natgillin/translations-raw huggingface dataset:
Ikke almindelig: Alopeci, dermatitis, tør hud, erythema, flushing, fotosensitivitet, pruritus, udslæt, urticaria, svedtendens.
Uncommon: Alopecia, dermatitis, dry skin, erythema, flushing, photosensitivity, pruritus, rash, urticaria, sweating
Informer også lægen om, at de tager Cozaar Comp., hvis De skal have et jodholdigt kontrastmiddel.
Please also inform your doctor when it is planned to apply iodine contrast media about taking Cozaar Comp.
Psykiske forstyrrelser Ikke almindelig: Søvnløshed.
Psychiatric disorders Uncommon: Insomnia
Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B1180 Bruxelles
Belgium Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B-1180 Brussels
Virkningen og sikkerheden er påvist for indikationen “behandling af essentiel hypertension hos patienter, hvis blodtryk ikke reguleres tilstrækkeligt med hydrochlorthiazid eller losartan som monoterapi”.
The efficacy and safety are established for the indication “treatment of essential hypertension in patients whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy”.
Ikke almindelig: angst, angstforstyrrelser, panikangst, forvirring, depression, unormale drømme, søvnforstyrrelser, somnolens, hukommelsessvækkelse.
Uncommon: Anxiety, anxiety disorder, panic disorder, confusion, depression, abnormal dreams, sleep disorder, somnolence, memory impairment
• Gulsot (gulfarvning af øjne og hud), betændelse i bugspytkirtlen
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
Hydrochlorthiazids diuretiske virkning reducerer plamavolumen, øger plasmareninaktiviteten og øger aldosteronsekretionen med deraf følgende stigning i urinkalium og tab af bikarbonat samt fald i serumkalium.
The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin activity and increases aldosterone secretion, with consequent increases in urinary potassium and bicarbonate loss, and decreases in serum potassium.
• Behandling af hypertension hos patienter, hvis blodtryk ikke reguleres tilstrækkeligt med losartan eller hydrochlorthiazid.
• Treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide.
Merck Sharp & Dohme Ltd., Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU, Storbritannien
Merck Sharp & Dohme Ltd., Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom
Lever og galdeveje Ikke kendt: Abnorm leverfunktion.
Hepato-biliary disorders Not known: Liver function abnormalities
Overfølsomhed over for losartan, sulfonamid-afledte stoffer (som hydrochlorthiazid) eller over for et eller flere af hjælpestofferne.
• Hypersensitivity to losartan, sulphonamide-derived substances (as hydrochlorothiazide) or to any of the excipients
Losartan/hydrochlorthiazid-tabletter bør ikke anvendes til patienter i hæmodialyse.
Losartan and hydrochlorothiazide tablets are not recommended for haemodialysis patients.
Luxemburg Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B1180 Bruxelles, Belgien
Luxembourg Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B-1180 Brussels, Belgium
• Diarré, mavesmerter, kvalme, fordøjelsesbesvær
• Diarrhoea, abdominal pain, nausea, indigestion,
Almene symptomer og reaktioner på administrationsstedet Almindelig: Asteni, fatigue, smerter i brystet.
General disorders and administration site conditions Common: Asthenia, fatigue, chest pain
Almene symptomer og reaktioner på administrationsstedet Ikke almindelig: Feber, svimmelhed.
General disorders and administration site conditions Uncommon: Fever, dizziness
Cozaar Comp. er indiceret til behandling af essentiel hypertension hos patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret på losartan eller hydrochlorthiazid alene.
Cozaar Comp is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone.
Cozaar Comp. og Cozaar Comp Forte (losartan/hydrochlorthiazid) er blevet medtaget på listen over produkter, hvis produktresuméer skal harmoniseres.
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.
Angioødem
Angiooedema
Lægemidler til behandling af arthritis urica (probenecid, sulfinpyrazon og aalopurinol) Dosisjustering af urikosuriske lægemidler kan være nødvendig, da hydrochlorthiazid kan øge koncentrationen af serumurinsyre.
Dosage adjustment of uricosuric medicinal products may be necessary since hydrochlorothiazide may raise the level of serum uric acid.
Den højeste daglige dosis er 2 tabletter af losartan/hydrochlorthiazid 50 mg/12,5 mg filmovertrukne tabletter eller 1 tablet dagligt af losartan/hydrochlorthiazid 100 mg/25 mg filmovertrukne tabletter.
The maximum daily dose is 2 tablets per day of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets
LISTE OVER HJÆLPESTOFFER Lactosemonohydrat.
LIST OF EXCIPIENTS Lactose-monohydrate.
• Stikken og prikken eller lignende fornemmelser, smerter i arme og ben, rysten, migræne, besvimelse
• Pins and needles or similar sensations, pain in the extremities, trembling, migraine, fainting,
• hvis De har nedsat hjertefunktion
• if you have heart failure
Ikke almindelig: Agranulocytose, aplastisk anæmi, hæmolytisk anæmi, leukopeni, purpura, trombocytopeni.
Uncommon: Agranulocytosis, aplastic anaemia, haemolytic anaemia, leukopenia, purpura, thrombocytopenia
Normal vedligeholdelsesdosis for Cozaar Comp. er én Cozaar Comp. 50 mg/12,5 mg tablet (losartan 50 mg/hydrochlorthiazid 12,5 mg) én gang dagligt.
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.
Storbritannien Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Storbritannien
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, United Kingdom
Luxemburg Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180
Luxembourg Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Indehaveren af markedsføringstilladelsen Fremstiller <Udfyldes nationalt>
Marketing Authorisation Holder and Manufacturer <To be completed nationally>
• Søvnløshed, hovedpine, svimmelhed
• Insomnia, headache, dizziness,
• Nældefeber, kløe, betændelse i huden, udslæt, rødme af huden, lysfølsomhed, tør hud, rødmen, svedtendens, hårtab
• Hives, itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss,
Immunsystemet Sjælden: Anafylaktisk reaktion.
Immune system disorders Rare:
Dosis kan øges til 2 tabletter af losartan/hydrochlorthiazid 50 mg/12,5 mg filmovertrukne tabletter én gang dagligt, eller dosis kan ændres til 1 tablet af losartan/hydrochlorthiazid 100 mg/25 mg filmovertrukne tabletter (en højere styrke) pr. dag.
This can be increased to 2 tablets once daily of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or changed to 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets (a stronger strength) per day.
Losartan-hydrochlorthiazid
Losartan-Hydrochlorothiazide
Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180
Belgium Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Cozaar Comp. indeholder
What Cozaar Comp contains
• Muskelsmerter eller muskelkramper, smerter i benene, rygsmerter
• Muscle pain or cramps, leg pain, back pain,
Som resultat af den diuretiske virkning af hydrochlorthiazid øges plasmareninaktiviteten og aldosteronsekretionen, serumkalium falder, og koncentrationen af angiotensin-II reduceres.
Further, as a result of its diuretic effect, hydrochlorothiazide increases plasma renin activity, increases aldosterone secretion, decreases serum potassium, and increases the levels of angiotensin II.
Angiotensin-II bindes til den AT1-receptor, som findes i mange væv (f.eks. vaskulær glat muskulatur, binyrerne, nyrerne og hjertet), og frembringer mange betydningsfulde biologiske reaktioner, herunder vasokonstriktion og frigørelse af aldosteron.
Angiotensin II binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart)
Metabolisme og ernæring Ikke almindelig: Anoreksi, arthritis urica.
Metabolism and nutrition disorders Uncommon: Anorexia, gout
- Behandling af essentiel hypertension hos patienter, hvis blodtryk ikke reguleres tilstrækkeligt med hydrochlorthiazid eller losartan som monoterapi
- Treatment of essential hypertension in patients whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy
Øjne Ikke almindelig: Forbigående sløret syn, xantopsi.
Uncommon: Transient blurred vision, xanthopsia Vascular disorders
Merck Sharp & Dohme GmbH Donau-City-Straße 6, 1220 Wien Østrig
Merck Sharp & Dohme GmbH Donau-City-Straße 6
Filmovertrukken tablets
Film coated tablets
Cozaar Comp. 50 mg/12,5 mg Hver tablet indeholder 63,13 mg lactosemonohydrat.
Cozaar Comp 50 mg/12.5 mg Each tablet contains 63.13 mg lactose monohydrate.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 100 filmovertrukne tabletter
PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets
Cozaar Comp. 100 mg/25 mg Hver tablet indeholder 126,26 mg lactosemonohydrat.
Cozaar Comp 100 mg/25 mg Each tablet contains 126.26 mg lactose monohydrate.
Cozaar Comp. 100 mg/12,5 mg indeholder også: Hvidt farvekoncentrat [eller de enkelte indholdsstoffer i koncentratet: Hydroxypropylcellulose (E463), hypromellose (E464) og titandioxid (E171)] samt carnaubavoks (E903).
Cozaar Comp 100 mg/12.5 mg also contain: white color concentrate [or the individual ingredients of the concentrate: hydroxypropyl cellulose (E463), hypromellose (E464) and titanium dioxide (E171)] and carnauba wax (E903).
De må ikke tage Cozaar Comp., hvis De ammer.
You must not take Cozaar Comp if you are breast-feeding.
• hvis De har urinsur gigt
• if you have had gout
Cozaar Comp. kan administreres med eller uden mad.
Cozaar Comp tablets should be swallowed with a glass of water Cozaar Comp may be administered with or without food.
Cozaar Comp. 50 mg/12,5 mg, Cozaar Comp. 100 mg/12,5 mg, Cozaar Comp. 100 mg/25 mg:
Cozaar Comp 50 mg/12.5 mg, Cozaar Comp 100 mg/25 mg:
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 eller 280 filmovertrukne tabletter.
PHARMACEUTICAL FORM AND CONTENTS 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 film-coated tablets.
Cozaar Comp. 100 mg/12,5 mg Hver tablet indeholder 88,40 mg lactosemonohydrat.
Cozaar Comp 100 mg/12.5 mg Each tablet contains 88.40 mg lactose monohydrate.
Almindelig: Hovedpine, svimmelhed.
Common: Headache, dizziness
Ikke almindelig: Smerter i armene, ledhævelse, smerter i knæene, knogle-, led- og muskelsmerter, skuldersmerter, stivhed, arthralgi, arthritis, koksalgi, fibromyalgi, muskelsvaghed.
Musculoskeletal and connective tissue disorders Common: Muscle cramp, back pain, leg pain, myalgia Uncommon: Arm pain, joint swelling, knee pain, musculoskeletal pain, shoulder pain, stiffness, arthralgia, arthritis, coxalgia, fibromyalgia, muscle weakness
Den diuretiske virkning af hydrochlorthiazid reducerer plasmavolumenet med deraf følgende stigning i plasmareninaktiviteten, stigning i adolsteronudskillelsen, stigning i urinkalium og bikarbonattab samt fald i plasmakalium.
The diuretic action of HCTZ reduces plasma volume, with consequent increase in plasma renin activity, increase in adolsterone secretion, increase in urinary K+ and HCO-3 loss, and decrease in plasma K+.
Losartan er en oralt aktiv angiotensin II-receptorantagonist, der påvirker AT1-receptor-undertypen.
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.
• Forstoppelse, luftafgang fra tarmen, mavegener, mavekramper, opkastning, tør mund, betændelse i spytkirtlen, tandpine
• Constipation, wind, stomach upsets, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• hvis De har "aorta- eller mitralklapstenose" (forsnævring af hjerteklapperne) eller "hypertrofisk kardiomyopati" (en sygdom der medfører fortykkelse af hjertemusklen)
• if you have ‘aortic or mitral valve stenosis' (narrowing of the valves of the heart) or
Hyzaar Forte 100/25 mg 100 mg losartankalium25 mg hydrochlorthiazid
Hyzaar Forte 100/25 mg 100 mg losartan potassium25 mg hydrochlorothiazide
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 14, 15, 28, 30, 50, 56, 84, 90, 98 eller 280 filmovertrukne tabletter.
PHARMACEUTICAL FORM AND CONTENTS 14, 15, 28, 30, 50, 56, 84, 90, 98, or 280 film coated-tablets.
Mave-tarmkanalen Ikke almindelig: Sialoadenitis, spasmer, maveirritation, kvalme, opkastning, diarré, forstoppelse.
Gastrointestinal disorders Uncommon: Sialoadenitis, spasms, stomach irritation, nausea, vomiting, diarrhoea, constipation
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7, 14, 28, 30, 50, 56, 84, 90, 98 eller 280 filmovertrukne tabletter.
PHARMACEUTICAL FORM AND CONTENTS 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 film-coated tablets
• hvis De tidligere har haft hævelse af ansigt, læber, svælg eller tunge
Take special care with Cozaar Comp • if you have previously suffered from swelling of the face, lips, throat or tongue
Ikke almindellig: Faciale ødemer, feber.
Uncommon: Facial oedema, fever
COZAAR COMP. filmovertrukne tabletter losartankalium og hydrochlorthiazid
COZAAR COMP film-coated Tablets losartan potassium and hydrochlorothiazide
Cozaar Comp. 50 mg/12,5 mg og Cozaar Comp. 100 mg/25 mg indeholder også titandioxid (E171), quinolingult (E104) og carnaubavoks (E903).
Cozaar Comp 50 mg/12.5 mg and Cozaar Comp 100 mg/25 mg also contain titanium dioxide (E171), quinoline yellow aluminum lake (E104) and carnauba wax (E903).
Cozaar Comp. 50 mg/12,5 mg indeholder 4,24 mg (0,108 mEq) kalium.
Cozaar Comp 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.
Cozaar Comp. 50 mg/12,5 mg indeholder 50 mg losartankalium og 12,5 mg hydrochlorthiazid som aktive indholdsstoffer.
Cozaar Comp 50 mg/12.5 mg> contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp. 100 mg/25 mg indeholder 100 mg losartankalium og 25 mg hydrochlorthiazid som aktive indholdsstoffer.
Cozaar Comp 100 mg/25 mg> contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.
CHMP fandt, at der ikke var et positivt benefit/risk-forhold for indikationen for initial behandling af hypertension med fastdosiskombinationen.
The CHMP concluded that the indication for the initial therapy of hypertension with the fixed dose combination (FDC) does not have a positive benefit-risk ratio, and therefore is not acceptable.
Refraktær hyponatriæmi.
• Refractory hyponatraemia
FORTZAAR® 100 mg/25 mg, comprimate filmate
FORTZAAR® 100/25 mg, comprimate filmate
Nyrer og urinveje Ikke almindelig: Nykturi, hyppig vandladning, urinvejsinfektion.
Renal and urinary disorders Uncommon: Nocturia, urinary frequency, urinary tract infection
Hver tablet indeholder 100 mg losartan (som kaliumsalt) og 25 mg hydrochlorthiazid som de aktive indholdsstoffer.
Each tablet contains 100 mg of losartan (as potassium salt) and 25 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Cozaar Comp. 100 mg/12,5 mg og Cozaar Comp. 100 mg/25 mg indeholder 8,48 mg (0,216 mEq) kalium.
Cozaar Comp 100 mg/12.5 mg mg and Cozaar Comp 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium.
• hvis De tager vanddrivende medicin
• if you take diuretics (water pills)
Cozaar Comp. 100 mg/25 mg indeholder også: Titandioxid (E171), quinolingult (E104) og carnaubavoks (E903).
Cozaar Comp 100 mg/25 mg also contain:, Titanium dioxide (E171), Quinoline yellow aluminum lake (E104), and Carnauba wax (E903)
Cozaar Comp. 100 mg/12,5 mg indeholder 100 mg losartankalium og 12,5 mg hydrochlorthiazid som aktive indholdsstoffer.
Cozaar Comp100 mg/12.5 mg mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp. bør ikke anvendes til patienter med svær leverinsufficiens (se pkt.
Cozaar Comp is contraindicated for patients with severe hepatic impairment (see section 4.3 and
Hver tablet indeholder 50 mg losartan (som kaliumsalt) og 12,5 mg hydrochlorthiazid som de aktive indholdsstoffer.
Each tablet contains 50 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Hver tablet indeholder 100 mg losartan (som kaliumsalt) og 12,5 mg hydrochlorthiazid som de aktive indholdsstoffer.
Each tablet contains 100 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Almindelig: Hoste, øvre luftvejsinfektion, stoppet næse, sinuitis, sinuslidelser.
• Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder,
Og Cozaar Comp. 100 mg/25 mg indeholder 8,48 mg (0,216 mEq) kalium.
and Cozaar Comp 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.
Hjerte
Forte
6.6 Regler for destruktion og anden håndtering
6.6 Special precautions for disposal <and other handling> No special requirements.
FORTZAAR (Losartan/Hydrochlorthiazide)
FORTZAAR (Losartan/Hydrochlorothiazide)
Cozaar Comp. 100 mg/25 mg fås som filmovertrukne tabletter uden delekærv.
Cozaar Comp 100 mg/25 mg is supplied as unscored film-coated tablets.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar Comp. 100 mg/25 mg filmovertrukne tabletter
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar Comp 100 mg/25 mg film-coated tablets
- 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 anbefaler CHMP ændring af den/de markedsføringstilladelse(r), hvis produktresuméer, etikettering og indlægsseddel er anført i bilag III til Cozaar Comp. og tilknyttede navne (se bilag I).
the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Cozaar Comp. and associated names (see Annex I).
LÆGEMIDLETS NAVN Cozaar Comp. 100 mg/25 mg Losartan og hydrochlorthiazid
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/25 mg Losartan and hydrochlorothiazide
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar Comp. 50 mg/12,5 mg filmovertrukne tabletter
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar Comp 50 mg/12.5 mg film-coated tablets
Ikke almindelig: Konstipation, tandsmerter, tør mund, flatulens, gastritis, opkastning.
Common: Abdominal pain, nausea, diarrhoea, dyspepsia Uncommon: Constipation, dental pain, dry mouth, flatulence, gastritis, vomiting
Kombinationen af losartan og hydrochlorthiazid kan have tilbøjelighed til at dæmpe diuretikainduceret hyperurikæmi.
Hydrochlorothiazide has been shown to cause modest increases in uric acid; the combination of losartan and hydrochlorothiazide tends to attenuate the diuretic-induced hyperuricemia.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 100 mg losartan og 25 mg hydrochlorthiazid.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar Comp. 100 mg/12,5 mg filmovertrukne tabletter
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar Comp 100 mg/12.5 mg film-coated tablets
Cosaar Plus - Filmtabletten 50 mg losartankalium
Cosaar Plus - Filmtabletten 50 mg losartan potassium12.5 mg hydrochlorothiazide
Korrektion af væske- og elektrolytbalance, hepatisk koma og hypotension behandles henhold til gældende procedurer.
Suggested measures include induction of emesis if ingestion is recent, and correction of dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures.
Ikke almindelig: Lille stigning i urinstof og serumkreatininkoncentration.
Common: Hyperkalaemia, mild reduction of haematocrit and haemoglobin Uncommon: Mild increase in urea and creatinine serum levels Very rare: Increase in hepatic enzymes and bilirubin.
LÆGEMIDLETS NAVN Cozaar Comp. 50 mg/12,5 mg Losartan og hydrochlorthiazid
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 50 mg/12.5 mg Losartan and hydrochlorothiazide
HYZAAR (Losartan/Hydrochlorthiazide)
HYZAAR (Losartan/Hydrochlorothia zide)
Cozaar Comp. 100 mg/25 mg Lysegule, ovale filmovertrukne tabletter mærket 747 på den ene side og glatte på den anden side.
Light yellow, oval film-coated tablets marked 747 on one side and plain on the other.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 50 mg losartan og 12,5 mg hydrochlorthiazid.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Cozaar Comp. 100 mg/12,5 mg indeholder 8,48 mg (0,216 mEq) kalium.
Cozaar Comp 100 mg/12.5 mg mg contains 8.48 mg (0.216 mEq) of potassium.
LÆGEMIDLETS NAVN Cozaar Comp. 100 mg/12,5 mg Losartan og hydrochlorthiazid
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/12.5 mg Losartan and hydrochlorothiazide
Cozaar Comp. 100 mg/12,5 mg fås som filmovertrukne tabletter uden delekærv.
Cozaar Comp 100 mg/12.5 mg mg is supplied as unscored film-coated tablets.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar Comp. 100 mg/25 mg filmovertrukne tabletter - blister
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 100 mg/25 mg film-coated tablets blister
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 100 mg losartan og 12,5 mg hydrochlorthiazid.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Cozaar Comp. 100 mg/25 mg filmovertrukne tabletter Losartan og hydrochlorthiazid
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/25 mg mg film-coated tablets Losartan and hydrochlorothiazide
Knogler, led, muskler og bindevæv Ikke almindelig: Muskelkramper.
Musculoskeletal and connective tissue disorders Uncommon: Muscle cramps
MSD BV Waarderweg 39 2031 BN Haarlem Holland
Norway MSD BV Waarderweg 39
Ikke almindelig: Gener i svælget, pharyngitis, laryngitis, dyspnø, bronkitis, epistaksis, rhinitis, respiratorisk kongestion.
Common: Cough, upper respiratory infection, nasal congestion, sinusitis, sinus disorder Uncommon: Pharyngeal discomfort, pharyngitis, laryngitis, dyspnoea, bronchitis, epistaxis, rhinitis, respiratory congestion
Cozaar Comp. 50 mg/12,5 mg - PVC/PE/PVDC blisterpakninger med aluminiumsfolie i pakninger à 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 eller 280 tabletter.
Cozaar Comp 50 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets.
Cozaar Comp. 50 mg/12,5 mg filmovertrukne tabletter Losartan og hydrochlorthiazid
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 50 mg/12.5 mg mg film-coated tablets Losartan and hydrochlorothiazide
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar Comp. 50 mg/12,5 mg filmovertrukne tabletter - blister
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 50 mg/12.5 mg film-coated tablets blister
Via G. Fabbroni 6, 00191 Rom, Italien
Merck Sharp & Dohme Italia S.p.A. via G Fabbroni 6 , 00191 Rome Italy
Cozaar Comp. 100 mg/12,5 mg - PVC/PE/PVDC blisterpakninger med aluminiumsfolie i pakninger à 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tabletter.
Cozaar Comp 100 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablets.
Medlemsstat Indehaver af markedsføringstilladelse
Marketing Authorisation Holder Invented name
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar Comp. 100 mg/12,5 mg filmovertrukne tabletter - blister
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 100 mg/12.5 mg film-coated tablets blister