lowered systolic/diastolic blood pressure by 14.0/5.1 mmHg, compared to 11.6/3.6 mmHg for ramipril, consistent with aliskiren being non-inferior to ramipril at the doses chosen and the differences in systolic and diastolic blood pressure were statistically significant.
Maltese: 6/3.6 mmHg għal ramipril, konsistenti b'aliskiren li mhuwiex inferjuri għal ramipril bid-dożi magħżula u d-differenzi fil-pressjoni sistolika u dijastolika tad-demm kienu sinifikanti statistikament.
English: Rasilez 150 mg film-coated tablets are available in the following packs: - Unit packs containing 7, 14, 28, 30, 50, 56, 90 or 98 tablets - Unit packs containing 56x1 tablets in perforated unit-dose blisters - Multipacks containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets - Multipacks containing 98 (2x49x1) tablets in perforated unit-dose blisters
Maltese: - Pakketti uniċi li jkun fihom 7, 14, 28, 30, 50, 56, 90 jew 98 pillola - Pakketti uniċi li jkun fihom 56x1 pillola f'folji perforati li jistgħu jinqasmu f'dożi singoli
English: The primary endpoint was a composite of cardiovascular and renal complications.
Maltese: It tragward finali primarju kien taħlita ta' kumplikazzjonijiet kardjovaskulari u renali.
English: Rasilez 300 mg film-coated tablets are available in the following packs: - Unit packs containing 7, 14, 28, 30, 50, 56, 90 or 98 tablets - Unit packs containing 56x1 tablets in perforated unit-dose blisters - Multipacks containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets - Multipacks containing 98 (2x49x1) tablets in perforated unit-dose blisters
Maltese: - Pakketti multipli li jkun fihom 84 (3x28), 90 (3x30), 98 (2x49) jew 280 (20x14) pillola - Pakketti multipli li jkun fihom 98 (2x49x1) pillola f'folji perforati li jistgħu jinqasmu f'dożi singoli
English: The safety and efficacy of aliskiren in children aged 6 to 17 years have not yet been established.
Maltese: Is- sigurtà u l-effikaċja ta' aliskiren fit-tfal minn età ta' 6 sa 17-il sena għadhom ma ġewx determinati s'issa.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Rasilez 150 mg film-coated tablets Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
Maltese: Rasilez 150 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 150 mg aliskiren (bħala hemifumarate).
English: Not known (frequency cannot be estimated from the available data): spinning sensation, low level of sodium in the blood, shortness of breath, nausea, vomiting, signs of liver disorder (nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes).
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli): sensazzjoni li kollox qed idur bik, livell baxx ta' sodju fid-demm, qtugħ ta' nifs, dardir, rimettar, sinjali ta' disturb tal-fwied (dardir, nuqqas ta' aptit, awrina ta' lewn skur jew sfurija tal-ġilda u l-għajnejn).
English: Fertility
Maltese: Iperkalimja
English: Hypersensitivity reactions including anaphylactic reactions and angioedema In controlled clinical studies, angioedema and hypersensitivity reactions occurred rarely during treatment with aliskiren with rates comparable to treatment with placebo or comparators.
Maltese: Reazzjonijiet ta' sensittività eċċessiva inkluż reazzjonijiet anafilattiċi u anġjoedema Fi studji kliniċi kkontrollati, anġjoedema u reazzjonijiet ta' sensittività eċċessiva seħħew b'mod rari waqt il-kura b'aliskiren b'rati li setgħu jitqabblu mal-kura bi plaċebo jew komparaturi.
English: B. PACKAGE LEAFLET
Maltese: Karatteristiċi f'pazjenti
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 280 (20 packs of 14) film-coated tablets Multipack: 98 (2 packs of 49 x 1) film-coated tablets
Maltese: Pakkett b'ħafna: 98 (2 pakketti ta' 49 x 1) pillola miksija b'rita
English: However, the significance of the non-inferiority testing was not maintained when the analysis was performed on the per-protocol set in which the least square mean change in msSBP from baseline was -7.84 mmHg with aliskiren and -9.04 mmHg with enalapril.
Maltese: Madanakollu, is-sinifikat tal-ittestjar dwar in-nuqqas ta' inferjorità ma nżammx meta lanaliżi twettqet fuq is-sett skont il-protokoll li fih l-inqas bidla kwadra medja fl-msSBP mil-linja bażi kienet ta' -7.84 mmHg b'aliskiren u ta' -9.04 mmHg b'enalapril.
English: Renal dysfunction
Maltese: Artralġja
English: The usual recommended starting dose of aliskiren in elderly patients is 150 mg.
Maltese: Id-doża inizjali ta' aliskiren irrakkomandata għal pazjenti anzjani hi ta' 150 mg.
English: Rasilez 300 mg film-coated tablets - Each tablet contains 300 mg aliskiren (as hemifumarate).
Maltese: Kull pillola fiha 300 mg aliskiren (bħala hemifumarate).
English: - if the patient is less than 2 years of age.
Maltese: - jekk il-pazjent ikollu età ta' inqas minn sentejn.
English: Results from a mechanistic study showed that the MDR1 (P-gp) gene expression in juvenile rats was significantly lower when compared to adult rats.
Maltese: Skont riżultati miksuba minn studju mekkanistiku deher li l-espressjoni tal-ġene MDR1 (P-gp) f'firien mhux adulti kien sinifikament anqas meta mqabbel mal-firien adulti.
English: It should not be used in children from 2 to less than 6 years of age, and is not recommended for use in children and adolescents from 6 to less than 18 years of age.
Maltese: M'għandhiex tintuża fi tfal fl-età ta' minn sentejn sa inqas minn 6 snin u mhijiex irrakkomandata li tintuża fi tfal u adolexxenti fl-età ta' minn 6 snin sa inqas minn 18-il sena.
English: 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: 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: The incidence of adverse events tended to be higher in patients with diabetes, or with GFR <60 ml/min/1.73 m², or with age ≥ 65 years; however, there was no difference between patients treated with aliskiren and those treated with enalapril.
Maltese: <60 ml/min/1.73 m2, jew li għandhom ≥ 65 sena; madanakollu, ma kien hemm ebda differenza bejn pazjenti ttratati b'aliskiren u dawk ittrattati b'enalapril.