FrancophonIA/ELRC3.0 huggingface dataset:
English: • diuretics (water tablets), medicines for the treatment of gout, such as allopurinol, therapeutic vitamin D and calcium supplements, medicines for the treatment of diabetes (oral agents or insulins)
Maltese: • dijuretiċi (pilloli tal-awrina), mediċini għall-kura tal-gotta, bħal allopurinol, vitamina D
English: Diovan Comp 160mg/25 mg 160 mg / 25 mg film-coated tablets oral
Maltese: Diovan Comp 160mg/25 mg 160 mg / 25 mg pilloli miksija b'rita orali
English: There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Maltese: Hemm esperjenza limitata b'hydrochlorothiazide waqt it-tqala, speċjalment waqt l-ewwel trimestru.
English: Diovan Comp 160 mg/25 mg160 mg / 25 mg film-coated tablets oral
Maltese: Diovan Comp 160 mg/25 mg160 mg / 25 mg pilloli miksija b'rita orali
English: Diovan Comp 80 mg/12.5 mg80 mg / 12.5 mg film-coated tablets oral
Maltese: Diovan Comp 80 mg/12.5 mg80 mg / 12.5 mg pilloli miksija b'rita orali
English: CORIXIL 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Maltese: CORIXIL 160/12.5 mg 160 mg / 12.5 mg pilloli miksija b'rita orali
English: Diovan Comp 160mg/25 160 mg / 25 mg film-coated tablets oral
Maltese: Diovan Comp 160mg/25 160 mg / 25 mg pilloli miksija b'rita orali
English: Diovan Comp 320 mg/25 mg320 mg / 25 mg film-coated tablets oral
Maltese: Diovan Comp 320 mg/25 mg320 mg / 25 mg pilloli miksija b'rita orali
English: Diovan Comp 320mg/25 mg 320 mg / 25 mg film-coated tablets oral
Maltese: Diovan Comp 320mg/25 mg 320 mg / 25 mg pilloli miksija b'rita orali
English: Antidiabetic agents (oral agents and insulin)
Maltese: Sustanzi antidijabetiċi (sustanzi mill-ħalq u insulina)
English: In patients with severe renal impairment (creatinine clearance <30 ml/min) and patients undergoing dialysis no data are available for Diovan Comp. Valsartan is highly bound to plasma protein and is not to be removed by dialysis, whereas clearance of hydrochlorothiazide will be achieved by dialysis.
Maltese: F'pazjenti b'indeboliment renali qawwi (tneħħija tal-krejatinina ta' <30 ml/min) u f'pazjenti li qed jagħmlu d-dijalisi ma huwa disponibbli l-ebda tagħrif għal Diovan Comp. Valsartan jeħel ħafna mal proteini fil-plażma u ma jitneħħiex bid-dijalisi, filwaqt li t-tneħħija ta' hydrochlorothiazide tinkisebbid-dijalisi.
English: Coadministration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.
Maltese: L-għoti flimkien ta' dijuretiċi thiazide, inkluż hydrochlorothiazide, jista' jżid linċidenza ta' reazzjonijiet ta' sensittività eċċessiva għal allopurinol.
English: No dose adjustment is required for patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min).
Maltese: L-ebda aġġustament fid-doża ma huwa meħtieġ għal pazjenti b'indeboliment renali minn ħafif sa moderat (tneħħija tal-krejatinina ≥30 ml/min).
English: • sad mood (depression)
Maltese: • burdata ta' dwejjaq (depressjoni)
English: The CHMP agreed on including in the harmonised PI interaction of Diovan Comp with: Metformin and iodine contrast agents.
Maltese: Is-CHMP qabel li jinkludi fil-PI armonizzat l-azzjoni reċiproka ta' Diovan Comp ma': Metformina u sustanzi ta' kuntrast jodati.
English: • medicines that may increase the amount of potassium in your blood, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, heparin
Maltese: • mediċini oħra li jistgħu jżidu l-ammont ta' potassium fid-demm tiegħek, bħal supplimenti tal potassium, sostituti tal-melħ li fihom il-potassium, mediċini li ma jitilfux il-potassium, heparin
English: Take special care with Diovan Comp
Maltese: Jekk tinsa tieħu Diovan Comp
English: Diovan Comp 160/25 mg 160 mg / 25 mg film-coated tablets oral
Maltese: Diovan Comp 160/25 mg 160 mg / 25 mg pilloli miksija b'rita orali
English: Combined with hydrochlorothiazide, a significant additional reduction in blood pressure is achieved.
Maltese: F'taħlita ma' hydrochlorothiazide, jinkiseb tnaqqis addizjonali sinifikanti fil-pressjoni tad-demm.
English: Co-Diovane 80/12,5 mg 160 mg / 12.5 mg film-coated tablets oral
Maltese: Co-Diovane 80/12,5 mg 160 mg / 12.5 mg pilloli miksija b'rita orali
English: The increase in mean AUC is linear and dose proportional in the therapeutic range.
Maltese: Iż-żieda fil-medja tal-AUC hija lineari u fi proporzjon mad-doża filmedda terapewtika.
English: Co-Diovan forte 160/25 mg 160 mg / 25 mg film-coated tablets oral
Maltese: Co-Diovan forte 160/25 mg 160 mg / 25 mg pilloli miksija b'rita orali
English: • medicines that may reduce the amount of potassium in your blood, such as corticosteroids, some laxatives
Maltese: • mediċini oħra li jistgħu jnaqqsu l-ammont ta' potassium fid-demm tiegħek, bħal kortikosterojdi,
English: • dehydration (with symptoms of thirst, dry mouth and tongue, infrequent urination, dark colored urine, dry skin)
Maltese: • deidrazzjoni (b'sintomi ta' għatx, ħalq u lsien xotti, ma' tgħaddix l-awrina frekwenti, awrina skura, ġilda xotta)
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also section 4.3 and 4.4).
Maltese: Trabi ta' ommijiet li ħadu AIIRAs għandhom jiġu osservati mill-qrib għall-pressjoni baxxa (ara wkoll sezzjoni 4.3 u 4.4).
English: Co-Diovan 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Maltese: Co-Diovan 160/12.5 mg 160 mg / 12.5 mg pilloli miksija b'rita orali
English: Absorption of thiazide diuretics, including hydrochlorothiazide, is impaired in the presence of anionic exchange resins.
Maltese: L-assorbiment ta' dijuretiċi thiazide, inkluż hydrochlorothiazide, huwa indebolit fil-preżenza ta' rażi ta' skambju anjoniku.
English: Patients with severe chronic heart failure or other conditions with stimulation of the reninangiotensin-aldosterone-system
Maltese: Pazjenti b'insuffiċjenza qawwija u kronika tal-qalb jew kundizzjonijiet oħra bi stimulazzjoni tassistema ta' renin-angiotensin-aldosterone
English: Co-Diovan forte 320/25 mg 320 mg / 25 mg film-coated tablets oral
Maltese: Co-Diovan forte 320/25 mg 320 mg / 25 mg pilloli miksija b'rita orali
English: AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see also section 5.3).
Maltese: Espożizzjoni għal terapija b'AIIRAs waqt it-tieni u t-tielet trimestru hija magħrufa li tinduċi tossiċità lill-fetu uman (funzjoni renali mnaqqsa, fluwidu amnjotiku mhux suffiċjenti, ittardjar ta' lossifikazzjoni tal-qorriegħa tar-ras) u tossiċità neonatali (insuffiċjenza renali, pressjoni baxxa, iperkalimja)
English: In addition, a significantly greater percentage of patients responded (BP <140/90 mmHg or SBP reduction ≥20 mmHg or DBP reduction
Maltese: MSDBP < 100 mmHg u MSDBP ≥ 100 mmHg.
English: Co-Diovane 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Maltese: Co-Diovane 320/12.5 mg 320 mg / 12.5 mg pilloli miksija b'rita orali
English: Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide.
Maltese: Metformin għandu jintuża b'kawtela minħabba r-riskju ta' aċidożi lattika ikkaġunata minn insuffiċjenza funzjonali renali li jista' jkun hemm u li hija marbuta ma' hydrochlorothiazide.
English: Co-Diovane 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Maltese: Co-Diovane 160/12.5 mg 160 mg / 12.5 mg pilloli miksija b'rita orali
English: Diovan Comp 320/25 mg 320 mg / 25 mg film-coated tablets oral
Maltese: Diovan Comp 320/25 mg 320 mg / 25 mg pilloli miksija b'rita orali
English: In addition, a significantly greater percentage of patients responded (BP <140/90 mmHg or SBP reduction ≥20 mmHg or DBP reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 160/12.5 mg (50%) compared to hydrochlorothiazide 25 mg (25%).
Maltese: Flimkien ma' dan, perċentwal ogħla b'mod sinifikanti ta' pazjenti kellhom rispons (pressjoni <140/90 mmHg jew tnaqqis fil-pressjoni sistolika ≥20 mmHg jew tnaqqis fil-pressjoni diajstolika ≥10 mmHg) b'valsartan/ hydrochlorothiazide 160/12.5 mg (50%) meta mqabbel ma' hydrochlorothiazide 25 mg (25%).
English: • other medicines to lower your blood pressure, such as beta blockers or methyldopa, or medicines that tighten your blood vessels or stimulate your heart, such as noradrenaline or adrenaline
Maltese: • mediċini oħra li jbaxxulek il-pressjoni, bħal imblokkaturi beta jew methyldopa, jew mediċini li jdejqu l-vini u l-arterji tiegħek jew jistimulawlek qalbek, bħal noradrenaline jew adrenaline
English: Luxembourg Novartis Pharma GmbH Roonstrasse 25
Maltese: Il-Ġermanja Novartis Pharma GmbH Roonstrasse 25
English: Germany Novartis Pharma GmbH Roonstrasse 25
Maltese: Il-Polonja Novartis Pharma GmbH Roonstrasse 25
English: According with CHMP recommendation, have been included interaction with valsartan and interaction with hydroclortiazide.
Maltese: Skont ir-rakkomandazzjoni tas-CHMP, ġew inklużi l-interazzjoni mal-valsartan u l-interazzjoni malidroklorotijażide.
English: Co-Diovane 160/25 mg 160 mg / 25 mg film-coated tablets oral
Maltese: Co-Diovane 160/25 mg 160 mg / 25 mg pilloli miksija b'rita orali
English: These doses in marmoset, respectively, represent 0.9 and 3.5 times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis.
Maltese: Dawn id-dożi fil-marmoset, rispettivament, jirrapreżentaw, 0.9 u 3.5 drabi l-ogħla doża rrakkomandata fil-bniedem (MRHD) ta' valsartan u hydrochlorothiazide fuq bażi ta' mg/m2.
English: Olmesartan 40 Irbesartan 300 Candesartan 32
Maltese: Irbesartan 300 Candesartan 32
English: 2112 Veresegyhaz Hungary
Maltese: 2112 Veresegyhaz
English: U kabelovny 130 102 37 Prague 10 Czech Republic
Maltese: U kabelovny 130 102 37 Prague 10 Ir-Repubblika Ċeka
English: CHINOIN PRIVATE CO. LTD.
Maltese: Chinoin Private Co.
English: The total body and renal clearance are 157176 and 3-3.5 ml/min, respectively.
Maltese: Ittneħħija mill-ġisem kollu u renali huma 157-176 u 3-3.5 ml/min, rispettivament.
English: Irbesartan Zentiva contains lactose.
Maltese: Irbesartan Zentiva fih lactose.
English: 63.09 17404 Riells i Viabrea (Girona) - Spain
Maltese: Riells i Viabrea (Girona) Spanja
English: Date of first authorisation: 19 January 2007 Date of latest renewal: 19 January 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Jannar 2007 Data tal-aħħar tiġdid: 19 ta' Jannar 2012
English: Date of latest renewal: 19 January 2012
Maltese: Data tal-aħħar tiġdid: 19 ta' Jannar 2012
English: Approximately 33% of patients in the irbesartan group reached the primary renal composite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20% relative risk reduction versus placebo (p = 0.024) and 23% relative risk reduction compared to amlodipine (p = 0.006)].
Maltese: Madwar 33% tal-pazjenti fil-grupp t'irbesartan laħqu l-endpoint primarju renali kompost mqabbel ma' 39% u 41% fil-gruppi tal-plaċebo u amlodipine [20% tnaqqis relattiv tar-riskju kontra l-plaċebo (p = 0.024) u 23% tnaqqis relattiv tar-riskju mqabbel ma' amlodipine (p = 0.006)].
English: Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Maltese: Mediċini anti-infjammatorji mhux sterojdi: meta jingħataw antagonisti ta' angiotensin II flimkien ma' mediċini anti-infjammatorji mhux sterojdi (i.e. inibituri COX-2 selettivi, acetylsalicylic acid (> 3 g/kuljum) u NSAIDs mhux selettivi), jista' jkun hemm attenwazzjoni tal-effett kontra lpressjoni għolja.
English: The terminal elimination half-life of irbesartan is 11-15 hours.
Maltese: Il-halflife t'eliminazzjoni terminali t'irbesartan hija 11-15 sigħat.
English: Lithium: the combination of lithium and Irbesartan Zentiva is not recommended (see section 4.5).
Maltese: Lithium: it-taħlit ta' litju u Irbesartan Zentiva mhuwiex rakkomandat (ara sezzjoni 4.5).
English: Reduction of blood pressure with 0.5 mg/kg (low), 1.5 mg/kg (medium) and 4.5 mg/kg (high) target titrated doses of irbesartan was evaluated in 318 hypertensive or at risk (diabetic, family history of hypertension) children and adolescents aged 6 to 16 years over a three week period.
Maltese: Tnaqqis tal-pressjoni tad-demm b'0.5 mg/kg (baxx), 1.5 mg/kg (medju) u 4.5 mg/kg (għoli) livelli mixtieqa ddożati ta' irbesartan kienu evalwati fi 318-il tifel u tifla u adoloxxenti ta' bejn is-6 u s16-il sena bi pressjoni għolja jew f'riskju (dijabetiċi, passat ta' pressjoni għolja fil-familja) fuq perjodu ta' tliet ġimgħat.
English: For N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance:
Maltese: Għal N-nitrosodimethylamine (NDMA) u N nitrosodiethylamine (NDEA) ilMAH għandu jintroduċi l-ispeċifikazzjonijiet li ġejjin għas-sustanza talmediċina:
English: Other medicines and Irbesartan Zentiva
Maltese: Mediċini oħra u Irbesartan Zentiva
English: What Irbesartan Zentiva contains  The active substance is irbesartan.
Maltese: Is-sustanza attiva hi irbesartan.
English: Lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Lactose: pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, bid-defiċjenza totali ta' lactase jew bi problemi ta' assorbiment ta' glucose-galactose m'għandhomx jieħdu din ilmediċina.
English: Patients were titrated from 75 mg to a maintenance dose of 300 mg Irbesartan Zentiva, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Maltese: Il-pazjenti ngħataw doża aġġustata minn 75 mg għal doża ta' manteniment ta' 300 mg ta' Irbesartan Zentiva, minn 2.5 mg għal 10 mg ta' amlodipine, jew plaċebo skont kemm felħu.
English: Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Maltese: Irbesartan ma jimpedixxix ACE (kininase-II), enzima li tiġġenera angiotensin-II u tiddiżintegra ukoll il-bradikinina f'metaboliti inattivi.
English: While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Maltese: Waqt li pressjoni simili ġiet milħuqa fil-gruppi kollha talkura, inqas individwi fil-grupp t'irbesartan 300 mg (5.2%) minn dawk bil-plaċebo (14.9%) jew fil-grupp t'irbesartan 150 mg (9.7%) laħqu l-endpoint ta' proteinuria li tidher, li jfisser 70% ta' tnaqqis fir-risku relattiv meta mqabbel mal-plaċebo (p = 0.0004) għal doża l-għolja.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan Zentiva, amlodipine and placebo.
Maltese: IDNT kienet prova double blind, ikkontrollata, ta' morbożità u mortalità li qabblet Irbesartan Zentiva, amlodipine u plaċebo.
English: Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows: 3.8 mmHg (low dose), 3.2 mmHg (medium dose), 5.6 mmHg (high dose).
Maltese: Il-bidla medja aġġustata filpressjoni tad-demm diastolika meħuda meta pazjent ikun bil-qiegħda (SeDBP) kienet kif ġej: 3.8 mmHg (doża baxxa), 3.2 mmHg (doża medja), 5.6 mmHg (doża għolja).
English: Patients in all treatment groups typically received between 2 and 4 antihypertensive agents (e.g., diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg.
Maltese: Il-pazjenti fil-gruppi ta' kura kollha tipikament irċevew bejn 2 u 4 mediċini kontra lpressjoni għolja (p.e. dijuretiċi, beta blockers, alpha blockers) biex laħqu il-livell imfassal minn qabel ta' pressjoni ta' ≤ 135/85 mmHg jew tnaqqis ta' 10 mmHg fil-pressjoni sistolika jekk illinja bażi kienet > 160 mmHg.
English: Sixty per cent (60%) of patients in the placebo group reached this target blood pressure whereas this figure was 76% and 78% in the irbesartan and amlodipine groups respectively.
Maltese: Sittin fil-mija (60%) ta' pazjenti fil-grupp tal-plaċebo leħqu dan ittargit tal-pressjoni filwaqt li din il-figura kienet 76% u 78% fil-gruppi t'irbesartan u amlodipine rispettivament.
English: At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
Maltese: B'dożi għoljin ħafna (≥ 500 mg/kg/jum) tibdil diġenerattiv fil-kliewi (bħal nefrite interstizja, nefħa tubulari, tubi basofiliċi, żidiet fil-konċentrazjonijiet fil-plażma 'tal-urea u krejatinina) ġew stimulati b'irbesartan f'firien u f'makakki u huma meqjusa bħala sekondarji għall-effetti ipotensivi tal-mediċina li kkaġunat tnaqqis fil-perfużjoni renali.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 January 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TA L-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 ta' Jannar 2007
English: Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis) and severe allergic reactions (anaphylactic shock).
Maltese: Effetti mhux mixtieqa, fejn il-frekwenza mhijiex magħrufa huma: tħoss rasek iddur bik, uġigħ ta' ras, disturbi fit-togħma, żarżir fil-widnejn, bugħawwieġ, uġigħ fil-ġogi u fil-muskoli, tnaqqis finnumru tal-plejtlits, funzjoni tal-fwied anormali, livelli għoljin ta' potassium fid-demm, funzjoni tal-kliewi indebolita, infjammazzjoni tal-vini ż-żgħar li taffettwa l-ġilda (kundizzjoni magħrufa bħala leukocytoclastic vasculitis) u reazzjonijiet allerġiċi severi (xokk anafilattiku).
English: While this is not documented with Irbesartan Zentiva, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Maltese: Għalkemm m'hemm xejn dokumentat li dan isir b'Irbesartan Zentiva, effetti simili għandhom ikunu antiċipati b'antagonisti tar-riċetturi angiotensin-II.
English: The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
Maltese: effetti avversi ma kinetx relatata mad-doża (doża li ngħatat fil-firxa rrikmandata), sess, età, razza, jew mat-tul tal-kura.
English: The study examined the long-term effects (2 years) of Irbesartan Zentiva on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
Maltese: Listudju eżamina l-effetti fit-tul (sentejn) ta' Irbesartan Zentiva fuq il-progressjoni għal proteinuria klinikali (li tidher) (ir-rata ta' tneħħija t'albumina 'mal-urina (UAER) > 300 mg/jum, u żjieda f' UAER 'tal-inqas 30% mill-linja bażi).
English: Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
Maltese: Irbesartan b'mod sinifikattiv naqqas ir-riskju relattiv fl-endpoint primarju kombinat fejn il-krejatinina fis-serum tirdoppja, mard renali fl-aħħar stadju (ESRD) jew mortalità mill-kawżi kollha.
English: At 24 hours the reduction of blood pressure was 60-70% of the corresponding peak diastolic and systolic responses at the recommended doses.
Maltese: F'24 siegħa it-tnaqqis tal-pressjoni kien 60%-70% 'tal-ogħla rispons fid-diastolika u sistolika bid-dożi rrikmandati.
English: Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice daily dosing on the same total dose.
Maltese: Doża darba kuljum ta' 150 mg tat respons fl-inqas livell u dak medju ta' 24 siegħa simili għad-doża li tingħata darbtejn kuljum bl-istess total tad-doża.
English: Irbesartan AUC and Cmax values were also somewhat greater in oldersubjects (≥ 65 years) than those of young subjects (18 - 40 years).
Maltese: Il-valuri ta' irbesartan AUC u Cmax kienu xi ftit ogħla f'individwi akbar fl-età (≥ 65 sena) milli f'individwi żgħar (18-40 sena).
English: The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Maltese: Lużu ta' AIIRAs huwa kontra-indikat matul it-tieni u t-tielet trimestri tat-tqala (ara sezzjonijiet 4.3 u 4.4).
English: Aliskiren-containing products and ACE-inhibitors: 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: Prodotti li fihom aliskiren jew inibituri ta' ACE: dejta minn provi kliniċi wriet li imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS) 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: After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Maltese: Wara li jingħata mill-ħalq, irbesartan jiġi assorbit sew: studji ta' bijodisponibiltà assoluta urew valuri ta' madwar 60%-80%.
English: Iif you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Zentiva” and “Warnings and precautions”).
Maltese: Jekk qed tieħu inibitur ta' ACE jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux Irbesartan Zentiva” u “Twissijiet u prekawzjonijiet”).
English: Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan-treated patients (3.3%) than for placebo-treated patients (4.5%).
Maltese: Twaqqif minħabba xi effetti avversi kliniċi jew tal-laboratorju kienu inqas frekwenti filpazjenti kkurati b'irbesartan (3.3%) milli fil-pazjenti kkurati bil-plaċebo (4.5%).
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 150 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 150 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Maltese: Kull pillola fiha: irbesartan 150 mg LISTA TA' EĊĊIPJENTI Eċċipjenti: fih ukoll lactose monohydrate.
English: o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Maltese: - inibitur ta' ACE (pereżempju enalapril, lisinopril, ramipril), b'mod partikulari jekk għandek problemi tal-kliewi relatati mad-dijabete. - aliskiren
English: Irbesartan Zentiva 75 mg film-coated tablets irbesartan
Maltese: Irbesartan Zentiva 75 mg pilloli irbesartan
English: In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
Maltese: F'pazjenti dijabetiċi bi pressjoni għolja b'insuffiċenzja renali kronika u bi proteinuria li tidher, iperkalimja (≥ 5.5 mEq/L) ġrat f'46.3% talpazjenti fil-grupp ta' irbesartan u f'26.3% tal-pazjenti fil-grupp talplaċebo.
English: Gastrointestinal disorders Common:
Maltese: Disturbi vaskulari Komuni: