FrancophonIA/ELRC3.0 huggingface dataset:
English: Combination therapy studies are available for Tekturna added to the diuretic hydrochlorothiazide, the ACEI ramipril, the calcium channel blocker amlodipine, the angiotensin receptor antagonist valsartan, and the beta blocker atenolol.
Maltese: Hemm studji b'terapija ta' kombinazzjoni għal Tekturna miżjud mad-dijuretiku hydrochlorthiazide, lACEI ramipril, l-imblukkatur tal-kanali tal-calcium amlodipine, l-antagonist tar-riċettur ta' langiotensin valsartan, u l-imblukkatur beta atenolol.
English: • At the request of the EMEA.
Maltese: • Fuq talba ta' l-EMEA.
English: Treatment with Tekturna resulted in an overall incidence of adverse reactions similar to placebo up to 300 mg.
Maltese: Kura b'Tekturna wasslet għal inċidenza globali ta' reazzjonijiet avversi simili għal plaċebo sa' 300 mg.
English: The concomitant use of aliskiren with ciclosporin, a highly potent P-gp inhibitor, and other potent Pgp inhibitors (quinidine, verapamil), is contraindicated (see section 4.5).
Maltese: L-użu konkomittanti ta' aliskiren ma' ciclosporin, inibitur ta' P-gp qawwi ħafna, u inibituri ta' P-gp qawwija oħrajn (quinidine, verapamil), huwa kontra-indikat (ara sezzjoni 4.5).
English: - Keep this leaflet.
Maltese: Tieħux Tekturna jekk ħriġt tqila.
English: In diabetic hypertensive patients, Tekturna provided additive blood pressure reductions when added to ramipril, while the combination of Tekturna and ramipril had a lower incidence of cough (1.8%) than ramipril (4.7%).
Maltese: F'pazjenti dijabetiċi li għandhom il-pressjoni għolja, Tekturna ipprovda tnaqqis addittiv tal-pressjoni tad-demm meta ngħata ma' ramipril, filwaqt li l-kombinazzjoni ta' Tekturna u ramipril kellha anqas każijiet ta' sogħla (1.8%) minn ramipril (4.7%).
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: Tekturna did not affect the serum concentration of creatinine but was associated with an increased frequency (4.2% vs. 1.9% for placebo) of serum potassium concentration ≥6.0 mmol/l, although this was not statistically significant.
Maltese: Tekturna ma effettwax il-konċentrazzjoni fis-serum tal-krejatinina iżda kien assoċjat ma' żieda fil-frekwenza (4.2% vs 1.9% għal plaċebo) tal-konċentrazzjoni tal-potassium fis-serum ≥ 6.0 mmol/l, għalkemm dan ma kienx statistikament sinifikanti.
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: 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: 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: 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: You should not take Tekturna together with grapefruit juice.
Maltese: M'ghandekx tieħu Tekturna mal-meraq tal-grejpfrut.
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: 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: 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: 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: The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
Maltese: Il-potenzjal ta' interazzjonijiet fis-sit P-gp x'aktarx li jkunu jiddependu mill-grad ta' inibizzjoni tat-trasportatur.
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: In diabetic hypertensive patients, Tekturna monotherapy was safe and effective.
Maltese: F'pazjenti dijabetiċi bil-pressjoni għolja, monoterapija ta' Tekturna kienet sigura u effettiva.
English: At steady state the non-linearity may be more pronounced.
Maltese: Fi stat fiss in-nuqqas ta' linejarità tista' tkun tidher aktar.
English: EU/1/07/408/011 EU/1/07/408/012 EU/1/07/408/013 EU/1/07/408/014 EU/1/07/408/015 EU/1/07/408/016
Maltese: EU/1/07/408/011 EU/1/07/408/012 EU/1/07/408/013 EU/1/07/408/014
English: Serum potassium: Increases in serum potassium were minor and infrequent in patients with essential hypertension treated with Tekturna alone (0.9% compared to 0.6% with placebo).
Maltese: Żiediet tal-potassium fis-serum kienu minuri u mhux frekwenti f'pazjenti bilpressjoni għolja naturali kkurata b'Tekturna waħdu (0.9% imqabbla ma' 0.6% bil-plaċebo).
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: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 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
English: However, in one study where Tekturna was used in combination with an ACEI in a diabetic population, increases in serum potassium were more frequent (5.5%).
Maltese: Madankollu, fi studju wieħed fejn Tekturna intuża ma' ACEI f'popolazzjoni ta' pazjenti dijabetiċi iżżiediet tal-potassium fis-serum kienu aktar frekwenti (5.5%).
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: EU/1/07/408/001 EU/1/07/408/002 EU/1/07/408/003 EU/1/07/408/004 EU/1/07/408/005 EU/1/07/408/006 EU/1/07/408/008
Maltese: EU/1/07/408/001 EU/1/07/408/002 EU/1/07/408/003 EU/1/07/408/004
English: In experimental animals, it has been shown that P-gp is a major determinant of Tekturna bioavailability.
Maltese: F'annimali esperimentali, intwera li P-gp jiddetermina bil-kbir il-biodisponibilità ta' Tekturna.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Maltese: • Fi żmien 60 jum minn meta jintlaħaq avveniment importanti (farmakoviġilanza jew tnaqqis tar
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: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
Maltese: Kull pillola miksija b'rita fiha 150 mg aliskiren (bħala hemifumarate).
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: Multipack comprising 3 packs, each containing 30 tablets.
Maltese: Pakkett b'ħafna li jkun fih 3 pakketti, kull wieħed bi 30 pillola.
English: Coadministration of Tekturna had no significant impact on atorvastatin, valsartan, metformin or amlodipine pharmacokinetics.
Maltese: Meta Tekturna ingħata ma' atorvastatin, valsartan, metformin jew amlodipine dan ma kellux impatt sinifikanti fuq il-farmakokinetika tagħhom.
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: History of angioedema with aliskiren.
Maltese: Storja ta' anġjoedima b'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 Tekturna, or the treatment should start under close medical supervision.
Maltese: Din ilkundizzjoni għandha tiġi korretta qabel ma jingħata Tekturna, jew il-kura għandha tinbeda taħt superviżjoni medika stretta.
English: Potassium and potassium-sparing diuretics
Maltese: Potassium fis-serum:
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: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
Maltese: Kull pillola miksija b'rita fiha 300 mg aliskiren (bħala hemifumarate).
English: Not known (frequency cannot be estimated from the available data): Kidney problems.
Maltese: Mhux magħruf (ma tistax tittieħed stima tal-frekwenza mid-dejta disponibbli): Problemi fil-kliewi.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 30 May 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: L-MAH jintrabat sabiex iwettaq l-istudji u attivitajiet oħra ta' farmakoviġilanza kif hemm fid-dettal fil-Pjan ta' Farmakoviġilanza, kif miftiehem fil-verżjoni tat-30 Mejju 2007 tal-Pjan ta' l-Immaniġġar tar-Riskju (RMP) li hemm f'Modulu 1.8.2 ta' l-Applikazzjoni Għall-Awtorizzazzjoni Għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti ta' l-RMP miftiehem mis-CHMP.
English: 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: Tekturna 150 mg film-coated tablets Aliskiren
Maltese: Tekturna 150 mg pilloli miksijin b'rita Aliskiren
English: What Tekturna looks like and contents of the pack Tekturna 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Maltese: Id-Dehra ta' Tekturna u l-kontenuti tal-pakkett Tekturna 150 mg pilloli miksijin b'rita huma pilloli roża ċar, konvessi miż-żewġ naħat, tondi, ittimbrati ‘IL' fuq naħa u ‘NVR' fuq in-naħa l-oħra.
English: Hence, interactions due to inhibition or induction of CYP450 isoenzymes are not expected.
Maltese: Għalhekk, interazzjonijiet minħabba l-inibizzjoni jew linduzzjoni ta' l-isoenzimi CYP450 mhumiex mistennija.
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: 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: 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: 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: Tekturna 300 mg film-coated tablets Aliskiren
Maltese: Tekturna 300 mg pilloli miksijin b'rita Aliskiren
English: What Tekturna 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: Common (affecting less than 1 in 10 patients): Diarrhoea.
Maltese: Effetti komuni (jeffettwaw anqas minn 1 f'kull 10 pazjenti): Dijarrea.
English: Preliminary data suggest that irbesartan may decrease Tekturna AUC and Cmax.
Maltese: Tagħrif preliminari jindika li irbesartan jista' jnaqqas xi ftit l-AUC u s-Cmax ta' Tekturna.
English: Fertility, pre-natal development and post-natal development were unaffected in rats at doses up to 250 mg/kg/day.
Maltese: Il-fertilità, l-iżvilupp ta' qabel u wara t-twelid ma kienux effettwati fil-firien b'dożi sa 250 mg/kg/jum.
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: 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: In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Tekturna 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' Tekturna 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: Patients receiving other medicinal products inhibiting the renin-angiotensin system (RAS), and/or those with reduced kidney function and/or diabetes mellitus are at an increased risk of hyperkalaemia during aliskiren therapy.
Maltese: Pazjenti li jkunu qed jirċievu prodotti mediċinali oħrajn li jinibixxu s-sistema renin-angiotensin (RAS), u/jew dawk b'funzjoni tal-kliewi mnaqqsa u/jew dijabete mellitus għandhom riskju akbar li jkollhom iperkalimja waqt it-terapija b'aliskiren.
English: Film-coated tablet Light-pink, biconvex, round tablet, imprinted “IL” on one side and “NVR” on the other side.
Maltese: Pillola miksija b'rita Pillola roża ċar, konvessa miż-żewġ naħat, tonda, ittimbrata ‘IL' fuq naħa u ‘NVR' fuq in-naħa l-oħra.
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: Co-administration of aliskiren 300 mg with ketoconazole 200 mg resulted in a 76% increase in aliskiren AUC but P-gp inhibitors such as ketoconazole are expected to increase tissue concentrations more than plasma concentrations.
Maltese: L-għotja fl-istess ħin ta' aliskiren 300 mg ma' ketoconazole 200 mg wasslet għal żieda ta' 76% flAUC ta' aliskiren iżda inibituri ta' P-gp bħal ketoconazole huma mistennija li jgħollu lkonċentrazzjonijiet fit-tessuti aktar milli fil-plażma.
English: Hypromellose Macrogol
Maltese: Macrogol
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: Multipack comprising 3 packs, each containing 28 tablets.
Maltese: Pakkett b'ħafna li jkun fih 3 pakketti, kull wieħed ikun fih 28 pillola.
English: Tekturna induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide and to ramipril.
Maltese: Tekturna ikkawża tnaqqis fil-pressjoni tad-demm akbar meta żdied ma' hydrochlorthiazide u ma' ramipril.
English: Although this has not been investigated for aliskiren, it is known that P-gp also controls tissue uptake of a variety of substrates and P-gp inhibitors can increase the tissue-to-plasma concentration ratios.
Maltese: Għalhekk huwa irrakkomandat li l-effetti jkunu monitorati meta tinbeda u tkun qed tiġi aġġustata t-terapija ta' furosemide biex dan ma jkunx sotto-utilizzat f'sitwazzjonijiet kliniċi ta' volum żejjed.
English: Therefore caution should be exercised when aliskiren is administered with moderate P-gp inhibitors such as ketoconazole (see section 4.5).
Maltese: Għalhekk, għandha ssir kawtela meta aliskiren jingħata ma' inibituri ta' P-gp moderati bħal ketoconazole (ara sezzjoni 4.5).
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
English: 49 film-coated tablets
Maltese: 49 pillola miksija b'rita
English: In hypertensive patients, once-daily administration of Tekturna 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' Tekturna 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: B-type natriuretic peptide (BNP) levels were reduced by 25% in the Tekturna arm compared to placebo.
Maltese: Il-livelli ta' peptajd natrijuretiku tat-tip-B (BNP) kienu mnaqqsa b'25% fil-fergħa ta' Tekturna meta mqabbla mal-plaċebo għalkemm is-sinifikat kliniku għadu mhux magħruf.
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: The clinical relevance of a reduction in UACR is not established in the absence of an effect on blood pressure.
Maltese: Ir-rilevanza klinika tattnaqqis fl-UACR mhux stabbilit fl-assenza ta' effett fuq il-pressjoni tad-demm.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 2 (dated 5 July 2006) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Maltese: Lulju 2006) li hemm f'Modulu 1.8.1 ta' l-Applikazzjoni għall-Awtorizzazzjoni Għat-Tqegħid fisSuq, tkun twaqqfet u qed taħdem qabel u waqt li l-prodott ikun fis-suq.
English: Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected (see P-glycoprotein interactions below).
Maltese: Madankollu, inibituri ta' CYP3A4 ta' spiss jeffettwaw ukoll P-gp. Żieda fl-esponiment għal aliskiren waqt l-għotja fl-istess ħin ta' inibituri ta' CYP3A4 li jimpedixxu wkoll P-gp tista' għalhekk tkun mistennija (ara interazzjonijiet ma' glikoproteina-P hawn taħt).
English: Novartis Pharma Servic Tel: +386 1 300 75 77
Maltese: Tel: +386 1 300 75 77
English: Compared to a diuretic (hydrochlorothiazide - HCTZ), Tekturna 300 mg lowered systolic/diastolic blood pressure by 17.0/12.3 mmHg, compared to 14.4/10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Maltese: Studji b'monoterapija b'Tekturna urew li l-effetti li jbaxxi l-pressjoni kienu jitqabblu ma' klassijiet oħra ta' aġenti li jbaxxu l-pressjoni inklużi ACEI u ARB. Meta mqabbel ma' dijuretiku (hydrochlorothiazide - HCTZ), Tekturna 300 mg naqqas il-pressjoni sistolika/dijastolika tad-demm b'17.0/12.3 mmHg, imqabbel ma' 14.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/408/007
Maltese: FIS-SUQ EU/1/07/408/007
English: In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of Tekturna 150 mg was well tolerated.
Maltese: Fi studju ta' 3 xhur fuq 302 pazjenti b'insuffiċjenza tal-qalb stabbli u mhux severa (Klassi funzjonali NYHA II u III), li kollha kemm huma kienu qed jirċievu terapija standard għall-insuffiċjenza tal-qalb iż-żieda ta' Rasliez 150 mg kienet tollerata sew.
English: As for any medicine that acts directly on the RAS, Tekturna should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Maltese: Bħal kull mediċina oħra li taħdem direttament fuq irRAS, Tekturna m'għandux jintuża waqt l-ewwel trimestru tat-tqala jew f'nisa li qed jippjanaw biex joħorġu tqal u huwa kontraindikat waqt it-tieni u t-tielet trimestri (ara sezzjoni 4.3).
English: These combinations were well tolerated.
Maltese: Dawn il-kombinazzjonijiet kienu tollerati sew.
English: Component of a multipack comprising 3 packs, each containing 28 tablets.
Maltese: Jagħmel parti minn pakkett b'ħafna li jkun fih 3 pakketti, kull wieħed ikun fih 28 pillola.
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.