FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the CVMP's view was that, as for Dexdomitor, the benefits outweigh the identified risks.
Maltese: Għaldaqstant, il-fehma tas-CVMP kienet li, bħal fil-każ ta' Dexdomitor, il-benefiċċji huma akbar mir-riskji identifikati.
English: • when carrying out mildly to moderately painful procedures and examinations that require the animal to be restrained or sedated and made less sensitive to pain (analgesia) but are non-invasive (do not involve breaking the skin or a body cavity).
Maltese: • meta jitwettqu proċeduri li jikkawżaw uġigħ moderat sa ħafif u eżaminazzjonijiet li jeħtieġu li l-annimal ikun imrażżan jew taħt effett sedattiv u jkun anqas sensittiv għall-uġigħ (analġeżija) imma li mhumiex invażivi (ma jinvolvux qsim tal-ġilda jew ta' kavità tal-ġisem).
English: The dose in each species depends on the body surface area in dogs (calculated using bodyweight) and bodyweight in cats, and on the use, type of injection and any other medicines that are being used.
Maltese: Id-doża f'kull speċi tiddependi fuq l-erja tas-superfiċje tal-ġisem fil-klieb (ikkalkulata permezz tal-piż tal-ġisem) u l-piż tal-ġisem fil-qtates, u fuq l-użu, tip ta' infezzjoni u kwalunkwe mediċina
English: How has Sedadex been studied?
Maltese: Kif ġie studjat Sedadex?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Sedadex, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward is-sigurtà ta' Sedadex, inklużi l-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti tal-kura tas-saħħa u mis-sidien tal-annimali jew dawk li jieħdu ħsiebhom.
English: It works by preventing the release of the neurotransmitter noradrenaline from nerve cells in the body.
Maltese: Din taħdem billi tipprevjeni r-rilaxx tan-newrotrasmettitur magħruf bħala noradrenaline miċ-ċelloli tan-nervituri fil-ġisem.
English: • as premedication (treatment given before inducing general anaesthesia).
Maltese: • bħala premedikazzjoni (kura mogħtija qabel l-għoti ta' loppju ġenerali).
English: pre-filled syringe (glass) without blister pre-filled pen (glass) (SureClick)
Maltese: Użu għal taħt il-ġilda pinna mimlija għal-lest (ħġieġ) (SureClick)
English: Package size pre-filled syringe (glass)
Maltese: 0.6 ml (10 mg/ml) Siringa waħda mimlija għal-lest (mhux ġo folja)
English: 1 pre-filled pen
Maltese: Daqs tal-pakkett
English: Strength Pharmaceutical
Maltese: Kontenut (konċentrazzjoni)
English: Clopido grel 1A Pharma 75 mg l t o r
Maltese: Mnejn jingħata Il-pakkett
English: Package size
Maltese: Daqs tal-pakkett t x
English: 28027 Madrid
Maltese: 28027 MADRID, Spanja
English: 2770-192 Paço d' Arcos Portugal
Maltese: 2770-192 Paço d' Arcos, Il-Portugall
English: H-1123 Budapest
Maltese: H-1123 Budapest, L-Ungerija
English: Lindenplatz 1 85540, Haar, Germany
Maltese: Lindenplatz 1 85540, Haar, Il-Ġermanja
English: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- Viale Shakespeare 47, 00144 Rome
Maltese: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- Viale Shakespeare 47, 00144
English: Member State Invented name
Maltese: Stat Membru Isem Inventat
English: Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo P.O.
Maltese: Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo P.O. Box 214
English: Skanstes street 13, LV-1013, Riga
Maltese: Skanstes street 13, LV-1013, Riga, Il-Latvija
English: 00-867 Warsaw
Maltese: 00-867 Warsaw, Il-Polonja
English: EXPO 2000, east wing, sections B1 & B2, 1st fl.
Maltese: EXPO 2000, east wing, sections B1 &
English: Tatoiou Street, Nea Erythraia 14671 Greece
Maltese: Tatoiou Street, Nea Erythraia 14671, Il-Greċja
English: 2700-547 Amadora Portugal
Maltese: 2700-547 Amadora, Il-Portugall
English: Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar
Maltese: MSD Chibropharm GmbH Postfach 1202 D-85530
English: Chronic heart failure
Maltese: Insuffiċjenza kardijaka kronika
English: Merck Sharp Dohme Chibret 3 av. Hoche
Maltese: Merck Sharp Dohme Chibret 3 av.
English: Contra-indications (SPC section 4.3)
Maltese: Kontraindikazzjonijiet (SPC sezzjoni 4.3)
English: WEEK 2 (Day 8-14)
Maltese: ĠIMGĦA 2 (Jum 8-14)
English: The volume of distribution of losartan is 34 litres.
Maltese: Il-volum ta' distribuzzjoni ta' losartan hi ta' 34 litru.
English: 1407 Sofia
Maltese: 1407 Sofia, Il-Bulgarja
English: ELITE I and ELITE II Study
Maltese: Studju ELITE I u ELITE II
English: WEEK 1 (day 1-7)
Maltese: ĠIMGĦA 1 (Jum 1-7)
English: Via G. Fabbroni 6, 00191 Rome, Italy
Maltese: Via G. Fabbroni 6, 00191 Rome, LItalja
English: Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, 1000 Ljubljana
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, 1000 Ljubljana, Is-Slovenja
English: • inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),
Maltese: • infjammazzjoni tal-vażi tad-demm (vaskulite li tinkludi purpura Henoch-Schonlein),
English: Bulgaria Merck Sharp & Dohme Bulgaria EOOD
Maltese: Merck Sharp & Dohme Bulgaria EOOD
English: Cozaar 12.5 mg, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively.
Maltese: Cozaar 12.5 mg, 25 mg, 50 mg u 100 mg fihom ukoll il-potassju fl-ammonti li ġejjin: 1.06 mg (0.027 mEq), 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) u 8.48 mg (0.216 mEq) rispettivament.
English: Hungary Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
Maltese: Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
English: The systemic bioavailability of losartan tablets is approximately 33%.
Maltese: Il-bijodisponibilità sistemika tal-pilloli losartan hi ta' madwar 33%.
English: Pharmacotherapeutic group: Angiotensin II Receptor Antagonists, ATC code: C09CA01
Maltese: Antagonisti tar-riċettatur ta' Angiotensin II, komuni, Kodiċi ATC: C09CA01
English: Losartan is predominantly metabolised by cytochrome P450 (CYP) 2C9 to the active carboxy-acid metabolite.
Maltese: Losartan huwa prinċipalment metabolizzat b'cytochrome P450 (CYP) 2C9 għal metabolit attiv ta' carboxy-acid.
English: RENAAL-Study
Maltese: Studju RENAAL
English: Finland Merck Sharp & Dohme B.V. Waarderweg 39
Maltese: Merck Sharp & Dohme B.V. Waarderweg 39
English: • serum creatinine and serum potassium in patients with heart failure,
Maltese: • Kreatinina fis-serum u potassju fis-serum f'pazjenti b'insuffiċjenza kardijaka,
English: Sector 1, Bucureşti
Maltese: Sector 1, Bucureşti, Ir-Romanija
English: Germany VARIPHARM ARZNEIMITTEL GmbH
Maltese: ARZNEIMITTEL GmbH
English: Lactose monohydrate.
Maltese: mg lactose monohydrate.
English: Poland MSD Polska Sp. z o.o.
Maltese: MSD Polska Sp. z o.o. Chłodna 51
English: The active substance is losartan potassium.
Maltese: Is-sustanza attiva hi losartan potassium.
English: The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose (E464).
Maltese: Is-sustanza l-oħra huma microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose (E464).
English: 75114 Paris Cedex 08 France
Maltese: Paris Cedex 08, Franza
English: Muscoskeletal and connective tissue disorders:
Maltese: Disturbi muskolu-skeletiċi u tat-tessut konnettiv:
English: 11415 Tallinn Estonia
Maltese: Tallinn, L-Estonja
English: The frequency of adverse events listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza ta' każijiet avversi elenkati hawn isfel hija mfissra bil-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100, < 1/10); mhux komuni (≥ 1/1,000, < 1/100); rari (≥ 1/10,000, < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Hypotension and Electrolyte/Fluid Imbalance
Maltese: Pressjoni Baxxa u Żbilanċ Elettroliti/Fluwidu
English: 2003 PC Haarlem The Netherlands
Maltese: 2003 PC Haarlem L-Olanda
English: Each tablet contains the following inactive ingredients: microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572) hydroxypropyl cellulose (E463) hypromellose (E464)
Maltese: Kull pillola fiha s-sustanzi mhux attivi li ġejjin: microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572) hydroxypropyl cellulose (E463) hypromellose (E464)
English: Romania Merck Sharp & Dohme Romania S.R.L.
Maltese: Merck Sharp & Dohme Romania S.R.L.
English: Losartan is a synthetic oral angiotensin-II receptor (type AT1) antagonist.
Maltese: Losartan huwa riċettatur antagonista sintetiku u orali tar-riċettatur angiotensin-II (tip AT1).
English: Treatment with losartan reduced the risk of stroke by 25% relative to atenolol (p=0.001 95% confidence interval 0.63-0.89).
Maltese: It-trattament b'losartan naqqas ir-riskju ta' puplesija b'25% meta mqabbel ma' atenolol (p=0.001 95% intervall ta' kunfidenza 0.63-0.89).
English: Hyperkalaemia (serum potassium >5.5 mmol/l) occurred in 1.5% of patients in hypertension clinical trials.
Maltese: Iperkalemja (>5.5 mmol/l potassju fis-serum) seħħet f'1.5% tal-pazjenti li kellhom pressjoni għolja fil-provi kliniċi.
English: Following an oral dose/intravenous administration of 14C-labeled losartan in man, about 35% / 43% of radioactivity is recovered in the urine and 58%/ 50% in the faeces.
Maltese: Wara doża meħuda mill-ħalq/ġol-vina ta' losartan ittikkettat b'14C fil-bniedem, madwar 35% / 43% ta' radjoattività ġiet irkuprata fl-urina u 58%/ 50% fl-ippurgar.
English: Cozaar is supplied in the following pack sizes:
Maltese: Cozaar hija fornuta fid-daqsijiet ta' pakketti li ġejjin:
English: • numbness or tingling sensation (paraesthesia),
Maltese: • tirżiħ jew sensazzjoni ta' tnemnim (paraestesija)
English: Therapeutic Indications (SPC section 4.1)
Maltese: Indikazzjonijiet terapewtiċi (SPC sezzjoni 4.1)
English: Angiotensin II also stimulates smooth muscle cell proliferation.
Maltese: Angiotensin II jissensitizza wkoll il-proliferazzjoni taċ-ċelloli lixxi tal-muskoli.
English: LIFE-Study
Maltese: Studju LIFE
English: Each pack contains a total of 35 tablets:
Maltese: Kull pakkett fih total ta' 35 pillola:
English: Losartan may also delay progression of diabetic nephropathy and is also indicated for the reduction of renal disease progression in patients with type 2 diabetes, hypertension and microalbuminuria (>30 mg/24 hours) or proteinuria (>900 mg/24 hours).
Maltese: Losartan jista' jittardja wkoll il-progressjoni ta' nefropatija dijabetika u huwa indikat ukoll għattnaqqis fil-progressjoni ta' mard renali f'pazjenti b'dijabete tip 2, pressjoni għolja u mikroalbuminurja (>30 mg/24 siegħa) jew proteinurja (>900 mg/24 siegħa).
English: Batch
Maltese: Hoche
English: This is the indication currently proposed by the applicant and has been registered in 15 member states of the EU.
Maltese: Din hija l-indikazzjoni proposta fil-preżent mill-applikant u ġiet irreġistrata fi 15-il Stat Membru ta' l-UE.
English: Latvia
Maltese: Il-Latvija
English: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Losartan tablets.
Maltese: Fi provi kliniċi b'kontrolli, bidliet klinikament importanti f'parametri tal-laboratorju standard rarement kienu assoċjati ma' l-għoti ta' pilloli Losartan.
English: Investigations: common: hypoglycaemia, hyperkalaemia
Maltese: Investigazzjonijiet: komuni: ipogliċemija, iperkalemija
English: Blood pressure was significantly lowered to similar levels in the two groups.
Maltese: Il-pressjoni tad-demm kienet sinifikament mnaqqsa għal-livelli simili fiż-żewġ gruppi.
English: Hypersensitivity
Maltese: Sensittività eccessiva
English: happening in 1 in 10,000 to 1 in 1,000 patients very rare:
Maltese: li jseħħu f'pazjent 1 f'kull 10,000 sa pazjent 1 f'kull 1,000 pazjent rari ħafna:
English: Cardiac disorders: rare: syncope, artrial fibrillation, cerebrovascular accident Vascular disorders: uncommon: hypotension, including orthostatic hypotension Respiratory, thoracic and mediastinal disorders: uncommon: dyspnoea
Maltese: Disturbi tal-qalb: rari: sinkope, fibrillazzjoni atrijali, aċċident ċerebrovaskulari Disturbi vaskulari: komuni: pressjoni baxxa, li tinkludi pressjoni ortostatika baxxa Disturbi respiratorji, toraċiċi u medjastinali: komuni: dispnea
English: In a clinical study conducted in type 2 diabetic patients with nephropathy, 9.9% of patients treated with Losartan tablets developed hyperkalaemia >5.5 mEq/l and 3.4% of patients treated with placebo (see section 4.4, ‘Electrolyte imbalances').
Maltese: Fi studju kliniku li sar fuq pazjenti li kellhom dijabete ta' tip 2 b'nefropatija, iperkalemija >5.5 mEq/l żviluppat f'9.9% ta' pazjenti ttrattati bil-pilloli Losartan u fi 3.4% ta' pazjenti trattati bi plaċebo (ara sezzjoni 4.4, ‘Żbilanċi elettrolitiċi').
English: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU
Maltese: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Ir-Renju Unit
English: Symptoms of intoxication
Maltese: Sintomi ta' intossikazzjoni
English: -Reduction in risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy” (“LIFE indication”)”
Maltese: -“Tnaqqis fir-riskju ta' morbidità u mortalità f'pazjenti bi pressjoni għolja b'ipertrofija ventrikulari xellugija” (“indikazzjoni LIFE”)”
English: Blood pressure reduction at the end of the dosing interval was 70 - 80 % of the effect seen 5-6 hours postdose.
Maltese: It-tnaqqis fil-pressjoni tad-demm fl-aħħar ta' l-intervall dożat kien ta' 70 - 80 % ta' l-effett li deher 5 - 6 sigħat wara d-doża.
English: Cozaar, Cozaar Startpakke
Maltese: Id-Danimarka Cozaar, Cozaar Startpakke L-Estonja
English: Primary hyperaldosteronism
Maltese: Iperaldosteroniżmu primarju
English: Cardiac disorder: Uncommon: palpitations, angina pectoris
Maltese: Disturbi fil-qalb: Mhux komuni: palpitazzjonijiet, anġina pectoris
English: Luxembourg COZAAR 100 mg Luxembourg COZAAR 50 MG Luxembourg COZAAR 12,5 mg Luxembourg COZAAR CARDIO START Luxembourg LOORTAN 100 mg Luxembourg LOORTAN 50 mg Luxembourg LOORTAN 12,50 mg Luxembourg LOORTAN CARDIO START
Maltese: MG Il-Lussemburgu COZAAR 12,5 mg Il-Lussemburgu COZAAR CARDIO START Il-Lussemburgu LOORTAN 100 mg Il-Lussemburgu LOORTAN 50 mg Il-Lussemburgu LOORTAN 12,50 mg Il-Lussemburgu LOORTAN CARDIO START
English: Each Cozaar 100 mg tablet contains 51.0 mg lactose monohydrate.
Maltese: Kull pillola ta' Cozaar 100 mg fiha 51.0 mg lactose monohydrate.
English: Both losartan and its active metabolite are ≥99% bound to plasma proteins, primarily albumin.
Maltese: Kemm losartan u l-metabolit attiv tiegħu huma ≥99% marbutin ma' proteini fil-plażma, prinċipalment l-albumina.
English: Losartan does not have an agonist effect nor does it block other hormone receptors or ion channels important in cardiovascular regulation.
Maltese: Losartan m'għandux effett agonista u lanqas ma jimblokka riċettaturi ormonali oħra jew kanali ijoniċi importanti fil-kontroll kardjovaskulari.
English: Cozaar contains lactose monohydrate.
Maltese: Cozaar fih lactose monohydrate.
English: Belgium Therabel Pharma S.A. Rue Egide Van Ophem 108 B-1180 Brussels
Maltese: Il-Lussemburgu Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, IlBelġju
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: Treatment with losartan resulted in a 13.0% risk reduction (p=0.021, 95 % confidence interval 0.77-0.98) compared with atenolol for patients reaching the primary composite endpoint.
Maltese: It-trattament b' losartan irriżulta fi tnaqqis ta' 13.0% fir-riskju (p=0.021, 95 % intervall ta' kunfidenza 0.77-0.98) imqabbel ma' atenolol għal pazjenti li jilħqu l-ewwel punt ta' riferiment kompost prinċipali.
English: The CHMP considered that the text concerning pregnancy and lactation in the SPC (sections 4.3, 4.4 and 4.6) needed to be amended to include the outcome of the PhVWP report on ACE Inhibitors and angiotensin II receptors antagonists (AIIRAs) and recommendations on the use during the first trimester of pregnancy (EMEA/CHMP/PhVWP/474692/2007).
Maltese: Is-CHMP qies li t-test li jikkonċerna t-tqala u t-treddigħ fl-SPC (sezzjonijiet 4.3, 4.4 u 4.6) kien jeħtieġ li jiġi emendat biex jinkludi l-effett tar-rapport PhVWP fuq Impedituri ACE u fuq antagonisti tarriċetturi angiotensin II (AIIRAs) u rakkomandazzjonijiet fuq l-użu waqt l-ewwel trimestru tat-tqala (EMEA/CHMP/PhVWP/474692/2007).
English: In a clinical trial it was found that fluconazole (inhibitor of CYP2C9) decreases the exposure to the active metabolite by approximately 50%.
Maltese: Fi prova klinika nstab li fluconazole (impeditur ta' CYP2C9) inaqqas l-espożizzjoni għal metabolit attiv b'madwar 50%.
English: - The use of losartan in paediatric patients should be included in sections 4.2, 4.4, 4.8, 5.1 and 5.2 of the SPC, and the relevant sections of the Package Leaflet.
Maltese: - L-użu ta' losartan f'pazjenti pedjatriċi għandu jkun inkluż f'sezzjonijiet 4.2, 4.4, 4.8, 5.1 u 5.2 talSPC, u fis-sezzjonijiet relevanti tal-Fuljett ta' Tagħrif.
English: • itching (pruritus),
Maltese: • ħakk (prurite),
English: Angiooedema.
Maltese: Anġjodema.
English: 2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6) Lactation (see section 4.6)
Maltese: It-tieni u t-tielet trimestru ta' tqala (ara sezzjonijiet 4.4 u 4.6) Treddigħ
English: • inflammation of the liver (hepatitis),
Maltese: • infjammazzjoni tal-fwied (epatite),
English: Each pack contains a total of 28 tablets:
Maltese: Kull pakkett fih total ta' 28 pillola:
English: Renal clearance of losartan and its active metabolite is about 74 mL/min and 26 mL/min, respectively.
Maltese: It-tneħħija mill-kliewi ta' losartan u l-metabolit attiv tiegħu hi ta' madwar 74 ml/min u 26 ml/min, rispettivament.
English: The Losartan Intervention For Endpoint Reduction in Hypertension [LIFE] study was a randomised, triple-blind, active-controlled study in 9193 hypertensive patients aged 55 to 80 years with ECGdocumented left-ventricular hypertrophy.
Maltese: L-istudju ta' Intervent b'Losartan għal Tnaqqis fil-Punt ta' Riferiment Aħħari [LIFE] kien studju randomizzat, triple-blind, b'kontrolli attivi li sar fuq 9,193 pazjent bi pressjoni għolja fl-etajiet ta' bejn 55 sa 80 sena u b'ipertrofija fil-ventrikula tax-xellug iddokumentata b'ECG.
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 investigati f'50 pazjent pedjatriku bi pressjoni għolja > xahar sa < 16-il sena ta' età wara għoti orali ta' darba kuljum ta' madwar 0.54 sa 0.77 mg/ kg ta' losartan (dożi medji).
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 in vitro u in vivo u l-metabolit farmakoloġikament attiv tiegħu ta' carboxylic acid, E-3174 jimblokka l-azzjonijiet fiżjoloġiċi rilevanti kollha ta' angiotensin II, irrispettivament tas-sors jew il-passaġġ fis-sintesi tiegħu.
English: PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, or 280 pillola.
English: Lithuania UAB Merck Sharp & Dohme, Geležinio Vilko 18A,
Maltese: UAB Merck Sharp & Dohme, Geležinio Vilko 18A, LT- 01112 Vilnius, Il-Litwanja
English: Film-coated tablets
Maltese: MG FILM-COATED TABLETS
English: Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorbtion Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Maltese: Intolleranza għal gallatosju, defiċjenza għal Lapp lactase, malassorbiment ta' glukosju-gallattosju:
English: No difference in exposure was found with concomitantly treatment with fluvastatin (weak inhibitor of CYP2C9).
Maltese: Ma nstabet l-ebda differenza fl-espożizzjoni bi trattament flimkien ma' fluvastatin (impeditur ħafif ta' CYP2C9).
English: Electrolyte imbalances
Maltese: Żbilanċi elettrolitiċi:
English: Denmark 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: Nervous system disorders: common: dizziness
Maltese: Disturbi fis-sistema nervuża: komuni: sturdamenti
English: happening in 1 in 100 to 1 in 10 patients uncommon happening in 1 in 1,000 to 1 in 100 patients rare:
Maltese: li jseħħu f'pazjent 1 f'kull 100 sa 1 f'kull 10 pazjenti mhux komuni li jseħħu f'pazjent 1 f'kull 1,000 sa pazjent 1 f'kull 100 pazjent rari:
English: Ear and labyrinth disorders: common: vertigo
Maltese: Disturbi fil-widnejn u fis-sistema labirintika: komuni: vertiġini
English: - Reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG ( See section 5.1 Life Study, Race)
Maltese: - Tnaqqis fir-riskju ta' attakk ta' puplesija f'pazjenti bi pressjoni għolja b'ipertrofija ventrikolari xellugija ddokumentata mill-ECG (Ara Sezzjoni 5.1 Studju Life, Razza)
English: An increased mortality was observed in ELITE II in the small subgroup (22% of all HF patients) taking beta-blockers at baseline.
Maltese: II fis-sottogrupp (22% tal-pazjenti HF) li kien qed jieħu beta-blockers bħala punt ta' riferiment.
English: PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 jew 500 pillola.
English: PHARMACEUTICAL FORM AND CONTENTS 100 tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 100 pillola.
English: In a controlled clinical trial on patients with cardiac insufficiency, increase in blood urea, serum creatinine and serum potassium has been reported.
Maltese: Fi prova klinika b'kontrolli, fuq pazjenti b'insuffiċjenza kardijaka, ġew rapportati każijiet ta' żieda fl-urea fid-demm, kreatinina fis-serum u potassju fis-serum.
English: HDPE bottles of 100 tablets.
Maltese: Fliexken ta' HDPE ta' 100 pillola.
English: PHARMACEUTICAL FORM AND CONTENTS 100 or 300 tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 100 jew 300 pillola.
English: • Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race).
Maltese: • Tnaqqis fir-riskju ta' puplesija f'pazjenti li għandhom pressjoni għolja b'ipertrifija fil-ventrikula tax-xellug iddokumentata b'ECG (ara sezzjoni 5.1: Studju LIFE, Razza).
English: Uncommon: asthenia, fatigue, oedema
Maltese: Komuni: astenja, għeja, edema
English: • severe chest pain (angina pectoris),
Maltese: • uġigħ fis-sider qawwi (anġina pectoris)
English: During the referral procedure, the MAH proposed amending the indication to substitute “cardiovascular morbidity and mortality” with “stroke”.
Maltese: Waqt il-proċedura ta' referenza, il-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) ippropona li tiġi emendata l-indikazzjoni li tissostitwixxi “morbidità u mortalità kardjovaskulari” b'“attakk ta' puplesija”.