FrancophonIA/ELRC3.0 huggingface dataset:
English: Most of these emerging substitutions have been shown to reduce simeprevir anti-HCV activity in cell culture replicon assays.
Maltese: Il-maġġoranza ta' dawn is-sostituzzjonijiet li tfaċċaw intwerew li jnaqqsu lanti-HCV ta' simeprevir f'assaġġi ta' replikon fil-kultura ċellulari.
English: Severe bradycardia and heart block
Maltese: Ma sarux studji dwar
English: 12 weeks OLYSIO + sofosbuvir (without ribavirin) may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options (see sections 4.4 and 5.1)
Maltese: 12-il ġimgħa OLYSIO + sofosbuvir (mingħajr ribavirin) jista' jiġi kkunsidrat għal pazjenti meqjusa li għandhom riskju baxx għal progressjoni klinika tal-marda u li sussegwentement ikollhom għażliet għal trattament mill-ġdid (ara sezzjonijiet
English: What OLYSIO contains - The active substance is simeprevir.
Maltese: - Is-sustanza attiva hi simeprevir.
English: In patients with HCV genotype 1a with a baseline Q80K amino acid substitution an emerging R155K substitution was observed most frequently at failure.
Maltese: F'pazjenti b'ġenotip 1a ta' HCV b'linja bażi ta' sostituzzjoni ta' aċidu amminiku ta' Q80K, sostituzzjoni ta' R155K li tkun qed titfaċċa ġiet osservata b'mod ta' spiss fil-falliment.
English: 4.4 and 5.1).
Maltese: 4.4, 4.5 u 5.1).
English: Contraindicated (see section 4.3)
Maltese: Kontraindikat (ara sezzjoni 4.3)
English: BLISTER BLISTER (CALENDAR)
Maltese: FOLJA FOLJA (KALENDARJU)
English: hereditary angioedema.
Maltese: anġjoedima ereditarja.
English: (see sections 4.3, 4.4 and 5.1).
Maltese: (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: PVC/polychlorotrifluoroethylene (PCTFE) - Alu blisters:
Maltese: Folji PVC/polychlorotrifluoroethylene (PCTFE) - Alu:
English: Tabulated list of adverse reactions:
Maltese: Lista ttabulata ta' reazzjonijiet avversi:
English: Preliminary study results indicated a hazard ratio for the primary endpoint of 1.09 in favour of placebo (95% Confidence Interval: 0.97, 1.22, 2-sided p=0.17).
Maltese: Riżultati ta' studji preliminari indikaw proporzjon ta' periklu għattragward finali primarju ta' 1.09 favur plaċebo (95% Confidence Interval: 0.97, 1.22, 2-sided p=0.17).
English: EU/1/07/409/001-010 EU/1/07/409/021-030
Maltese: EU/1/07/409/021-030
English: Dual RAAS blockade
Maltese: Imblokk doppju ta' RAAS
English: Some side effects can be serious:
Maltese: Effetti sekondarji possibbli:
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Riprazo.
Maltese: Indutturi ta' P-gp (St. John's wort, rifampicin) għalhekk jistgħu jnaqqsu l-biodisponibilità ta' Riprazo.
English: - Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Maltese: Bla interazzjonijiet - Komposti kimiċi li kienu investigati fi studji ta' farmakokinetika klinika kienu jinkludu acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate u hydrochlorothiazide.
English: Date of first authorisation: 22 August 2007 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 22 Awwissu 2007 Data tal-aħħar tiġdid: 24 Awwissu 2012
English: - Co-administration of aliskiren with either metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of Riprazo.
Maltese: - Meta aliskiren jingħata ma' metformin (↓28%), amlodipine (↑29%) jew cimetidine (↑19%) isCmax jew AUC ta' Riprazo inbidlu b'bejn 20% u 30%.
English: Rifampicin, which is an inducer of P-gp, reduced aliskiren bioavailability by approximately 50% in a clinical study.
Maltese: Rifampicin, li huwa induttur ta' P-gp, naqqas il-bijodisponibilità b'madwar 50% waqt studju kliniku.
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' 76% jew 97% fl-AUC ta' aliskiren, rispettivament.
English: In healthy subjects, itraconazole (100 mg) increases AUC and Cmax of aliskiren (150 mg) by 6.5-fold and 5.8-fold, respectively.
Maltese: F'indiviwi f'saħħithom, itraconazole (100 mg) iżid AUC u Cmax ta' aliskiren (150 mg) b'6.5 darbiet u 5.8 darbiet, rispettivament.
English: The adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi għall-mediċina (Tabella 1) huma elenkati taħt it-titlu tal-frekwenza, l-aktar frekwenti l-ewwel, bil-konvenzjoni li ġejja: komuni ħafna (≥1/10); 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: Luxembourg/Luxemburg Novartis Pharma GmbH Tél/Tel: +49 911 273 0
Maltese: Deutschland Novartis Pharma GmbH Tel: +49 911 273 0
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 tarrenin, Kodiċi ATC:
English: Pharmacovigilance Plan or risk minimisation activities.
Maltese: Pjan ta' Farmakoviġilanza jew l-attivitajiet ta' minimizzazzjoni tar-riskju;
English: Riprazo has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged
Maltese: Riprazo kien studjat f'1,864 pazjent ta' etajiet minn 65 sena 'l fuq, u f'426 pazjent ta' etajiet minn 75 sena 'l fuq.
English: - Hereditary or idiopathic angioedema.
Maltese: - Anġjoedima ereditarja jew idjopatika.
English: No effect on QT interval was reported in a randomised, double-blind, placebo, and active-controlled study using standard and Holter electrocardiography.
Maltese: Ma ġiex irrappurtat l-ebda effett fi studju randomised, double-blind, kontrollat bi plaċebo u bissustanza attiva b'elettrokardjografija standard u Holter.
English: The effects of Riprazo on warfarin pharmacokinetics have not been evaluated.
Maltese: Warfarin L-effetti ta' Riprazo fuq il-farmakokinetika ta' warfarin ma kienux evalwati.
English: • Timelines to submit further data on colorectal hyperplasia events from ALTITUDE study.
Maltese: • Dati ta' skadenza sabiex tiġi sottomessa aktar dejta dwar episodji ta' iperplasija kolorettali millistudju ALTITUDE;
English: 98 film-coated tablets (2x49) (perforated unit-dose blister)
Maltese: 98 pillola miksija b'rita (2x49) (folji perforati diviżibbli f'dożi singoli)
English: In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Riprazo 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
Maltese: F'pazjenti li ma kellhomx rispons xieraq għall-5 mg ta' l-imblokkatur tal-kanali tal-calcium amlodipine, iż-żieda ta' Riprazo 150 mg kellu effett li jbaxxi l-pressjoni simili għal dak miksub meta d-doża ta' amlodopine tiżdied għal 10 mg iżda kien hemm anqas każijiet ta' edema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs amlodipine 10 mg 11.2%).
English: Aliskiren 150 mg or 300 mg per day or ramipril 5 mg or 10 mg per day were administered for 36 weeks with optional add-on therapy of hydrochlorothiazide (12.5 mg or 25 mg) at week 12, and amlodipine (5 mg or 10 mg) at week 22.
Maltese: Ingħataw 150 mg jew 300 mg aliskiren kuljum jew 5 mg jew 10 mg ramipril kuljum għal 36 ġimgħa bil-possibbiltà ta' terapija miżjuda b'hydrochlorothiazide (12.5 mg jew 25 mg) fit-12il ġimgħa, u amlodipine (5 mg jew 10 mg) fit-22 ġimgħa.
English: When administered with atorvastatin (80 mg), steady-state aliskiren (300 mg) AUC and Cmax increased by 50%.
Maltese: Meta ingħata ma' atorvastatin (80 mg), l-AUC u Cmax ta' aliskiren (300 mg) fi stat fiss żdiedu b'50%.
English: Combination therapy studies are available for Riprazo added to the diuretic hydrochlorothiazide, the calcium channel blocker amlodipine and the beta blocker atenolol.
Maltese: Hemm studji b'terapija ta' kombinazzjoni għal Riprazo miżjud mad-dijuretiku hydrochlorthiazide, limblukkatur tal-kanali tal-calcium amlodipine u l-imblukkatur beta atenolol.
English: - Organic anion transporting polypeptide (OATP) inhibitors Preclinical studies indicate that aliskiren might be a substrate of organic anion transporting polypeptides.
Maltese: - Inibituri tal-pompa organika ta' esportazzjoni anjonika (OATP) Studji prekliniċi juru li aliskiren jista' jkun sustanza ta' pompa organika ta' esportazzjoni anjonika.
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Riprazo.
Maltese: Fi provi kliniċi kkontrollati, bidliet klinikament rilevanti f'parametri standard tal-laboratorju kienu assoċjati b'mod mhux komuni ma' l-għoti ta' Riprazo.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) Hypotension, syncope, stroke, hyperkalaemia, and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system (see section 5.1).
Maltese: Kienu rrappurtati pressjoni baxxa, sinkope, puplesija, iperkalemija u bidliet fil-funzjoni renali (inkluż insuffiċjenza akuta tal-kliewi) f'individwi suxxettibbli, speċjalment meta ġew ikkombinati prodotti mediċinali li jaffettwaw din is-sistema (ara sezzjoni 5.1).
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: In a 8-week study in 754 hypertensive elderly (≥ 65 years) and very elderly patients (30% ≥ 75 years) aliskiren at doses of 75 mg, 150 mg and 300 mg provided statistically significant superior reduction in blood pressure (both systolic and diastolic) when compared to placebo.
Maltese: Fi studju ta' 8 ġimgħat f'754 anzjan bi pressjoni għolja (≥ 65 sena) u pazjenti anzjani ħafna (30%≥ 75 sena) l-għoti ta' aliskiren b'dożi ta' 75 mg, 150 mg u 300 mg pprovdew tnaqqis superjuri statistikament sinifikanti fil-pressjoni tad-demm (kemm sistolika u dijastolika) meta mqabbel ma' plaċebo.
English: an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc. - ketoconazole, a medicine used to treat fungal infections.
Maltese: jew - “imblukkatur tar-riċetturi ta' angiotensin II” bħal valsartan, telmisartan, irbesartan, eċċ. - ketoconazole, mediċina li tintuża biex tikkura infezzjonijiet tal-fungu.
English: - Second and third trimesters of pregnancy (see section 4.6).
Maltese: - It-tieni u t-tielet trimestri tat-tqala (ara sezzjoni 4.6).
English: You may
Maltese: Tista'
English: or an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.
Maltese: jew b' “imblukkatur tar-riċetturi ta' angiotensin II” bħal valsartan, telmisartan, irbesartan, eċċ.
English: Tolerability was comparable in both treatment arms, however cough was more often reported with the ramipril regimen than the aliskiren regimen (14.2% vs. 4.4%), whilst diarrhoea was more common with the aliskiren regimen than for the ramipril regimen (6.6% vs. 5.0%).
Maltese: It-tollerabbiltà kienet komparabbli fiż-żewġ gruppi ttrattati, madanakollu s-sogħla kienet aktar irrappurtata b'ramipril milli b'aliskiren (14.2% vs. 4.4%), filwaqt li d-dijarrea kienet aktar komuni b'aliskiren milli b'ramipril (6.6% vs. 5.0%).
English: - certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
Maltese: - ċerti tipi ta' mediċini li jtaffu l-uġigħ msejħa mediċini antiinfjammatorji mhux sterojdi (NSAIDs).
English: In clinical studies in hypertensive patients, Riprazo had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Maltese: Fi studji kliniċi f'pazjenti bi pressjoni għolja, Riprazo 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: In addition, an increased incidence of serious adverse outcomes was observed with aliskiren compared to placebo for renal complications (4.7% versus 3.3%), hyperkalaemia (36.9% versus 27.1%), hypotension (18.4% versus 14.6%) and stroke (2.7% versus 2.0%).
Maltese: Barra minn hekk, kienet osservata inċidenza akbar ta' kondizzjonijiet avversi serji b'aliskiren meta mqabbel ma' plaċebo għal kumplikazzjonijiet renali (4.7% kontra 3.3%), iperkalemija (36.9% kontra 27.
English: In clinical studies Riprazo 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, Riprazo 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, sindrome nefrotika jew pressjoni għolja renovaskulari.
English: P-glycoprotein (P-gp) potent inhibitors
Maltese: Inibituri potenti ta' P-gp
English: In experimental animals, it has been shown that P-gp is a major determinant of Riprazo bioavailability.
Maltese: F'annimali esperimentali, intwera li P-gp jiddetermina bil-kbir il-biodisponibilità ta' Riprazo.
English: - The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent 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-gp qawwija oħrajn (eż. quinidine), huwa kontra-indikat (ara sezzjoni 4.5).
English: 56 film-coated tablets (perforated unit-dose blister)
Maltese: 56 pillola miksija b'rita (folji perforati diviżibbli f'dożi singoli)
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
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: 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 issir kawtela meta aliskiren jingħata ma' ketoconazole, verapamil jew inibituri moderati oħrajn ta' P-gp (clarithromycin, telithromycin, erythromycin, amiodarone).
English: Packs containing 56 and 98 (2x49) tablets are perforated unit-dose blisters.
Maltese: Pakketti li jkun fihom 56 u 98 (2x49) pillola huma folji perforati diviżibbli f'dożi singoli.
English: - if you have diabetes mellitus 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 etc.
Maltese: - jekk inti għandek dijabete mellitus jew indeboliment tal-funzjoni tal-kliewi u qed tingħata kura b'waħda minn dawn il-klassijiet ta' mediċini użati għall-kura tal-pressjoni għolja: b' “impeditur tal-enzima li tikkonverti angiotensin” bħal enalapril, lisinopril, ramipril eċċ.
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: Riprazo 150 mg film-coated tablets Aliskiren
Maltese: Riprazo 150 mg pilloli miksijin b'rita Aliskiren
English: Skin and subcutaneous tissue disorders Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndrome, toxic epidermal necrolysis (TEN) and oral mucosal
Maltese: Reazzjonijiet avversi serji fuq il-ġilda (SCARs) li jinludu s-sindrom ta' Stevens Johnson, nekroliżi epidermali tossika (TEN) u reazzjonijiet mukużi fil-ħalq, raxx, ħakk, urtikarja
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: 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, doubleblind, 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 m bi jew mingħajr mard kardjovaskulari.
English: • A commitment to submit the final study report of the epidemiological study on ischaemic
Maltese: • Impenn li jiġi sottomess ir-rapport ta' studju finali tal-istudju epidemijoloġiku dwar il-kolite iskemika;
English: - The active substance is aliskiren (as hemifumarate) 300 mg. - The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol, microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).
Maltese: microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171),
English: Riprazo 300 mg film-coated tablets Aliskiren
Maltese: Riprazo 300 mg pilloli miksijin b'rita Aliskiren
English: At steady state meals with low fat content reduce Cmax by 76% and AUC0tau 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: When aliskiren was co-administered with furosemide, the AUC and Cmax of furosemide were reduced by 28% and 49%, respectively.
Maltese: Meta aliskiren ingħata ma' furosemide, l-AUC u Cmax ta' furosemide tnaqqsu b'28% u 49% rispettivament.
English: A single dose 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: Dual blockade of the renin-angiotensin-aldosterone system by combining aliskiren with an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB) is therefore not recommended.
Maltese: Għalhekk, imblokk doppju tas-sistema reninangiotensin-aldosterone permezz tal-kombinazzjoni ta' aliskiren ma' impedituri tal-enzima li tikkonverti angiotensin (ACEI) jew ma' imblukkaturi tar-riċetturi ta' angiotensin II (ARB) mhuwiex rakkomandat.
English: The safety and efficacy of Riprazo in children aged below 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Riprazo fit-tfal minn età taħt it-18-il sena ma ġewx determinati s'issa.
English: • Deadlines for submission of the APOLLO study results.
Maltese: • Dati ta' skadenza għas-sottomissjoni tar-riżultati tal-istudju APOLLO;
English: - History of angioedema with aliskiren.
Maltese: - Storja ta' anġjoedima b'aliskiren.
English: Coadministration of Riprazo had no significant impact on atorvastatin, metformin or amlodipine pharmacokinetics.
Maltese: Meta Riprazo ingħata ma' atorvastatin, metformin jew amlodipine dan ma kellux impatt sinifikanti fuq il-farmakokinetika tagħhom.
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: Grapefruit juice should not be taken together with Riprazo (see section 4.5).
Maltese: Il-meraq tal-grejpfruit m'gћandux jittieћed flimkien ma' Riprazo (ara sezzjoni 4.5).
English: The RMP shall include the following:
Maltese: Mhux komuni:
English: Do not take Riprazo if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis), itraconazole (a medicine used to treat fungal infections) or quinidine (a medicine used to correct heart rhythm).
Maltese: Teħux Riprazo jekk qed tieħu ciclosporin (mediċna użata fit-trapjanti sabiex jevita li l-organu jkun riġettat jew għal kundizzjonijiet oħrajn, eż. artrite rewmatojde jew dermatite atopika), itraconazole (mediċina użata biex ikunu ttrattati infezzjonijiet tal-fungu) jew quinidine (mediċna użata biex tirranġa r-ritmu tal-qalb).
English: PSURs
Maltese: Talc
English: Riprazo is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min/1.73 m2).
Maltese: Riprazo mhux irrakkomandat għall-użu f'pazjenti b'indeboliment renali sever (rata talfiltrazzjoni fil-glomeruli (GFR) < 30 ml/min/1.73 m2).
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: Immune system disorders
Maltese: Disturbi fis-sistema immuni Rari:
English: In the event of severe and persistent diarrhoea, Riprazo therapy should be stopped (see section 4.8).
Maltese: Fil-każ ta 'dijarea severa u persistenti, it-terapija b'Riprazo għandha titwaqqaf (ara sezzjoni 4.8).
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.