FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal products affected by serum potassium disturbances Periodic monitoring of serum potassium is recommended when Irbesartan/Hydrochlorothiazide Teva is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Maltese: Teva jiġu mogħtija ma' prodotti mediċinali oħra li jaffettwaw disturbi marbuta mal-potassju fis-serum (eż. digitalis glycosides, antiarritmiċi).
English: Tinnitus
Maltese: Treddigħ
English: Psychiatric disorders:
Maltese: Kategorija farmakoterapewtika:
English: Electrolyte imbalance
Maltese: Żbilanċ elettrolitiku
English: Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
Maltese: Irbesartan jiġi metabolizzat prinċipalment b'CYP2C9 u b'mod anqas estensiv bi glukuronidazzjoni.
English: Should NDMA and NDEA be detected in parallel in an API batch, this should lead to rejection of the respective batch, considering that a combined contamination would translate into a combined risk, which may be higher than one additional case of cancer in 100.000 individuals.
Maltese: Jekk l-NDMA u n-NDEA jinstabu b'mod parallel f'lott API, dan għandu jwassal għal rifjut tal-lott rispettiv, meta jitqies li kontaminazzjoni kkombinata tissarraf f'riskju kombinat, li jista' jkun ogħla minn każ addizzjonali ta' kanċer f'100,000 individwu.
English: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).
Maltese: Skont data disponibbli minn studji epidemjoloġiċi, ġiet osservata assoċjazzjoni kumulattiva dipendenti mid-doża bejn HCTZ u NMSC (ara wkoll sezzjonijiet 4.4 u 5.1).
English: Immune system disorders:
Maltese: Disturbi fis-sistema immuni:
English: Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnaesemia.
Maltese: Ġie muri li t-thiazides iżidu l-eliminazzjoni urinarja tal-magnesju, li jista' jirriżulta f'ipomagnesemja.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini (EMA): http://www.ema.europa.eu/
English: Irbesartan and hydrochlorothiazide (at doses up to 300 mg irbesartan/25 mg hydrochlorothiazide) have been safely administered with other antihypertensive agents including calcium channel blockers and beta-adrenergic blockers.
Maltese: Irbesartan u hydrochlorothiazide (f'dożi sa 300 mg irbesartan/25 mg hydrochlorothiazide) ingħataw mingħajr periklu ma' mediċini oħra kontra l-pressjoni għolja inklużi l-imblokkaturi tal-kanali ta' calcium u imblokkaturi beta-adrenergic.
English: Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting.
Maltese: Sintomi ta' allarm li jindikaw żbilanċ fil-fluwidu jew fl-elettroliti huma nixfa fil-ħalq, għatx, debulizza, letarġija, ħedla, irrekwitezza, uġigħ fil-muskoli jew bugħawwieġ, għeja muskolari kbira, pressjoni baxxa, oligurja, takikardija, u disturbi gastrointestinali bħal dardir jew rimettar.
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-tieni u t-tielet trimestru ta' tqala (ara sezzjonijiet 4.3 u 4.4).
English: Tablet coating for 300 mg/12.5 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, iron oxide yellow and iron oxide black.
Maltese: Il-kisi tal-pillola ta' qawwa ta' 300 mg/12.5 mg: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, iron oxide yellow u iron oxide black.
English: Lithium The combination of lithium and Irbesartan/Hydrochlorothiazide Teva is not recommended (see section 4.5).
Maltese: Litju Il-kombinazzjoni ta' litju u Irbesartan/Hydrochlorothiazide mhix rakkomandata (ara sezzjoni 4.5).
English: The trough to peak effects measured by cuff during office visits were 68 % and 76 % for irbesartan/hydrochlorothiazide 150 mg/12.5 mg and irbesartan/hydrochlorothiazide 300 mg/12.5 mg, respectively.
Maltese: L-effetti mill-inqas għall-aktar għolja mkejla mid-dirgħajn waqt viżiti fl-uffiċċju kienu 68 % u 76 % għal irbesartan/hydrochlorothiazide 150 mg/12.5 mg u irbesartan/hydrochlorothiazide 300 mg/12.5 mg, rispettivament.
English: Transient blurred vision, xanthopsia, acute myopia and secondary acute angle-closure glaucoma
Maltese: xantopsja, mijopija akuta u glawkoma akuta sekondarja ta'
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Maltese: Meta tiġi ddijanjostikata tqala, trattament b'AIIRAs għandu jitwaqqaf minnufih, u jekk xieraq, għandha tinbeda terapija alternattiva (ara sezzjonijiet 4.3 u 4.6).
English: • decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan.
Maltese: • tnaqqis tal-potassium fis-serum minħabba hydrochlorothiazide u mfixkla parzjalment meta hydrochlorothiazide ingħata flimkien ma' irbesartan.
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials.
Maltese: It-Tabella 1 tagħti r-reazzjonijiet avversi osservati minn rapportaġġ spontanju u fi provi kkontrollati bi plaċebo.
English: Furthermore, irbesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/kg/day, in macaques at ≥ 10 mg/kg/day).
Maltese: Barra minn hekk irbesartan ikkaġuna iperplasja/ipertrofija taċ-ċelluli ġukstaglomerulari (f'firien b'≥ 90 mg/kg/jum, f'makakki b' ≥ 10 mg/kg/jum).
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 fil-konċentrazzjonijiet tal-urea u tal-kreatinina 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: Vertigo, paraesthesia, lightheadedness, restlessness
Maltese: Vertiġini, paraestesja, rasek fl-arja, irrikwitezza
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets
Maltese: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg pilloli miksija b'rita Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg pilloli miksija b'rita Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg pilloli miksija b'rita
English: The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an overall placebo-subtracted systolic/diastolic reductions of up to 13.6/11.5 mmHg.
Maltese: Il-kombinazzjoni ta' 300 mg irbesartan u 12.5 mg hydrochlorothiazide irriżultaw fi tnaqqis fuq kollox tal-pressjoni sistolika/dijastolika, mnaqqsa għal plaċebo, sa 13.6/11.5 mmHg.
English: Hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test.
Maltese: Hydrochlorothiazide li jinsab f'dan il-prodott mediċinali tista' tipproduċi riżultat analitiku pożittiv f'test anti-doping.
English: Dizziness
Maltese: Dożaġġ
English: Teva Pharmaceuticals S.R.L Tel: +40 212306524
Maltese: Tel: +40 212306524
English: In patients with creatinine clearance < 20 ml/min, the elimination half-life of hydrochlorothiazide was reported to increase to 21 hours.
Maltese: F'pazjenti bi tneħħija ta' kreatinina < 20 ml/min, l-half-life ta' l-eliminazzjoni ta' hydrochlorothiaze ġiet irrapportata li tiżdied għal 21 siegħa.
English: Chest pain
Maltese: Popolazzjoni pedjatrika
English: Increases in blood urea nitrogen (BUN), creatinine and creatine kinase Decreases in serum potassium and sodium
Maltese: Żidiet fin-nitroġenu ta' l-urea tad-demm (BUN), kreatinina u creatine kinase
English: Grounds for CHMP opinion
Maltese: Raġunijiet għall-opinjoni tas-CHMP Billi
English: In comparison to the daily intake levels calculated based on ICH M7(R1) using non-clinical toxicology, it is possible to generate additional safety factors ranging from 2.73 - 27.3 for NDMA and 10.0 - 100 for NDEA, by defining 0.03 ppm as the common technical target limit for NDEA and NDMA in tetrazole sartan APIs.
Maltese: 0-100 għal NDEA, billi jiġu definiti 0.03 ppm bħala l-limitu ta' mira teknika komuni għal NDEA u NDMA f'APIs tat-tetrazole sartan.
English: Epidemiological studies have shown that long term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
Maltese: Studji epidemjoloġiċi wrew li kura fit-tul b'hydrochlorothiazide tnaqqas ir-riskju ta' mwiet u morbidità kardjovaskulari.
English: Anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria
Maltese: vaskulite kutanea), reazzjonijiet tal-ġilda bħal ta' lupus eritematożi, reazzjonijiet ' fotosensittivi, raxx, urtikarja
English: Obligatory risk assessments to be performed for manufacturing processes of the drug substances in order to evaluate the theoretical risk of N-nitrosamine formation and contamination
Maltese: Valutazzjonijiet obbligatorji tar-riskju li għandhom jitwettqu għall-proċessi tal-manifattura tassustanzi tal-mediċina sabiex jiġi evalwat ir-riskju teoretiku tal-formazzjoni u l-kontaminazzjoni ta' N-nitrosamina
English: Orthostatic dizziness Headache
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: After the transitional period of 2 years, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented.
Maltese: Wara l-perjodu tranżitorju ta' sentejn, għandu jiġi implimentat limitu għall-NDMA u l-NDEA ta' massimu ta' 0.03 ppm.
English: Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Maltese: Thiazides jistgħu jnaqqsu l-eliminazzjoni urinarja tal-kalċju u jikkaġunaw il-kalċju fis-serum jogħla xi ftit b'mod għaddien fin-nuqqas ta' disturbi magħrufin marbuta mal-metaboliżmu tal-kalċju.
English: Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalaemia, hyponatraemia, and hypochloremic alkalosis).
Maltese: Thiazides, li jinkludu hydrochlorothiazide, jistgħu jikkaġunaw żbilanċ fil-fluwidu jew fl-elettroliti (ipokalimja, iponatremja u alkalożi ipokloremika).
English: White opaque PVC-PVdC - Aluminium blisters or Aluminium - Aluminium blisters.
Maltese: Folji opaki tal-PVC-PVdC - Aluminju:
English: 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: F'pazjenti, li għandhom it-ton vaskulari u l-funzjoni renali jiddependu l-aktar mill-attivita' tas-sistema renin-angiotensin-aldosterone (eż. 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 (ara sezzjoni 4.5).
English: The CHMP also carried out a risk assessment for patients previously exposed to NDMA and NDEA in sartans and calculated daily intake levels based on the principles of ICH M7(R1) which are associated with an additional lifetime risk of 1 in 100,000 patients.
Maltese: IsCHMP wettaq ukoll valutazzjoni tar-riskju għal pazjenti li qabel kienu esposti għal NDMA u NDEA f'sartani u kkalkula livelli ta' konsum ta' kuljum ibbażati fuq il-prinċipji ta' ICH M7(R1) li huma assoċjati ma' riskju addizzjonali matul il-ħajja ta' 1 minn kull 100,000 pazjent.
English: Thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Maltese: Ipokalemija jew ipomagneżemja ikkaġunati minn thiazides jistgħu jiffavorixxu l-bidu ta' arritmiji kardijaċi kkawżati minn digitalis (ara sezzjoni 4.4);
English: Excipient
Maltese: Eċċipjent
English: Anaphylactic reaction including anaphylactic shock
Maltese: Reazzjoni anafilattika inkluż xokk anafilattiku
English: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed.
Maltese: Skont data disponibbli minn studji epidemjoloġiċi, ġiet osservata assoċjazzjoni kumulattiva dipendenti mid-doża bejn HCTZ u NMSC.
English: Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in the irbesartan and hydrochlorothiazide combination, 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 li tinsab fil-kombinazzjoni ta' irbesartan u hydrochlorothiazide, ġew rapporttati effetti minimi jew xejn.
English: An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Maltese: Ġie osservat riskju akbar ta' kanċer tal-ġilda mhux melanoma (NMSC) [karċinoma taċ-ċellula bażali (BCC) u karċinoma taċ-ċellula skwamuża (SCC)] b'doża kumulattiva li tiżdied ta' esponiment għal hydrochlorothiazide (HCTZ) fiż-żewġ studji epidemjoloġiċi bbażati fuq ir-Reġistru Nazzjonali talKanċer tad-Danimarka.
English: Jaundice Hepatitis, abnormal liver function
Maltese: Epatite, funzjoni anormali tal fwied
English: In these patients, an incremental blood pressure lowering effect was observed for both systolic blood pressure (SBP) and diastolic blood pressure (DBP) (13.3 and 8.3 mmHg, respectively).
Maltese: F'dawn ilpazjenti, kien osservat tnaqqis inkrementali fil-pressjoni tad-demm kemm għal pressjoni sistolika taddemm (SBP) kif ukoll għal pressjoni dijastolika tad-demm (DBP) (13.3 u 8.3 mmHg, rispettivament).
English: Tables 2 and 3 below detail the adverse reactions reported with the individual components of Irbesartan/Hydrochlorothiazide Teva.
Maltese: It-Tabelli 2 u 3 hawn taħt jiddeskrivi fid-dettall ir-reazzjonijiet avversi marbuta mal-komponenti individwali rapportati ta' Irbesartan/Hydrochlorothiazide Teva.
English: Cough
Maltese: FOLJA
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 placebosubtracted systolic/diastolic reductions of 15.8/10.0 mmHg.
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: Calcium salts
Maltese: Magnesium stearate
English: Renal and urinary disorders:
Maltese: Disturbi fil-kliewi u fis-sistema urinarja:
English: The CHMP, as a consequence, considers that the benefit-risk balance of products containing candesartan, irbesartan, losartan, olmesartan, valsartan remains favourable subject to the conditions described above.
Maltese: Is-CHMP, bħala konsegwenza, jikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti li jkun fihom candesartan, irbesartan, losartan, olmesartan, valsartan jibqa' favorevoli soġġett għallkondizzjonijiet deskritti hawn fuq.
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' renin u fil-livelli ta' angiotensin-II u fi tnaqqis fil-konċentrazzjoni tal-plażma aldosterone.
English: One side of the tablet debossed with the number "93".
Maltese: Naħa waħda tal-pillola għandha intaljata fuqha l-kodiċi "93".
English: The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Maltese: Thiazides jistgħu jżidu l-effett ipergliċemiku tal-beta-blockers u ta' diazoxide.
English: Other interactions
Maltese: Interazzjonijiet oħra
English: Pack size of 50x1 film coated tablet in unit dose blisters.
Maltese: Daqs tal-pakkett ta' 50x1 pillola miksija b'rita f'folji ta' doża unika.
English: • CHMP could not identify cancer screening methods that patients would benefit from, considering the uncertainty of the target organ(s) of NDMA/NDEA toxicity in humans and the risks of measures to monitor patients such as colonoscopy or gastroscopy which may exceed the theoretical excess cancer risk.
Maltese: • Is-CHMP ma setax jidentifika metodi ta' skrinjar tal-kanċer li minnhom jibbenefikaw ilpazjenti, meta titqies l-inċertezza tal-organu/organi fil-mira tat-tossiċità NDMA/NDEA filbnedmin u r-riskji ta' miżuri biex jissorveljaw pazjenti bħal kolonoskopija jew gastroskopija li jistgħu jaqbżu r-riskju teoretiku eċċessiv ta' kanċer.
English: • Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg.
Maltese: • Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg may jista' jingħata lil pazjenti meta l-pressjoni tad-demm tagħhom mhix qed tiġi kontrollata b'mod xieraq b'Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg.
English: Most of the above mentioned effects appear to be due to the pharmacological activity of irbesartan (blockade of angiotensin-II-induced inhibition of renin release, with stimulation of the renin-producing cells) and occur also with angiotensin converting enzyme inhibitors.
Maltese: Il-parti l-kbira mill-effetti msemmija hawn fuq jidhru li ġraw minħabba l-attivita` farmakoloġika ta' irbesartan (imblokk ta' l-inibizzjoni stimulata minn angiotensin II tal-ħelsien ta' renin, b'stimulazzjoni ta' ċelluli li jipproduċu renin) u jseħħu wkoll b'impedituri ta' enzimi li jikkonvertu angiotensin.
English: Teva Nederland B.V. Tel: +31 8000228400
Maltese: Tel: +31 8000228400
English: The active ingredients are irbesartan and hydrochlorothiazide.
Maltese: • Is-sustanzi attivi huma irbesartan u hydrochlorothiazide.
English: Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Maltese: Fuq il-bażi tal mekkaniżmu ta' azzjoni farmakoloġika ta' hydrochlorothiazide l-użu tiegħu matul it-tieni u t-tielet trimestru jista' jikkomprometti l-perfużjoni tal-fetu-plaċentali u jista' jikkawża effetti fuq il-fetu u effetti neonatali bħal ikterus, disturbi bil-bilanċ elettrolitiku u tromboċitopenija.
English: Irbesartan/Hydrochlorothiazide Teva with alcohol
Maltese: Irbesartan/Hydrochlorothiazide Teva ma' xorb
English: Fever
Maltese: Suffejra
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg pilloli miksija b'rita irbesartan/hydrochlorothiazide
English: How to take Irbesartan/Hydrochlorothiazide Teva
Maltese: Kif taħżen Irbesartan/Hydrochlorothiazide Teva
English: Flushing
Maltese: Fwawar
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets EU/1/09/583/049-072
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/583/049-072
English: The types and incidences of adverse events reported for patients treated with the combination were similar to the adverse event profile for patients on monotherapy.
Maltese: It-tipi u l-inċidenzi ta' episodji avversi rrapportati għal pazjenti ttrattati bil-kombinazzjoni kienu simili għall-profil ta' l-episodju avvers għal pazjenti fuq monoterapija.
English: Anticholinergic agents (e.g. atropine, beperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Maltese: Il-mediċini antikolinerġiċi (eż. atropine, beperiden) jistgħu jżidu l-bijodisponibilità tad-dijuretiċi tat-tip thiazide billi jnaqqsu l-motilità gastro-intestinali u r-rata ta' tbattil ta' l-istonku.
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg pilloli miksija b'rita irbesartan/hydrochlorothiazide
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: Bħal fil-każ ta' l-inibituri ACE, l-użu konkomitanti ta' antagonisti ta' angiotensin II u NSAIDs jista' jwassal għal riskju akbar ta' deterjorament tal-funzjoni renali, inkluża l-possibbilità ta' insuffiċjenza renali akuta, u żieda ta' potassium fis-serum, speċjalment f'pazjenti li diġà kellhom funzjoni renali ħażina.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Maltese: Żidiet riversibbli tal-konċentrazzjonijiet ta' litju fis-serum u tossiċità ġew irrapportati waqt l amministrazzjoni konkomitanti tal-litju mal-impedituri tal-enzimi li jikkonvertu angiontensin.
English: Latent diabetes mellitus may become manifest during thiazide therapy.
Maltese: Tista tibda tidher dijabete mellittus moħbija waqt terapija b'thiazides.
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 Teva.
Maltese: Tagħrif addizzjonali dwar komponenti individwali: minbarra r-reazzjonijiet avversi msemmijin hawn fuq għal dan il-prodott kombinat, reazzjonijiet avversi oħrajn li ġew irrapportati ma' wieħed minn dawn il-komponenti individwali jistgħu jkunu reazzjonijiet avversi potenzjali b'Irbesartan/Hydrochlorothiazide Teva.
English: In addition to NDMA and NDEA, other N-nitrosamines have been detected in a few sartan-containing medicinal products.
Maltese: Minbarra l-NDMA u n-NDEA, N-nitrosamini oħra ġew skoperti fi ftit prodotti mediċinali li fihom issartan.
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg pilloli miksija b'rita irbesartan/hydrochlorothiazide