FrancophonIA/ELRC3.0 huggingface dataset:
English: • Severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin,
Maltese: • Reazzjonijiet serji fuq il-ġilda (nekroliżi epidermali tossika u/jew reazzjonijiet mukużi fil-ħalq
English: Liver disordera,*, hepatitisa, liver failurea,** Skin and subcutaneous tissue disorders Common
Maltese: Disturb fil-fwieda,*, epatitea, insuffiċjenza tal-fwieda,** Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Komuni
English: In a study in 880 randomised patients not adequately responsive to aliskiren 300 mg treatment, the combination of aliskiren/hydrochlorothiazide 300 mg/25 mg produced systolic/diastolic blood pressure reductions of 15.8/11.0 mmHg, which were significantly greater than aliskiren 300 mg monotherapy.
Maltese: Fi studju fuq 880 pazjent randomised li ma wrewx rispons xieraq għal kura b'aliskiren 300 mg, ittaħlita aliskiren/hydrochlorothiazide 300 mg/25 mg ikkawżat tnaqqis fil-pressjoni sistolika/dijastolika tad-demm ta' 15.
English: Cardiac arrhythmiash
Maltese: Arritemiji kardijaċih
English: The risk of hypokalaemia is greater in patients with cirrhosis of the liver, patients experiencing brisk diuresis, patients with inadequate oral electrolyte intake and patients receiving concomitant therapy with corticosteroids or adrenocorticotropic hormone (ACTH) (see sections 4.5 and 4.8).
Maltese: Ir-riskju ta' ipokalimja huwa akbar f'pazjenti b'ċirrożi tal-fwied, pazjenti li jkunu qed jingħataw dijureżi mgħaġġla, pazjenti li ma jkunux qed jieħdu ammont xieraq ta' elettroliti u pazjenti li jkunu qed jirċievu terapija fl-istess ħin b'kortikosterojdi jew ormon adreno-kortikotropiku (ACTH) (ara sezzjonijiet 4.5 u 4.8).
English: Cutaneous lupus erythematosus-like reactionsh, reactivation of cutaneous lupus erythematosush, vasculitis necrotising and toxic epidermal necrolysish
Maltese: Reazzjonijiet fil-ġilda bħal f'lupus erythematosush, riattivazzjoni ta' lupus erythematosus fil-ġildah, vaskulite li tinnekrotizza u nekroliżi epidermali tossikah
English: No pharmacokinetic data on Rasilez HCT are available in the paediatric population.
Maltese: M'hemmx dejta farmakokinetika dwar Rasilez HCT għall-popolazzjoni pedjatrika.
English: The average differences between aliskiren and placebo for the low and mid dose groups were <0.2 mmHg.
Maltese: Id-differenzi medji bejn aliskiren u l-plaċebo għall-gruppi tad-doża baxxa u tannofs kienu ta' <0.2 mmHg.
English: Extensive clinical data are available for hydrochlorothiazide and these are reflected in the relevant sections.
Maltese: Hemm dejta kliniċi estensivi għal hydrochlorothiazide u dawn kienu riflessi fissezzjonijiet rilevanti.
English: MDR1/Mdr1a/1b (P-gp) was found to be the major efflux system involved in intestinal absorption and biliary excretion of aliskiren in pre-clinical studies.
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 t-tneħħija mill-marrara ta' aliskiren.
English: Rasilez HCT 150 mg/25 mg film-coated tablets
Maltese: Rasilez HCT 150 mg/25 mg pilloli miksija b'rita
English: 280 film-coated tablets (20 packs of 1)
Maltese: 280 pillola miksija b'rita (20 pakkett ta' 1)
English: • Sleep disturbances
Maltese: • Disturb fil-vista
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: If blood pressure remains uncontrolled after 2-4 weeks of therapy, the dose may be titrated up to a maximum of Rasilez HCT 300 mg/25 mg daily.
Maltese: Jekk il-pressjoni tibqa' ma tkunx ikkontrollata wara 2-4 ġimgħat ta' kura, d-doża tista' tiġi titrata sa massimu ta' Rasilez HCT 300 mg/25 mg kuljum.
English: Co-administration of aliskiren had no significant impact on atorvastatin, metformin or amlodipine pharmacokinetics.
Maltese: Meta aliskiren ingħata ma' atorvastatin, metformin jew amlodipine dan ma kellux impatt sinifikanti fuq il-farmakokinetika tagħhom.
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: The incidence of adverse reactions showed no association with gender, age, body mass index, race or ethnicity.
Maltese: Il-frekwenza ta' reazzjonijiet avversi wriet li m'hemmx assoċjazzjoni mas-sess, età, indiċi tal-massa tal-ġisem, razza jew etniċità.
English: The mode of action of thiazides is through inhibition of the Na+Cl- symporter by competing for the Cl- site, thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly by this diuretic action reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Maltese: Il-mod ta' kif jaħdmu d-dijuretiċi thiazide huwa permezz tal-inibizzjoni tas-simportatur Na+Cl- billi jikkompeti għas-sit tas-Cl-, b'hekk jeffettwa il-mekkaniżmi li bihom jerġgħu jiġu assorbiti l-elettroliti: iżid direttament l-eskrezzjoni ta' sodium u chloride b'madwar l-istess ammont, u indirettament b'din l-azzjoni dijuretika billi jnaqqas il-volum tal-plażma, b'konsegwenza ta' żidiet fl-attività tar-renin fil-plażma, sekrezzjoni ta' aldosterone u telf tal-potassium fl-awrina tnaqqis tal-potassium fis-serum.
English: The rate and extent of absorption of Rasilez HCT are equivalent to the bioavailability of aliskiren and hydrochlorothiazide when administered as individual monotherapies.
Maltese: Ir-rata u l-livell ta' assorbiment ta' Rasilez HCT huma ekwivalenti għal biodisponibilità ta' aliskiren u hydrochlorothiazide meta jingħataw bħala monoterapiji individwali.
English: • Swelling of hands, ankles or feet (peripheral oedema)
Maltese: • Nefħa tal-idejn, għekiesi jew saqajn (edema periferali)
English: The systemic exposure to aliskiren in 8-day old rats was >400-fold higher than in adult rats.
Maltese: L-espożizzjoni sistemika għal aliskiren fil-firien li kellhom 8t ijiem kienet ta' >400 darba ogħla minn dik fost il-firien adulti.
English: The findings observed in the 2-week and 13-week toxicity studies were consistent with those observed previously with aliskiren or hydrochlorothiazide monotherapies.
Maltese: Is-sejbiet osservati fl-istudji ta' tossiċità ta' ġimagħtejn u 13-il ġimgħa kienu konsistenti ma' dawk osservati qabel b'monoterapiji ta' aliskiren u hydrochlorothiazide.
English: Rasilez HCT 300 mg/25 mg film-coated tablets
Maltese: Rasilez HCT 300 mg/25 mg pilloli miksija b'rita
English: Visual impairmenth
Maltese: Anemija aplastikah
English: Rasilez HCT 300 mg/12.5 mg film-coated tablets
Maltese: Rasilez HCT 300 mg/12.5 mg pilloli miksija b'rita
English: • Nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes (signs of liver disorder) (frequency not known: frequency cannot be estimated from the available data).
Maltese: • Dardir, nuqqas ta' aptit, awrina ta' lewn skur jew il-ġilda u l-għajnejn jisfaru (sinjali ta' disturb fil-fwied) (frekwenza mhux magħrufa: ma tistax tittieħed stima tal-frekwenza mid-data disponibbli).
English: Other medicines and Rasilez HCT
Maltese: Mediċini oħra u Rasilez HCT
English: 98 film-coated tablets (2 packs of 49)
Maltese: 98 pillola miksija b'rita (2 pakketti ta' 49)
English: No adjustment of the initial dose is required for patients with mild to moderate hepatic impairment (see sections 4.3, 4.4 and 5.2).
Maltese: Mhux meħtieġ li jkun hemm aġġustar tad-doża f'pazjenti b'indeboliment epatiku ħafif għal moderat (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Rasilez HCT is contraindicated in children from birth to less than 2 years.
Maltese: Rasilez HCT huwa kontraindikat fit-tfal mit-twelid sal-età ta' inqas minn sentejn.
English: 280 film-coated tablets (20 packs of 14)
Maltese: 280 pillola miksija b'rita (20 pakkett ta' 14)
English: • Severely decreased urine output (possible signs of renal disorder or renal failure), weakness
Maltese: • Tnaqqis gravi fl-ammont ta' awrina li għaddi (sinjali possibbli ta' disturb fil-kliewi jew insuffiċjenza renali), dgħufija (astenja)
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 150 mg aliskiren (bħala hemifumarate) u 25 mg hydrochlorothiazide.
English: • Muscle spasm
Maltese: • Dgħufija
English: • Itchy rash and other types of rash
Maltese: • Raxx bil-ħakk u tipi oħrajn ta' raxx
English: Orthostatic hypotensionh
Maltese: Indeboliment fil-vistah
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 300 mg aliskiren (bħala hemifumarate) u 25 mg hydrochlorothiazide.
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 fi firien b'doża ta' 1500 mg/kg/jum ma kienux statistikament sinifikanti.
English: In this population, Rasilez HCT 150 mg/12.5 mg to 300 mg/25 mg provided dose-dependent systolic/diastolic blood pressure reduction from 20.6/12.4 mmHg to 24.8/14.5 mmHg, which were significantly superior to the respective monotherapies.
Maltese: F'din il-popolazzjoni, Rasilez HCT 150 mg/12.5 mg sa 300 mg/25 mg ipprovdiet tnaqqis fil-pressjoni sistolika/dijastolika tad-demm minn 20.6/12.4 mmHg sa 24.8/14.5 mmHg, li kienu superjuri b'mod sinifikanti għal monoterapiji rispettivi.
English: Do not take this medicine if you are pregnant (see section ‘Do not take Rasilez HCT').
Maltese: Tiħux din il-mediċina jekk ħriġt tqila (ara sezzjoni Tiħux Rasilez HCT).
English: A cumulative doseresponse relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Maltese: Studju ieħor wera assoċjazzjoni possibbli bejn il-kanċer tax-xoffa (SCC) u l esponiment għal HCTZ: 633 każ ta' kanċer tax-xoffa tqabblu ma' 63,067 kontroll tal-popolazzjoni, blużu ta' strateġija ta' teħid ta' kampjuni b'riskju ssettjat Intweriet relazzjoni għar-rispons tad-doża kumulattiva b'OR aġġustata ta' 2.1 (95 % CI: 1.7-2.6) li tiżdied għal OR 3.9 (3.0-4.9) għal użu kbir (~25,000 mg) u OR 7.7 (5.7-10.5) għall-ogħla doża kumulattiva (~100,000 mg) (ara wkoll is-sezzjoni
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 300 mg aliskiren (bħala hemifumarate) u 12.5 mg hydrochlorothiazide.
English: In this study, Rasilez HCT in doses from 150 mg/12.5 mg to 300 mg/25 mg produced dose-dependent blood pressure reductions (systolic/diastolic) from 17.6/11.9 mmHg to 21.2/14.3 mmHg, respectively, compared to 7.5/6.9 mmHg with placebo.
Maltese: F'dan l-istudju, Rasilez HCT f'dożi minn 150 mg/12.5 mg sa 300 mg/25 mg ikkawżaw tnaqqis fil-pressjoni tad-demm (sistolika/dijastolika) minn 17.6/11.9 mmHg sa 21.
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 150 mg aliskiren (bħala hemifumarate) u 12.5 mg hydrochlorothiazide.
English: In a large placebo-controlled clinical study, the opposite effects of aliskiren (150 mg or 300 mg) and hydrochlorothiazide (12.5 mg or 25 mg) on serum potassium approximately balanced each other in many patients.
Maltese: Fi studju kliniku kbir ikkontrollat bi plaċebo, l-effetti opposti ta' aliskiren (150 mg jew 300 mg) u hydrochlorotiazide (12.5 mg jew 25 mg) fuq il-potassium fis-serum bejn wieħed u ieħor ibbilanċaw lill-xulxin f'ħafna pazjenti.
English: Rasilez HCT 300 mg/25 mg film-coated tablets Tablet core:
Maltese: Rasilez HCT 300 mg/25 mg pilloli miksija b'rita Qalba tal-pillola:
English: Rasilez HCT contains lactose and wheat starch (containing gluten) This medicine contains lactose (milk sugar).
Maltese: Rasilez HCT fih lactose u lamtu tal-qamħ (li fih il-gluten) Din il-mediċina fiha lactose (zokkor tal-ħalib).
English: Rasilez HCT 150 mg/12.5 mg film-coated tablets
Maltese: U KWANTITATTIVA Rasilez HCT 150 mg/12.5 mg pilloli miksija b'rita
English: 280 film-coated tablets (20 packs of14)
Maltese: 280 pillola miksija b'rita (20 pakkett ta'14)
English: MARKETING AUTHORISATION NUMBER(S) Rasilez HCT 150 mg/12.5 mg film-coated tablets EU/1/08/491/001-020
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Rasilez HCT 150 mg/12.5 mg pilloli miksija b'rita EU/1/08/491/001-020
English: Rasilez HCT 150 mg/12.5 mg film-coated tablets Tablet core:
Maltese: Rasilez HCT 150 mg/12.5 mg pilloli miksija b'rita Qalba tal-pillola:
English: − Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulphonamide-derived substances.
Maltese: − Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1, jew għal xi derivati oħrajn ta' sulphonamide.
English: Rasilez HCT 150 mg/25 mg film-coated tablets Tablet core:
Maltese: Rasilez HCT 150 mg/25 mg pilloli miksija b'rita Qalba tal-pillola:
English: Renal artery stenosis and renovascular hypertension No controlled clinical data are available on the use of Rasilez HCT in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Maltese: Stenożi tal-arterja renali u pressjoni renovaskulari għolja M'hemmx tagħrif kliniku kkontrollat dwar l-użu ta' Rasilez HCT f'pazjenti bi stenożi tal-arterja renali unilaterali jew bilaterali, jew fi stenożi f'kilwa waħda.
English: In a study in 183 randomised patients with severe hypertension (mean sitting diastolic blood pressure ≥ 105 and < 120 mmHg), aliskiren treatment regimen with optional addition of hydrochlorothiazide 25 mg was shown to be safe and efficacious in reducing blood pressure.
Maltese: Fi studju f'183 pazjent randomised bi pressjoni għolja severa (medja tal-pressjoni dijastolika bilqiegħda ta' ≥ 105 u < 120 mmHg), kura b'kors ta' aliskiren bl-opżjon li jiżdied hydrochlorothiazide 25 mg deher li kien sigur u effikaċji biex ibaxxi l-pressjoni.
English: Rasilez HCT 300 mg/12.5 mg film-coated tablets Tablet core:
Maltese: Rasilez HCT 300 mg/12.5 mg pilloli miksija b'rita Qalba tal-pillola:
English: • Inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
Maltese: • Infjammazzjoni tal-arterji u tal-vini b'sintomi bħal raxx, tikek vjola fl-aħmar, deni (vaskulite)
English: Where there is involvement of the tongue, glottis or larynx, adrenaline should be administered.
Maltese: Fejn ikun involut l-ilsien, il-glottide jew il-laringi, għandha tingħata l-adrenalina.
English: 90 film-coated tablets.
Maltese: 90 pillola miksija b'rita.
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 150 mg/25 mg film-coated tablets aliskiren/hydrochlorothiazide
Maltese: Rasilez HCT 150 mg/25 mg pilloli miksijin b'rita aliskiren/hydrochlorothiazide
English: • Severe allergic reaction (anaphylactic reaction), allergic reactions (hypersensitivity) and angioedema (the symptoms of which can include difficulties in breathing or swallowing, rash, itching, hives or swelling of the face, hands and feet, eyes, lips and/or tongue, dizziness).
Maltese: • Reazzjoni allerġika severa (reazzjoni anafilattika), reazzjonijiet allerġiċi (sensittività eċċessiva) u anġjoedema (liema sintomi jistgħu jinkludu d-diffikultajiet fit-teħid tan-nifs jew biex tibla', raxx, ħakk, ħorriqija jew nefħa fil-wiċċ, fl-idejn u s-saqajn, fl-għajnejn, ix-xufftejn u/jew flilsien, sturdamet).
English: Statistically significantly higher incidences in the occurrence of cardiac failure and ischaemic stroke were also found for aliskiren compared to enalapril in patients with NYHA I/II with hypertension, and in the occurrence of chronic cardiac failure and ventricular extrasystole in patients with NYHA III/IV with hypertension.
Maltese: Instabu wkoll inċidenzi ogħla statistikament sinifikanti fid-drabi fejn seħħew insuffiċjenza kardijaka u puplesija iskemika b'aliskiren imqabbel ma' enalapril f'pazjenti b'NYHA I/II bi pressjoni għolja, u fid-drabi fejn seħħew insuffiċjenza kardijaka kronika u ektrasistole ventrikulari f'pazjenti b'NYHA III/IV bi pressjoni għolja.
English: Aplastic anaemiah
Maltese: Persuni anzjani
English: Rasilez HCT has been shown to be effective as a once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Maltese: Rasilez HCT intwera li huwa effettiv bħala kura li tingħata darba kuljum kontra l-pressjoni għolja f'pazjenti aduti, ikun x'ikun is-sess, l-età, l-indiċi tal-massa tal-ġisem u l-etniċità.
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 150 mg/12.5 mg film-coated tablets aliskiren/hydrochlorothiazide
Maltese: Rasilez HCT 150 mg/12.5 mg pilloli miksijin b'rita aliskiren/hydrochlorothiazide
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), ilmarġini 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: 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 nstab 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: Urticaria and other forms of rasha,h
Maltese: Urticaria u forom oħra ta' raxxa,h
English: Coadministration of orange or apple juice with aliskiren 150 mg resulted in a 62% decrease in aliskiren AUC or in a 63% decrease in aliskiren AUC, respectively.
Maltese: L-għoti flimkien tal-meraq tal-larinġ jew tat-tuffieħ ma' aliskiren 150 mg wassal għal tnaqqis ta' 62% fl-AUC ta' aliskiren jew għal tnaqqis ta' 63% fl-AUC ta' aliskiren, rispettivament.
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 300 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Maltese: Rasilez HCT 300 mg/25 mg pilloli miksijin b'rita aliskiren/hydrochlorothiazide
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 300 mg/12.5 mg film-coated tablets aliskiren/hydrochlorothiazide
Maltese: Rasilez HCT 300 mg/12.5 mg pilloli miksijin b'rita aliskiren/hydrochlorothiazide
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: Rasilez HCT 300 mg/12.5 mg film-coated tablets are violet white, oval film-coated tablets imprinted with “CVI” on one side and “NVR” on the other.
Maltese: Rasilez HCT 300 mg/12.5 mg pilloli miksijin b'rita huma pilloli miksijin b'rita vjola bojod, ovali stampati b' “CVI” fuq naħa u “NVR” fuq l-oħra.
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 ta' non-inferjorità ma kienx miżmum meta l-analiżi twettqet fuq is-sett skont il-protokoll fejn l-inqas bidla medja kwadra (least square mean) fl-msSBP mil-linja bażi kienet ta' -7.84 mmHG b'aliskiren u9.04 mmHG b'enalapril.
English: By inhibiting the enzyme renin, aliskiren inhibits the RAAS at the point of activation, blocking the conversion of angiotensinogen to angiotensin I and decreasing levels of angiotensin I and angiotensin II.
Maltese: Bl-inibizzjoni tal-enzima renin, aliskiren jinibixxi r-RAAS fil-punt tal-attivazzjoni, u b'hekk jimblokka l-konverżjoni ta' angiotensin f'angiotensin I u jnaqqas il-livell ta' angiotensin I u angiotensin II.
English: Rasilez HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Rasilez HCT hu kontraindikat f'pazjenti b'indeboliment gravi tal-kliewi jew anurija (ara sezzjonijiet 4.2 u 4.3).
English: • Severe upper stomach pain (pancreatitis)
Maltese: • Sturdament, mejt meta tkun bilwieqfa
English: Hypercalcaemiah, hyperglycaemiah, worsening of diabetic metabolic stateh
Maltese: Iperkalċimijah, Ipergliċemijah, l-istat metaboliku tad-dijabete jmur għall-agħarh
English: The adverse reactions previously reported with one of the individual components of Rasilez HCT (aliskiren and hydrochlorothiazide) and included in the tabulated list of adverse reactions may occur with Rasilez HCT.
Maltese: Ir-reazzjonijiet avversi rrappurtati qabel b'wieħed mill-komponenti individwali ta' Rasilez HCT (aliskiren u hydrochlorothiazide) u nklużi fil-lista ttabulata ta' reazzjonijiet avversi jistgħu jseħħu b'Rasilez HCT.
English: Rasilez HCT 150 mg/12.5 mg film-coated tablets White, biconvex, ovaloid film-coated tablet imprinted with “LCI” on one side and “NVR” on the other.
Maltese: Rasilez HCT 150 mg/12.5 mg pilloli miksija b'rita Pillola bajda, konvessa miż-żewġ naħat, b'għamla ovali miksija b'rita stampata b' “LCI” fuq naħa u “NVR” fuq l-oħra.
English: Dyspnoeaa
Maltese: Dijarea
English: In this study, aliskiren at a target dose of 300 mg was compared to enalapril at a target dose of 20 mg when added to standard of care which included a beta blocker (and a mineralocorticoid receptor antagonist in 37% of patients) and a diuretic as needed.
Maltese: F'dan l-istudju, aliskiren mogħti b'doża mmirata ta' 300 mg tqabbel ma' enalapril mogħti b'doża mmirata ta' 20 mg meta miżjud ma' kura standard li kienet tinkludi imblokkatur beta (u riċettur ta' antagonist mineralokortikojde f'37% tal-pazjenti) u prodott dijuretiku skont il-ħtieġa.
English: • Difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress including pneumonitis and pulmonary oedema)
Maltese: • Diffikultà biex tieħu n-nifs flimkien ma' deni, sogħla, tisfir, qtugħ ta' nifs (distress respiratorju li jinkludi pulmonite u edima fil-pulmuni)
English: The usual recommended starting dose of aliskiren in elderly patients aged 65 years or older is 150 mg.
Maltese: Id-doża rakkomandata tal-bidu tas-soltu ta' aliskiren f'pazjenti anzjani li jkollhom 65 sena jew aktar hija ta' 150 mg.