FrancophonIA/ELRC3.0 huggingface dataset:
English: If goal blood pressure (<140/90 mmHg) was not reached, hydrochlorothiazide (12.5 mg) was added first and, if needed, the dose of losartan or atenolol was then increased to 100 mg once daily.
Danish: Hvis det forud fastsatte blodtryk (<140/90 mmHg) ikke blev nået, tilføjedes først hydrochlorthiazid (12,5 mg) og hvis nødvendigt blev dosis af losartan eller atenolol øget til 100 mg én gang dagligt.
English: • if you have severely impaired kidney function or your kidneys are not producing any urine.
Danish: • hvis De har alvorligt nedsat nyrefunktion, eller hvis Deres nyrer ikke danner urin
English: • as first step treatment in patients with moderate to severe hypertension and in patients with high or very high cardiovascular risk
Danish: • Som førstevalgsbehandling hos patienter med moderat til svær hypertension og hos patienter med høj eller meget høj risiko for kardiovaskulær sygdom.
English: 00-867 Warsaw
Danish: 00-867 Warsawa, Polen
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).
Danish: Patienter med nyreinsufficiens og patienter i hæmodialyse Initial dosisjustering er ikke nødvendig hos patienter med moderat nyreinsufficiens (dvs. kreatininclearance 30-50 ml/min).
English: Antidiabetic drugs (oral agents and insulin):
Danish: Antidiabetika (orale lægemidler eller insulin)
English: The data available do not show that a first line therapy with the FDC is of advantage as compared to a stepwise approach within the approved indication.
Danish: De tilgængelige data viser ikke, at førstevalgsbehandling med fastdosiskombinationen er fordelagtig sammenlignet med en trinvis tilgang for så vidt angår den godkendte indikation.
English: Dilutional hyponatraemia may occur in oedematous patients in hot weather.
Danish: Hyponatriæmi ved overhydrering kan forekomme hos ødematøse patienter i varmt vejr.
English: During the administration of losartan the removal of the angiotensin II negative feedback on renin secretion leads to increased plasma-renin activity (PRA).
Danish: Under administration af losartan fører fjernelse af angiotensin-II's negative feedback på reninsekretionen til øget plasmareninaktivitet (PRA).
English: In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of the iodine product.
Danish: I tilfælde af diuretikainduceret dehydrering er der øget risiko for akut nyresvigt, især ved høje doser af jodpræparatet.
English: Overdosage can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.
Danish: Overdosering kan medføre fald i blodtrykket, hjertebanken, langsom puls, ændringer i blodets elektrolytter og væskemangel.
English: Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity; concomitant use is not recommended.
Danish: Diuretika reducerer den renale udskillelse af lithium og kan medføre høj risiko for lithiumforgiftning; samtidig anvendelse anbefales ikke.
English: If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
Danish: Hvis digitalis også er indtaget, kan hypokaliæmi forstærke hjertearytmier.
English: Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, Cozaar Comp should be used with caution in patients with a history of mild to moderate hepatic impairment.
Danish: Baseret på farmakokinetiske data, som viser signifikant forhøjede plasmakoncentrationer af losartan hos cirrhotiske patienter, bør Cozaar Comp. anvendes med forsigtighed hos patienter med mild til moderat leverinsufficiens i anamnesen.
English: Therefore, the plasma concentrations of potassium and creatinine clearance values should be closely monitored; especially patients with heart failure and a creatinine clearance between 30-50 ml/ min should be closely monitored.
Danish: Derfor bør kaliums plasmakoncentration såvel som kreatininclearance monitoreres tæt, især patienter med hjertesvigt og kreatininclearance på 30-50 ml/min bør monitoreres tæt.
English: Patients with a history of angiooedema (swelling of the face, lips, throat, and/or tongue) should be closely monitored (see section 4.8).
Danish: Patienter med angioødem i anamnesen (hævelse af ansigt, læber, svælg og/eller tunge) bør monitoreres nøje (se pkt.
English: Amphotericin B (parenteral), corticosteroids, ACTH or stimulant laxatives Hydrochlorothiazide may intensify electrolyte imbalance, particularly hypokalaemia.
Danish: Amphotericin B (parenteralt), kortikosteroider, ACTH eller stimulerende laksantia Hydrochlorthiazid kan intensivere elektrolyforstyrrelserne, især hypokaliæmi.
English: Losartan is a synthetically produced oral angiotensin-II receptor (type AT1) antagonist.
Danish: Losartan er en syntetisk, oral angiotensin-II-receptorantagonist (type AT1).
English: Bulgaria Merck Sharp & Dohme Bulgaria EOOD
Danish: Bulgarien Merck Sharp & Dohme Bulgaria EOOD
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.
Danish: Hos patienter med nedsat funktion af venstre ventrikel, gav losartan 25 mg og 50 mg positiv hæmodynamik og neurohormonal effekt karakteriseret ved en stigning i hjerteindeks og fald i lungekapillærtryk, systemisk vaskulær modstand, gennemsnitlig systemisk arterietryk og hjerterytme samt reduktion i cirkulerende koncentrationer af henholdsvis aldosteron og noradrenalin.
English: Therefore, the use of Cozaar Comp tablets is not recommended.
Danish: Derfor kan anvendelse af Cozaar Comp. tabletter ikke anbefales.
English: Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidney.
Danish: Hydrochlorthiazid metaboliseres ikke, men udskilles hurtigt via nyrerne.
English: • Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels.
Danish: • Øget indhold af kalium (som kan medføre unormal hjerterytme), nedsat hæmoglobin.
English: Cozaar Comp is effective in reducing blood pressure in males and females, blacks and non-blacks and in younger (<65 years) and older (≥65 years) patients and is effective in all degrees of hypertension.
Danish: Cozaar Comp. reducerer blodtrykket effektivt hos mænd og kvinder, negroide og ikke-negroide, samt hos såvel yngre (<65 år) som ældre (≥ 65 år) patienter.
English: The pharmacokinetics of losartan and its active metabolite are linear with oral losartan potassium doses up to 200 mg.
Danish: Losartans og dets aktive metabolits farmakokinetik er lineær med orale doser af losartankalium på op til 200 mg.
English: The reason for this broader indication is that the LIFE study was not a placebo-controlled study, studying the effect on stroke only compared to placebo, but an actively controlled study, comparing a losartan based with an atenolol based antihypertensive treatment using a primary composite endpoint of CV death, stroke and MI.
Danish: Begrundelsen for denne bredere indikation er, at LIFE-undersøgelsen ikke var en placebokontrolleret undersøgelse, hvor det kun var virkningen på slagtilfælde, der blev sammenlignet med placebo, men derimod en aktivt kontrolleret undersøgelse, hvori forskerne sammenlignede en losartan-baseret behandling med en atenolol-baseret behandling mod hypertension, og hvor det sammensatte primære slutmål var kardiovaskulær død, slagtilfælde og myokardieinfarkt.
English: When pregnancy is diagnosed, treatment with Cozaar Comp should be stopped immediately and, if appropriate, alternative therapy should be started.
Danish: Når graviditet diagnosticeres, bør behandling med Cozaar Comp. seponeres omgående, og hvis det er hensigtsmæssigt, bør alternativ behandling påbegyndes.
English: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis.
Danish: De mest almindelige observerede tegn og symptomer er elektrolytdepletering (hypokaliæmi, hypochloræmi, hyponatriæmi) og dehydrering som resultat af kraftig diurese.
English: As a consequence of inhibiting the renin-angiotensin-aldosterone 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 forandringer i nyrefunktionen herunder nyresvigt (især hos patienter hvis nyrefunktion er afhængig af renin-angiotensinaldosteronsystemet som patienter med svær hjerteinsufficiens eller tidligere nedsat nyrefunktion).
English: Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) Possible increased responsiveness to the muscle relaxant.
Danish: Skeletale muskelafslappende stoffer, nondepolariserende (f.eks. tubocurarin) Mulighed for forøget respons på muskelafslappende stoffer.
English: Dosage adjustment of antidiabetic agents, including insulin, may be required (see section 4.5).
Danish: Dosisjustering af medicin til behandling af diabetes, herunder insulin, kan være nødvendig (se pkt.
English: Cozaar Comp is supplied in the following pack sizes:
Danish: Cozaar Comp. fås i følgende pakningsstørrelser:
English: WHAT COZAAR COMP IS AND WHAT IT IS USED FOR Cozaar Comp is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).
Danish: COZAAR COMP.'S VIRKNING OG HVAD DE SKAL BRUGE DET TIL Cozaar Comp. er en kombination af en angiotensin II-receptorantagonist (losartan) og et vanddrivende lægemiddel (hydrochlorthiazid).
English: Cytotoxic agents (eg cyclophosphamide, methotrexate) Thiazides may reduce the renal excretion of cytotoxic medicinal products and potentiate their myelosuppressive effects.
Danish: Cytotoksiske lægemidler (f.eks. cyclophosphamid, methotrexat) Thiazider kan reducere den renale ekskretion af cytotoksiske lægemidler og styrke deres myelosuppressive effekt.
English: There is no therapeutic experience with losartan in patients with severe hepatic impairment.
Danish: Der er ingen terapeutisk erfaring med losartan til patienter med svær leverinsufficiens.
English: Despite these increases, antihypertensive activity and suppression of the plasma aldosterone concentration are maintained, indicating effective angiotensin II receptor blockade.
Danish: Selv med disse stigninger bibeholdes den antihypertensive aktivitet og suppressionen af plasmaaldosteronkoncentrationen, hvilket tyder på angiotensin-II-receptorblokering.
English: Calcium salts
Danish: Kalciumsalte
English: Such conditions should be corrected before the administration of Cozaar Comp tablets (see sections 4.2. and 4.3.
Danish: Disse tilstande bør korrigeres før administration af Cozaar Comp. tabletter (se pkt.
English: Should exposure to Cozaar Comp have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: Hvis eksponering for losartan har fundet sted fra 2. trimester af graviditeten, anbefales ultralydskontrol af nyrefunktionen og kraniet.
English: Reproductive system and breast disorders Uncommon: Decreased libido, impotence
Danish: Det reproduktive system og mammae Ikke almindelig: Nedsat libido, impotens.
English: Merck Sharp & Dohme OÜ Peterburi tee 46, Tallinn 11415, Estonia
Danish: Merck Sharp & Dohme OÜ Peterburi tee 46, Tallinn 11415, Estland
English: Ear and labyrinth disorders Uncommon: Vertigo, tinnitus
Danish: Øre og labyrint Ikke almindelig: Vertigo, tinnitus.
English: Following oral and intravenous administration of 14C-labeled losartan potassium, circulating plasma radioactivity primarily is attributed to losartan and its active metabolite.
Danish: Efter oral og intravenøs administration af 14C-mærket losartankalium, er cirkulerende plasmaradioaktivitet primært knyttet til losartan og dets aktive metabolit.
English: As the MAH did not submit data to demonstrate a clear population that would benefit from the FDC with regards to cardiovascular outcome, the benefit/risk of the indication in first line could be assessed and the indication is not warranted by the CHMP.
Danish: Eftersom indehaveren af markedsføringstilladelsen ikke fremlagde nogen data til påvisning af, at en klart afgrænset population kunne drage fordel af fastdosiskombinationen med hensyn til det kardiovaskulære udfald, kunne benefit/risk-forholdet for indikationen som førstevalgsbehandling vurderes, og CHMP anser ikke indikationen for begrundet.
English: Coadministration of a thiazide may increase the incidence of hypersensitivity reactions to allopurinol.
Danish: Samtidig administration af et thiazid kan øge incidensen af hypersensitivitetsreaktioner over for allopurinol.
English: Additional adverse events that have been seen with one of the individual components and may be potential adverse events with losartan potassium/ hydrochlorothiazide are the following:
Danish: Yderligere bivirkninger, som er set med en af komponenterne, og som kan være mulige bivirkninger ved losartankalium/hydrochlorthiazid er følgende:
English: INFORMATION IN BRAILLE N/A
Danish: INFORMATION I BRAILLE-SKRIFT
English: The LIFE study has been assessed in the past and this has led to the registration of the more extensive indication, i.e. the reduction of the cardiovascular morbidity and mortality (as measured by the combined incidence of CV death, stroke and MI) instead of stroke only.
Danish: LIFE-undersøgelsen er tidligere blevet vurderet, og dette førte til registreringen af den mere omfattende indikation, det vil sige reduktion af kardiovaskulær morbiditet og mortalitet (målt ved hjælp af kombineret forekomst af kardiovaskulær død, slagtilfælde og myokardieinfarkt) i stedet for slagtilfælde alene.
English: The plasma concentrations of losartan and its active metabolite and the absorption of hydrochlorothiazide in elderly hypertensives are not significantly different from those in young hypertensives.
Danish: Losartans og dets aktive metabolits plasmakoncentration samt absoprtionen af hydrochlorthiazid hos ældre hypertensive patienter var ikke signifikant forskellig fra den, der sås hos unge hypertensive patienter.
English: In patients receiving thiazides, hypersensitivity reactions may occur with or without a history of allergy or bronchial asthma.
Danish: Der kan ved thiazidbehandling forekomme allergiske reaktioner hos patienter, som ikke har eller har haft tilfælde af allergi eller astma bronchiale.
English: In a study specifically designed to assess the incidence of cough in patients treated with losartan as compared to patients treated with ACE inhibitors, the incidence of cough reported by patients receiving losartan or hydrochlorothiazide was similar and was significantly less than in patients treated with an ACE inhibitor.
Danish: I en undersøgelse som var specielt designet til at vurdere incidensen af hoste hos patienter, der blev behandlet med losartan sammenlignet med patienter, der fik ACE-hæmmere, var incidensen af hoste, der blev rapporteret af de patienter, der fik losartan eller hydrochlorthiazid den samme, og den var signifikant mindre end hos de patienter, der blev behandlet med en ACE-hæmmer.
English: Just resume your usual schedule.
Danish: Tag blot den næste tablet til sædvanlig tid.
English: 2003 PC Haarlem
Danish: 2003 PC Haarlem Holland
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyophathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Danish: Aorta- og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Som det er tilfældet med andre vasodilatorer er særlig forsigtighed indiceret hos patienter, der har aorta- eller mitralstenose eller obstruktiv hypertrofisk kardiomyopati.
English: Infants whose mothers have taken Cozaar Comp should be closely observed for hypotension (see also section 4.3 and 4.4).
Danish: Spædbørn, hvis mødre har taget Cozaar Comp., bør observeres omhyggeligt for hypotension (se også pkt.
English: Thiazide diuretics may increase serum calcium levels due to decreased excretion.
Danish: Thiaziddiuretika kan øge serumcalciumkoncentrationen på grund af nedsat ekskretion.
English: Via G Fabbroni 6, 00191 Rome Italy
Danish: Via G Fabbroni 6, 00191 Rom, Italien
English: The use of Cozaar Comp is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: Anvendelse af Cozaar Comp. kan ikke anbefales i 1. trimester af graviditeten (se pkt.
English: Thiazides pass into human milk and may inhibit lactation.
Danish: Thiazider passerer over i modermælken hos mennesker og kan hæmme amningen.
English: Use in patients with intravascular volume depletion Volume and /or sodium depletion should be corrected prior to administration of Losartan/HCTZ tablets.
Danish: Patienter med intravaskulær væskemangel Væske- og/eller natriummangel bør korrigeres før administration af losartan/hydrochlorthiazidtabletter.
English: Symptomatic hypotension, especially after the first dose, may occur in patients who are volumeand/or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Danish: Symptomatisk hypotension, især efter første dosis, kan forekomme hos patienter med væske- og/eller natriummangel ved kraftig behandling med diuretika, saltrestriktiv diæt, diarré eller opkastning.
English: Cozaar Comp contains lactose.
Danish: Cozaar Comp. indeholder lactose.
English: The administration of the losartan/hydrochlorothiazide combination induced a decrease in the red blood cell parameters (erythrocytes, haemoglobin, haematocrit), a rise in urea-N in the serum, a decrease in heart weight (without a histological correlate) and gastrointestinal changes (mucous membrane lesions, ulcers, erosions, haemorrhages).
Danish: Administration af losartan/hydrochlorthiazidkombinationen inducerede et fald i de røde blodcelleparametre (erytrocytter, hæmoglobin, hæmatokrit), en stigning i urinstof-N i serum, fald i hjertevægt (uden histologisk korrelat) og gastrointestinale forandringer (læsion af slimhindemembranen, mavesår, erosioner, blødninger).
English: Studies in rats indicate that losartan crosses the bloodbrain barrier poorly, if at all.
Danish: Undersøgelser med rotter viser, at losartan næppe passerer blod-hjernebarrieren.
English: Hydrochlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk.
Danish: Hydrochlorthiazid Hydrochlorthiazid passerer placentabarrieren, men ikke blod-hjernebarrieren og udskilles i modermælk.
English: • Others (eg bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, terfenadine, vincamine IV).
Danish: Andre (f.eks. bepridil, cisaprid, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidin, terfenadin, vincamin IV).
English: Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, as it may cause intrahepatic cholestasis, and since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Danish: Thiazider bør anvendes med forsigtighed til patienter med nedsat leverfunktion eller progressiv leversygdom, da mindre ændringer i væske- og elektrolytbalancen kan udløse hepatisk koma.
English: Dose titration with the individual components (losartan and hydrochlorothiazide) is recommended.
Danish: Dosistitrering med de individuelle komponenter (losartan og hydrochlorthiazid) anbefales.
English: The CHMP considered that the following warnings should be included in the SPC in all MSs: Haemodialysis; Black patients; Obstructive valvular disease; Surgery/anaesthesia.
Danish: CHMP var af den opfattelse, at følgende advarsler skal inkluderes i produktresuméet i alle medlemsstater: Hæmodialyse; negroide patienter; obstruktiv hjerteklapsygdom; operation/anæstesi.
English: Following oral administration in patients with mild to moderate alcoholic cirrhosis of the liver, plasma concentrations of losartan and its active metabolite were, respectively, 5-fold and 1.7-fold greater than those seen in young male volunteers.
Danish: Hos patienter med mild til moderat alkoholinduceret levercirrose var losartans og dets aktive metabolits plasmakoncentration efter oral administration henholdsvis 5 og 1,7 gange højere end hos unge frivillige mænd.
English: • Class III antiarrythmics (eg amiodarone, sotalol, dofetilide, ibutilide).
Danish: Klasse III antiarytmika (f.eks. amiodaron, sotalol, dofetilid, ibutilid).
English: Therefore, the CHMP considered that the benefit risk for the indication Reduction in risk of cardiovascular morbidity and mortality ( or risk of stroke_) in hypertensive patients with left ventricular hypertrophy is negative and this indication is not acceptable for the FDC.
Danish: CHMP var derfor af den opfattelse, at benefit/risk-forholdet for indikationen Reduktion af risiko for kardiovaskulær morbiditet og mortalitet (eller risiko for slagtilfælde) hos hypertensive patienter med venstresidig ventrikelhypertrofi er negativt, og denne indikation kan ikke godkendes for fastdosiskombinationen.
English: Neither losartan nor the active metabolite can be removed by hemodialysis.
Danish: Hverken losartan eller den aktive metabolit kan fjernes ved hæmodialyse.
English: Therefore, Cozaar Comp should not be given to children.
Danish: Derfor bør Cozaar Comp. ikke gives til børn.
English: Losartan/HCTZ tablets must not be used in patients with severe renal impairment (i.e. creatinine clearance <30 ml/min) (see section 4.3).
Danish: Losartan/hydrochlorthiazid-tabletter må ikke anvendes til patienter med svær nyreinsufficiens (dvs. kreatininclearance <30 ml/min) (se pkt.
English: Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
Danish: Thiazider påvirker den renale tubulære mekanisme for elektrolytreabsorption, hvorved hydrochlorthiazid øger udskillelsen af natrium og chlorid i tilnærmelsesvis ækvivalente mængder.
English: Patients were randomised to once daily losartan 50 mg or once daily atenolol 50 mg.
Danish: Patienterne blev randomiseret til losartan 50 mg én gang dagligt eller atenolol 50 mg én gang dagligt.
English: • if you are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the other ingredients in this medicine.
Danish: • hvis De er overfølsom (allergisk) over for losartan, hydrochlorthiazid eller et af de øvrige indholdsstoffer
English: Tatoiou Street, Nea Erythraia 14671, Greece
Danish: Grækenland VIANEX A.E. Tatoiou Street, Nea Erythraia 14671, Grækenland
English: • Low blood pressure, which may be associated with changes in posture (feeling light-headed or weak when you stand up, angina (chest pain), abnormal heartbeat, cerebrovascular accident (TIA, “mini-stroke”), heart attack, palpitations,
Danish: • Lavt blodtryk, som kan være forbundet med ændring i stilling (man føler sig ør eller svag, når man rejser sig op), angina (smerter i brystet), unormal hjertebanken, slagtilfælde (forbigående iskæmisk hændelse i hjernen), hjerteanfald, følelse af at hjertet hamrer eller slår meget hurtigt (palpitation)
English: Hydrochlorothiazide (HCTZ) is a thiazide diuretic which has also been used as an antihypertensive agent.
Danish: Hydrochlorthiazid er et thiaziddiuretikum, der også har været anvendt som et middel mod hypertension.
English: • Frequent urination including at night, abnormal kidney function including inflammation of the kidneys, urinary infection, sugar in the urine,
Danish: • Hyppig vandladning også om natten, unormal nyrefunktion, herunder nyrebetændelse, urinvejsinfektion, sukker i urinen
English: 2031 BN Haarlem
Danish: 2031 BN Haarlem Holland