FrancophonIA/ELRC3.0 huggingface dataset:
English: The other ingredients are crospovidone type A, hypromellose substitution type 2910 (3 mPa s), magnesium stearate, macrogol 4000, microcrystalline cellulose, povidone K-30, colloidal anhydrous silica, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).
Maltese: Is-sustanzi l-oħra huma crospovidone tip A, hypromellose tip ta' sostituzzjoni 2910 (3 mPa s), magnesium stearate, macrogol 4000, microcrystalline cellulose, povidone K-30, colloidal anhydrous silica, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).
English: Black iron oxide (E 172) Red iron oxide (E 172)
Maltese: Iron oxide iswed (E 172)
English: PVC/polychlorotrifluoroethylene (PCTFE) - Alu blisters:
Maltese: Folji tal-PVC/polychlorotrifluoroethylene (PCTFE) - Alu:
English: INFORMATION IN BRAILLE Rasilez 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Rasilez 300 mg
English: Pharmacokinetic interaction with other medicinal products Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Maltese: Interazzjoni farmakokinetika ma' prodotti mediċinali oħra Komposti kimiċi li kienu investigati fi studji ta' farmakokinetika klinika kienu jinkludu acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate u hydrochlorothiazide.
English: INFORMATION IN BRAILLE Rasilez 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Rasilez 150 mg
English: This medicine contains an active substance called aliskiren.
Maltese: Din il-mediċina fiha sustanza attiva msejħa aliskiren.
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Maltese: 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) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; renin inhibitor, ATC code: C09XA02
Maltese: Sustanzi li jaħdmu fuq is-sistema tar-renin-angiotensin; inibitur tar renin, Kodiċi ATC: C09XA02 Mekkaniżmu ta' azzjoni
English: Rasilez 300 mg film-coated tablets EU/1/07/405/011-020
Maltese: Rasilez 300 mg pilloli miksija b'rita EU/1/07/405/011-020
English: Rasilez 150 mg film-coated tablets PA/Alu/PVC - Alu blisters:
Maltese: Rasilez 150 mg pilloli miksija b'rita Folji PA/Alu/PVC - Alu:
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Rasilez.
Maltese: Indutturi ta' P-gp (St. John's wort, rifampicin) għalhekk jistgħu jnaqqsu l-biodisponibilità ta' Rasilez.
English: What Rasilez contains - The active substance is aliskiren (as hemifumarate).
Maltese: X'fih Rasilez - Is-sustanza attiva hi aliskiren (bħala hemifumarate).
English: An increased incidence of hyperkalaemia (20.9% versus 17.5%), renal impairment/renal failure (16.6% versus 12.1%) and hypotension (17.1% versus 12.6%) was observed in the aliskiren group compared with placebo and was greater in patients with diabetes.
Maltese: iperkalemija (20.9% kontra 17.5%), fl-indeboliment tal-kliewi/insuffiċjenza tal-kliewi (16.6% kontra 12.1%) u fil-pressjoni baxxa (17.1% kontra 12.6%) fost il-grupp mogħti aliskiren imqabbel mal plaċebo u kienet akbar fost il-pazjenti bid-dijabete.
English: Rasilez 150 mg film-coated tablets EU/1/07/405/001-010
Maltese: Rasilez 150 mg pilloli miksija b'rita EU/1/07/405/001-010
English: NAME OF THE MARKETING AUTHORISATION HOLDER Noden Pharma DAC
Maltese: Il-Manifattur Noden Pharma DAC
English: Do not take this medicine if you are pregnant (see section “Do not take Rasilez”).
Maltese: Tiħux din il-mediċina jekk ħriġt tqila (ara sezzjoni “Tiħux Rasilez”).
English: - Children from birth to less than 2 years (see sections 4.2 and 5.3).
Maltese: - Tfal mit-twelid sal-età ta' inqas minn sentejn (ara sezzjonijiet 4.2 u 5.3).
English: Mean weight was 68.0 kg with 57.7% of patients having BMI greater than or equal to the 95th percentile for age and gender.
Maltese: Il-piż medju kien ta' 68.0 kg b'57.7% tal-pazjenti kellhom BMI akbar minn jew daqs dak fil-95 perċentwali skont l-età u s-sess.
English: Combination therapy studies are available for aliskiren added to the diuretic hydrochlorothiazide, the calcium channel blocker amlodipine and the beta blocker atenolol.
Maltese: Hemm studji b'terapija ta' kombinazzjoni għal aliskiren miżjud mad-dijuretiku hydrochlorthiazide, l imblukkatur tal-kanali tal-calcium amlodipine u l-imblukkatur beta atenolol.
English: Results from an in vitro MDR1 human tissue study suggested an age and tissue dependent pattern of MDR1 (P-gp) transporter maturation.
Maltese: Ir-riżultati minn studju tat-tessut tal-bniedem MDR1 in vitro ssuġġerew mudell ta' maturazzjoni tat trasportaturi MDR1 (P-gp) dipendenti fuq l-età u t-tessuti.
English: Warfarin The effects of aliskiren on warfarin pharmacokinetics have not been evaluated.
Maltese: Warfarin L-effetti ta' aliskiren fuq il-farmakokinetika ta' warfarin ma kienux evalwati.
English: In a multicentre, randomised, double-blind, 8-week study with aliskiren monotherapy (3 dose groups by weight category [≥20 kg to <50 kg; ≥50 kg to <80 kg; ≥80 kg to ≤150 kg]: low 6.25/12.5/25 mg [0.13-0.31 mg/kg]; mid 37.5/75/150 mg [0.75-1.88 mg/kg]; and high dose 150/300/600 mg [3.0-7.5 mg/kg], with a wide dose ratio between the low, mid and high dose groups [1:6:24]) in 267 paediatric hypertensive patients aged 6 to 17 years, mostly overweight/obese, aliskiren lowered office and ambulatory blood pressure in a dose-dependent manner during the initial 4 week dose-finding phase of the study (Phase 1).
Maltese: 1.88 mg/kg]; u għolja 150/300/600 mg [3.0-7.5 mg/kg], bi proporzjon ta' doża wiesa' bejn il-gruppi ta' doża baxxa, medja u dik għolja [1:6:24]) fuq 267 pazjent pedjatriku bi pressjoni għolja b'età minn 6 snin sa 17-il sena, il-biċċa l-kbira b'piż żejjed/ħoxnin ħafna, aliskiren naqqas il-pressjoni meħuda fluffiċċju u dik ambulatorja b'mod dipendenti mid-doża waqt il-fażi inizjali ta' 4 ġimgħat tal-istudju li fiha ġiet determinata d-doża (Fażi 1).
English: 56 x 1 film-coated tablet
Maltese: 56 x 1 pillola miksija b'rita
English: Other medicines and Rasilez
Maltese: Mediċini oħra u Rasilez
English: Angioedema, erythema Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskolu-skelettriċi u tat-tessuti konnettivi Komuni:
English: Uncommon (may affect up to 1 in 100 people): Skin rash (this may also be a sign of allergic reactions or angioedema - see “Rare” side effects below), kidney problems including acute renal failure (severely decreased urine output), swelling of hands, ankles or feet (peripheral oedema), severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin, blistering of the lips, eyes or mouth, skin peeling, fever), low blood pressure, palpitations, cough, itching, itchy rash (urticaria), increased liver enzymes.
Maltese: Raxx tal-ġilda (dan jista' jkun sinjali ta' reazzjonijiet allerġiċi jew anġjoedima - ara l-effetti sekondarji “Rari” hawn taħt), problemi bil-kliewi li jinkludu indeboliment akut tal-kliewi (tnaqqis serju fl-awrina), nefħa tal-idejn, għekiesi jew saqajn (edema periferali), reazzjonijiet serji fuq il-ġilda (nekroliżi epidermali tossika u/jew reazzjonijiet mukużi fil-ħalq - ħmura fil-ġilda, infafet fix-xofftejn, fl-għajnejn jew il-ħalq, tqaxxir talġilda, deni), pressjoni tad-demm baxxa, palpitazzjonijiet, sogħla, ħakk, raxx bil-ħakk (urtikarja), żieda fl-enzimi tal-fwied.
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of aliskiren.
Maltese: Fi provi kliniċi kkontrollati, bidliet klinikament rilevanti f'parametri standard tal-laboratorju kienu assoċjati b'mod mhux komuni ma' l-għoti ta' aliskiren.
English: Compared to a diuretic (hydrochlorothiazide - HCTZ), Rasilez 300 mg lowered systolic/diastolic blood pressure by 17.0/12.3 mmHg, compared to 14.4/10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Maltese: (hydrochlorothiazide - HCTZ), Rasilez 300 mg naqqas il-pressjoni sistolika/dijastolika tad-demm b'17.0/12.3 mmHg, imqabbel ma' 14.2/10.5 mmHg għal HCTZ 25 mg wara 12-il ġimgħa ta' kura.
English: Meals with a high fat content reduce Cmax by 85% and AUC by 70%.
Maltese: xaħam naqqsu is-Cmax b' 85% u l-AUC b'70%.
English: In particular there was an increased incidence of renal dysfunction (14.5% versus 12.4%), hyperkalaemia (39.1% versus 29.0%), hypotension-related events (19.9% versus 16.3%) and adjudicated stroke endpoints (3.4% versus 2.7%).
Maltese: disfunzjoni renali (14.5% kontra 12.4%), iperkalemija (39.1% kontra 29.0%), episodji b'rabta ta' pressjoni baxxa (19.9% kontra 16.
English: Multipacks containing 280 (20x14) tablets.
Maltese: Pakketti multipli li jkun fihom 280 (20x14) pillola.
English: In clinical studies in hypertensive patients, Rasilez had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Maltese: Rasilez ma kellux effetti klinikament importanti fuq il-kolesterol totali, lipoproteina tal-kolesterol ta' densità għolja (HDL-C), trigliċeridi ta' waqt is-sawm, glucose ta' waqt is-sawm jew uric acid.
English: Titanium dioxide (E 171)
Maltese: Iron oxide aħmar (E 172)
English: Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndrome, toxic epidermal necrolysis (TEN) and oral mucosal reactions, rash, pruritus, urticaria
Maltese: Stevens Johnson, nekroliżi epidermali tossika (TEN) u reazzjonijiet mukużi fil-ħalq, raxx, ħakk, urtikarja
English: The starting dose in each group was assigned depending on weight with three groups: ≥20 to <50 kg, ≥50 to <80 kg, and ≥80 to ≤150 kg.
Maltese: Id-doża inizjali f'kull grupp tfasslet skont il-piż fit-tliet gruppi: minn ≥20 sa <50 kg, minn ≥50 sa <80 kg, u minn ≥80 sa ≤150 kg.
English: - The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-glycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated (see section 4.5).
Maltese: - L-użu konkomittanti ta' aliskiren ma' ciclosporin u itraconazole, żewġ inibituri ta' P-gp qawwija ħafna, u inibituri ta' P-glikoproteina (P-gp) qawwija oħrajn (eż. quinidine), huwa kontra-indikat (ara sezzjoni 4.5).
English: The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
Maltese: Il potenzjal ta' interazzjonijiet fis-sit P-gp x'aktarx li jkunu jiddependu mill-grad ta' inibizzjoni tattrasportatur.
English: Multipacks containing 98 (2x49x1) tablets in perforated unit dose blisters.
Maltese: Pakketti multipli li jkun fihom 98 (2x49x1) pillola f'folji perforati li jistgħu jinqasmu f'dożi singoli.
English: 90 film-coated tablets (3x30)
Maltese: 90 pillola miksija b'rita (3 pakketti ta' 30)
English: Currently available data are described in sections 4.8, 5.1, and 5.2.
Maltese: Data disponibbli hija deskritta fis-sezzjonijiet 4.8, 5.1, u 5
English: Multipacks containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets.
Maltese: Pakketti multipli li jkun fihom 84 (3x28), 90 (3x30), 98 (2x49) jew 280 (20x14) pillola.
English: Study results indicated a non-significant effect of aliskiren with a hazard ratio of 0.92 (95% Confidence Interval: 0.76-1.12; p=0.41, aliskiren vs. placebo).
Maltese: Kunfidenza: 0.76-1.12; p=0.41, aliskiren vs. placebo).
English: 98 film-coated tablets (2x49x1)
Maltese: 98 pillola miksija b'rita (2 pakketti ta' 49x1)
English: In clinical studies aliskiren has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated GFR < 30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
Maltese: Fil-provi kliniċi, aliskiren ma ġiex investigat f'pazjenti li għandhom il-pressjoni għolja u li jbatu minn indeboliment renali sever (krejatinina fis-serum ≥ 150 μmol/l jew 1.70 mg/dl fin-nisa u ≥ 177 μmol/l jew 2.00 mg/dl fl-irġiel u/jew rata ta' GFR stmata < 30 ml/min/1.73 m2), li kellhom dijalisi fil-passat,
English: Aliskiren 150 mg (increased to 300 mg if tolerated) added to conventional therapy was evaluated in a double-blind placebo-controlled randomised trial in 1,639 patients with reduced ejection fraction hospitalised for an episode of acute heart failure (NYHA Class III-IV) who were haemodynamically stable at baseline.
Maltese: Aliskiren 150 mg (miżjud għal 300 mg jekk ittollerat) mogħti mat-terapija konvenzjonali kien evalwat waqt prova randomizzata double-blind ikkontrollata bil-plaċebo f'1,639 pazjent bil-frazzjoni tal ejezzjoni mnaqqsa u li kellhom jiddaħħlu l-isptar minħabba episodju ta' insuffiċjenza akuta tal-qalb
English: Rasilez may be used alone or in combination with other antihypertensive agents with the exception of use in combination with angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.1).
Maltese: Rasilez jista' jintuża waħdu jew ma' aġenti oħra li jbaxxu l-pressjoni bl-eċċezzjoni ta' użu flimkien ma' impedituri tal-enzima li tikkonverti angiotensin (ACEI) jew ta' imblukkaturi tar-riċetturi ta' angiotensin II (ARB) f'pazjenti b'dijabete mellitus jew b'indeboliment renali (rata tal-filtrazzjoni filglomeruli (GFR) < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: There was no significant benefit of adding aliskiren to enalapril (primary endpoint: hazard ratio of 0.93 with 95% Confidence Interval: 0.85-1.03; p=0.1724, combination versus enalapril).
Maltese: Ma kienx hemm benefiċċju sinifikattiv meta aliskiren żdied ma' enalapril (endpoint primarju: proporzjon ta' periklu ta' 0.93 b'Intervall ta' Kunfidenza ta' 95%: 0.85-1.03; p=0.1724, bejn il-mediċini mogħtija flimkien u enalapril waħdu).
English: Aliskiren is minimally excreted via the renal route, and only 0.6% of the aliskiren dose is recovered in urine following oral administration (see section 5.2).
Maltese: Aliskiren jitneħħa b'mod minimu permezz tar rotta renali, u wara għoti orali 0.6% biss tad-doża ta' aliskiren hija rkuprata fl-awrina (ara sezzjoni 5.2).
English: Torasemide renal excretion is known to be mediated by organic anion transporters (OATs).
Maltese: It-tneħħija renali ta' torasemide hija magħrufa li hija medjata minn trasportaturi tal anjoni organiċi (OATs - organic anion transporters).
English: Co-administration of aliskiren with either metformin (↓28%), amlodipine (↑29%) or cimetidine
Maltese: Meta aliskiren jingħata ma' metformin (↓28%), amlodipine (↑29%) jew cimetidine (↑19%) is-Cmax jew AUC ta' Rasilez inbidlu b'bejn 20% u 30%.
English: In the subgroup of patients with diabetes mellitus the hazard ratio was 1.64 in favour of placebo (95% Confidence Interval: 1.15-2.33), whereas the hazard ratio in the subgroup of patients without diabetes was 0.69 in favour of aliskiren (95% Confidence Interval: 0.50-0.94); p-value for interaction = 0.0003.
Maltese: Fis-sottogrupp ta' pazjenti bid-dijabete mellitus il-proporzjon ta' periklu kien ta' 1.64 favur il-plaċebo (95% Intervall ta' Kunfidenza: 1.15-2.33), filwaqt li r-rata ta' periklu fis-sottogrupp ta' pazjenti mingħajr id-dijabete kien ta' 0.69 favur aliskiren (95% Intervall ta'
English: Other inducers of P-gp (St. John's wort) might decrease the bioavailability of aliskiren.
Maltese: Indutturi oħrajn ta' P-gp (St. John's Wort) jistgħu jnaqqsu l-bijodisponibilità ta' aliskiren.
English: Multipacks containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets.
Maltese: Pakketti multipli li jkun fihom 84 (3x28), 98 (2x49) jew 280 (20x14) pillola.
English: See also section “Do not take Rasilez”.
Maltese: Ara wkoll is-sezzjoni “Tiħux Rasilez”.
English: Rasilez 150 mg film-coated tablets Rasilez 300 mg film-coated tablets
Maltese: Rasilez 150 mg pilloli miksijin b'rita Rasilez 300 mg pilloli miksija b'rita
English: Posology
Maltese: Funzjonali
English: Nausea, vomiting
Maltese: Anġjoedima, eritema
English: At steady state meals with low fat content reduce Cmax by 76% and AUC0-tau by 67% in hypertensive patients.
Maltese: Fi stadju stabbli ikliet b'kontenut baxx ta' xaħam naqqas is-Cmax b'76% u l-AUC0-tau b'67% f'pazjenti bi pressjoni għolja.
English: Rasilez 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: Rasilez m'għandux jintuża fit-tfal minn età ta' sentejn sa inqas minn 6 snin minħabba tħassib dwar sigurtà dovut għal esponiment eċċessiv potenzjali għal aliskiren (ara sezzjonijiet 4.3, 4.4, 5.2 u 5.3).
English: Aliskiren has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Maltese: Aliskiren ġie evalwat għas-sigurtà f'aktar minn 7,800 pazjent, inklużi aktar minn 2,300 ittrattati għal aktar minn 6 xhur, u aktar minn 1,200 għal aktar minn sena.
English: Co-administration of ketoconazole (200 mg) or verapamil (240 mg) with aliskiren (300 mg) resulted in a 76% or 97% increase in aliskiren AUC, respectively.
Maltese: L-għoti ta' ketoconazole (200 mg) jew verapamil (240 mg) ma' aliskiren (300 mg) irriżulta f'żieda ta'
English: (95.4% Confidence Interval: 0.987, 1.218, 2-sided p=0.0787).
Maltese: Ir-riżultati finali tal-istudji indikaw proporzjon ta' periklu għattragward finali primarju ta' 1.097 favur plaċebo (95.4% Confidence Interval: 0.987, 1.218, 2-sided p=0.0787).
English: The mean weight of patients concomitantly treated with furosemide and 300 mg aliskiren (84.6 kg) was higher than the weight of patients treated with furosemide alone (83.4 kg).
Maltese: 300 mg aliskiren (84.6 kg) kien aktar mill-piż tal-pazjenti kkurati b'furosemide waħdu (83.4 kg).
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 ta' l-Assoċjazzjoni Tal-Qalb ta' New York [NYHA]) (ara sezzjoni 5.1).
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, double blind, 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: 84 film-coated tablets (3x28)
Maltese: 84 pillola miksija b'rita (3 pakketti ta' 28)
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 akut tal-kiewi, meta l-pazjenti bi stenożi tal-arterja renali jiġu kkurati b'aliskiren.
English: Co-administration 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 tal meraq 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: Unit packs containing 14, 28, 30, 50, 56, 90 or 98 tablets.
Maltese: Pakketti uniċi li jkun fihom 14, 28, 30, 50, 56, 90 jew 98 pillola.
English: Hence, interactions due to inhibition or induction of CYP450 isoenzymes are not expected.
Maltese: Għalhekk, interazzjonijiet minħabba l-inibizzjoni jew l induzzjoni ta' l-isoenzimi CYP450 mhumiex mistennija.
English: After multiple doses of furosemide (60 mg/day) co-administered with aliskiren (300 mg/day) to patients with heart failure the urinary sodium excretion and the urine volume were reduced during the first 4 hours by 31% and 24%, respectively, as compared to furosemide alone.
Maltese: mogħti ma' aliskiren (300 mg/jum) lill-pazjenti b'insuffiċjenza tal-qalb, it-tneħħija tas-sodium mal awrina u l-volum tal-awrina waqt l-ewwel 4 sigħat tnaqqsu b'31% u 24%, rispettivament, meta mqabbla ma' furosemide waħdu.
English: In a pooled analysis of efficacy and safety data from clinical studies 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: 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: 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: Unit packs containing 56x1 tablets in perforated unit dose blisters.
Maltese: Pakketti uniċi li jkun fihom 56x1 pillola f'folji perforati li jistgħu jinqasmu f'dożi singoli.
English: The safety and efficacy of Rasilez in children aged 6 to 17 years have not yet been established.
Maltese: Is-sigurtà u l effikaċja ta' Rasilez fit-tfal minn età ta' 6 snin sa 17-il sena għadhom ma ġewx determinati s'issa.
English: - if you have diabetes or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril or an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan.
Maltese: - jekk għandek id-dijabete jew funzjoni indebolita tal-kliewi u qed tiġi kkurat b'xi waħda minn dawn iż-żewġ klassijiet ta' mediċini li ġejjin li jintużaw għal kura ta' pressjoni tad-demm għolja: inibitur tal-enzima li tikkonverti angiotensin bħal enalapril, lisinopril, ramipril jew imblokkatur tar-riċetturi ta' angiotensin II bħal valsartan, telmisartan, irbesartan.
English: Liver disorder*, jaundice, hepatitis, liver failure** Skin and subcutaneous tissue disorders Uncommon:
Maltese: Disturbi fil-fwied*, suffejra, epatite, insuffiċjenza tal-fwied**
English: Organic anion transporting polypeptide (OATP) inhibitors Preclinical studies indicate that aliskiren might be a substrate of organic anion transporting polypeptides.
Maltese: (OATP - organic anion transporting polypeptide)” hawn taħt), hemm potenzjal li aliskiren inaqqas lesponiment għal torasemide fil-plażma permezz ta' interferenza mal-proċess ta' assorbiment.
English: - if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis), itraconazole (a medicine used to treat fungal infections) or quinidine (a medicine used to correct heart rhythm).
Maltese: - jekk qed tieħu ciclosporin (mediċina li tintuża f'każ ta' trapjant sabiex jiġi evitat li l-organu jiġi riġettat jew għal kundizzjonijiet oħra, eż artrite rewmatojde jew dermatite atopika), itraconazole (mediċina wżata biex tikkura infezzjonijiet tal-fungu) jew quinidine (mediċina li tintuża biex tirranġa r-ritmu tal-qalb).