FrancophonIA/ELRC3.0 huggingface dataset:
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-tne ija 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 ra el) b'mikroalbuminurja (valsartan: 58 µg/min; amlodipine: 55.4 µg/min), bi pressjoni tad-demm normali jew g olja u b'funzjoni renali ppreservata (krejatinina fid-demm <120 µmol/l).
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilità, tqala u treddig
English: poloxamer (188), citric acid anhydrous, sodium citrate, artificial blueberry flavour, propylene glycol (E1520), sodium hydroxide, hydrochloric acid, purified water.
Maltese: poloxamer (188), anhydrous citric acid, tog ma artifi jali ta' blueberry, propylene glycol
English: Angioedema, Rash, Pruritus
Maltese: An joedima, Raxx, akk
English: • The other ingredients are sucrose, methyl parahydroxybenzoate (E218), potassium sorbate,
Maltese: • Is-sustanzi l-o ra huma sucrose, methyl parahydroxybenzoate (E218), potassium sorbate,
English: Approximately 70% of the dose absorbed is eliminated in the bile, essentially in the unchanged form.
Maltese: Madwar 70% tad-do a assorbita hija eliminata fil-bili, essenzjalment f'forma mhux mibdula.
English: Note: The total amount of solution that can be measured into the oral syringe is 5 ml.
Maltese: Nota: L-ammont totali ta' soluzzjoni li jista' jitkejjel fis-siringa orali huwa ta' 5 ml.
English: - Severe hepatic impairment, biliary cirrhosis and cholestasis.
Maltese: − Indeboliment epatiku sever, irro i biljari u kolestasi.
English: Contains sucrose, methyl parahydroxybenzoate (E218) and poloxamer (188) (see leaflet for further information).
Maltese: Fih sucrose, methyl parahydroxybenzaote (E218) u poloxamer (188) (ara l-fuljett g al iktar informazzjoni).
English: FIN-02130 Espoo Finland (Tel: + 358-9-6133 22 11)
Maltese: Espoo Finland (Tel: + 358-9-6133 22 11)
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' sog la xotta waqt terapija b'inibitur ta' ACE, 19.5% ta' l-individwi fil-prova li r evew valsartan u 19.0% ta' dawk li r evew dijuretiku thiazide kellhom esperjenza ta' sog la meta mqabbel ma' 68.5% ta' dawk ikkurati b'inibitur ta' ACE (P<0.05).
English: Combined with hydrochlorothiazide, a significant additional reduction in blood pressure is achieved.
Maltese: F'ta lita ma' hydrochlorothiazide, jintla aq tnaqqis addizzjonali sinifikanti fil-pressjoni tad-demm.
English: Diovan has not been studied in patients with severe hepatic dysfunction (see sections 4.2, 4.3 and 4.4).
Maltese: Diovan ma kienx studjat f'pazjenti b'disfunzjoni epatika severa (ara sezzjonijiet 4.2, 4.3 u 4.4).
English: - Post-myocardial infarction and/or heart failure (studied in adult patients only)
Maltese: - Wara infart mijokardiku u/jew insuffi jenza tal-qalb (studjat f'pazjenti adulti biss)
English: Use in adults
Maltese: L-u u fl-adulti
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 je amina l-effika ja ta' valsartan biex inaqqas l-UAE f'391 pazjent bi pressjoni g olja (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 talkrejatinina fis-serum = 80 µmol/l).
English: Pharma Nagano III.
Maltese: NOVARTIS s.r.o. Pharma Nagano III.
English: • Once opened, the bottle can be stored for up to 3 months at temperatures below 30°C.
Maltese: • Ladarba jinfeta , il-flixkun jista' ji i ma un sa 3 xhur f'temperaturi ta t 30°C.
English: Children weighing between 18 kg and <35 kg received valsartan 80 mg or enalapril 10 mg; those between 35 kg and <80 kg received valsartan 160 mg or enalapril 20 mg; those 80 kg received valsartan 320 mg or enalapril 40 mg.
Maltese: dawk bejn ≥35 kg u <80 kg ir evew valsartan ta' 160 mg jew enalapril ta' 20 mg; dawk li ji nu ≥80 kg ir evew valsartan ta' 320 mg jew enalapril ta' 40 mg.
English: 1 dispenser kit containing one press in bottle adapter, one 5 ml oral syringe and one 30 ml dosing cup.
Maltese: Sett li fih adapter press in tal-fliexken, siringa orali wa da ta' 5 ml u tazza ta' 30 ml g ad-do a .
English: The half-life of valsartan is 6 hours.
Maltese: Il-half-life ta' valsartan hija 6 sig at.
English: Daily oral dosing of neonatal/juvenile rats (from a postnatal day 7 to postnatal day 70) with valsartan at doses as low as 1 mg/kg/day (about 10-35% of the maximum recommended paediatric dose of 4 mg/kg/day on systemic exposure basis)produced persistent, irreversible kidney damage.
Maltese: Id-do a orali ta' kuljum ta' rieden tat-twelid/ uvenili (minn jum 7 ta' wara li jkunu twieldu sa jum 70) b'do i ta' valsartan li jin lu sa 1 mg/kg/kuljum (madwar 10-35% tad-do a pedjatrika massima rakkomandata ta' 4 mg/kg/kuljum fuq ba i ta' espo izzjoni sistemika) abet mag ha sara persistenti u irreversibbli fil-kliewi.
English: • If you weigh less than 35 kg o the usual dose is 20 mg of valsartan (corresponding to 7 ml of the solution).
Maltese: • Jekk ti en inqas minn 35 kg o id-do a normali hija ta' 20 mg ta' valsartan (li tikkorrispondi ma' 7 ml tassoluzzjoni).
English: • muscle pain (myalgia)
Maltese: • u ig fil-muskoli (majal ja)
English: Dose adjustment is therefore not required in patients with renal impairment (creatinine clearance >10 ml/min).
Maltese: Galhekk mhux metie austament tad-doa f'pazjenti b'indeboliment renali (tneija tal-krejatinina >10 ml/min).
English: Valsartan is primarily eliminated by biliary excretion in faeces (about 83% of dose) and renally in urine (about 13% of dose), mainly as unchanged drug.
Maltese: Valsartan huwa eliminat primarjament permezz ta' eskrezzjoni biljari fl-ippurgar (madwar 83% tad-do a) u renali fl-awrina (madwar 13% tad-do a), l-aktar b ala medi ina mhux mibdula.
English: FIN-02130 Espoo (Tel: + 358-9-6133 22 11)
Maltese: Espoo (Tel: + 358-9-6133 22 11)
English: There is limited clinical experience with Diovan in paediatric patients with mild to moderate hepatic impairment.
Maltese: Te isti esperjenza klinika limitata b'Diovan f'pazjenti pedjatri i b'indeboliment epatiku moderat.
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-pla ma f'kon entrazzjonijiet baxxi (inqas minn 10% ta' l-AUC ta' valsartan).
English: In a double-blind randomized study in 90 children aged 1 to 6 years, which was followed by a oneyear open-label extension, two deaths and isolated cases of marked liver transaminases elevations were observed.
Maltese: Fi studju randomised double-blind fuq 90 tifel u tifla li g andhom bejn sena u 6 snin, li warajh saret estensjoni open-label ta' sena, ew osservati ew ka ijiet ta' mewt u ka ijiet i olati ta' idiet a entwati fil-livelli ta' transaminases tal-fwied.
English: Diovan oral solution contains poloxamer (188) which may cause softened stools.
Maltese: Diovan soluzzjoni orali fiha poloxamer (188) li jista' jikkaw a ppurgar artab.
English: Use in paediatric patients aged 6 to 18 years with hepatic impairment As in adults, Diovan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3, 4.4 and 5.2).
Maltese: U u f'pazjenti pedjatri i b'indeboliment epatiku li g andhom minn 6 sa 18 -il sena B al fl-adulti, Diovan huwa kontraindikat f'pazjenti pedjatri i b'indeboliment epatiku sever, irro i biljari u f'pazjenti bil-kolestasi (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Clinical experience in children at or above 6 years of age In a clinical study involving 261 hypertensive paediatric patients 6 to 16 years of age, patients who weighed <35 kg received 10, 40 or 80 mg of valsartan tablets daily (low, medium and high doses), and patients who weighed 35 kg received 20, 80, and 160 mg of valsartan tablets daily (low, medium and high doses).
Maltese: Esperjenzi klini i fuq tfal li g andhom minn 6 snin ‘il fuq Fi studju kliniku li kien jinkludi 261 pazjent pedjatriku bil-pressjoni g olja f'età ta' bejn 6 u 16 -il sena, dawk il-pazjenti li kienu ji nu <35 kg ir evew 10, 40, jew 80 mg ta' pilloli ta' valsartan kuljum (do i baxxi, medji u g olja), u pazjenti li kienu ji nu ≥35 kg ir evew 20, 80, u 160 mg ta' pilloli ta' valsartan kuljum (do i baxxi, medji u g olja).
English: Nausea, Diarrhoea
Maltese: Tqallig, Dijarea
English: Decrease in haemoglobin, Decrease in haematocrit, Neutropenia, Thrombocytopenia
Maltese: Tnaqqis fl-emoglobina, Tnaqqis fl-ematokrita, Newtropenija, Trombo itopenija
English: Missing information: clinical management and use of pharmacotherapy in paediatric heart failure, paediatric recent myocardial infarction, paediatric hypertension with renal impairment (GFR < 30 mL/min) and paediatric hypertension with mild to moderate hepatic impairment.
Maltese: Informazzjoni nieqsa: estjoni klinika u l-u u tal-farmakoterapija fl-insuffi jenza tal-qalb fit-tfal, infart mijokardijaku re enti fit-tfal, pressjoni g olja fit-tfal b'indeboliment renali (GFR < 30 mL/min) u pressjoni g olja fit-tfal b'indeboliment epatiku moderat.
English: As valsartan is an angiotensin II antagonist, it cannot be excluded that the use of Diovan may be associated with impairment of the renal function.
Maltese: Peress li valsartan huwa antagonist ta' angiotensin II, ma jistax ji i esklu li l-u u ta' Diovan jista' ji i asso jat ma' indeboliment fil-funzjoni renali.
English: Treatment of hypertension in children and adolescents 6 to 18 years of age.
Maltese: Kura ta' pressjoni g olja fit-tfal u l-adolexxenti ta' bejn 6 u 18 -il sena.
English: In a study of 26 paediatric hypertensive patients (aged 1 to 16 years) given a single dose of a suspension of valsartan (mean: 0.9 to 2 mg/kg, with a maximum dose of 80 mg), the clearance (litres/h/kg) of valsartan was comparable across the age range of 1 to 16 years and similar to that of adults receiving the same formulation.
Maltese: Fi studju ta' 26 pazjent pedjatriku bil-pressjoni g olja (f'età ta' bejn sena u 16 -il sena) ew mog tija do a singola ta' sospensjoni ta' valsartan (medja ta' 0.9 sa 2 mg/kg, b'do a massima ta' 80 mg), ittne ija (litri/h/kg) ta' valsartan kienet wa da komparabbli fil-medda tal-età bejn sena u 16 -il sena u simili g al dik ta' adulti li jkunu qed jircievu l-istess formulazzjoni.
English: Diovan 3 mg/ml oral solution can be used to treat high blood pressure in children and adolescents 6 to 18 years of age.
Maltese: Diovan 3 mg/ml ta' soluzzjoni orali jista' jintu a g all-kura ta' pressjoni tad-demm g olja fit-tfal u l-adolexxenti fl-età ta' bejn 6 u 18 -il sena.
English: 1 bottle containing 160 ml oral solution.
Maltese: Flixkun li fih 160 ml ta' soluzzjoni orali.
English: Diovan oral solution contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Maltese: Diovan soluzzjoni orali fiha methyl parahydroxybenzaote li jista' jikkaw a reazzjonijiet aller i i (possibilment tard).
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI G AT-TQEG ID FIS-SUQ [Biex timtela mill-pajji partikolari]
English: It comes with a dispensing kit containing one press in bottle adapter, one 5 ml oral polypropylene dosing syringe and one 30 ml polypropylene dosing cup.
Maltese: Ji i b'sett apposta li fih adapter press-in talflixkun, siringa wada tal-polypropylene gad-doa orali u tazza wada tal-polypropylene ta' 30 ml gad-doa.
English: Valsartan is an orally active, potent, and specific angiotensin II (Ang II) receptor antagonist.
Maltese: Valsartan huwa antagonist qawwi u spe ifiku tar-ri ettur ta' angiotensin II (Ang II) attiv b'mod orali.
English: Overall, the three dose levels of valsartan (low, medium and high) significantly reduced systolic blood pressure by 8, 10, 12 mmHg from the baseline, respectively.
Maltese: B'mod enerali, it-tliet livelli ta' do a ta' valsartan (baxxa, medja u g olja) naqqset sinifikament il-pressjoni tad-demm sistolika bi 8, 10, 12 mm
English: In controlled clinical studies in adult patients with hypertension, the overall incidence of adverse reactions (ADRs) was comparable with placebo and is consistent with the pharmacology of valsartan.
Maltese: Fi studji klini i kkontrollati f'pazjenti adulti bi pressjoni g olja, l-in idenza globali ta' reazzjonijiet avversi (ADRs) kienet komparabbli mal-pla ebo u hija konsistenti mal-farmakolo ija ta' valsartan.
English: Clinical experience in children less than 6 years of age Two clinical studies were conducted in patients aged 1 to 6 years with 90 and 75 patients, respectively.
Maltese: Esperjenza klinika fuq tfal li g andhom inqas minn 6 snin ew imwettqa ew studji klini i fuq pa jenti bejn 1 sena u 6 snin b'90 u 75 pazjent rispettivament.
English: 180 ml amber type III glass bottle with a white child resistant polypropylene cap, including a polyethylene sealing disk and a yellow tamper evident ring, in addition the pack includes one dispensing kit containing one 5 ml oral dosing polypropylene syringe, one press in bottle adapter and one 30 ml polypropylene dosing cup.
Maltese: Flixkun tal- ie ta' 180 ml ta' kulur ambra tat-tip III b'g atu abjad tal- polypropylene li ma jistax jinfeta mit-tfal, inklu disk tas-si ill tal-polyethylene u irku isfar li juri jekk il-flixkun ikunx ie mbabas, barra minn hekk il-pakkett fih sett li jinkludi siringa wa da tal- polypropylene ta' 5 ml g addo a orali,wie ed adapter press-in tal-fliexken u tazza wa da ta' 30 ml g ad-do a .
English: Potential risks: renal impairment, elevation of liver function values, hypersensitivity including angioedema and serum sickness, hemoglobin/hematocrit decreased and medication error including overdose.
Maltese: Riskji identifikati: iperkalimja u pressjoni baxxa Riskji potenzjali: indeboliment renali, ieda fil-valuri tal-funzjoni tal-fwied, sensittività e essiva nklu an joedema u mard fis-serum, tnaqqis flemoglobina/ematokrit u ball fil-medikazzjoni nklu do a e essiv.
English: Patients were randomized to one of 3 doses of valsartan (160, 320 and 640 mg/od) and treated for 30 weeks.
Maltese: Il-pazjenti kienu randomised g al wa da minn 3 do i ta' valsartan (160, 320 u 640 mg/od) u kkurati g al 30 img a.
English: As in adults, Diovan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3 and 5.2).
Maltese: B al fl-adulti, Diovan huwa kontra-indikat f'pazjenti pedjatri i b'indeboliment epatiku sever, irro i biljari u f'pazjenti bil-kolestasi (ara sezzjonijiet 4.3 u 5.2).
English: In this leaflet:
Maltese: Tie ux Diovan:
English: In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (p<0.05) less in patients treated with valsartan than in those treated with an ACE inhibitor (2.6% versus 7.9% respectively).
Maltese: Fi provi klini i fejn valsartan kien imqabbel ma' inibitur ta' ACE, l-in idenza ta' sog la 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: o the usual dose is 40 mg of valsartan (corresponding to 13 ml of the solution).
Maltese: • Jekk ti en 35 kg jew iktar: o id-do a normali hija ta' 40 mg ta' valsartan (li tikkorrispondi g al 13 ml ta' soluzzjoni).
English: • allergic reactions with rash, itching and hives; symptoms of fever, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
Maltese: • jista' jkollok reazzjonjiet aller i i bir-raxx, akk u orriqija, sintomi ta' deni, nef a fil- ogi u ig fil- ogi, u ig fil-muskoli, glandoli tal-limfa minfu a u/jew sintomi li jixb u lill influwenza (sinjali tal-marda tas-serum)
English: The antihypertensive effect of valsartan have been evaluated in four randomized, double-blind clinical studies in 561 paediatric patients from 6 to 18 years of age and 165 paediatric patients 1 to 6 years of age.
Maltese: L-effett ta' kontra l-pressjoni g olja ta' valsartan ew ivalutati f'erba' studji klini i double-blind randomised f'561 pazjent minn 6 sa 18 -il sena u 165 pazjent pedjatriku minn sena sa 6 snin.
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 konklu li 160-320 mg ta' valsartan ipprodu a tnaqqis ta' rilevanza klinika fil-UAE f'pazjent bi pressjoni g olja b'dijabete tat-tip 2.
English: Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day.
Maltese: Valsartan ma kellu l-ebda effetti avversi fuq il-prestazzjoni riproduttiva tal-rieden iriel jew nisa fuq doi orali sa 200 mg/kg/kuljum.
English: The initial dose for the Diovan oral solution is 20 mg (corresponding to 7 ml of the solution) once daily for children below 35 kg of weight and 40 mg (corresponding to 13 ml of the solution) once daily for those weighing 35 kg or more.
Maltese: Id-do a inizzjali g al Diovan soluzzjoni orali hija ta' 20 mg (li tikkorrispondi g al 7 ml tassoluzzjoni) darba kuljum g al tfal li jkunu ji nu inqas minn 35 kg u 40 mg (li tikkorrispondi g al 13 ml ta' soluzzjoni) darba kuljum g al dawk li jkunu ji nu 35 kg jew iktar.
English: • sudden loss of consciousness (syncope)
Maltese: • telf ta' koxjenza f'daqqa (sinkope)
English: • Do not use Diovan after the expiry date which is stated on the pack.
Maltese: • Tu ax Diovan wara d-data ta' skadenza li tidher fuq il-pakkett.
English: Stella-Klein-Löw-Weg 17 A-1020 Wien (Tel: + 43-1-8665 70)
Maltese: Wien (Tel: + 43-1-8665 70)
English: Consistent results were observed for diastolic blood pressure with reductions of 9.1 mmHg and 8.5 mmHg with valsartan and enalapril, respectively.
Maltese: 0001). ew osservati ri ultati konsistenti g al pressjoni tad-demm dijastolika bi tbaxxijiet ta' 9.1 mmHg u 8.5 mmHg b'valsartan u enalapril rispettivament.
English: Metabolism and nutrition disorders Uncommon
Maltese: Disturbi fil-metaboli mu u n-nutrizzjoni Mhux komuni
English: • severely decreased kidney function (signs of acute renal failure)
Maltese: • tnaqqis sever fil-funzjoni tal-kliewi (sinjali ta' insuffi jenza renali akuta)
English: 5.1 Pharmacodynamic properties
Maltese: 5.1 Tag rif farmakodinamiku
English: No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min (see sections 4.2 and 5.2).
Maltese: Ma huwa me tie l-ebda a ustament tad-do a g al pazjenti pedjatri i bi tne ija ta' krejatinina ta' >30 ml/min (ara sezzjonijiet 4.2 u 5.2).
English: The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4).
Maltese: L-u u ta' Antagonisti tar-Ri ettur ta' Angiotensin II (AIIRAs) mhux irrakkomandat waqt l-ewwel trimestru tat-tqala (ara sezzjoni 4.4).
English: Hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Diovan oral solution as it contains sucrose.
Maltese: Intolleranza ereditarja g all-fructose, assorbiment a in ta' glucose-galactose jew insuffi jenza ta' sucrase-isomaltase
English: These effects above mentioned represent an expected exaggerated pharmacological effect of angiotensin converting enzyme inhibitors and angiotensin II type 1 blockers; such effects are observed if rats are treated during the first 13 days of life.
Maltese: Dawn l-effetti hawn imsemmija jirrapre entaw effett farmakolo iku e a erat u mistenni ta' inibituri ta' angiotensin converting enzyme anotensin u mblukkaturi ta' angiotensin II
English: No dose adjustment is required for adult patients with creatinine clearance >10 ml/min (see sections 4.2 and 5.2).
Maltese: L-ebda a ustament tad-do a ma hu me tie g al pazjenti adulti bi tne ija tal-krejatinina ta' >10 ml/min (ara sezzjonijiet 4.2 u 5.2).
English: The safety profile seen in controlled-clinical studies in adult patients with post-myocardial infarction and/or heart failure varies from the overall safety profile seen in hypertensive patients.
Maltese: Il-profil ta' sigurtà osservat fl-istudji klini i kkontrollati f'pazjenti adulti wara infart mijokardijaku u/jew insuffi jenza tal-qalb ivarja mill-profil ta' sigurtà globali osservat f'pazjenti bi pressjoni g olja.
English: Once opened, the bottle can be stored for up to 3 months at temperatures below 30°C.
Maltese: Ladarba jinfeta , il-flixkun jista' ji i ma un sa 3 xhur f'temperaturi ta t 30°C.
English: For children who are unable to swallow tablets, the use of the Diovan oral solution up to 80 mg valsartan (corresponding to 27 ml) is recommended.
Maltese: G at-tfal li ma jkunux jistg u jibilg u pilloli, huwa rakkomadat l-u u ta' Diovan soluzzjoni orali sa 80 mg valsartan (li jikkorrispondi g al 27 ml).
English: HOW TO TAKE DIOVAN
Maltese: KIF TA EN DIOVAN
English: In non-clinical safety studies, high doses of valsartan (200 to 600 mg/kg body weight) caused in rats a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit) and evidence of changes in renal haemodynamics (slightly raised plasma urea, and renal tubular hyperplasia and basophilia in males).
Maltese: Fi studji mhux klini i dwar is-sigurtà, do i g olja ta' valsartan (200 sa 600 mg/kg pi tal- isem) ikkaw aw tnaqqis fil-parametri ta' elluli omor tad-demm fil-firien (eritro iti, emoglobina, ematokrita) u evidenza ta' bidliet fl-emodinamika renali (urea fil-pla ma kemmxejn mi juda, u iperplasija tubulari renali u ba ofilja fl-ir iel).
English: Cough
Maltese: MHUX
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 g andha titwaqqaf minnufih, u, jekk xieraq, g andha tinbeda terapija alternattiva (ara sezzjonijiet 4.3 u 4.6).
English: Short-term administration of Diovan to twelve patients with renovascular hypertension secondary to unilateral renal artery stenosis did not induce any significant changes in renal haemodynamics, serum creatinine, or blood urea nitrogen (BUN).
Maltese: L-g oti g al tul ta' mien qasir ta' Diovan lil 12-il pazjent bi pressjoni g olja renovaskulari sekondarja g al stenosi unilaterali ta' l-arterja renali ma kkaw a l-ebda bidliet sinifikanti flemodinamika renali, fil-krejatinina fis-serum jew fin-nitrogen fid-demm mill-urea (BUN).
English: For all the ADRs reported from post-marketing experience and laboratory findings, it is not possible to apply any ADR frequency and therefore they are mentioned with a "not known" frequency.
Maltese: G all-ADRs kollha rrapportati mill-esperjenza ta' wara t-tqeg id fis-suq u mis-sejbiet tal-laboratorju, l-frekwenza ta' l-ADR mhux possibli li ti i applikata u g alhekk huma msemmija bi frekwenza "mhux mag rufa ".
English: The dose should be adjusted based on blood pressure response up to a maximum dose of 80 mg valsartan (corresponding to 27 ml of the solution).
Maltese: Id-do a g andha ti i a ustata skont ir-rispons mill-pressjoni tad-demm sa do a massima ta' 80 mg valsartan (li tikkorrispondi g al soluzzjoni ta' 27 ml).