FrancophonIA/ELRC3.0 huggingface dataset:
English: Section 4.2 - Posology and Method of Administration Under this section the CHMP identified several area of disagreement.
Maltese: Sezzjoni 4.2 - Pożoloġija u metodu ta' kif għandu jingħata Is-CHMP identifika bosta punti ta' diverġenza f'din is-sezzjoni.
English: Diovan Comp may increase the effects of other agents with antihypertensive properties (e.g. ACEI, beta blockers, calcium channel blockers).
Maltese: Diovan Comp jista' jżid l-effetti ta' sustanzi oħra li għandhom effett kontra l-pressjoni (eż. ACEI, imblokkaturi tar-riċetturi beta, u imblokkaturi tal-kanali tal-calcium).
English: At 30 weeks, the percentage change in UAE was significantly reduced by 36% from baseline with valsartan 160 mg (95%CI: 22 to 47%), and by 44% with valsartan 320 mg (95%CI: 31 to 54%).
Maltese: Wara 30 ġimgħa, il-persentaġġ tal-bidla fil-UAE kien imnaqqas b'mod sinifikanti b'36% mil-linja bażi b'valsartan 160 mg (95%CI: 22 sa 47%), u b'44% b'valsartan 320 mg (95%CI: 31 sa 54%).
English: Necrotising vasculitis and toxic epidermal necrolysis, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus
Maltese: Vaskulite li tinnekrotizza u nekroliżi talepidermide tossika, reazzjonijiet fil-ġilda jixbħu lil lupus erythematosus, rijattivazzjoni ta' lupus erythematosus fil-ġilda
English: • ciclosporin, a medicine used for organ transplant to avoid organ rejection
Maltese: • ciclosporin, mediċina li tintuża għat-trapjanti tal-organi biex jiġi evitat ir-riġett ta' organu
English: Thiazide diuretics, including hydrochlorothiazide, have been reported to exacerbate or activate systemic lupus erythematosus.
Maltese: Dijuretiċi thiazide, inkluż hydrochlorothiazide, kienu rrappurtati li jħarrxu jew jattivaw lupus erythematosus sistemiku.
English: Patients were randomised to one of 3 doses of valsartan (160, 320 and 640 mg/od) and treated for 30 weeks.
Maltese: Il-pazjenti kienu randomised għal waħda minn 3 dożi ta' valsartan (160, 320 u 640 mg/od) u kkurati għal 30 ġimgħa.
English: The combination led to kidney damage (nephropathy with tubular basophilia, rises in plasma urea, plasma creatinine and serum potassium, increases in urine volume and urinary electrolytes from 30 mg/kg/day valsartan + 9 mg/kg/day hydrochlorothiazide in rats and 10 + 3 mg/kg/d in marmosets), probably by way of altered renal haemodynamics.
Maltese: It-taħlita wasslet għal ħsara fil-kilwa (nefropatija b'bażolfilja tattubi żgħar, urea fil-plażma, krejatinina fil-plażma u potassium fis-serum għolew, żidiet fil-volum talawrina u fl-elettroliti fl-awrina minn 30 mg/kg/jum valsartan + 9 mg/kg/jum hydrochlorothiazide filfirien u 10 + 3 mg/kg/jum fil- marmosets), probabbli minħabba emodinamika renali mibdula.
English: The Diovan Reduction of Proteinuria (DROP) study further examined the efficacy of valsartan in reducing UAE in 391 hypertensive patients (BP=150/88 mmHg) with type 2 diabetes, albuminuria (mean=102 µg/min; 20-700 µg/min) and preserved renal function (mean serum creatinine = 80 µmol/l).
Maltese: L-istudju Diovan Reduction of Proteinuria (DROP) kompla jeżamina l-effikaċja ta' valsartan biex inaqqas l-UAE f'391 pazjent bi pressjoni għolja (BP=150/88 mmHg) u b'dijabete tat-tip 2, albuminurja (medja=102 µg/min; 20-700 µg/min) u b'funzjoni renali ppreservata (medja tal-krejatinina fis-serum = 80 µmol/l).
English: The difference in systolic BP reduction between the 320/25 mg and 320/12.5 mg doses also reached statistical significance.
Maltese: Id-differenza fit-tnaqqis tal-pressjoni sistolika bejn id-dożi ta' 320/25 mg u 320/12.5 mg ukoll laħqet sinifikat statistiku.
English: Thiazides, including hydrochlorothiazide, may increase the risk of adverse effects caused by amantadine.
Maltese: It-thiazides, inkluż hydrochlorothiazide, jistgħu jżidu r-riskju ta' effetti avversi kkawżati minn amantadine.
English: Respiratory distress including pneumonitis and pulmonary oedema
Maltese: Tbatija fit-teħid tan-nifs inkluż pulmonite u edima fil-pulmuni
English: Also, should be taken into account the overall favourable benefit/risk profile of the valsartan/HCTZ 160/25 and 320/25 mg.
Maltese: Barra minn hekk, għandu jiġi kkunsidrat il-profil ta' benefiċċju/riskju kumplessivament favorevoli ta' valsartan/HCTZ 160/25 u 320/25 mg.
English: Novartis Pharma GmbH Brunner Strasse 59
Maltese: L-Awstrija Novartis Pharma GmbH Brunner Strasse 59
English: Frequency of adverse reactions with valsartan
Maltese: Frekwenza ta' reazzjonijiet avversi b'valsartan
English: The mode of action of thiazides is through inhibition of the Na+Cl- symporter perhaps by competing for the Cl- site, thereby affecting electrolyte reabsorption mechanisms:directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly by this diuretic action reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Maltese: Il-mod kif jaħdmu t-thiazides huwa permezz ta' inibizzjoni tas-symporter ta' Na+Cl- forsi billi jikkompetu għas-sit ta' Cl- , b'hekk jaffettwaw il-mekkaniżmi ta' assorbiment millġdid tal-elettroliti: jżidu b'mod dirett it-tneħħija ta' sodium u chloride bejn wieħed u ieħor f'ammonti ekwivalenti, u b'mod indirett permezz ta' din l-azzjoni dijuretika jnaqqsu l-volum tal-plażma, b'konsegwenza ta' żidiet fl-attività ta' renin fil-plażma, sekrezzjoni ta' aldosterone u telf ta' potassium mal-awrina, u tnaqqis fil-potassium tas-serum.
English: Additional information on the individual components Adverse reactions previously reported with one of the individual components may be potential undesirable effects with Diovan Comp as well, even if not observed in clinical trials or during postmarketing period.
Maltese: Informazzjoni addizzjonali dwar il-komponenti individwali Reazzjonijiet avversi li kienu rrappurtati qabel b'wieħed mill-komponenti individwali jistgħu possibilment ikunu effetti mhux mixtieqa b'Diovan Comp ukoll, anke jekk ma ġewx osservati filprovi kliniċi jew waqt il-perjodu ta' wara t-tqegħid fis-suq.
English: The difference in BP reductions between the 160/25 mg and 160/12.5 mg doses also reached statistical significance.
Maltese: Id-differenza fit-tnaqqis tal-pressjoni bejn id-dożi ta' 160/25 mg u 160/12.5 mg ukoll laħqet sinifikat statistiku.
English: • Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists”, which help to control high blood pressure.
Maltese: • Valsartan jagħmel parti minn klassi ta' mediċini magħrufa bħala “antagonisti tar-riċettur ta' angiotensin II”, li jgħinu biex jikkontrollaw pressjoni għolja tad-demm.
English: • Swallow the tablet with a glass of water.
Maltese: • Ibla' l-pillola ma' tazza ilma.
English: Regarding the Sodium and/or volume-depleted patients, the CHMP agreed to delete the last sentence of this paragraph considering this was textbook knowledge: “Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular weakness, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting”
Maltese: Rigward il-pazjenti b'ammont baxx ta' sodju u/jew fil-volum, is-CHMP qabel li jneħħi l-aħħar sentenza ta' dan il-paragrafu minħabba li dan kien għarfien xjentifiku bażiku: “Is-sinjali ta' twissija ta' nuqqas ta' bilanċ tal-fluwidu jew tal-elettroliti huma nixfa fil-ħalq, għatx, dgħufija, letarġija, ħedla, irrikwetezza, uġigħ jew bugħawwieġ fil-muskoli, mijastenija, ipotensjoni, oligurja, takikardija, u disturbi gastrointestinali bħalma huma nawżea jew remettar”
English: (Calculations assume an oral dose of 320 mg/day valsartan in combination with 25 mg/day hydrochlorothiazide and a 60-kg patient.)
Maltese: (Ilkalkulazzjonijiet jassumu doża mill-ħalq ta' 320 mg/jum valsartan flimkien ma' 25 mg/jum hydrochlorothiazide u pazjent ta' 60-kg.)
English: Concomitant use of thiazide diuretics, including hydrochlorothiazide, with beta blockers may increase the risk of hyperglycaemia.
Maltese: L-użu konkomitanti ta' dijuretiċi thiazide, inkluż hydrochlorothiazide, ma' imblokkaturi beta jista' jżid ir-riskju ta' ipergliċemija.
English: This should be taken into account during dosetitration".
Maltese: Dan għandu jiġi kkunsidrat waqt it-titolazzjoni tad-doża".
English: • Do not use Diovan Comp after the expiry date which is stated on the pack.
Maltese: • Tużax Diovan Comp wara d-data ta' skadenza li tidher fuq il-pakkett.
English: This leaflet was last approved in {MM/YYYY}.
Maltese: Jista jseħħ li titqawwa l-pressjoni baxxa mal-waqqaf.
English: Valsartan is primarily eliminated in faeces (about 83% of dose) and urine (about 13% of dose), mainly as unchanged drug.
Maltese: Valsartan huwa eliminat primarjament fl-ippurgar (madwar 83% tad-doża) u fl-awrina (madwar 13% tad-doża), l-aktar bħala mediċina mhux mibdula.
English: Dose titration with the individual components is recommended.
Maltese: Titrazzjoni tad-doża bil-komponenti individwali hija rrakkomandata.
English: Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000-fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Maltese: Valsartan ma jurix attività agonista parzjali fir-riċettur AT1 u għandu affinità ferm aktar ogħla (madwar 20,000 darba) għar-riċettur AT1 milli għar-riċettur AT2.
English: Renal clearance of hydrochlorothiazide is composed of passive filtration and active secretion into the renal tubule.
Maltese: Tneħħija renali ta' hydrochlorothiazide hija magħmula minn filtrazzjoni passiva u sekrezzjoni attiva għal ġot-tubu żgħir renali.
English: High doses of the valsartan - hydrochlorothiazide combination caused falls in red blood cell indices (red cell count, haemoglobin, haematocrit, from 100 + 31 mg/kg/d in rats and 30 + 9 mg/kg/d in marmosets).
Maltese: Dożi għoljin tat-taħlita ta' valsartan - hydrochlorothiazide ikkawżaw tnaqqis fl-indiċi taċ-ċelluli ħomor tad-demm (għadd ta' ċelluli ħomor, emoglobina, ematokrit, minn 100 + 31 mg/kg/jum fil-firien u 30 + 9 mg/kg/jum fil-marmosets).
English: Due to the hydrochlorothiazide component, Diovan Comp is contraindicated in patients with severe renal impairment (see sections 4.3, 4.4 and 5.2).
Maltese: Minħabba l-komponent hydrochlorothiazide, Diovan Comp huwa kontraindikat f'pazjenti b'indeboliment renali sever (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 160/25 mg (81%) and valsartan/ hydrochlorothiazide 160/12.5 mg (76%) compared to placebo (29%) and the respective monotherapies, i.e. hydrochlorothiazide 12.5 mg (41%), hydrochlorothiazide 25 mg (54%), and valsartan 160 mg (59%).
Maltese: Flimkien ma' dan, perċentwal ogħla b'mod sinifikanti ta' pazjenti kellhom rispons (pressjoni dijastolika <90 mmHg jew tnaqqis ≥10 mmHg) b'valsartan/hydrochlorothiazide 160/25 mg (81%) u valsartan/ hydrochlorothiazide 160/12.5 mg (76%) meta mqabbla ma' plaċebo (29%) u malmonoterapiji rispettivi tagħhom, i.e., hydrochlorothiazide 12.5 mg (41%), hydrochlorothiazide 25 mg (54%), u valsartan 160 mg (59%).
English: The terminal half-life is 6-15 h.
Maltese: Il-half-life terminali hija bejn 6-15 -il siegħa.
English: Valsartan is an orally active and specific angiotensin II (Ang II) receptor antagonist.
Maltese: Valsartan huwa antagonist qawwi u speċifiku tar-riċettur ta' angiotensin II (Ang II) attiv b'mod orali.
English: Thiazide diuretics, including hydrochlorothiazide, may alter glucose tolerance and raise serum levels of cholesterol, triglycerides and uric acid.
Maltese: Dijuretiċi thiazide, inkluż hydrochlorothiazide, jistgħu jibdlu t-tolleranza għal glucose u jgħollu llivelli ta' kolesterol, trigliċeridi u uric acid fis-serum.
English: It was concluded that 160-320 mg of valsartan produced clinically relevant reductions in UAE in hypertensive patients with type 2 diabetes.
Maltese: Kien konkluż li 160-320 mg ta' valsartan ipproduċa tnaqqis ta' rilevanza klinika fil-UAE f'pazjent bi pressjoni għolja b'dijabete tat-tip 2.
English: Musculoskeletal and connective tissue disorders Uncommon
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue Mhux komuni
English: In a double-blind, randomised, placebo-controlled, factorial design trial comparing various dose combinations of valsartan/hydrochlorothiazide to their respective components, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 160/12.5 mg (17.8/13.5 mmHg) and 160/25 mg (22.5/15.3 mmHg) compared to placebo (1.9/4.1 mmHg) and the respective monotherapies, i.e., hydrochlorothiazide 12.5 mg (7.3/7.2 mmHg), hydrochlorothiazide 25 mg (12.7/9.3 mmHg) and valsartan 160 mg (12.1/9.4 mmHg).
Maltese: Fi prova b'disinn ta' fattur, double-blind, randomised, ikkontrollata bi plaċebo li qabblet diversi taħlitiet ta' dożi ta' valsartan/ hydrochlorothiazide mal-komponenti rispettivi tagħhom, kien osservat tnaqqis ogħla b'mod sinifikanti fil-pressjoni sistolika/dijastolika medja bit-taħlita ta' valsartan/ hydrochlorothiazide 160/12.5 mg (17.8/13.5 mmHg) u 160/25 mg (22.5/15.3 mmHg) meta mqabbla ma' plaċebo (1.9/4.1 mmHg) u mal-monoterapiji rispettivi tagħhom, i.e., hydrochlorothiazide 12.5 mg (7.3/7.2 mmHg), hydrochlorothiazide 25 mg (12.7/9.3 mmHg) u valsartan 160 mg (12.1/9.4 mmHg).
English: Agranulocytosis, leucopenia, haemolytic anaemia, bone marrow depression
Maltese: Agranuloċitożi, lewkopenija, anemija emolitika, depressjoni tal-mudullun tal-għadam
English: Hepatic disease does not significantly affect the pharmacokinetics of hydrochlorothiazide.
Maltese: Mard epatiku ma jaffettwax b'mod sinifikanti l-farmakokinetika ta' hydrochlorothiazide.
English: In a double-blind, randomised, placebo-controlled, factorial design trial comparing various dose combinations of valsartan/hydrochlorothiazide to their respective components, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 320/12.5 mg (21.7/15.0 mmHg) and 320/25 mg (24.7/16.6 mmHg) compared to placebo (7.0/5.9 mmHg) and the respective monotherapies, i.e. hydrochlorothiazide 12.5 mg (11.1/9.0 mmHg), hydrochlorothiazide 25 mg (14.5/10.8 mmHg) and valsartan 320 mg (13.7/11.3 mmHg).
Maltese: Fi prova b'disinn ta' fattur, double-blind, randomised, ikkontrollata bi plaċebo li qabblet diversi taħlitiet ta' dożi ta' valsartan/ hydrochlorothiazide mal-komponenti rispettivi tagħhom, kien osservat tnaqqis ogħla b'mod sinifikanti fil-pressjoni sistolika/dijastolika medja bit-taħlita ta' valsartan/ hydrochlorothiazide 320/12.5 mg (21.7/15.0 mmHg) u 320/25 mg (24.7/16.6 mmHg) meta mqabbel ma' plaċebo (7.0/5.9 mmHg) u l-monoterapiji rispettivi tagħhom, i.e., hydrochlorothiazide 12.5 mg (11.1/9.0 mmHg), hydrochlorothiazide 25 mg (14.5/10.8 mmHg) u valsartan 320 mg (13.7/11.3 mmHg).
English: − Severe hepatic impairment, biliary cirrhosis and cholestasis.
Maltese: − Indeboliment epatiku sever, ċirrożi biljari u kolestasi.
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 ssir dijanjosi ta' tqala, kura b'AIIRAs għandha titwaqqaf minnufih, u, jekk xieraq, għandha tinbeda terapija alternattiva (ara sezzjonijiet 4.3 u 4.6).
English: In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 320/25 mg (85%) and 320/12.5 mg (83%) compared to placebo (45%) and the respective monotherapies, i.e. hydrochlorothiazide 12.5 mg (60%), hydrochlorothiazide 25 mg (66%), and valsartan 320 mg (69%).
Maltese: u 320/12.5 mg (83%) meta mqabbla ma' plaċebo (45%) u mal-monoterapiji rispettivi tagħhom, i.e., hydrochlorothiazide 12.5 mg (60%), hydrochlorothiazide 25 mg (66%), u valsartan 320 mg
English: • anti-cholinergic medicines, such as atropine or biperiden
Maltese: • mediċini antikolinerġiċi, bħal atropine jew biperiden
English: Nervous system disorders Rare
Maltese: Disturbi fis-sistema nervuża Rari ħafna
English: • arthritis medicines
Maltese: • mediċini tal-artrite
English: − Second and third trimester of pregnancy (section 4.4 and 4.6).
Maltese: − It-tieni jew it-tielet trimestru tat-tqala (sezzjonijiet 4.4 u 4.6).
English: − Hypersensitivity to valsartan, hydrochlorothiazide, other sulfonamide-derived medicinal products or to any of the excipients.
Maltese: − Sensittività eċċessiva għal valsartan, għal hydrochlorothiazide, jew għal prodotti mediċinali oħra imnisslin minn sulfonamide jew għal xi sustanzi mhux attivi.
English: • if you suffer from hyperaldosteronism.
Maltese: • jekk issofri minn iperaldosteroniżmu.
English: Many may feel quite normal.
Maltese: Ħafna jistgħu jħossuhom pjuttost normali.
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 bażi talmekkaniżmu ta' azzjoni farmakoloġika ta' hydrochlorothiazide l-użu tiegħu waqt it-tieni u t-tielet trimestru jista' jikkomprometti l-perfużjoni tal-plaċenta u l-fetu u jista' jikkawża effetti fil-fetu u fittarbija tat-twelid bħal icterus, disturb fil-bilanċ tal-elettroliti u tromboċitopenija.
English: The MAH justified the choice of not including information on the involvement of transporter proteins in section 4.5 of Diovan Comp SPC, in line with the outcome of the Diovan referral.
Maltese: Il-MAH iġġustifika l-għażla li ma jinkludix tagħrif dwar l-involviment ta' proteini ta' trasport fis-sezzjoni 4.5 ta' Diovan Comp SPC, b'konformità marriżultat tar-referenza ta' Diovan.
English: In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (P <0.05) lower in patients treated with valsartan than in those treated with an ACE inhibitor (2.6% versus 7.9% respectively).
Maltese: Fi provi kliniċi fejn valsartan kien imqabbel ma' inibitur ta' ACE, l-inċidenza ta' sogħla xotta kienet inqas b'mod sinifikanti (P<0.05) f'pazjenti kkurati b'valsartan meta mqabbel ma' dawk ikkurati b'inibitur ta' ACE (2.6% kontra 7.9% rispettivament).
English: Pharmacotherapeutic group: Angiotensin II antagonists and diuretics, valsartan and diuretics; ATC code: C09D A03.
Maltese: L-użu ta' Antagonisti tar-Riċettur ta' Angiotensin II (AIIRAs) mhux irrakkomandat waqt l-ewwel trimestru tat-tqala (ara sezzjoni 4.4).
English: In a double-blind, randomised, active-controlled trial in patients not adequately controlled on valsartan 80 mg, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 80/12.5 mg (9.8/8.2 mmHg) compared to valsartan 80 mg (3.9/5.1 mmHg) and valsartan 160 mg (6.5/6.2 mmHg).
Maltese: Fi prova double-blind, randomised, ikkontrollata b'mod attiv f'pazjenti li ma kinux ikkontrollati b'mod adegwat fuq valsartan 80 mg, tnaqqis ogħla b'mod sinifikanti fil-pressjoni sistolika/dijastolika medja kien osservat bit-taħlita ta' valsartan/hydrochlorothiazide 80/12.5 mg (9.8/8.2 mmHg) meta mqabbel ma' valsartan 80 mg (3.9/5.1 mmHg) u valsartan 160 mg (6.5/6.2 mmHg).
English: Treatment with thiazide diuretics, including hydrochlorothiazide, has been associated with hyponatraemia and hypochloraemic alkalosis.
Maltese: Kura b'dijuretiċi thiazide, inkluż hydrochlorothiazide, kienet assoċjata ma' iponatrimija u alkalożi ipokloremika.
English: Investigations Not known
Maltese: Investigazzjonijiet Mhux magħruf
English: Following intravenous administration, plasma clearance of valsartan is about 2 l/h and its renal clearance is 0.62 l/h (about 30% of total clearance).
Maltese: Wara għoti ġol-vini, tneħħija mill-plażma ta' valsartan hija madwar 2 l/h u t-tneħħija renali tiegħu hija 0.62 l/h (madwar 30% tat-tneħħija totali).
English: Nervous system disorders Very rare
Maltese: Disturbi fis-sistema nervuża Rari
English: Diovan Comp film-coated tablets contain two active substances called valsartan and hydrochlorothiazide.
Maltese: Pilloli Diovan Comp miksijin b'rita fihom żewġ sustanzi attivi msejħa valsartan u hydrochlorothiazide.
English: Section 4.8 - Undesirable Effects
Maltese: Sezzjoni 4.8 - Effetti mhux mixtieqa
English: There have been isolated reports of haemolytic anaemia in patients receiving concomitant treatment with methyldopa and hydrochlorothiazide.
Maltese: Kien hemm rapporti iżolati ta' anemija emolitika f'pazjenti li kienu qed jirċievu kura konkomitanti b'methyldopa u hydrochlorothiazide.
English: • medicines that affect or can be affected by potassium blood levels, such as digoxin, a medicine to control the heart rhythm, some antipsychotic medicines
Maltese: • mediċini li jaffettwaw jew li jistgħu jiġu affettwati mill-livelli tal-potassium fid-demm, bħal digoxin, mediċina li tikkontrolla r-ritmu tal-qalb, xi mediċini antipsikotiċi
English: According to “Guideline on SPCs”, the CHMP placed ADR syncope in the frequency category “not known”.
Maltese: Skont il-“Linja gwida dwar l-SPCs”, is-CHMP poġġa s-sinkope tal-ADR fil-kategorija ta' frekwenza “mhux magħrufa”.
English: Metabolism and nutrition disorders Uncommon
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni
English: The AIIR (angiotensin II receptor) antagonists should not be contraindicated during breast-feeding.
Maltese: Antagonisti ta' angiotensin II u dijuretiċi, valsartan u dijuretiċi;
English: Metabolism and nutrition disorders Not known
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux magħruf
English: Pancreatitis
Maltese: Pakrejatite
English: • lung infection; breathlessness
Maltese: • infezzjoni fil-pulmun; qtugħ ta' nifs
English: Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Maltese: Kull pillola fiha 320 mg ta' valsartan u 25 mg ta' hydrochlorothiazide.
English: • medicines to treat cancer, such as methotrexate or cyclophosphamide
Maltese: • mediċini biex jikkuraw il-kanċer, bħal methotrexate jew cyclophosphamide
English: • the level of blood urea nitrogen and creatinine increased in blood (which can indicate abnormal kidney function)
Maltese: • il-livell ta' nitrogen tal-urea fid-demm u l-krejatinina fid-demm jiżdided (li jistgħu jindikaw funzjoni mhux normali tal-kliewi)
English: In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotaemia, and in rare cases with acute renal failure.
Maltese: F'pazjenti li l-funzjoni renali tagħhom tista' tiddependi fuq l-attività tas-sistema renin-angiotensinaldosterone (eż. pazjenti b'insuffiċjenza konġestiva tal-qalb severa), kura b'inibituri ta' angiotensin converting enzyme kienet assoċjata ma' oligurja u/jew ażotemja progressiva u f'każijiet rari ma' insuffiċjenza renali akuta.
English: In controlled clinical trials with valsartan/hydrochlorothiazide the potassium lowering effect of hydrochlorothiazide was attenuated by the potassium-sparing effect of valsartan.
Maltese: Fi provi kliniċi kkontrollati b'valsartan/ hydrochlorothiazide l-effett li hydrochlorothiazide jbaxxi l-potassium tnaqqas mill-effett li valsartan ma jitlifx il-potassium.
English: Co-Dalzad (80+12.5) mg 80 mg / 12,5 mg film-coated tablets oral
Maltese: Co-Dalzad (80+12.5) mg 80 mg / 12,5 mg pilloli miksija b'rita orali
English: Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Maltese: Kull pillola fiha 320 mg ta' valsartan u 12.5 mg ta' hydrochlorothiazide.
English: Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
Maltese: Kull pillola fiha 160 mg ta' valsartan u 25 mg ta' hydrochlorothiazide.
English: • muscle relaxing medicines, such as tubocurarine
Maltese: • mediċini li jirrilassaw il-muskoli, bħal tubocurarine
English: • lithium, a medicine used to treat some types of psychiatric illness
Maltese: • lithium, mediċina użata biex tikkura xi tipi ta' mard psikjatriku