FrancophonIA/ELRC3.0 huggingface dataset:
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 t-tnaqqis tal-pressjoni kien 60 %-70 % ta' logħla rispons fid-diastolika u sistolika bid-dożi rakkomandati.
English: Other medicines and Irbesartan Teva
Maltese: Mediċini oħra u Irbesartan Teva
English: Limited accumulation of irbesartan (< 20 %) is observed in plasma upon repeated once-daily dosing.
Maltese: Akkumulazzjoni limitata t'irbesartan (< 20 %) giet osservata fil-plażma meta doża ta' darba kuljum kienet ripetuta.
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of drugs.
Maltese: Filwaqt li ma hemm ebda tagħrif epidemijoloġiku dwar ir-riskji b'Impedituri ta' Reċetturi ta' Angiotensin II (AIIRAs), jistgħu jeżistu riskji simili għal din il-klassi ta' mediċini.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing irbesartan, amlodipine and placebo.
Maltese: IDNT kienet prova double blind, ikkontrollata, ta' morbożità u mortalità li qabblet irbesartan, amlodipine u l-plaċebo.
English: In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
Maltese: Studji in vitro indikaw li irbesartan huwa prinċipalment ossidat bl-enzima cytochrome P450 CYP2C9; l-isoenzima CYP3A4 għandha effett negliġibli.
English: • Hypersensitivity to the active substance or to any of the excipients listed insection 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults (twelve children over 12 years, nine children between 6 and 12 years).
Maltese: Minn dawn it-23 tifel u tifla, 21 setgħu jiġu evalwati għall-komparazzjoni ta' farmakokinetiċi ma' adulti (tnax-il tifel u tifla 'l fuq minn 12-il sena, disa' t-itfal ta' bejn 6 u 12-il sena).
English: The major circulating metabolite is irbesartan glucuronide (approximately 6 %).
Maltese: Il-metabolit l-iktar importanti li jiċċirkola huwa irbesartan glucuronide (madwar 6 %).
English: Swensweg 5
Maltese: Pallagi út 13
English: Pack sizes of 50 x 1 and 56 x 1 film-coated tablet in unit dose blisters.
Maltese: Pakketti b'daqsijiet ta' 50 x 1 u 56 x 1 pilloli miksija b'rita f'folji ta' doża unika.
English: • Second and third trimesters of pregnancy (see section 4.4 and 4.6).
Maltese: • It-tieni u t-tielet trimestru tat-tqala (ara sezzjonijiet 4.4 u 4.6).
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 16-il sena bi pressjoni għolja jew f'riskju (dijabetiċi, passat ta' pressjoni għolja fil-familja) fuq perjodu ta'
English: Brampton Road Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Maltese: Eastbourne, East Sussex
English: Irbesartan Teva 75 mg film-coated tablets Irbesartan Teva 150 mg film-coated tablets Irbesartan Teva 300 mg film-coated tablets
Maltese: Irbesartan Teva 75 mg pilloli miksija b'rita Irbesartan Teva 150 mg pilloli miksija b'rita Irbesartan Teva 300 mg pilloli miksija b'rita
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Maltese: GmbH Tel: +43 1970070
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the irbesartan 300 mg group (34 %) than in the placebo group (21 %).
Maltese: Rigressjoni għal albuminurja normali (< 30 mg/jum) kienet aktar frekwenti fil-grupp ta' irbesartan 300 mg (34 %) milli fil-grupp tal-plaċebo (21 %).
English: Not known (frequency cannot be estimated from the available data): 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: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-data disponibbli): sensazzjoni ta' tidwir, uġigħ ta' ras, disturbi fit-togħma, ċenċil fil-widnejn, bugħawwieġijiet, uġigħ fil-ġogi u l-muskoli, tnaqqis fin numru ta' plejtlits, funzjoni mhix normali tal-fwied, livelli ogħla ta' potassju fid-demm, funzjoni indebolita tal-kliewi, infjammazzjoni tal-vażi ż-żgħar tad-demm li prinċipalment jaffettwaw il-ġilda (kundizzjoni magħrufa bħala vaskulite lewkoċitiklastika) u reazzjonijiet allerġiċi severi (xokk anafilattiku).
English: The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
Maltese: L-inċidenza ta' effetti avversi ma kinetx relatata mad-doża (doża li ngħatat fil-firxa rrikmandata), sess, età, razza, jew mat-tul it-trattament.
English: Gastrointestinal disorders Common:
Maltese: Mhux komuni: sogħla Disturbi gastrointestinali Komuni:
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 ta' trattament, 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-punt ta' riferiment ta' protejnurja li tidher, li jfisser 70 % ta' tnaqqis fir-risku relattiv meta mqabbel mal-plaċebo (p = 0.0004) għal doża l-għolja.
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 filkliewi (bħal nefrite interstizjali, nefħa tubulari, tubi basofiliċi, żidiet fil-konċentrazjonijiet fil-plażma ta' l-urea u kreatinina) 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: In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2 %) and the placebo groups (56.5 %).
Maltese: Fi studji kliniċi kkontrollati bi plaċebo f'pazjenti bi pressjoni għolja, l-inċidenza globali ta' effetti avversi ma kinetx differenti bejn dawk li ħadu irbesartan (56.2 %) u l-grupp li ħa l-plaċebo (56.5 %).
English: Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or allcause mortality.
Maltese: Irbesartan b'mod sinifikattiv naqqas ir-riskju relattiv fl-endpoint primarju kombinat fejn il-kreatinina fis-serum tirdoppja, mard renali fl-aħħar stadju (ESRD) jew mortalità mill-kawżi kollha.
English: Irbesartan Teva is available in pack sizes of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98 and 100 film-coated tablets in non-perforated blisters; pack sizes of 50 x 1 and 56 x 1 film-coated tablet in unit dose blisters and pack size of 28 film-coated tablets in non-perforated calendar blisters.
Maltese: Irbesartan Teva jiġu f'kaxxi ta' 7 pilloli, 14-il pillola, 28, 30, 56, 60, 80, 84, 98 u 100 pillola miksija b'rita f'folji mhux ipperforati; pakketti b'daqsijiet ta' 50 x 1 u 56 x 1 pilloli miksija b'rita f'folji ta'
English: Patients were titrated from 75 mg to a maintenance dose of 300 mg irbesartan, 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, minn 2.5 mg għal 10 mg ta' amlodipine, jew plaċebo skond kemm felħu.
English: PVC/PVdC white opaque - aluminium blisters.
Maltese: Folji tal-aluminju PVC/PVdC bojod opaki.
English: In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/L) occurred in 29.4 % of the patients in the irbesartan 300 mg group and 22 % of the patients in the placebo group.
Maltese: F'pazjenti dijabetiċi bi pressjoni għolja b'mikroalbuminurja u b'funzjoni renali normali, iperkalimja (≥ 5.5 mEq/L) seħħet f'29.4 % (jiġifieri komuni ħafna) tal pazjenti fil-grupp li ħadu 300 mg ta' irbesartan u fi 22 % tal-pazjenti fil-grupp tal plaċebo.
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 wrew valuri ta' madwar 60 %-80 %.
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 4.8, 5.1, 5.2 imma l-ebda rakkomandazzjoni dwar il pożoloġija ma tista' tingħata.
English: Ελλάδα Teva Ελλάς Α.Ε.
Maltese: Sewqan u tħaddim ta' magni
English: • The concomitant use of Irbesartan Teva with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5
Maltese: L-użu fl-istess ħin ta' Irbesartan Teva 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 5.1).
English: Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows: 3.8 mm Hg (low dose), 3.2 mm Hg (medium dose), 5.6 mm Hg (high dose).
Maltese: Il-bidla medja aġġustata fil-pressjoni tad-demm dijastolika 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: Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect.
Maltese: Sottogruppi ta' sess, razza, età, tul tad-dijabete, l-linja bażi tal-pressjoni, kreatinina fis-serum, u rata ta' eliminazzjoni t'albumina ġew assessjati għall-effett ta' trattament.
English: In 1.7 % of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Maltese: F'1.7 % tal-pazjenti bi pressjoni għolja b'mard dijabetiku avanzat renali kkurati b'irbesartan, kien osservat tnaqqis fl-emoglobina*, li ma kienx klinikament sinifikanti.
English: A. LABELLING
Maltese: A/AG
English: In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-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: F'pazjenti li għandhom it-ton vaskulari u l-funzjoni renali tagħhom jiddependu l-aktar mill-attività tassistema renin-angiotesin-aldosterone (p.e. pazjenti li jbatu minn insuffiċjenza tal-qalb konġestiva jew mard renali, inkluż stenosi ta' l-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: 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 it-targit tal-pressjoni filwaqt li din ilfigura kienet 76 % u 78 % fil-gruppi t'irbesartan u amlodipine rispettivament.
English: Cardiac disorders Uncommon: tachycardia Vascular disorders Common:
Maltese: Disturbi fil-qalb Mhux komuni: takikardija Disturbi vaskulari Komuni:
English: A limited accumulation of irbesartan (18 %) in plasma was observed upon repeated once daily dosing.
Maltese: Kienet osservata akkumulazzjoni limitata ta' irbesartan (18 %) fil-plażma meta kienet ripetuta doża waħda kuljum.
English: Pharmacotherapeutic group: Angiotensin-II antagonists, plain.
Maltese: Antagonisti tar-Riċettur ta' Angiotensin II (AIIRAs) m'għandhomx jinbdew matul it-tqala.
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: hypersensitivity reactions such as angioedema, rash, urticaria, anaphylactic reaction, anaphylactic shock
Maltese: Mhux magħruf: reazzjonijiet ta' sensittività eċċessiva bħal anġjoedema, raxx, urtikarja, reazzjoni anafilattika, xokk anafilattiku Disturbi fil-metaboliżmu u n-nutrizzjoni
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 fil-pazjenti kkurati b'irbesartan (3.3 %) milli fil-pazjenti kkurati bil-plaċebo (4.5 %).
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: 2031GA Haarlem The Netherlands
Maltese: Swensweg 5 2031GA Haarlem
English: The following presents the adverse drug reactions that were reported in placebo-controlled trials in which 1,965 hypertensive patients received irbesartan.
Maltese: It-tabella li ġejja tippreżenta r-reazzjonijiet avversi tal-mediċina li ġew irrappurtati fi provi kliniċi bilplaċebo bħala kontroll li fihom 1,965 pazjent bi pressjoni għolja rċevew irbesartan.
English: Do not use this medicine after the expiry date that is stated on the outer carton or foil after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-kartuna u fuq il-folja wara EXP.
English: Teva GmbH Tel: +49 73140208
Maltese: Tel: +49 73140208
English: In patients insufficiently controlled with 150 mg once daily, the dose of irbesartan can be increased to 300 mg, or other anti-hypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: 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: Therefore, this combination is not recommended (see section 4.4).
Maltese: mhumiex rakkomandati (ara sezzjoni 4.4).
English: 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: (i.e. inibituri COX-2 selettivi, acetylsalicylic acid (> 3 g/kuljum) u NSAIDs mhux selettivi), jista' jkun hemm attenwazzjoni ta' l-effett kontra l-pressjoni għolja.
English: Date of first authorisation: 30 October 2009 Date of latest renewal: 18 July 2014
Maltese: Data tal-aħħar tiġdid: 18 ta' Lulju 2014
English: Adverse reactions additionally reported from post-marketing experience are also listed.
Maltese: Reazzjonijiet avversi rrapportati addizzjonalment minn esperjenza ta' wara t-tqegħid fis-suq huma elenkati wkoll.
English: Pack size of 28 film-coated tablets in non-perforated calendar blisters.
Maltese: Pakketti b'daqsijiet ta' 28 pillola miksija b'rita f'folji mhux ipperforati b'kalendarju.
English: Lithium The combination of lithium and irbesartan is not recommended (see section 4.5).
Maltese: Il-kombinazzjoni ta' litju u irbesartan mhix rakkomandata (ara sezzjoni 4.5).
English: At the end of the three weeks the mean reduction from baseline in the primary efficacy variable, trough seated systolic blood pressure (SeSBP) was 11.7 mm Hg (low dose), 9.3 mm Hg (medium dose), 13.2 mm Hg (high dose).
Maltese: effikaċja, il-pressjoni tad-demm sistolika meħuda meta pazjent ikun bil-qiegħda (SeSBP) kienet 11.7 mmHg (doża baxxa), 9.3 mmHg (doża medja), 13.2 mmHg (doża għolja).
English: • Each Irbesartan Teva 75 mg film-coated tablet contains 75 mg irbesartan.
Maltese: • Kull Irbesartan Teva 75 mg pillola miksija b'rita fiha 75 mg irbesartan
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 rakkomandata) ġie osservat; għalfejn jiġri dan għadu mhux magħruf.
English: The safety and efficacy of Irbesartan Teva in children aged 0 to 18 has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Irbesartan Teva fi tfal ta' bejn 0 u 18-il sena ma ġewx determinati s'issa.
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: Lantagoniżmu selettiv tar-riċetturi ta' angiotensin-II (AT1) jirriżulta f'żidiet fil-livelli fil-plażma ta'
English: Contents of the pack and other information What Irbesartan Teva contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Irbesartan Teva
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 l-pressjoni meħuda meta pazjent ikun mindud jew bil-qiegħda (i.e. 24 siegħa wara id-doża) b'medja ta' 8-13/5-8 mmHg (sistolika/dijastolika) aktar milli minn dawk bil-plaċebo.
English: Irbesartan Teva 75 mg film-coated tablets Irbesartan
Maltese: Irbesartan Teva 75 mg pilloli miksija b'rita Irbesartan
English: Irbesartan Teva 300 mg film-coated tablets EU/1/09/576/027 7 tablets EU/1/09/576/028 14 tablets
Maltese: EU/1/09/576/001 7 pilloli EU/1/09/576/002 14-il pillola EU/1/09/576/003 28 pillola
English: Following oral or intravenous administration of 14C irbesartan, 80-85 % of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Maltese: C irbesartan mill-ħalq jew ġol-vini, 80-85 % tar-radjuattività li tiċċirkola fil-plażma hi attribwita għal irbesartan mhux mibdul.
English: dysgeusia
Maltese: L-Ungerija
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 wriet ebda tossiċità.
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'mikroalbuminurja 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 use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Maltese: L-użu ta' AIIRAs huwa kontraindikat matul it-2 u t-3 trimestru ta' tqala (ara sezzjonijiet 4.3 u 4.4).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola miksija b'rita, jiġifieri essenzjalment ‘ħieles mis-sodium'.
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 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, protejnurja ≥ 900 mg/jum u kreatinina fis-serum li tvarja minn 1.0-3.0 mg/dl, ġew eżaminati l-effetti fit-tul (medja ta' 2.6 sena) ta' irbesartan fuq l-avvanz ta'
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
Maltese: Brampton Road Hampden Park
English: Irbesartan Teva belongs to a group of medicines known as angiotensin-II receptor antagonists.
Maltese: Irbesartan Teva tappartjeni għal grupp ta' mediċini magħrufa bħala antagonisti tar-riċetturi angiotensin-II.
English: Respiratory, thoracic and mediastinal disorders Uncommon: cough
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni: disfunzjoni sesswali
English: How to store Irbesartan Teva
Maltese: Irbesartan Teva jintuża f'pazjenti adulti
English: Irbesartan Teva 150 mg film-coated tablets Irbesartan
Maltese: Irbesartan Teva 150 mg pilloli miksija b'rita Irbesartan
English: • Each Irbesartan Teva 300 mg film-coated tablet contains 300 mg irbesartan.
Maltese: • Kull Irbesartan Teva 300 mg pillola miksija b'rita fiha 300 mg irbesartan - Is-sustanzi l-oħra huma:
English: 2031 GA Haarlem The Netherlands
Maltese: Swensweg 5 2031 GA Haarlem
English: Exposure to AIIRAs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Maltese: Espożizzjoni għal terapija AIIRAs matul it-tieni u t-tielet trimestri hija magħrufa li twassal għal tossiċità tal-fetu uman (tnaqqis fil-funzjoni tal-kliewi, oligohydraminjos, tnaqqis fl-ossifikazzjoni talkranju) u tossiċità neonatali (nuqqas fil-funzjoni tal-kliewi, pressjoni baxxa, iperkalemija).
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 batuta.
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: (7.9 %), pressjoni baxxa (2.2 %), sturdament (1.9 %), sogħla (0.9 %).