natgillin/translations-raw huggingface dataset:
Markant hyperkalcæmi kan være tegn på skjult hyperparathyroidisme. 
Marked hypercalcemia may be evidence of hidden hyperparathyroidism.
Tyskland MSD Chibropharm GmbH Postfach 1202 D-85530 Haar, Tyskland 
Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar
Patienter med sjælden arvelig galactoseintolerance, Lapp-lactasemangel eller glucose/galactosemalabsorption bør ikke tage denne medicin (se pkt. 
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine (see section 6.1).
Andre stoffer, der kan inducere hypotension, som tricykliske antidepressiva, antipsykotika, baclofen, amifostin: Samtidig anvendelse af disse lægemidler, der som hoved- eller sideeffekt sænker blodtrykket, kan øge risikoen for hypotension. 
Other substances inducing hypotension like tricyclic antidepressants, antipsychotics, baclofene, amifostine: Concomitant use with these drugs that lower blood pressure, as main or side-effect, may increase the risk of hypotension.
I en samlet analyse af 16 dobbeltblindede kliniske undersøgelser med 4131 patienter, var incidensen af spontant rapporteret hoste hos patienter, der fik losartan den samme (3,1%) som hos de patienter, der fik placebo (2,6%) eller hydrochlorthiazid (4,1%), hvorimod incidensen med ACE-hæmmere var 8,8%). 
In addition, in an overall analysis of 16 double-blind clinical trials in 4131 patients, the incidence of spontaneously reported cough in patients treated with losartan was similar (3.1%) to that of patients treated with placebo (2.6%) or hydrochlorothiazide (4.1%), whereas the incidence with ACE inhibitors was 8.8%.
Der var ikke tegn på teratogenicitet hos rotter eller kaniner, der havde fået behandling med losartan/hydrochlorthiazid-kombinationen. 
There was no evidence of teratogenicity in rats or rabbits treated with the losartan/hydrochlorothiazide combination.
Cozaar Comp. kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines, Cozaar Comp tablets can cause side effects, although not everybody gets them.
Den antihypertensive virkning af Cozaar Comp. holder i 24 timer. 
The antihypertensive effect of Cozaar Comp is sustained for a 24-hour period.
Korticosteroider, ACTH Øget elektrolytdepletering, især hypokalæmi. 
Corticosteroids, ACTH Intensified electrolyte depletion, particularly hypokalemia.
Lad blisterpakningen blive i den ydre karton. 
Keep the blister in the outer carton.
Cozaar Comp. anvendes til behandling af essentiel hypertension (forhøjet blodtryk). 
Cozaar Comp is indicated for the treatment of essential hypertension (high blood pressure).
Cozaar Comp. kan administreres sammen med andre antihypertensiva. 
Cozaar Comp may be administered with other antihypertensive agents.
• hvis De har diabetes 
• if you are diabetic
LIFE-undersøgelsen 
LIFE Study
Farmakoterapeutisk klassifikation: Kombination af angiotensin II-receptor(type AT1)-antagonist og thiaziddiuretikum, antihypertensivum, ATC-kode: C09DA01 
Pharmacotherapeutic group: Combination containing an angiotensin II-receptor(type AT1)-antagonist and a thiazide diuretic, Antihypertensive, ATC code: C09DA01
Behandling med Cozaar Comp. bør seponeres, og patienten observeres nøje. 
Therapy with Cozaar Comp should be discontinued and the patient observed closely.
Vigtig information om nogle af de øvrige indholdsstoffer i Cozaar Comp. 
Important information about some of the ingredients of Cozaar Comp
Afsnit 4.3 Kontraindikationer 
Section 4.3 Contra-indications
Der er ingen klinisk signifikant effekt på plasmakoncentrationsprofilen, når losartan gives sammen med et standardiseret måltid. 
There was no clinically significant effect on the plasma concentration profile of losartan when the drug was administered with a standardized meal.
• hvis De har højt indhold af kalcium eller lavt indhold af kalium eller De er på en diæt med lavt kalium 
• if you have high calcium or low potassium levels or you are on a low potassium diet
Der er ingen erfaring med brug af Cozaar Comp. til børn. 
There is no experience with the use of Cozaar Comp in children.
Mens den foreslåede indikation for losartanmonoterapi derfor blev godkendt af et flertal på CHMPs plenarmøde og blev understøttet af følgende ordlyd: “risikoreduktion af slagtilfælde hos hypertensive patienter med venstresidig ventrikelhypertrofi dokumenteret ved EKG”, så gælder følgende betragtninger for fastdosiskombinationen: 
Therefore, whilst the proposed indication for losartan monotherapy was considered approvable after a majority vote by the CHMP plenum and is supported with the following wording: “reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy, documented by ECG”, the following considerations apply for the FDC:
Hertfordshire EN11 9BU Storbritannien 
Hertfordshire, EN11 9BU United Kingdom
Føtal toksicitet hos rotter, som fremgik af en let stigning i overtallige ribben i F1-generationen, sås når hunrotter blev behandlet før og under gestationen. 
Foetal toxicity in rats, as evidenced by a slight increase in supernumerary ribs in the F1 generation, was observed when females were treated prior to and throughout gestation.
• hvis De er overfølsom (allergisk) over for andre sulfonamidafledte stoffer (f.eks. andre thiazider, 
• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e. g. other thiazides,
Pressoraminer (f.eks. adrenalin) Mulig nedsættelse af respons på pressoraminer, men ikke tilstrækkelig til at udelukke anvendelsen. 
Pressor amines (e.g., adrenaline) Possible decreased response to pressor amines but not sufficient to preclude their use.
Når det er klinisk hensigtsmæssigt, kan det overvejes at skifte direkte fra monoterapi til den faste kombination hos patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret. 
When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled.
Frankrig Merck Sharp Dohme Chibret 3 av. Hoche 
Merck Sharp Dohme Chibret 3 av. Hoche
Når angiotensin II-antagonister administreres samtidigt med NSAID (dvs. selektive COX-2 hæmmere, acetylsalicylsyre i antiinflammatoriske doser og non-selektive NSAID) kan afsvækning af den antihypertensive virkning forekomme. 
When angiotensin II antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid at anti-inflammatory doses) and non-selective NSAIDs, attenuation of the antihypertensive effect may occur.
Almindelige (berører færre end én person ud af 10 men flere end én person ud af 100): 
Common (affecting less than one person in 10 but more than one person in 100):
Der er rapporteret om tilfælde af thrombocytopeni hos nyfødte og føtal eller neonatal icterus efter behandling af moderen med thiazider. 
Cases of thrombocytopenia in neonates and fetal or neonatal jaundice were reported after treating the mothers with thiazides.
Efter oral administration absorberes losartan godt og undergår firstpass metabolisme, hvorved der dannes en aktiv carboxylsyremetabolit og andre inaktive metabolitter. 
Following oral administration, losartan is well absorbed and undergoes first-pass metabolism, forming an active carboxylic acid metabolite and other inactive metabolites.
Som det sås i undersøgelser med losartan alene, forekom føtale og neonatale bivirkninger, herunder nyretoksicitet og fosterdød, når gravide rotter blev behandlet med losartan/hydrochlorthiazidkombinationen sent i gestationen og/eller diegivningen. 
As observed in studies with losartan alone, adverse foetal and neonatal effects, including renal toxicity and foetal death, occurred when pregnant rate were treated with the losartan/hydrochlorothiazide combination during late gestation and/or lactation.
Indehaveren af markedsføringstilladelsen blev anmodet om at fremlægge data vedrørende sikkerhed og virkning for disse patientundergrupper (Losartan, Atenolol, Losartan + hydrochlorthiazid, Atenolol + hydrochlorthiazid) for at få en større indsigt i hydrochlorthiazids bidrag til det samlede benefit/riskforhold. 
The MAH was asked to provide data on safety and efficacy for these subgroups of patients (Losartan, Atenolol, Losartan + HCTZ, Atenolol + HCTZ) in order to gain more insight into the contribution of HCTZ to the overall benefit risk ratio.
Tag dog ikke dobbelt dosis hvis De har glemt at tage en tablet. 
However, if you miss a dose, do not take an extra dose.
Efter oral administration falder losartans og dets aktive metabolits plasmakoncentration polyeksponentielt med en terminal halveringstid på henholdsvis ca. 2 timer og 6-9 timer. 
Following oral administration, plasma concentrations of losartan and its active metabolite decline polyexponentially with a terminal half-life of about 2 hours and 6-9 hours, respectively.
Stigning i biotilgængelighed over for thiazidtypediuretika ved at nedsætte den gastrointestinale motilitet samt mavetømningshastigheden. 
Increase of the bioavailability to thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
• hvis De har lavt indhold af kalium, lavt indhold af natrium eller højt indhold af kalcium, som ikke kan forbedres ved behandling 
• if you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment
Slovenien Merck Sharp & Dohme, inovativna zdravila d.o.o., Smartinska cesta 140, 1000 Ljubljana, Slovenien 
Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o., Smartinska cesta 140, 1000 Ljubljana
• hvis De kaster/har kastet voldsomt op eller har/har haft kraftig diarré 
• if you have or have had severe vomiting and/or diarrhoea
Behandling med thiazider bør seponeres, før der udføres tests af parathyroideafunktionen. 
Thiazides should be discontinued before carrying out tests for parathyroid function.
Andre antihypertensiva, undtagen ACE-hæmmere, angiotensin II-antagonister eller betablokkere, blev tilføjet hvis dette var nødvendigt for at opnå det ønskede blodtryk. 
Other antihypertensives, with the exception of ACE inhibitors, angiotensin II antagonists or beta-blockers were added if necessary to reach the goal blood pressure.
• hvis De har alvorligt nedsat leverfunktion 
• if you have severely impaired liver function
Thiazider passerer placentabarrieren og findes i navlestrengsblodet. 
Thiazides pass the placental barrier and are found in cord blood.
Det har været rapporteret, at rifampicin og fluconazol reducerede den aktive metabolits koncentration. 
Rifampicin and fluconazole have been reported to reduce levels of active metabolite.
Alkohol, barbiturater, narkotiske stoffer eller antidepressiva Potensering af orthostatisk hypotension kan forekomme. 
Alcohol, barbiturates, narcotics or antidepressants: Potentiation of orthostatic hypotension may occur.
Det er også vigtigt for lægen at vide, om de tager anden medicin til at nedsætte Deres blodtryk, steroider, medicin til behandling af cancer, smertestillende medicin, medicin mod svampeinfektioner, eller medicin mod ledbetændelse, resiner mod forhøjet kolesterol, f.eks. colestyramin, medicin til muskelafslapning, sovemedicin; opioid medicin, f.eks. morfin, "pressoraminer", f.eks. adrenalin eller andre lægemidler fra samme gruppe; (diabetesmedicin til at tage gennem munden eller insulin). 
It is also important for your doctor to know if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, drugs for treatment of fungal infections, or arthritis medicines, resins used for high cholesterol, such as colestyramine, medicines which relax your muscles, sleeping tablets; opioid medicines such as morphine , ‘pressor amines' such as adrenaline or other drugs from the same group; (oral agents for diabetes or insulins).
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. 
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.
• hvis De har alvorligt nedsat nyrefunktion, eller hvis Deres nyrer ikke danner urin 
• if you have severely impaired kidney function or your kidneys are not producing any urine.
• Som førstevalgsbehandling hos patienter med moderat til svær hypertension og hos patienter med høj eller meget høj risiko for kardiovaskulær sygdom. 
• as first step treatment in patients with moderate to severe hypertension and in patients with high or very high cardiovascular risk
00-867 Warsawa, Polen 
00-867 Warsaw
Patienter med nyreinsufficiens og patienter i hæmodialyse Initial dosisjustering er ikke nødvendig hos patienter med moderat nyreinsufficiens (dvs. kreatininclearance 30-50 ml/min). 
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).
Antidiabetika (orale lægemidler eller insulin) 
Antidiabetic drugs (oral agents and insulin):
De tilgængelige data viser ikke, at førstevalgsbehandling med fastdosiskombinationen er fordelagtig sammenlignet med en trinvis tilgang for så vidt angår den godkendte indikation. 
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.
Hyponatriæmi ved overhydrering kan forekomme hos ødematøse patienter i varmt vejr. 
Dilutional hyponatraemia may occur in oedematous patients in hot weather.
Under administration af losartan fører fjernelse af angiotensin-II's negative feedback på reninsekretionen til øget plasmareninaktivitet (PRA). 
During the administration of losartan the removal of the angiotensin II negative feedback on renin secretion leads to increased plasma-renin activity (PRA).
I tilfælde af diuretikainduceret dehydrering er der øget risiko for akut nyresvigt, især ved høje doser af jodpræparatet. 
In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of the iodine product.
Overdosering kan medføre fald i blodtrykket, hjertebanken, langsom puls, ændringer i blodets elektrolytter og væskemangel. 
Overdosage can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.
Diuretika reducerer den renale udskillelse af lithium og kan medføre høj risiko for lithiumforgiftning; samtidig anvendelse anbefales ikke. 
Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity; concomitant use is not recommended.
Hvis digitalis også er indtaget, kan hypokaliæmi forstærke hjertearytmier. 
If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
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. 
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.
Derfor bør kaliums plasmakoncentration såvel som kreatininclearance monitoreres tæt, især patienter med hjertesvigt og kreatininclearance på 30-50 ml/min bør monitoreres tæt. 
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.
Patienter med angioødem i anamnesen (hævelse af ansigt, læber, svælg og/eller tunge) bør monitoreres nøje (se pkt. 
Patients with a history of angiooedema (swelling of the face, lips, throat, and/or tongue) should be closely monitored (see section 4.8).
Amphotericin B (parenteralt), kortikosteroider, ACTH eller stimulerende laksantia Hydrochlorthiazid kan intensivere elektrolyforstyrrelserne, især hypokaliæmi. 
Amphotericin B (parenteral), corticosteroids, ACTH or stimulant laxatives Hydrochlorothiazide may intensify electrolyte imbalance, particularly hypokalaemia.
Losartan er en syntetisk, oral angiotensin-II-receptorantagonist (type AT1). 
Losartan is a synthetically produced oral angiotensin-II receptor (type AT1) antagonist.
Bulgarien Merck Sharp & Dohme Bulgaria EOOD 
Bulgaria Merck Sharp & Dohme Bulgaria EOOD
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. 
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.
Derfor kan anvendelse af Cozaar Comp. tabletter ikke anbefales. 
Therefore, the use of Cozaar Comp tablets is not recommended.
Hydrochlorthiazid metaboliseres ikke, men udskilles hurtigt via nyrerne. 
Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidney.
• Øget indhold af kalium (som kan medføre unormal hjerterytme), nedsat hæmoglobin. 
• Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels.
Cozaar Comp. reducerer blodtrykket effektivt hos mænd og kvinder, negroide og ikke-negroide, samt hos såvel yngre (<65 år) som ældre (≥ 65 år) patienter. 
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.
Losartans og dets aktive metabolits farmakokinetik er lineær med orale doser af losartankalium på op til 200 mg. 
The pharmacokinetics of losartan and its active metabolite are linear with oral losartan potassium doses up to 200 mg.
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. 
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.
Når graviditet diagnosticeres, bør behandling med Cozaar Comp. seponeres omgående, og hvis det er hensigtsmæssigt, bør alternativ behandling påbegyndes. 
When pregnancy is diagnosed, treatment with Cozaar Comp should be stopped immediately and, if appropriate, alternative therapy should be started.
De mest almindelige observerede tegn og symptomer er elektrolytdepletering (hypokaliæmi, hypochloræmi, hyponatriæmi) og dehydrering som resultat af kraftig diurese. 
The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis.
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). 
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).
Skeletale muskelafslappende stoffer, nondepolariserende (f.eks. tubocurarin) Mulighed for forøget respons på muskelafslappende stoffer. 
Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) Possible increased responsiveness to the muscle relaxant.
Dosisjustering af medicin til behandling af diabetes, herunder insulin, kan være nødvendig (se pkt. 
Dosage adjustment of antidiabetic agents, including insulin, may be required (see section 4.5).
Cozaar Comp. fås i følgende pakningsstørrelser: 
Cozaar Comp is supplied in the following pack sizes:
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). 
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).
Cytotoksiske lægemidler (f.eks. cyclophosphamid, methotrexat) Thiazider kan reducere den renale ekskretion af cytotoksiske lægemidler og styrke deres myelosuppressive effekt. 
Cytotoxic agents (eg cyclophosphamide, methotrexate) Thiazides may reduce the renal excretion of cytotoxic medicinal products and potentiate their myelosuppressive effects.
Der er ingen terapeutisk erfaring med losartan til patienter med svær leverinsufficiens. 
There is no therapeutic experience with losartan in patients with severe hepatic impairment.
Selv med disse stigninger bibeholdes den antihypertensive aktivitet og suppressionen af plasmaaldosteronkoncentrationen, hvilket tyder på angiotensin-II-receptorblokering. 
Despite these increases, antihypertensive activity and suppression of the plasma aldosterone concentration are maintained, indicating effective angiotensin II receptor blockade.
Kalciumsalte 
Calcium salts
Disse tilstande bør korrigeres før administration af Cozaar Comp. tabletter (se pkt. 
Such conditions should be corrected before the administration of Cozaar Comp tablets (see sections 4.2. and 4.3.
Hvis eksponering for losartan har fundet sted fra 2. trimester af graviditeten, anbefales ultralydskontrol af nyrefunktionen og kraniet. 
Should exposure to Cozaar Comp have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Det reproduktive system og mammae Ikke almindelig: Nedsat libido, impotens. 
Reproductive system and breast disorders Uncommon: Decreased libido, impotence
Merck Sharp & Dohme OÜ Peterburi tee 46, Tallinn 11415, Estland 
Merck Sharp & Dohme OÜ Peterburi tee 46, Tallinn 11415, Estonia
Øre og labyrint Ikke almindelig: Vertigo, tinnitus. 
Ear and labyrinth disorders Uncommon: Vertigo, tinnitus
Efter oral og intravenøs administration af 14C-mærket losartankalium, er cirkulerende plasmaradioaktivitet primært knyttet til losartan og dets aktive metabolit. 
Following oral and intravenous administration of 14C-labeled losartan potassium, circulating plasma radioactivity primarily is attributed to losartan and its active metabolite.
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. 
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.
Samtidig administration af et thiazid kan øge incidensen af hypersensitivitetsreaktioner over for allopurinol. 
Coadministration of a thiazide may increase the incidence of hypersensitivity reactions to allopurinol.