FrancophonIA/ELRC3.0 huggingface dataset:
English: Special warnings and precautions for use (SPC section 4.4) The CHMP considered that the following warnings needed to be included in the SPC for Cozaar in all MSs: Hypersensitivity; Angioedema; Surgery; Anaesthesia; Haemodialysis; Kidney transplant; Black patients; Obstructive valvular disease.
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen (produktresumé, afsnit 4.4) CHMP var af den opfattelse, at følgende advarsler skulle inkluderes i produktresuméet for Cozaar i alle medlemsstater: hypersensitivitet, angioødem, operation, anæstesi, hæmodialyse, nyretransplantation, negroide patienter, obstruktiv hjerteklapsygdom.
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).
Danish: Losartans farmakokinetik blev undersøgt hos 50 hypertensive pædiatriske patienter i alderen > 1 måned til < 16 år, efter at de havde fået en oral administration på ca. 0,54 til 0,77 mg/kg losartan (gennemsnitlige doser) én gang dagligt.
English: Therefore losartan must not be administered in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
Danish: Losartan må derfor ikke gives til patienter med svært nedsat leverfunktion (se afsnit 4.2, 4.3 og 5.2).
English: Vascular disorders: common: hypotension
Danish: Vaskulære sygdomme Almindelig: Hypotension.
English: • fainting (syncope),
Danish: • Besvimelse (synkope)
English: The usual starting dose is 50 mg of Cozaar once daily.
Danish: Normal startdosis er 50 mg Cozaar én gang dagligt.
English: happening in less than 1 in 10,000 patients not known
Danish: Forekommer hos færre end 1 ud af 10.000 patienter
English: • to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal amount of protein).
Danish: • at beskytte nyrerne hos type 2-diabetikere med forhøjet blodtryk, hvor laboratorieprøver viser nedsat nyrefunktion og proteinuri ≥0,5 g pr. dag (en tilstand hvor urinen indeholder en unormal mængde protein);
English: In patients >50 kg, the usual dose is 50 mg once daily.
Danish: Til patienter > 50 kg er den sædvanlige dosis 50 mg én gang dagligt.
English: Use in patients with renal impairment and haemodialysis patients: No initial dosage adjustment is necessary in patients with renal impairment and in haemodialysis patients.
Danish: Patienter med nyreinsufficiens og patienter i hæmodialyse Initial dosisjustering er ikke nødvendig hos patienter med nyreinsufficiens og patienter i hæmodialyse.
English: Symptomatic hypotension, especially after the first dose and after increasing of the dose, may occur in patients who are volume- and/or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Danish: Symptomatisk hypotension, især efter den første dosis og efter dosisøgning, kan forekomme hos patienter med væske- og/eller natriummangel som følge af behandling med højdosis-diuretika, begrænsning på salt i kosten, diarré eller opkastning.
English: As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported (in particular, in patients whose renal function is dependent on the renin angiotensin aldosterone system such as those with severe cardiac insufficiency or pre-existing renal dysfunction).
Danish: Som følge af hæmningen af renin-angiotensinsystemet er der rapporteret om forandringer i nyrefunktionen, herunder nyreinsufficiens (især hos patienter, hvis nyrefunktion er afhængig af reninangiotensin-aldosteronsystemet, som f.eks. patienter med svær hjerteinsufficiens eller præeksisterende renal dysfunktion).
English: - Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with ACE inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication.
Danish: - Behandling af kronisk hjerteinsufficiens (hos patienter på ≥ 60 år), når behandling med ACE-hæmmere ikke anses for at være egnet på grund af inkompatibilitet, især hoste, eller kontraindikation.
English: Gastrointestinal disorders: Uncommon: abdominal pain, obstipation
Danish: Mave-tarmkanalen Ikke almindelig: Abdominal smerte, obstipation.
English: Filmcoated tablet Oral use
Danish: Tabletter filmovertrukne Oral anvendelse
English: Cozaar contains lactose monohydrate.
Danish: Cozaar indeholder lactosemonohydrat.
English: In some patients the dose may later be increased to 100 mg losartan (two tablets Cozaar 50 mg) once daily
Danish: Hos nogle patienter kan dosis senere øges til 100 mg losartan (to tabletter Cozaar 50 mg) én gang dagligt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Trifold
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Trefold
English: 2003 PC HAARLEM the Netherlands
Danish: 2003 PC Haarlem Holland
English: PHARMACEUTICAL FORM AND CONTENTS 7 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7 filmovertrukne tabletter
English: Heart Failure
Danish: Hjerteinsufficiens
English: Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan.
Danish: Patienter med hjerteinsufficiens, som er blevet stabiliseret med en ACE-hæmmer, bør ikke skiftes over til losartan.
English: PHARMACEUTICAL FORM AND CONTENTS 100 or 300 tablets.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 100 eller 300 tabletter.
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”).
Danish: • patienter med både højt blodtryk og en fortykkelse af hjertevæggen, hvor Cozaar kan nedsætte risikoen for slagtilfælde ("LIFE"-indikationen).
English: • if your liver function is severely impaired,
Danish: • Deres leverfunktion er alvorligt nedsat,
English: There is no therapeutic experience with losartan in patients with severe hepatic impairment.
Danish: Der er ingen terapeutisk erfaring med losartan hos patienter med svært nedsat leverfunktion.
English: Generally, the dose should be increased weekly step-by-step (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week) up to the usual maintenance dose of 50 mg losartan (one tablet Cozaar 50 mg) once daily, according to your condition.
Danish: Dosis bør sædvanligvis øges trinvis en gang om ugen (dvs 12,5 mg dagligt i den første uge, 25 mg dagligt i den næste uge, 50 mg dagligt i den tredje uge) op til en vedligeholdelsesdosis på 50 mg losartan (en tablet Cozaar 50 mg) én gang dagligt afhængigt af Deres tilstand.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally]
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt]
English: • serum creatinine and serum potassium in patients with heart failure,
Danish: • Ændring i kreatinin og kalium i blodet hos patienter med nedsat hjertefunktion
English: • Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with ACE inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication.
Danish: • Behandling af kronisk hjerteinsufficiens (hos patienter ≥60 år), når behandling med ACEhæmmere ikke anses for at være velegnet på grund af uforligelighed, især hoste, eller kontraindikation.
English: The use of losartan is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: Anvendelse af losartan kan ikke anbefales i 1. trimester af graviditeten (se pkt.
English: The antihypertensive effect of Cozaar was established in a clinical study involving 177 hypertensive paediatric patients 6 to 16 years of age with a body weight > 20 kg and a glomerular filtration rate > 30 ml/ min/ 1.73 m2.
Danish: Cozaars antihypertensive virkning blev fastslået i en klinisk undersøgelse, der omfattede 177 hypertensive pædiatriske patienter i alderen 6-16 år med en kropsvægt på > 20 kg og en glomerulær filtrationsrate på > 30 ml/min/1,73 m2.
English: Cozaar has been studied in children.
Danish: Brug til børn og unge Cozaar er undersøgt hos børn.
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.
Danish: Generelt bør dosis titreres med ugentlige intervaller (f.eks. 12,5 mg dagligt, 25 mg dagligt, 50 mg dagligt) til normal vedligeholdelsesdosis på 50 mg én gang dagligt, som det kan tolereres af patienten.
English: It is important to tell your doctor before taking Cozaar:
Danish: Tal med lægen eller apoteket, inden De tager Cozaar:
English: • sleep disorders,
Danish: • Søvnforstyrrelser
English: Take special care with Cozaar
Danish: Vær ekstra forsigtig med at tage Cozaar
English: Belgium Therabel Pharma S.A. Rue Egide Van Ophem 108 B-1180 Brussels
Danish: Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Bruxelles, Belgien
English: Renal and urinary disorders: not known: urinary tract infections
Danish: Nyrer og urinveje Ikke kendt: Urinvejsinfektioner.
English: Skin and subcutaneous tissue disorders: not known: urticaria, pruritus, rash
Danish: Hud og subkutane væv Ikke kendt: Urticaria, pruritus, udslæt.
English: • Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment.
Danish: • Behandling af nyresygdom hos patienter med hypertension og type 2-diabetes mellitus med proteinuri ≥0,5 g/dag som del af en antihypertensiv behandling.
English: • increase in blood urea,
Danish: • Stigning i urinstoffet i blodet
English: A lower dose should be considered for patients with a history of hepatic impairment.
Danish: Lavere dosis bør overvejes til patienter med leverinsufficiens i anamnesen.
English: The following wording has been added to SPC Section 4.8 Undesirable effects:
Danish: Følgende ordlyd er tilføjet produktresuméet, afsnit 4.8 Bivirkninger:
English: Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 6.1).
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne (se pkt.
English: Infants whose mothers have taken losartan should be closely observed for hypotension (see also section 4.3 and 4.4).
Danish: Spædbørn, hvis mødre har taget losartan, bør observeret omhyggeligt for hypotension (se også pkt.
English: In elderly hypertensive patients the plasma concentrations of losartan and its active metabolite do not differ essentially from those found in young hypertensive patients.
Danish: Losartans og dets aktive metabolits plasmakoncentration hos ældre hypertensive patienter var ikke signifikant forskellig fra den, der sås hos unge hypertensive patienter.
English: - Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria > 0.5 g/day as part of an antihypertensive treatment
Danish: - Behandling af nyresygdom hos patienter med hypertension og type 2-diabetes mellitus med proteinuri > 0,5 g/dag som led i en antihypertensiv behandling
English: The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take losartan").
Danish: Cozaar bør ikke gives til patienter med alvorligt nedsat leverfunktion (se afsnittet "Tag ikke Cozaar").
English: General disorders and administration site conditions: not known: flu-like symptoms
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke kendt: Influenzalignende symptomer.
English: LORTAAN IC
Danish: LOORTAN IC
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).
Danish: Når graviditet diagnosticeres, bør behandling med losartan seponeres omgående, og hvis det er hensigtsmæssigt, bør alternativ behandling påbegyndes (se pkt.
English: The patients should have a left ventricular ejection fraction equal to or greater than 40% and should be stabilised under the treatment of the chronic heart failure.
Danish: Patienterne bør have en venstre ventrikels uddrivningsfraktion, der er lig med eller større end 40 %, og bør stabiliseres under behandlingen for den kroniske hjerteinsufficiens.
English: LIST OF EXCIPIENTS Lactose monohydrate.
Danish: LISTE OVER HJÆLPESTOFFER Lactosemonohydrat.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDDEL
English: - Reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG ( See section 5.1 Life Study, Race)
Danish: - Risikoreduktion af slagtilfælde hos hypertensive patienter med venstresidig ventrikelhypertrofi dokumenteret ved EKG (se afsnit 5.1 Life-undersøgelsen, Race)
English: PVC/aluminum foil/nylon blisters with aluminum foil lidding in packs of 10, 14 and 28.
Danish: PVC/aluminiumsfolie/nylonblister med aluminiumsfolie i pakninger à 10, 14 og 28 tabletter.
English: • if you suffer from heart failure with or without renal impairment or concomitant severe life threatening cardiac arrhythmias.
Danish: • hvis De har nedsat hjertefunktion, med eller uden nedsat nyrefunktion, eller samtidig alvorlig livstruende rytmeforstyrrelser i hjertet.
English: Treatment usually starts with 50 mg losartan (one tablet Cozaar 50 mg) once a day.
Danish: Behandlingen starter normalt med 50 mg losartan (en tablet Cozaar 50 mg) én gang dagligt.
English: • feeling of increased heart rate (palpitations),
Danish: • Følelse af at hjertet slår meget hurtigt (palpitationer)
English: Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG
Danish: Reduktion af risikoen for stroke hos hypertensive patienter med hypertrofi af venstre ventrikel, som er dokumenteret ved EKG
English: Cozaar may be administered with other antihypertensive agents (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used hypoglycemic agents (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Danish: Cozaar kan administreres sammen med andre antihypertensiva (f.eks. diuretika, calciumkanalblokkere, alfa- eller betablokkere samt centralt virkende lægemidler) såvel som med insulin og andre almindeligt anvendte hypoglykæmiske lægemidler (f.eks. sulfonylurinstoffer, glitazoner og glucosidasehæmmere).
English: INSTRUCTIONS ON USE [To be completed nationally] [For referral procedures]
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN [Udfyldes nationalt]
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).
Danish: II-receptorantagonister (AIIRA'er) og anbefalinger om anvendelse i graviditetens første trimester (EMEA/CHMP/PhVWP/474692/2007).
English: As with other drugs that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon discontinuation of therapy.
Danish: Som for andre lægemidler, der påvirker renin-angiotensin-aldosteronsystemet, er der rapporteret om øget carbamid og serumkreatinin hos patienter med bilateral nyrearteriestenose eller unilateral nyrearteriestenose (hvis funktionelt ennyret); disse ændringer i nyrefunktionen kan være reversible ved seponering af behandlingen.
English: PHARMACEUTICAL FORM AND CONTENTS 7, 14, 21, 28, 50, 98, 210 or 500 film-coated tablets.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7, 14, 21, 28, 50, 98, 210 eller 500 filmovertrukne tabletter.
English: happening in 1 in 10,000 to 1 in 1,000 patients very rare:
Danish: Forekommer hos 1 ud af 10.000 til 1 ud af 1.000 patienter
English: Common: dizziness, vertigo Uncommon: somnolence, headache, sleep disorders
Danish: Ikke almindelig: Somnolens, hovedpine, søvnproblemer.
English: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function including renal failure have been reported in patients at risk; these changes in renal function may be reversible upon discontinuation of therapy (see section 4.4)
Danish: Som følge af hæmning af renin-angiotensin-aldosteronsystemet er der rapporteret om ændringer i nyrefunktionen, herunder nyresvigt, hos risikopatienter; disse ændringer i nyrefunktionen kan være reversible ved seponering af behandlingen (se pkt.
English: • flu-like symptoms,
Danish: • Influenzalignende symptomer
English: Pregnancy and Lactation should be contraindicated and the appropriate wording included in sections 4.3, 4.4 and 4.6 of the SPC, and the relevant sections of the Package Leaflet.
Danish: Graviditet og amning skal kontraindiceres, og den korrekte ordlyd skal inkluderes i afsnit 4.3, 4.4 og 4.6 i produktresuméet samt i de relevante afsnit af indlægssedlen.
English: - Pregnancy and Lactation should be contraindicated and the appropriate wording included in sections 4.3, 4.4 and 4.6 of the SPC, and the relevant sections of the Package Leaflet.
Danish: - Graviditet og amning skal kontraindiceres, og den relevante ordlyd skal inkluderes i afsnit 4.3, 4.4 og 4.6 i produktresuméet samt i de relevante afsnit af indlægssedlen.
English: Losartan 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').
Danish: Eksponering for losartan i 2. og 3. trimester inducerer føtotoksicitet hos mennesker (nedsat nyrefunktion, oligohydramnios, forsinket kranieossifikation) og neonatal toksicitet (nyresvigt,
English: Skin and subcutanous tissue disorders: uncommon: urticaria, pruritus, rash
Danish: Hud og subkutane væv Ikke almindelig: Urticaria, pruritus, udslæt.
English: Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
Danish: Losartan anbefales heller ikke til børn med leverinsufficiens (se også afsnit 4.4).
English: Renal clearance of losartan and its active metabolite is about 74 mL/min and 26 mL/min, respectively.
Danish: Losartans og dets aktive metabolits plasmaclearance er henholdsvis ca. 600 ml/min og 50 ml/ min. Losartans og dets aktive metabolits renalclearance er henholdsvis ca. 74 ml/min og 26 ml/min.
English: SPECIAL STORAGE CONDITIONS Keep the blister in the outer carton.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale yderpakning.
English: INFORMATION IN BRAILLE [To be completed nationally] [For referral procedures]
Danish: INFORMATION I BRAILLE-SKRIFT [Udfyldes nationalt]
English: Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom
Danish: Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU Storbritannien
English: Losartan tablets may be administered with other blood pressure lowering medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Danish: Cozaartabletter kan gives sammen med anden blodtrykssænkende medicin (f.eks. diuretika, kalciumkanalblokkere, alfa- eller beta-blokkere og centralt virkende lægemidler) og også sammen med insulin og anden medicin, som bruges til at nedsætte blodglucosen (f.eks. sulfonylurinstoffer, glitazoner og glucosidasehæmmere).
English: For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients >20 to <50 kg.
Danish: Til patienter, der kan sluge en tablet, er den anbefalede dosis 25 mg én gang dagligt til patienter >20 til <50 kg. I særlige tilfælde kan dosis øges til maksimalt 50 mg én gang dagligt.
English: Pediatric Hypertension
Danish: Pædiatrisk hypertension
English: The patients should have a left ventricular ejection fraction ≤ 40% and should be stabilised under the treatment of the chronic heart failure.
Danish: Patienterne bør have en venstre ventrikels uddrivningsfraktion, der er ≤ 40 %, og bør stabiliseres under behandlingen for den kroniske hjerteinsufficiens.
English: Characteristics in Patients
Danish: Patientkarakteristika
English: For more information, talk to your doctor.
Danish: Tal med lægen for at få yderligere information.
English: Losartan is also not recommended in children with hepatic impairment (see section 4.2).
Danish: Losartan anbefales heller ikke til børn med leverinsufficiens (se afsnit 4.2).
English: The side effects of medicines are classified as follows: very common: happening in more than 1 in 10 patients common:
Danish: Meget almindelig: Forekommer hos flere end 1 ud af 10 patienter Almindelig:
English: Respiratory, thoracic and mediastinal disorders: not known: cough
Danish: Luftveje, thorax og mediastinum Ikke kendt: Hoste.
English: • liver function abnormalities,
Danish: Ikke kendt: Abnorm leverfunktion.
English: Cardiac disorders: not known: syncope, palpitations
Danish: Hjerte Ikke kendt: Synkope, palpitationer.
English: 21 film-coated tablets of 12.5 mg and 7 film-coated tablets of 50 mg losartan potassium.
Danish: 21 filmovertrukne tabletter à 12,5 mg og 7 filmovertrukne tabletter à 50 mg losartankalium.
English: • debility,
Danish: • Svækkelse
English: The following wording has been added to SPC section 4.2 Posology and Method of Administration:
Danish: Følgende ordlyd er tilføjet produktresuméets afsnit 4.2 Dosering og indgivelsesmåde:
English: Lithuania UAB Merck Sharp & Dohme, Geležinio Vilko 18A,
Danish: UAB Merck Sharp & Dohme, Geležinio Vilko 18A, LT- 01112 Vilnius, Litauen
English: The following adverse events have been reported in post-marketing experience: Blood and lymphatic system disorders: not known: Anaemia, thrombocytopenia
Danish: Blod og lymfesystem Ikke kendt: Anæmi, trombocytopeni.
English: • reduced number of thrombocytes,
Danish: • Nedsat antal blodplader
English: Nervous system disorders: common: dizziness
Danish: Nervesystemet Almindelig: Svimmelhed.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.
Danish: Fortæl det altid til lægen eller apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
English: Luxembourg Therabel Pharma S.A. - Rue Egide Van Ophem 108
Danish: Luxemburg Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgien
English: Renal Function Impairment
Danish: • Unormal leverfunktion
English: • migraine,
Danish: • Hovedpine
English: 21 film-coated tablets of 12.5 mg and 14 film-coated tablets of 50 mg losartan potassium.
Danish: 21 filmovertrukne tabletter à 12,5 mg og 14 filmovertrukne tabletter à 50 mg losartankalium.
English: Losartan is not recommended in children with glomerular filtration rate < 30ml/ min/ 1.73 m2as no data are available (see section 4.2).
Danish: Losartan anbefales ikke til børn med en glomerulær filtrationsrate < 30 ml/min/1,73 m2, da der ikke foreligger data herfor (se afsnit 4.2).
English: • somnolence,
Danish: • Søvnighed
English: Gastrointestinal disorders: uncommon: diarrhoea, nausea, vomiting
Danish: Mave-tarmkanalen Ikke almindelig: Diarré, kvalme, opkastning.
English: Marketing Authorisation Holder and Manufacturer
Danish: Medlemsstat Indehaver af markedsføringstilladelse