natgillin/translations-raw huggingface dataset:
Almene symptomer og reaktioner på administrationsstedet Ikke kendt: Influenzalignende symptomer. 
General disorders and administration site conditions: not known: flu-like symptoms
LOORTAN IC 
LORTAAN IC
Når graviditet diagnosticeres, bør behandling med losartan seponeres omgående, og hvis det er hensigtsmæssigt, bør alternativ behandling påbegyndes (se pkt. 
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).
Patienterne bør have en venstre ventrikels uddrivningsfraktion, der er lig med eller større end 40 %, og bør stabiliseres under behandlingen for den kroniske hjerteinsufficiens. 
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.
LISTE OVER HJÆLPESTOFFER Lactosemonohydrat. 
LIST OF EXCIPIENTS Lactose monohydrate.
BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDDEL 
GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
- Risikoreduktion af slagtilfælde hos hypertensive patienter med venstresidig ventrikelhypertrofi dokumenteret ved EKG (se afsnit 5.1 Life-undersøgelsen, Race) 
- Reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG ( See section 5.1 Life Study, Race)
PVC/aluminiumsfolie/nylonblister med aluminiumsfolie i pakninger à 10, 14 og 28 tabletter. 
PVC/aluminum foil/nylon blisters with aluminum foil lidding in packs of 10, 14 and 28.
• hvis De har nedsat hjertefunktion, med eller uden nedsat nyrefunktion, eller samtidig alvorlig livstruende rytmeforstyrrelser i hjertet. 
• if you suffer from heart failure with or without renal impairment or concomitant severe life threatening cardiac arrhythmias.
Behandlingen starter normalt med 50 mg losartan (en tablet Cozaar 50 mg) én gang dagligt. 
Treatment usually starts with 50 mg losartan (one tablet Cozaar 50 mg) once a day.
• Følelse af at hjertet slår meget hurtigt (palpitationer) 
• feeling of increased heart rate (palpitations),
Reduktion af risikoen for stroke hos hypertensive patienter med hypertrofi af venstre ventrikel, som er dokumenteret ved EKG 
Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG
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). 
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).
INSTRUKTIONER VEDRØRENDE ANVENDELSEN [Udfyldes nationalt] 
INSTRUCTIONS ON USE [To be completed nationally] [For referral procedures]
II-receptorantagonister (AIIRA'er) og anbefalinger om anvendelse i graviditetens første trimester (EMEA/CHMP/PhVWP/474692/2007). 
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).
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. 
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.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7, 14, 21, 28, 50, 98, 210 eller 500 filmovertrukne tabletter. 
PHARMACEUTICAL FORM AND CONTENTS 7, 14, 21, 28, 50, 98, 210 or 500 film-coated tablets.
Forekommer hos 1 ud af 10.000 til 1 ud af 1.000 patienter 
happening in 1 in 10,000 to 1 in 1,000 patients very rare:
Ikke almindelig: Somnolens, hovedpine, søvnproblemer. 
Common: dizziness, vertigo Uncommon: somnolence, headache, sleep disorders
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. 
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)
• Influenzalignende symptomer 
• flu-like symptoms,
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. 
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.
- 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. 
- 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.
Eksponering for losartan i 2. og 3. trimester inducerer føtotoksicitet hos mennesker (nedsat nyrefunktion, oligohydramnios, forsinket kranieossifikation) og neonatal toksicitet (nyresvigt, 
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').
Hud og subkutane væv Ikke almindelig: Urticaria, pruritus, udslæt. 
Skin and subcutanous tissue disorders: uncommon: urticaria, pruritus, rash
Losartan anbefales heller ikke til børn med leverinsufficiens (se også afsnit 4.4). 
Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
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. 
Renal clearance of losartan and its active metabolite is about 74 mL/min and 26 mL/min, respectively.
SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale yderpakning. 
SPECIAL STORAGE CONDITIONS Keep the blister in the outer carton.
INFORMATION I BRAILLE-SKRIFT [Udfyldes nationalt] 
INFORMATION IN BRAILLE [To be completed nationally] [For referral procedures]
Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU Storbritannien 
Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom
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). 
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).
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. 
For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients >20 to <50 kg.
Pædiatrisk hypertension 
Pediatric Hypertension
Patienterne bør have en venstre ventrikels uddrivningsfraktion, der er ≤ 40 %, og bør stabiliseres under behandlingen for den kroniske hjerteinsufficiens. 
The patients should have a left ventricular ejection fraction ≤ 40% and should be stabilised under the treatment of the chronic heart failure.
Patientkarakteristika 
Characteristics in Patients
Tal med lægen for at få yderligere information. 
For more information, talk to your doctor.
Losartan anbefales heller ikke til børn med leverinsufficiens (se afsnit 4.2). 
Losartan is also not recommended in children with hepatic impairment (see section 4.2).
Meget almindelig: Forekommer hos flere end 1 ud af 10 patienter Almindelig: 
The side effects of medicines are classified as follows: very common: happening in more than 1 in 10 patients common:
Luftveje, thorax og mediastinum Ikke kendt: Hoste. 
Respiratory, thoracic and mediastinal disorders: not known: cough
Ikke kendt: Abnorm leverfunktion. 
• liver function abnormalities,
Hjerte Ikke kendt: Synkope, palpitationer. 
Cardiac disorders: not known: syncope, palpitations
21 filmovertrukne tabletter à 12,5 mg og 7 filmovertrukne tabletter à 50 mg losartankalium. 
21 film-coated tablets of 12.5 mg and 7 film-coated tablets of 50 mg losartan potassium.
• Svækkelse 
• debility,
Følgende ordlyd er tilføjet produktresuméets afsnit 4.2 Dosering og indgivelsesmåde: 
The following wording has been added to SPC section 4.2 Posology and Method of Administration:
UAB Merck Sharp & Dohme, Geležinio Vilko 18A, LT- 01112 Vilnius, Litauen 
Lithuania UAB Merck Sharp & Dohme, Geležinio Vilko 18A,
Blod og lymfesystem Ikke kendt: Anæmi, trombocytopeni. 
The following adverse events have been reported in post-marketing experience: Blood and lymphatic system disorders: not known: Anaemia, thrombocytopenia
• Nedsat antal blodplader 
• reduced number of thrombocytes,
Nervesystemet Almindelig: Svimmelhed. 
Nervous system disorders: common: dizziness
Fortæl det altid til lægen eller apoteket, hvis De bruger anden medicin eller har brugt det for nylig. 
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.
Luxemburg Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgien 
Luxembourg Therabel Pharma S.A. - Rue Egide Van Ophem 108
• Unormal leverfunktion 
Renal Function Impairment
• Hovedpine 
• migraine,
21 filmovertrukne tabletter à 12,5 mg og 14 filmovertrukne tabletter à 50 mg losartankalium. 
21 film-coated tablets of 12.5 mg and 14 film-coated tablets of 50 mg losartan potassium.
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). 
Losartan is not recommended in children with glomerular filtration rate < 30ml/ min/ 1.73 m2as no data are available (see section 4.2).
• Søvnighed 
• somnolence,
Mave-tarmkanalen Ikke almindelig: Diarré, kvalme, opkastning. 
Gastrointestinal disorders: uncommon: diarrhoea, nausea, vomiting
Medlemsstat Indehaver af markedsføringstilladelse 
Marketing Authorisation Holder and Manufacturer
magnesiumstearat (E572), hydroxypropylcellulose (E463), hypromellose (E464). 
The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose (E464).
Hvide, ovale filmovertrukne tabletter mærket 952 på den ene side og med delekærv på den anden side. 
White, oval film-coated tablets marked 952 on one side and scored on the other.
Blister til Cozaar 12,5 mg filmovertrukne tabletter Blister til Cozaar 50 mg filmovertrukne tabletter 
Blister for Cozaar 12.5 mg film-coated tablets Blister for Cozaar 50 mg film-coated tablets
Lactosemonohydrat. 
Lactose monohydrate.
Losartan er en oralt aktiv angiotensin II (Ang-II)-receptorantagonist, der påvirker AT1-receptorundertypen. 
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.
Hvis Deres nedsatte hjertefunktion er blevet stabiliseret med ACE-hæmmere, behøver De ikke at skifte til Cozaar; 
If your heart failure has been stabilised with an ACE inhibitor you should not be switched to losartan .
DATO FOR ÆNDRING AF TEKSTEN 
DATE OF REVISION OF THE TEXT {MM/YYYY}
Behandlingen starter normalt med 12,5 mg losartan (en tablet Cozaar 12,5 mg) én gang dagligt. 
Patients with Heart Failure Treatment usually starts with 12.5 mg losartan (one tablet Cozaar 12.5 mg) once a day.
Hver tablet indeholder følgende inaktive indholdsstoffer: Mikrokrystallinsk cellulose (E460) Lactosemonohydrat 
Each tablet contains the following inactive ingredients: microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572) hydroxypropyl cellulose (E463) hypromellose (E464)
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 100 filmovertrukne tabletter. 
PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 100 tabletter. 
PHARMACEUTICAL FORM AND CONTENTS 100 tablets.
• Blodtryksfald, der viser sig, når man rejser sig fra liggende eller siddende stilling, og som kan have forbindelse til størrelsen af dosis 
• dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position,
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Storbritannien 
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU
Følgende bivirkninger forekom oftere hos patienter, der fik losartan end placebo: 
The following adverse events occurred more often in patients receiving losartan than placebo: Blood and lymphatic system disorders: not known: anaemia
Merck Sharp & Dohme GmbH Donau-City-Straße 6, 1220 Wien, Østrig 
Merck Sharp & Dohme GmbH Donau-City-Straße 6
Følgende ordlyd er tilføjet indlægssedlen, afsnit 2 Vigtig information som De skal læse, før De tager COZAAR: 
The following wording has been added to the Package Leaflet Section 2 Before you take Cozaar: Use in children and adolescents <COZAAR> has been studied in children.
SÅDAN SKAL DE TAGE COZAAR 
HOW TO TAKE Cozaar
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 eller 500 tabletter. 
PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets.
Hver Cozaar 100 mg tablet indeholder 51,0 mg lactosemonohydrat. 
Each Cozaar 100 mg tablet contains 51.0 mg lactose monohydrate.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter. 
PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
Patienter med intravaskulær væskemangel 
Use in patients with intravascular volume depletion:
Losartan anbefales ikke til børn med en glomerulær filtrationsrate < 30 ml/min/1,73 m2, da der ikke foreligger data herfor (se også afsnit 4.4). 
It is not recommended in children with glomerular filtration rate < 30 ml/ min / 1.73 m2, as no data are available (see also section 4.4).
Filmovertrukken tablet 
Film-coated tablets
Cozaar 100 mg tablet Hvide, dråbeformede filmovertrukne tabletter mærket 960 på den ene side og glatte på den anden side. 
White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other.
Cozaar filmovertrukne tabletter losartankalium 
Cozaar film-coated tablets losartan potassium
Cozaar 12,5 mg - PVC/PE/PVDC blisterpakninger med aluminiumsfolie i pakninger à 7, 14, 21, 28, 50, 98, 210 eller 500 tabletter. 
Cozaar 12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 14, 21, 28, 50, 98, 210 or 500 tablets.
• Muskel- eller ledsmerter 
• muscle and joint pain,
Almene symptomer og reaktioner på administrationsstedet Almindelig: Asteni/træthed. 
General disorders and administration site conditions: common: asthenia/fatigue
Storbritannien Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Storbritannien 
Ireland Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU
Anvendelse til pædiatriske patienter med nyreinsufficiens Losartan bør ikke gives til børn med glomerulær filtrationshastighed <30 ml/min/1,73m2, da der ikke findes dokumentation herfor (se pkt. 
Use in pediatric patients with renal function impairment Losartan is not recommended in children with glomerular filtration rate < 30ml/ min/ 1.73 m2as no data are available (see section 4.2).
Hver Cozaar 12,5 mg tablet indeholder 12,5 mg losartan (som kaliumsalt). 
Each Cozaar 12.5 mg Tablet contains 12.5 mg of losartan (as potassium salt).
• Lokal hævelse (ødem). 
• localised swelling (oedema).
2. og 3 trimester af graviditeten (se pkt. 
2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6) Lactation (see section 4.6)
salterstatninger, der indeholder kalium eller kaliumbesparende medicin som visse vanddrivende lægemidler [amilorid, triamteren, spironolacton] eller heparin). 
• medicines which retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines such as certain diuretics [amiloride, triamteren, spironolactone] or heparine),
CHMP var betænkelig ved, at benefit/risk-forholdet for denne indikation ikke kunne fastlægges på passende vis. Indikationen er primært baseret på resultaterne af de kliniske undersøgelser ELITE I og II. 
The CHMP was concerned that the benefit/risk ratio of this indication could not be adequately established.
SÅDAN OPBEVARER DE COZAAR 
HOW TO STORE Cozaar
• Kvalme 
• nausea,
• Nældefeber (urticaria) 
• hives (urticaria),
• Spørg lægen eller på apoteket, hvis der er mere, De vil vide. 
• If you have any further questions, ask your doctor or your pharmacist.
Mave-tarmkanalen Ikke kendt: Diarré. 
Gastrointestinal disorders: not known: diarrhoea
• Lægen har ordineret Cozaar til Dem personligt. 
• This medicine has been prescribed for you.
Målet med undersøgelsen var at vise losartankaliums nyrebeskyttende virkning ud over dets gavnlige indvirkning på blodtrykket. 
751 Patients were treated with Losartan The objective of the study was to demonstrate a nephroprotective effect of Losartan potassium over and above the benefit of a blood lowering pressure.
Sjælden: Hypersensitivitet: Anafylaktiske reaktioner, angioødem inklusive hævelse af larynx og glottis, som medfører luftvejsobstruktion og/eller hævelse af ansigt, læber, svælg og/eller tunge. 
Immune system disorders: rare: hypersensitivity: anaphylactic reactions, angiooedema including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue; in some of these patients angiooedema had been reported in the past in connection with the administration of other medicines, including ACE inhibitors; vasculitis, including Henoch-Schonlein purpura.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver Cozaar 12,5 mg filmovertrukken tablet indeholder 12,5 mg losartankalium Hver Cozaar 50 mg filmovertrukken tablet indeholder 50 mg losartankalium. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each Cozaar 12.5 mg film-coated mg tablet contains 12.5 mg losartan potassium.
Cozaar 12,5 mg tablet Blå, ovale, filmovertrukne tabletter mærket 11 på den ene side og glatte på den anden side. 
Blue, oval film-coated tablets marked 11 on one side and plain on the other.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar 12,5 mg filmovertrukne tabletter 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar 12.5 mg film-coated tablets
Luxemburg Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B1180 Brussels, Belgien 
Luxembourg Merck Sharp & Dohme BVChaussée de Waterloo 1135
Hver Cozaar 25 mg tablet indeholder 25 mg losartan (som kaliumsalt). 
Each Cozaar 25 mg Tablet contains 25 mg of losartan (as potassium salt).
Ydre karton for Cozaar 12,5 mg og 50 mg (startpakke) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 12.5 mg and 50 mg (titration package blister)
Hver Cozaar 100 mg tablet indeholder 100 mg losartankalium. 
Each Cozaar 100 mg tablet contains 100 mg of losartan potassium.
Cozaar fås som filmovertrukne tab1etter uden delekærv indeholdende 25 mg losartankalium. 
Cozaar is supplied as unscored film-coated tablets containing 25 mg of losartan potassium.
Der er ikke erfaring med behandling til patienter med svær leverinsufficiens. 
There is no therapeutic experience in patients with severe hepatic impairment.
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Flaskeetiket til Cozaar 12,5 mg HDPE-flaske 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 12.5 mg HDPE bottle
Hver Cozaar 50 mg tablet indeholder 50 mg losartan (som kaliumsalt). 
Each Cozaar 50 mg Tablet contains 50 mg of losartan (as potassium salt).
Cozaar 12,5 mg tabletter kan også indeholde carnaubavoks (E903), titandioxid (E171), indigocarmin (E132). 
The Cozaar 12.5 mg tablets also may contain carnauba wax (E903), titanium dioxide (E171), indigo carmine (E132) aluminum lake.
Cozaar fås som filmovertrukne tab1etter uden delekærv indeholdende 100 mg losartankalium. 
Cozaar is supplied as unscored film-coated tablets containing 100 mg of losartan potassium.
Særnavn 
Member State Invented name
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt] 
MARKETING AUTHORISATION HOLDER [To be implemented nationally]
• Reduktion af risiko for stroke hos hypertensive patienter med hypertrofi af venstre ventrikel, som er dokumenteret ved EKG (se pkt. 
• Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race).
Hver Cozaar 50 mg tablet indeholder 25,5 mg lactosemonohydrat. 
Each Cozaar 50 mg tablet contains 25.5 mg lactose monohydrate.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) 
Route of administration
Cozaar fås som filmovertrukne tab1etter med delekærv indeholdende 50 mg losartankalium. 
Cozaar is supplied as scored film-coated tablets containing 50 mg of losartan potassium.
Almene symptomer og reaktioner på administrationsstedet Ikke almindelig: Asteni/træthed. 
General disorders and administration site conditions: uncommon: asthenia/fatigue
COZAAR CARDIO START 
Cozaar Startpakke
Hver Cozaar 12,5 mg tablet indeholder 25,5 mg lactosemonohydrat. 
Each Cozaar 12,5 mg tablet contains 25.5 mg lactose monohydrate.
Hver Cozaar 100 mg tablet indeholder 100 mg losartan (som kaliumsalt). 
Each Cozaar 100 mg Tablet contains 91 100 mg of losartan (as potassium salt).
Hver Cozaar 12,5 mg tablet indeholder 12,5 mg losartankalium. 
Each Cozaar 12.5 mg tablet contains 12.5 mg of losartan potassium.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar 100 mg filmovertrukne tabletter 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar 100 mg film-coated tablets
Hver Cozaar 25 mg tablet indeholder 25 mg losartankalium. 
Each Cozaar 25 mg tablet contains 25 mg of losartan potassium.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar 25 mg filmovertrukne tabletter 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar 25 mg film-coated tablets
Cozaar fås som filmovertrukne tab1etter uden delekærv indeholdende 12,5 mg losartankalium. 
What Cozaar looks like and contents of the pack Cozaar is supplied as unscored film-coated tablets containing 12.5 mg of losartan potassium.
Hver Cozaar 25 mg tablet indeholder 12,75 mg lactosemonohydrat. 
Each Cozaar 25 mg tablet contains12.75 mg lactose monohydrate.