FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of losartan have been investigated in 50 hypertensive paediatric patients > 1 month to < 16 years of age following once daily oral administration of approximately 0.54 to 0.77 mg/ kg of losartan (mean doses).
Maltese: Il-farmakokinetiċi ta' losartan ġew mistħarrġa f'50 pazjent tifel u tifla bil-pressjoni għolja fl-etajiet ta' > minn xahar sa < 16-il sena wara l-għoti mill-ħalq kuljum ta' madwar 0.54 sa 0.77 mg/kg ta' losartan (dożi medji).
English: Excipient:
Maltese: Stħarriġ:
English: • In controlled clinical trials in approximately 3300 adult patients 18 years of age and older for essential hypertension
Maltese: • Fi prova klinika bil-kontrolli f'madwar 3300 pazjent adult ta' 18-il sena jew aktar għal pressjoni għolja essenzjali
English: COZAAR and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension Losartan potassium
Maltese: Cozaar u ismijiet assoċjati (ara Anness I) 2.5 mg/ml trab u solvent għal suspensjoni orali Losartan potassium
English: • a 240 ml amber polyethylene terephthalate (PET) bottle with polypropylene child resistant closure for mixing the suspension,
Maltese: • flixkun ta' 240 ml polyethylene terephthalate (PET) ta' lewn ambra b'għatu reżistenti għat-tfal li jintuża biex titħallat is-suspensjoni,
English: In a controlled clinical trial in approximately 3900 patients 20 years of age and older with cardiac insufficiency the following adverse events were reported:
Maltese: Fi prova klinika b'kontrolli f'madwar 3900 pazjent ta' 20 sena u aktar b'insuffiċjenza kardijaka l-effetti avversi li ġejjin ġew irrapportati:
English: Treatment of intoxication
Maltese: Trattament ta' intossikazzjoni
English: This pack contains:
Maltese: Mhux magħruf:
English: The use of losartan is contraindicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and
Maltese: L-użu ta' losartan hu kontraindikat waqt it-2 u t-3 trimestru ta' tqala (ara sezzjoni 4.3 u 4.4 ).
English: One bottle of reconstituted suspension (200 ml) contains 500 mg of losartan potassium.
Maltese: Kull flixkun ta' suspensjoni rikostitwita (200 ml) fiha 500 mg ta' losartan potassium.
English: Paediatric Hypertension
Maltese: Popolazzjoni pedjatrika
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 għandhom ikollhom frazzjoni ta' tfigħ fil-ventrikola tax-xellug ta' ≤ 40% u għandhom jiġu stabilizzati taħt it-tratatment ta' insuffiċjenza kronika tal-qalb.
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 dijurnali naturali jibqa' jinżamm.
English: In vitro and in vivo losartan and its pharmacologically active carboxylic acid metabolite E-3174 block all physiologically relevant actions of angiotensin II, regardless of the source or route of its synthesis.
Maltese: Losartan u l-metabolit farmakoloġikament attiv tiegħu ta' carboxylic acid E-3174 jimblokka l-azzjonijiet fiżjoloġiċi in vitro and in vivo rilevanti kollha ta' angiotensin II, irrispettivament tas-sors jew il-passaġġ fis-sintesi tiegħu.
English: Treatment usually starts with 12.5 mg losartan (5 ml of COZAAR suspension) once a day.
Maltese: It-trattament ġeneralment jibda b'pillola waħda ta' 12.5 mg losartan (5 ml ta' suspensjoni COZAAR) darba kuljum.
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 t-tqala tiġi dijanjonizzata, it-trattament b'losartan għandu jitwaqqaf minnufih, u, jekk jixraq, terapija alternattiva għandha tiġi mibdija (ara sezzjonijiet 4.3 u 4.6).
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 medicinal products.
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: In controlled clinical trials of approximately 3300 adult patients 18 years of age and older for essential hypertension with losartan the following adverse events were reported.
Maltese: Fil-provi kliniċi b'kontrolli fuq madwar 3300 pazjent adult ta' 18-il sena u fuqhom għal pressjoni essenzjali għolja b'losartan, ir-reazzjonijiet avversi li ġejjin ġew irraportati.
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: • għal pazjenti li għandhom kemm il-pressjoni għolja kif ukoll tħaxxin tal-ventrikolu tax-xellug, COZAAR intwera li jista' jnaqqas r-riskju ta' puplesija (“indikazzjoni LIFE”).
English: Use in children and adolescents (6 to 16 years):
Maltese: Użu fi tfal u adoloxxenti (minn 6 sa 16-il sena):
English: Losartan may be administered with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide).
Maltese: Losartan jista' jiġi mogħti ma' mediċini oħra ta' kontra l-pressjoni għolja, speċjalment mad-dijuretiċi (eż. hydrochlorothiazide).
English: not known: Anaemia, thrombocytopenia
Maltese: Anemija, tromboċitopenija
English: It was found that concomitant treatment of losartan with rifampicine (inducer of metabolism enzymes) gave a 40 % reduction in plasma concentration of the active metabolite.
Maltese: Instab li trattament fl-istess ħin b'losartan ma' rifampicin (sensitizzatur ta' enżimi metaboliċi) wassal għal tnaqqis ta'40% fil-konċentrazzjoni tal-metabolit attiv fil-plażma.
English: Nervous system disorders: uncommon: dizziness, headache rare: paraesthesia
Maltese: Disturbi fis-sistema nervuża: mhux komuni: sturdament, uġigħ ta' ras rari: paraestesija
English: Losartan is not recommended in children with hepatic impairment (see section 4.2).
Maltese: Losartan mhux rakkomandat fi tfal b'indeboliment epatiku (ara sezzjoni 4.2).
English: See package leaflet for instructions on how to prepare COZAAR 2.5 mg/ml oral suspension.
Maltese: Ara l-Fuljett ta' Tagħrif dwar struzzjonijiet ta' kif tiġi preparata s-suspensjoni orali ta' COZAAR 2.5 mg/ml.
English: Therefore, losartan is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Maltese: Għalhekk, losartan huwa kontraindikat f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.3 u 4.4).
English: When comparing preschool children with adolescents these differences became statistically significant.
Maltese: Meta ġew mqabbla l-etajiet ta' tfal ta' qabel l-iskola u l-adoloxxenti dawn id-differenzi kienu statistikament sinifikanti.
English: • One foil sachet filled with 500 mg losartan potassium powder
Maltese: Fih 500 mg ta' losartan potassium
English: Each sachet contains 500 mg of losartan potassium powder.
Maltese: Kull qartas fih 500 mg ta' trab ta' losartan potassium.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intoleranza għal fruttosju m'għandhomx jieħdu din il-mediċina.
English: For Healthcare providers only: See Package Leaflet for instructions on how to prepare Losartan potassium oral suspension.
Maltese: Għal fornituri li jipprovdu servizz ta' kura biss: Ara l-Fuljett ta' Tagħrif dwar struzzjonijiet ta' kif tiġi preparata s-suspensjoni orali ta' losartan.
English: Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, The Netherlands
Maltese: Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, L-Olanda
English: One ml solvent contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, and 50.6 mg sorbitol.
Maltese: 1 ml ta' solvent fih 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, u 50.6 mg sorbitol.
English: Safety data should be presented in the PSUR separated by age group and used formulation (e.g. tablets or oral suspension).
Maltese: Dejta ta' sigurtà għandha tiġi ppreżentata fil-PSUR f'kategoriji ta' grupp tal-età u l-formulazzjoni użata (eż. pilloli jew suspensjoni orali).
English: Adult Patients with high blood pressure and type 2 diabetes Treatment usually starts with 50 mg losartan (20 ml of COZAAR suspension) once a day.
Maltese: It-trattament ġeneralment jibda b'pillola waħda ta' 50 mg losartan (20 ml ta' suspensjoni COZAAR) darba kuljum.
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 tal-effett ta' kontra l-pressjoni għolja.
English: Czech Republic Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39,2003 PC, Haarlem, The Netherlands
Maltese: Repubblika Ċeka Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39,2003 PC, Haarlem, L-Olanda
English: Nervous system disorders: Common: dizziness, vertigo
Maltese: Disturbi fis-sistema nervuża: komuni: sturdament
English: • to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence ofimpaired renal function and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal amount of protein).
Maltese: • sabiex jipproteġi l-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: Remove the syringe and take the medicine.
Maltese: Neħħi d-dispenser u agħti l-mediċina.
English: Skin and subcutaneous tissue disorders:
Maltese: Disturbi muskolu-skeletriċi u tat-tessut konnettiv:
English: Czech Republic Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39, 2003 PC, Haarlem, The Netherlands
Maltese: Repubblika Ċeka Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39, 2003 PC, Haarlem, L-Olanda
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 skont il-ħtieġa ta' żewġ gruppi.
English: The dose should generally be titrated at weekly intervals (i.e. 12.5 mg daily, 25 mg daily, 50 mg daily) to the usual maintenance dose of 50 mg once daily, as tolerated by the patient.
Maltese: 12.5 mg kuljum, 25 mg kuljum, 50 mg kuljum) għal doża ta' manteniment ġenerali ta' 50 mg darba kuljum, kif ittolerata mill-pazjent..
English: Each sachet of powder for oral suspension delivers 500 mg of losartan potassium.
Maltese: Kull qartas ta' trab għal suspensjoni orali jagħti 500 mg ta' losartan potassium.
English: Renal and urinary disorders:
Maltese: Disturbi gastrointestinali:
English: Luxembourg Merck Sharp & Dohme BV -Chaussée de Waterloo 1135 - B-1180 Brussels, Belgium
Maltese: Il-Lussemburgu Merck Sharp & Dohme BV -Chaussée de Waterloo 1135 - B-1180
English: Losartan 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: Losartan jista' jiġi mogħti ma' mediċini ta' kontra l-pressjoni għolja oħrajn (eż. dijuretiċi, impedituri tal-kanali tal-kalċju, impedituri alfa- jew beta- u mediċini li jaġixxu b'mod ċentrali) kif ukoll mal-insulina u mediċini ipogliċemiċi komuni oħra (eż. sulfonylureas, glitazones u impedituri ta' glucosidase).
English: Consequently, there is no potentiation of undesirable bradykininmediated effects.
Maltese: Konsegwentement, m'hemmx effetti potenzjali mhux mixtieqa li jistgħu jsiru b'bradikinin.
English: Use in patients with renal impairment and haemodialysis patients:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali:
English: The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight administered once a day (up to 25 mg or 10 ml of COZAAR suspension).
Maltese: Id-doża rakkomandata li wieħed jibda biħa f'pazjenti li jiżnu bejn 20 u 50 kg hi ta' 0.7 mg ta' losartan għal kull kg ta' piż korporali li jingħata darba kuljum (sa25 mg jew10 ml ta' suspensjoni ta' COZAAR).
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: • to treat patients with chronic heart failure when therapy with specific medicines calledangiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower highblood 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: 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 b'aktar minn 100 mg) kuljum ma ġewx studjati f'pazjenti pedjatriċi.
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: Therefore losartan must not be administered in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
Maltese: Għalhekk losartan m'għandux jingħata lil pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: After reconstitution, store the liquid suspension in a refrigerator (at 2°C - 8°C) for up to 4 weeks.
Maltese: Wara r-rikostituzzjoni, aħżen is-suspensjoni likwida fi friġġ (f'temperatura ta' 2°C - 8°C) għal mhux aktar minn 4 ġimgħat.
English: Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan.
Maltese: Jekk l-insuffiċjenza kardijaka tiegħek ġiet stabilizzata b'impeditur ACE, inti m'għandekx tinqaleb fuq losartan.
English: • Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with Angiotensinconverting enzyme (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 ta' Angiotensin-converting enzymes mhux ikkonsidrat xieraq minħabba inkompatibilità, speċjalment sogħla, jew kontraindikazzjonijiet.
English: In a clinical study conducted in type 2 diabetic patients with nephropathy, the incidence of hyperkalemia was higher in the group treated with losartan as compared to the placebo group (see section 4.8).
Maltese: Fi studju kliniku li sar fuq pazjenti dijabetiċi ta' tip 2 b'nefropatija, l-inċidenza ta' iperkalemija kienet ogħla fil-grupp ittrattat b'losartan meta mqabbel mal-grupp li ħa l-plaċebo (ara sezzjoni 4.8).
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: Patients were randomised to once daily Losartan 50 mg or once daily atenolol 50 mg.
Maltese: Il-pazjenti kienu randomizzati għal doża ta' Losartan 50 mg darba kuljum u atenolol 50 mg darba kuljum.
English: Use in pediatric patients with renal impairment
Maltese: L-użu f'pazjenti pedjatriċi b'indeboliment renali
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 tal-imluħa li fihom il-potassju, jew mediċini li jirristrinġu l-potassju flurina bħal ċertu dijuretiċi [amiloride, triamteren, spironolactone] jew eparina),
English: Concomitant use with other substances which may induce hypotension as an adverse reaction (like tricyclic antidepressants, antipsychotics, baclofen, and amifostine) may increase the risk of hypotension.
Maltese: L-użu konġunt ta' sustanzi oħra li jistgħu jinduċu l-pressjoni baxxa bħala reazzjoni avversa (bħal mediċini triċikliċi li jaġixxu kontra d-dipressjoni, antipsikotiċi, baclofen, u amifostine) jistgħu jżidu r-riskju ta' pressjoni baxxa.
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: 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: Investigations: uncommon: increase in blood urea, serum creatinine and serum potassium has been reported.
Maltese: Stħarriġ: mhux komuni: żieda tal-urea fid-demm, ta' kreatinina fis-serum u ta' potassju fis-serum ġew irrapportati.
English: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products 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: Hypertension and type 2 diabetes with renal disease In a controlled clinical trial in 1513 type 2 diabetic patients 31 years of age and older with proteinuria (RENAAL study, see section 5.1) the most common drug-related adverse reactions which were reported for losartan are as follows:
Maltese: Pazjenti bi pressjoni għolja u dijabete ta' tip II ma' mard tal-kliewi Fi prova klinika b'kontrolli f'1513-il pazjent 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 kienu dawn li ġejjin:
English: COZAAR and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension [See Annex I - To be completed nationally]
Maltese: COZAAR u ismijiet assoċjati (ara Anness I) 2.5 mg/ml trab u solvent għal suspensjoni orali [Ara Anness I - Sabiex jitlesta fil-pajjiż stess]
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION COZAAR and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension Losartan potassium.
Maltese: U MNEJN GĦANDU JINGĦATA COZAAR u ismijiet assoċjati (ara Anness I) 2.5 mg/ml trab u solvent għal suspensjoni orali Losartan potassium.
English: Patients who weighted >20 kg to < 50 kg received either 2.5, 25 or 50 mg of losartan daily and patients who weighted > 50 kg received either 5, 50 or 100 mg of losartan daily.
Maltese: Pazjenti li kienu jiżnu > 20 kg sa < 50 kg irċevew ta' filtrazzjoni glomerulari ta' > 30 ml/min/1.73m jew 2.5, 25 jew 50 mg ta' losartan kuljum u pazjenti li kienu jiżnu > 50 kg irċevew jew 5, 50 jew 100 mg ta' losartan kuljum.
English: The usual initial dose of losartan in patients with heart failure is 12.5 mg once daily.
Maltese: Id-doża inizjali ta' losartan li ġeneralment tingħata f'pazjenti li għandhom insuffiċjenza kardijaka hi ta' 12.5 mg darba kuljum.
English: In patients >50 kg, the usual dose is 50 mg once daily.
Maltese: F'pazjenti li jiżnu >50 kg id-doża li ġeneralment tingħata hi ta' 50 mg kuljum.
English: The following information is intended for medical or healthcare professionals only:
Maltese: Oqgħod attent jekk qed tieħu il-mediċini li ġejjin waqt li tkun qed tieħu COZAAR:
English: One ml suspension contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, 50.6 mg sorbitol,.and 1.275 mg lactose.
Maltese: 1 ml ta' suspensjoni fih 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, 50.6 mg sorbitol, u 1.275 mg lactose.
English: General disorders and administration site conditions: not known: flu-like symptoms
Maltese: Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata: mhux magħruf: sintomi bħal tal-influwenza
English: Muscoskeletal and connective tissue disorders: not known: myalgia, arthralgia
Maltese: Disturbi tad-demm u tas-sistema limfatika: mhux magħruf: anemija
English: Unless continued losartan therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Maltese: Għajr meta t-terapija b'losartan hija kkonsidrata essenzjali, il-pazjenti li jippjanaw tqala għandhom jinqalbu fuq trattamenti oħra ta' kontra l-pressjoni li għandhom profil ta' sigurtà stabilit għal użu fi tqala.
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' anġjoedema (nefħa fil-wiċċ, ix-xofftejn, il-griżmejn, u /jew l-ilsien) għandhom jiġu monitorati mill-qrib (ara sezzjoni 4.8).
English: Vascular disorders: uncommon: hypotension, including orthostatic hypotension
Maltese: Disturbi vaskulari: mhux komuni: pressjoni baxxa, li tinkludi pressjoni ortostatika baxxa
English: The active metabolite is 10- to 40- times more active than Losartan on a weight for weight basis.
Maltese: Il-metabolit attiv huwa minn 10 sa 40 darba aktar attiv minn losartan fuq bażi ta' piż għal piż.
English: One ml suspension contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, 50.6 mg sorbitol and 1.275 mg lactose.
Maltese: 1 ml ta' suspensjoni fiha 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, 50.6 mg sorbitol u 1.275 mg lactose.
English: Discard the excess solvent not used in the preparation of the suspension.
Maltese: Wara li jiġi rikostitwit bħala suspensjoni mis-solvent COZAAR huwa likwidu ofwajt
English: Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem The Netherlands
Maltese: Id-Danimarka Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem L-Olanda
English: Methylhydroxybenzoate and propylhydroxybenzoate.
Maltese: Methylhydroxybenzoate u propylhydroxybenzoate.