FrancophonIA/ELRC3.0 huggingface dataset:
English: In particular, valproateinduced acute liver failure and liver-related deaths have been reported at a higher rate in patients with hereditary neurometabolic syndromes caused by mutations in the gene for the mitochondrial enzyme polymerase γ (POLG), e.g. Alpers-Huttenlocher Syndrome.
Maltese: B'mod partikolari, falliment akut tal-fwied indott minn valproate u mewt relatat mal-fwied ġew rappurtati b'rata ogħla f'pazjenti b'sindromi newrometaboliċi ereditarji kkawżati minn mutazzjonijiet fil-ġene għall-enzima polimerażi mitokondrijali y (POLG), eż. is-Sindrome ta' Alpers-Huttenlocher.
English: POLG mutation testing should be performed in accordance with current clinical practice for the diagnostic evaluation of such disorders (see section 4.3).
Maltese: Testijiet ta' mutazzjonijiet POLG għandhom jitwettqu f'konformità mal-prattika klinika attwali għall-evalwazzjoni dijanjostika ta' disturbi bħal dawn (ara sezzjoni 4.3).
English: Kidney tumours: Patients with severe kidney impairment who received lithium for more than 10 years may have a risk of developing a benign or malignant kidney tumour (microcysts, oncocytoma or collecting duct renal carcinoma).
Maltese: Tumuri tal-kliewi: Pazjenti b'indeboliment tal-kliewi gravi li rċevew litju għal iktar minn 10 snin jistgħu ikunu f'riskju li jiżviluppaw tumur tal-kliewi beninn jew malinn (mikroċesti, onkoċitoma, jew karċinoma renali tal-kanal tal-ġbir).
English: Valproate may trigger or worsen clinical signs of underlying mitochondrial diseases caused by mutations of mitochondrial DNA as well as the nuclear encoded POLG gene.
Maltese: Valproate jista' jiskatta jew jiggrava sinjali kliniċi ta' mard mitokondrijali bażi kkawżat minn mutazzjonijiet tad-DNA mitokondrijali kif ukoll il-ġene tal-POLG kodifikat b'mod nukleari.
English: If you have a genetic problem causing a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome) Warnings and precautions
Maltese: Jekk għandek problema ġenetika speċifika li tikkawża disturb mitokondrijali (eż. is-sindrome ta' AlpersHuttenlocher)
English: • in neonates up to 4 weeks of age (see section 4.4).
Maltese: • fi trabi tat-twelid sal-età ta' 4 ġimgħat (ara sezzjoni 4.4).
English: Renal impairment <invented name> is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury and in patients in the perioperative liver transplantation period (see section 4.3).
Maltese: <isem ivvintat> huwa kontraindikat f'pazjenti b'indeboliment renali gravi (GFR < 30 ml/min/1.73m2) u/jew bi ħsara akuta fil-kliewi u f'pazjenti fil-perjodu ta' qabel l-operazzjoni ta' trapjant tal-fwied (ara sezzjoni 4.3).
English: Side effects of unknown frequency: Muscle weakness that is constant.
Maltese: Effetti sekondarji ta' frekwenza mhux magħrufa:
English: PRAC recommendations on signals for update of the product information
Maltese: Rakkomandazzjonijiet tal-PRAC dwar sinjali għallaġġornament tal-informazzjoni tal-prodott
English: Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period (see section 4.3).
Maltese: Optimark huwa kontraindikat f'pazjenti b'indeboliment renali gravi (GFR < 30 ml/min/1.73m2) u/jew bi ħsara akuta fil-kliewi u f'pazjenti li kellhom trapjant tal-fwied jew f'pazjenti fil-perjodu ta' qabel loperazzjoni ta' trapjant tal-fwied (ara sezzjoni 4.3).
English: In light of the data submitted by the marketing authorisation holders and the advice provided by the Pharmacogenomics Working Party, the PRAC concluded that the evidence is sufficient to support a causal association between valproate and aggravation of underlying mitochondrial diseases, including risk of hepatotoxicity occurring mainly in patients suffering from POLG (polymerase gamma) mutations.
Maltese: Fid-dawl tad-dejta sottomessa mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq u l-parir ipprovdut mill-Grupp ta' Ħidma tal-Farmakoġenomika, il-PRAC ikkonkluda li l-evidenza hija suffiċjenti biex tappoġġja assoċjazzjoni kawżali bejn valproate u l-aggravar ta' mard mitokondrijali bażi, inkluż riskju ta' ħepatotossiċità li normalment isseħħ f'pazjenti li jsofru minn mutazzjonijiet POLG (gamma polimerażi).
English: IMNM is clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment.
Maltese: IMNM hija kkaratterizzata klinikament b'dgħjufija persistenti tal-muskoli prossimali u b'żieda fil-kinase tal-kreatina fis-serum, li jibqgħu preżenti minkejja li titwaqqaf il-kura blistatini.
English: Having considered the available evidence from the literature, the PRAC has agreed that the MAHs for medicinal products containing atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin or lovastatin should submit a variation within 2 months to amend the product informations as described below (new text underlined):
Maltese: Wara li kkunsidra l-evidenza disponibbli mil-letteratura, il-PRAC qabel li d-detenturi talawtorizzazzjonijiet għat-tqegħid fis-suq (MAHs) għall-prodotti mediċinali li fihom atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin jew lovastatin għandhom jissottomettu varjazzjoni fi żmien xahrejn biex jemendaw l-informazzjoni dwar il-prodotti kif deskritt hawn isfel (it-test il-ġdid huwa sottolinjat):
English: Optimark is contraindicated in these patients (see section 4.3).
Maltese: Optimark huwa kontraindikat f'dawn il-pazjenti (ara sezzjoni 4.3).
English: There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins.
Maltese: Kien hemm rapporti rari ta' mijopatija li tinnekrotizza medjata mis-sistema immunitarja (IMNM) waqt jew wara l-kura b'xi statini.
English: Frequency not known: Immune-mediated necrotizing myopathy (see section 4.4) Package Leaflet:
Maltese: Mijopatija li tinnekrotizza medjata mis-sistema immunitarja (ara sezzjoni
English: 4.3 Contraindications <invented name> is contraindicated in patients with severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury, in patients in the perioperative liver transplantation period and in neonates up to 4 weeks of age (see section 4.4).
Maltese: <isem ivvintat> huwa kontraindikat f'pazjenti b'indeboliment renali gravi (GFR < 30 ml/min/1.73m2) u/jew bi ħsara akuta fil-kliewi, u f'pazjenti fil-perjodu ta' qabel l-operazzjoni ta' trapjant tal-fwied u fi trabi tat-twelid sal-età ta' 4 ġimgħat (ara sezzjoni 4.4).
English: Member State EU / EEA
Maltese: Stat membru EU / EEA
English: Calcium salts and vitamin D
Maltese: Calcium salts u vitamina D
English: Medicinal products that could induce torsades de pointes
Maltese: Prodotti mediċinali li jistgħu jinduċu torsades de pointes
English: Sweden Novartis Sverige AB Box 1150
Maltese: L-Isvezja Novartis Sverige AB Box 1150
English: Hungary Novartis Hungaria Kft. Bartók Béla út 43-47
Maltese: L-Ungerija Novartis Hungaria Kft. Bartók Béla út 43-47
English: 2 & 4, rue Lionel Terray 92500 RUEIL-MALMAISON, France
Maltese: 2 & 4, rue Lionel Terray 92500
English: Norway Novartis Norge AS Postboks 237 Økern 0510 Oslo
Maltese: In-Norveġja Novartis Norge AS Postboks 237 Økern 0510
English: H-1114 Budapest
Maltese: H-1114
English: FIN-02130 Espoo
Maltese: FIN-02130
English: Mean absolute bioavailability is 23%.
Maltese: Il-bijodisponibiltà assoluta medja hija ta' 23%.
English: Belgium N.V. Novartis Pharma S.A. Medialaan 40, bus 1
Maltese: Il-Belġju N.V. Novartis Pharma S.A. Medialaan 40, bus 1
English: Netherlands Novartis Pharma B.V. Raapopseweg 1 Postbus 241 NL-6824 DP Arnhem
Maltese: L-Olanda Novartis Pharma B.V. Raapopseweg 1 Postbus 241 NL-6824 DP Arnhem
English: Beta blockers and diazoxide
Maltese: Imblokkaturi beta u diazoxide
English: Valsartan shows multiexponential decay kinetics (t½α <1 h and t½ß about 9 h).
Maltese: Valsartan juri kinetika ta' diżintegrazzjoni multiesponenzjali (t½α <1 h u t½ß madwar 9 h).
English: “Treatment of essential hypertension in adults”
Maltese: “Trattament tal-ipertensjoni essenzjali fl-adulti”
English: Iceland Novartis Healthcare A/S Lyngbyvej 172
Maltese: L-Islanda Novartis Healthcare A/S Lyngbyvej 172
English: Photosensitisation
Maltese: Fotosensitizzazzjoni
English: Netherlands Novartis Pharma B.V. Raapopseweg 1
Maltese: L-Olanda Novartis Pharma B.V. Raapopseweg 1
English: Denmark Novartis Healthcare A/S Lyngbyvej 172
Maltese: Id-Danimarka Novartis Healthcare A/S Lyngbyvej 172
English: • fever (cutaneous lupus erythematosus)
Maltese: • deni (lupus erythematosus tal-ġilda)
English: • Some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine,
Maltese: • Xi antipsikotiċi (eż. thioridazine, chlorpromazine, levomepromazine, trifluoperazine,
English: Lithuania Novartis Finland Oy Metsänneidonkuja 10
Maltese: Il-Litwanja Novartis Finland Oy Metsänneidonkuja 10
English: Digoxin and indomethacin could interact with the hydrochlorothiazide component of Diovan Comp (see interactions related to hydrochlorothiazide).
Maltese: Digoxin u indomethacin jista' jkollhom interazzjoni mal-komponent hydrochlorothiazide ta' Diovan Comp (ara interazzjonijiet relatati ma' hydrochlorothiazide).
English: Finland Novartis Finland Oy Metsänneidonkuja 10
Maltese: Il-Finlandja Novartis Finland Oy Metsänneidonkuja 10
English: • some antibiotics (tetracyclines), anaesthetics and sedatives
Maltese: • xi antibijotiċi (tetracyclines), anestetiċi u sedattivi
English: • Others (e.g. bepridil, cisapride, diphemanil, erythromycin i.v., halofantrin, ketanserin,
Maltese: • Oħrajn (eż. bepridil, cisapride, diphemanil, erythromycin i.v., halofantrin, ketanserin,
English: Anticholinergic agents (e.g. atropine, biperiden)
Maltese: Sustanzi antikolinerġiċi (eż. atropine, biperiden)
English: But according to the European hypertension treatment Guidelines (Mancia et al., Eur Heart J 2007;28(12):1462-536) it is no longer warranted.
Maltese: Iżda skont il-Linji Gwida Ewropej għattrattament tal-ipertensjoni (Mancia et al., Eur Heart J 2007;28(12):1462-536) dan m'għadux aktar rikjest.
English: Psychiatric disorders Rare
Maltese: Disturbi psikjatriċi Rari
English: Constipation, gastrointestinal discomfort
Maltese: Stitikezza, skomfort gastrointestinali
English: Other hypersensitivity/allergic reactions including serum sickness
Maltese: Reazzjonijiet oħra ta' sensittività eċċessiva/allerġiċi inkluż marda tas-serum
English: Diovan Comp contains valsartan and hydroclortiazide.
Maltese: Diovan Comp fih valsartan u idroklorotijażide (hydrochlorothiazide).
English: This metabolite is pharmacologically inactive.
Maltese: Dan il-metabolit mhux attiv farmakoloġikament.
English: Medicinal products associated with potassium loss and hypokalaemia (e.g. kaliuretic diuretics, corticosteroids, laxatives, ACTH, amphotericin, carbenoxolone, penicillin G, salicylic acid and derivatives)
Maltese: L-użu konkomitanti fejn jeħtieġ li tintuża l-kawtela Prodotti mediċinali assoċjati ma' telf ta' potassium u ipokalimija (eż. dijuretiċi kalijuretiċi, kortikosterojdi, lassattivi, ACTH, amphotericin, carbenoxolone, penicillin G, salicylic acid u derivattivi)
English: Valsartan is an orally active angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ) is a diuretic.
Maltese: II receptor blocker - ARB) oralment attiv u idroklorotijażide (HCTZ) huwa dijuretiku.
English: Diovan Comp is contraindicated in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Maltese: Diovan Comp huwa kontraindikat f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Angioedema, rash, pruritus
Maltese: Angjoedima, raxx, ħakk
English: • Class III antiarrhythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide)
Maltese: III (eż. amiodarone, sotalol, dofetilide, ibutilide)
English: Interactions related to valsartan
Maltese: Interazzjonijiet relatati ma' valsartan
English: − Severe renal impairment (creatinine clearance <30 ml/min), anuria.
Maltese: − Indeboliment renali sever (tneħħija tal-krejatinina <30 ml/min), nuqqas ta' produzzjoni ta'
English: Circulating hydrochlorothiazide is bound to serum proteins (40-70%), mainly serum albumin.
Maltese: Hydrochlorothiazide li jiċċirkola huwa mwaħħal mal-proteini fis-serum (40-70%), l-aktar malalbumina fis-serum.
English: There were significant divergences in the contraindications.
Maltese: Kien hemm diverġenzi sinifikanti fil-kontraindikazzjonijiet.
English: was reduced (p <0.001) by 42% (-24.2 µg/min; 95% CI: -40.4 to -19.1) with valsartan and approximately 3% (-1.7 µg/min; 95% CI: -5.6 to 14.9) with amlodipine despite similar rates of blood pressure reduction in both groups.
Maltese: 001) b'42% (-24.2 µg/min; 95% CI: -40.4 sa -19.1) b'valsartan u b'madwar 3% (-1.7 µg/min; 95% CI: -5.6 sa 14.9) b'amlodipine minkejja rati simili ta' tnaqqis filpressjoni tad-demm fiż-żewġ gruppi.
English: A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC).
Maltese: Metabolit hydroxy kien identifikat fil-plażma f'konċentrazzjonijiet baxxi (inqas minn 10% ta' l-AUC ta' valsartan).
English: • Class Ia antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide)
Maltese: Ia (eż. quinidine, hydroquinidine, disopyramide)
English: − Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.
Maltese: − Ipokalimija refrattorja, iponatrimija, iperkalċimija, u iperuriċemija sintomatika.
English: Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid >3 g/day), and non-selective NSAIDs NSAIDS can attenuate the antihypertensive effect of both angiotensin II antagonists and hydrochlorothiazide when administered simultaneously.
Maltese: Mediċini anti-infjammatorji mhux sterojdi (NSAIDs), inkluż inibituri selettivi ta' COX-2, acetylsalicylic acid >3 g/kuljum, u NSAIDs mhux selettivi NSAIDs jistgħu jnaqqsu l-effett ta' kontra l-pressjoni għolja kemm ta' anatgonisti ta' angiotensin II kif ukoll ta' hydrochlorothiazide meta jingħataw fl-istess ħin.
English: I-21040 Origgio (VA)
Maltese: I-21040
English: Frequency of adverse reactions with valsartan/hydrochlorothiazide
Maltese: Frekwenza ta' reazzjonijiet avversi b'valsartan/hydrochlorothiazide
English: Absolute bioavailability of hydrochlorothiazide is 60-80% after oral administration.
Maltese: Bijodisponibbiltà assoluta ta' hydrochlorothiazide hija bejn 60-80% wara għoti mill-ħalq.
English: In drug interaction studies with valsartan, no interactions of clinical significance have been found with valsartan or any of the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide.
Maltese: Fi studji dwar l-interazzjoni tal-mediċina b'valsartan, ma nstabet l-ebda interazzjoni ta' sinifikanza klinika b'valsartan jew b'xi wieħed mis-sustanzi li ġejjin: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide.
English: Cardiac arrhythmias
Maltese: Artralġja
English: • Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”).
Maltese: • Hydrochlorothiazide jagħmel parti minn grupp ta' mediċini msejħa dijuretiċi thiazide (magħrufa wkoll bħala “pilloli tal-awrina”).
English: Valsartan is highly bound to serum proteins (94-97%), mainly serum albumin.
Maltese: Valsartan huwa mwaħħal ħafna mal-proteini fis-serum (94-97%), l-aktar ma' l-albumina fis-serum.
English: Serum uric acid increased, Serum bilirubin and Serum creatinine increased, Hypokalaemia, Hyponatraemia, Elevation of Blood Urea Nitrogen, Neutropenia
Maltese: Żieda ta' uric acid fis-serum, Żieda ta' bilirubin fis-serum u ta' krejatinina fis-serum, Ipokalimija, Iponatrimija, Livelli ogħla ta' Nitrogen tal-Urea fid-Demm, Newtropenija
English: The half-life of valsartan is 6 hours.
Maltese: Il-half-life ta' valsartan hija 6 sigħat.
English: • carbamazepine, a medicine used to treat seizure conditions
Maltese: • carbamazepine, mediċina li tintuża biex tikkura kundizzjonijiet ta' aċċessjonijiet
English: Avoid taking alcohol until you have talked to your doctor.
Maltese: Evita li tixrob l-alkoħol sakemm tkellem lit-tabib tiegħek.
English: Adverse drug reactions are ranked by frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Reazzjonijiet avversi għall-mediċina huma kklassifikati skont il-frekwenza, bl-aktar frekwenti mniżżla l-ewwel, bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittiehed stima mid-data disponibbli).
English: The MARVAL (Micro Albuminuria Reduction with Valsartan) study assessed the reduction in urinary albumin excretion (UAE) with valsartan (80-160 mg/od) versus amlodipine (5-10 mg/od), in 332 type 2 diabetic patients (mean age: 58 years; 265 men) with microalbuminuria (valsartan: 58 µg/min; amlodipine: 55.4 µg/min), normal or high blood pressure and with preserved renal function (blood creatinine <120 µmol/l).
Maltese: L-istudju MARVAL (Micro Albuminuria Reduction with Valsartan) ivvaluta t-tnaqqis fit-tneħħija ta' l-albumina fl-awrina (UAE) b'valsartan (80-160 mg/od) kontra amlodipine (5-10 mg/od), f'332 pazjent b'dijabete tat-tip 2 (età medja: 58 sena; 265 raġel) b'mikroalbuminurja (valsartan: 58 µg/min; amlodipine: 55.4 µg/min), bi pressjoni tad-demm normali jew għolja u b'funzjoni renali ppreservata (krejatinina fid-demm <120 µmol/l).
English: • syncope (fainting)
Maltese: • sinkope (ħass ħażin)
English: The magnitude of these effects is small and has minimal clinical importance.
Maltese: Il-kobor ta' dawn l-effetti huwa żgħir u għandu importanza klinika minima.
English: D-90429 Nürnberg provas 160 maxx 160/25 mg 160 mg / 25 mg film-coated tablets oral
Maltese: D-90429 Nürnberg provas 160 maxx 160/25 mg 160 mg / 25 mg pilloli miksija b'rita orali
English: Interactions related to hydrochlorothiazide
Maltese: Interazzjonijiet relatati ma' hydrochlorothiazide
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of drugs.
Maltese: Filwaqt li m'hemmx tagħrif epidemjoloġiku kkontrollat dwar ir-riskju b'Inibituri tarRiċettur ta' Angiotensin II (AIIRAs), jistgħu jeżistu riskji simili għal din il-klassi ta' mediċini.
English: In a pharmacokinetics trial in patients with mild (n=6) to moderate (n=5) hepatic dysfunction, exposure to valsartan was increased approximately 2-fold compared with healthy volunteers.
Maltese: Fi prova ta' farmakokinetika f'pazjenti b'disfunzjoni epatika ħafifa (n=6) sa moderata (n=5), esponiment għal valsartan żdied madwar darbtejn aktar meta mqabbel ma' voluntiera b'saħħithom.
English: • light-headedness
Maltese: • tnaqqis fl-aptit
English: In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced cough compared to 68.5% of those treated with an ACE inhibitor (P <0.05).
Maltese: Fi prova klinika ta' pazjenti b'passat ta' sogħla xotta waqt terapija b'inibitur ta' ACE, 19.5% ta' l-individwi fil-prova li rċevew valsartan u 19.0% ta' dawk li rċevew dijuretiku thiazide kellhom esperjenza ta' sogħla meta mqabbel ma' 68.5% ta' dawk ikkurati b'inibitur ta' ACE (P<0.05).
English: Cholestyramine and cholestipol resins
Maltese: Rażi ta' cholestyramine u cholestipol
English: D-90429 Nürnberg provas 320 maxx 320/25 mg 320 mg / 25 mg film-coated tablets oral
Maltese: D-90429 Nürnberg provas 320 maxx 320/25 mg 320 mg / 25 mg pilloli miksija b'rita orali
English: Dose-dependent decreases in serum potassium occurred in controlled clinical studies with valsartan + hydrochlorothiazide.
Maltese: Tnaqqis tal-potassium fis-serum li jiddependi mid-doża seħħ fi studji kkontrollati b'valsartan + hydrochlorothiazide.
English: • muscle disorder
Maltese: • disturb fil-muskoli
English: Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
Maltese: Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR Ir-Renju Unit
English: The combination of valsartan/HCTZ was generally well-tolerated and the adverse event and adverse drug reaction profiles were consistent with the pharmaceutical class.
Maltese: Il-kombinazzjoni ta' valsartan/HCTZ kienet ġeneralment tollerata sew u l-profili ta' avveniment avvers u ta' reazzjoni avversa għall-mediċina kienu konformi mal-klassi farmaċewtika.
English: Immune system disorders Very rare
Maltese: Disturbi fis-sistema immuni Rari ħafna
English: • amantadine (a medicine used to prevent influenza)
Maltese: • amantadine (mediċina li tintuża biex tilqa' kontra l-influwenza)
English: In marmosets, damage was observed in the gastric mucosa (from 30 + 9 mg/kg/d).
Maltese: Fil-marmosets, ħsara kienet osservata fil-mukuża tal-istonku (minn 30 + 9 mg/kg/jum).
English: The systemic availability of hydrochlorothiazide is reduced by about 30% when co-administered with valsartan.
Maltese: Id-disponibbiltà sistemika ta' hydrochlorothiazide tonqos b'madwar 30% meta jingħata flimkien ma' valsartan.
English: Respiratory, thoracic and mediastinal disorders Very rare
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Rari ħafna
English: Similar findings were seen with valsartan/hydrochlorothiazide in rats and rabbitsIn embryo-fetal development (Segment II) studies with valsartan/hydrochlorothiazide in rat and rabbit, there was no evidence of teratogenicity; however, fetotoxicity associated with maternal toxicity was observed.
Maltese: Fl-istudji tal-iżvilupp tal-embriju u l-fetu (Segment II) b'valsartan/hydrochlorothiazide fil-far u l-fenek, ma kien hemm lebda evidenza ta' teratoġeniċità; mandankollu, tossiċità tal-fetu assoċjata ma' tossiċità tal-omm kienet osservata.
English: These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data
Maltese: Dawn l-effetti sekondarji jistgħu jseħħu b'ċertu frekwenzi, li huma definiti kif ġej: komuni ħafna: jaffettwaw aktar minn persuna waħda minn kull 10 li qed jużawh komuni: jaffettwaw minn persuna waħda sa 10 minn kull 100 li qed jużawh mhux komuni: jaffettwaw minn persuna waħda sa 10 minn kull 1,000 li qed jużawh rari: jaffettwaw minn persuna waħda sa 10 minn kull 10,000 li qed jużawh rari ħafna: jaffettwaw inqas minn persuna waħda minn kull 10,000 li qed jużawh mhux magħruf: il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli
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' mortalità u morbożità kardjovaskulari.
English: Hypokalaemia has been reported under treatment with thiazide diuretics, including hydrochlorothiazide.
Maltese: Ipokalimija kienet irrappurtata taħt kura b'dijuretiċi thiazide, inkluż hydrochlorothiazide.
English: Increase of serum potassium
Maltese: Żieda fil-postassium tas-serum
English: The distribution and elimination kinetics have generally been described by a bi-exponential decay function.
Maltese: Il-kinetika tad-distribuzzjoni u l-eliminazzjoni kienet ġeneralment deskritta permezz ta' funzjoni ta' tnaqqis bi-esponentali.
English: • Keep this leaflet.
Maltese: • jekk inti ma tistax tgħaddi l-awrina.
English: Largo Umberto Boccioni 1
Maltese: LPB Istituto Farmaceutico S.r.l. Largo Umberto Boccioni 1
English: Hydrochlorothiazide crosses the placenta.
Maltese: Hydrochlorothiazide jgħaddi minn ġol-plaċenta.