FrancophonIA/ELRC3.0 huggingface dataset:
English: The full European Public Assessment Report for Avastin can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Ir-Rapport sħiħ ta' Valutazzjoni Pubblika Ewropew għal Avastin jista' jinstab fis-sit elettroniku talAġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is Avastin?
Maltese: X'inhu Avastin?
English: Avastin has been authorised in the EU since 12 January 2005.
Maltese: Avastin ilu awtorizzat fl-UE mit-12 ta' Jannar 2005.
English: Avastin is a cancer medicine that contains the active substance bevacizumab.
Maltese: Avastin huwa mediċina tal-kanċer li fiha s-sustanza attiva bevacizumab.
English: On 22 May 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Avastin.
Maltese: Fit-22 ta' Mejju 2014, il-Kumitat għall-Prodotti Meċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li tirrakkomanda r-rifjut ta' bidla fl-awtorizzazzjoni għat-tqegħid fis-suq tal-prodott mediċinali Avastin.
English: It is used, in combination with other chemotherapy medicines (medicines to treat cancer), to treat certain types of the following cancers: cancer of the colon or rectum (large intestine); breast cancer; lung cancer; kidney cancer; cancer of the ovary; cancer of the fallopian tube or the peritoneum (the membrane lining the abdomen).
Maltese: Jintuża flimkien ma' mediċini oħrajn talkemoterapija (mediċini għall-kura tal-kanċer), biex jikkura ċerti tipi tal-kanċers li ġejjin: kanċer talkolon jew tar-rektum (il-musrana l-kbira); kanċer tas-sider; kanċer tal-pulmun; kanċer tal-kliewi; kanċer tal-ovarji; kanċer tat-tubu fallopjan jew tal-peritonju (il-membrana li tiksi l-istonku).
English: The active substance in Avastin, bevacizumab, is a monoclonal antibody (a type of protein), that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that
Maltese: Is-sustanza attiva f'Avastin, bevacizumab, hija antikorp monoklonali (tip ta' proteina), li ġie mfassal sabiex jirrikonoxxi u jeħel mal-fattur ta' tkabbir endoteljali vaskulari (VEGF), proteina li tiċċirkola fid
English: Refusal of a change to the marketing authorisation for Avastin (bevacizumab)
Maltese: Avastin (bevacizumab)
English: Avastin was also expected to be used to treat adult patients with newly diagnosed glioblastoma in combination with radiotherapy (treatment with radiation) and temozolomide (another cancer medicine).
Maltese: Avastin kien mistenni li jintuża wkoll għall-kura ta' pazjenti adulti li jkunu għadhom kemm ġew iddijanjostikati bi glijoblastoma flimkien mar-radjuterapija (kura bir-radjazzjoni) u ma' temozolomide (mediċina oħra kontra l-kanċer).
English: What was Avastin expected to be used for?
Maltese: Għal x'hiex kien mistenni li jintuża Avastin?
English: Although there was an improvement in progression-free survival, it could not be considered clinically relevant because of limitations in the methods available to measure the size of brain tumours.
Maltese: Għalkemm kien hemm xi titjib fissopravivenza mingħajr progress, ma setax jitqies li dan kien klinikament rilevanti minħabba llimitazzjonijiet fil-metodi disponibbli għall-kejl tad-daqs tat-tumuri fil-moħħ.
English: The company presented the results from one main study with Avastin involving 921 patients with newly diagnosed glioblastoma.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studju ewlieni b'Avastin li kien jinvolvi 921 pazjent li kienu għadhom kemm ġew iddijanjostikati bi glijoblastoma.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 September 2014.
Maltese: Wara li kkunsidra r-raġunijiet għal din ittalba, is-CHMP eżamina mill-ġdid l-opinjoni inizjali u kkonferma r-rifjut tal-bilda fl-awtorizzazzjoni għattqegħid fis-suq fit-22 ta' Settembru 2014.
English: The company informed the CHMP that there are no consequences for patients with glioblastoma receiving Avastin in clinical trials: patients will continue to receive Avastin in the on-going and future clinical trials.
Maltese: Il-kumpanija infurmat lis-CHMP li ma hemm l-ebda konsegwenza għall-pazjenti bi glijoblastoma li qegħdin jingħataw Avastin fil-provi kliniċi: il-pazjenti sejrin ikomplu jingħataw Avastin fil-provi kliniċi li għaddejjin bħalissa u dawk futuri.
English: The change concerned an extension of indication to add treatment of glioblastoma (an aggressive type of brain cancer).
Maltese: (tip ta' kanċer tal-moħħ aggressiv).
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Avastin in the treatment of newly diagnosed glioblastoma did not outweigh its risks.
Maltese: Għaldaqstant, is-CHMP sostna r-rakkomandazzjoni preċedenti tiegħu li l-bidla flawtorizzazzjoni għat-tqegħid fis-suq għandha tiġi rrifjutata.
English: --1 Porcine circovirus type 2 ORF2 subunit antigen ≥4.5 log2 ELISA units* * Antibody titre obtained according to the in vivo potency test in chickens
Maltese: --1 Porcine circovirus tip 2 ORF2 subunit antigen ≥4.5 log2 ELISA units* *Titolu tal-antikorpi miksub minn testijiet ta' potenza in vivo fil-flieles.
English: Packaging Content Package size
Maltese: Ipakkjar Kontenut Daqs talpakkett
English: MA (EU) number
Maltese: MA (EU) numru Isem ivvintat
English: Invented name
Maltese: 1 fjala
English: 160 mg 80 kg to 160 kg 320 mg
Maltese: 160 mg 80 kg sa 160 kg 320 mg
English: Member State EU/EEA
Maltese: UE/EE
English: 18 kg to <35 kg
Maltese: 18 kg sa <35 kg
English: Laboratório Normal-Produtos Farmacêuticos, Lda Rua do Centro Empresarial, Edificio 8 Quinta da Beloura
Maltese: Laboratório Normal-Produtos Farmacêuticos, Lda Rua do Centro Empresarial,
English: The average accumulation factor is about 1.7.
Maltese: Il-fattur medju ta' akkumulazzjoni huwa madwar 1.7.
English: 35 kg to <80 kg
Maltese: 35 kg sa <80 kg
English: Mean absolute bioavailability is 23% and 39% with tablets and solution formulation, respectively.
Maltese: Ilbijodisponibiltà assoluta medja hija ta' 23% u 39% bil-pilloli bil-formulazzjoni tas-soluzzjoni rispettivament.
English: Baseline therapy included ACE inhibitors (93%), diuretics (86%), digoxin (67%) and beta blockers (36%).
Maltese: Terapija fil-linja ba i kienet tinkludi inibituri ta' ACE (93%), dijureti i (86%), digoxin (67%) u imblokkaturi tar-ri etturi beta (36%).
English: Adverse 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), including isolated reports.
Maltese: Ir-reazzjonijet avversi huma mni la skond il-frekwenza, bl-aktar frekwenti l-ewwel, bl-u u talkonvenzjoni li ejja: komuni afna ( 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 afna (<1/10,000), inklu rapporti iolati.
English: All-cause mortality was similar in the valsartan (19.9%), captopril (19.5%), and valsartan + captopril (19.3%) groups.
Maltese: Mortalità minn kull kaw a kienet simili fil-gruppi ta' valsartan (19.9%), captopril (19.5%), u valsartan + captopril (19.3%).
English: Children and adolescents 6 to 18 years of age
Maltese: Tfal u adolexxenti f'età ta' bejn 6 u 18-il sena
English: Reductions in systolic blood pressure were comparable in patients receiving valsartan (15 mmHg) and enalapril (14 mm Hg) (non-inferiority p-value <0.0001).
Maltese: It-tbaxxijiet fil-pressjoni tad-demm g olja kienu paragunabbli ma' pazjenti li r evew valsartan (15 mmHg) u enalapril (14 mm Hg) (non inferiority pvalue <0.
English: FIN-02130 Espoo (Tel: + 358-9-6133 22 11)
Maltese: Espoo Finland (Tel: + 358-9-6133 22 11)
English: Composite mortality and morbidity risk was significantly reduced by 18.3% (95% CI: 8% to 28%) with valsartan compared with placebo (31.0% vs. 36.3%).
Maltese: Ir-riskju ta' mortalità u morbidità komposta kien imnaqqas b'mod sinifikanti bi 18.3% (95% CI: 8% sa 28%) b'valsartan meta mqabbel mal-pla ebo (31.0% vs. 36.3%).
English: The apparent clearance of valsartan following oral administration is approximately 4.5 l/h.
Maltese: It-tne ija apparenti ta' valsartan wara g oti orali hija madwar 4.5 l/h.
English: Provas 40 mg 40 mg
Maltese: Provas 40 mg
English: Discontinuations due to various types of renal dysfunction occurred in 1.1% of valsartan-treated patients, 1.3% in valsartan+captopril patients, and 0.8% of captopril patients.
Maltese: Twaqqif min abba tipi differenti ta' disfunzjoni renali se f'1.1% tal-pazjenti kkurati b'valsartan, f'1.3% tal-pazjenti kkurati b'valsartan+captopril, u f'0.8% talpazjenti kkurati b'captopril.
English: Provas 80 mg 80 mg
Maltese: Provas 80 mg
English: The mean daily dose of Diovan in Val-HeFT was 254 mg.
Maltese: Id-do a medja ta' kuljum ta' Diovan f'Val-HeFT kienet ta' 254 mg.
English: Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid >3 g/day), and non-selective NSAIDs
Maltese: Medi ini anti-infjammatorji mhux sterojdi (NSAIDs), inklu inibituri selettivi ta' COX-2, acetylsalicylic acid >3 g/kuljum, u NSAIDs mhux selettivi Meta antagonisti ta' angiotensin II jing ataw flimkien ma' NSAIDs, jista' jkun hemm tnaqqis taleffett li jbaxxi l-pressjoni.
English: All cause mortality was similar (p=NS) in the valsartan (19.7%) and placebo (19.4%) groups.
Maltese: Mortalità minn kull kaw a kienet simili (p=NS) fil-gruppi ta' valsartan (19.7%) u tal-pla ebo (19.4%).
English: • certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
Maltese: • ertu tip ta' pilloli li jmewtu l-u ig imsej a medi ini anti-infjammatorji mhux sterojdi (NSAIDs).
English: Regarding renal function, doubling of serum creatinine was observed in 4.2% of valsartan-treated patients, 4.8% of valsartan+captopril-treated patients, and 3.4% of captopril-treated patients.
Maltese: Dwar il-funzjoni renali, irduppjar tal-krejatinina fis-serum kien osservat f'4.2% tal-pazjenti kkurati b'valsartan, f'4.8% tal-pazjenti kkurati b'valsartan+captopril, u fi 3.4% tal-pazjenti kkurati b'captopril.
English: The half-life of valsartan is 6 hours.
Maltese: Il-half-life ta' valsartan hija 6 sigat.
English: Rixil 320 mg 320 mg
Maltese: Rixil 320 mg
English: There is limited clinical experience with Diovan in paediatric patients with mild to moderate hepatic impairment.
Maltese: Teisti esperjenza klinika limitata b'Diovan f'pazjenti pedjatri i b'indeboliment epatiku moderat.
English: The VALsartan In Acute myocardial iNfarcTion trial (VALIANT) was a randomised, controlled, multinational, double-blind study in 14,703 patients with acute myocardial infarction and signs, symptoms or radiological evidence of congestive heart failure and/or evidence of left ventricular systolic dysfunction (manifested as an ejection fraction 40% by radionuclide ventriculography or 35% by echocardiography or ventricular contrast angiography).
Maltese: In Acute myocardial iNfarcTion (VALIANT) kienet studju randomised, ikkontrollat, multinazzjonali u double-blind f'14,703 pazjenti b'infart mijokardijaku akut u sinjali, sintomi jew evidenza radjolo ika ta' insuffi jenza kon estiva tal-qalb u/jew disfunzjoni sistolika talventriklu tax-xellug (manifestata b ala frazzjoni ta' tfig 'il barra ta' 40% permezz ta' radionuclide ventriculography jew ta' 35% permezz ta' ekukardjografija jew an jografija ventrikulari b'kuntrast).
English: Provas 320 mg 320 mg
Maltese: Provas 320 mg
English: Rixil 40 mg 40 mg
Maltese: Rixil 40 mg
English: Rua do Centro Empresarial, Edificio 8 Quinta da Beloura
Maltese: Quinta da Beloura
English: Provas 160 mg 160 mg
Maltese: Provas 160 mg
English: Rixil 160 mg 160 mg
Maltese: Rixil 160 mg
English: Rixil 80 mg 80 mg
Maltese: Rixil 80 mg
English: Val-HeFT was a randomised, controlled, multinational clinical trial of valsartan compared with placebo on morbidity and mortality in 5,010 NYHA class II (62%), III (36%) and IV (2%) heart failure patients receiving usual therapy with LVEF <40% and left ventricular internal diastolic diameter (LVIDD) >2.9 cm/m2.
Maltese: Val-HeFT kienet prova klinika multinazzjonali, randomised, ikkontrollata ta' valsartan imqabbel ma' pla ebo dwar il-morbidità u l-mortalità f'5,010 pazjenti b'insuffi jenza tal-qalb ta' klassi NYHA II (62%), III (36%) u IV (2%) li r evew it-terapija tas-soltu b'LVEF ta' <40% u b'dijametru dijastoliku intern tal-ventriklu tax-xellug (LVIDD) ta' >2.9 cm/m2.
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: Tareg 80 mg 80 mg
Maltese: Tareg 80 mg
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 kwa i proporzjonali ma' jieda fid-do a tul il-firxa ta' do a kliniku (40 sa 160 mg darbtejn kuljum).
English: Cordinate 40 mg 40 mg
Maltese: Cordinate 40 mg
English: Tareg 40 mg 40 mg
Maltese: Tareg 40 mg
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 sekondarja jistg u jse u b' ertu frekwenzi, li huma definiti kif ej: komuni afna: jaffettwaw aktar minn persuna wa da minn kull 10 li qed ju awh komuni: jaffettwaw minn persuna wa da sa 10 minn kull 100 li qed ju awh mhux komuni: jaffettwaw minn persuna wa da sa 10 minn kull 1,000 li qed ju awh rari: jaffettwaw minn persuna wa da sa 10 minn kull 10,000 li qed ju awh rari afna: jaffettwaw inqas minn persuna wa da minn kull 10,000 li qed ju awh mhux mag ruf: il-frekwenza ma tistax ti i stmata mit-tag rif disponibbli.
English: Diovane 40 mg 40 mg
Maltese: Diovane 40 mg
English: Cordinate 80 mg 80 mg
Maltese: Cordinate 80 mg
English: In some cases your doctor may prescribe higher doses (e.g. 160 mg or 320 mg).
Maltese: F'xi ka ijiet ittabib tieg ek jista' jippreskrivi do i og la (e . 160 mg jew 320 mg).
English: Dalzad 80 mg 80 mg
Maltese: Dalzad 80 mg
English: Diovane 80 mg 80 mg
Maltese: Diovane 80 mg
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-tneija 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 rael) 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: Cordinate 320 mg 320 mg
Maltese: Cordinate 320 mg
English: Maximum dose studied in clinical trials
Maltese: Do a massima studjata fi provi klini i
English: In clinically stable patients, therapy may be initiated as early as 12 hours after a myocardial infarction.
Maltese: F'pazjenti klinikament stabbli, it-terapija tista' tinbeda minn 12-il sieg a wara infart mijokardijaku.
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: Tfal li kienu ji nu bejn ≥18 kg u <35 kg ir evew valsartan ta' 80 mg jew enalapril ta' 10 mg; dawk bejn ≥35 kg u <80kg 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: Do not stop taking your medicine unless your doctor tells you to.
Maltese: Twaqqafx it-te id talmedi ina tieg ek sakemm ma jg idlekx hekk it-tabib tieg ek.
English: Dalzad 40 mg 40 mg
Maltese: Dalzad 40 mg
English: Cordinate 160 mg 160 mg
Maltese: Cordinate 160 mg
English: Diovane 160 mg 160 mg
Maltese: Diovane 160 mg
English: Tareg 320 mg 320 mg
Maltese: Tareg 320 mg
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' jii assojat ma' indeboliment fil-funzjoni renali.
English: Tareg 160 mg 160 mg
Maltese: Tareg 160 mg
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-doa), l-aktar bala mediina mhux mibdula.
English: Diovane 320 mg 320 mg
Maltese: Diovane 320 mg
English: The primary benefit was a 27.5% (95% CI: 17 to 37%) reduction in risk for time to first heart failure hospitalisation (13.9% vs. 18.5%).
Maltese: Il-benefi ju l-aktar importanti kien tnaqqis ta' 27.5% (95% CI: 17 sa 37%) fir-riskju g amien sa l-ewwel d ul fl-isptar min abba insuffi jenza tal-qalb (13.9% vs. 18.5%).
English: Dalzad 160 mg 160 mg
Maltese: Dalzad 160 mg
English: Syncope, Headache
Maltese: Tqallig , Dijarea
English: Dalzad 320 mg 320 mg
Maltese: Dalzad 320 mg
English: Overall, the three dose levels of valsartan (low, medium and high) significantly reduced systolic blood pressure by 8, 10, 12 mm Hg 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 this subgroup all-cause mortality was significantly reduced with valsartan compared to placebo by 33% (95% CI: -6% to 58%) (17.3% valsartan vs. 27.1% placebo) and the composite mortality and morbidity risk was significantly reduced by 44% (24.9% valsartan vs. 42.5% placebo).
Maltese: F'dan is-sottogrupp il-mortalità minn kull kaw a kienet imnaqqsa b'mod sinifikanti b'valsartan bi 33% (95% CI: -6% sa 58%) meta mqabbel mal-pla ebo (17.3% valsartan vs. 27.1% pla ebo) u r-riskju kompost ta' mortalità u morbidità kien imnaqqas b'mod sinifikanti b'44% (24.9% valsartan vs.
English: In a double-blind randomized study in 90 children aged 1 to 6 years, which was followed by a one-year 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: Recent myocardial infarction
Maltese: Disturbi gastro-intestinali
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 pa jent rispettivament.
English: The safety profile of valsartan was consistent with the clinical course of patients treated in the postmyocardial infarction setting.
Maltese: Il-profil ta' sigurtà ta' valsartan kien konsistenti mal-progressjoni klinika ta' pazjenti kkurati flambjent ta' wara infart mijokardijaku.
English: Valsartan may be used in patients treated with other post-myocardial infarction therapies, e.g. thrombolytics, acetylsalicylic acid, beta blockers, statins, and diuretics.
Maltese: Valsartan jista' ji i w at f'pazjenti kkurati b'terapiji ta' wara infart mijokardijaku o ra, e . tromboliti i, acetylsalicylic acid, imblokkaturi tar-ri etturi beta, statins, u dijureti i.
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: Uu f'pazjenti pedjatrii b'indeboliment epatiku li gandhom minn 6 sa 18 -il sena Bal fl-adulti, Diovan huwa kontraindikat f'pazjenti pedjatrii b'indeboliment epatiku sever, irroi biljari u f'pazjenti bil-kolestasi (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Impaired hepatic function
Maltese: Indeboliment tal-funzjoni epatika
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 ir iel jew nisa fuq do i orali sa 200 mg/kg/kuljum.
English: In patients receiving an ACE inhibitor without a beta-blocker, all cause mortality was similar (p=NS) in the valsartan (21.8%) and placebo (22.5%) groups.
Maltese: F'pazjenti li r evew inibitur ta' ACE ming ajr imblokkatur tar-ri etturi beta, il-mortalità minn kull kaw a kienet simili (p=NS) fil-gruppi ta' valsartan (21.8%) u pla ebo (22.5%).
English: There was no difference between valsartan and captopril in all-cause mortality based on age, gender, race, baseline therapies or underlying disease.
Maltese: Ma kienx hemm differenza bejn valsartan u captopril fil-mortalità minn kull kaw a bba at fuq età, sess, razza, terapiji fil-linja ba i jew marda li hemm pre enti.
English: • to treat adult patients after a recent heart attack (myocardial infarction).
Maltese: • g all-kura ta' pazjenti adulti wara attakk tal-qalb re enti (infart mijokardijaku).
English: Combining valsartan with captopril did not add further benefit over captopril alone.
Maltese: Ta lita ta' valsartan ma' captopril ma iditx aktar benefi ju fuq captopril wa du.
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) cannot be used.
Maltese: Diovan jintu a meta grupp ta' medi ini msej a inibituri ta' Angiotensin Converting Enzyme (ACE) (medikazzjoni g all-kura ta' insuffi jenza tal-qalb) ma jistg ux ji u w ati jew jista' jintu a flimkien ma' inibituri ta' ACE meta imblokkaturi tar-ri etturi beta (medikazzjoni o ra g all-kura ta' insuffi jenza tal-qalb) ma jistg ux ji u w ati.
English: No dose adjustment is required for adult patients with a creatinine clearance >10 ml/min (see sections 4.4 and 5.2).
Maltese: L-ebda a ustament fid-do a ma huwa me tie f'pazjenti adulti bi tne ija tal-krejatinina ta' >10 ml/min (ara sezzjonijiet 4.4 u 5.2).
English: Treatment of clinically stable adult 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 adulti klinikament stabbli li g andhom insuffi jenza sintomatika tal-qalb jew disfunzjoni sistolika mhux sintomatika tal-ventriklu tax-xellug wara infart mijokardijaku re enti (12-il sieg a - g axart ijiem) (ara sezzjonijiet 4.4 u 5.1).
English: PHARMACOLOGICAL PROPERTIES
Maltese: Kategorija farmakoterapewtika:
English: Paediatric hypertension
Maltese: Popolazzjoni pedjatrika