FrancophonIA/ELRC3.0 huggingface dataset:
English: Restless legs syndrome is a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Maltese: Is-sindromu ta' riġlejn irrekwieti huwa disturb li jġiegħel lill-pazjent iċaqlaq riġlejh u dirgħajh bla kontroll biex iwaqqaf sensazzjonijiet ta' skumdità, ta' uġigħ jew ta' sensazzjonijiet strambi fil-ġisem, normalment bil-lejl.
English: Oxynal, Targin and associated names are marketed in all EU Member States except Croatia, Greece, Lithuania and Malta.
Maltese: Oxynal, Targin u ismijiet assoċati jitqiegħdu fis-suq fl-Istati Membri kollha tal-UE minbarra l-Kroazja, ilGreċja, il-Litwanja u Malta.
English: Based on the evaluation of the available data and the scientific discussion within the Committee, the CHMP agreed that the study had convincingly shown that Oxynal and Targin are beneficial in the treatment of symptoms of severe to very severe restless legs syndrome when standard therapy has failed.
Maltese: Abbażi tal-evalwazzjoni tad-dejta disponibbli u d-diskussjoni xjentifika fil-Kumitat, is-CHMP qabel li l-istudju wera b'mod konvinċenti li Oxynal u Targin huma ta' benefiċċju fil-kura ta' sintomi tas-sindromu ta' riġlejn irrekwieti severi sa severi ħafna meta tkun falliet terapija standard.
English: On 23 October 2014, the European Medicines Agency completed an arbitration procedure for Oxynal, Targin and associated names.
Maltese: Fit-23 ta' Ottubru 2014, l-Aġenzija Ewropea għall-Mediċini lestiet proċedura ta' arbitraġġ għal Oxynal, Targin u ismijiet assoċjati.
English: Oxynal and Targin are medicines used to treat severe pain that can only be managed with opioids.
Maltese: Oxynal u Targin huma mediċini użati għall-kura ta' uġigħ sever li jista' jiġi ġestit biss b'opjojdi.
English: Overall summary of the scientific evaluation of Novosis Goserelin 3,6 mg Implantat and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Novosis Goserelin 3,6 mg Implantat u lismijiet assoċjati (ara Anness I)
English: • The Committee considered the referral triggered under Article 36 of Directive 2001/83/EC for Novosis Goserelin and associated names as listed in Annex I.
Maltese: • Il-Kumitat ikkunsidra r-riferiment mibdi taħt l-Artikolu 36 tad-Direttiva 2001/83/KE għal Novosis Goserelin u l-ismijiet assoċjati kif elenkati f'Anness I.
English: Novartis Hungaria Kft. Bartók Béla út 43-47 H-1114 Budapest
Maltese: Novartis Hungaria Kft. Bartók Béla út 43-47 H-1114
English: 2 and 4, rue Lionel Terray 92500 RUEIL-MALMAISON France
Maltese: 2 and 4, rue Lionel Terray 92500
English: Critical Evaluation
Maltese: Evalwazzjoni Kritika
English: Largo Umberto Boccioni 1 I-21040 Origgio
Maltese: Largo Umberto Boccioni 1 I-21040
English: Novartis Sverige AB Kemistvägen 1B P.O.
Maltese: Novartis Sverige AB Kemistvägen 1B P.O. Box 1150
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' sustanzi mhux attivi
English: Baseline therapy included ACE inhibitors (93%), diuretics (86%), digoxin (67%) and beta blockers (36%).
Maltese: Terapija fil-linja bażi kienet tinkludi inibituri ta' ACE (93%), dijuretiċi (86%), digoxin (67%) u imblokkaturi tar-riċetturi beta (36%).
English: Hard capsules
Maltese: Kapsuli iebsa
English: • certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
Maltese: • ċertu tip ta' pilloli li jmewtu l-uġigħ imsejħa mediċini anti-infjammatorji mhux sterojdi (NSAIDs).
English: Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC code: C09CA03
Maltese: Antagonisti ta' Angiotensin II, waħedhom, Kodiċi ATC: C09CA03
English: Valsartan also demonstrated beneficial effects on signs and symptoms of HF.
Maltese: Valsartan wera wkoll effetti ta' benefiċċju fuq sinjali u sintomi ta' HF.
English: Allcause mortality was similar in the valsartan (19.9%), captopril (19.5%), and valsartan + captopril (19.3%) groups.
Maltese: Mortalità minn kull kawża kienet simili fil-gruppi ta' valsartan (19.9%), captopril (19.5%), u valsartan + captopril (19.3%).
English: Do not take Diovan:
Maltese: Tieħux Diovan:
English: • lithium, a medicine used to treat some types of psychiatric illness.
Maltese: • lithium, mediċina wżata għall-kura ta' xi tipi ta' mard psikjatriku.
English: Angioedema, Rash, Pruritus
Maltese: Anġjoedima, Raxx, Ħakk
English: Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid >3 g/day), and non-selective NSAIDs When angiotensin II antagonists are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur.
Maltese: Mediċini anti-infjammatorji mhux sterojdi (NSAIDs), inkluż inibituri selettivi ta' COX-2, acetylsalicylic acid >3 g/kuljum, u NSAIDs mhux selettivi Meta antagonisti ta' angiotensin II jingħataw flimkien ma' NSAIDs, jista' jkun hemm tnaqqis tal-effett li jbaxxi l-pressjoni.
English: The mean daily dose of Diovan in Val-HeFT was 254 mg.
Maltese: Id-doża medja ta' kuljum ta' Diovan f'Val-HeFT kienet ta' 254 mg.
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, indometacin, 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, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
English: Box 23490 Nicosia Cyprus
Maltese: P.O. Box 23490
English: The CHMP was also of the opinion that the 320 milligram dose provides a modest, statistically significant additional reduction in MSDBP and MSSBP compared to 160mg and a similarly modest increase in the rate of blood pressure control.
Maltese: Il-CHMP kien ukoll tal-opinjoni li doża ta' 320 milligramma tipprovdi tnaqqis addizzjonali modest, statistikament sinjifikanti fl-MSDBP u MSSBP meta mqabbla ma' 160mg u żieda modesta simili fir-rata tal-kontroll tal-pressjoni tad-demm.
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 mniżżla skond il-frekwenza, bl-aktar frekwenti l-ewwel, bl-użu talkonvenzjoni 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), inkluż rapporti iżolati.
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-plaċebo (31.0% vs. 36.3%).
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 radjoloġika ta' insuffiċjenza konġestiva tal-qalb u/jew disfunzjoni sistolika talventriklu tax-xellug (manifestata bħala frazzjoni ta' tfigħ 'il barra ta' ≤40% permezz ta' radionuclide ventriculography jew ta' ≤35% permezz ta' ekukardjografija jew anġjografija ventrikulari b'kuntrast).
English: Whilst there is no controlled epidemiological data on the risk with AIIRAs, similar risks may exist for this class of drugs.
Maltese: Filwaqt li m'hemmx tagħrif epidemjoloġiku kkontrollat dwar ir-riskju b'AIIRAs, jistgħu jeżistu riskji simili għal din il-klassi ta' mediċini.
English: • muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)
Maltese: • spażmi fil-muskoli, ritmu tal-qalb mhux normali (sinjali ta' iperkalimja)
English: All cause mortality was similar (p=NS) in the valsartan (19.7%) and placebo (19.4%) groups.
Maltese: Mortalità minn kull kawża kienet simili (p=NS) fil-gruppi ta' valsartan (19.7%) u tal-plaċebo (19.4%).
English: At 24 weeks, UAE 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: The safety and tolerability of valsartan in patients with severe renal failure (creatinine clearance of <10 ml/min) was not evaluated in any clinical study.
Maltese: Is-sigurtà u t-tollerabbiltà ta' valsartan f'pazjenti b'funzjoni tal-kliewi severa (eliminazzjoni tal-kreatinina ta' < 10 ml/min) ma ġew evalwati f'ebda studju kliniku.
English: • if you suffer from aldosteronism.
Maltese: • jekk issofri minn aldosteroniżmu.
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 captopriltreated 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: Approximately 70% of the dose absorbed is eliminated in the bile, essentially in the unchanged form.
Maltese: Madwar 70% tad-doża assorbita hija eliminata fil-bili, essenzjalment f'forma mhux mibdula.
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 minħabba tipi differenti ta' disfunzjoni renali seħħ 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: 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: Diovan contains valsartan, an orally Angiotensin II Receptor Antagonist (AIIRA).
Maltese: Diovan fih valsartan, Angiotensin II Receptor Antagonist (AIIRA) li jittieħed mill-ħalq.
English: Czech Republic NOVARTIS s.r.o.
Maltese: Novartis s.r.o.
English: Sessions 4.5, 5.1, and 5.2 have been updated in order to guarantee the safety of the medicine.
Maltese: Is-Sezzjonijiet 4.5, 5.1, u 5.2 ġew aġġornati sabiex jiggarantixxu s-sigurtà tal-mediċina.
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' plaċebo dwar il-morbidità u l-mortalità f'5,010 pazjenti b'insuffiċjenza tal-qalb ta' klassi NYHA II (62%), III (36%) u IV (2%) li rċevew it-terapija tas-soltu b'LVEF ta' <40% u b'dijametru dijastoliku intern tal-ventriklu tax-xellug (LVIDD) ta' >2.9 cm/m2.
English: • severely decreased kidney function (signs of acute renal failure)
Maltese: • tnaqqis sever fil-funzjoni tal-kliewi (sinjali ta' insuffiċjenza renali akuta)
English: -Severe hepatic impairment, biliary cirrhosis and cholestasis.
Maltese: -Indeboliment epatiku sever, ċirrożi biljari u kolestasi.
English: In Study 27 the kinetic of valsartan was also investigated in hypertensive patients with impairment of renal function (creatine clearance rate: 16-116 mL/min).
Maltese: Fl-Istudju 27, il-kinetika ta' valsartan ġiet investigata wkoll f'pazjenti bi pressjoni għolja b'indeboliment tal-funzjoni renali (rata ta' eliminazzjoni tal-kreatinina: 16-116 mL/min).
English: Each capsule contains 160 mg valsartan.
Maltese: Kull kapsula fiha 160 mg valsartan.
English: Diovan was included in the list of products for Summary of Products Characteristics (SPC) harmonization, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended, as the above-mentioned medicinal product does not have the same SPC across all EU Member States, Iceland and Norway.
Maltese: Diovan ġie inkluż fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodott (SPC), imfassla mill-CMD(h), skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendata, minħabba li lprodott mediċinali msemmi fuq ma għandux l-istess SPC fl-Istati Membri tal-UE kollha, fl-Iżlanda u fin-Norveġja.
English: However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended (see sections 4.4 and 5.1).
Maltese: Madankollu, il-kombinazzjoni tripla ta' inibitur ACE, beta blocker u valsartan mhijiex rakkomandata (ara sezzjonijiet 4.4 u 5.1).
English: In CHMP's opinion the wording “not recommended” should be used until there is more solid supportive benefit/risk-profile evidence to triple combination.
Maltese: Fl-opinjoni tal-CHMP, ilkliem “mhux rakkomandata” għandu jintuża sakemm ikun hemm evidenza tal-profil benefiċċju/riskju aktar solida u ta' appoġġ għall-kombinazzjoni tripla.
English: The following sentence has been added to Section 5.2: “Diovan has not been studied in patients with severe hepatic dysfunction”.
Maltese: Is-sentenza li ġejja ġiet miżjuda mas-Sezzjoni 5.2: “Diovan ma ġiex studjat f'pazjenti b'disfunzjoni tal-fwied severa”.
English: “Treatment of symptomatic heart failure when Angiotensin Converting Enzyme (ACE) inhibitors could not be used, or as add-on therapy to ACE inhibitors when beta blockers could not be used”
Maltese: “Kura ta' indeboliment tal-qalb sintomatiku meta inibituri ta' Angiotensin Converting Enzyme (ACE) ma setgħux jintużaw, jew bħala terapija addizzjonali għal inibituri ACE meta beta blockers ma setgħux jintużaw”
English: The Diovan Reduction of Proteinuria (DROP) study further examined the efficacy of valsartan in reducing UAE in 391 hypertensive patients (BP=150/88 mmHg) with type 2 diabetes, albuminuria (mean=102 µg/min; 20-700 µg/min) and preserved renal function (mean serum creatinine = 80 µmol/l).
Maltese: L-istudju Diovan Reduction of Proteinuria (DROP) kompla jeżamina l-effikaċja ta' valsartan biex inaqqas l-UAE f'391 pazjent bi pressjoni għolja (BP=150/88 mmHg) u b'dijabete tat-tip 2, albuminurja (medja=102 µg/min; 20-700 µg/min) u b'funzjoni renali ppreservata (medja talkrejatinina fis-serum = 80 µmol/l).
English: • diarrhea
Maltese: • debbulizza
English: • other medicines that lower blood pressure, especially water pills (diuretics).
Maltese: • mediċini oħra li jbaxxu l-pressjoni tad-demm, speċjalment pilloli ta' l-awrina (dijuretiċi).
English: Syncope, Headache
Maltese: Sinkope, Uġigħ ta' ras
English: Combined with hydrochlorothiazide, a significant additional reduction in blood pressure is achieved.
Maltese: F'taħlita ma' hydrochlorothiazide, jintlaħaq tnaqqis addizzjonali sinifikanti fil-pressjoni tad-demm.
English: The apparent clearance of valsartan following oral administration is approximately 4.5 l/h.
Maltese: It-tneħħija apparenti ta' valsartan wara għoti orali hija madwar 4.5 l/h.
English: Hypersensitivity including serum sickness
Maltese: Sensittività eċċessiva ikluż marda tas-serum
English: At 30 weeks, the percentage change in UAE was significantly reduced by 36% from baseline with valsartan 160 mg (95%CI: 22 to 47%), and by 44% with valsartan 320 mg (95%CI: 31 to 54%).
Maltese: Il-pazjenti kienu randomised għal waħda minn 3 dożi ta' valsartan (160, 320 u 640 mg mg (95%CI: 22 sa 47%), u b'44% b'valsartan 320 mg (95%CI: 31 sa 54%).
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 siegħa wara infart mijokardijaku.
English: Recent myocardial infarction
Maltese: Infart mijokardijaku reċenti
English: In controlled clinical studies in 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 kliniċi kkontrollati f'pazjenti bi pressjoni għolja, l-inċidenza globali ta' reazzjonijiet avversi (ADRs) kienet komparabbli mal-plaċebo u hija konsistenti mal-farmakoloġija ta' valsartan.
English: Regarding the indication in recent myocardial infarction the CHMP noted that this indication was limited to patients intolerants to ACE inhibitors in some Member States.
Maltese: Fir-rigward tal-indikazzjoni f'infart mijokardijaku riċenti, il-CHMP innota li din l-indikazzjoni kienet limitata għal pazjenti intolleranti għal inibituri ACE f'xi Stati Membri.
English: Diovan 40 mg capsules, hard can be used for two different conditions:
Maltese: Diovan 40 mg kapsuli, iebsa jista' jintuża għal żewġ kundizzjonijiet differenti:
English: Decrease in haemoglobin, Decrease in haematocrit, Neutropenia, Thrombocytopenia
Maltese: Tnaqqis fl-emoglobina, Tnaqqis fl-ematokrita, Newtropenija, Tromboċitopenija
English: • tiredness
Maltese: • dijarea
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 kawża bbażat fuq età, sess, razza, terapiji fil-linja bażi jew marda li hemm preżenti.
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 rċevew inibitur ta' ACE mingħajr imblokkatur tar-riċetturi beta, il-mortalità minn kull kawża kienet simili (p=NS) fil-gruppi ta' valsartan (21.8%) u plaċebo (22.5%).
English: Considering the non inferiority in clinical outcome of valsartan compared to current standard treatment, an ACEI, the CHMP adopted the following harmonised wording for this indication:
Maltese: Wara li kkunsidra n-nuqqas ta' inferjorità f'riżultat kliniku ta' valsartan meta mqabbel mal-kura standard attwali, ACEI, il-CHMP adotta l-formolazzjoni armonizzata li ġejja għal din l-indikazzjoni:
English: One film-coated tablet contains 40 mg of valsartan One capsule contains 40 mg of valsartan One film-coated tablet contains 80 mg of valsartan One capsule contains 80 mg of valsartan One film-coated tablet contains 160 mg of valsartan One capsule contains 160 mg of valsartan One film-coated tablet contains 320 mg of valsartan
Maltese: Pillola waħda miksija b'rita fiha 40 mg valsartan Kapsula waħda fiha 40 mg valsartan Pillola waħda miksija b'rita fiha 80 mg valsartan Kapsula waħda fiha 80 mg valsartan Pillola waħda miksija b'rita fiha 160 mg valsartan Kapsula waħda fiha 160 mg valsartan Pillola waħda miksija b'rita fiha 320 mg valsartan
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-benefiċċju l-aktar importanti kien tnaqqis ta' 27.5% (95% CI: 17 sa 37%) fir-riskju għaż-żmien sa lewwel dħul fl-isptar minħabba insuffiċjenza tal-qalb (13.9% vs. 18.5%).
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' jiġi wżat f'pazjenti kkurati b'terapiji ta' wara infart mijokardijaku oħra, eż. trombolitiċi, acetylsalicylic acid, imblokkaturi tar-riċetturi beta, statins, u dijuretiċi.
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 għal waħda minn 3 dożi ta' valsartan (160, 320 u 640 mg/od) u kkurati għal 30 ġimgħa.
English: Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000 fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Maltese: Valsartan ma jurix attività agonista parzjali fir-riċettur AT1 u għandu affinità ferm aktar ogħla (madwar 20,000 darba) għar-riċettur AT1 milli għar-riċettur AT2.
English: Symptoms
Maltese: EFFETTI
English: AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalemia); see also section 5.3 “Preclinical safety data”.
Maltese: Espożizzjoni għal terapija b'AIIRAs waqt it-tieni u t-tielet trimestru hija magħrufa li tinduċi tossiċità lill-fetu uman (funzjoni renali mnaqqsa, fluwidu amnjotiku mhux suffiċjenti, ittardjar ta' lossifikazzjoni tal-qorriegħa tar-ras) u tossiċità neonatali (insuffiċjenza renali, pressjoni baxxa, iperkalimja); ara wkoll sezzjoni 5.3 “Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà tal-mediċina”.
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 kawża kienet imnaqqsa b'mod sinifikanti b'valsartan bi 33% (95% CI: -6% sa 58%) meta mqabbel mal-plaċebo (17.3% valsartan vs. 27.1% plaċebo) u r-riskju kompost ta' mortalità u morbidità kien imnaqqas b'mod sinifikanti b'44% (24.9% valsartan vs.
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 jiġi eskluż li l-użu ta' Diovan jista' jkun assoċjat ma' indeboliment fil-funzjoni renali.
English: Rash, Pruritis
Maltese: Raxx, Ħakk
English: Increase of serum potassium
Maltese: Żjieda fil-potassium fis-serum
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 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: Each capsule contains 40 mg valsartan.
Maltese: Kull kapsula fiha 40 mg valsartan.