FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with proteinuria and a serum creatinine of 1.3 - 3.0 mg/dl were randomised to receive Losartan 50 mg once a day, titrated if necessary, to achieve blood pressure response, or to placebo, on a background of conventional antihypertensive therapy excluding ACE-inhibitors and angiotension II antagonists.
Maltese: Pazjenti bi protejnurja u b'livelli ta' 1.3 - 3.0 mg/dl ta' kreatinina fis-serum kienu randomizzati biex jirċievu Losartan 50 mg darba kuljum, b'mod iddożat jekk meħtieġ, sabiex jintlaħaq rispons għal pressjoni tad-demm, jew għal plaċebo, fi sfond ta' terapija ta' kontra l-pressjoni konvenzjonali li teskludi impedituri ACE u antagonisti ta' angiotensin II.
English: Each Cozaar 25 mg tablet contains 25 mg of losartan potassium.
Maltese: Kull pillola ta' 25 mg Cozaar fiha 25 mg ta' losartan potassium.
English: The patients should have a left ventricular ejection fraction ≤ 40% and should be stabilised under the treatment of the chronic heart failure
Maltese: Il-pazjenti għandu jkollhom frazzjoni ta' tfigħ fil-ventrikola tax-xellug ta' ≤ 40% u għandhom jiġu stabilizzati taħt it-tratatment ta' insuffiċjenza kronika tal-qalb.
English: Each Cozaar 12.5 mg tablet contains 12.5 mg of losartan potassium.
Maltese: Kull pillola ta' 12.5 mg Cozaar fiha 12.5 mg ta' losartan potassium.
English: Cozaar may be administered with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide).
Maltese: Cozaar jista' jiġi mogħti ma' mediċini oħra ta' kontra l-pressjoni għolja, speċjalment mad-dijuretiċi (eż. hydrochlorothiazide).
English: Losartan is also not recommended in children with hepatic impairment (see section 4.2).
Maltese: Losartan ukoll mhux rakkomandat fi tfal b'indeboliment epatiku (ara sezzjoni 4.2).
English: Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Maltese: Il-pazjenti għandhom ikunu idratati sew u konsiderazzjoni għandha tingħata sabiex il-funzjoni renali tibqa' tiġi monitorata wara l-bidu ta' terapija konkomitanti, u perijodikament wara din.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 100 mg losartan potassium.
English: In the ELITE II Study Losartan 50 mg once daily (starting dose 12.5 mg, increased to 25 mg, then 50 mg once daily) was compared with captopril 50 mg three times daily (starting dose 12.5 m, increased to 25 mg and then to 50 mg three times daily).
Maltese: Fl-Istudju ELITE II Losartan 50 mg li ngħata darba kuljum (b'doża inizjali ta' 12.5 mg, miżjuda għal 25 mg, imbagħad għal 50 mg darba kuljum) kien imqabbel ma' captopril 50 mg li ngħata tliet darbiet kuljum (doża tal-bidu ta' 12.5 mg, miżjuda għal 25 mg u mbagħad għal 50 mg tliet darbiet kuljum).
English: Cosaar 100 mg - Filmtabletten 100 mg
Maltese: Cosaar 100 mg - Filmtabletten
English: When comparing preschool children with adolescents these differences became statistically significant.
Maltese: Meta t-tfal ta' qabel l-età ta' l-iskola tqabblu ma' adolexxenti, dawn id-differenzi saru statistikament sinjifikanti.
English: non-steroidal anti-inflammatory drugs such as indomethacin, including cox-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the blood lowering effect of losartan.
Maltese: • mediċini mhux sterojdi u mhux infjammatorji bħal indomethacin, li jinkludu impedituri ta' cox-2 ( mediċini li jnaqqsu l-infjammazzjoni, u li jistgħu jintużaw biex ittaffu l-uġigħ) peress li jistgħu jnaqqsu l-effett fuq id-demm ta' losartan.
English: If goal blood pressure (< 140/90 mmHg) was not reached, hydrochlorothiazide (12.5 mg) was added first and, if needed, the dose of Losartan or atenolol was then increased to 100 mg once daily.
Maltese: Jekk il-pressjoni tad-demm bersalljata (< 140/90 mmHg) ma ntlaħqitx, ingħatat doża ta' hydrochlorothiazide (12.5 mg) l-ewwel u, jekk meħtieġ id-doża ta' Losartan jew atenolol ġiet miżjuda sa 100 mg darba kuljum.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each Cozaar 12.5 mg film-coated mg tablet contains 12.5 mg losartan potassium.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola Cozaar miksija b'rita ta' 12.5 mg fiha 12.5 mg losartan potassium.
English: in patients with high blood pressure and a thickening of the left ventricle, COZAAR has been shown to decrease the risk of stroke (“LIFE indication”).
Maltese: Cozaar intwera li jista' jnaqqas r-riskju ta' puplesija (“indikazzjoni LIFE”).
English: Doses above 1.4 mg/ kg (or in excess of 100 mg) daily have not been studied in pediatric patients.
Maltese: Dożi ta' aktar minn 1.4 mg/kg (jew f'eċċess ta' 100 mg) kuljum ma ġewx studjati f'pazjenti pedjatriċi.
English: The pharmacokinetic parameters for the metabolite differed to a greater extent between the age groups.
Maltese: Il-parametri farmakokinetiċi għall-metabolit varjaw sewwa bejn il-gruppi ta' l-età.
English: Hepatobiliary disorders: rare: hepatitis not known: liver function abnormalities
Maltese: Disturbi fil-fwied u fil-marrara: rari: epatite mhux magħruf: abnormalitajiet fil-funzjonament tal-fwied
English: LIST OF EXCIPIENTS Lactose monohydrate.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Lactose monohydrate.
English: Cozaar 25 mg tablet
Maltese: Cozaar pillola ta' 25 mg
English: Patients with a history of angiooedema (swelling of the face, lips, throat, and/ or tongue) should be closely monitored (See section 4.8).
Maltese: Pazjenti bi storja ta' anġjodema (nefħa fil-wiċċ, ix-xofftejn, il-griżmejn, u /jew l-ilsien) għandhom jiġu monitorati mill-qrib (ara sezzjoni 4.8).
English: Cozaar 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Maltese: Cozaar 100 mg - Folji tal-PVC/PE/PVDC b'għotjien b'fojl ta' l-aluminju f'pakketti ta' 7, 10 pilloli, 14, 15-il pillola, 20, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
English: - Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with ACE inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication.
Maltese: - Kura ta' falliment kroniku tal-qalb (f'pazjenti ≥ 60 sena), meta kura b'impedituri ACE mhijiex ikkunsidrata addattata minħabba inkompatibilità, speċjalment sogħla, jew kontraindikazzjoni.
English: The following wording has been added to SPC Section 5.1.Pharmacodynamic Properties:
Maltese: Il-formolazzjoni li ġejja ġiet miżjuda ma' sezzjoni 5.1. tal-SPC Tagħrif farmakodinamiku:
English: When losartan is administered orally, about 4% of the dose is excreted unchanged in the urine, and about 6% of the dose is excreted in the urine as active metabolite.
Maltese: Meta losartan jiġi mogħti mill-ħalq, madwar 4% tad-doża tiġi eliminata mingħajr ma titbidel fl-urina, u madwar 6% tad-doża tiġi eliminata fl-urina bħala l-metabolit attiv.
English: The following wording has been added to SPC Section 5.2 Pharmacokinetic properties:
Maltese: Il-formolazzjoni li ġejja ġiet miżjuda ma' sezzjoni 5.2 tal-SPC Tagħrif Farmakokinetiku:
English: • to treat patients with chronic heart failure when therapy with specific medicines called angiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable by your doctor.
Maltese: • biex jittratta pazjenti b'insuffiċjenza kardijaka kronika meta terapija b'mediċini speċifiċi msejħa impedituri ta' enżimi li jikkonvertu anġjotensin (impedituri ACE, mediċina użata biex tnaqqas il-pressjoni għolja) mhix konsidrata adattata mit-tabib tiegħek.
English: Following oral administration, losartan is well absorbed and undergoes first-pass metabolism, forming an active carboxylic acid metabolite and other inactive metabolites.
Maltese: Wara li jingħata mill-ħalq, losartan jiġi assorbit sew u jgħaddi minn proċess ta' first-pass metabolism, bil-formazzjoni ta' metabolit attiv ta' carboxylic acid u metaboliti mhux attivi oħra.
English: Whilst the ELITE I indicated an reduction in risk of mortality due to heart failure in patients taking losartan, as compared to captopril, the ELITE II study was not powered to establish equal efficacy between losartan and captopril.
Maltese: Waqt li ELITE I indika tnaqqis fir-riskju ta' mortalità dovuta għal falliment talqalb f'pazjenti li jkunu qegħdin jieħdu losartan, meta mqabbel ma' captopril, l-istudju ELITE II ma kienx imfassal biex jistabbilixxi effikaċja indaqs bejn losartan u captopril.
English: Uncommon: symptomatic hypotension (especially in patients with intravascular volume depletion, e.g. patients with severe heart failure or under treatment with high dose diuretics), dose-related orthostatic effects, rash.
Maltese: Mhux komuni: pressjoni baxxa sintomatika (speċjalment f'pazjenti bi żvojtar ta' volumi intravaskulari eż. pazjenti b'insuffiċjenza tal-qalb severa jew taħt trattament b'dożi għolja ta' dijuretiċi), effetti ortostatiċi relatati mad-doża, raxx.
English: - Renal protection in patients with Type-2 diabetes and proteinuria The CHMP considered the benefit/risk ratio of this indication is positive.
Maltese: - Protezzjoni renali f'pazjenti b'dijabete tip-2 u proteinurja Is-CHMP ikkunsidra l-proporzjon ta' riskju/benefiċċju għal din l-indikazzjoni bħala wieħed pożittiv.
English: • if you have had a history of angiooedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 ‘Possible side effects'),
Maltese: • jekk għandek storja ta' anġjodema (nefħa tal-wiċċ, ix-xofftejn, il-griżmejn, u/jew l-ilsien) (ara wkoll sezzjoni 4 ‘Effetti sekondarji li jista' jkollu'),
English: In patients >50 kg, the usual dose is 50 mg once daily.
Maltese: F'pazjenti >50 kg, id-doża normali ta' kuljum hija 50 mg darba kuljum.
English: • liver function abnormalities,
Maltese: • abnormalitajiet fil-funzjoni tal-fwied,
English: The dose-response relationship became very obvious in the low dose group compared to the middle dose group (period I: -6.2 mmHg vs. -11.65 mmHg), but was attenuated when comparing the middle dose group with the high dose group (period I: -11.65 mmHg vs. -12.21 mmHg).
Maltese: -11.65 mmHg), iżda kienet imnaqqsa meta l-grupp ta' doża tan-nofs tqabbel mal-grupp ta' doża għolja (perijodu I: -11.65 mmHg vs. -12.21 mmHg).
English: Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.
Maltese: Sintomi ta' doża eċċesiva huma pressjoni baxxa, żieda fit-taħbit tal-qalb, u possibilment tnaqqis fit-taħbit tal-qalb.
English: Hypertensive patients with left ventricular hypertrophy In a controlled clinical trial in hypertensive patients with left ventricular hypertrophy the following adverse events were reported:
Maltese: Pazjenti bil-pressjoni għolja b'ipertrofija fil-ventrikola tax-xellug Fi prova klinika b'kontrolli b'pazjenti bi pressjoni għolja u b'ipertrofija fil-ventrikola tax-xellug, l-effetti avversi li ġejjin kienu rapportati:
English: Cardiac disorders: not known: syncope, palpitations
Maltese: Disturbi kardijaċi: mhux magħruf: sinkope, palpitazzjonijiet
English: The main areas of disharmony of the existing Summary of Product Characteristics were section 4.1 Therapeutic Indications, section 4.3 Contraindications, and section 4.4 Special Warnings and Precautions for Use.
Maltese: L-oqsma ewlenin ta' nuqqas ta' armonija tas-Sommarju tal-Karatteristiċi tal-Prodott eżistenti kienu sezzjoni 4.1 Indikazzjonijiet Terapewtiċi, sezzjoni 4.3 Kontra-indikazzjonijiet, u sezzjoni 4.4
English: Each Cozaar 50 mg tablet contains 50 mg of losartan potassium.
Maltese: Kull pillola ta' 50 mg Cozaar fiha 50 mg ta' losartan potassium.
English: Therefore, losartan is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Maltese: Għalhekk, losartan huwa kontra-indikat f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.3 u 4.4)
English: Use in pediatric patients with renal function impairment Losartan is not recommended in children with glomerular filtration rate < 30ml/ min/ 1.73 m2as no data are available (see section 4.2).
Maltese: Minħabba li ma hemm l-ebda tagħrif disponibbli, losartan mhuwiex irrakkomandat fi tfal b'rata ta' filtrazzjoni glomerulari < 30ml/ min/ 1.73 m2 (ara sezzjoni 4.2).
English: In this leaflet:
Maltese: mhux magħruf:
English: Both biliary and urinary excretion contribute to the elimination of losartan and its metabolites.
Maltese: Kemm l-eliminazzjoni biljari u dik urinarja jikkontribwixxu għall-eliminazzjoni ta' losartan u l-metabolit tiegħu.
English: In this study 3152 patients with heart failure (NYHA Class II-IV) were followed for almost two years (median: 1.5 years) in order to determine whether Losartan is superior to captopril in reducing all cause mortality.
Maltese: II-IV) kienu invistati għal madwar sentejn (medjan: 1.5 sena) sabiex jiġi stabbilit jekk Losartan hux superjuri għal captopril biex inaqqas il-mortalità ta' kull kawża.
English: Pregnancy and Lactation should be contraindicated and the appropriate wording included in sections 4.3, 4.4 and 4.6 of the SPC, and the relevant sections of the Package Leaflet.
Maltese: It-Tqala u Treddigħ għandhom ikunu kontraindikati u l formolazzjoni addattata għandha tiġi inkluża fis-sezzjonijiet 4.3, 4.4 u 4.6 ta' l-SPC, u fis-sezzjonijietrelevanti tal-Fuljett ta' Tagħrif.
English: Losartan tablets may be administered with other blood pressure lowering medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Maltese: Il-pilloli Losartan jistgħu jingħataw ma' mediċini oħra li jnaqqsu l-pressjoni tad-demm (eż. dijuretiċi, imblokkaturi tal-kanal tal-kalċju, imblokkaturi alfa jew beta u mediċini li jaġixxu b'mod ċentrali) kif ukoll ma' l-insulina u mediċini oħra li ġeneralment jingħataw għad-dijabete li jnaqqsu l-livell ta' glukosju fid-demm (eż. sulfonylureas, glitazones u impedituri ta' glucosidase).
English: In repeated dose toxicity studies, the administration of losartan induced a decrease in the red blood cell parameters (erythrocytes, haemoglobin, haematocrit), a rise in urea-N in the serum and occasional rises in serum creatinine, a decrease in heart weight (without a histological correlate) and gastrointestinal changes (mucous membrane lesions, ulcers, erosions, haemorrhages).
Maltese: Fi studji dwar l-effett tossiku minn dożi ripetuti, l-għoti ta' losartan issensitizza tnaqqis fil-parametri taċ-ċelluli l-ħomor tad-demm (eritroċiti, emoglobina u ematokrit), żieda fil-urea-N fis-serum u kull tant żmien żidied fil-livell ta' kreatinina fis-serum, piż imnaqqas tal-qalb (mingħajr spjegazzjoni ħistoloġika), u bidliet gastrointestinali (feriti mukużi tar-rita, ulċeri, tgħawwir, emorraġiji).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg losartan potassium.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 25 mg losartan potassium.
English: The proposed indication is based on the results from the RENAAL study, where the effect of losartan was investigated on a composite primary endpoint of renal endpoints and mortality in patients with Type II diabetes mellitus with proteinuria.
Maltese: L-indikazzjoni proposta hija bbażata fuq ir-riżultati mill-istudju RENAAL, fejn l-effett ta' losartan kien investigat fuq punt ta' tmiem primarju kompost ta' punti ta' tmiem renali u mortalità f'pazjenti b'dijabete mellitus Tip II bi proteinurja.
English: Cozaar and associated names (see Annex I) 12.5 mg film-coated tablets Cozaar and associated names (see Annex I) 25 mg film-coated tablets Cozaar and associated names (see Annex I) 50 mg film-coated tablets Cozaar and associated names (see Annex I) 100 mg film-coated tablets
Maltese: Cozaar u ismijiet assoċjati (ara Anness I) 12.5 mg pilloli miksija b'rita Cozaar u ismijiet assoċjati (ara Anness I) 25 mg pilloli miksija b'rita Cozaar u ismijiet assoċjati (ara Anness I) 50 mg pilloli miksija b'rita Cozaar u ismijiet assoċjati (ara Anness I) 100 mg pilloli miksija b'rita
English: Therefore, the CHMP proposed that the indication should be re-worded to “Treatment of renal disease in patients with hypertension and Type II diabetes mellitus with proteinuria > 0.5g/day as part of an antihypertensive treatment” to reflect the inclusion criteria of the RENAAL study.
Maltese: Għaldaqstant, is-CHMP ippropona li l-indikazzjoni għandha tkun ifformulata mill-ġdid għal “Kura ta' mard renali f'pazjenti bi pressjoni għolja u b'dijabete mellitus Tip II bi proteinurja > 0.5g/jum bħala parti minn kura kontra l-pressjoni għolja” biex tirrifletti l-kriterji ta' inklużjoni ta' l-istudju RENAAL.
English: Should exposure to losartan have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Maltese: Jekk l-espożizzjoni għal losartan tkun seħħet mit-tieni trimestru ta' tqala, verifiċi bl-ultrasawnd għal funzjoni renali u l-kranju huma rakkomandati.
English: The use of losartan is contra-indicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and
Maltese: L-użu ta' losartan hu kontra-indikat waqt it-2ni u t-3et tliet xhur ta' tqala (ara sezzjonijiet 4.3 u 4.4).
English: The rates of cardiovascular death and myocardial infarction were not significantly different between the treatment groups.
Maltese: Ir-rata ta' mortalità għal kull kawża ma kinetx sinifikament differenti bejn iż-żewġ gruppi ta' trattament.
English: • Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with ACE inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication.
Maltese: • Trattament ta' insuffiċjenza kronika tal-qalb (f'pazjenti ≥ 60 sena), meta t-trattament b'impedituri ACE mhux ikkonsidrat xieraq minħabba inkompatibilità, speċjalment sogħla, jew kontra-indikazzjonijiet.
English: In a controlled clinical trial in patients with cardiac insufficiency the following adverse events were reported:
Maltese: Fi prova klinika b'kontrolli f'pazjenti b'insuffiċjenza kardijaka l-effetti avversi li ġejjin ġew irrapportati:
English: Cozaar 50 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets.
Maltese: Cozaar 50 mg - folji tal-PVC/PE/PVDC b'għotjien b'fojl ta' l-aluminju f'pakketti ta' 7, 10 pilloli, 14, 15-il pillola, 20, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
English: For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients >20 to <50 kg.
Maltese: Għal pazjenti li jistgħu jibilgħu pilloli, id-doża rrakkomandata hija 25 mg darba kuljum f'pazjenti >20 sa <50 kg.
English: The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy.
Maltese: L-effett massimu kontra l-pressjoni għolja jintlaħaq fi żmien 3-6 ġimgħat minn wara li tinbeda t-terapija.
English: There was also a significant risk reduction for doubling of the serum creatinine and for end-stage renal failure in the patient group treated with losartan.
Maltese: Kien hemm ukoll tnaqqis sinjifikanti fir-riskju għall-irdoppjar tal-kreatinin fis-serum u għal indeboliment renali fi stadju ta' tmiem fil-grupp ta' pazjenti kkurati b'losartan.
English: Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system.
Maltese: Pazjenti b'aldosteroniżmu primarju ġeneralment mhux ser jirrispondu għal mediċini ta' kontra l-pressjoni li jaġixxu b'impediment fuq is-sistema renin-angiotensin.
English: Each Cozaar 25 mg Tablet contains 25 mg of losartan (as potassium salt).
Maltese: Kull Pillola ta' 25 mg Cozaar fiha 25 mg ta' losartan (bħala mluħa tal-potassju).
English: Each Cozaar 100 mg Tablet contains 91 100 mg of losartan (as potassium salt).
Maltese: Kull Pillola ta' 100 mg Cozaar fiha 100 mg ta' losartan (bħala mluħa tal-potassju).
English: Each Cozaar 12.5 mg Tablet contains 12.5 mg of losartan (as potassium salt).
Maltese: Kull Pillola ta' 12.5 mg Cozaar fiha 12.5 mg ta' losartan (bħala mluħa tal-potassju).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg losartan potassium.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 12.5 mg losartan potassium.
English: LORTAAN IC- Titulação 12.5 mg + 50 mg
Maltese: Cozaar Startpakke 12,5 mg + 50 mg
English: Therefore losartan must not be administered in patients with severe hepatic impairment (see sections 4.2, 4.3and 5.2).
Maltese: Għalhekk losartan m'għandux jingħata lil pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
Maltese: Losartan huwa wkoll mhux rakkomandat fi tfal b'indeboliment epatiku (ara wkoll sezzjoni 4.4).
English: Patients with heart failure who have been stabilised with an ACE inihibitor should not be switched to losartan.
Maltese: Jekk l-insuffiċjenza kardijaka tiegħek ġiet stabilizzata b'impeditur ACE, inti m'għandekx tinqaleb fuq losartan.
English: In both comparator-controlled (not placebo-controlled) clinical studies on patients with heart failure the tolerability of Losartan was superior to that of captopril, measured on the basis of a significantly lower rate of discontinuations of therapy on account of adverse events and a significantly lower frequency of cough.
Maltese: Fiż-żewġ studji kliniċi komparattivi b'kontrolli (mhux kontrollati bi plaċebo) fuq pazjenti b'insuffiċjenza kardijaka, it-tollerabilità ta' Losartan kienet superjuri għal dik ta' captopril, imkejla fuq bażi ta' rata sinifikament mnaqqsa ta waqfiet mit-terapija minħabba każijiet avversi u frekwenza sinifikament mnaqqsa ta' sogħla.
English: Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG
Maltese: Tnaqqis fir-riskju ta' puplesija f'pazjenti bi pressjoni għolja li għandhom ipertropija fil-ventrikula tax-xellug iddokumentata b'ECG
English: In controlled clinical trials for essential hypertension with losartan the following adverse events were reported
Maltese: Fil-provi kliniċi b'kontrolli għal pressjoni essenzjali għolja b'losartan, ir-reazzjonijiet avversi li ġejjin ġew irraportati:
English: The LIFE study has been assessed in the past and this has led to the registration of the more extensive indication, i.e. the reduction of the cardiovascular morbidity and mortality (as measured by the combined incidence of CV death, stroke and MI) instead of stroke only.
Maltese: L-istudju LIFE ġie vvalutat fil-passat u dan wassal għar-reġistrazzjoni ta' l-indikazzjoni iktar estensiva, jiġifieri t-tnaqqis tal-morbidità u tal-mortalità kardjovaskulari (kif imkejlin blinċidenza kkumbinata ta' mewt KV, attakk ta' puplesija u MI (attakk tal-qalb)) minflok ta' attakk ta' puplesija biss.
English: Pharmacokinetics in paediatric patients
Maltese: Farmakokinetiċi f'pazjenti pedjatriċi
English: Patients with Heart Failure Treatment usually starts with 12.5 mg losartan (one tablet Cozaar 12.5 mg) once a day.
Maltese: It-trattament ġeneralment jibda b'pillola waħda ta' 12.5 mg losartan (pillola Cozaar 12.5 mg) darba kuljum.
English: The results showed roughly similar pharmacokinetic parameters of losartan following oral administration in infants and toddlers, preschool children, school age children and adolescents.
Maltese: Ir-riżultati wrew parametri farmakokinetiċi bejn wieħed u ieħor simili ta' losartan wara għoti orali fit-trabi u fi tfal żgħar li jkunu għadhom kif telqu jimxu, tfal ta' qabel l-età ta' l-iskola, tfal ta' età ta' l-iskola u adolexxenti.
English: Cozaar 100 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Maltese: Il-pilloli ta' 100 mg Cozaar jista' jkun fihom ukoll Carnauba wax (E903), Titanium dioxide (E171).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 50 mg losartan potassium.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 50 mg losartan potassium.