FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with a history of angioedema may be at increased risk of experiencing angioedema during treatment with aliskiren (see sections 4.3 and 4.8).
Maltese: Pazjenti bi storja ta‟ anġjoedima jistgħu jkunu f‟riskju akbar li jġarrbu anġjoedima waqt kura b‟aliskiren (ara sezzjonijiet 4.3 u 4.8).
English: There have also been reports of peripheral oedema, increase in blood creatinine and severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN) and oral mucosal reactions.
Maltese: Kien hemm ukoll rapporti ta‟ edima periferali, żieda fil-kreatinina fid-demm u reazzjonijiet avversi serji fuq il-ġilda (SCARs), inkluża n-nekroliżi epidermali tossika (TEN) u reazzjonijiet mukużi fil-ħalq.
English: Reproductive toxicity studies with aliskiren did not reveal any evidence of embryofoetal toxicity or teratogenicity at doses up to 600 mg/kg/day in rats or 100 mg/kg/day in rabbits.
Maltese: Studji dwar it-tossiċità fuq is-sistema riproduttiva b‟aliskiren ma wrew l-ebda evidenza ta‟ tossiċità għall-embriju/fetu jew teratoġeniċità b‟dożi sa 600 mg/kg/jum fil-firien jew 100 mg/kg/jum fil-fniek.
English: Risk Management Plan (RMP)
Maltese: Sistema ta‟ l-immaniġġar tar-riskju (RMP)
English: 56 film-coated tablets (perforated unit-dose blister)
Maltese: 56 pillola miksija b‟rita (folji perforati diviżibbli f‟dożi singoli)
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Sprimeo.
Maltese: Fi provi kliniċi kkontrollati, bidliet klinikament rilevanti f‟parametri standard tal-laboratorju kienu assoċjati b‟mod mhux komuni ma‟ l-għoti ta‟ Sprimeo.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta‟ l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu
English: A single dose drug interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold.
Maltese: Studju dwar interazzjoni b‟doża waħda f‟individwi b‟saħħithom wera li ciclosporin (200 u 600 mg) iżid is-Cmax ta‟ aliskiren 75 mg b‟madwar 2.5 drabi u l-AUC b‟madwar 5 darbiet.
English: Uncommon (affecting less than 1 in 100 patients): 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.
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 tal-ġilda, deni), pressjoni tad-demm baxxa.
English: Sprimeo 150 mg film-coated tablets Aliskiren
Maltese: Sprimeo 150 mg pilloli miksijin b‟rita Aliskiren
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta‟ sustanzi mhux attivi, ara sezzjoni 6.1.
English: Packs containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets are multi-packs.
Maltese: Pakketti li fihom 84 (3x28), 90 (3x30), 98 (2x49) jew 280 (20x14) pillola huma pakketti b‟ħafna.
English: Sprimeo is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min/1.73 m2).
Maltese: Sprimeo mhux irrakkomandat għall-użu f‟pazjenti b‟indeboliment renali sever (rata talfiltrazzjoni fil-glomeruli (GFR) < 30 ml/min/1.73 m2).
English: Co-administration with aliskiren 150 mg resulted in a 61% decrease in aliskiren AUC and coadministration with aliskiren 300 mg resulted in a 38% decrease in aliskiren AUC.
Maltese: L-għoti tiegħu 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: 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: 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‟ sfond.
English: FOLDING BOX FOR UNIT PACK CONTAINING PCTFE/PVC BLISTERS
Maltese: LI JKUN FIHA FOLJI PCTFE/PVC
English: The incidence of adverse reactions showed no association with gender, age, body mass index, race or ethnicity.
Maltese: L-inċidenza ta‟ reazzjonijiet avversi ma wrietx assoċjazzjoni mas-sess, età, indiċi tal-massa tal-ġisem, razza jew etniċità.
English: Multipack comprising 2 packs, each containing 49 tablets.
Maltese: Pakkett b‟ħafna li jkun fih 2 pakketti, kull wieħed ikun fih 49 pillola.
English: Multipack comprising 3 packs, each containing 30 tablets.
Maltese: Pakkett b‟ħafna li jkun fih 3 pakketti, kull wieħed bi 30 pillola.
English: Meals with a high fat content reduce Cmax by 85% and AUC by 70%.
Maltese: Ikliet b‟kontenut għoli ta‟ xaħam naqqsu is-Cmax b‟ 85% u l-AUC b‟70%.
English: Sprimeo 300 mg film-coated tablets Aliskiren
Maltese: Sprimeo 300 mg pilloli miksijin b‟rita Aliskiren
English: Aliskiren is an orally active, non-peptide, potent and selective direct inhibitor of human renin.
Maltese: Aliskiren huwa inibitur dirett tar-renin tal-bniedem, attiv b‟mod orali, selettiv u potenti, mhux peptajd.
English: This condition should be corrected prior to administration of Sprimeo, or the treatment should start under close medical supervision.
Maltese: Din ilkundizzjoni għandha tiġi korretta qabel ma jingħata Sprimeo, jew il-kura għandha tinbeda taħt superviżjoni medika stretta.
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: Following oral absorption, peak plasma concentrations of aliskiren are reached after 1-3 hours.
Maltese: Wara assorbiment orali, il-konċentrazzjonijiet ta‟ aliskiren fil-plażma laħqu l-quċċata wara 1-3 siegħat.
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 fss hija madwar 135 litru, li jindika li aliskiren jinfirex b‟mod estensiv fl-ispazju extravaskulari.
English: Light-pink, biconvex, round tablet, imprinted “IL” on one side and “NVR” on the other side.
Maltese: Pillola roża ċar, konvessa miż-żewġ naħat, tonda, ittimbrata „IL‟ fuq naħa u „NVR‟ fuq in-naħa l-oħra.
English: EU/1/07/407/031 EU/1/07/407/032 EU/1/07/407/033 EU/1/07/407/034 EU/1/07/407/035 EU/1/07/407/036
Maltese: EU/1/07/407/031 EU/1/07/407/032 EU/1/07/407/033 EU/1/07/407/034
English: 84 film-coated tablets
Maltese: 84 pillola miksija b‟rita
English: Sprimeo is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Maltese: Sprimeo jiġi f‟pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
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 dosages 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 sinjifikanti statistikament.
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: FOLDING BOX FOR UNIT PACK CONTAINING PA/ALU/PVC BLISTERS
Maltese: LI JKUN FIHA FOLJI PA/ALU/PVC
English: - Keep this leaflet.
Maltese: Tieħux Sprimeo jekk ħriġt tqila.
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 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.
English: The concomitant use of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5 and 5.1).
Maltese: L-użu konkomitanti ta‟ aliskiren ma‟ ARBs jew ACEIs huwa kontra-indikat f‟pazjenti b‟dijabete mellitus jew b‟indeboliment renali (GFR < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.2, 4.4, 4.5 u 5.1).
English: A number of these patients had a history of angioedema or symptoms suggestive of angioedema, which in some cases followed use of other medicines that can cause angioedema, including RAAS blockers (angiotensin converting enzyme inhibitors or angiotensin receptor blockers) (see section 4.8).
Maltese: Numru minn dawn il-pazjenti kellhom storja ta‟ anġjoedima jew sintomi li jissuġġerixxu anġjoedima, li f‟xi każijiet seħħet wara użu ta‟ mediċini oħra li jistgħu jikkawżaw anġjoedima, inkluż imblokkaturi tal-RAAS (impedituri tal-enzima li tikkonverti angiotensin jew imblokkaturi tar-riċettur ta‟ angiotensin) (ara sezzjoni 4.8).
English: EU/1/07/407/021 EU/1/07/407/022 EU/1/07/407/023 EU/1/07/407/024 EU/1/07/407/025 EU/1/07/407/026
Maltese: EU/1/07/407/021 EU/1/07/407/022 EU/1/07/407/023 EU/1/07/407/024
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 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 90 pillola miksija b‟rita 98 pillola miksija b‟rita
English: België/Belgique/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11
Maltese: België/Belgique/Belgien Novartis Pharma N.V.
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 kontra-indikat (ara sezzjoni 4.3).
English: Hypertension
Maltese: Iperkalimja
English: Sprimeo belongs to a new class of medicines called renin inhibitors.
Maltese: Rasliez jagħmel parti minn klassi ġdida ta‟ mediċini li jissejjħu inibituri ta‟ renin.
English: Whereas other agents that inhibit the RAAS (ACEI and angiotensin II receptor blockers (ARB)) cause a compensatory rise in plasma renin activity (PRA), treatment with aliskiren decreases PRA in hypertensive patients by approximately 50 to 80%.
Maltese: angiotensin II (ARB)) jikkawżaw żieda ta‟ kumpens fl-attività ta‟ renin fil-plażma (PRA), il-kura b‟aliskiren tnaqqas il-PRA f‟pazjenti bil-pressjoni għolja b‟madwar 50 sa 80%.
English: impairment (GFR < 60 ml/min/1.73 m
Maltese: Sprimeo mhux irrakkomandat għall-użu f‟pazjenti b‟indeboliment renali sever (GFR < 30 ml/min/1.73 m
English: Sprimeo 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 m
Maltese: Sprimeo 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: 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 darbiet ogħla, rispettivament, mill-għola doża rrakkomandata fil-bniedem (300 mg).
English: What Sprimeo contains - The active substance is aliskiren (as hemifumarate) 300 mg. - The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol,
Maltese: - Is-sustanzi l-oħra huma crospovidone, hypromellose, magnesium stearate, macrogol,
English: One colonic adenoma and one caecal adenocarcinoma recorded in rats at the dose of 1,500 mg/kg/day were not statistically significant.
Maltese: Każ ta‟ adenoma fil-kolon u każ ta‟ adenokarċinoma fil-musrana l-għamja li kien reġistrat fi firien b‟doża ta‟ 1,500 mg/kg/jum ma kienux statistikament sinifikanti.
English: Although aliskiren has known 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, 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: Co-administration of Sprimeo had no significant impact on atorvastatin, metformin or amlodipine pharmacokinetics.
Maltese: Meta Sprimeo ingħata ma‟ atorvastatin, metformin jew amlodipine dan ma kellux impatt sinifikanti fuq il-farmakokinetika tagħhom.
English: The change in plasma levels of aliskiren in the presence of ketoconazole or verapamil is expected to be within the range that would be achieved if the dose of aliskiren were doubled; aliskiren doses of up to 600 mg, or twice the highest recommended therapeutic dose, have been found to be well tolerated in controlled clinical trials.
Maltese: Il-bidla fil-livelli tal-plażma ta‟ aliskiren filpreżenza ta‟ ketoconazole jew verapamil hija mistennija li tkun fil-medda li tintlaħaq li kieku d-doża ta‟ aliskiren kellha tiġi rduppjata; id-dożi ta‟ aliskiren ta‟ mhux aktar minn 600 mg, jew darbtejn logħla d-doża terapewtika rakkomandata, instabu li jkunu ttollerati sewwa fi provi kliniċi kkontrollati.
English: Multipack comprising 3 packs, each containing 28 tablets.
Maltese: Pakkett b‟ħafna li jkun fih 3 pakketti, kull wieħed ikun fih 28 pillola.
English: P-gp substrates or weak inhibitors
Maltese: Sottostrati ta‟ P-gp jew inibituri dgħajfa
English: Packs containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets are multi-packs.
Maltese: Pakketti li fihom 84 (3x28), 98 (2x49) jew 280 (20x14) pillola huma pakketti b‟ħafna.
English: Therefore, the potential exists for interactions between OATP inhibitors and aliskiren when administered concomitantly (see interaction with Grapefruit juice).
Maltese: Għaldaqstant, jeżisti l-potenzjal li jkun hemm interazzjonijiet bejn l-inibituri ta‟ OATP u aliskiren meta jingħataw flimkien (ara l-interazzjoni tal-meraq tat-tronġa).
English: Hypotension was also uncommon (<1%) during combination therapy with other antihypertensive agents.
Maltese: Pressjoni baxxa kienet ukoll mhux komuni (< 1%) waqt terapija kombinata b‟aġenti kontra l-pressjoni għolja oħrajn.
English: Concomitant use of Sprimeo with ARBs or ACEIs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Maltese: L-użu konkomitanti ta‟ Sprimeo ma‟ ARBs jew ACEIs huwa kontra-indikat f‟pazjenti b‟indeboliment renali (GFR < 60 ml/min/1.73 m2) (ara sezzjoni 4.3).
English: The antihypertensive effect is substantially present within two weeks (85-90%) after initiating therapy with 150 mg once daily.
Maltese: L-effett li titbaxxa l-pressjoni jseħħ fi żmien ġimgħatejn (85-90%) wara li tibda t-terapija b‟150 mg kuljum.
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: 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 Sprimeo looks like and contents of the pack Sprimeo 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side.
Maltese: Id-Dehra ta' Sprimeo u l-kontenuti tal-pakkett Sprimeo 300 mg pilloli miksijin b‟rita huma pilloli aħmar ċar, konvessi miż-żewġ naħat, f‟għamla ovali, ittimbrati „IU‟ fuq naħa u „NVR‟ fuq in-naħa l-oħra.
English: Description
Maltese: Deskrizzjoni
English: In hypertensive patients, once-daily administration of Sprimeo at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Maltese: F‟pazjenti bil-pressjoni għolja, l-għotja darba kuljum ta‟ Sprimeo b‟dożi ta‟ 150 mg u 300 mg ikkawżaw tnaqqis dipendenti mid-doża fil-pressjoni tad-demm sistolika u dijastolika li nżammu fuq perijodu sħiħ ta‟ 24 siegħa ta‟ l-intervall bejn id-dożi (b‟hekk żammew il-benefiċċju ta‟ kmieni filgħodu) b‟medja fil-proporzjon bejn l-ogħla u l-anqas għar-rispons dijastoliku sa‟ 98% għad-doża ta‟ 300 mg. 85 sa 90% ta‟ l-effett massimu li jbaxxi l-pressjoni deher wara ġimgħatejn.
English: Sprimeo 150 mg film-coated tablets
Maltese: Sprimeo 150 mg pilloli miksijin b‟rita
English: 280 film-coated tablets
Maltese: 280 pillola miksija b‟rita.
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: Dan it-tnaqqis x‟aktarx jiġri minħabba l-inibizzjoni, medjata minn polipeptajd organiku li jittrasporta il-joni, talassorbiment ta‟ aliskiren permezz tal-meraq tal-grejpfrut mill-passaġġ gastrointestinali.
English: At steady state the non-linearity may be more pronounced.
Maltese: Fi stat fiss in-nuqqas ta‟ linejarità tista‟ tkun tidher aktar.
English: OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Maltese: (INKLUŻA L-KAXXA Ċ-ĊELESTI) LI JKUN FIHA FOLJI PA/ALU/PVC
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 kienu konsistenti ma‟ l-irritazzjoni lokali li hi magħrufa jew ma‟ l-effetti farmakoloġiċi mistennija ta‟ aliskiren.
English: Rare: Musculoskeletal and connective tissue disorders Common: Renal and urinary disorders Uncommon: General disorders and administration site conditions Uncommon: Investigations Common:
Maltese: Insuffiċjenza akuta tal-kliewi, indeboliment tal-kliewi Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Mhux komuni: Investigazzjonijiet Komuni:
English: Administration of a single oral dose of 300 mg aliskiren was associated with very minor changes in the pharmacokinetics of aliskiren (change in Cmax of less than 1.2 fold; increase in AUC of up to 1.6 fold) compared to matched healthy subjects.
Maltese: L-għoti ta‟ doża waħda ta‟ 300 mg aliskiren kienet assoċjata ma‟ tibdiliet baxxi talfarmakokinetiċi ta‟ aliskiren (bidla fis-Cmax ta‟ anqas minn 1.2 drabi; żieda fil-AUC sa 1.6 drabi) mqabbel ta‟ pazjenti b‟saħħithom imlaqqgħin.
English: - verapamil, a medicine used to lower high blood pressure, to correct heart rhythm or to treat angina pectoris.
Maltese: - verapamil, mediċina li tintuża biex tbaxxi l-pressjoni għolja, biex tirranġa r-ritmu tal-qalb jew għall-kura ta‟ anġina pectoris.
English: In post-marketing experience, renal dysfunction and cases of acute renal failure have been reported in patients at risk (see section 4.4).
Maltese: Fl-esperjenza ta‟ wara t-tqegħid fis-suq, disfunzjoni tal-kliewi u każijiet ta‟ insuffiċjenza akuta talkliewi kienu rrappurtati f‟pazjenti li kienu f‟riskju (ara sezzjoni 4.4).
English: The pharmacokinetics of aliskiren were evaluated in patients with varying degrees of renal insufficiency.
Maltese: Il-farmakokinetika ta‟ aliskiren kienetevalwata f‟pazjenti bi gradi varji ta‟ insuffiċjenza renali.
English: Component of a multipack comprising 3 packs, each containing 30 tablets.
Maltese: Jagħmel parti minn pakkett b‟ħafna li jkun fih 3 pakketti, kull wieħed ikun fih 30 pillola.
English: Sprimeo is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2).
Maltese: Sprimeo mhux irrakkomandat għall-użu f‟pazjenti b‟indeboliment renali sever (GFR < 30 ml/min/1.73 m2).
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, lindiċi tal-massa tal-ġisem u l-etniċità.
English: Sprimeo 300 mg film-coated tablets
Maltese: Sprimeo 300 mg pilloli miksijin b‟rita
English: Component of a multipack comprising 2 packs, each containing 49 tablets.
Maltese: Jagħmel parti minn pakkett b‟ħafna li jkun fih 2 pakketti, kull wieħed ikun fih 49 pillola.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 90 film-coated tablets
Maltese: 7 pilloli miksijin b‟rita 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 90 pillola miksija b‟rita
English: Preclinical studies indicate that aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion.
Maltese: Studji prekliniċi jindikaw li l-għoti ta‟ aliskiren flimkien ma‟ ketoconazole jtejjeb l-assorbiment gastrointestinali ta‟ aliskiren u jnaqqas l-eskrezzjoni biljari.
English: In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Sprimeo 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‟ Sprimeo 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: Film-coated tablet
Maltese: Żieda fil-kreatinina tad-demm