FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the CHMP considered that the benefit risk for the indication Reduction in risk of cardiovascular morbidity and mortality ( or risk of stroke_) in hypertensive patients with left ventricular hypertrophy is negative and this indication is not acceptable for the FDC.
Maltese: Għaldaqstant, is-CHMP ikkunsidra li l-benefiċċju riskju għall-indikazzjoni Tnaqqis fir-riskju ta' morbidità u mortalità kardjovaskulari (jew riskju ta' attakk ta' puplesija) f'pazjenti bi pressjoni għolja b'ipertrofija ventrikolari xellugija hija negattiva u din l-indikazzjoni mhijiex aċċettabbli għall-FDC.
English: Common: Cough, upper respiratory infection, nasal congestion, sinusitis, sinus disorder Uncommon: Pharyngeal discomfort, pharyngitis, laryngitis, dyspnoea, bronchitis, epistaxis, rhinitis, respiratory congestion
Maltese: Sogħla, infezzjoni fil-passaġġ ta' fuq, konġestjoni nażali, sinusite, disturb fis-sinus Mhux komuni: Skumdità farinġeali, farinġite, larinġite, dispnea, bronkite, epistassi, rinite, konġestjoni respiratorja
English: Following an oral dose of 14C-labeled losartan in man, about 35% of radioactivity is recovered in the urine and 58% in the feces.
Maltese: Wara doża meħuda mill-ħalq ta' losartan ittikkettat b'14C fil-bniedem, madwar 35% ta' radjoattività ġiet irkuprata fl-urina u 58% fl-ippurgar.
English: Thiazides should be discontinued before carrying out tests for parathyroid function.
Maltese: Thiazides għandhom jiġu mwaqqfa qabel ma jsiru testijiet għal funzjoni tal-paratajrojd.
English: Hypotension and electrolyte/fluid imbalance
Maltese: Pressjoni baxxa u l-iżbilanċ ta' l-elettroliti/fluwidu
English: Uncommon: Alopecia, dermatitis, dry skin, erythema, flushing, photosensitivity, pruritus, rash, urticaria, sweating
Maltese: Mhux komuni: Alopeċja, dermatite, ġilda xotta, eritema, ħmura, fotosensittività, ħakk, raxx, urtikarja, togħrieq
English: Cozaar Comp 100 mg/12.5 mg also contain: white color concentrate [or the individual ingredients of the concentrate: hydroxypropyl cellulose (E463), hypromellose (E464) and titanium dioxide (E171)] and carnauba wax (E903).
Maltese: Cozaar Comp 100 mg/12.5 mg fih ukoll: konċentrat tal-kulur abjad [jew l-ingredjenti individwali talkonċentrat: hydroxypropyl cellulose (E463), hypromellose (E464) u titanium dioxide (E171)] u carnauba wax (E903).
English: Cozaar Comp 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.
Maltese: Cozaar Comp 50 mg/12.5 mg fihom 4.24 mg (0.108 mEq) ta' potassju.
English: Losartan/HCTZ tablets must not be used in patients with severe renal impairment (i.e. creatinine clearance <30 ml/min) (see section 4.3).
Maltese: Il-pilloli losartan/HCTZ m'għandhomx jintużaw f'pazjenti b'indeboliment renali sever (i.e. tneħħija ta' kreatinina <30 ml/min) (ara sezzjoni 4.4).
English: The concomitant use of potassium sparing diuretics, potassium supplements and potassium containing salt substitutes with losartan/ hydrochlorothiazide 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: PHARMACEUTICAL FORM AND CONTENTS 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 4, 7, 10 pilloli, 14-il pillola, 20, 28, 30, 50, 84, 56, 98, jew 280 pillola miksija b'rita.
English: Not applicable.
Maltese: Effett addittiv.
English: Cozaar Comp 50 mg/12.5 mg and Cozaar Comp 100 mg/25 mg also contain titanium dioxide (E171), quinoline yellow aluminum lake (E104) and carnauba wax (E903).
Maltese: Cozaar Comp 50 mg/12.5 mg u Cozaar Comp 100 mg/25 mg fihom ukoll titanium dioxide (E171), quinoline yellow aluminum lake (E104) u carnauba wax (E903).
English: In case of high dosages of salicylates hydrochlorothiazide may enhance the toxic effect of the salicylates on the central nervous system.
Maltese: F'każ ta' dożi għoljin ta' salicylates, hydrochlorothiazide jista' jħarrax l-effetti tossiċi ta' salicylates fuq is-sistema nervuża ċentrali.
English: • Reduction of cardiovascular morbidity and mortality (or risk of stroke) in hypertensive patients with left ventricular hypertrophy.
Maltese: • tnaqqis fil-morbidità u mortalità kardjovaskulari (jew riskju ta' attakk ta' puplesija) f'pazjenti bi pressjoni għolja b'ipertrofija ventrikolari xellugija.
English: Forte
Maltese: Tqala
English: Alcohol, barbiturates, narcotics or antidepressants: Potentiation of orthostatic hypotension may occur.
Maltese: Alkoħol, barbiturati, narkotiċi jew mediċini ta' kontra d-dipressjoni:
English: • 2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6)
Maltese: It-2ni u t-2et trimestru tat-tqala (ara sezzjonijiet 4.4 u 4.6) Treddigħ (ara sezzjoni 4.6)
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 mkejla bi tnaqqis fl-inċidenza kkombinata ta' mewt kardjovaskulari, puplesija u infart mijokardijaku.
English: In clinical trials with losartan potassium salt and hydrochlorothiazide, no adverse events peculiar to this combination of substances were observed.
Maltese: Fi provi kliniċi bil-melħ ta' losartan potassium u hydrochlorothiazide, ma ġewx osservati każijiet avversi partikulari għal din il-mediċina kkombinata.
English: Musculoskeletal and connective tissue disorders Common: Muscle cramp, back pain, leg pain, myalgia Uncommon: Arm pain, joint swelling, knee pain, musculoskeletal pain, shoulder pain, stiffness, arthralgia, arthritis, coxalgia, fibromyalgia, muscle weakness
Maltese: Bugħawwieġ, uġigħ fid-dahar, uġigħ fir-riġlejn, uġigħ fil-muskolu Mhux komuni: Uġigħ fid-dirgħajn, tinfiħ tal-ġogi, uġigħ fl-irkoppa, uġigħ muskoloskeletriku, uġigħ fl-ispallejn, ebusija, artrite, koxalġja, fibromajlaġja, debolezza muskolari.
English: In some patients with compromised renal function who are being treated with non-steroidal antiinflammatory drugs, including selective cyclooxygenase-2 inhibitors, the co-administration of angiotensin II receptor antagonists may result in a further deterioration of renal function.
Maltese: F'xi pazjenti bil-funzjoni tal-kliewi kompromessa li qed jiġu trattati wkoll b'mediċini mhux sterojdi ta' kontra l-infjammazzjoni, li jinkludu impedituri cyclooxygenase-2 silettivi, l-amministrazzjoni flimkien ta' antagonisti għar-riċettaturi ta' angiotensin II jista' jirriżulta f'deterjorazzjoni akbar filfunzjoni renali.
English: There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa.
Maltese: Kien hemm rapporti iżolati ta' anemija emolitika li seħħet meta hydrochlorothiazide u methyldopa ngħataw flimkien.
English: Cytotoxic agents (eg cyclophosphamide, methotrexate) Thiazides may reduce the renal excretion of cytotoxic medicinal products and potentiate their myelosuppressive effects.
Maltese: Sustanzi ċitotossiċi (eż cyclophosphamide, methotrexate) Thiazides jistgħu jnaqqsu l-eliminazzjoni mill-kliewi ta' prodotti mediċinali ċitotossiċi u jħarrxu leffetti majelosuppressivi tagħhom.
English: There was no evidence of teratogenicity in rats or rabbits treated with the losartan/hydrochlorothiazide combination.
Maltese: Ma kien hemm ebda evidenza ta' teratoġeniċità fil-firien jew fniek ittrattati bil-kombinazzjoni ta' losartan/hydrochlorothiazide.
English: In clinical trials, after 12 weeks of therapy with losartan 50 mg/hydrochlorothiazide 12.5 mg, trough sitting diastolic blood pressure was reduced by an average of up to 13.2 mmHg.
Maltese: Fi provi kliniċi, wara 12-il sena ta' terapija b'50 mg losartan /12.5 mg hydrochlorothiazide, il-pressjoni dijastoka l-aktar baxxa meta bilqiegħda tnaqqset għal medja ta' 13.2 mmHg.
English: Cozaar Comp 100 mg/12.5 mg mg contains 8.48 mg (0.216 mEq) of potassium.
Maltese: Cozaar Comp 100 mg/12.5 mg mg fihom 8.48 mg (0.216 mEq) ta' potassju.
English: COZAAR-Comp 100 mg/12.5 mg Filmcoated tablets
Maltese: COZAAR-Comp 100 mg/12.5 mg Film-coated tablets
English: Cozaar Comp 50 mg/12.5 mg> contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Maltese: Cozaar Comp 50 mg/12.5 mg fiha 50 mg ta' losartan potassium u 12.5 mg ta' hydrochlorothiazide bħala s-sustanzi attivi.
English: Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazides.
Maltese: It-tħarrix jew l-attivazzjoni ta' lupus eritematosi sistematika ġie rapportat bl-użu ta' thiazides.
English: Hydrochlorothiazide has been shown to cause modest increases in uric acid; the combination of losartan and hydrochlorothiazide tends to attenuate the diuretic-induced hyperuricemia.
Maltese: Hydrochlorothiazide intwera li jikkaġuna żidied apprezzabbli fl-aċidu uriku; il-kombinazzjoni ta' losartan u hydrochlorothiazide għandu mnejn jimmodera l-iperurikemja sensitizzata bid-dijuretiku.
English: COZAAR COMP film-coated Tablets losartan potassium and hydrochlorothiazide
Maltese: Cozaar Comp pilloli miksijin b'rita losartan potassium u hydrochlorothiazide
English: The active substances are losartan potassium and hydrochlorothiazide.
Maltese: Is-sustanzi attivi huma losartan potassium u hydrochlorothiazide
English: PHARMACEUTICAL FORM AND CONTENTS 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 7 pilloli, 14-il pillola, 28, 30, 50, 56, 84, 90, 98, jew 280 pillola miksija b'rita
English: The administration of the losartan/hydrochlorothiazide combination induced a decrease in the red blood cell parameters (erythrocytes, haemoglobin, haematocrit), a rise in urea-N in the serum, a decrease in heart weight (without a histological correlate) and gastrointestinal changes (mucous membrane lesions, ulcers, erosions, haemorrhages).
Maltese: L-għoti tal-kombinazzjoni losartan/hydrochlorothiazide ġabet tnaqqis fil-parametri taċ-ċelluli l-ħomor tad-demm (eritroċiti, emaglobina, ematokrit), żieda fil-urea-N fis-serum, piż imnaqqas tal-qalb (mingħajr spjegazzjoni ħistoloġika), u bidliet gastro-intestinali (feriti mukużi tar-rita, ulċeri, tgħawwir, emorraġiji).
English: The diuretic action of HCTZ reduces plasma volume, with consequent increase in plasma renin activity, increase in adolsterone secretion, increase in urinary K+ and HCO-3 loss, and decrease in plasma K+.
Maltese: L-azzjoni dijuretika ta' HCTZ tnaqqas il-volum tal-plażma, b'żieda konsegwenti flattività ta' renin fil-plażma, żieda fit-tnixxija ta' aldosterone, żieda fit-telf mill-awrina ta' K+ u HCO3, u tnaqqis ta' K+ fil-plażma.
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: PACKAGE LEAFLET: INFORMATION FOR THE USER
Maltese: Mhux komuni: Nuqqas ta' rqad
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 (Ang- II) attiv oralment li jaħdem fuq is-sottotip ta' riċettur AT1, b'hekk jimblokka l-effett ta' Ang-II fil-kaskata tas-sistema ta' renin angiotensin (RAS).
English: Cozaar Comp 100 mg/25 mg> contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.
Maltese: Cozaar Comp 100 mg/25 mg fiha 100 mg ta' losartan potassium u 25 mg ta' hydrochlorothiazide bħala s-sustanzi attivi.
English: Therefore, losartan/hydrochlorothiazide should not be administered to children and adolescents.
Maltese: Għalhekk, losartan/hydrochlorothiazide m'għandux jiġi amministrat fi tfal u adoloxxenti.
English: Rifampicin and fluconazole have been reported to reduce levels of active metabolite.
Maltese: Rifampicin u fluconazole ġew rapportati li jnaqqsu l-livell tal-metabolit attiv.
English: Common: Headache, dizziness
Maltese: Haar, Il-Ġermanja
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: • Diarrhoea, abdominal pain, nausea, indigestion,
Maltese: • Dijarea, uġigħ addominali, nawsea, indiġestjoni
English: The maximum daily dose is 2 tablets per day of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets
Maltese: Id-doża massima ta' kuljum hi ta' 2 pilloli kuljum ta' Losartan / hydrochlorothiazide 50 mg/12.5 mg Pilloli Miksijin b'Rita jew pillola 1 kuljum ta' losartan / hydrochlorothiazide 100 mg/25 mg Pillola Miksija b'Rita
English: and Cozaar Comp 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.
Maltese: u Cozaar Comp 100 mg/25 mg fihom 8.48 mg (0.216 mEq) ta' potassju
English: In addition to the active metabolite, inactive metabolites are formed, including two major metabolites formed by hydroxylation of the butyl side chain and a minor metabolite, an N-2 tetrazole glucuronide.
Maltese: Barra mill-metabolit attiv ifformat, metaboliti mhux attivi huma fformati wkoll, li jinkludu żewġ metaboliti iffurmati mill-idrosilazzjoni tan-naħa tal-katina butyl u metabolit ieħor żgħir, tip ta' N-2 tetrazole glucuronide.
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/25 mg Losartan and hydrochlorothiazide
Maltese: TAL-PRODOTT MEDIĊINALI Cozaar Comp 100 mg/25 mg Losartan u hydrochlorothiazide
English: Dose titration with the individual components (losartan and hydrochlorothiazide) is recommended.
Maltese: Titrazzjoni tad-doża bil-komponenti individwali (losartan u hydrochlorothiazide) huwa rakkomandat.
English: • Loss of appetite, increased uric acid levels or frank gout, increased blood sugar levels, abnormal blood electrolyte levels,
Maltese: • Nuqqas t'aptit, żieda fil-livelli ta' aċidu uriku jew gotta franka, żieda fil-livelli ta' zokkor, livelli elettrolitiċi abnormali fid-demm,
English: Hepato-biliary disorders Not known: Liver function abnormalities
Maltese: • Epatite (infjammazzjoni tal-fwied) testijiet abnormali tal-funzjoni tal-fwied
English: HOW TO STORE COZAAR COMP
Maltese: Tieħux Cozaar Comp
English: Because losartan decreases uric acid, losartan in combination with hydrochlorothiazide attenuates the diureticinduced hyperuricemia.
Maltese: Peress li losartan inaqqas l-aċidu uriku, losartan flimkien ma' hydrochlorothiazide jimmodera l-iperuriċemija sensitizzata bid-dijuretiku.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 100 mg losartan potassium u 25 mg hydrochlorothiazide.
English: Anaphylactic reactions, angioedema, urticaria
Maltese: infezzjoni awrinarja, zokkor fl-awrina,
English: Angiooedema
Maltese: FARMAĊEWTIKU
English: • if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldesterone by the adrenal gland, caused by an abnormality within the gland).
Maltese: • Jekk tbati minn iperaldosteroniżmu primarju (sindromu assoċjat ma tnixxija ogħla ta' l-ormon aldosterone li joħroġ mill-glandola adrenali, ikkawżata minn abnormalità fi ħdan il-glandola).
English: The MAH was asked to provide data on safety and efficacy for these subgroups of patients (Losartan, Atenolol, Losartan + HCTZ, Atenolol + HCTZ) in order to gain more insight into the contribution of HCTZ to the overall benefit risk ratio.
Maltese: Il-MAH kien mitlub jipprovdi tagħrif fuq is-sigurtà u l-effikaċja għal dawn is-sottogruppi ta' pazjenti (Losartan, Atenolol, Losartan + HCTZ, Atenolol + HCTZ) sabiex jifhem aħjar il-kontribuzzjoni ta' HCTZ fir-rigward tal-proporzjon ta' benefiċċju riskju totali.
English: • if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function)
Maltese: • jekk għandek tidjiq ta' l-arterji (arteroxlerosi), anġina pectoris (uġigħ fis-sider dovut għal funzjoni batuta tal-qalb)
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp 50 mg/12.5 mg Losartan and hydrochlorothiazide
Maltese: TAL-PRODOTT MEDIĊINALI Cozaar Comp 50 mg/12.5 mg Losartan u hydrochlorothiazide
English: Cozaar Comp 100 mg/12.5 mg mg and Cozaar Comp 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium.
Maltese: Cozaar Comp 50 mg/12.5 mg fih 4.24 mg (0.108mEq) ta' potassju, Cozaar Comp 100 mg/12.5 mg u Cozaar Comp 100 mg/25 mg fihom 8.48 mg (0.216 mEq) potassju.
English: It is also important for your doctor to know if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, drugs for treatment of fungal infections, or arthritis medicines, resins used for high cholesterol, such as colestyramine, medicines which relax your muscles, sleeping tablets; opioid medicines such as morphine , ‘pressor amines' such as adrenaline or other drugs from the same group; (oral agents for diabetes or insulins).
Maltese: Huwa importanti wkoll li t-tabib tiegħek għandu jkun jaf jekk intiex tieħu mediċini biex tbaxxi l-pressjoni, sterojdi, mediċini biex tittratta l-kanċer, mediċini kontra l-uġigħ, mediċini għattrattament ta' infezzjonijiet tal-moffa, jew mediċini għal artrite, reżini użata għal kolesterol għoli, bħal coleostyramine, mediċini li jirralassaw il-muskoli, pilloli ta' l-irqad, mediċini opjojdibħal morfina, ‘amini pressor' bħal adrenalinajew mediċini oħra mill-istess grupp; (aġenti orali għal dijabete jew insulina).
English: Cozaar Comp is effective in reducing blood pressure in males and females, blacks and non-blacks and in younger (<65 years) and older (≥65 years) patients and is effective in all degrees of hypertension.
Maltese: Cozaar Comp huwa effettiv biex inaqqas il-pressjoni tad-demm f'irġiel u nisa, persuni suwed u dawk mhux suwed u f'pazjenti iżgħar (<65 years) u akbar (≥65 years) u hu effettiv f'kull grad tal-pressjoni għolja.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Maltese: STATEMENT OF ACTIVE SUBSTANCE(S) Kull pillola fiha 50 mg losartan potassium u 12.5 mg hydrochlorothiazide.
English: Cozaar Comp 100 mg/12.5 mg Each tablet contains 88.40 mg lactose monohydrate.
Maltese: Cozaar Comp 100 mg/12.5 mg Kull pillola 88.40 mg lactose monohydrate Cozaar Comp 100 mg/25 mg Kull pillola 126.26 mg lactose monohydrate
English: Angiotensin II, a potent vasoconstrictor, is the primary active hormon 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: NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/12.5 mg Losartan and hydrochlorothiazide
Maltese: TAL-PRODOTT MEDIĊINALI Cozaar Comp 100 mg/12.5 mg Losartan u hydrochlorothiazide
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 amministrat 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: In the LIFE study an additional benefit was noted with regards to stroke for the losartan based strategy, and effects were similar with regard to MI and CV mortality, indicating that the demonstrated beneficial effect of beta-blockade on CV morbidity and mortality in general was also present for losartan.
Maltese: Fl-istudju LIFE kien innotat benefiċċju addizjonali fir-rigward ta' attakk ta' puplesija għall-istrateġija bbażata fuq losartan, u l-effetti kienu simili fir-rigward talmortalità MI u KV.
English: It is important to continue taking Cozaar Comp for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
Maltese: Cozaar Comp jista' jingħata ma' mediċini oħra ta' kontra l-pressjoni għolja.
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 idrati sew u konsiderazzjoni għandha tingħata għal monitoraġġ tal-funzjoni renali wara l-bidu tat-terapija konkomitanti, u perijodikament wara dan.
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 talmortalità kardjovaskulari (kif imkejlin bl-inċidenza kkumbinata ta' mewt kardjuvaskulari (KV), attakk ta' puplesija u MI (attakk tal-qalb)) minflok ta' attakk ta' puplesija biss.
English: Film-coated tablets Oral use
Maltese: Żomm fil-kontenitur oriġinali.
English: Immune system disorders Rare:
Maltese: Disturbi fis-sistema nervuża Komuni:
English: Metabolism and nutrition disorders Uncommon: Anorexia, hyperglycaemia, hyperuricaemia, hypokalaemia, hyponatraemia
Maltese: Mhux komuni: Anoreksja, ipergliċemija, iperuriċemija, ipokalemja, iponatremja Disturbi psikjatriċi
English: Additional adverse events that have been seen with one of the individual components and may be potential adverse events with losartan potassium/ hydrochlorothiazide are the following:
Maltese: Każijiet avversi addizzjonali li seħħew b'wieħed mill-komponenti individwali u li jista' jikkawża effetti avversi potenzjali b'losartan potassium/hydrochlorothiazide huma li ġejjin:
English: Musculoskeletal and connective tissue disorders Uncommon: Muscle cramps
Maltese: Disturbi muskolu-skeletriku u tat-tessut konnettiv Komuni:
English: • Symtomatic hyperuricaemia/gout
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: The CHMP was concerned that there is no evidence that supports each of the two substances in Cozaar Comp (losartan and HCTZ) having a documented contribution to the claimed indication as required by the The NfG on fixed dose combination products.
Maltese: Is-CHMP kien imħasseb li ma hemm l-ebda evidenza li tappoġġja kull waħda miż-żewġ sustanzi f'Cozaar Comp (losartan u HCTZ) billi kellu kontribuzzjoni ddokumentata għall-indikazzjoni kklejmjata kif meħtieġa mill-NfG fuq prodotti ta' kombinazzjoni ta' doża fissa.
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp and associated names (see Annex I) 50 mg/12.5 mg film-coated tablets Cozaar Comp and associated names (see Annex I) 100 mg/12.5 mg film-coated tablets Cozaar Comp and associated names (see Annex I) 100 mg/25 mg film-coated tablets [To be implemented nationally]
Maltese: Cozaar Comp u ismijiet assoċjati (ara Anness I) 50 mg/12.5 mg pilloli miksijin b'rita Cozaar Comp u ismijiet assoċjati (ara Anness I) 100 mg/12.5 mg pilloli miksijin b'rita Cozaar Comp u ismijiet assoċjati (ara Anness I) 100 mg/25 mg pilloli miksijin b'rita [Sabiex jiġi implimentat fil-pajjiż]
English: Consequently, there is thus no increase in bradykinin-mediated undesirable effects.
Maltese: Konsegwentement, m'hemmx effetti potenzjali mhux mixtieqa li jistgħu jsiru b'bradykinin.
English: Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide.
Maltese: Metformin għandu jintuża b'kawtela minħabba r-riskju ta' aċidosi lattika sensitizzata bil-possibilità ta' insuffiċjenza renali funzjonali marbuta ma' hydrochlorothiazide.