FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours-10 days) myocardial infarction (see sections 4.4 and 5.1).
Maltese: Kura ta' pazjenti klinikament stabbli li għandhom insuffiċjenza sintomatika tal-qalb jew disfunzjoni sistolika mhux sintomatika tal-ventriklu tax-xellug wara infart mijokardijaku reċenti (12-il siegħagħaxart ijiem) (ara sezzjonijiet 4.4 u 5.1).
English: Hard gelatine capsules
Maltese: Kapsuli iebsa tal-ġelatina orali
English: • Do not use Diovan after the expiry date which is stated on the pack.
Maltese: • Tużax Diovan wara d-data ta' skadenza li tidher fuq il-pakkett.
English: “Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours - 10 days) myocardial infarction”
Maltese: “Kura ta' pazjenti klinikament stabbli b'indeboliment sintomatiku tal-qalb jew b'disfunzjoni sistolika ventrikolari tax-xellug asintomatika wara infart mijokardijaku riċenti (12-il siegħa - 10 ijiem)”
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-doża) u renali fl-awrina (madwar 13% tad-doża), l-aktar bħala mediċina mhux mibdula.
English: Musculoskeletal and connective tissue disorders Not known
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue Mhux magħrufa
English: • to treat symptomatic heart failure.
Maltese: .9 Doża eċċessiva Sintomi
English: Therefore the MAH should address the lack of (additional) clinical benefit and increased adverse events In conclusion; the CHMP adopts the revised text: “The recommended starting dose of Diovan is 40 mg twice daily.
Maltese: Bħala konklużjoni; il-CHMP jadotta t-test rivedut: “Id-doża rakkomandata tal-bidu ta' Diovan hija 40 mg darbtejn kuljum.
English: AUC and Cmax values of valsartan are almost proportional with increasing dose over the clinical dosing range (40 to 160 mg twice a day).
Maltese: Il-valuri ta' l-AUC u Cmax ta' valsartan huma kważi proporzjonali ma' żjieda fid-doża tul il-firxa ta' dożaġġ kliniku (40 sa 160 mg darbtejn kuljum).
English: Excretion:
Maltese: Pożoloġija:
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Maltese: Jekk it-taħlita tkun neċessarja, hija rrakkomandata sorveljanza b'attenzjoni tal-livelli ta' lithium fis-serum.
English: Elevation of liver function values including increase of serum bilirubin
Maltese: Żjieda fil-valuri tal-funzjoni tal-fwied inkluż żjieda fil-bilirubin fis-serum
English: Nausea, Diarrhoea
Maltese: Tqalligħ, Dijarea
English: The dosing schedule for the therapeutic use of valsartan in heart failure was based on the Val-HeFT study.
Maltese: Prova ta' Indeboliment tal-Qalb ta' Valsartan (Val-HeFT).
English: Each capsule contains 80 mg valsartan.
Maltese: Kull kapsula fiha 80 mg valsartan.
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 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: Diovan 160 mg capsules, hard can be used for three different conditions:
Maltese: Diovan 160 mg kapsuli, iebsa jista' jintuża għal tliet kundizzjonijiet differenti:
English: The CHMP considered the VALIANT study which demonstrated that valsartan given as monotherapy is at least as effective as captopril given as monotherapy in the reduction of total mortality after an acute myocardial infarction.
Maltese: Il-CHMP ikkunsidra l-istudju VALIANT li wera li valsartan meta mogħti bħala monoterapija huwa għallinqas effettiv daqs captopril meta mogħti bħala monoterapija fit-tnaqqis tal-mortalità totali wara infart mijokardijaku akut.
English: The CHMP proposed wording has been accepted by the MAH.
Maltese: Il-formolazzjoni proposta tal-CHMP ġiet aċċettata mill-MAH.
English: The combination with ACE inhibitors is not recommended (see sections 4.4 and 5.1).
Maltese: It-taħlita ma' inibituri ta' ACE mhux irrakkomandata (ara sezzjonijiet 4.4 u 5.1).
English: The therapeutic indication for heart failure is supported primarily by a large long-term morbidity trial Valsartan Heart Failure Trial (Val-HeFT) Valsartan reduced the risk related to first morbid event, mortality, the total number of Heart Failure (HF) hospitalizations.
Maltese: Valsartan naqqas irriskju relatat mal-ewwel episodju tal-morbidità, il-mortalità, in-numru totalità ta' żjarat l-isptar minħabba Indeboliment tal-Qalb (HF).
English: Diovan and associated names (see Annex I) 40 mg film-coated tablets Diovan and associated names (see Annex I) 40 mg capsules, hard Diovan and associated names (see Annex I) 80 mg film-coated tablets Diovan and associated names (see Annex I) 80 mg capsules, hard Diovan and associated names (see Annex I) 160 mg film-coated tablets Diovan and associated names (see Annex I) 160 mg capsules, hard Diovan and associated names (see Annex I) 320 mg film-coated tablets [See Annex I -To be completed nationally] Valsartan
Maltese: Diovan u ismijiet assoċjati miegħu (Ara Anness I) 40 mg pilloli miksija b'rita Diovan u ismijiet assoċjati miegħu (Ara Anness I) 40 mg kapsuli, iebsa Diovan u ismijiet assoċjati miegħu (Ara Anness I) 80 mg pilloli miksija b'rita Diovan u ismijiet assoċjati miegħu (Ara Anness I) 80 mg kapsuli, iebsa Diovan u ismijiet assoċjati miegħu (Ara Anness I) 160 mg pilloli miksija b'rita Diovan u ismijiet assoċjati miegħu (Ara Anness I) 160 mg kapsuli, iebsa Diovan u ismijiet assoċjati miegħu (Ara Anness I) 320 mg pilloli miksija b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] Valsartan
English: Treatment of symptomatic heart failure when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1).
Maltese: Kura ta' insuffiċjenza sintomatika tal-qalb meta inibituri ta' Angiotensin Converting Enzyme (ACE) ma jistgħux jiġu wżati, jew bħala terapija miżjuda ma' inibituri ta' ACE meta mblokkaturi tar-riċetturi beta ma jistgħux jiġu wżati (ara sezzjonijiet 4.4 u 5.1).
English: Other conditions with stimulation of the renin-angiotensin system In patients whose renal function may depend on the activity of the renin-angiotensin 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 and/or death.
Maltese: Kundizzjonijiet oħra bi stimulazzjoni tas-sistema renin-angiotensin F'pazjenti li l-funzjoni renali tagħhom tista' tiddependi fuq l-attività tas-sistema renin-angiotensin (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 u/jew mewt.
English: Diovan and associated names (see Annex I) 80 mg capsules, hard Valsartan
Maltese: Diovan u ismijiet assoċjati miegħu (Ara Anness I) 80 mg kapsuli, iebsa Valsartan
English: -Second and third trimester of pregnancy (see sections 4.4 and 4.6).
Maltese: -It-tieni jew it-tielet trimestru tat-tqala (ara sezzjonijiet 4.4 u 4.6).
English: Evaluation of patients with heart failure should always include assessment of renal function (see section 4.2).
Maltese: Valutazzjoni ta' pazjenti wara infart mijokardijaku għandha dejjem tinkludi valutazzjoni tal-funzjoni renali (ara sezzjoni 4.2).
English: • unusual bleeding or bruising (signs of thrombocytopenia)
Maltese: • fsada jew tbenġil mhux tas-soltu (sinjali ta' tromboċitopenija)
English: In some cases your doctor may prescribe higher doses (e.g. 160 mg or 320 mg).
Maltese: F'xi każijiet it-tabib tiegħek jista' jippreskrivi dożi ogħla (eż. 160 mg jew 320 mg).
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-għoti għal tul ta' żmien qasir ta' Diovan lil 12-il pazjent bi pressjoni għolja renovaskulari sekondarja għal stenosi unilaterali ta' l-arterja renali ma kkawża l-ebda bidliet sinifikanti flemodinamika renali, fil-krejatinina fis-serum jew fin-nitrogen fid-demm mill-urea (BUN).
English: Regarding renal impairment, the use of valsartan 80 mg as the starting dose, with no dosage adjustment, in patients with reduced renal function (creatinine clearance rate >10 ml/min) is supported by both efficacy and safety data from Study 27 and by pharmacokinetic data from Study 12.
Maltese: Fir-rigward tal-indeboliment tal-kliewi, l-użu ta' valsartan 80 mg bħala d-doża tal-bidu, mingħajr aġġustament fid-dożaġġ, f'pazjenti b'funzjoni renali mnaqqsa (rata ta' eliminazzjoni tal-kreatinina > 10 ml/min) hija appoġġjata minn dejta kemm tal-effikaċja kif ukoll tas-sigurtà minn Studju 27 u minn dejta farmakokinetika minn Studju 12.
English: Diovan and associated names (see Annex I) 40 mg capsules, hard Valsartan
Maltese: Diovan u ismijiet assoċjati miegħu (Ara Anness I) 40 mg kapsuli, iebsa Valsartan
English: Pharma Nagano III.
Maltese: Ir-Repubblika Ċeka NOVARTIS s.r.o. Pharma Nagano III.
English: Diovan and associated names (see Annex I) 160 mg capsules, hard Valsartan
Maltese: Diovan u ismijiet assoċjati miegħu (Ara Anness I) 160 mg kapsuli, iebsa Valsartan
English: The use of AIIRAs is contra-indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Maltese: L-użu ta' AIIRAs huwa kontra-indikat waqt it-tieni u t-tielet trimestru tat-tqala (ara sezzjonijiet 4.3 u 4.4).
English: Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Maltese: Barra dan, l-użu ta' antagonisti ta' angiotensin II flimkien ma' NSAIDs jista' jwassal għal żjieda fir-riskju ta' rkadar tal-funzjoni renali u żjieda fil-potassium fis-serum.
English: The CHMP considered it acceptable to remove this contraindication, as the primary route of elimination of valsartan is via biliary route and renal clearance accounts for less than 30% of plasma clearance.
Maltese: Il-CHMP qies li jkun aċċettabbli li din il-kontra-indikazzjoni titneħħa, minħabba li r-rotta primarja ta' eliminazzjoni ta' valsartan hija permezz tar-rotta biljari u l-eliminazzjoni mill-kliewi tammonta għal inqas minn 30% tal-eliminazzjoni mill-plasma.
English: This indication was approved in all Member States and the CHMP adopted the following wording:
Maltese: Din l-indikazzjoni ġiet approvata fl-Istati Membri kollha u l-CHMP adotta lformolazzjoni li ġejja:
English: Diovan and associated names (see Annex I) 320 mg film-coated tablets Valsartan
Maltese: Diovan u ismijiet assoċjati miegħu (Ara Anness I) 320 mg pilloli miksija b'rita Valsartan
English: The CHMP considered that the elimination of valsartan at steady-state is similar in patients with renal impairment when compared with healthy volunteers and adopted the following wording: “No dosage adjustment is required for patients with a creatinine clearance >10 ml/min.”
Maltese: Il-CHMP qies li l-eliminazzjoni ta' valsartan b'rata fissa hija simili f'pazjenti b'indeboliment renali meta mqabbla ma' voluntiera b'saħħithom u adotta l-formolazzjoni li ġejja: “Ebda aġġustament fid-dożaġġ ma huwa meħtieġ għal pazjenti b'eliminazzjoni tal-kreatinina >10 ml/min.”
English: Diovan and associated names (see Annex I) 320 mg film-coated tablets Valsartan [See Annex I - To be completed nationally]
Maltese: Diovan u ismijiet assoċjati miegħu (Ara Anness I) 320 mg pilloli miksija b'rita Valsartan [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Valsartan is an orally active, potent, 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: These doses in rats (200 and 600 mg/kg/day) are approximately 6 and 18 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Maltese: Fil-firien dawn id-dożi (200 sa 600 mg/kg/kuljum) huma madwar 6 u 18-il darba ogħla mid-doża massima rrakkomandata fil-bniedem fuq bażi ta' mg/m2 (kalkulazzjonijet jassumu doża orali ta' 320 mg/kuljum u pazjent ta' 60-kg).
English: Diovan is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE inhibitors when beta blockers (another medication to treat heart failure)
Maltese: Diovan jintuża meta grupp ta' mediċini msejħa inibituri ta' Angiotensin Converting Enzyme (ACE) (medikazzjoni għall-kura ta' insuffiċjenza tal-qalb) ma jistgħux jiġu wżati jew jista' jintuża flimkien ma' inibituri ta' ACE meta imblokkaturi tar-riċetturi beta (medikazzjoni oħra għall-kura ta' insuffiċjenza tal-qalb) ma jistgħux jiġu wżati.
English: “Treatment of essential hypertension”
Maltese: “Trattament ta' pressjoni għolja essenzjali”
English: -Hypersensitivity to the active substance or to any of the excipients.
Maltese: -Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi.
English: No dosage adjustment is required for patients with a creatinine clearance >10 ml/min (see sections 4.4 and 5.2)
Maltese: L-ebda aġġustament fid-doża ma huwa meħtieġ f'pazjenti bi tneħħija tal-krejatinina ta' >10 ml/min (ara sezzjonijiet 4.4 u 5.2).
English: Diovan and associated names (see Annex I) 80 mg film-coated tablets Valsartan
Maltese: Diovan u ismijiet assoċjati miegħu (Ara Anness I) 80 mg pilloli miksija b'rita Valsartan
English: Combining valsartan with captopril did not add further benefit over captopril alone.
Maltese: Taħlita ta' valsartan ma' captopril ma żiditx aktar benefiċċju fuq captopril waħdu.
English: The potential for hepatic function per se to affect the kinetics of valsartan is therefore limited, except in the case of biliary obstruction or cholestatic liver disease (defined as an alkaline phosphatase concentration > 2 X Upper Limit of Normal).
Maltese: Il-potenzjal għall-funzjoni tal-fwied fih innifsu li jaffettwa l-kinetiċi ta' valsartan huwa għalhekk limitat, għajr fil-każ ta' ostruzzjoni biljari jew marda tal-fwied kolestatika (definita bħala konċentrazzjoni ta' alkaline phosphatase > 2 X il-Limitu ta' Fuq tan-Normal).
English: In patients whose renal function may depend on the activity of the renin-angiotensin 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 and/or death.
Maltese: F'pazjenti li l-funzjoni renali tagħhom tista' tiddependi fuq l-attività tas-sistema renin-angiotensin (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 u/jew mewt.
English: Exposure to valsartan is not correlated with the degree of liver dysfunction, although the presence of liver disease tended to increase the valsartan plasma AUC.
Maltese: Esponiment għal valsartan mhuwiex korrelatat mal-grad ta' disfunzjoni tal-fwied, għalkemm ilpreżenza tal-marda tal-fwied kellha t-tendenza li żżid l-AUC tal-plasma ta' valsartan.
English: In hypertensive patients with type 2 diabetes and microalbuminuria, valsartan has been shown to reduce the urinary excretion of albumin.
Maltese: L-istudju MARVAL (Micro Albuminuria Reduction with Valsartan)
English: Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Maltese: Dijuretiċi li ma jitilfux potassium, supplimenti ta' potassium, sostitwenti tal-melħ li fihom il-potassium u sustanzi oħra li jistgħu jżidu l-livelli tal-potassium.
English: The main discussion for this section concerned the presentation of ADRs in the SPC.
Maltese: Id-diskussjoni ewlenija għal din is-sezzjoni kellha x'taqsam mal-preżentazzjoni ta' ADRs fl-SPC.
English: Each film-coated tablet contains 320 mg valsartan.
Maltese: Kull pillola miksija b'rita fiha 320 mg valsartan.
English: Metabolism and nutrition disorders Not known
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux magħrufa
English: Valsartan does not undergo extensive biotransformation and 70% of the available dose is excreted.
Maltese: Valsartan ma jgħaddix minn bijotrasformazzjoni estensiva u 70% tad-doża disponibbli tiġi eliminata mill-ġisem.
English: After an initial dose of 20 mg twice daily, valsartan should be titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few weeks.
Maltese: Wara doża tal-bidu ta' 20 mg darbtejn kuljum, valsartan għandu jiġi ttitrat għal 40 mg, 80 mg, u 160 mg darbtejn kuljum fuq il-ftit ġimgħat ta' wara.
English: Post-myocardial infarction and/or heart failure
Maltese: Wara infart mijokardijaku u/jew insuffiċjenza tal-qalb
English: Diovan 80 mg capsules, hard can be used for three different conditions:
Maltese: Diovan 80 mg kapsuli, iebsa jista' jintuża għal tliet kundizzjonijiet differenti:
English: Patients treated with valsartan had a better quality of life as demonstrated by change in the Minnesota Living with Heart Failure Quality of Life score from baseline at endpoint than placebo.
Maltese: Pazjenti kkurati b'valsartan kellhom kwalità ta' ħajja aħjar kif muri millbidla fil-punteġġ Minnesota Living with Heart Failure Quality of Life mil-linja bażi fir-riżultat tattmiem meta mqabbel mal-plaċebo.
English: Diovan and associated names (see Annex I) 160 mg film-coated tablets Valsartan
Maltese: Diovan u ismijiet assoċjati miegħu (Ara Anness I) 160 mg pilloli miksija b'rita Valsartan
English: Caution should be observed when initiating therapy in post-myocardial infarction patients.
Maltese: Għandu jkun hemm kawtela meta tinbeda terapija f'pazjenti li kellhom infart mijokardijaku.
English: The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4).
Maltese: L-użu ta' Antagonisti tar-Riċettur ta' Angiotensin II (AIIRAs) mhux irrakkomandat waqt l-ewwel trimestru tat-tqala (ara sezzjoni 4.4).
English: Valsartan may be administered with other heart failure therapies.
Maltese: Valsartan jista' jingħata ma' terapiji oħrajn ta' indeboliment tal-qalb.
English: Each film-coated tablet contains 80 mg valsartan.
Maltese: Kull pillola miksija b'rita fiha 80 mg valsartan.
English: Results appearing to favour placebo (composite mortality and morbidity was 21.9% in placebo vs. 25.4% in valsartan group) were observed for those patients receiving the triple combination of an ACE inhibitor, a beta blocker and valsartan.
Maltese: Riżultati li jidrhu jiffavorixxu plaċebo (mortalità u morbidità komposta kienu 21.9% fil-plaċebo vs. 25.
English: • allergic reaction with symptoms such as rash, itching, dizziness, swelling of face or lips or tongue or throat, difficulty breathing or swallowing (signs of angioedema)
Maltese: • raxx, ħakk, flimkien ma' wħud mis-sinjali jew sintomi li ġejjin: deni, uġigħ fil-ġogi, uġigħ filmuskoli, glandoli tal-limfa minfuħa u/jew sintomi li jixbħu lill-influwenza (sinjali tal-marda tasserum)
English: In the overall Val-HeFT population, valsartan treated patients showed significant improvement in NYHA class, and heart failure signs and symptoms, including dyspnoea, fatigue, oedema and rales compared to placebo.
Maltese: Val-HeFT, pazjenti kkurati b'valsartan urew titjib sinifikanti fil-klassi ta' NYHA, u fis-sinjali u sintomi ta' insuffiċjenza tal-qalb, inkluż qtugħ ta' nifs, għeja, edima u tħarħir meta mqabbel mal-plaċebo.
English: Acute renal failure, Elevation of serum creatinine
Maltese: Insuffiċjenza renali akuta , Żjieda fil-krejatinina fis-serum
English: He may also combine Diovan with an additional medicine (e.g. a diuretic).
Maltese: Huwa jista' wkoll jikkombina Diovan ma' mediċina oħra (eż. dijuretiku).
English: You obtain the 20 mg dose by dividing the 40 mg tablet.
Maltese: Inti tikseb id-doża ta' 20 mg billi taqsam il-pillola ta' 40 mg.
English: The safety profile seen in controlled-clinical studies in 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 kliniċi kkontrollati f'pazjenti wara infart mijokardijaku u/jew insuffiċjenza tal-qalb ivarja mill-profil ta' sigurtà globali osservat f'pazjenti bi pressjoni għolja.
English: Uptitration to 80 mg and 160 mg twice daily should be done at intervals of at least two weeks to the highest dose, as tolerated by the patient.
Maltese: Titrazzjoni 'l fuq sa 80 mg u 160 mg darbtejn kuljum għandha ssir f'intervalli ta' mill-inqas ġimagħtejn sal-ogħla doża, kif ittollerata mill-pazjent.
English: Renal failure and impairment, Elevation of serum creatinine General disorders and administration site conditions Uncommon
Maltese: Insuffiċjenza u indeboliment renali, Żjieda filkrejatinina fis-serum Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Mhux komuni
English: • purplished-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)
Maltese: • ponot ħomor fil-vjola, deni, ħakk (sinjali ta' infjammazzjoni tal-vini u l-arterji msejħa vaskulite)
English: Use of Diovan in patients with heart failure commonly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed (see section 4.2).
Maltese: L-użu ta' Diovan f'pazjenti wara infart mijokardijaku b'mod komuni jwassal għal xi tnaqqis filpressjoni tad-demm, iżda twaqqif tat-terapija minħabba pressjoni baxxa sintomatika li tippersisti ġeneralment ma jkunx neċessarju dejjem jekk jiġu segwiti l-istruzzjonijiet dwar id-dożaġġ (ara sezzjoni 4.2).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Maltese: Informazzjoni li mhux klinika, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni u riskju ta' kanċer, ma turi l-ebda periklu speċjali għall-bnedmin.
English: The wording proposed by the MAH in the SPC was acceptable to the CHMP and the following wording was adopted: “In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4).”
Maltese: “F'pazjenti b'indeboliment tal-fwied ħafif għal moderat mingħajr kolestażi, id-doża ta' valsartan ma għandhiex taqbeż 80 mg (ara sezzjoni 4.4).”
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: Għall-ADRs kollha rrapportati mill-esperjenza ta' wara t-tqegħid fis-suq u mis-sejbiet tal-laboratorju, l-frekwenza ta' l-ADR mhux possibli li tiġi applikata u għalhekk huma msemmija bi frekwenza "mhux magħrufa ".
English: Valsartan does not inhibit ACE (also known as kininase II) which converts Ang I to Ang II and degrades bradykinin.
Maltese: Valsartan ma jinibixxix ACE (magħruf ukoll bħala kininase II) li jaqleb Ang I għal Ang II u jiddegrada bradykinin.
English: Each film-coated tablet contains 160 mg valsartan.
Maltese: Kull pillola miksija b'rita fiha 160 mg valsartan.