FrancophonIA/ELRC3.0 huggingface dataset:
English: Celsentri is used in combination with other HIV medicines, and only in patients who have been treated for HIV infection before and only when the HIV-1 they are infected with is ‘CCR5-tropic', which is determined by a blood test.
Maltese: Celsentri jintuża f'kombinazzjoni ma' mediċini oħra kontra l-HIV, u biss f'pazjenti li ġew ikkurati għallinfezzjoni tal-HIV qabel u biss meta l-HIV-1 li huma nfettati bih ikun ‘CCR5-tropic', li jiġi ddeterminat b'test tad-demm.
English: In the studies Celsentri was compared with placebo (a dummy treatment).
Maltese: Fl-istudji Celsentri tqabbel ma' plaċebo (kura finta).
English: How does Celsentri work?
Maltese: Kif jintuża Celsentri?
English: Celsentri cannot work against viruses that attach to another protein called CXCR4, or when it can attach to both CCR5 and CXCR4.
Maltese: Meta jeħel mal-proteina, Celsentri jipprevjeni l-virus milli jidħol fiċ-ċelloli.
English: Celsentri does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Celsentri ma jfejjaqx l-infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjati mal-AIDS.
English: Similar results were also seen when looking at the patients who continued treatment with Celsentri 300 mg twice a day for 48 weeks.
Maltese: Riżultati simili dehru wkoll meta wieħed ħares lejn il-pazjenti li komplew il-kura b'Celsentri 300 mg darbtejn kuljum għal 48 ġimgħa.
English: Patients who have reduced kidney function may need to take Celsentri less frequently.
Maltese: Il-pazjenti li għandhom funzjoni indebolita tal-kliewi jaf ikollhom bżonn jieħdu Celsentri inqas frekwenti.
English: Celsentri tablets must not be used in patients who are hypersensitive (allergic) to peanut and soya.
Maltese: Il-pilloli Celsentri ma għandhomx jintużaw fil-pazjenti li huma ipersensittivi (allerġiċi) għall-karawett u s-sojja.
English: All of the patients also took ‘optimised background therapy' (a combination of other HIV medicines chosen for each patient to increase the chances of reducing the levels of HIV in the blood).
Maltese: Il-pazjenti kollha ħadu wkoll ‘terapija ta' bażi ottimizzata' (kombinazzjoni ta' mediċini oħrajn kontra l-HIV magħżulin għal kull pazjent biex iżidu ċ-ċans li jitnaqqsu l-livelli tal-HIV fid-demm).
English: The full EPAR for Aprovel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Aprovel was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Maltese: Aprovel tqabbel ma' plaċebo (trattament finta) f'712-il pazjent u tqabbel ma' mediċini oħra kontra lipertensjoni (atenolol, enalapril, amlodipina) f'823 pazjent.
English: Aprovel is a medicine that contains the active substance irbesartan.
Maltese: Aprovel huwa mediċina li fiha s-sustanza attiva irbesartan.
English: This is a summary of the European public assessment report (EPAR) for Aprovel.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Aprovel.
English: The usual recommended dose of Aprovel is 150 mg once a day.
Maltese: Id-doża normalment rakkomandata ta' Aprovel hija ta' 150 mg darba kuljum.
English: When used with hydrochlorothiazide, the effects of the two medicines were additive.
Maltese: Meta użat malidroklorotijażide, l-effetti taż-żewġ mediċini kienu addittivi.
English: The active substance in Aprovel, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Aproval, irbesartan hija ‘antagonista tar-riċettur tal-anġjotensina II' li jfisser li jimblokka l-azzjoni ta' ormon fil-ġisem imsejjaħ anġjotensina II.
English: In the second kidney disease study, Aprovel reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
Maltese: Fit-tieni studju dwar il-mard tal-kliewi, Aprovel naqqas b'20% r-riskju relattiv ta' rduppjar tal-livelli ta' kreatinina fid-demm, talbżonn ta' trapjant ta' kilwa jew ta' dijaliżi, jew ta' mewt tal-pazjent matul l-istudju meta mqabbel malplaċebo.
English: A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.
Maltese: Doża inizjali ta' 75 mg tista' tintuża filpazjenti li għaddejjin minn emodijaliżi (teknika ta' tisfija tad-demm) jew f'pazjenti li għandhom iktar minn 75 sena.
English: What benefit has Aprovel shown during the studies?
Maltese: Liema benefiċċju wera Aprovel waqt l-istudji mwettqa?
English: Other information about Aprovel
Maltese: Informazzjoni oħra dwar Aprovel:
English: The most common side effect with Aprovel (seen in more than 1 patient in 10) is hyperkalaemia (high blood potassium levels).
Maltese: L-iktar effett sekondarju komuni b'Aprovel (li deher f'iktar minn pazjent 1 minn kull 10) hija ipogliċemija (livelli għoli ta' potassju fid-demm).
English: In the blood pressure studies, Aprovel was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Maltese: Fl-istudji dwar il-pressjoni għolja, irriżulta li Aprovel kien ferm aktar effettiv mill-plaċebo biex inaqqas il-pressjoni tad-demm dijastolika u kellu effetti simili għal mediċini għall-ipertensjoni.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aprovel on 27 August 1997.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Aprovel valida fl-Unjoni Ewropea kollha fis-22 ta' Awwissu 2007.
English: Aprovel is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Maltese: Aprovel jintuża wkoll għall-kura ta' mard fil-kliewi f'adulti li jbatu minn ipertensjoni u dijabete tat-tip 2.
English: What is Aprovel?
Maltese: X'inhu Aprovel?
English: For the treatment of kidney disease, Aprovel was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Maltese: Aprovel ġie studjat ukoll f'żewġ studji kbar dwar il-mard tal-kliewi f'2,326 pazjent li għandhom dijabete tat-tip 2.
English: If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide.
Maltese: Jekk il-pressjoni taddemm ma tkunx ikkontrollata kif xieraq, id-doża tista' tiżdied għal 300 mg kuljum jew inkella jistgħu jiżdiedu mediċini oħra għal ipertensjoni, bħall-idroklorotijażide.
English: Aprovel in combination with aliskirencontaining medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Maltese: Aprovel ma għandux jintuża flimkien ma' mediċini li fihom l-aliskiren (użat fil-kura tal-ipertensjoni essenzjali) f'pazjenti biddijabete, jew insuffiċjenza moderata jew gravi fil-kliewi.
English: The CHMP decided that Aprovel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Aprovel huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How does Aprovel work?
Maltese: Għal xiex jintuża Aprovel?
English: In the first kidney disease study, Aprovel was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Maltese: Fl-ewwel studju dwar il-mard tal-kliewi irriżulta li Aprovel kien ferm aktar effettiv mill-plaċebo biex inaqqas ir-riskju li ssir ħsara lill-kliewi kif tkejlet it-tneħħija tal-proteini.
English: What is the risk associated with Aprovel?
Maltese: X'inhu r-riskju assoċjat ma' Aprovel?
English: How has Aprovel been studied?
Maltese: Kif ġie studjat Aprovel?
English: OLM-M = olmesartan medoxomil, LS = least squares, LOCF = last observation carried forward * Significant difference vs.
Maltese: OLM-M = olmesartan medoxomil, LS = least squares, LOCF = last observation carried forward
English: Linearity/non-linearity
Maltese: Lineari / mhux lineari
English: Serum creatinine
Maltese: Investigazzjonijiet Serum krejatinina
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 7 December 2011
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI 7 ta' Diċembru 2011
English: Takeda Ireland Limited, Bray Business Park, Kilruddery, Co. Wicklow, Ireland
Maltese: Takeda Ireland Limited, Bray Business Park, Kilruddery, Co.
English: These are ranked by frequency, 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), including isolated reports.
Maltese: (≥ 1/10); komuni (≥ 1/100, < 1/10); mhux komuni (≥ 1/1,000, < 1/100); rari (≥ 1/10,000, < 1/1,000); rari ħafna (< 1/10,000), inklużi rapporti iżolati.
English: The major enzyme responsible for azilsartan metabolism is CYP2C9.
Maltese: L-enżima prinċipali responsabbli għallmetaboliżmu azilsartan hija CYP2C9.
English: No data are available.
Maltese: L-ebda dejta hi disponibbli.
English: For Ipreziv, olmesartan medoxomil and valsartan, respectively dizziness was observed at an incidence of 3.0%, 3.3% and 1.8%; headache at 4.8%, 5.5% and 7.6% and dyslipidemia at 3.5%, 2.4% and 1.1%.
Maltese: Għal Ipreziv, olmesartan medoximil u valsartan, ripettivament sturdament kien osservat b'inċidenza ta' 3.0%, 3.3% u 1.8%, uġigħ ta' ras ta' 4.8%, 5.5%
English: Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE inhibitor with an angiotensin II receptor blocker.
Maltese: (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) u VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) eżaminaw l-użu tal-kombinazzjoni ta' inibitur ta' ACE flimkien ma' imblokkatur tar-riċetturi ta' angiotensin II.
English: Small mean increases of serum uric acid were observed with Ipreziv (10.8 µmol/l) compared with placebo (4.3 µmol/l).
Maltese: Żidiet medji żgħar ta' aċidu uriku fis-serum kienu osservati b'Ipreziv (10.8 µmol/l) meta mqabbla ma' placebo (4.3 µmol/l).
English: Activated renin-angiotensin-aldosterone system
Maltese: Imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS)
English: croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.
Maltese: sodju kroskarmellosju, ċellulosi mikrokristallina, u sterat tal-manjesju.
English: Overall, 51% of patients were male and 26% were 65 years or older (5% ≥ 75 years); 67% were white and 19% were black.
Maltese: B'mod ġenerali, 51% tal-pazjenti kienu rġiel u 26% kellhom 65 sena jew aktar (5% ≥ 75 sena); 67% kienu bojod u 19% kienu suwed.
English: In seven double blind controlled studies, a total of 5941 patients (3672 given Ipreziv, 801 given placebo, and 1468 given active comparator) were evaluated.
Maltese: Fis-seba' studji doppji għomja kkontrollati, total ta' 5,941 pazjent (3,672 mogħtija Ipreziv, 801 mogħtija plaċebo, u 1468 mogħtija komparatur attiv) kienu evalwati.
English: Ipreziv is provided in blister packs with each blister pack having either 14 tablets or 15 tablets within cartons containing: - 14, 28, 30, 56, 90 or 98 tablets for 20 mg tablets - 14, 28, 30, 56, 90 or 98 tablets for 40 mg tablets - 14, 28, 30, 56, 90 or 98 tablets for 80 mg tablets
Maltese: - 14, 28, 30, 56, 90 jew 98 pillola għal pilloli ta' 20 mg - 14, 28, 30, 56, 90 jew 98 pillola għal pilloli ta' 40 mg - 14, 28, 30, 56, 90 jew 98 pillola għal pilloli ta' 80 mg
English: Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Denmark Manufacturer:
Maltese: Takeda Pharma A/S, Dybendal Alle 10, 2630
English: Clinic SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) (LOCF) Study 1
Maltese: Klinika SBP: LS Tibdil Medju mill-Linja Bażi (BL) sas-6 Ġimgħa (mm Hg) (LOCF)
English: Doses were force-titrated at Week 2 from 20 to 40 mg and 40 to 80 mg for Ipreziv, and 20 to 40 mg and 160 to 320 mg, respectively, for olmesartan medoxomil and valsartan
Maltese: 40 mg u 40 sa 80 mg ta' Ipreziv, u 20 sa 40 mg u 160 sa 320 mg, rispettivament, għal
English: Pharmacotherapeutic group: Angiotensin II antagonists, plain ATC Code: C09CA09
Maltese: Kodiċi ATC: C09CA09
English: NAME OF THE MARKETING AUTHORISATION HOLDER Takeda Logo
Maltese: FIS-SUQ Takeda Logo
English: What Ipreziv contains - The active substance is azilsartan medoxomil (as potassium) either 20 mg, 40 mg or 80 mg - The other ingredients are mannitol, fumaric acid, sodium hydroxide, hydroxypropylcellulose,
Maltese: - Is-sustanza attiva hija azilsartan medoxomil (bħala potassju) jew 20 mg, 40 mg jew 80 mg - Is-sustanzi l-oħra huma mannitol, aċidu fumariku, idrossidu tas-sodju, idroksipropilċellulosi,
English: It is important to keep taking Ipreziv every day.
Maltese: Huwa importanti li tkompli tieħu Ipreziv kuljum.
English: Cartons containing aluminum blisters packs integrated with desiccant.
Maltese: Kartun li fihom pakketti b'folji tal-aluminju integrati b'dessikant.
English: Following an oral dose of 14C-labelled azilsartan medoxomil, approximately 55% of radioactivity was recovered in feces and approximately 42% in urine, with 15% of the dose excreted in urine as azilsartan.
Maltese: Eliminazzjoni Wara doża orali ta' 14C-tabellata ta' azilsartan medoxomil, madwar 55% ta' radjoattività kienet irkuprata fil-purgar u madwar 42% fl-awrina, b'15% tad-doża mneħħija fl-awrina bħala azilsartan.
English: EU/1/11/735/001 14 tablets EU/1/11/735/002 28 tablets EU/1/11/735/012 30 tablets EU/1/11/735/003 56 tablets EU/1/11/735/013 90 tablets EU/1/11/735/004 98 tablets
Maltese: EU/1/11/735/001 14-il pillola EU/1/11/735/002 28 pillola EU/1/11/735/012 30 pillola EU/1/11/735/003 56 pillola EU/1/11/735/013 90 pillola EU/1/11/735/004 98 pillola
English: EU/1/11/735/016 14 tablets EU/1/11/735/009 28 tablets EU/1/11/735/017 30 tablets EU/1/11/735/010 56 tablets EU/1/11/735/018 90 tablets EU/1/11/735/011 98 tablets
Maltese: EU/1/11/735/016 14-il pillola EU/1/11/735/009 28 pillola EU/1/11/735/017 30 pillola EU/1/11/735/010 56 pillola EU/1/11/735/018 90 pillola EU/1/11/735/011 98 pillola
English: EU/1/11/735/005 14 tablets EU/1/11/735/006 28 tablets EU/1/11/735/014 30 tablets EU/1/11/735/007 56 tablets EU/1/11/735/015 90 tablets EU/1/11/735/008 98 tablets
Maltese: EU/1/11/735/005 14-il pillola EU/1/11/735/006 28 pillola EU/1/11/735/014 30 pillola EU/1/11/735/007 56 pillola EU/1/11/735/015 90 pillola EU/1/11/735/008 98 pillola
English: Administration of Ipreziv for up to 5 days in subjects with mild (Child-Pugh A) or moderate (ChildPugh B) hepatic impairment resulted in slight increase in azilsartan exposure (AUC increased by 1.3 to 1.6 fold, see section 4.2).
Maltese: L-amministrazzjoni ta' Ipreziv sa 5 ijiem f'suġġetti b'indeboliment ħafif ta' indeboliment epatiku (Child-Pugh A) jew moderat (Child-Pugh B) rriżulta f'żieda żgħira f'esposizzjoni ta' azilsartan (AUC żied minn 1.3 għal 1.6 il-darba (ara sezzjoni 4.2)).
English: During controlled clinical studies in healthy subjects, once daily doses up to 320 mg of Ipreziv were administered for 7 days and were well tolerated.
Maltese: Waqt studji kliniċi kkontrollati f'persuni f'saħħithom, dożi mogħtija darba kuljum sa 320 mg ta' Ipreziv kienu amministrati għal 7 ijiem u kienu tollerati sew.
English: The safety and efficacy of Ipreziv in children and adolescents 0 to < 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Ipreziv fi tfal u adolexxenti ta' età minn 0 sa < 18-il sena għadhom ma ġewx stabbiliti.
English: Mannitol (E 421)
Maltese: Aċidu fumariku (E 297)
English: Coadministration of Ipreziv 40 and 80 mg with a calcium channel blocker (amlodipine) or a thiazidetype diuretic (chlortalidone) resulted in additional blood pressure reductions compared with the other antihypertensive alone.
Maltese: L-amministrazzjoni ta' Ipreziv 40 u 80 mg flimkien ma' imblokkatur tal-kanali tal-kalċju (amlodipine) jew dijuretiku tat-tip tijazide (klortalidon) irriżulta fi tnaqqis miżjud fil-pressjoni tad-demm meta mqabbla ma' l-anti-ipertensiv ieħor waħdu.
English: Adverse reactions were reported at a similar frequency for the Ipreziv 20 mg dose as with the 40 and 80 mg doses in one placebo controlled study.
Maltese: Reazzjonijiet avversi kienu rrapurtati b'frekwenza simili f'Ipreziv b'doża ta' 20 mg kif ukoll f'dożi ta' 40 u 80 mg għal studju wieħed ikkontrollat b'plaċebo.
English: What Ipreziv looks like and contents of the pack Ipreziv are white round tablets debossed “ASL” on one side and either “20”, “40” or “80” on the other.
Maltese: Ipreziv huma pilloli bojod tondi b'”ASL” debuzzat fuq naħa waħda u “20”, “40” jew “80” fuq in-naħa l-oħra.
English: o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Maltese: o inibitur ta' ACE (pereżempju enalapril, lisinopril, ramipril), b'mod partikulari jekk għandek problemi tal-kliewi relatati mad-dijabete
English: The elimination half-life of azilsartan is approximately 11 hours and renal clearance is approximately 2.3 ml/min.
Maltese: Iżżmien tal-eliminazzjoni bin-nofs ta' azilsartan hi madwar 11-il siegħa u t-tneħħija renali hi ta' madwar 2.3 ml/min.
English: Dizziness
Maltese: Ipreziv.
English: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Maltese: permezz tal-użu kombinat ta' inibituri ta' ACE, imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren, hu assoċjat ma' frekwenza ogħla ta' avvenimenti avversi bħal pressjoni baxxa, iperkalimja u tnaqqis fil-funzjoni tal-kliewi (li jinkludi insuffiċjenza akuta tal-kliewi) meta mqabbel mal-użu ta' sustanza waħda li taġixxi fuq RAAS (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: Primary End point:
Maltese: Studju 1
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu
English: Mechanism of action and pharmacodynamic effect Azilsartan medoxomil is an orally active prodrug that is rapidly converted to the active moiety, azilsartan, which selectively antagonises the effects of angiotensin II by blocking its binding to the AT1 receptor in multiple tissues (see section 5.2).
Maltese: Mekkaniżmu ta' azzjoni u l-effett farmakodinamiku Azilsartan medoxomil hija prodroga attiva mill-ħalq li rapidament tinbidel għal frazzjoni attiva, azilsartan, li b'mod selettiv jantagonizza l-effetti ta' anġjotensina II billi jimblokka l-legatura tagħha mar-riċettur AT1 fit-tessuti multipli (ara sezzjoni 5.2).
English: Dose proportionality in exposure was established for azilsartan in the azilsartan medoxomil dose range of 20 mg to 320 mg after single or multiple dosing.
Maltese: Il-proporzjonalità fid-doża fl-espożizzjoni ġiet stabbilita għal azilsartan fil-firxa tad-doża medoxomil azilsartan ta' 20 mg sa 320 mg wara dożaġġ singolu jew multiplu.
English: - Heparin (a medicine for thinning the blood) - Diuretics (water tablets) - Aliskiren or other medicines to lower your blood pressure (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker, such as enalapril, lisinopril, ramipril or valsartan,
Maltese: - Aliskiren jew mediċini oħrajn li jbaxxu l-pressjoni tad-demm tiegħek (inibitur ta' enzima li tibdel angiotensin jew imblokkatur ta' riċettur ta' angiotensin II, bħal enalapril, lisinopril,
English: Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day), and non-selective NSAIDs When angiotensin II receptor antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Maltese: Attenzjoni meħtieġa bl-użu konkomitanti Mediċini anti-infjammatorji mhux sterojdi (NSAIDs), inklużi inibituri COX-2 selettivi, aċidu aċitilsaliċiliku > 3 g/kuljum), u NSAIDs mhux selettivi
English: No initial dose adjustment with Ipreziv is necessary in elderly patients (see section 5.2), although consideration can be given to 20 mg as a starting dose in the very elderly (≥ 75 years), who may be at risk of hypotension.
Maltese: M'hemmx bżonn ta' aġġustament inizjali fid-doża b'Ipreziv f'pazjenti anzjani (ara sezzjoni 5.2), għalkemm konsiderazzjoni tista' tingħata sa 20 mg bħala doża tal-bidu fl-anzjani akbar (≥ 75 sena), li jistgħu jkunu f'riskju ta' pressjoni baxxa.
English: Whilst there are no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of medicinal products.
Maltese: Filwaqt li m'hemm l-ebda dejta epidemjoloġika kkontrollata fuq ir-riskju b'antagonisti tar-riċetturi ta' angiotensin II, riskji simili jistgħu jkunu jeżistu għal din il klassi ta'prodotti mediċinali.
English: Ipreziv at doses of 20, 40 or 80 mg has been evaluated for safety in clinical studies in patients treated for up to 56 weeks.
Maltese: B'dożi ta' 20, 40 jew 80 mg Ipreziv ġie evalwat għas-sigurtà f'studji kliniċi f'pazjenti kkurati sa 56 ġimgħa.
English: Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.
Maltese: II huwa l-aġent prinċipali li jikkawza id-djieq tal-vini jew arterji tas-sistema renin-anġjotensina, b'effetti li jinkludu vażokostrizzjoni, stimulazzjoni ta' sintesi u ħelsien ta' aldosteron, stimulazzjoni kardijaka, u riassorbiment renali ta' sodju.
English: The possibility of similar effects cannot be excluded with Ipreziv.
Maltese: Il-possibbiltà ta' effetti simili ma tistax tiġi eskluża b'Ipreziv.
English: In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with congestive heart failure, severe renal impairment or renal artery stenosis), treatment with medicinal products that affect this system, such as angiotensinconverting enzyme inhibitors and angiotensin II receptor antagonists, has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure.
Maltese: Sistema attivata ta' renin-anġjotensina-aldosteron F'pazjenti li t-ton vaskulari u l-funzjoni renali jiddependu b'mod predominanti fuq l-attività tas-sistema renin-anġjotensina-aldosteron (eż. pazjenti b'insuffiċjenza tal-qalb, indeboliment renali serju jew stenosi tal-arterja renali), kura bi prodotti mediċinali li jaffettwaw din is-sistema, bħall-inibituri talenżimi li jikkonvertu l-anġjotensina u l-antagonisti tar-riċetturi ta' anġjotensina
English: - The concomitant use of Ipreziv with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m2) (see sections 4.5 and 5.1).
Maltese: - Fit-tieni u t-tielet trimestru tat-tqala (ara sezzjonijiet 4.4 u 4.6). - L-użu fl-istess ħin ta' Ipreziv ma' prodotti li jkun fihom aliskiren hu kontraindikat f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (GFR < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u
English: Breastfeeding
Maltese: Anġjotensina
English: 24-Hour Mean SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) Study 1
Maltese: Punt Aħħari Primarju: 24-Siegħa Medja SBP: LS Tibdil Medju mill-Linja Bażi (BL) sas-6 Ġimgħa (mm Hg)