FrancophonIA/ELRC3.0 huggingface dataset:
English: AbsorptionAfter 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: Each tablet contains: irbesartan 150 mg
Maltese: Kull pillola fiha: irbesartan 150 mg
English: The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
Maltese: L-antagoniżmu selettiv tar-riċetturi ta' angiotensin-II (AT1) jirriżulta f'żidiet fil-livelli fil-plażma ta' renin u fil-livelli ta' angiotensin-II u fi tnaqqis fil-konċentrazzjoni tal-plażma aldosterone.
English: significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects.
Maltese: żidiet sinifikanti tal-krejatina kinazi fil-plażma ġew osservati frekwentement (1.7%) f'individwi li ħadu l-kura b'irbesartan.
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 tassistema 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: Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
Maltese: It-termini mmarkati bi stilla (*) jirreferu għar-reazzjonijiet avversi li ġew irrappurtati b'mod addizzjonali f'> 2% tal-pazjenti dijabetiċi bi presssjoni għolja b'insuffiċjenza renali kronika u proteinurja ċara u iżjed milli fil-grupp tal-plaċebo.
English:  The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188.
Maltese: Is-sustanzi l-oħra huma microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, u poloxamer 188.
English: In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of Aprovel on the progression of renal disease and all-cause mortality were examined.
Maltese: F'1,715-il pazjent bi pressjoni għolja u b'dijabete tip 2, proteinuria ≥ 900 mg/jum u krejatinina fisserum li tvarja minn 1.0-3.0 mg/dl, ġew eżaminati l-effetti fit-tul (medja ta' 2.6 sena) ta' Aprovel fuq l-avvanz ta' mard renali u l-kawżi kollha ta' mortalità.
English: In a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse reactions occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
Maltese: Fi prova li fiha l-parteċipanti ntagħżlu b'mod każwali ta' 318-il tifel u tifla bi pressjoni għolja u adoloxxenti ta' bejn is-6 u s-16-il sena, dawn ir-reazzjonijiet avversi li ġejjin ġraw fil-fażi double-blind mifruxa fuq tliet ġimgħat: uġigħ ta' ras (7.9%), pressjoni baxxa (2.2%), sturdament (1.9%), sogħla (0.9%).
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi gastro-intestinali
English: leukocytoclastic vasculitis
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Pharmacotherapeutic group: Angiotensin-II antagonists, plain.
Maltese: Antagonisti ta' angiotensin-II, sempliċi.
English: Thu
Maltese: għeja
English: In patients not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at trough of 7-10/3-6 mm Hg (systolic/diastolic).
Maltese: F'pazjenti li mhux ikkontrollati sew b'irbesartan waħdu, iż-żieda ta' doża baxxa ta' hydrochlorothiazide (12.5 mg) ma' irbesartan darba kuljum tirriżulta fi tnaqqis aktar tal-pressjoni fl-inqas livell ta' 7-10/3-6 mm/Hg (sistolika/dijastolika) aġġustata għall-plaċebo.
English: Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Maltese: Wara l-għoti ta' 14C irbesartan mill-ħalq jew ġol-vini, 80-85% tar-radjuattività li tiċċirkola fil-plażma hi attribwita għal irbesartan mhux mibdul.
English: In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i.e., uncommon) but in excess of placebo.
Maltese: F'pazjenti dijabetiċi bi pressjoni għolja b'mikroalbuminuria u funzjoni normali tal-kliewi, sturdament ortostatiku u pressjoni baxxa ortostatika ġew irrapportati f'0.5% tal-pazjenti (jiġifieri mhux komuni) iżda iżjed milli fil-grupp tal-plaċebo.
English: The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Maltese: L-istudju “Irbesartan u n-Nefropatija bid-Diabete (IDNT)” juri li irbesartan inaqqas il-progressjoni talmard renali fil-pazjenti b'insuffiċjenza renali kronika u b'proteinuria li tidher.
English: Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Maltese: Inqas minn żieda proporzjonali t'assorbiment orali b'dożi ‘il fuq minn 600 mg (id-doppju taddoża massima rrikmandata) ġie osservat; għalfejn jiġri dan għadu mhux magħruf.
English: Aprovel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Maltese: Aprovel b'doża ta' 150 mg darba kuljum ġeneralment jipprovdi kontroll aħjar matul l24 siegħa għall-pressjoni tad-demm minn 75 mg.
English: Package leaflet: Information for the user Aprovel 150 mg tablets irbesartan
Maltese: Informazzjoni għall-utent Aprovel 150 mg pilloli irbesartan
English: Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme).
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10): sturdament, dardir/rimettar u għeja u testijiet tad-demm jistgħu juru livelli ogħla ta' enzim li jkejjel il-funzjoni tal-muskolu u talqalb (enzim ta' creatine kinase).
English: Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect.
Maltese: Sotto gruppi ta' sess, razza, età, tul tad-dijabete, l-linja bażi tal-pressjoni, krejatinina fis-serum, u rata ta' tneħħija t'albumina ġew assessjati għall-effett tal-kura.
English: Each tablet of Aprovel 75 mg contains 75 mg irbesartan.
Maltese: Kull pillola ta' Aprovel 75 mg fiha 75 mg ta' irbesartan.
English: The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg. Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i.e. 24 hours after dosing) by an average of 8-13/5-8 mm Hg (systolic/diastolic) greater than those associated with placebo.
Maltese: Dożi ta' 150-300 mg darba kuljum iniżżlu il-pressjoni meħudha meta pazjent ikun mindud jew bil-qiegħda (i.e. 24 siegħa wara id-doża) b'medja ta' 8-13/5-8 mm Hg (sistolika/dijastolika) aktar milli minn dawk bil-plaċebo.
English: Method of Administration
Maltese: Metodu ta' għoti
English: In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/kg/day in rats and ≥ 100 mg/kg/day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Maltese: Fi studji mhux kliniċi ta' sigurtà, dożi għoljin ta' irbesartan (≥ 250 mg/kg/jum f'firien u ≥ 100mg/kg/jum f'makakki) ikkawżaw tnaqqis fil-parametri taċ-ċelluli ħomor tad-demm (eritroċiti, emoglobina, ematokrit).
English: Each tablet of Aprovel 150 mg contains 150 mg irbesartan.
Maltese: Kull pillola fiha 150 mg irbesartan.
English: Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Aprovel has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Maltese: Dijuretiċi u mediċini oħra kontra l-pressjoni għolja: mediċini oħra kontra l-pressjoni għolja jistgħu jżidu l-effetti ta' tnaqqis fil-pressjoni ta' irbesartan; madankollu Aprovel ingħata mingħajr periklu ma' mediċini oħra ta' kontra l-pressjoni għolja, bħal beta-blockers, imblokkaturi tal-kanali ta' calcium li jaħdmu fit-tul, u dijuretiċi thiazides.
English: Package leaflet: Information for the user Aprovel 75 mg tablets irbesartan
Maltese: Informazzjoni għall-utent Aprovel 75 mg pilloli irbesartan
English: Losartan
Maltese: takikardija
English: Close monitoring of serum potassium in patients at risk is recommended (see section 4.5).
Maltese: Huwa rrakkomandat monitoraġġ mill-qrib tal-potassju fis-serum f'pazjenti f'riskju (ara sezzjoni 4.5).
English: Package leaflet: Information for the user Aprovel 300 mg tablets irbesartan
Maltese: Informazzjoni għall-utent Aprovel 300 mg pilloli irbesartan
English: Aprovel 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Aprovel 75 mg jinstabu f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5).
Maltese: Ġenerali: f'pazjenti li għandhom it-ton vaskulari u l-funzjoni renali tagħhom jiddependu l-aktar millattività tas-sistema renin-angiotesin-aldosterone (p.e. pazjenti li jbatu minn insuffiċjenza tal-qalb konġestiva jew mard renali, inkluż stenosi tal-arterja renali), il-kura b'inibituri ta' enzimi li jikkonvertu angiotensin jew antagonisti tar-riċetturi t'angiotensin-II li jaffettwaw din is-sistema ġew assoċjati ma' pressjoni baxxa akuta, ażotemja, oligurja, jew rarament insuffiċjenza akuta renali (ara sezzjoni 4.5).
English: Aprovel 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Maltese: Aprovel 150 mg miksijin b'rita jinstabu f'pakketti f'folji ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: Aprovel 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Aprovel 300 mg jinstabu f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: There was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Maltese: Ma kienx hemm evidenza ta' mutaġeniċità, klastoġeniċità jew karċinoġeniċità.
English: Aprovel 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Maltese: Aprovel 75 mg miksijin b'rita jinstabu f'pakketti f'folji ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: Aprovel 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Aprovel 150 mg jinstabu f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it. As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased regimen.
Maltese: Għallendpoint sekondarju ta' każijiet kardjovaskulari fatali u mhux fatali, ma kienx hemm differenza bejn it-tlett gruppi tal-pazjenti fil-popolazzjoni totali, għalkemm inċidenza akbar ta' MI mhux fatali ġiet murija f'nisa u inċidenza inqas ta' MI mhux fatali ġiet murija f'irġiel fil-grupp t'irbesartan kontra lgrupp ibbażat fuq il-plaċebo.
English: Cartons of 56 x 1 film-coated tablet in PVC/PVDC/Aluminium perforated unit dose blisters.
Maltese: Pakketti ta' 56 x 1 pillola kull waħda f'folji perforati tal-PVC/PVDC/Aluminju ta' doża waħda.
English: Tablet core:
Maltese: Effikaċja klinika:
English: EU/1/97/046/001-003 EU/1/97/046/010 EU/1/97/046/013
Maltese: EU/1/97/046/001-003 EU/1/97/046/010
English: Aprovel 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Maltese: Aprovel 300 mg miksijin b'rita jinstabu f'pakketti f'folji ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: Excipient with known effect: 51.00 mg of lactose monohydrate per film-coated tablet.
Maltese: Eċċipjent b'effett magħruf: 51.00 mg ta' lactose monohydrate kull pillola.
English: Marketing Authorisation Holder: sanofi-aventis groupe 54, rue La Boétie
Maltese: 54, rue La Boétie
English: The study examined the long-term effects (2 years) of Aprovel 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: L-istudju eżamina l-effetti fit-tul (sentejn) ta' Aprovel fuq il-progressjoni għal proteinuria klinikali (li tidher) (ir-rata ta' tneħħija t'albumina 'mal-urina (UAER)
English: Cartons of 98 tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 98 pillola miksija b'rita f'folji tal-PVC/PVDC/Aluminium blisters.
English: EU/1/97/046/011 - 14 tablets EU/1/97/046/004 - 28 tablets EU/1/97/046/005 - 56 tablets EU/1/97/046/014 - 56 x 1 tablets EU/1/97/046/006 - 98 tablets
Maltese: EU/1/97/046/011 - 14-il pillola EU/1/97/046/004 - 28 pillola EU/1/97/046/005 - 56 pillola EU/1/97/046/014 - 56 x 1 pillola EU/1/97/046/006 - 98 pillola
English: As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
Maltese: Kif osservat f'inibituri ta' enzimi li jikkonvertu angiotensin, irbesartan u l-antagonisti ta' angiotensin l-oħrajn huma apparentament inqas effettivi biex iniżżlu l-pressjoni f'nies suwed milli f'dawk li mhumiex suwed, possibilment minħabba li hemm prevelanza ogħla ta' renin baxx f'popolazzjoni ta' razza sewda bi pressjoni għolja (ara sezzjoni 5.1).
English: Cartons of 28 tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 28 pillola f'folji tal-PVC/PVDC/Aluminju.
English: What Aprovel looks like and contents of the pack Aprovel 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Maltese: Il-pilloli Aprovel 150 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2872 imnaqqax fuq in-naħa l-oħra.
English: In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.
Maltese: Fil-perjodu ta' 26 ġimgħa ta' din il-prova open-label, l-aktar anomaliji frekwenti tallaboratorju li ġew osservati kienu żidiet fil-kreatina (6.5%) u valuri għoljin ta' CK fi 2% tat-tfal riċevituri.
English: Irbesartan and its metabolites are eliminated by both biliary and renal pathways.
Maltese: Irbesartan u il-metaboliti tiegħu jiġu eliminati permezz ta' sistemi biljari u renali.
English: Cartons of 56 x 1 tablet in PVC/PVDC/Aluminium perforated unit dose blisters.
Maltese: Pakketti ta' 56 x 1 pillola miksija b'rita f'folji perforati tal-PVC/PVDC/Aluminju ta' doża waħda.
English: EU/1/97/046/021 - 14 tablets EU/1/97/046/022 - 28 tablets EU/1/97/046/035 - 30 tablets EU/1/97/046/023 - 56 tablets EU/1/97/046/024 - 56 x 1 tablets EU/1/97/046/032 - 84 tablets EU/1/97/046/038 - 90 tablets EU/1/97/046/025 - 98 tablets
Maltese: EU/1/97/046/021 - 14-il pillola EU/1/97/046/022 - 28 pillola EU/1/97/046/035 - 30 pillola EU/1/97/046/023 - 56 pillola EU/1/97/046/024 - 56 x 1 pillola EU/1/97/046/032 - 84 pillola EU/1/97/046/038 - 90 pillola EU/1/97/046/025 - 98 pillola
English: EU/1/97/046/016 - 14 tablets EU/1/97/046/017 - 28 tablets EU/1/97/046/034 - 30 tablets EU/1/97/046/018 - 56 tablets EU/1/97/046/019 - 56 x 1 tablets EU/1/97/046/031 - 84 tablets EU/1/97/046/037 - 90 tablets EU/1/97/046/020 - 98 tablets
Maltese: EU/1/97/046/016 - 14-il pillola EU/1/97/046/017 - 28 pillola EU/1/97/046/034 - 30 pillola EU/1/97/046/018 - 56 pillola EU/1/97/046/019 - 56 x 1 pillola EU/1/97/046/031 - 84 pillola EU/1/97/046/037 - 90 pillola EU/1/97/046/020 - 98 pillola
English: EU/1/97/046/021-025 EU/1/97/046/032 EU/1/97/046/035 EU/1/97/046/038
Maltese: EU/1/97/046/032 EU/1/97/046/035
English: Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Maltese: Pressjoni għolja renovaskulari: hemm riskju ikbar ta' pressjoni baxxa severa u ta' insuffiċjenza renali meta pazjenti li għandhom stenosi bilaterali 'tal-arterja renali jew stenosi 'tal-arterja b'kilwa waħda taħdem, jiġu kkurati bi prodotti mediċinali li jaffettwaw is-sistema renin-angiotensin-aldosterone.
English: The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/kg) up to a maximum daily dose of 150 mg for four weeks.
Maltese: Il-farmakokinetiċi ta' irbesartan kienu ikkalkulati fi 23 tifel u tifla bi pressjoni għolja wara l-għoti ta' doża waħda jew aktar kuljum ta' irbesartan (2 mg/kg) sa doża massima ta' kuljum ta' 150 mg għal erba' ġimgħat.
English: Plasma protein binding is approximately 96%, with negligible binding to cellular blood components.
Maltese: L-irbit mal-proteini tal-plażma kien madwar 96%, b'irbit negliġibbli ma' komponenti ċellulari taddemm.
English: Irbesartan had no effect upon fertility of treated rats and their offspring up to the dose levels inducing the first signs of parental toxicity (see section 5.3).
Maltese: Irbesartan ma kellu ebda effett fuq il-fertilità ta' firien ikkurati u fuq il-frieħ tagħhom sal-livelli taddoża li jagħtu bidu għall-ewwel sinjali ta' tossiċità parentali (ara sezzjoni 5.3).
English: As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Maltese: Bħalma jseħħ bl-inibituri ACE, l-użu konkomitanti ta' antagonisti ta' angiotensin II u NSAIDs jista' jirriżulta f'żjieda fir-riskju li teħżien il-funzjoni renali, inkluża l-possibbilità ta' insuffiċjenza renali akuta, u żjieda fil-potassium fis-serum, speċjalment f'pazjenti li diġà kellhom funzjoni renali bagħtuta.
English: Available pharmacodynamic/toxicological data in rats have shown excretion of irbesartan or its metabolites in milk (for details see 5.3).
Maltese: Dejta farmakodinamika / tossikoloġika fil-firien uriet li kien hemm eliminazzjoni ta' irbesartan jew ilmetaboliti tiegħu fil-ħalib tas-sider (gћad-dettalji ara 5.3).
English: What Aprovel looks like and contents of the pack Aprovel 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Maltese: Il-pilloli Aprovel 300 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2873 imnaqqax fuq in-naħa l-oħra.
English: What Aprovel looks like and contents of the pack Aprovel 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Maltese: Il-pilloli Aprovel 300 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2773 imnaqqax fuq in-naħa l-oħra.
English: EU/1/97/046/012 - 14 tablets EU/1/97/046/007 - 28 tablets EU/1/97/046/008 - 56 tablets EU/1/97/046/015 - 56 x 1 tablets EU/1/97/046/009 - 98 tablets
Maltese: EU/1/97/046/012 - 14-il pillola EU/1/97/046/007 - 28 pillola EU/1/97/046/008 - 56 pillola EU/1/97/046/015 - 56 x 1 pillola EU/1/97/046/009 - 98 pillola
English: Sanofi S.p.A. Tel: 800 536389
Maltese: Tel: 800 536389
English: Clinical efficacy
Maltese: GĦAMLA KWALITATTIVA
English: EU/1/97/046/026 - 14 tablets EU/1/97/046/027 - 28 tablets EU/1/97/046/036 - 30 tablets EU/1/97/046/028 - 56 tablets EU/1/97/046/029 - 56 x 1 tablets EU/1/97/046/033 - 84 tablets EU/1/97/046/039 - 90 tablets EU/1/97/046/030 - 98 tablets
Maltese: EU/1/97/046/026 - 14-il pillola EU/1/97/046/027 - 28 pillola EU/1/97/046/036 - 30 pillola EU/1/97/046/028 - 56 pillola EU/1/97/046/029 - 56 x 1 pillola EU/1/97/046/033 - 84 pillola EU/1/97/046/039 - 90 pillola EU/1/97/046/030 - 98 pillola
English: EU/1/97/046/010 - 14 tablets EU/1/97/046/001 - 28 tablets EU/1/97/046/002 - 56 tablets EU/1/97/046/013 - 56 x 1 tablets EU/1/97/046/003 - 98 tablets
Maltese: EU/1/97/046/010 - 14-il pillola EU/1/97/046/001 - 28 pillola EU/1/97/046/002 - 56 pillola EU/1/97/046/013 - 56 x 1 pillola EU/1/97/046/003 - 98 pillola
English: Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists.
Maltese: Aprovel jappartjeni għall-grupp ta' mediċini magħrufa bħala antagonisti tar-riċetturi angiotensin-II.
English: EU/1/97/046/004-006 EU/1/97/046/011 EU/1/97/046/014
Maltese: EU/1/97/046/011 EU/1/97/046/014
English: Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100): taħbit tal-qalb aktar mgħaġġel, fwawar, sogħla, dijarea, indiġestjoni/qrusa fl-istonku, disfunzjoni sesswali (problemi fl-attività sesswali), uġigħ fis-sider.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg tablets.
Maltese: Aprovel 150 mg pilloli.
English: Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation.
Maltese: Irbesartan jiġi metabolizzat bil-fwied permezz talkonjugazzjoni ma' glucoronide u ta' ossidazjoni.
English: What Aprovel looks like and contents of the pack Aprovel 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Maltese: Il-pilloli Aprovel 75 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2771 imnaqqax fuq in-naħa l-oħra.
English: Each tablet of Aprovel 300 mg contains 300 mg irbesartan.
Maltese: Kull pillola fiha 300 mg irbesartan.