FrancophonIA/ELRC3.0 huggingface dataset:
English: During their December 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Yasminelle and associated names, that the objections raised by Hungary should not prevent the approval of the variation applied for and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be the final versions achieved during the Coordination group procedure.
Maltese: Waqt il-laqgħa tiegħu f'Diċembru 2007, is-CHMP, fid-dawl tat-tagħrif kollu mressaq u fid-dawl taddiskussjoni xjentifika fi ħdan il-Kumitat, kien tal-fehma li l-bilanċ bejn il-benefiċċji u r-riskji huwa favorevoli għal Yasminelle u l-ismijiet assoċjati, li l-oġġezzjonijiet imqajma mill-Ungerija ma għandhomx jimpedixxu l-approvazzjoni tal-varjazzjoni li għalihom tressqet applikazzjoni u li s-Sommarju talKaratteristiċi tal-Prodott, it-tikketta u l-fuljett ta' tagħrif ta' l-Istat Membru ta' Referenza għandhom ikunu lverżjonijiet finali milħuqa waqt il-proċedura tal-grupp ta' koordinament.
English: Article 5(11) of Commission Regulation (EC) No 1084/2003
Maltese: Artikolu 5(11) tar-Regolament tal-Kummissjoni (KE) Nru 1084/2003.
English: Hungary referred the reasons for disagreement to the EMEA on 12 October 2007.
Maltese: L-Ungerija rreferiet ir-raġunijiet għan-nuqqas ta' qbil lill-EMEA fil-12 ta' Ottubru 2007.
English: The arbitration procedure started on 18 October 2007.
Maltese: Il-proċedura ta' arbitraġġ bdiet fit-18 ta' Ottubru 2007.
English: Yasminelle and associated names (see Annex I)
Maltese: Yasminelle u ismijiet oħra assoċjati (ara anness I)
English: The final opinion was converted into a Decision by the European Commission on 17 June 2008.
Maltese: L-opinjoni finali hija konvertita f'Deċiżjoni mill-Kummissjoni Ewropea fi 17 ta' Ġunju 2008.
English: The proposed package concept, the so-called wallet with the product and package leaflet wrapped in transparent cellophane was considered to be a serious public concern.
Maltese: Il-kunċett ta' pakkett propost, l-hekk imsejħa kaxxa bil-prodott u l-fuljett ta' tagħrif imgeżwer fis-cellophane trasparenti tqis bħala problema pubblika serja.
English: The cellophane wrapping could not be accepted as an outer packaging due to the risk that during usage the product (wallets) would get separated from the package leaflet.
Maltese: Il-kisi bis-cellophane ma setax ikun aċċettat bħala imballaġġ estern minħabba r-riskju li, waqt l-użu, il-prodott (kaxxi) jista' jiġi sseparat mill-fuljett ta' tagħrif.
English: These Member States were not able to reach an agreement in respect of the variation to the Marketing Authorisation within the time frame as referred to in Article 5(6) of Commission Regulation (EC) No 1084/2003.
Maltese: Dawn l-Istati Membri ma setgħux jilħqu qbil fir-rigward tal-varjazzjoni ta' l-Awtorizzazzjoni għatTqegħid fis-Suq saż-żmien previst mill-Artikolu 5(6) tar-Regolament tal-Kummissjoni (KE) Nru 1084/2003.
English: The Mutual Recognition Procedure started on 18 June 2007.
Maltese: Il-Proċedura ta' Rikonoxximent Reċiproku bdiet fit-18 ta' Ġunju 2007.
English: The MAH submitted variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the medicinal product in the framework of Article 5 of Commission Regulation (EC) No 1084/2003.
Maltese: Id-dententur ta' l-awtorizzazzjoni għat-tqegħid fuq is-suq (MAH) ippreżenta applikazzjoni għal varjazzjoni suġġetta għall-Proċedura ta' Rikonoxximent Reċiproku ta' l-Awtorizzazzjoni għat-Tqegħid fis-suq talmediċinal fl-ambitu ta' l-Artikolu 5 tar-Regolament tal-Kummissjoni (KE) Nru 1984/2003.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
Maltese: KUMITAT GĦALL-PRODOTTI MEDIĊINALI
English: A positive opinion was adopted by majority on 13 December 2007.
Maltese: Fit-13 ta' Diċembru 2007, ġiet adottata opinjoni pożittiva b'maġġoranza.
English: Via Provinciale Schito 131 I-80058 Torre Annunziata/NA Italy
Maltese: Via Provinciale Schito 131 I-80058 Torre Annunziata/NA L-Italja
English: Metabolism and elimination
Maltese: Metaboliżmu u eliminazzjoni
English: Linearity/non-linearity
Maltese: Linejarità/nuqqas ta‟ linejarità
English: CYP450 interactions
Maltese: Interazzjonijiet ma‟ CYP450
English: Aliskiren does not inhibit the CYP450 isoenzymes (CYP1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A).
Maltese: Aliskiren ma jinibixxix l-iżoenzimi CYP450 (CYP1A2, 2C8, 2C9, 2C19, 2D6, 2E1 u 3A).
English: PVC/polychlorotrifluoroethylene (PCTFE) - Alu blisters:
Maltese: Folji PVC/ polychlorotrifluoroethylene (PCTFE) - Alu:
English: The absolute bioavailability of aliskiren is approximately 2-3%.
Maltese: Il-biodisponibilità assoluta ta‟ aliskiren hija madwar 2-3%.
English: Many may feel quite normal.
Maltese: Ħafna nies iħossuhom normali.
English: Aliskiren does not induce CYP3A4.
Maltese: Aliskiren ma jinduċix CYP3A4.
English: Approximately 1.4% of the total oral dose is metabolised.
Maltese: Madwar 1.4% tad-doża orali totali tiġi metabolizzata.
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: 31 July 2012
Maltese: 31 ta' Lulju 2012
English: BLISTER BLISTER (CALENDAR)
Maltese: FOLJA (KALENDARJU)
English: Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Maltese: Komposti kimiċi li kienu investigati fi studji ta‟ farmakokinetika klinika kienu jinkludu acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate u hydrochlorothiazide.
English: Aliskiren is metabolised minimally by the cytochrome P450 enzymes.
Maltese: Aliskiren jiġi metabolizzat millanqas mill-enzimi cytochrome P450.
English: PA/Alu/PVC - Alu blisters:
Maltese: Folji PA/Alu/PVC - Alu:
English: You may require medical attention.
Maltese: Jista‟ jkollok bżonn attenzjoni medika.
English: Renal artery stenosis
Maltese: Stenożi ta‟ l-arterja renali
English: Pharmacovigilance system
Maltese: Sistema ta‟ Farmakoviġilanza
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: hereditary angioedema.
Maltese: Anġjoedima ereditarja jew idjopatika.
English: Nervous system disorders Common: Vascular disorders Uncommon: Gastrointestinal disorders Common: Immune system disorders Rare: Skin and subcutaneous tissue disorders Uncommon:
Maltese: Disturbi fis-sistema nervuża Komuni: Disturbi vaskulari Mhux komuni: Disturbi gastro-intestinali Komuni: Disturbi fis-sistema immuni Rari:
English: P-glycoprotein interactions
Maltese: Interazzjonijiet ma‟ glikoproteina P
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 Sprimeo.
Maltese: Meta aliskiren jingħata ma‟ metformin (↓28%), amlodipine (↑29%) jew cimetidine (↑19%) is-Cmax jew AUC ta‟ Sprimeo inbidlu b‟bejn 20% u 30%.
English: Non-steroidal anti-inflammatory drugs (NSAIDs)
Maltese: Mediċini antinfjammatorji mhux sterojdi (NSAIDs)
English: an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.
Maltese: “impeditur tal-enzima li tikkonverti angiotensin” bħal enalapril, lisinopril, ramipril eċċ.
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, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <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: In this leaflet:
Maltese: Mhux komuni:
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: Aliskiren plasma protein binding is moderate (47-51%) and independent of the concentration.
Maltese: Ir-rabta mal-proteini fil-plażma ta‟ alsikiren hija moderata (47-51%) u ma tiddependix fuq il-konċentrazzjoni.
English: The enzyme responsible for this metabolism is CYP3A4.
Maltese: L-enzima responsabbli għal dan il-metaboliżmu hija CYP3A4.
English: No interactions have been identified.
Maltese: L-ebda interazzjonijiet ma ġew identifikati.
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: Angioedema
Maltese: Anġjoedima
English: Combination therapy studies are available for Sprimeo added to the diuretic hydrochlorothiazide, the calcium channel blocker amlodipine and the beta blocker atenolol.
Maltese: Hemm studji b‟terapija ta‟ kombinazzjoni għal Sprimeo miżjud mad-dijuretiku hydrochlorthiazide, limblukkatur tal-kanali tal-calcium amlodipine u l-imblukkatur beta atenolol.
English: Moderate P-gp inhibitors
Maltese: Inibituri moderati ta‟ P-gp
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: Pharmacotherapeutic group: Renin inhibitor, ATC code: C09XA02
Maltese: Inibitur tar-renin, Kodiċi ATC:
English: Aliskiren is mainly eliminated as unchanged compound in the faeces (78%).
Maltese: Aliskiren jiġi eliminat bħala kompost kimiku mhux mibdul fl-ippurgar (78%).
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: or an “angiotensin 2 receptor blocker” such as valsartan, telmisartan, irbesartan etc. - ketoconazole, a medicine used to treat fungal infections.
Maltese: jew - “imblukkatur tar-riċetturi ta‟ angiotensin 2” bħal valsartan, telmisartan, irbesartan, eċċ. - ketoconazole, mediċina li tintuża biex tikkura infezzjonijiet tal-fungu.
English: In clinical studies in hypertensive patients, Sprimeo 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, Sprimeo 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: 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: No relevant interactions with atenolol, digoxin, amlodipine or cimetidine have been observed.
Maltese: Ma dehru l-ebda interazzjonijiet rilevanti ma‟ atenolol, digoxin, amlodipine jew cimetidine.
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Sprimeo.
Maltese: Indutturi ta‟ P-gp (St. John‟s wort, rifampicin) għalhekk jistgħu jnaqqsu l-biodisponibilità ta‟ Sprimeo.
English: Warfarin The effects of Sprimeo on warfarin pharmacokinetics have not been evaluated.
Maltese: Warfarin L-effetti ta‟ Sprimeo fuq il-farmakokinetika ta‟ warfarin ma kienux evalwati.
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: Haemoglobin and haematocrit: Small decreases in haemoglobin and haematocrit (mean decreases of approximately 0.05 mmol/l and 0.16 volume percent, respectively) were observed.
Maltese: Deher tnaqqis żgħir fl-emoglobina u ematokrit (medja ta‟ tnaqqis b‟madwar 0.05 mmol/l u 0.16 perċentwali tal-volum, rispettivament).
English: Aliskiren was devoid of any mutagenic potential in the in vitro and in vivo mutagenicity studies.
Maltese: Aliskiren kien nieqes minn kull potenzjal mutaġeniku fl-istudji dwar il-mutaġeniċità in vitro u in vivo.
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: 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: In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Sprimeo 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‟ Sprimeo 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: 98 film-coated tablets (2x49) (perforated unit-dose blister)
Maltese: 98 pillola miksija b‟rita (2x49) (folji perforati diviżibbli f‟dożi
English: or an “angiotensin 2 receptor blocker” such as valsartan, telmisartan, irbesartan etc.
Maltese: jew b‟ “imblukkatur tar-riċetturi ta‟ angiotensin 2” bħal valsartan, telmisartan, irbesartan, eċċ.
English: EU/1/07/407/007 84 film-coated tablets (3x28) EU/1/07/407/009 98 film-coated tablets (2x49) EU/1/07/407/010 280 film-coated tablets (20x14)
Maltese: FIS-SUQ EU/1/07/407/007 84 pillola miksija b‟rita (3x28) EU/1/07/407/009 98 pillola miksija b‟rita (2x49) EU/1/07/407/010 280 pillola miksija b‟rita (20x14)
English: Gender, weight and ethnicity have no clinically relevant influence on aliskiren pharmacokinetics.
Maltese: Is-sess, piż u etniċità m‟għandhomx influwenza klinikament rilevanti fuq il-farmakokinetika ta‟ aliskiren.
English: P-gp potent inhibitors
Maltese: Inibituri potenti ta‟ P-gp
English: In clinical studies Sprimeo 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, Sprimeo 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: Treatment with Sprimeo resulted in an overall incidence of adverse reactions similar to placebo up to 300 mg.
Maltese: Kura b‟Sprimeo wasslet għal inċidenza globali ta‟ reazzjonijiet avversi simili għal plaċebo sa‟ 300 mg.
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
Maltese: Kull pillola miksija b‟rita fiha 150 mg aliskiren (bħala hemifumarate).
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
Maltese: Kull pillola miksija b‟rita fiha 300 mg aliskiren (bħala hemifumarate).
English: Safety pharmacology studies did not reveal any adverse effects on central nervous, respiratory or cardiovascular function.
Maltese: Studji dwar is-sigurtà farmakoloġika ma wrew l-ebda effetti avversi fuq is-sistema nervuża ċentrali, respiratorja jew funzjoni kardjovaskulari.
English: After single dose administration in the dose range of 75 to 600 mg, a 2-fold increase in dose results in a ~2.3 and 2.6fold increase in AUC and Cmax, respectively.
Maltese: Wara li tingħata doża waħda fil-medda ta‟ dożi bejn 75 u 600 mg, meta d-doża tiġi rduppjata jkun hemm żieda ta‟ ~2.3 u 2.6-il darba fl-AUC u s-Cmax rispettivament.
English: When administered with atorvastatin, steady-state Sprimeo AUC and Cmax increased by 50%.
Maltese: Meta ngħata ma‟ atorvastatin, l-AUC u Cmax fi stat fiss ta‟ Sprimeo żdiedu b‟50%.
English: Sprimeo has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Maltese: Sprimeo 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: Packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Maltese: Pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
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: No carcinogenic potential was detected.
Maltese: Ma nstabx potenzjal karċinoġenu.
English: No patients discontinued therapy due to anaemia.
Maltese: Ħadd mill-pazjenti ma waqqaf it-terapija minħabba anemija.
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: 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: Packs containing 14, 28, 30, 50, 56, 90, 98 or 280 tablets.
Maltese: Pakketti li jkun fihom 14, 28, 30, 50, 56, 90, 98 jew 280 pillola.
English: Laboratory findings
Maltese: Sejbiet tal-laboratorju
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: Rash, severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN) and oral mucosal reactions
Maltese: Raxx, reazzjonijiet avversi serji fuq il-ġilda (SCARs), nekroliżi epidermali tossika (TEN) u reazzjonijiet mukużi fil-ħalq
English: When administered with atorvastatin (80 mg), steady-state aliskiren (300 mg) AUC and Cmax increased by
Maltese: Meta ingħata ma‟ atorvastatin (80 mg), l-AUC u Cmax ta‟ aliskiren (300 mg) fi stat fiss żdiedu b‟50%.
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: Co-administration of aliskiren 300 mg with ketoconazole 200 mg or verapamil 240 mg resulted in a 76% or 97% increase in aliskiren AUC, respectively.
Maltese: L-għotja fl-istess ħin ta‟ aliskiren 300 mg ma‟ ketoconazole 200 mg jew verapamil 240 mg wasslet għal żieda ta‟ 76% jew 97% fl-AUC ta‟ aliskiren, rispettivament.
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: 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: 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: 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: 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.