FrancophonIA/ELRC3.0 huggingface dataset:
English: The doses in rats and rabbits provided systemic exposures of 1 to 4 and 5 times higher, respectively, than the maximum recommended human dose (300 mg).
Maltese: Id-dożi fil-firien u fniek kienu jipprovdu esponimenti sistemiċi ta' 1 sa 4 u 5 darbiet ogħla, rispettivament, mill-ogħla doża rrakkomandata fil-bniedem (300 mg).
English: Following intravenous administration, the mean volume of distribution at steady state is approximately 135 litres, indicating that aliskiren distributes extensively into the extravascular space.
Maltese: Wara li jingħata minn ġol-vina, il-medja tal-volum ta' distribuzzjoni fi stat fiss hija madwar 135 litru, li jindika li aliskiren jinfirex b'mod estensiv fl-ispazju ekstravaskulari.
English: - Alcohol, barbiturates or narcotics
Maltese: Tenħtieġ kawtela waqt użu konkomitanti - Alkoħol,barbiturati u narkotiċi
English: Therefore, concomitant use of aliskiren and P-gp potent inhibitors is contraindicated (see section 4.3).
Maltese: Għalhekk, l-użu ta' aliskiren u inibituri potenti ta' P-gp f'daqqa huwa kontraindikat (ara sezzjoni 4.3).
English: Concomitant use of aliskiren with ARBs or ACEIs is contraindicated in patients with renal impairment (GFR <60 ml/min/1.73 m2) (see section 4.3).
Maltese: ARBs jew ACEIs huwa kontra-indikat f'pazjenti b'indeboliment renali (GFR <60 ml/min/1.73 m (ara sezzjoni 4.3).
English: Geriatric patients aged 65 years and over
Maltese: Pazjenti Ġerjatriċi li għandhom 65 sena u aktar
English: Concomitant use of Rasitrio with ARBs or ACEIs is contraindicated in patients with diabetes mellitus (see section 4.3).
Maltese: L-użu konkomitanti ta' Rasitrio ma' ARBs jew ACEIs huwa kontraindikat f'pazjenti b'dijabete mellitus (ara sezzjoni 4.3).
English: Brown, ovaloid convex film-coated tablet with bevelled edges, with “VIV” debossed on one side and “NVR” on the other.
Maltese: Pillola miksija b'rita kannella, konvessa f'forma ta' bajda bil-ġnub tasturati, b'“VIV” imnaqqxa fuq naħa waħda u “NVR” fuq in-naħa l-oħra.
English: Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets Aliskiren/amlodipine/hydrochlorothiazide
Maltese: Rasitrio 150 mg/5 mg/12.5 mg pilloli miksija b'rita Aliskiren/amlodipine/hydrochlorothiazide
English: Renal dysfunction, acute renal failure Reproductive system and breast disorders Common
Maltese: Disfunzjoni fil-kliewi, indeboliment sever tal-kliewi Disturbi fis-sistema riproduttiva u fis-sider Komuni
English: Rasitrio combines three antihypertensive active substances with complementary mechanisms to control blood pressure in patients with essential hypertension: aliskiren belongs to the direct renin inhibitor class, amlodipine to the calcium channel blocker class and hydrochlorothiazide to the thiazide diuretics class.
Maltese: Rasitrio jħallat flimkien tliet sustanzi attivi li jbaxxu l-pressjoni b'mekkaniżmi li jikkumplimentaw lil xulxin biex jikkontrollaw il-pressjoni f'pazjenti bi pressjoni għolja naturali: aliskiren jagħmel parti minn klassi ta' inibituri diretti ta' renin, amlodipine minn klassi ta' imblukkatur tal-kanal tal-kalċju u hydrochlorothiazide minn klassi ta' dijuretiċi ta' thiazide.
English: What Rasitrio looks like and contents of the pack - Rasitrio 300 mg/5 mg/25 mg film-coated tablets are pale orange-brown, oval tablets, with
Maltese: Kif jidher Rasitrio u l-kontenut tal-pakkett - Il-pilloli miksija b'rita Rasitrio tat-300 mg/5 mg/25 mg huma kannella fl-oranġjo, ovali,
English: Therefore, caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors (clarithromycin, telithromycin, erythromycin, amiodarone).
Maltese: Għalhekk għandha ssir kawtela meta aliskiren jingħata ma' ketoconazole, verapamil jew inibituri moderati oħrajn ta' P-gp (clarithromycin, telithromycin, erythromycin, amiodarone).
English: Thiazides, including hydrochlorothiazide, may reduce the renal excretion of cytotoxic agents (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
Maltese: It-thiazides, inkluż hydrochlorthiazide, jistgħu jnaqqsu t-tneħħija renali ta' sustanzi ċitotossiċi (eż. ċiklofosfamid, methotrexate) u jsaħħu l-effetti majelosoppressivi tagħhom.
English: The fertility of rats was unaffected at doses of up to aliskiren 250 mg/kg/day and hydrochlorothiazide 4 mg/kg/day (see section 5.3).
Maltese: Fi studju wieħed fil-firien kien hemm effetti avversi fuq il-fertilità maskili (ara sezzjoni 5.3). Il-fertilità tal-firien ma kinitx affettwata b'dożi ta' aliskiren sa 250 mg/kg/kuljum u hydrochlorothiazide 4 mg/kg/day (ara sezzjoni 5.3).
English: Findings during repeat-dose toxicity studies in animals were consistent with the known local irritation potential or the expected pharmacological effects of aliskiren.
Maltese: Is-sejbiet waqt studji ta' tossiċità minn dożi ripetuti fl-annimali kienu konsistenti mal-kapaċità għal irritazzjoni lokali li hi magħrufa jew mal-effetti farmakoloġiċi mistennija ta' aliskiren.
English: • muscle spasm
Maltese: • uġigħ fid-dahar
English: Cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, vasculitis necrotising and toxic epidermal necrolysis
Maltese: Reazzjonijiet fil-ġilda bħal f'lupus erythematosus, riattivazzjoni ta' lupus erythematosus fil-ġilda, vaskulite li tinnekrotizza u nekroliżi
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, to other dihydropyridine derivatives, or to other sulphonamide-derived substances.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1, għal derivati oħrajn ta' dihydropyridine, jew għal xi derivati oħrajn ta' sulphonamide.
English: Hypersensitivity Metabolism and nutrition disorders Very common Hypokalaemia Common
Maltese: Sensittività eċċessiva Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna
English: No additional blood pressure lowering effect was detected with 300 mg aliskiren compared to 150 mg aliskiren.
Maltese: Ma deher l-ebda effett ta' tnaqqis ieħor fil-pressjoni taddemm meta ngħataw 300 mg aliskiren imqabbel ma' 150 mg aliskiren.
English: There is more than 95% of the absorbed dose being excreted as unchanged compound in the urine.
Maltese: Hemm aktar minn 95% tad-doża assorbita li tiġi mneħħija bħala sustanza mhux mibdula fl-awrina.
English: The incidence of any adverse reactions potentially related to hypotension in a short-term controlled study was 4.9% with Rasitrio versus up to 3.7% with dual combinations.
Maltese: L-inċidenza ta' kwalunkwe reazzjonijiet mhux mixtieqa marbuta potenzjalment ma' pressjoni għolja waqt studju qasir ikkontrollat kienet ta' 4.9% b'Rasitrio kontra t-3.7% b'kombinazzjonijiet doppji.
English: Coadministration 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: What Rasitrio contains - Each Rasitrio 300 mg/10 mg/25 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate), 10 mg amlodipine (as besylate) and 25 mg hydrochlorothiazide.
Maltese: X'fih Rasitrio - Kull pillola Rasitrio miksija b'rita tat-300 mg/10 mg/25 mg fiha 300 mg aliskiren (bħala hemifumarate), 10 mg amlodipine (bħala besylate) u 25 mg hydrochlorothiazide.
English: What Rasitrio looks like and contents of the pack - Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets are violet white, oval tablets, with “YIY”
Maltese: Kif jidher Rasitrio u l-kontenut tal-pakkett - Il-pilloli miksija b'rita Rasitrio tal-150 mg/5 mg/12.5 mg huma bojod fil-vjola, ovali, b'“YIY”
English: This decrease is likely due to an inhibition of organic anion transporting polypeptide-mediated uptake of aliskiren by grapefruit juice in the gastrointestinal tract.
Maltese: Studji prekliniċi juru li aliskiren jista' jkun sustrat għall-polypeptides organiċi li jittrasportaw l-anjoni.
English: Hypokalaemia may result in muscle spasms and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain antiarrhythmic medicinal products.
Maltese: Ipokalimja tista' twassal għal spażmi tal-muskoli u/jew arritmiji kardijaċi aktar evidenti assoċjati mal-użu fl-istess ħin ta' digitalis glycosides jew ċerti prodotti mediċinali kontra l-arritmiji.
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 fis-sezzjonijiet rilevanti.
English: - Medicinal products affecting serum potassium levels Concomitant use of other agents affecting the RAAS, of NSAIDs or of agents that increase serum potassium levels (e.g. potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, heparin) may lead to increases in serum potassium.
Maltese: - Prodotti mediċinali li jaffettwaw livelli ta' potassium fis-serum L-użu flimkien ma' aġenti oħra li jaffettwaw l-RAAS, ta' NSAIDs jew ta' aġenti li jżidu l-livelli ta' potassium fis-serum (eż. dijuretiċi li ma jħallux il-potassium jintilef, supplimenti tal-potassium, sostituti tal-melħ li fihom il-potassium, heparin) jista' jwassal għal żidied tal-potassium fis-serum.
English: What Rasitrio contains - Each Rasitrio 300 mg/5 mg/25 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 25 mg hydrochlorothiazide.
Maltese: X'fih Rasitrio - Kull pillola Rasitrio miksija b'rita tat-300 mg/5 mg/25 mg fiha 300 mg aliskiren (bħala hemifumarate), 5 mg amlodipine (bħala besylate) u 25 mg hydrochlorothiazide.
English: Do not take Rasitrio - if you are allergic to aliskiren, to amlodipine, to other dihydropyridine-derived medicines (known as calcium channel blockers), to hydrochlorothiazide, to sulphonamide-derived medicines (medicines used to treat chest or urinary infections) or to any of the other ingredients of this medicine (listed in section 6).
Maltese: Tiħux Rasitrio - jekk inti allerġiku għal aliskiren, amlodipine, għal mediċini oħrajn derivati minn dihydropyridine (magħrufin bħala mblukkaturi tal-kanal tal-kalċju), hydrochlorothiazide, mediċini derivati ta' sulphonamide (mediċini li jintużaw għall-kura ta' infezzjonijiet fis-sider jew tal-awrina) jew għal xi sustanzi oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: In experimental animals, it has been shown that P-gp is a major determinant of aliskiren bioavailability.
Maltese: F'annimali esperimentali, intwera li P-gp jiddetermina bil-kbir il-bijodisponibbiltà ta' aliskiren.
English: fever (toxic epidermal necrolysis).
Maltese: tqaxxir tal-ġilda, deni (nekrolożi epidermali tossika).
English: - Medicinal products that could induce torsades de pointes Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes, in particular Class Ia and Class III antiarrhythmics and some antipsychotics.
Maltese: - Prodotti mediċinali li jistgħu jwasslu għal torsades de pointes Minħabba r-riskju ta' ipokalimja, hydrochlorothiazide għandu jingħata b'kawtela meta jkun assoċjat flimkien ma' prodotti mediċinali li jistgħu jwasslu għal torsades de pointes, b'mod partikulari antiirrittmiċi ta' Klassi
English: What Rasitrio contains - Each Rasitrio 300 mg/10 mg/12.5 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate), 10 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide.
Maltese: X'fih Rasitrio - Kull pillola Rasitrio miksija b'rita tat-300 mg/10 mg/12.5 mg fiha 300 mg aliskiren (bħala hemifumarate), 10 mg amlodipine (bħala besylate) u 12.5 mg hydrochlorothiazide.
English: Due to its hydrochlorothiazide component, Rasitrio is contraindicated in patients with anuria or severe renal impairment (GFR <30 ml/min/1.73 m2) (see section 4.3).
Maltese: Minħabba l-komponent ta' hydrochlorothiazide, Rasitrio huwa kontraindikat f'pazjenti li jbatu minn anurja jew indeboliment renali sever (GFR <30 ml/min/1.73 m2) (ara sezzjoni 4.3).
English: Blood and lymphatic system disorders Rare
Maltese: Disturbi tad-demm u tas-sistema limfatika Rari
English: In clinical trials low blood pressure occurred more frequently in patients taking Rasitrio than those taking only dual combinations of aliskiren/amlodipine, aliskiren/hydrochlorothiazide or amlodipine/hydrochlorothiazide (see section 2).
Maltese: Fi provi kliniċi pressjoni baxxa seħħet b'mod aktar frekwenti f'pazjenti li kienu qed jieħdu Rasitrio milli f'dawk li kienu qed jieħdu biss kombinazzjonijiet b'żewġ mediċini ta' aliskiren/amlodipine, aliskiren/hydrochlorothiazide jew amlodipine/hydrochlorothiazide (ara sezzjoni 2).
English: The concomitant use of aliskiren and ACEIs or ARBs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2).
Maltese: L-użu konkomitanti ta' aliskiren u ACEIs jew ARBs huwa kontra-indikat f'pazjenti b'indeboliment renali (GFR <60 ml/min/1.73 m2).
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: Oral co-administration of aliskiren and furosemide had no effect on the pharmacokinetics of aliskiren but reduced exposure to furosemide by 20-30% (the effect of aliskiren on furosemide administered intramuscularly or intravenously has not been investigated).
Maltese: L-għoti ta' aliskiren flimkien ma' furosemide mill-ħalq ma kellu l-ebda effett fuq il-farmakokinetika ta' aliskiren iżda naqqas l-esponiment għal furosemide b'20-30% (l-effett ta' aliskiren fuq furosemide mogħti ġol-muskolu jew fil-vina ma ġiex investigat).
English: Renal clearance of lithium is reduced by thiazides, therefore the risk of lithium toxicity may be increased with hydrochlorothiazide.
Maltese: L-eliminazzjoni ta' lithium mill-kliewi titnaqqas mit-thiazides, għalhekk ir-riskju ta' tossiċità b'lithium tiżdied b'hydrochlorothiazide.
English: The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
Maltese: Il-farmakokinetika ta' amlodipine mhijiex affettwata b'mod sinifikanti mill-indeboliment renali.
English: - Non-depolarising skeletal muscle relaxants Thiazides, including hydrochlorothiazide, potentiate the action of skeletal muscle relaxants such as curare derivatives.
Maltese: ˗ Rilassanti tal-muskoli skelettriċi li mhumiex depolarizzanti It-thiazides, inkluż hydrochlorthiazide, isaħħu l-azzjoni tar-rilassanti tal-muskoli skelettriċi bħalma huma d-derivati ta' curare.
English: Rasitrio 300 mg/10 mg/12.5 mg film-coated tablets Aliskiren/amlodipine/hydrochlorothiazide
Maltese: Rasitrio 300 mg/10 mg/12.5 mg pilloli miksija b'rita Aliskiren/amlodipine/hydrochlorothiazide
English: Rasitrio 300 mg/10 mg/25 mg film-coated tablets Aliskiren/amlodipine/hydrochlorothiazide
Maltese: Rasitrio 300 mg/10 mg/25 mg pilloli miksija b'rita Aliskiren/amlodipine/hydrochlorothiazide
English: What Rasitrio looks like and contents of the pack - Rasitrio 300 mg/5 mg/12.5 mg film-coated tablets are light pink, oval tablets, with “LIL”
Maltese: Kif jidher Rasitrio u l-kontenut tal-pakkett - Il-pilloli miksija b'rita Rasitrio tat-300 mg/5 mg/12.5 mg huma roża ċar, ovali, b'“LIL”
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 150 mg aliskiren (bħala hemifumarate), 5 mg amlodipine (bħala besylate) u 12.5 mg hydrochlorothiazide.
English: What Rasitrio contains - Each Rasitrio 300 mg/5 mg/12.5 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide.
Maltese: X'fih Rasitrio - Kull pillola Rasitrio miksija b'rita tat-300 mg/5 mg/12.5 mg fiha 300 mg aliskiren (bħala hemifumarate), 5 mg amlodipine (bħala besylate) u 12.5 mg hydrochlorothiazide.
English: Reproductive system and breast disorders Common
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni
English: Amlodipine has demonstrated beneficial clinical effects in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Maltese: Amlodipine wera effetti kliniċi ta' ġid f'pazjenti b'anġina kronika stabbli, b'anġina vażospastika u b'mard tal-arterji koronarji ddokumentat b'mod anġjografiku.
English: Risk of symptomatic hypotension
Maltese: Riskju ta' sintomi ta' pressjoni baxxa
English: • swelling of hands, ankles or feet (peripheral oedema)
Maltese: • nefħa tal-idejn, għekiesi jew saqajn (edema periferali)
English: When combined, the consolidated effects of inhibition of the reninangiotensin-aldosterone system, calcium channel-mediated vasodilatation and sodium chloride excretion result in a reduction of blood pressure to a greater degree than the corresponding dual combinations.
Maltese: Meta mħallta flimkien, l-effetti konsolidali tal-inibizzjoni tas-sistema ta' renin-angiotensin-aldosterone, tal-vasodilatazzjoni permezz tal-kanal talkalċju u l-eskrezzjoni tal-kloru tas-sodju jwasslu għal tnaqqis fil-pressjoni tad-demm f'livell ogħla mill-kombinazzjonijiet doppji korrispondenti.
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate), 10 mg amlodipine (as besylate) and 25 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 300 mg aliskiren (bħala hemifumarate), 10 mg amlodipine (bħala besylate) u 25 mg hydrochlorothiazide.
English: Rasitrio 300 mg/5 mg/25 mg film-coated tablets Aliskiren/amlodipine/hydrochlorothiazide
Maltese: Rasitrio 300 mg/5 mg/25 mg pilloli miksija b'rita Aliskiren/amlodipine/hydrochlorothiazide
English: It is also available in multi-packs of 98 tablets (2 packs of 49) in calendar blisters.
Maltese: Huwa disponibbli wkoll f'pakketti b'ħafna bi 98 pillola (2 pakketti ta' 49) f'folji bil-kalendarju.
English: • ankle swelling
Maltese: • ħalq xott
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 25 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 300 mg aliskiren (bħala hemifumarate), 5 mg amlodipine (bħala besylate) u 25 mg hydrochlorothiazide.
English: In a study conducted in patients with end stage renal disease (ESRD) receiving haemodialysis, dialysis clearance of aliskiren was low (<2% of oral clearance).
Maltese: Fi studju mwettaq f'pazjenti b'mard renali fl-aħħar stadju (ESRD) mogħtija l-emodijalisi, it-tneħħija ta' aliskiren waqt id-dijalisi kien baxx (<2% tat-tneħħija orali).
English: The efficacy and safety of aliskiren-based therapy were compared to ramipril-based therapy in a 9month 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: • cough
Maltese: Kisja
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.
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.
English: Preclinical studies indicate that aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion.
Maltese: Kienet osservata varjabbiltà kbira fl-esponiment bejn l-individwi.
English: In a 28 to 54 week open label safety study, efficacy was measured as secondary endpoint and Rasitrio at a dose of 300/10/25 mg produced mean blood pressure reductions (systolic/diastolic) of 37.3/21.8 mmHg over 28 to 54 weeks of treatment.
Maltese: Waqt studju open label li dam bejn 28 u 54 ġimgħa, l-effikaċja tkejlet bħala endpoint sekondarju u Rasitrio f'doża ta' 300/10/25 mg wassal għal tnaqqis fil-medja tal-pressjoni tad-demm (sistolika/dijastolika) ta' 37.3/21.8 mmHg fuq medda ta' bejn 28 u 54 ġimgħa ta' trattament.
English: Pale orange-brown, ovaloid convex film-coated tablet with bevelled edges, with “OIO” debossed on one side and “NVR” on the other.
Maltese: Pillola miksija b'rita kannella fl-oranġjo mifti, konvessa f'forma ta' bajda bil-ġnub tasturati, b'“OIO” mnaqqxa fuq naħa waħda u “NVR” fuq in-naħa l-oħra.
English: Rasitrio 300 mg/5 mg/12.5 mg film-coated tablets Aliskiren/amlodipine/hydrochlorothiazide
Maltese: Rasitrio 300 mg/5 mg/12.5 mg pilloli miksija b'rita Aliskiren/amlodipine/hydrochlorothiazide
English: As with other medicinal products acting on the renin-angiotensinaldosterone system (RAAS), angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have been reported in patients treated with aliskiren.
Maltese: Bħal bi prodotti mediċinali oħra li jaħdmu fuq is-sistema tar-renin -angiotensin-aldosterone, anġjoedima jew sintomi li jissuġġerixxu anġjoedima (nefħa fil-wiċċ, fixxofftejn, fil-gerżuma u/jew fl-ilsien) kienu rrappurtati f'pazjenti kkurati b'aliskiren.
English: Clinically significant hypotension due to amlodipine overdose calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output.
Maltese: Pressjoni baxxa klinikament sinifikanti minħabba dożaġġi eċċessivi ta' amlodipine teħtieġ appoġġ kardjovaskulari attiv inkluż monitoraġġ frekwenti ta' funzjoni kardijaka u respiratorja, żidiet flestremitajiet u attenzjoni għall-volum fil-fluwidu li jiċċirkola u l-għemil tal-awrina.
English: Anuria.
Maltese: Anurija.
English: If hypokalaemia develops during hydrochlorothiazide therapy Rasitrio should be discontinued until stable correction of the potassium balance.
Maltese: Jekk l-ipokalimja tiżviluppa waqt it-terapija b'hydrochlorothiazide Rasitrio għandu jitwaqqaf sakemm ikun hemm stabilità korretta fil- bilanċ tal-potassju.
English: NSAIDs may also weaken the diuretic and antihypertensive activity of hydrochlorothiazide.
Maltese: NSAIDS jistgħu wkoll idgħajfu l-attività dijuretika u ta' kontra l-pressjoni għolja ta' hydrochlorothiazide.
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: In a 36-week study involving 820 patients with ischaemic left ventricular dysfunction, no changes in ventricular remodelling as assessed by left ventricular end systolic volume were detected with aliskiren compared to placebo on top of background therapy.
Maltese: Fi studju ta' 36 ġimgħa li involva 820 pazjent b'disfunzjoni ventrikulari iskemika tax-xellug, ebda bidla fil-mudellar ventrikulari mill-ġdid kif ivvalutat mill-volum sistoliku ventrikolari tax-xellug tattmiem ma ġiet mikxufa b'aliskiren meta mqabbel ma' plaċebo apparti kura ta' sfond.
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate), 10 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 300 mg aliskiren (bħala hemifumarate), 10 mg amlodipine (bħala besylate) u 12.5 mg hydrochlorothiazide.
English: Aliskiren/amlodipine/hydrochlorothiazide combination In hypertensive patients, once-daily administration of Rasitrio provided clinically meaningful reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval.
Maltese: Kombinazzjoni ta' aliskiren/amlodipine/hydrochlorothiazide F'pazjenti bi pressjoni għolja, l-għoti darba kuljum ta' Rasitrio wassal għal tnaqqis sinifikanti klinikament kemm tal-pressjoni tad-demm sistolika u dijastolika u li nżamm matul l-intervall sħiħ ta' 24 siegħa bejn doża u oħra.
English: “OIO” debossed on one side and “NVR” on the other.
Maltese: b'“OIO” mnaqqxa fuq naħa waħda u b'“NVR” fuq in-naħa l-oħra.