FrancophonIA/ELRC3.0 huggingface dataset:
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li tfassal biex jagħraf u jeħel ma' struttura speċifika (imsejħa antiġen) li tinstab f'ċerti ċelloli fil-ġisem.
English: What are the risks associated with Nivolumab BMS?
Maltese: X'inhuma r-riskji assoċjati ma' Nivolumab BMS?
English: The medicine is available as a concentrate for making up a solution for infusion (drip) into a vein.
Maltese: Il-mediċina tiġi bħala konċentrat biex issir soluzzjoni għall-infużjoni (dripp) fil-vina.
English: For the full list of all side effects and restrictions with Nivolumab BMS, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Nivolumab BMS, ara l-fuljett ta'
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nivolumab BMS, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Ġiet ipprovduta wkoll informazzjoni ta' appoġġ minn studju ieħor li indika li Nivolumab BMS jista' jipproduċi rispons f'pazjenti li l-marda tagħhom kienet aggravat
English: The medicine was associated with improved survival over docetaxel in patients with advanced, previously treated squamous NSCLC, a patient group who have few treatment options.
Maltese: Pazjenti li lkanċer tagħhom esprima b'mod ċar PD-1 dehru li wrew l-ikbar benefiċċju, iżda billi pazjenti oħrajn irrispondew ukoll, jinħtieġu iktar studji biex jiġi ċċarat liema gruppi huma l-iktar probabbli li jibbenefikaw mill-mediċina.
English: Intravenous use Vial (glass) 15 ml (20 mg/ml) 1 vial
Maltese: 15 ml (20 mg/ml)
English: 300mg Concentrate for solution for infusion
Maltese: 300 mg Konċentrat għal soluzzjoni għallinfużjoni
English: EMA procedure number
Maltese: Numru tal-proċedura ta' l-EMA
English: (Invented) name Strength
Maltese: Isem (ivvintat)
English: Ethnic differences
Maltese: Differenzi etniċi:
English: Bucharest Business Park Şos.
Maltese: Bucharest Business Park
English: Norway MSD BV Waarderweg 39
Maltese: In-Norveġja MSD BV Waarderweg 39
English: 28027 MADRID
Maltese: 28027 MADRID, Spanja
English: Poland MSD Polska Sp. z o.o.
Maltese: MSD Polska Sp. z o.o. ul.
English: Skanstes street 13, LV-1013, Riga, Latvia
Maltese: Skanstes street 13, LV-1013, Riga, Il-Latvija
English: Sector 1, Bucureşti
Maltese: Sector 1, Bucureşti, Ir-Rumanija
English: The volume of distribution of losartan is 34 liters.
Maltese: Il-volum ta' distribuzzjoni ta' losartan hi ta' 34 litru.
English: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- viale Shakespeare 47, 00144 Rome, Italy
Maltese: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- viale Shakespeare 47 , 00144
English: 2700-547 Amadora, Portugal
Maltese: 2700-547 Amadora, Il-Portugall
English: 00191 Rome, Italy
Maltese: 00191 Rome, L-Italja
English: • Decreased sexual appetite, impotence,
Maltese: • Tnaqqis fil-ġibda sesswali, impotenza,
English: Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o., Smartinska cesta 140, 1000 Ljubljana
Maltese: Is-Slovenja Merck Sharp & Dohme, inovativna zdravila d.o.o., Smartinska cesta 140, 1000 Ljubljana, Is-Slovenja
English: Carbamazepine Risk of symptomatic hyponatremia.
Maltese: Carbamazepine Riskju ta' iponatremja sintomatika.
English: Via G Fabbroni 6, 00191 Rome Italy
Maltese: Via G Fabbroni 6, 00191 Rome, LItalja
English: Cholestyramine and colestipol resins:
Maltese: Reżini ta' cholestyramine u colestipol:
English: Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar
Maltese: Il-Ġermanja MSD Chibropharm GmbH Postfach 1202 D-85530
English: Bulgaria Merck Sharp & Dohme Bulgaria EOOD
Maltese: Il-Bulgarja Merck Sharp & Dohme Bulgaria EOOD
English: Lindenplatz 1 85540, Haar Germany
Maltese: Lindenplatz 1 85540, Haar Il-Ġermanja
English: Tatoiou Street, Nea Erythraia 14671, Greece
Maltese: Tatoiou Street, Nea Erythraia 14671, il-Greċja
English: Quinte da Fonte Edificio Vasco da Gama, 19 P.O.
Maltese: Edificio Vasco da Gama, 19
English: Section 4.3 Contra-indications
Maltese: Sezzjoni 4.3 Kontra-indikazzjonijiet
English: Merck Sharp & Dohme OÜ Peterburi tee 46, Tallinn 11415, Estonia
Maltese: Merck Sharp & Dohme OÜ Peterburi tee 46, Tallinn 11415, L-Estonja
English: Hungary Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
Maltese: L-Ungerija Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
English: 75114 Paris Cedex 08 France
Maltese: Paris Cedex 08 Franza
English: • Some antipsychotics (eg thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol).
Maltese: • Xi antipsikotiċi (eż. thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol).
English: In the losartan group 44% of the patients received HCTZ, in the atenolol group 38%.
Maltese: Fil-grupp losartan 44% tal-pazjenti rċievew HCTZ, fil-grupp ta' atenolol 38%.
English: BOX 214
Maltese: P.O. BOX 214
English: They may cause fetal electrolyte disturbances and possibly other reactions that have been observed in adults.
Maltese: Jistgħu joħolqu disturbi elettrolitiċi fetali u possibilment reazzjonijiet oħra li ġew osservati f'adulti.
English: Corticosteroids, ACTH Intensified electrolyte depletion, particularly hypokalemia.
Maltese: Kortikosterojdi, ACTH Żvojtjar elettrolitiku intensifikat, partikolarment ipokalemja.
English: • Class III antiarrythmics (eg amiodarone, sotalol, dofetilide, ibutilide).
Maltese: III (eż. amiodarone, sotalol, dofetilide, ibutilide).
English: INFORMATION IN BRAILLE N/A
Maltese: INFORMAZZJONI BIL-BRAILLE
English: 2770-192 Paço d' Arcos, Portugal
Maltese: 2770-192 Paço d' Arcos, Il-Portugall
English: • Class Ia antiarrythmics (eg quinidine, hydroquinidine, disopyramide).
Maltese: Ia (eż. quinidine, hydroquinidine, disopyramide).
English: Ireland Merck Sharp & Dohme Limited, Hertford Road,
Maltese: Merck Sharp & Dohme Limited, Hertford Road,
English: Hydrochlorothiazide is a thiazide diuretic.
Maltese: Hydrochlorothiazide huwa dijuretiku ta' thiazide.
English: Germany VARIPHARM ARZNEIMITTEL GMBH
Maltese: ARZNEIMITTEL GMBH
English: Generally losartan causes a decrease in serum uric acid (usually <0.4 mg/dL) which was persistent in chronic therapy.
Maltese: Ġeneralment losartan jikkaġuna tnaqqis fl-aċidu uriku fis-serum (ġeneralment <0.4 mg/dl) persistenti f'terapija kronika.
English: Romania Merck Sharp & Dohme Romania S.R.L.
Maltese: Ir-Rumanija Merck Sharp & Dohme Romania S.R.L.
English: Losartan is a synthetically produced oral angiotensin-II receptor (type AT1) antagonist.
Maltese: Losartan huwa riċettatur antagonista sintetiku u orali ta' angiotensin-II (tip AT1).
English: 2780-730 Paço d´Arcos Portugal
Maltese: 2780-730 Paço d´Arcos, Il-Portugall
English: Cozaar Comp. and Cozaar Comp Forte (losartan/hydrochlorothiazide) have been included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Maltese: Cozaar Comp. u Cozaar Comp Forte (losartan/hydrochlorothiazide) ġew inklużi fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodott (SPC) imfassal mis-CMD(h), b'mod konformi ma' l-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendata.
English: Belgium Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B-1180 Brussels
Maltese: Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B-1180 Brussels
English: LIFE Study
Maltese: Studju LIFE
English: The mean length of follow up was 4.8 years.
Maltese: Iż-żmien medju ta' follow-up kien ta' 4.8 snin.
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: • Severe renal impairment (i.e. creatinine clearance <30 ml/min)
Maltese: Indeboliment renali sever (i.e tneħħija ta' kreatinina < 30 ml/min) Anurja.
English: • Others (eg bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, terfenadine, vincamine IV).
Maltese: • Oħrajn (eż bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
English: Hertfordshire, EN11 9BU United Kingdom
Maltese: Hertfordshire EN11 9BU Ir-Renju Unit
English: Reproductive system and breast disorders Uncommon: Decreased libido, impotence
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni: Tnaqqis fl-aptit sesswali, impotenza
English: Pharmacotherapeutic group: Combination containing an angiotensin II-receptor(type AT1)-antagonist and a thiazide diuretic, Antihypertensive, ATC code: C09DA01
Maltese: Mediċina kkombinata li fiha antagonist tar-riċettatur ta' angiotensin II (tip AT1) u dijuretiku ta' thiazide, Mediċina ta' kontra l-pressjoni għolja Kodiċi ATC: C09DA01
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: ul.
Maltese: Şos.
English: The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation.
Maltese: L-aktar manifestazzjoni probabbli ta' doża eċċessiva tkun presjoni baxxa u takikardja; bradikardja tista' sseħħ minn stimulazzjoni parasimpatetika (vegus).
English: In addition, in an overall analysis of 16 double-blind clinical trials in 4131 patients, the incidence of spontaneously reported cough in patients treated with losartan was similar (3.1%) to that of patients treated with placebo (2.6%) or hydrochlorothiazide (4.1%), whereas the incidence with ACE inhibitors was 8.8%.
Maltese: Barraminhekk, f'analiżi globali ta' 16-il prova klinika double-blind f'4131 pazjent, l-inċidenza ta' sogħla rapportata spontanjament f'pazjenti trattati b'losartan kienet simili (3.1%) għal dik trattata bi plaċebo (2.6%) jew hydrochlorothiazide (4.1%), filwaqt li l-inċidenza ta' impedituri ACE kienet ta' 8.8%.
English: Antidiabetic drugs (oral agents and insulin):
Maltese: Mediċini kontra d-dijabete (mediċini orali u insulina):
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of drugs.
Maltese: Filwaqt li m'hemmx dejta epidemjoloġika b'kontrolli fuq ir-riskju b'Impedituri għarRiċettaturi ta' Amgiotensin II (AIIRAs), riskji simili jistgħu jeżistu għal din il-klassi ta' mediċini.
English: HDPE bottles of 100 tablets.
Maltese: Fliexken tal-HDPE ta' 100 pillola.
English: Luxembourg Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Maltese: Il-Lussemburgu Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Il-Belġju
English: Belgium Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Maltese: Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Il-Belġju
English: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, United Kingdom
Maltese: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Ir-Renju Unit
English: Uncommon: Agranulocytosis, aplastic anaemia, haemolytic anaemia, leukopenia, purpura, thrombocytopenia
Maltese: Mhux komuni: Agranuloċitosi, anemija aplastika, anemija emolitika, lewkopenja, purpura, tromboċitopenija
English: Cozaar Comp 50 mg/12.5 mg Each tablet contains 63.13 mg lactose monohydrate.
Maltese: Cozaar Comp 50 mg/12.5 mg Kull pillola 63.13 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: Merck Sharp & Dohme Ltd., Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom
Maltese: Merck Sharp & Dohme Ltd., Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU, Ir-Renju Unit
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-MAH ippropona li tiġi emendata l-indikazzjoni li tissostitwixxi “morbidità u mortalità kardjovaskulari” b'“attakk ta' puplesija”.
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: Luxembourg Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B-1180 Brussels, Belgium
Maltese: Il-Lussemburgu Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B-1180 Brussels, Il-Belġju
English: Uncommon: Hypotension, orthostatic hypotension, sternalgia, angina pectoris, grade II-AV block, cerebrovascular event, myocardial infarction, palpitation, arrhythmias (atrial fibrillations, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation)
Maltese: Mhux komuni: Pressjoni baxxa, pressjoni baxxa malli tqum minn pożizzjoni ta' serħan, sternalġja, anġina pectoris, grad II - blokk AV, każ ċerebrovaskulari, infart mijokardijaku, palpitazzjoni, arritmiji (fibrillazzjonijiet atrijali, bradikardja tas-sinus, takikardja ventrikulari, fibrillazzjoni ventrikulari)
English: Lithuania UAB Merck Sharp & Dohme, Geležinio Vilko 18A,
Maltese: Il-Litwanja UAB Merck Sharp & Dohme, Geležinio Vilko 18A, LT- 01112 Vilnius, il-Litwanja
English: Vascular disorders Uncommon: Vasculitis
Maltese: Disturbi vaskulari Mhux komuni: Vaskulite
English: Cozaar Comp 50 mg/12.5 mg, Cozaar Comp 100 mg/25 mg:
Maltese: Cozaar Comp 50 mg/12.5 mg, Cozaar Comp 100 mg/12.5 mg and Cozaar Comp 100 mg/25 mg:
English: The CHMP considered that the text concerning pregnancy and lactation in the SPC (sections 4.3, 4.4 and 4.6) should 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) 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: Hydrochlorothiazide (HCTZ) is a thiazide diuretic which has also been used as an antihypertensive agent.
Maltese: Hydrochlorothiazide (HCTZ) huwa dijuretiku thiazide li intuża wkoll bħala mediċina kontra lpressjoni għolja.
English: Merck Sharp & Dohme GmbH Donau-City-Straße 6
Maltese: L-Awstrija Merck Sharp & Dohme GmbH Donau-City-Straße 6, 1220 Wien L-Awstrija
English: Uncommon: Transient blurred vision, xanthopsia Vascular disorders
Maltese: Mhux komuni: Vista mċajjra għaddiena, ksantopsja Disturbi vaskulari
English: In patients with left ventricular failure, 25 mg and 50 mg doses of losartan produced positive hemodynamic and neurohormonal effects characterized by an increase in cardiac index and decreases in pulmonary capillary wedge pressure, systemic vascular resistance, mean systemic arterial pressure and heart rate and a reduction in circulating levels of aldosterone and norepinephrine, respectively.
Maltese: F'pazjenti li għandhom insuffiċjenza ventrikulari tan-naħa tax-xellug, dożi ta' 25 mg u 50 mg ta' losartan ipproduċa effetti emodinamiċi u newro-ormonali pożittivi ikkaraterizzati b'żieda fl-indiċi kardijaku u tnaqqis fil-pulmonary capillary wedge pressure, reżistenza vaskulari sistematika, pressjoni arterjali sistematika medja u r-rata tal-qalb u tnaqqis fil-livelli ċirkolatorji ta aldosterone u norepinephrine, rispettivament.
English: Blood and lymphatic system disorders Uncommon: Anaemia, Henoch-Schönlein purpura, ecchymosis, haemolysis
Maltese: Mhux komuni: anemija, purpura Henoch-Schönlein, eċċimosi, emolisi
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' NSAIDs (i.e. impedituri silettivi ta' COX-2, acetylsalicylic acid f'dożi ta' kontra l-infjammazzjoni) u NSAIDs mhux silettivi, jista' jkun hemm attenwazzjoni ta' l-effett kontra l-pressjoni għolja.
English: When pregnancy is diagnosed, treatment with Cozaar Comp should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Maltese: Meta tqala tiġi dijanjonizzata, it-trattament b'Cozaar Comp għandu jitwaqqaf immedjatament, u jekk jixraq, terapija alternattiva għandha tinbeda (ara sezzjonijiet 4.3 u 4.6).
English: Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidney.
Maltese: Hydrochlorothiazide mhux metabolizzat imma jiġi eliminat malajr minn ġol-kliewi.
English: Amphotericin B (parenteral), corticosteroids, ACTH or stimulant laxatives Hydrochlorothiazide may intensify electrolyte imbalance, particularly hypokalaemia.
Maltese: Amphotericin B (parenterali), kortikosterojds, ACTH jew purganti stimulanti Hydrochlorothiazide għandu mnejn jintensifika l-iżbilanċ elettrolitiku, b'mod partikolari lipokalemija
English: Cozaar Comp 50 mg/12.5 mg, Cozaar Comp 100 mg/12.5 mg and Cozaar Comp 100 mg/25 mg: Each tablet contains the following inactive ingredients: microcrystalline cellulose(E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose(E464).
Maltese: Cozaar Comp 50 mg/12.5 mg, Cozaar Comp 100 mg/12.5 mg u Cozaar Comp 100 mg/25 mg fihom issustanzi l-oħra li ġejjin: microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose (E464)
English: Use in patients with renal impairment and haemodialysis patients No initial dosage adjustment is necessary in patients with moderate renal impairment (i.e. creatinine clearance 30-50 ml/min).
Maltese: L-ebda aġġustament fid-doża mhu meħtieġ għal pazjenti li għandhom indeboliment renali moderat (i.e. tneħħija ta' kreatinina 30-50 ml/min).
English: Therefore Cozaar Comp is contraindicated in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
Maltese: Għalhekk Cozaar Comp huwa kontra-indikat f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: Therefore, whilst the proposed indication for losartan monotherapy was considered approvable after a majority vote by the CHMP plenum and is supported with the following wording: “reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy, documented by ECG”, the following considerations apply for the FDC:
Maltese: Għaldaqstant, l-indikazzjoni proposta kienet ikkunsidrata approvabbli wara vot ta' maġġoranza millplenum tas-CHMP u hija appoġġjata bil-formolazzjoni li ġejja: “tnaqqis ta' riskju ta' attakk ta' puplesija f'pazjenti bi pressjoni għolja b'ipertrofija ventrikolari xelluġija, iddokkumentata b'ECG”, ilkunsiderazzjonijiet li ġejjin japplikaw għall-FDC:
English: Uncommon (affecting less than one person in 100 but more than one person in 1,000):
Maltese: Mhux komuni: ≥ 1/1,000, ≤ 1/100 Rari:
English: Cozaar Comp therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see also 5.3 'Preclinical safety data').
Maltese: L-espożizzjoni għat-terapija b'Cozaar Comp waqt it-tieni u t-tielet trimestri hi magħrufa li tinduċi tossiċità fil-fetu uman (tnaqqis fil-funzjoni tal-kliewi, oligoħidramnios, dewmien għal ossifikazzjoni tal-kranju) u tossiċità lit-tarbija għadha titwieled (insuffiċjenza renali, pressjoni baxxa, iperkalemja) (ara wkoll 5.3 ‘Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà tal-mediċina').
English: Measurements of blood pressure 24 hours post-dose relative to 5 - 6 hours post-dose demonstrated blood pressure reduction over 24 hours; the natural diurnal rhythm was retained.
Maltese: Il-kejl tal-pressjoni tad-demm 24 siegħa wara d-doża imqabbel ma' 5-6 sigħat wara d-doża wera tnaqqis fil-pressjoni fuq 24 siegħa; bir-ritmu diurnali naturali jibqa' jinżamm.
English: Cozaar Comp 100 mg/25 mg also contain:, Titanium dioxide (E171), Quinoline yellow aluminum lake (E104), and Carnauba wax (E903)
Maltese: Cozaar Comp 100 mg/25 mg fih ukoll:, Titanium dioxide (E171), Quinoline yellow aluminum lake (E104), u Carnauba wax (E903)
English: The use of Cozaar Comp is contra-indicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and 4.4).
Maltese: L-użu ta' Cozaar-Comp hu kontra-indikat waqt it-2ni u t-3et tliet xhur ta' tqala (ara sezzjonijiet 4.3 u 4.4).
English: HYZAAR (Losartan/Hydrochlorothia zide)
Maltese: HYZAAR (Losartan/Hydrochlorothiazide)
English: Uncommon: Nervousness, paraesthesia, peripheral neuropathy, tremor, migraine, syncope
Maltese: Nervożità, paraestesja, newropatija periferika, rogħda, emikranja, sinkope
English: Pressor amines (e.g., adrenaline) Possible decreased response to pressor amines but not sufficient to preclude their use.
Maltese: Amini pressors (eż., adrenalina) Possibiltà ta' rispons imnaqqas għal amini pressor imma mhux biżżejjed biex jevita l-użu tagħhom.
English: The usual maintenance dose of Cozaar Comp is one tablet of Cozaar Comp 50 mg/12.5 mg (losartan 50 mg/HCTZ 12.5 mg) once daily.
Maltese: Id-doża inizjali u ta' manteniment ta' Cozaar Comp hi ta' pillola waħda ta' Cozaar Comp 50 mg/12.5 mg (50 mg losartan/12.5 mg HCTZ) darba kuljum.
English: • Anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, sleepiness, memory impairment,
Maltese: • Ansjetà, nervożitàm disturb ta' paniku (attakki ta' paniku rikorrenti), konfużjoni, dipressjoni,
English: - Reduction in risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy.
Maltese: - Tnaqqis fir-riskju ta' morbidità u mortalità kardjovaskulari f'pazjenti bi pressjoni għolja b'ipertrofija ventrikulari xellugija.
English: PHARMACEUTICAL FORM AND CONTENTS 14, 15, 28, 30, 50, 56, 84, 90, 98, or 280 film coated-tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 14, 15-il pillola, 28, 30, 50, 56, 84, 90, 98, jew 280 pillola miksija b'rita.
English: Anaphylactic reaction
Maltese: Sustanza mhux attiva
English: HYZAAR (Losartan/Hydrochlorothiazide) Luxembourg COZAAR PLUS FORTE 100 MG/25 MG Luxembourg COZAAR PLUS 50 MG/12,5 MG Luxembourg LOORTAN PLUS FORTE 100 mg/25 mg Luxembourg LOORTAN PLUS 50 mg/12,5 mg Malta
Maltese: MG/12,5 MG Il-Lussemburgu LOORTAN PLUS FORTE 100 mg/25 mg Il-Lussemburgu LOORTAN PLUS 50 mg/12,5 mg Malta
English: Cosaar Plus - Filmtabletten 50 mg losartan potassium12.5 mg hydrochlorothiazide
Maltese: Cosaar Plus - Filmtabletten 50 mg losartan potassium
English: Finland Merck Sharp & Dohme B.V. Waarderweg 39
Maltese: Il-Finlandja Merck Sharp & Dohme B.V.
English: Uncommon: Anxiety, anxiety disorder, panic disorder, confusion, depression, abnormal dreams, sleep disorder, somnolence, memory impairment
Maltese: Mhux komuni: Ansjetà, Disturb dwar l-ansjetà, Disturb ta' paniku, konfużjoni, dipressjoni, ħolm abnormali, disturbi fl-irqad, ħedla, memorja mfixxkla
English: Use in children and adolescents (< 18 years)
Maltese: L-użu fi tfal u adoloxxenti (< 18-il sena)