FrancophonIA/ELRC3.0 huggingface dataset:
English: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function including renal failure have been reported in patients at risk; these changes in renal function may be reversible upon discontinuation of therapy (see section 4.4)
Maltese: Bħala konsegwenza għall-impediment tas-sistema renin-angiotensin-aldosterone, bidliet fil-funzjoni renali, li jinkludi insuffiċjenza renali ġew irrapportati f'pazjenti li jinsabu f'riskju; dawn il-bidliet fil-funzjoni renali jistgħu jkunu riversibbli mat-twaqqif tat-terapija (ara sezzjoni 4.4).
English: • localised swelling (oedema).
Maltese: • nefħa lokalizzata (edema),
English: Blood pressure may also be lowered by one of the following drugs/ class of drugs: tricyclic antidepressants, antipsychotics, baclofene, amifostine,
Maltese: Sustanzi oħra li jissensitizzaw l-pressjoni baxxa bħal mediċini kontra d-dipressjoni triċikliċi, antipsikotiċi, baclofene, amifostene:
English: 2 tablets = 25 mg once daily
Maltese: 2 pilloli = 25 mg darba kuljum
English: Renal function should be regularly monitored during treatment with losartan as it may deteriorate.
Maltese: Il-funzjoni renali għandha tiġi monitorata regolarment waqt t-trattament b'losartan peress li tista' tisfaxxa.
English: • hives (urticaria),
Maltese: • ħorriqija (urtikarja),
English: Luxembourg Merck Sharp & Dohme BVChaussée de Waterloo 1135
Maltese: Il-Lussemburgu Merck Sharp & Dohme BV -Chaussée de Waterloo 1135 - B-1180
English: HOW TO STORE Cozaar
Maltese: Tieħux Cozaar
English: A package containing 35 tablets (21 pcs of 12.5 mg tablet and 14 pcs of the 50 mg tablet) or 28 tablets (21 pcs of 12.5 mg tablet and 7 pcs of the 50 mg tablet) is available in a PVC/PE/PVDC titration blister package.
Maltese: Pakkett li fih 35 pillola (21 biċċa b'pilloli ta' 12.5 mg u 14-il biċċa b'pilloli ta' 50 mg) huwa disponibbli f'pakkett ta' folji ttitrati tal-PVC/PE/PVDC.
English: The adverse experience profile for pediatric patients appears to be similar to that seen in adult patients.
Maltese: Il-profil ta' esperjenza avversa għal pazjenti pedjatriċi jidher li huwa simili għal dak li jidher f'pazjenti adulti.
English: Cozaar Startpakke
Maltese: COZAAR CARDIO START
English: Plasma clearance of losartan and its active metabolite is about 600 mL/min and 50 mL/min, respectively.
Maltese: It-tneħħija ta' losartan mill-plażma u tal-metabolit attiv tiegħu hija ta' madwar 600 ml/min u 50 ml/min, rispettivament.
English: Immune system disorders: rare: hypersensitivity: anaphylactic reactions, angiooedema including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue; in some of these patients angiooedema had been reported in the past in connection with the administration of other medicines, including ACE inhibitors; vasculitis, including Henoch-Schonlein purpura.
Maltese: Disturbi fis-sistema immuni: rari: sensittività eċċessiva: reazzjonijiet anafilattiċi, anġjodema li tinkludi tinfiħ tal-larinġi u l-glottide li tikkawża impediment fil-passaġġ ta' l-arja u/jew nefħa fil-wiċċ, ix-xofftejn, il-farinġi u/jew l-ilsien. f'xi wħud minn dawn il-pazjenti anġjodema kienet irrapportata fil-passat u marbuta ma' l-għoti ta' mediċini oħra li jinkludu impedituri ACE; vaskulite, li tinkludi purpura ta' Henoch-Schoenlein.
English: For the following individual and combined components of the primary endpoint, the results showed a significant risk reduction in the group treated with Losartan: 25.3 % risk reduction for doubling of the serum creatinine (p = 0.006); 28.6 % risk reduction for end-stage renal failure (p = 0.002); 19.9 % risk reduction for end-stage renal failure or death (p = 0.009); 21.0 % risk reduction for doubling of serum creatinine or end-stage renal failure (p = 0.01).
Maltese: 002); tnaqqis ta' riskju ta' 19.9 % għal insuffiċjenza renali ta' l-aħħar stadju jew mewt (p = 0.009); tnaqqis ta' riskju ta' 21.0 % għall-irdoppjar ta' kreatinina tas-serum jew insuffiċjenza renali ta' l-aħħar stadju (p = 0.01).
English: The Reduction of Endpoints in NIDDM with the Angiotensin II Receptor Antagonist Losartan RENAAL study was a controlled clinical study conducted worldwide in 1513 Type 2 diabetic patients with proteinuria, with or without hypertension.
Maltese: L-istudju kliniku b'kontrolli magħruf bħala RENAAL, “The Reduction of Endpoints in NIDDM with the Angiotensin II Receptor Antagonist Losartan”, sar madwar id-dinja kollha fuq 1513-il pazjent dijabetiku ta' Tip 2 u bi protejnurja, bi jew mingħajr pressjoni għolja.
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Maltese: DATA TA' META ĠIET RIVEDUTA
English: • dizziness,
Maltese: • remettar,
English: Cozaar 25 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7 or 28 tablets.
Maltese: Cozaar 25 mg - folji tal-PVC/PE/PVDC b'għotjien b'fojl ta' l-aluminju f'pakketti ta' 7 jew 28 pillola.
English: The results showed that the treatment with Losartan (327 events) as compared with placebo (359 events) resulted in a 16.1 % risk reduction (p = 0.022) in the number of patients reaching the primary composite endpoint.
Maltese: Ir-riżultati wrew li t-trattament b'Losartan (327 każ) meta mqabbel mal-plaċebo (359 każ) irriżulta fi tnaqqis fir-riskju ta' 16.1 % (p = 0.022) fl-għadd ta' pazjenti li jilħqu l-punt ta' riferiment aħħari prinċipali kompost.
English: Afterwards, close monitoring of the vital parameters should be performed.
Maltese: Wara dan, għandu jkun hemm monitoraġġ mill-qrib tal-parametri vitali.
English: Angiotensin II binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and elicits several important biological actions, including vasoconstriction and the release of aldosterone.
Maltese: Angiotensin II jintrabat mar-riċettatur AT1 li jinstab f'ħafna tessuti (eż. il-muskoli vaskulari lixxi, il-glandoli adrenali, il-kliewi u l-qalb) u jissensitizza diversi azzjonijiet bijoloġiċi importanti li jinkludu t-tidjiq tal-vażi tad-demm u r-rilaxx ta' aldosterone.
English: • if your liver function is impaired (see sections 2 "Do not take Losartan" and 3 ‘Dosage in special patient groups'),
Maltese: • jekk il-funzjoni tal-fwied tiegħek hi indebolita (ara sezzjonijiet 2 “Tieħux Cozaar”, u 3, “Id-doża di gruppi speċjali”).
English: A recent review in the BMJ shows that specifically the preventive effect on stroke of atenolol is lower than for other antihypertensives; RR of 1.26 (95%CI: 1.15 to 1.38).
Maltese: Opinjoni reċenti fil-BMJ turi li l-effett preventiv ta' atenolol fuq l-attakk ta' puplesija huwa iktar baxx milli għal mediċini oħrajn kontra l-pressjoni għolja; RR ta' 1.26 (95%CI:
English: Cozaar (losartan) was included in the list of products for Product Information harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of the Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised SPCs and therefore to harmonise these divergent SPCs across the European Union.
Maltese: Cozaar (losartan) kien inkluż fil-lista tal-prodotti għall-armonizzazzjoni tat-Tagħrif tal-Prodott, imfassla mis-CMD(h), b'mod konformi ma' l-Artikolu 30(2) tad-Direttiva 2001/83/KE sabiex issolvi diverġenzi fost SPCs awtorizzati fuq livell nazzjonali u għaldaqstant biex ikunu armonizzati dawn lSPCs diverġenti fl-Unjoni Ewropea kollha.
English: N/A
Maltese: ĠIMGĦA 4
English: Losartan 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, hyperkalaemia) (see also 5.3 'Preclinical safety data').
Maltese: L-espożizzjoni għat-terapija b'losartan waqt it-tieni u t-tielet trimestri hi magħrufa li tinduċi tossiċità fil-fetu uman (tnaqqis fil-funzjoni tal-kliewi, oligoħidramnios, dewmien għal ossifikazzjoni tal-kranju) u tossiċità lit-tarbija għadha titwieled (insuffiċjenza renali, pressjoni baxxa, iperkalemja) (ara wkoll 5.3 ‘Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà tal-mediċina').
English: if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland).
Maltese: • jekk tbati minn iperaldosteroniżmu primarja (sindromu assoċjat ma' żieda fil-produzzjoni ta' lormon aldosterone mill-glandola adrenali, ikkawżata minn abnormalità ġewwa l-glandola).
English: • elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.
Maltese: • livelli elevati ta' alanine aminotransferase (ALT) fid-demm, li ġeneralment jirriżolvu rwieħom malli jieqaf it-trattament.
English: Each Cozaar 25 mg tablet contains12.75 mg lactose monohydrate.
Maltese: Kull pillola ta' Cozaar 25 mg fiha 12.75 mg lactose monohydrate.
English: • cough,
Maltese: • sogħla,
English: In patients with mild to moderate alcohol-induced hepatic cirrhosis, the plasma levels of losartan and its active metabolite after oral administration were respectively 5 and 1.7 times higher than in young male volunteers (see section 4.2 and 4.4).
Maltese: F'pazjenti li għandhom ċirrosi tal-fwied minn ħafif sa moderat, ikkaġunat mill-alkoħol, il-livelli ta' losartan u l-metabolit attiv fil-plażma wara l-għoti mill-ħalq kienu ta' 5 darbiet u 1.7 darbiet ogħla rispettivament minn dawk ta' voluntieri rġiel żgħażagħ (ara sezzjonijiet 4.2 u 4.4).
English: Merck Sharp & Dohme GmbH Donau-City-Straße 6
Maltese: Merck Sharp & Dohme GmbH Donau-City-Straße 6, 1220 Wien, L-Awstrija
English: This composite endpoint can be considered as representative for CV morbidity and mortality, and has translated into this indication in many medicinal products that have been discussed in the CHMP (e.g. statins).
Maltese: Dan il-punt ta' tmiem kompost jista' jitqies rappreżentattiv għal morbidità u mortalità KV, u ġie tradott f'din l-indikazzjoni f'ħafna prodotti mediċinali li ġew diskussi fis-CHMP (per eżempju, statins).
English: Losartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Maltese: Losartan jappartjeni għal grupp ta' mediċini msejħa antagonisti tar-riċettatur ta' angiotensin-II.
English: Angiotensin II, a potent vasoconstrictor, is the primary active hormone of the renin/angiotensin system and an important determinant of the pathophysiology of hypertension.
Maltese: Angiotensin II, li jdejjaq b'mod qawwi l-arterji u l-vini, huwa l-ormon prinċipali attiv tas-sistema renin/anġiotensin u fattur determinanti tal-patofiżjoloġija tal-pressjoni għolja.
English: Measurements of blood pressure 24 hours post-dose relative to 5 - 6 hours post-dose demonstrated blood pressure reduction over 24 hours; the natural diurnal rhythm was retained.
Maltese: Il-kejl tal-pressjoni tad-demm 24 siegħa wara d-doża imqabbel ma' 5 - 6 sigħat wara d-doża wera tnaqqis fil-pressjoni fuq 24 siegħa; bir-ritmu diurnali naturali jibqa' jinżamm.
English: Each Cozaar 100 mg tablet contains 100 mg of losartan potassium.
Maltese: Kull pillola ta' 100 mg Cozaar fiha 100 mg ta' losartan potassium.
English: The primary endpoint did not show any statistically significant difference between Losartan and captopril in reducing all-cause mortality.
Maltese: Il-punt ta' riferiment aħħari prinċipali ma wriex differenza statistikament differenti bejn Losartan u captopril fi tnaqqis tal-mortalità ta' kull kawża.
English: • to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal amount of protein).
Maltese: • sabiex jipproteġi il-kliewi f'pazjenti li għandhom pressjoni għolja u dijabete ta' tip 2 b'evidenza ta' funzjoni renali indebolita u protejnurja ≥ 0.5 g kuljum (kundizzjoni fejn l-urina fiha ammont abnormali ta' proteini);
English: The Cozaar 12.5 mg tablets also may contain carnauba wax (E903), titanium dioxide (E171), indigo carmine (E132) aluminum lake.
Maltese: Il-pilloli ta' 12.5 mg Cozaar jista' jkun fihom ukoll carnauba wax (E903), titanium dioxide (E171), indigo carmine aluminum lake (E132).
English: • medicines which retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines such as certain diuretics [amiloride, triamteren, spironolactone] or heparine),
Maltese: • mediċini li jżommu l-potassju jew li jistgħu jżidu l-livelli ta' potassju (eż. supplimenti tal-potassju, sostituti ta' l-imluħa li fihom il-potassju, jew mediċini li jirristrinġu l-potassju flurina bħal ċertu dijuretiċi [amiloride, triamteren, spironolactone] jew eparina),
English: The concomitant use of potassium sparing diuretics, potassium supplements and potassium containing salt substitutes with losartan is not recommended (see section 4.5).
Maltese: L-użu konġunt ta' dijuretiċi li ma jinkoraġixxux it-teħid ta' potassju, supplimenti ta' potassju u sostituti mluħa li fihom il-potassju ma' losartan mhumiex rakkomandati (ara sezzjoni 4.5).
English: Losartan is an orally active angiotensin II (Ang- II) receptor antagonist acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade.
Maltese: Losartan huwa antagonist tar-riċettur angiotensin II (AngII) attiv oralment li jaħdem fuq is-sottotip ta' riċettur AT1, b'hekk jimblokka l-effett ta' Ang-II filkaskata tas-sistema ta' renin angiotensin (RAS).
English: As a consequence the observed 25% risk reduction with losartan versus atenolol brings the protective effect of losartan on stroke in the same range as for other antihypertensives.
Maltese: B'konsegwenza ta' dan it-tnaqqis fir-riskju osservat ta' 25% b'losartan meta mqabbel ma' atenolol iġib l-effett protettiv ta' losartan fuq l-attakk ta' puplesija fl-istess medda ta' mediċini oħrajn kontra l-pressjoni għolja.
English: In a clinical study conducted in type 2 diabetic patients with nephropathy, the incidence of hyperkalemia was higher in the group treated with Cozaar as compared to the placebo group (see section 4.8, 'Hypertension and type 2 diabetes with renal disease - Investigations' and ‘Post-marketing experience - Investigations' Therefore, the plasma concentrations of potassium as well as creatinine clearance values should be closely monitored, especially patients with heart failure and a Creatinine Clearance between 30-50 ml/ min should be closely monitored.
Maltese: Fi studju kliniku li sar fuq pazjenti dijabetiċi ta' tip 2 b'nefropatija, l-inċidenza ta' iperkalemija kienet ogħla fil-grupp ittrattat b'Cozaar meta mqabbel mal-grupp li ħa l-plaċebo (ara sezzjoni 4.8, ‘Pazjenti dijabetiċi ta tip II b'mard tal-kliewi u bi pressjoni għoljaStħarriġ' u ‘Esperjenza ta' wara t-tqegħid fis-suq - Stħarriġ'.
English: After a majority voting at the CHMP plenum, the CHMP recommended that the following wording be proposed to reflect the data from the ELITE I and II studies, within a second-line indication: “Treatment of chronic heart failure (in patients aged 60 or over), when treatment with ACE inhibitors is not considered suitable due to incompatibility or contraindications.
Maltese: Wara vot ta' maġġoranza fil-plenum tas-CHMP, is-CHMP irrakkomanda li tkun proposta lformolazzjoni li ġejja biex tirrifletti d-dejta mill-istudji ELITE I u II, fi ħdan indikazzjoni tat-tieni għażla: “Kura ta' indeboliment kroniku tal-qalb (f'pazjenti ta' età ta' 60 sena jew aktar), meta kura b'impedituri ACE ma tkunx ikkunsidrata addattata minħabba inkompatibilità jew kontraindikazzjoniet.
English: Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom
Maltese: Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon,
English: In addition to the active metabolite, inactive metabolites are formed.
Maltese: Barra mill-metabolit attiv ifformat, metaboliti mhux attivi huma fformati wkoll.
English: Renal and urinary disorders: not known: urinary tract infections
Maltese: Disturbi fil-kliewi u fis-sistema urinarja: mhux magħruf: infezzjonijiet fl-apparat urinarju
English: The primary endpoint was the composite of cardiovascular morbidity and mortality as measured by a reduction in the combined incidence of cardiovascular death, stroke and myocardial infarction.
Maltese: Il-punt ta' riferiment aħħari prinċipali kien il-kompost ta' morbidità u mortalità kardjovaskulari kif imkejla bi tnaqqis fl-inċidenza kkombinata ta' mewt kardjovaskulari, puplesija u infart mijokardijaku.
English: Based on the data submitted during the Article 30 Referral procedure and the outcome of the EU worksharing project assessment of these paediatric data, the CHMP considered that the conclusions of the European Paediatric Worksharing Project on losartan needed to be incorporated into sections 4.2, 4.4, 4.8, 5.1 and 5.2 of Summary of Product Characteristics and the relevant sections of the Package Leaflet.
Maltese: Abbażi tad-dejta sottomessa waqt il-proċedura ta' Referenza ta' l-Artikolu 30 u r-riżultat talvalutazzjoni ta' proġett ta' qsim tax-xogħol ta' l-UE ta' dawn id-dejta pedjatriċi, is-CHMP qies li lkonklużjonijiet tal-Proġett ta' Qsim tax-Xogħol Pedjatriku Ewropew fuq losartan ħtieġ li jkun inkorporat fis-sezzjonijiet 4.2, 4.4, 4.8, 5.1 u 5.2 tas-Sommarju tal-Karatteristiċi tal-Prodott u ssezzjonijiet relevanti tal-Fuljett ta' Tagħrif.
English: PVC/aluminum foil/nylon blisters with aluminum foil lidding in packs of 10, 14 and 28.
Maltese: Folji tal-PVC/fojl ta' l-aluminju/najlon b'għotjien b'fojl ta' l-aluminju f'pakketti ta' 10, 14 u 28 pillola.
English: • changes in kidney function (may be reversible upon discontinuation of treatment) including kidney failure,
Maltese: • bidliet fil-funzjoni tal-kliewi (li jistgħu jkunu riversibbli mat-twaqqif ta' trattament) li jinkludi insuffiċjenza renali,
English: • Treatment of essential hypertension.
Maltese: • Trattament ta' pressjoni essenzjali għolja.
English: Pregnancy
Maltese: IPPREŻENTATI
English: Use of losartan in children and adolescents
Maltese: Użu ta' losartan fit-tfal u adolexxenti
English: Investigations:
Maltese: Investigazzjonijiet
English: Consequently, there is no potentiation of undesirable bradykininmediated effects.
Maltese: Konsegwentement, m'hemmx effetti potenzjali mhux mixtieqa li jistgħu jsiru b'bradykinin.
English: PHARMACEUTICAL FORM AND CONTENTS 7, 14, 21, 28, 50, 98, 210 or 500 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 7, 14, 21, 28, 50, 98, 210 jew 500 pillola miksija b'rita.
English: Cozaar film-coated tablets losartan potassium
Maltese: Isem Ivvintat losartan potassium
English: Despite these increases, antihypertensive activity and suppression of plasma aldosterone concentration are maintained, indicating effective angiotensin II receptor blockade.
Maltese: Minkejja dawn iż-żidied, l-attività kontra l-pressjoni għolja u t-trażżin tal-konċentrazzjoni ta' aldosterone fil-plażma huma mantenuti, li jindika impediment effettiv għar-riċettatur ta' angiotensin II.
English: The side effects of medicines are classified as follows: very common: happening in more than 1 in 10 patients common:
Maltese: L-effetti sekondarji ta' mediċini huma kklassifikati kif ġej: komuni ħafna: li jseħħu f'aktar minn pazjent 1 f'kull 10 komuni:
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of drugs.
Maltese: Filwaqt li mhemmx tagħrif epidemjoloġiku b'kontrolli fuq ir-riskju b'Impedituri għarRiċettaturi ta' Amgiotensin II (AIIRAs), riskji bħal dawn jistgħu jeżistu għal din il-klassi ta' mediċini.
English: Therefore, the proposed indication was considered approvable after a majority vote by the CHMP plenum and is supported with the following wording: “reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy, documented by ECG”.
Maltese: Għaldaqstant, l-indikazzjoni proposta kienet ikkunsidrata approvabbli wara vot ta' maġġoranza millplenum tas-CHMP u hija appoġġjata bil-formolazzjoni li ġejja: “tnaqqis ta' riskju ta' attakk ta' puplesija f'pazjenti bi pressjoni għolja b'ipertrofija ventrikolari xelluġija, iddokkumentata b'ECG”.
English: When angiotensin II antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid at anti-inflammatory doses and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Maltese: Meta antagonisti ta' angiotensin II jiġu amministrati b'mod simultaneju ma' mediċini mhux sterojdi li jaġixxu kontra l-infjammazzjoni, NSAIDs (i.e. impedituri silettivi ta' COX-2, acetylsalicylic acid f'dożi ta' kontra l-infjammazzjoni u NSAIDs mhux silettivi), jista' jkun hemm attenwazzjoni ta' l-effett ta' kontra l-pressjoni għolja.
English: Cozaar 12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 14, 21, 28, 50, 98, 210 or 500 tablets.
Maltese: Cozaar 12.5 mg - folji tal-PVC/PE/PVDC b'għotjien b'fojl ta' l-aluminju f'pakketti ta' 7 pilloli, 14-il pillola, 21, 28, 50, 98 pillola, 210 pilloli jew 500 pillola.
English: • fainting (syncope),
Maltese: • ħass ħażon (sinkope)
English: Hypertension and type 2 diabetes with renal disease In a controlled clinical trial in type 2 diabetic patients with proteinuria (RENAAL study, see section 5.1) the most common drug-related adverse events which were reported for losartan are as follows: Nervous system disorders: common: dizziness
Maltese: Pazjenti bi pressjoni għolja u dijabete ta' tip II ma' mard tal-kliewi Fi prova klinika b'kontrolli b'pazjenti li għandhom dijabete ta' tip 2 bi protejnurja (studju RENAAL, ara sezzjoni 5.1) l-aktar każijiet avversi marbutin mal-mediċina li ġew rapportati għal losartan huma dawn li ġejjin:
English: • rash,
Maltese: • sturdament,
English: Other antihypertensive agents (diuretics, calcium antagonists, alpha- and beta-receptor blockers and also centrally acting antihypertensives) were permitted as supplementary treatment depending on the requirement in both groups.
Maltese: Mediċini ta' kontra l-pressjoni għolja (dijuretiċi, antagonisti tal-kalċju, impedituri ta' riċettaturi alfa u beta u wkoll mediċini ta' kontra l-pressjoni li jaġixxu b'mod ċentrali) kienu permessi bħala trattament supplimentari skond il-ħtieġa ta' żewġ gruppi.
English: - Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria > 0.5 g/day as part of an antihypertensive treatment
Maltese: - Kura ta' mard tal-kliewi f'pazjenti bi pressjoni għolja u b'dijabete mellitus tip 2 bi proteinurja > 0.5 g/kuljum bħala parti mill-kura kontra l-pressjoni għolja
English: When pregnancy is diagnosed, treatment with losartan should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Maltese: Meta tqala tiġi dijanjonizzata, it-trattament b'Cozaar għandu jitwaqqaf immedjatament, u jekk jixraq, terapija alternattiva għandha tiġi mibdija (ara sezzjonijiet 4.3 u 4.6).
English: Treatment with losartan, as compared with placebo, resulted in a 16.1% risk reduction in the number of patients reaching the primary composite endpoint.
Maltese: Kura b'losartan, kif imqabbla ma' plaċebo, irriżultat fi tnaqqis ta' 16.1% fir-riskju fin-numru ta' pazjenti li kienu qegħdin jilħqu l-punt ta' tmiem primarju kompost.
English: It was found that concomitant treatment of losartan with rifampicine (inducer of matabolism enzymes) gave a 40% reduction in plasma concentration of the active metabolite.
Maltese: Instab li trattament fl-istess ħin b'losartan b'rifampicin (sensitizzatur ta' enżimi metaboliċi) wassal għal tnaqqis ta'40% fil-konċentrazzjoni tal-metabolit attiv fil-plażma.
English: Severe hepatic impairment
Maltese: Indeboliment epatiku sever