FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy and safety of CoAprovel as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomized, double-blind, active-controlled, 8-week, parallel-arm study.
Maltese: L-effikaċja u s-sigurtà ta' CoAprovel bħala terapija inizjali għal pressjoni għolja severa (definita bħala SeDBP ≥ 110 mmHg) ġew evalwati fi studju b'aktar minn ċentru wieħed, b'mod każwali, doubleblind, ikkontrollat b'mod attiv ta' 8 ġimgħat, parallel-arm.
English: Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Maltese: Irbesartan ma jinpedixxix l-ACE (kinase-II), enzima li tiġġenera l-angiotensin-II u tiddiżintegra ukoll il-bradikinina f'metaboliti inattivi.
English: Calcium salts: thiazide diuretics may increase serum calcium levels due to decreased excretion.
Maltese: Calcium salts: dijuretiċi thiazide jistgħu jgħollu l-livelli ta' calcium fis-serum calcium minħabba tnaqqis ta' eskrezzjoni.
English: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
Maltese: Mhux magħrufa: żbilanċ fl-elettroliti (li tinkludi l-ipokalemija u l-iponatremja, ara sezzjoni 4.4), iperuriċemija glikożurja, ipergliċemija, żieda fil-kolesterol u trigliċeridi
English: Aliskiren-containing products or ACE-inhibitors: clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Maltese: Prodotti li fihom aliskiren jew inibituri ta' ACE: dejta minn provi kliniċi wriet li imblokk doppju tassistema renin-angiotensin-aldosterone (RAAS) permezz tal-użu kombinat ta' inibituri ta' ACE, imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren, hu assoċjat ma' frekwenza ogħla ta' avvenimenti avversi bħal pressjoni baxxa, iperkalimja u tnaqqis fil-funzjoni tal-kliewi (li jinkludi insuffiċjenza akuta tal-kliewi) meta mqabbel mal-użu ta' sustanza waħda li taġixxi fuq RAAS (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: 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 kontra-indikat matul it-tieni u t-tielet trimestri tat-tqala (ara sezzjonijiet 4.3 u 4.4).
English: Anti-doping test: hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test.
Maltese: Testijiet anti-doping: hydrochlorothiazide li jinsab f'dan il-prodott mediċinali tista' tipproduċi riżultat analitiku pożittiv f'test anti-doping.
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, red and yellow ferric oxides, carnauba wax.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, ferric oxides ħomor u sofor, carnauba wax.
English: Irbesartan is a potent, orally active, selective angiotensin-II receptor (AT1 subtype) antagonist.
Maltese: Irbesartan huwa antagonist qawwi, attiv mill-ħalq, antagonist selettiv tar-riċettur angiotensin-II (sub tip AT1).
English: While this is not documented with CoAprovel, a similar effect should be anticipated.
Maltese: Għalkemm m'hemm xejn dokumentat li dan isir b'CoAprovel, effetti simili għandhom ikunu mistennija.
English: 2) After the transitional period of 2 years, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented.
Maltese: 2) Wara l-perjodu tranżitorju ta' sentejn, għandu jiġi implimentat limitu għallNDMA u l-NDEA ta' massimu ta' 0.03 ppm.
English: Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Maltese: Lithium: żidiet riversibbli tal-konċentrazzjonijiet ta' lithium fis-serum u tossiċità ġew irrapportati waqt l-amministrazzjoni konkomitanti tal-lithium ma' l-impedituri ta' l-enzimi li jikkonvertu angiontensin.
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3350, red, yellow and black ferric oxides, pregelatinised starch, carnauba wax.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3350, ferric oxides ħomor, sofor u suwed, lamtu preġelatinizzat, carnauba wax.
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 mm Hg.
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 mm Hg.
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 filkliewi (bħal nefrite interstizjali, nefħa tubulari, tubi bażofiliċi, żidiet fil-konċentrazjonijiet 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: jaundice hepatitis, abnormal liver function
Maltese: suffejra epatite, funzjoni anormali tal-fwied
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 fil-livelli ta' angiotensin-II, u fi tnaqqis fil-konċentrazzjoni tal-plażma aldosterone.
English: Film-coating: Lactose monohydrate
Maltese: Eċċipjenti: fih ukoll lactose monohydrate.
English: There was no evidence of mutagenicity or clastogenicity with the irbesartan/hydrochlorothiazide combination.
Maltese: Ma kienx hemm evidenza ta' mutaġeniċità jew klasroġenitiċità bil-kombinazzjoni ta' irbesartan/hydrochlorothiazide.
English: Cartons of 56 x 1 tablets in PVC/PVDC/Aluminium perforated unit dose blisters.
Maltese: Pakketti ta' 56 x 1 pillola f'folji tal-PVC/PVDC/Aluminju perforati ta' doża waħda.
English: A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Maltese: Studju ieħor wera assoċjazzjoni possibbli bejn il-kanċer tax-xoffa (SCC) u l-esponiment għal HCTZ: 633 każ ta' kanċer tax-xoffa tqabblu ma' 63,067 kontroll tal-popolazzjoni, bl-użu ta' strateġija ta' teħid ta' kampjuni b'riskju ssettjat Intweriet relazzjoni għar-rispons tad-doża kumulattiva b'OR aġġustata ta' 2.1 (95 % CI: 1.7-2.6) li tiżdied għal OR 3.9 (3.0-4.9) għal użu kbir (~25,000 mg) u OR 7.7 (5.7-10.5) għall-ogħla doża kumulattiva (~100,000 mg) (ara wkoll is-sezzjoni 4.4).
English: Table 2: Adverse reactions reported with the use of irbesartan alone
Maltese: Tabella 2: Reazzjonijiet avversi rrapportati ma' l-użu ta' irbesartan waħdu
English: However, there was no difference in the half-life and accumulation of irbesartan.
Maltese: Madankollu ma kienx hemm differenza fil-half-life u flakkumulazzjoni ta' irbesartan.
English: Irbesartan AUC and Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18-40 years).
Maltese: Il-valuri ta' irbesartan AUC u Cmax kienu wkoll xi ftit iktar f'individwi akbar fl-età (≥ 65 sengħa) milli fil-pazjenti żgħar (18-40 sena).
English: Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended.
Maltese: It-titrazzjoni tad-doża bis-sustanzi individwali (i.e. irbesartan u hydochlorothiazide) tista' tiġi rrikmandata.
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'AIIRA għandu jitwaqqaf minnufih, u jekk xieraq, għandha tinbeda terapija alternattiva (ara sezzjonijiet 4.3 u 4.6).
English: aplastic anaemia, bone marrow depression, neutropenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
Maltese: Mhux magħrufa: anemija aplastika, dipressjoni tal-mudullun ta' l-għadam, newtropenja/agranuloċitożi, anemija emolitika, lewkopenja, tromboċitopenja
English: Oral use.
Maltese: Mhux applikabbli.
English: chest pain
Maltese: Popolazzjoni pedjatrika
English: No teratogenic effects were seen in rats given irbesartan and hydrochlorothiazide in combination at doses that produced maternal toxicity.
Maltese: Ma deherx li kien hemm effetti teratoġeniċi f'firien li ngħataw irbesartan u hydrochlorothiazide flimkien b'dożi li jipproduċu tossiċità materna.
English: NAME OF THE MEDICINAL PRODUCT CoAprovel 150 mg/12.5 mg tablets.
Maltese: IL-PRODOTT MEDIĊINALI CoAprovel 150 mg/12.5 mg pilloli.
English: Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in CoAprovel, 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' CoAprovel, l-effetti li ġew irrapportati kienu minimi jew xejn.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: Other interactions: the hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Maltese: Interazzjonijiet oħra: thiazides jistgħu jżidu l-effet ipergliċemiku tal-beta-blockers u ta' diazoxide.
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' krejatinina < 20 ml/min, l-half-life ta' l-eliminazzjoni ta' hydrochlorothiaze ġiet irrapportata li tiżdied għal 21 siegħa.
English: NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/12.5 mg tablets.
Maltese: IL-PRODOTT MEDIĊINALI CoAprovel 300 mg/12.5 mg pilloli.
English: However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium).
Maltese: Madankollu, dan l-effett ta' hydrochlorothiazide fuq il-potassium fis-serum, huwa mistenni li jiżdied bi prodotti mediċinali oħra assoċjati ma' telf ta' potassium u ipokalimja (p.e. dijuretiċi kalijuretiċi oħra, lassativi, amphotericin, carbenoxolone, penicillin G sodium).
English: As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Maltese: Bħal ma jiġri f'kombinazzjoni ta' żewġ sustanzi attivi, effetti sekondarji assoċjati ma' komponenti waħidhom ma jistgħux jiġu esklużi.
English: Each film-coated tablet contains 89.5 mg of lactose (as lactose monohydrate).
Maltese: Kull pillola miksija b'rita fiha 89.5 mg ta' lactose (bħala lactose monohydrate).
English: A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically forcetitrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Maltese: B'kollox 697 pazjent intagħżlu b'mod każwali fi proporzjon ta' 2:1 jew għal irbesartan/hydrochlorothiazide 150 mg/12.5 mg jew għal irbesartan 150 mg u ġew titrati bil-forza b'mod sistematiku (qabel ma r-rispons tagħhom għal doża iktar baxxa ġie vvalutat) wara ġimgħa għal irbesartan/hydrochlorothiazide 300 mg/25 mg jew irbesartan 300 mg, rispettivament.
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: diarrhoea
Maltese: FARMAĊEWTIKU
English: In patients not adequately controlled on 25 mg hydrochlorothiazide alone, the addition of irbesartan gave an added placebo-subtracted systolic/diastolic mean reduction of 11.1/7.2 mm Hg.
Maltese: F'pazjenti li ma kinux ikkontrollati sew meta ħadu 25 mg hydrochlorothiazide waħdu, meta ngħataw irbesartan ukoll kellhom tnaqqis miżjud medju fil-pressjoni sistolika/dijastolika ta' 11.1/7.2 mm Hg meta mnaqqsa għal plaċebo.
English: The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, red and yellow ferric oxides (E172).
Maltese: Is-sustanzi l-oħra huma microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, ferric oxide aħmar u isfar (E172).
English: orthostatic dizziness
Maltese: DIKJARAZZJONI TAS-SUSTANZI ATTIVI
English: Risk Management Plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 25 mg
Maltese: Kull pillola fiha: irbesartan 300 mg u hydrochlorothiazide 25 mg
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Pregelatinised 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: 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 farmakoloġiku ta' hydrochlorothiazide, l-użu tiegħu matul it-tieni u t-tielet trimestru jista' jikkomprometti l-perfużjoni fetu-plaċentali u jista' jikkawża effetti fuq il-fetu u effetti neonatali bħal ikterus, disturb fil-bilanċ tal-elettroliti u tromboċitopenja.
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 mm Hg, respectively).
Maltese: F'dawn il-pazjenti, kien osservat tnaqqis inkrementali fil-pressjoni tad-demm kemm għal pressjoni sistolika tad-demm (SBP) kif ukoll għal pressjoni dijastolika tad-demm (DBP) (13.3 u 8.3 mm Hg, rispettivament).
English: Musculoskeletal and connective tissue disorders:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi:
English: CoAprovel 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; CoAprovel 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg.
Maltese: Għandha tiġi kkonsidrata l-bidla diretta minn monoterapija għall-kombinazzjonijiet fissi meta tkun klinikament adattata:  CoAprovel 150 mg/12.5 mg jista' jingħata f' pazjenti, fejn il-pressjoni mhix qed tiġi kkontrollata sew b'hydrochlorothiazide jew irbesartan 150 mg waħidhom;  CoAprovel 300 mg/12.5 mg jista' jingħata lill-pazjenti li mhux qed ikunu kkontrollati b'mod suffiċjenti b'irbesartan 300 mg jew b'CoAprovel 150 mg/12.5 mg.  CoAprovel 300 mg/25 mg jista' jingħata lil pazjenti li ma jkunux qed jiġu kkontrollati b'mod suffiċjenti b'CoAprovel 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: Risk factors for developing acute angleclosure glaucoma may include a history of sulfonamide or penicillin allergy (see section 4.8).
Maltese: Fatturi ta' riskju għall-iżvilupp ta' glawkoma akuta tal-għeluq tal-angolu jistgħu jinkludu storja ta' allerġija għal sulfonamide jew għall-peniċillina (ara sezzjoni 4.8).
English: While hydrochlorothiazide is a sulfonamide, only isolated cases of acute angleclosure glaucoma have been reported so far with hydrochlorothiazide.
Maltese: Filwaqt li hydrochlorothiazide huwa sulfonamide, każijiet iżolati biss ta' glawkoma akuta ta' għeluq tal-angolu ġew irrapportati s'issa b'hydrochlorothiazide.
English: The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mm Hg.
Maltese: Iż-żieda ta' 12.5 mg hydrochlorothiazide ma' 300 mg ta' irbesartan darba waħda kuljum f'pazjenti li ma kinux ikkontrollati sew meta ħadu 300 mg irbesartan waħdu irriżulta f'aktar tnaqqis fil-pressjoni dijastolika korreta bil-plaċebo fl-inqas livelli (24 siegħa wara li tingħata d-doża) ta' 6.1 mmHg.
English: Each film-coated tablet of CoAprovel 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Maltese: CoAprovel 300 mg/25 mg fiha 300 mg irbesartan u 25 mg hydrochlorothiazide.
English: Each tablet contains 65.8 mg of lactose (as lactose monohydrate).
Maltese: Kull pillola miksija b'rita fiha 65.8 mg ta' lactose (bħala lactose monohydrate).
English: Corticosteroids, ACTH: electrolyte depletion, particularly hypokalaemia, may be increased; Digitalis glycosides: thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Maltese: Kortikosterojdi, ACTH: tnaqqis fl-elettroliti, speċjalment ipokalemija, jista' jiżdied; Digitalis glycosides: ipokalemija jew ipomagneżemja ikkaġunati minħabba thiazide jistgħu jiffavorixxu l-bidu ta' arritmiji kardijaċi kkawżati minn digitalis (ara sezzjoni 4.4); Mediċini anti-infjammatorji mhux sterojdi: l-amministrazzjoni ta' mediċini anti-infjammatorji mhux sterojdi jistgħu jnaqqsu l-effetti dijuretiċi, natrijuretiċi u ta' kontra l-pressjoni għolja tat-thiazide f'xi pazjenti;
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 ta' ċellola bażali (BCC) u karċinoma ta' ċellola skwamuża (SCC)] b'doża kumulattiva li tiżdied ta' esponiment għal hydrochlorothiazide (HCTZ) fiż-żewġ studji epidemjoloġiċi bbażati fuq ir-Reġistru Nazzjonali talKanċer fid-Danimarka.
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, debbulizza, letarġija, ħedla, irrekwitezza, uġigħ fil-muskoli jew bugħawwieġ, għeja kbira muskolari, pressjoni baxxa, oligurja, takikardija, u disturbi gastrointestinali bħal dardir jew rimettar.
English: weakness, muscle spasm
Maltese: Mhux magħrufa: għeja, spażmu tal-muskoli
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 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 (ara sezzjoni 4.5).
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take CoAprovel” and “Warnings and precautions”).
Maltese: Jekk qed tieħu inibitur ta' ACE jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux CoAprovel” u “Twissijiet u prekawzjonijiet”).
English: headache
Maltese: Dożaġġ
English: Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when CoAprovel 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 CoAprovel jiġi mogħti flimkien ma' prodotti mediċinali oħra affettwati b'disturbi tal-potassium fis-serum (p.e. digitalis glycosides, antiarritmiċi).
English: Lithium: the combination of lithium and CoAprovel is not recommended (see section 4.5).
Maltese: Lithium: mhux irrikmandat l-użu flimkien ta' lithium u CoAprovel (ara sezzjoni 4.5).
English: CoAprovel 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Il-pilloli CoAprovel 150 mg/12.5 mg huma pprovduti f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: Fri
Maltese: Tqala
English: Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mm Hg in patients with mild-to-moderate hypertension.
Maltese: Doża darba kuljum ta' 150 mg irbesartan u 12.5 mg ta' hydrochlorothiazide tat-tnaqqis tal-pressjoni sistolika/dijastolika fil-punt medjan ta' 12.9/6.9 mmHg aġġustat għal plaċebo (24 siegħa wara li ngħatat id-doża) f'pazjenti bi pressjoni għolja bejn ħafifa għal moderata.
English: CHINOIN PRIVATE CO. LTD. Lévai u.5.
Maltese: Lévai u.5.
English: EU/1/98/086/008 - 14 tablets EU/1/98/086/004 - 28 tablets EU/1/98/086/005 - 56 tablets EU/1/98/086/010 - 56 x 1 tablets EU/1/98/086/006 - 98 tablets
Maltese: EU/1/98/086/008 - 14-il pillola EU/1/98/086/004 - 28 pillola EU/1/98/086/005 - 56 pillola EU/1/98/086/010 - 56 x 1 pillola EU/1/98/086/006 - 98 pillola