FrancophonIA/ELRC3.0 huggingface dataset:
English: At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidneys (such as interstitial nephritis, tubular distention, 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 interstizjali, nefħa tubulari, tubi bażofiliċi, żidiet filkonċentrazjonijiet ta' l-urea u tal-krejatinina fil-plażma) ġew stimulati b'irbesartan f'firien u f'makakki u huma meqjusa bħala sekondarji għall-effetti ipotensivi tal-mediċina li waslet għal tnaqqis fil-perfużjoni renali.
English: Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Irbesartan Hydrochlorothiazide BMS.
Maltese: U wkoll, tneħħija renali ta' lithium titnaqqas b'thiazides u għalhekk, ir-riskju ta' tossiċita' minn lithium tista' tiżdied b'Irbesartan Hydrochlorothiazide BMS.
English: Peak effects occurred at 3-6 hours.
Maltese: L-ogħla effetti jseħħu f' 36 sigħat.
English: Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18-40 years).
Maltese: Ilvaluri ta' irbesartan AUC u Cmax kienu wkoll xi ftit iktar fil-pazjenti anzjani (≥ 65 sengħa) milli filpazjenti żgħar (18-40 sena).
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with Irbesartan Hydrochlorothiazide BMS (see section 4.5).
Maltese: Id-dijuretiċi li ma jnaqqsux il-potassium, supplimenti tal-potassium jew sostituti li fihom il-potassium għandhom jingħataw b'attenzjoni flimkien ma' Irbesartan Hydrochlorothiazide BMS (ara sezzjoni 4.5).
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' l-angiotensin-II (AT1), jirriżulta f'żidiet fil-livelli fil-plażma ta' renin u fillivelli ta' angiotensin-II, u fi tnaqqis fil-konċentrazzjoni tal-plażma aldosterone.
English: Irbesartan Hydrochlorothiazide BMS should not be given to children and adolescents (under 18 years).
Maltese: Irbesartan Hydrochlorothiazide BMS m'għandux jingħata lit-tfal u lill-adoloxxenti (inqas minn 18-il sena).
English: Digitalis glycosides: thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Maltese: Digitalis glycosides: ipokalemija jew ipomagneżemja ikkaġunati minħabba thiazide jistgħu jiffavorixxu l-bidu ta' arritmiji kardijaċi kkawżati minn digitalis (ara sezzjoni 4.4);
English: Pressor amines (e.g. noradrenaline): the effect of pressor amines may be decreased, but not sufficiently to preclude their use;
Maltese: Pressor amines (p.e. noradrenaline): l-effetti tal-pressor amines jistgħu jonqsu, iżda mhux biżżejjed biex teskludi l-użu tagħhom;
English: INFORMATION IN BRAILLE Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg
English: HOW TO TAKE IRBESARTAN HYDROCHLOROTHIAZIDE BMS
Maltese: X'fih Irbesartan Hydrochlorothiazide BMS
English: Common side effects (affect 1 to 10 users in 100) nausea/vomiting abnormal urination fatigue dizziness (including when getting up from a lying or sitting position) blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
Maltese: Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 utenti minn kull 100) dardir/rimettar tagħmel l-awrina mhux normali għeja sturdament (anki meta tqum minn mimdud jew minn bil-qiegħda) testijiet tad-demm jistgħu juru livelli ogħla ta' enzim li jkejjel il-funzjoni tal-muskoli u tal-qalb (creatine kinase) jew livelli għoljin ta' sustanzi li jkejlu l-funzjoni tal-kliewi (nitroġenu fl-urea tad-demm, creatinine).
English: weakness, muscle spasm
Maltese: għeja, spażmu tal-muskoli
English: INFORMATION IN BRAILLE Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg
English: MARKETING AUTHORISATION NUMBERS EU/1/06/369/023-028
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/369/023-028
English: Irbesartan Hydrochlorothiazide BMS is a combination of two active substances, irbesartan and hydrochlorothiazide.
Maltese: Irbesartan Hydrochlorothiazide BMS hu kombinazzjoni ta' żewġ sustanzi attivi, irbesartan u hydrochlorothiazide.
English: hepatitis, abnormal liver function
Maltese: Mhux epatite, funzjoni anormali tal-fwied
English: The trough to peak effects measured by cuff during office visits were 68% and 76% for Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg and Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg, respectively.
Maltese: L-effetti mill-inqas għal aktar mkejla mid-dirgħajn waqt il-viżti għand it-tabib kienu 68% u 76% għal Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg u Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg, rispettivament.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Pregelatinized starch Silicon dioxide Magnesium stearate Red and yellow ferric oxides
Maltese: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Lamtu preġelatinizzat Silicon dioxide Magnesium stearate Ferric oxides ħomor u sofor
English: Renal impairment: due to the hydrochlorothiazide component, Irbesartan Hydrochlorothiazide BMS is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min).
Maltese: Indeboliment renali: minħabba li fih il-komponent ta' hydrochlorothiazide, Irbesartan Hydrochlorothiazide BMS mhux irrikmandat għall-pazjenti b'disfunzjoni renali severa (tneħħija talkrejatinina < 30 ml/min).
English: impaired renal function including isolated cases of renal failure in patients at risk (see section 4.4)
Maltese: funzjoni renali indebolita inkluż każijiet iżolati ta' kollass renali f'pazjenti f'riskju (ara sezzjoni 4.4) nefħa fl-estremitajiet
English: Table 2: Adverse reactions reported with the use of irbesartan alone General disorders and administration site conditions:
Maltese: Tabella 2: Reazzjonijiet avversi rrapportati ma' l-użu ta' irbesartan waħdu Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata:
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, id-defiċjenza ta' Lapp lactase jew assorbiment ħażin tal-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Cartons of 56 tablets; 4 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 56 pillola; 4 strixxi ta' 14-il pillola f'folji tal-PVC/PVDC/Aluminju.
English: Uncommon side effects (affect 1 to 10 users in 1,000) diarrhoea low blood pressure fainting heart rate increased flushing swelling sexual dysfunction (problems with sexual performance) blood tests may show lowered levels of potassium and sodium in your blood.
Maltese: Effetti sekondarji mhux komuni (jaffettwaw minn 1 sa 10 utenti minn kull 1,000) dijarea pressjoni baxxa ħass ħażin taħbit mgħaġġel tal-qalb fwawar nefħa disturb sesswali (problemi fl-attività sesswali). testijiet tad-demm jistgħu juru livelli aktar baxxi ta' potassium u sodium fid-demm tiegħek.
English: OTHER
Maltese: It-Tnejn
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, azotemia, oliguria, or rarely acute renal failure.
Maltese: Ġenerali: f'pazjenti, li għandhom it-ton vaskulari u l-funzjoni renali jiddependu l-aktar mill-attivita' tas-sistema renin-angiotensin-aldosterone (p.e. pazjenti li jbatu minn insuffiċjenza tal-qalb konġestiva jew mard renali, inkluż stenożi ta' l-arterja renali), il-kura b'impedituri ta' enzimi li jikkonvertu angiotensin jew b'riċetturi antagonisti angiotensin-II li jaffetwaw din is-sistema ġew assoċjati ma' pressjoni baxxa akuta, ażotemja, oligurja, jew rarament insuffiċjenza renali akuta.
English: Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Irbesartan Hydrochlorothiazide BMS, minimal or no effects were reported.
Maltese: Żidiet fil-livelli tal-kolesterol u tat-trigliċeridi ġew assoċjati mat-terapija dijuretika thiazide; madankollu b'doża ta' 12.5 mg ta' Irbesartan Hydrochlorothiazide BMS, l-effetti li ġew irrapportati kienu minimi jew xejn.
English: Cartons of 56 x 1 film-coated tablets; 7 blister cards of 8 x 1 film-coated tablets each in PVC/PVDC/Aluminium perforated unit dose blisters.
Maltese: Pakketti ta' 56 x 1 pillola miksija b'rita; 7 strixxi ta' 8 x 1 pillola miksija b'rita kull waħda f'folji talPVC/PVDC/Aluminju perforati ta' doża waħda.
English: When assessed by ambulatory blood pressure monitoring, the combination 150 mg irbesartan and 12.5 mg hydrochlorothiazide once daily produced consistent reduction in blood pressure over the 24 hours period with mean 24-hour placebo-subtracted systolic/diastolic reductions of 15.8/10.0 mm Hg.
Maltese: Meta ġiet assessjata permezz ta' osservazzjoni ta' pressjoni ambulatorja, il-kombinazzjoni ta' 150 mg irbesartan u 12.5 mg hydrochlorothiazide darba kuljum, ikkawżat tnaqqis konsisteneti fil pressjoni matul perijodu ta' 24 siegħa bi tnaqqis medju f'24 siegħa tal-pressjoni sistolika/dijastolika ta' 15.
English: Hypersensitivity to the active substances, to any of the excipients (see section 6.1), or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) Second and third trimesters of pregnancy (see sections 4.4 and 4.6) Severe renal impairment (creatinine clearance < 30 ml/min) Refractory hypokalaemia, hypercalcaemia
Maltese: It-tieni u t-tielet trimestru tat-tqala (ara sezzjonijiet 4.4 u 4.6) Indeboliment renali sever (tneħħija tal-krejatinina < 30 ml/min) Ipokalimja rifrattorja, iperkalċimja
English: Lithium: the combination of lithium and Irbesartan Hydrochlorothiazide BMS is not recommended (see section 4.5).
Maltese: Għalhekk, il-kombinazzjoni ta' lithium u Irbesartan Hydrochlorothiazide BMS mhiex irrikkmandata (ara sezzjoni 4.4).
English: Marketing Authorisation Holder BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park
English: Cartons of 98 tablets; 7 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 98 pillola; 7 strixxi ta' 14-il pillola f'folji tal-PVC/PVDC/Aluminju.
English: Cartons of 28 tablets; 2 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 28 pillola; 2 strixxi ta' 14-il pillola f'folji tal-PCV/PVDC/Aluminju.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/369/017-022
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/369/017-022
English: Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Il-pilloli Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg huma pprovduti f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets.
Maltese: Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg pilloli.
English: Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg.
Maltese: Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg jista' jingħata lil pazjenti li ma jkunux qed jiġu kkontrollati b'mod suffiċjenti b'Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg.
English: Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Maltese: Wara li 14C irbesartan jingħata mill-ħalq jew ġol-vini, 80 - 85% tar-radjuattività li tiċċirkola fil-plażma hi attribwita għal irbesartan mhux mibdul.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets.
Maltese: Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg pilloli.
English: Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita ta' Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg fiha 300 mg irbesartan u 25 mg hydrochlorothiazide.
English: EU/1/06/369/017 - 14 tablets EU/1/06/369/018 - 28 tablets EU/1/06/369/019 - 56 tablets EU/1/06/369/020 - 56 x 1 tablets EU/1/06/369/021 - 84 tablets EU/1/06/369/022 - 98 tablets
Maltese: EU/1/06/369/017 - 14-il pillola EU/1/06/369/018 - 28 pillola EU/1/06/369/019 - 56 pillola EU/1/06/369/020 - 56 x 1 pillola EU/1/06/369/021 - 84 pillola EU/1/06/369/022 - 98 pillola
English: Table 3: Adverse reactions (regardless of relationship to medicinal product) reported with the use of hydrochlorothiazide alone
Maltese: Tabella 3: Reazzjonijiet avversi (minkejja r-relazzjoni mal-prodott mediċinali) rapportati ma' l-użu ta' hydrochlorothiazide waħdu
English: Anticholinergic agents (e.g. atropine, beperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Maltese: Ilmediċini antikolinerġiċi (p.e atropine, beperiden) jistgħu jżidu l-biodisponibilità tad-dijuretiċi tat-tip thiazide billi jnaqqsu l-motilità` gastro-intestinali u r-rata ta' tbattil ta' l-istonku.
English: EU/1/06/369/011 - 14 tablets EU/1/06/369/012 - 28 tablets EU/1/06/369/013 - 56 tablets EU/1/06/369/014 - 56 x 1 tablets EU/1/06/369/015 - 84 tablets EU/1/06/369/016 - 98 tablets
Maltese: EU/1/06/369/011 - 14-il pillola EU/1/06/369/012 - 28 pillola EU/1/06/369/013 - 56 pillola EU/1/06/369/014 - 56 x 1 pillola EU/1/06/369/015 - 84 pillola EU/1/06/369/016 - 98 pillola
English: Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when Irbesartan Hydrochlorothiazide BMS is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Maltese: Prodotti mediċinali affettwati b'tibdil tal-potassium fis-serum: osservazzjoni perjodika tal- potassium fis-serum hija rrikmandata meta Irbesartan Hydrochlorothiazide BMS jiġi mogħti flimkien ma' prodotti mediċinali oħra affettwati b'disturbi tal-potassium fis-serum (p.e. digitalis glycosides, antiarritmiċi).
English: Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Il-pilloli Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg huma pprovduti f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: Limited clinical data (7 out of 22 patients) suggest that patients not controlled with the 300 mg/12.5 mg combination may respond when uptitrated to 300 mg/25 mg.
Maltese: Dejta klinika limitata (7 minn 22 pazjent) tissuġġerixxi li l-pazjenti mhux ikkontrollati bilkombinazzjoni ta' 300 mg/12.5 mg jistgħu jiġu titrati 'l fuq għal 300 mg/25 mg.
English: cases of hypersensitivity reactions such as angioedema, rash, urticaria
Maltese: każijiet rari ta' reazzjonijiet ta' sensittività eċċessiva bħal anġjoedema, raxx, urtikarja
English: EU/1/06/369/023 - 14 tablets EU/1/06/369/024 - 28 tablets EU/1/06/369/025 - 56 tablets EU/1/06/369/026 - 56 x 1 tablets EU/1/06/369/027 - 84 tablets EU/1/06/369/028 - 98 tablets
Maltese: EU/1/06/369/023 - 14-il pillola EU/1/06/369/024 - 28 pillola EU/1/06/369/025 - 56 pillola EU/1/06/369/026 - 56 x 1 pillola EU/1/06/369/027 - 84 pillola EU/1/06/369/028 - 98 pillola
English: Food does not affect the bioavailability of Irbesartan Hydrochlorothiazide BMS.
Maltese: L-ikel ma jaffettwax il-biodisponibilità ta' Irbesartan Hydrochlorothiazide BMS.
English: With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6-12 hours.
Maltese: Bilhydrochlorothiazide, id-dijureżi tibda' fi żmien 2 sigħat, u l-ogħla effett ikun wara madwar 4 sigħat, waqt li l-azzjoni ddum madwar 6-12-il siegħa.
English: Side effects reported in clinical studies for patients treated with Irbesartan Hydrochlorothiazide BMS were:
Maltese: L-effetti sekondarji rrapportati fi studji kliniċi għal pazjenti kkurati b'Irbesartan Hydrochlorothiazide BMS kienu:
English: Irbesartan Hydrochlorothiazide BMS should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.3).
Maltese: Irbesartan Hydrochlorothiazide BMS m'għandux jintuża f'pazjenti b'indeboliment renali sever (tneħħija tal-krejatinina < 30 ml/min) (ara sezzjoni 4.3).
English: Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola ta' Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg fiha 150 mg irbesartan u 12.5 mg hydrochlorothiazide.
English: EU/1/06/369/001 - 14 tablets EU/1/06/369/002 - 28 tablets EU/1/06/369/003 - 56 tablets EU/1/06/369/004 - 56 x 1 tablets EU/1/06/369/005 - 98 tablets
Maltese: EU/1/06/369/001 - 14-il pillola EU/1/06/369/002 - 28 pillola EU/1/06/369/003 - 56 pillola EU/1/06/369/004 - 56 x 1 pillola EU/1/06/369/005 - 98 pillola
English: No dosage adjustment of Irbesartan Hydrochlorothiazide BMS is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Maltese: M'hemmx bżonn aġġustar fid-doża ta' Irbesartan Hydrochlorothiazide BMS f'pazjenti b'indeboliment epatiku minn ħafif sa moderat (ara sezzjoni 4.3).
English: EU/1/06/369/006 - 14 tablets EU/1/06/369/007 - 28 tablets EU/1/06/369/008 - 56 tablets EU/1/06/369/009 - 56 x 1 tablets EU/1/06/369/010 - 98 tablets
Maltese: EU/1/06/369/006 - 14-il pillola EU/1/06/369/007 - 28 pillola EU/1/06/369/008 - 56 pillola EU/1/06/369/009 - 56 x 1 pillola EU/1/06/369/010 - 98 pillola
English: Skin and subcutaneous tissue disorders:
Maltese: Disturbi muskolu-skeltrali u talconnective tissue:
English: Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola ta' Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg fiha 300 mg irbesartan u 12.5 mg hydrochlorothiazide.
English: Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of irbesartan tends to reverse the potassium loss associated with these diuretics.
Maltese: Preżumibbilment minħabba linblukkar fis-sistema renin-angiotensin-aldosterone, meta hydrochlorothiazide jingħata flimkien ma' irbesartan jista' jinqaleb bil-kontra t-telf tal-potassium assoċjat ma' dawn id-dijuretiċi.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/369/001-005
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/369/001-005
English: MARKETING AUTHORISATION NUMBERS EU/1/06/369/011-016
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/369/011-016
English: cough
Maltese: KGAA
English: Renal artery stenosis - 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 angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists.
Maltese: Stenożi ta' l-arterja renali-Pressjoni għolja renovaskulari: hemm riskju ikbar ta' pressjoni baxxa severa u ta' insuffiċjenza renali meta pazjenti li għandhom stenożi bilaterali ta' l-arterja renali, jew stenożi ta' l-arterja li tagħti għall-kilwa waħda taħdem, jiġu kkurati b'impedituri ta' l-enzima li tikkonverti langiotensin jew b' antagonisti tar-riċetturi angiotensin-II.
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 25 mg
Maltese: Kull pillola fiha: irbesartan 300 mg u hydrochlorothiazide 25 mg
English: Irbesartan/hydrochlorothiazide: the potential toxicity of the irbesartan/hydrochlorothiazide combination after oral administration was evaluated in rats and macaques in studies lasting up to 6 months.
Maltese: Irbesartan/hydrochlorothiazide: it-tossiċità potenzjali tal-kombinazzjoni ta' irbesartan/ hydrochlorothiazide wara li tingħata mill-ħalq ġiet evalwata f'firien u f'makakki (macaques) waqt studji li damu sa 6 xhur.
English: Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Maltese: Il-pilloli miksijin b'rita Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg huma fornuti fi strixxi ta' 14, 28, 56, 84 jew 98 pillola miksija b'rita.
English: Cartons of 84 film-coated tablets; 6 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 84 pillola miksija b'rita; 6 strixxi ta' 14-il pillola miksija b'rita f'folji talPVC/PVDC/Aluminju.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg tablets irbesartan/hydrochlorothiazide
Maltese: Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg pilloli irbesartan/hydrochlorothiazide
English: While this is not documented with Irbesartan Hydrochlorothiazide BMS, a similar effect should be anticipated.
Maltese: Għalkemm m'hemm xejn dokumentat li dan isir b'Irbesartan Hydrochlorothiazide BMS, effetti simili għandhom ikunu mistennija.
English: When measured by ambulatory blood pressure monitoring, the trough to peak effects of Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg were 100%.
Maltese: Meta mkejla permezz ta' osservazzjoni tal-pressjoni ambulatorja l-effetti mill-inqas għal aktar ta' Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg kienu 100%.
English: Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with Irbesartan Hydrochlorothiazide BMS.
Maltese: Aktar tagħrif fuq komponenti individwali: minbarra r-reazzjonijiet avversi msemmijin hawn fuq għal dan il-prodott kombinat, reazzjonijiet avversi oħrajn li ġew irrapportati ma' wieħed minn dawn ilkomponenti individwali jistgħu jkunu reazzjonijiet avversi potenzjali ma' Irbesartan Hydrochlorothiazide BMS.
English: When necessary, Irbesartan Hydrochlorothiazide BMS may be administered with another antihypertensive medicinal product (see section 4.5).
Maltese: Meta neċessarju, Irbesartan Hydrochlorothiazide BMS jista jingħata ma' prodott mediċinali ieħor kontra l-pressjoni għolja (ara sezzjoni 4.5).
English: Hepatic impairment: Irbesartan Hydrochlorothiazide BMS is not indicated in patients with severe hepatic impairment.
Maltese: Irbesartan Hydrochlorothiazide BMS mhux indikat f'pazjenti b'indeboliment epatiku sever.
English: Children should not take Irbesartan Hydrochlorothiazide BMS Irbesartan Hydrochlorothiazide BMS should not be given to children under 18 years of age.
Maltese: It-tfal ma għandhomx jieħdu Irbesartan Hydrochlorothiazide BMS Irbesartan Hydrochlorothiazide BMS ma għandux jingħata lil tfal iżgħar minn 18-il sena.
English: Important information about some of the ingredients of Irbesartan Hydrochlorothiazide BMS Irbesartan Hydrochlorothiazide BMS contains lactose.
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Irbesartan Hydrochlorothiazide BMS Irbesartan Hydrochlorothiazide BMS fih il-lactose.