FrancophonIA/ELRC3.0 huggingface dataset:
English: The concomitant use of Irbesaratn Zentiva with aliskiren-containing products is contraindicated in patients with diabetes mellitus or moderate to severe renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73m2) (see sections 4.5 and 5.1).
Maltese: L-użu fl-istess ħin ta' Irbesartan Zentiva ma' prodotti li jkun fihom aliskiren hu kontraindikat f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (rata ta filtrazzjoni mill-glomeruli (GFR) < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).
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 doubleblind mifruxa fuq tliet ġimgħat: uġigħ ta' ras (7.9%), pressjoni baxxa (2.2%), sturdament (1.9%), sogħla (0.9%).
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 300 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 300 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Maltese: Kull pillola fiha: irbesartan 300 mg LISTA TA' EĊĊIPJENTI Eċċipjenti: fih ukoll lactose monohydrate.
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 tal-mard renali fil-pazjenti b'insuffiċjenza renali kronika u b'proteinuria li tidher.
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Irbesartan Zentiva 300 mg group (34%) than in the placebo group (21%).
Maltese: Rigressjoni għal albuminuria normali (< 30 mg/jum) kienet iktar frekwenti fil-grupp ta' Irbesartan Zentiva 300 mg (34%) milli fil-grupp tal-plaċebo
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 Irbesartan Zentiva 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 fis-serum li tvarja minn 1.0-3.0 mg/dl, ġew eżaminati leffetti fit-tul (medja ta' 2.6 sena) ta' Irbesartan Zentiva fuq l-avvanz ta' mard renali u l-kawżi kollha ta' mortalità.
English: hypersensitivity reactions such as angioedema, rash, urticaria, anaphylactic reaction, anaphylactic shock
Maltese: reazzjonijiet ta' sensittività eċċessiva bħal anġjoedema, raxx, urtikarja, reazzjoni anafilattika, xokk anafilattiku Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux magħrufa:
English: Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Irbesartan Zentiva 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 Irbesartan Zentiva 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: 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 mill-attività tas-sistema renin-angiotesin-aldosterone (p.e. pazjenti li jbatu minn insuffiċjenza talqalb 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: 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: Għall-endpoint 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 filgrupp t'irbesartan kontra l-grupp ibbażat fuq il-plaċebo.
English: In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan Zentiva can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1)..
Maltese: F'pazjenti li mhumiex ikkontrollati biżżejjed b'150 mg darba kuljum, id-doża ta' Irbesartan Zentiva tista' tiżdied għal 300 mg, jew jistgħu jiġu miżjudin mediċini oħrajn ta' kontra l-pressjoni għolja (ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
English: The safety and efficacy of Irbesartan Zentiva in children aged 0 to 18 has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Irbesartan Zentiva fit-tfal ta' bejn 0 sa 18-il sena ma ġewx determinati s'issa.
English: What Irbesartan Zentiva is and what it is used for What you need to know before you take Irbesartan Zentiva How to take Irbesartan Zentiva Possible side effects
Maltese: Kif għandek tieħu Irbesartan Zentiva Effetti sekondarji possibli.
English: EU/1/06/376/038-039
Maltese: EU/1/06/376/028-033 EU/1/06/376/038-039
English: EU/1/06/376/034-035
Maltese: EU/1/06/376/016-021 EU/1/06/376/034-035
English: Irbesartan Zentiva belongs to a group of medicines known as angiotensin-II receptor antagonists.
Maltese: Irbesartan Zentiva jappartjeni għall-grupp ta' mediċini magħrufa bħala antagonisti tar-riċetturi angiotensin-II.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
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 talmuskolu u tal-qalb (enzim ta' creatine kinase).
English: Irbesartan Zentiva 150 mg film-coated tablets irbesartan
Maltese: Irbesartan Zentiva 150 mg pilloli irbesartan ISEM
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: Irbesartan Zentiva 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Irbesartan Zentiva 300 mg jinstabu f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: Irbesartan Zentiva 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Irbesartan Zentiva 75 mg jinstabu f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: Irbesartan Zentiva 300 mg film-coated tablets irbesartan
Maltese: Irbesartan Zentiva 300 mg pilloli irbesartan ISEM
English: Irbesartan Zentiva 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Irbesartan Zentiva 150 mg jinstabu f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: See also information under the heading “Do not take Irbesartan Zentiva”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Irbesartan Zentiva”.
English: Method of administration
Maltese: Metodu ta' għoti
English: EU/1/06/376/011 - 14 tablets EU/1/06/376/012 - 28 tablets EU/1/06/376/013 - 56 tablets EU/1/06/376/014 - 56 x 1 tablets EU/1/06/376/015 - 98 tablets
Maltese: EU/1/06/376/011 - 14-il pillola EU/1/06/376/012 - 28 pillola EU/1/06/376/013 - 56 pillola EU/1/06/376/014 - 56 x 1 pillola EU/1/06/376/015 - 98 pillola
English: Pregnancy and breast-feeding
Maltese: Pregelatinised maize starch
English: How to store Irbesartan Zentiva
Maltese: Kif taħżen Irbesartan Zentiva
English: Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan Zentiva, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Maltese: Iperkalimja: bħalma jiġri bi prodotti mediċinali oħra li jaffettwaw is-sistema ta' reninangiotensin-aldosterone, iperkalimja tista' sseħħ waqt il-kura b'Irbesartan Zentiva, speċjalment fil-preżenza t'indeboliment renali, proteinuria ovvja minħabba mard renali dovut għad-dijabete, u/jew insuffiċjenza tal-qalb.
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' 710/3-6 mm/Hg (sistolika/dijastolika) aġġustata għall-plaċebo.
English: Each tablet of Irbesartan Zentiva 75 mg contains 75 mg irbesartan.
Maltese: Kull pillola miksija b'rita fiha 75 mg irbesartan.
English: Österreich Zentiva, k.s.
Maltese: Danmark Zentiva, k.s.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS): there is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Maltese: Imblokk doppju tas-sistema tar-renin-angiotensin-aldosterone (RAAS - renin-angiotensinaldosterone system): hemm evidenza li l-użu fl-istess ħin ta' inibituri ta' ACE, imblokkaturi tarriċetturi ta' angiotensin II jew aliskiren iżid ir-riskju ta' pressjoni baxxa, iperkalimja u tnaqqis filfunzjoni tal-kliewi (li jinkludi insuffiċjenza akuta tal-kliewi).
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: Żewġ provi kbar, ikkontrollati, li fihom il-parteċipanti ntgħażlu b'mod każwali (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) u VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) eżaminaw l-użu talkombinazzjoni ta' inibitur ta' ACE flimkien ma' imblokkatur tar-riċetturi ta' angiotensin II. ONTARGET kien studju li twettaq f'pazjenti bi storja medika ta' mard kardjovaskulari jew ċerebrovaskulari, jew dijabete mellitus tip 2 akkumpanjat minn evidenza ta' ħsara fl-organu aħħari. VA NEPHRON-D kien studju li twettaq f'pazjenti b'dijabete mellitus tip 2 u nefropatija dijabetika.
English: Irbesartan Zentiva 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Maltese: Irbesartan Zentiva 300 mg miksijin b'rita jinstabu f'pakketti f'folji ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: Irbesartan Zentiva 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Maltese: Irbesartan Zentiva 150 mg miksijin b'rita jinstabu f'pakketti f'folji ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: Irbesartan Zentiva 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Maltese: Irbesartan Zentiva 75 mg miksijin b'rita jinstabu f'pakketti f'folji ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: EU/1/06/376/036-037
Maltese: EU/1/06/376/022-027 EU/1/06/376/036-037
English: EU/1/06/376/006 - 14 tablets EU/1/06/376/007 - 28 tablets EU/1/06/376/008 - 56 tablets EU/1/06/376/009 - 56 x 1 tablets EU/1/06/376/010 - 98 tablets
Maltese: EU/1/06/376/006 - 14-il pillola EU/1/06/376/007 - 28 pillola EU/1/06/376/008 - 56 pillola EU/1/06/376/009 - 56 x 1 pillola EU/1/06/376/010 - 98 pillola
English: EU/1/06/376/001 - 14 tablets EU/1/06/376/002 - 28 tablets EU/1/06/376/003 - 56 tablets EU/1/06/376/004 - 56 x 1 tablets EU/1/06/376/005 - 98 tablets
Maltese: EU/1/06/376/001 - 14-il pillola EU/1/06/376/002 - 28 pillola EU/1/06/376/003 - 56 pillola EU/1/06/376/004 - 56 x 1 pillola EU/1/06/376/005 - 98 pillola
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Maltese: Kif jidher Irbesartan Zentiva u l-kontenuti tal-pakkett Il-pilloli Irbesartan Zentiva 75 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2871 imnaqqax fuq in-naħa l-oħra.
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan Zentiva (see section 4.4).
Maltese: Kura li ssir qabel b'dożi għoljin ta' dijuretiċi tista' tirriżulta f'nuqqas fil-volum u riskju ta' pressjoni baxxa meta tinbeda l-kura b'Irbesartan Zentiva (ara sezzjoni 4.4).
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 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: Kif jidher Irbesartan Zentiva u l-kontenuti tal-pakkett Il-pilloli Irbesartan Zentiva 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: Each tablet of Irbesartan Zentiva 300 mg contains 300 mg irbesartan.
Maltese: Kull pillola ta' Irbesartan Zentiva 300 mg fiha 300 mg ta' irbesartan.
English: Each tablet of Irbesartan Zentiva 150 mg contains 150 mg irbesartan.
Maltese: Kull pillola miksija b'rita fiha 150 mg irbesartan.
English: EU/1/06/376/016 - 14 tablets EU/1/06/376/017 - 28 tablets EU/1/06/376/034 - 30 tablets EU/1/06/376/018 - 56 tablets EU/1/06/376/019 - 56 x 1 tablets EU/1/06/376/020 - 84 tablets EU/1/06/376/035 - 90 tablets EU/1/06/376/021 - 98 tablets
Maltese: EU/1/06/376/016 - 14-il pillola EU/1/06/376/017 - 28 pillola EU/1/06/376/034 - 30 pillola EU/1/06/376/018 - 56 pillola EU/1/06/376/019 - 56 x 1 pillola EU/1/06/376/020 - 84 pillola EU/1/06/376/035 - 90 pillola EU/1/06/376/021 - 98 pillola
English: EU/1/06/376/022 - 14 tablets EU/1/06/376/023 - 28 tablets EU/1/06/376/036 - 30 tablets EU/1/06/376/024 - 56 tablets EU/1/06/376/025 - 56 x 1 tablets EU/1/06/376/026 - 84 tablets EU/1/06/376/037 - 90 tablets EU/1/06/376/027 - 98 tablets
Maltese: EU/1/06/376/022 - 14-il pillola EU/1/06/376/023 - 28 pillola EU/1/06/376/036 - 30 pillola EU/1/06/376/024 - 56 pillola EU/1/06/376/025 - 56 x 1 pillola EU/1/06/376/026 - 84 pillola EU/1/06/376/037 - 90 pillola EU/1/06/376/027 - 98 pillola
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 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: Kif jidher ta' Irbesartan Zentiva u l-kontenuti tal-pakkett Il-pilloli Irbesartan Zentiva 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: Please see section 2 “Irbesartan Zentiva contains lactose”.
Maltese: Jekk jogħġbok ara sezzjoni 2 “ Irbesartan Zentiva fih lactose”.
English: EU/1/06/376/028 - 14 tablets EU/1/06/376/029 - 28 tablets EU/1/06/376/038 - 30 tablets EU/1/06/376/030 - 56 tablets EU/1/06/376/031 - 56 x 1 tablets EU/1/06/376/032 - 84 tablets EU/1/06/376/039 - 90 tablets EU/1/06/376/033 - 98 tablets
Maltese: EU/1/06/376/028 - 14-il pillola EU/1/06/376/029 - 28 pillola EU/1/06/376/038 - 30 pillola EU/1/06/376/030 - 56 pillola EU/1/06/376/031 - 56 x 1 pillola EU/1/06/376/032 - 84 pillola EU/1/06/376/039 - 90 pillola EU/1/06/376/033 - 98 pillola
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 reninangiotensin-aldosterone.
English: Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity.
Maltese: Esperjenza f'adulti esposti għal dożi sa 900 mg/jum għal 8 ġimgħat ma uriet ebda tossiċità.
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 (iddoppju tad-doża massima rrikmandata) ġie osservat; għalfejn jiġri dan għadu mhux magħruf.
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 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: Kif jidher ta' Irbesartan Zentiva u l-kontenuti tal-pakkett Il-pilloli Irbesartan Zentiva 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: 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 tal-laboratorju li ġew osservati kienu żidiet fil-kreatina (6.5%) u valuri għoljin ta' CK fi 2% tattfal riċevituri.
English: Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).
Maltese: Fuq il-perjodu talġimagħtejn ta' wara fejn il-pazjenti ġew re-randomised jew għal prodott mediċinali attiv jew għal plaċebo, il-pazjenti fuq plaċebo kellhom żidiet ta' 2.4 u 2.0 mmHg fis-SeSBP u SeDBP meta mqabbla ma' bidliet rispettivi ta' +0.1 u -0.3 mmHg f'dawk fuq id-dożi kollha ta' irbesartan (ara sezzjoni 4.2).
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 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: Kif jidher Irbesartan Zentiva u l-kontenuti tal-pakkett Il-pilloli Irbesartan Zentiva 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: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Maltese: Kif jidher Irbesartan Zentiva u l-kontenuti tal-pakkett Il-pilloli Irbesartan Zentiva 150 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2772 imnaqqax fuq in-naħa l-oħra.
English: Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation.
Maltese: Irbesartan jiġi metabolizzat bil-fwied permezz tal-konjugazzjoni ma' glucoronide u ta' ossidazjoni.
English: Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Maltese: Studji fuq annimali b'irbesartan urew effetti tossiċi li jgħaddu (żieda fil-formazzjoni tal-ħofor filpelvi renali, hydroureter, jew edema ta' taħt il-ġilda) fil-feti tal-firien, li ġew riżolvuti wara ittwelid.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 75 mg tablets.
Maltese: Irbesartan Zentiva 75 mg pilloli.
English: The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of Nnitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible.
Maltese: Il-MAH għandu jiżgura li l-proċessi ta' manifattura tas-sustanzi mediċinali użati għall-prodotti mediċinali tagħhom jiġu riveduti għar-riskju potenzjali ta' formazzjoni ta' N-nitrosamini u mibdula kif meħtieġ biex titnaqqas kemm jista' jkun il-kontaminazzjoni tan-nitrosamina.
English: Peak plasma concentrations are attained at 1.5 - 2 hours after oral administration.
Maltese: Logħla konċentrazzjonijiet fil-plażma jintleħqu wara 1.5-2 sigħat wara li jittieħed mill-ħalq.
English: arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps Renal and urinary disorders Not known:
Maltese: artralġja, mijalġja (f'xi każijiet assoċjata ma' żieda fil-livelli ta' creatine kinase fil-plażma), bugħawwieġ fil-muskoli Disturbi fil-kliewi u fis-sistema urinarja
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 300 mg tablets.
Maltese: Irbesartan Zentiva 300 mg pilloli.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 150 mg tablets irbesartan
Maltese: Informazzjoni għall-utent Irbesartan Zentiva 150 mg pilloli irbesartan
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s.
Maltese: Bħal fil-każi ta' prodotti mediċinali oħra li jaffettwaw is-sistema renin-angiotensin, pazjenti suwed bi pressjoni għolja wrew ferm inqas respons għal monoterapija b'irbesartan.
English: It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: Hu indikat ukoll għall-kura għall-mard renali f'pazjenti adulti li għandhom pressjoni għolja u dijabete mellitus ta' tip 2 bħala parti mill-kura kontra il-pressjoni għolja (ara sezzjoni jiet 4.3, 4.4, 4.5 u 5.1).