natgillin/translations-raw huggingface dataset:
Hypotension og elektrolyt - / væskeforstyrrelser Symptomatisk hypotension, især efter første dosis og efter forhøjelse af dosis, er mest sandsynligt hos patienter med væske - og/ eller natriummangel ved kraftig behandling med diuretika, saltrestriktiv diæt, diarré eller opkastning.
Hypotension and Electrolyte/ Fluid Imbalance Symptomatic hypotension, especially after the first dose and after increasing of the dose, may occur in patients who are volume- and/ or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
4. 2).
These conditions should be corrected prior to administration of Cozaar, or a lower starting dose should be used (see section 4.2).
Derfor bør kaliums plasmakoncentration såvel som kreatinin - clearance monitoreres tæt, især patienter med hjertesvigt og kreatinin- clearance på 30- 50 ml/ min bør monitoreres tæt.
In a clinical study conducted in type 2 diabetic patients with nephropathy, the incidence of hyperkalemia was higher in the group treated with Cozaar as compared to the placebo group (see section 4.8, 'Hypertension and type 2 diabetes with renal disease - Investigations’ and ‘ Post-marketing experience - Investigations’ Therefore, the plasma concentrations of potassium as well as 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.
4. 5).
The concomitant use of potassium sparing diuretics, potassium supplements and potassium containing salt substitutes with losartan is not recommended (see section 4.5).
Leverinsufficiens Baseret på farmakokinetiske data, som viser signifikant forhøjede plasmakoncentrationer af losartan hos cirrhotiske patienter, bør det overvejes at anvende en lavere dosis til patienter med nedsat leverfunktion i anamnesen.
27 Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment.
4. 2).
Losartan is also not recommended in children with hepatic impairment (see section 4.2).
22 Nyreinsufficiens Som følge af hæmningen af renin- angiotensinsystemet, er der rapporteret forandringer i nyrefunktionen herunder nyrefunktionsnedsættelse (især hos patienter hvis nyrefunktion er afhængig af renin - angiotensin- aldosteronsystemet som patienter med svær hjerteinsufficiens eller tidligere nedsat nyrefunktion).
Renal Function Impairment As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported (in particular, in patients whose renal function is dependent on the renin angiotensin aldosterone system such as those with severe cardiac insufficiency or pre-existing renal dysfunction).
4. 2).
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).
Samtidig anvendelse af losartan og ACE- hæmmere nedsætter nyrefunktionen.
Concomitant use of losartan and ACE-inhibitors has shown to impair renal function.
Primær hyperaldosteronisme Patienter med primær hyperaldosteronisme vil generelt ikke respondere på antihypertensiva, der virker ved hæmning af renin- angiotensinsystemet.
Primary hyperaldosteronism Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system.
Hjerteinsufficiens Hos patienter med hjerteinsufficiens, med eller uden nyreinsufficiens, er der, som med andre lægemidler der påvirker renin- angiotensinsystemet, risiko for svær arteriel hypotension og (ofte akut) nyreinsufficiens.
Heart failure In patients with heart failure, with or without renal impairment, there is - as with other drugs acting on the renin-angiotensin system - a risk of severe arterial hypotension, and (often acute) renal impairment.
5. 1).
The combination of losartan with a beta-blocker should be used with caution (see section 5.1).
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.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Galactoseintolerance, Lapp- lactasemangel, glucose/ galactosemalabsorption Patienter med sjælden arvelig galactoseintolerance, Lapp- lactasemangel eller glucose/ galactosemalabsorption bør ikke tage denne medicin.
Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorbtion Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
Graviditet Behandling med losartan bør ikke initieres under graviditet.
28 Pregnancy Losartan should not be initiated during pregnancy.
4. 3 og 4. 6).
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).
23 Andre advarsler og forholdsregler Som det blev bemærket i forbindelse med angiotensinkonverterende enzymhæmmere er losartan og de andre angiotensinantagonister tilsyneladende mindre effektive til sænkning af blodtrykket hos negroide personer i forhold til ikke- negroide, muligvis på grund af større prævalens af lav- renin tilstande i den negroide hypertensive population.
Other warnings and precautions As observed for angiotensin converting enzyme inhibitors, losartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
Andre lægemidler, som inducerer hypotension, f. eks. tricykliske antidepressiva, antipsykotika, baclofen, amifostin:
Other substances inducing hypotension like tricyclic antidepressants, antipsychotics, baclofene, amifostine:
Losartan metaboliseres hovedsageligt via cytokrom P450 (CYP) 2C9 til den aktive carboxylsyre - metabolit.
Losartan is predominantly metabolised by cytochrome P450 (CYP) 2C9 to the active carboxy-acid metabolite.
50%.
In a clinical trial it was found that fluconazole (inhibitor of CYP2C9) decreases the exposure to the active metabolite by approximately 50%.
Amilorid, triamteren, spironolacton), eller som kan forhøje kaliumkoncentrationerne (f. eks. heparin), kaliumtilskud eller kaliumholdige salterstatninger, medføre stigninger i serumkalium.
As with other drugs that block angiotensin II or its effects, concomitant use of other drugs which retain potassium (e. g. potassium-sparing diuretics: amiloride, triamterene, spironolactone) or may increase potassium levels (e. g. heparin), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium.
Der er rapporteret om reversible forhøjelser i serum lithiumkoncentrationerne samt toksicitet ved samtidig administration af lithium og ACE- hæmmere.
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
Der er også rapporteret om meget sjældne tilfælde med antiotensin- II- receptorantagonister.
Very rare cases have also been reported with antiotensin II receptor antagonists.
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.
4. 4).
Pregnancy The use of losartan is not recommended during the first trimester of pregnancy (see section 4.4).
4. 3 og 4. 4).
The use of losartan is contra-indicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and 4.4).
Epidemiologisk evidens for risiko for teratogenicitet efter eksponering for ACE- hæmmere i 1. trimester af graviditeten har ikke været konklusive; en lille risikostigning kan dog ikke udelukkes.
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk 29 cannot be excluded.
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 ').
4. 3 og 4. 4).
Infants whose mothers have taken losartan should be closely observed for hypotension (see also section 4.3 and 4.4).
4. 3).
Because of the potential for adverse effects on the nursing infant, losartan is contraindicated during breast-feeding (see section 4.3).
Meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10); ikke almindelig (≥1/ 1. 000, < 1/ 100); sjælden (≥1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The frequency of adverse events listed below is defined using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
I kontrollerede kliniske undersøgelser af essentiel hypertension, hypertensive patienter med hypertrofi af venstre ventrikel, kronisk hjerteinsufficiens samt hypertension og type 2- diabetes mellitus med nyresygdom, var den mest almindelige bivirkning svimmelhed.
In controlled clinical trials for essential hypertension, hypertensive patients with left ventricular hypertrophy, chronic heart failure as well as for hypertension and type 2 diabetes mellitus with renal disease, the most common adverse event was dizziness.
Hypertension I kontrollerede kliniske undersøgelser af essentiel hypertension med losartan blev følgende bivirkninger rapporteret:
Hypertension In controlled clinical trials for essential hypertension with losartan the following adverse events were reported
Nervesystemet Almindelig:
Nervous system disorders:
Somnolens, hovedpine, søvnproblemer.
Common: dizziness, vertigo Uncommon: somnolence, headache, sleep disorders
Hjerte Ikke almindelig:
Cardiac disorder:
Palpitationer, angina pectoris.
Uncommon: palpitations, angina pectoris
Vaskulære sygdomme Ikke almindelig:
Vascular disorders:
Symptomatisk hypotension (især hos patienter med intravaskulær væskemangel, f. eks. patienter med svær hjerteinsufficiens eller i behandling med højdosis diuretika), dosisrelateret orthostatiske effekter, udslæt.
Uncommon: symptomatic hypotension (especially in patients with intravascular volume depletion, e. g. patients with severe heart failure or under treatment with high dose diuretics), dose-related orthostatic effects, rash.
Mave- tarmkanalen Ikke almindelig:
Gastrointestinal disorders:
Abdominal smerte, obstipation.
Uncommon: abdominal pain, obstipation 30 General disorders and administration site conditions:
Asteni, træthed, ødemer
Uncommon: asthenia, fatigue, oedema
Svimmelhed.
Nervous system disorders: common: dizziness
Vertigo.
Ear and labyrinth disorders: common: vertigo
Almene symptomer og reaktioner på administrationsstedet Almindelig:
General disorders and administration site conditions: common: asthenia/ fatigue
Asteni/ træthed.
Chronic heart failure
Kronisk hjerteinsufficiens I en kontrolleret undersøgelse med patienter med hjerteinsufficiens blev følgende bivirkninger rapporteret:
In a controlled clinical trial in patients with cardiac insufficiency the following adverse events were reported:
Paræstesi.
Nervous system disorders: uncommon: dizziness, headache rare: paraesthesia
Synkope, atrieflimren, hjerneblødning.
Cardiac disorders: rare: syncope, artrial fibrillation, cerebrovascular accident
Hypotension, herunder orthostatisk hypotension.
Vascular disorders: uncommon: hypotension, including orthostatic hypotension
Dyspnø.
Respiratory, thoracic and mediastinal disorders: uncommon: dyspnoea
Diarré, kvalme, opkastning.
Gastrointestinal disorders: uncommon: diarrhoea, nausea, vomiting
Urticaria, pruritus, udslæt.
Skin and subcutanous tissue disorders: uncommon: urticaria, pruritus, rash
Asteni/ træthed.
General disorders and administration site conditions: uncommon: asthenia/ fatigue
Hypertension og type 2- diabetes med nyresygdom I en kontrolleret klinisk undersøgelse med type 2- diabetikere med proteinuri (RENAAL- undersøgelse, se pkt.
Hypertension and type 2 diabetes with renal disease
5. 1) er de mest almindelige bivirkninger, som blev rapporteret for losartan, følgende:
In a controlled clinical trial in type 2 diabetic patients with proteinuria (RENAAL study, see section 5.1) the most common drug-related adverse events which were reported for losartan are as follows:
Hypotension.
Vascular disorders: common: hypotension
Hypoglykæmi, hyperkaliæmi.
General disorders and administration site conditions: common: asthenia/ fatigue 31 Investigations: common: hypoglycaemia, hyperkalaemia
Følgende bivirkninger forekom oftere hos patienter, der fik losartan end placebo:
The following adverse events occurred more often in patients receiving losartan than placebo:
Anæmi.
Blood and lymphatic system disorders: not known: anaemia
Synkope, palpitationer.
Cardiac disorders: not known: syncope, palpitations
Orthostatisk hypotension.
Vascular disorders: not known: orthostatic hypotension
Diarré.
Gastrointestinal disorders: not known: diarrhoea
Rygsmerter.
Muscoskeletal and connective tissue disorders: not known: back pain
Urinvejsinfektioner.
Renal and urinary disorders: not known: urinary tract infections
Almene symptomer og reaktioner på administrationsstedet Ikke kendt:
General disorders and administration site conditions: not known: flu-like symptoms
Influenzalignende symptomer.
Post-marketing experience
Efter markedsføring Følgende bivirkninger er blevet rapporteret efter markedsføring:
The following adverse events have been reported in post-marketing experience:
Blod og lymfesystem Ikke kendt:
Blood and lymphatic system disorders: not known:
Anæmi, trombocytopeni.
Anaemia, thrombocytopenia
Hos nogle af disse patienter har der tidligere været rapporteret om angioødem i forbindelse med administration af anden medicin, herunder ACE- hæmmere; vaskulitis inklusive Schönlein- Henochs purpura.
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.
Migræne.
Nervous system disorders: not known: migraine
Hoste.
Respiratory, thoracic and mediastinal disorders: not known: cough
Abnorm leverfunktion.
Hepatobiliary disorders: rare: hepatitis not known: liver function abnormalities
Urticaria, pruritus, udslæt.
Skin and subcutaneous tissue disorders: not known: urticaria, pruritus, rash
Knogler, led, muskler og bindevæv Ikke kendt:
Muscoskeletal and connective tissue disorders:
Myalgi, artralgi.
32 not known: myalgia, arthralgia
Nyresygdomme:
Renal disorders:
4. 4).
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)
Undersøgelser I kontrollerede, kliniske undersøgelser var klinisk signifikante ændringer i standard laboratorieparametre sjældent associeret med administration af losartantabletter.
In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Losartan tablets.
Hyperkaliæmi
Elevations of ALT occurred rarely and usually resolved upon discontinuation of therapy.
27 (serumkalium > 5, 5 mmol/ l) forekom hos 1, 5% af patienterne i hypertensionsundersøgelserne.
Hyperkalaemia (serum potassium > 5.5 mmol/ l) occurred in 1.5% of patients in hypertension clinical trials.
4. 4 "Elektrolytforstyrrelser").
In a clinical study conducted in type 2 diabetic patients with nephropathy, 9.9% of patients treated with Losartan tablets developed hyperkalaemia > 5.5 mEq/ l and 3.4% of patients treated with placebo (see section 4.4, ‘ Electrolyte imbalances’).
Symptomer på forgiftning Der er indtil videre ingen erfaring med overdosering hos mennesker.
Symptoms of intoxication No experience with overdose in man is available so far.
Behandling af forgiftning Forholdsreglerne afhænger af tidspunktet for indtagelse af medicinen samt symptomernes type og sværhedsgrad.
Treatment of intoxication Measures are depending on the time of drug intake and kind and severity of symptoms.
Angiotensin II- receptorantagonister, ATC- kode:
Angiotensin II Receptor Antagonists, ATC code:
Losartan er en syntetisk, peroral angiotensin- II- receptorantagonist (type AT1).
Losartan is a synthetic oral angiotensin-II receptor (type AT1) antagonist.
Angiotensin- II, der er en potent vasokonstriktor, er det primære aktive hormon i renin- angiotensinsystemet og en betydningsfuld determinant for hypertensions patofysiologi.
Angiotensin II, a potent vasoconstrictor, is the primary active hormone of the renin/ angiotensin system and an important determinant of the pathophysiology of hypertension.
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) and elicits several important biological actions, including vasoconstriction and the release of aldosterone.
Angiotensin- II stimulerer også formeringen af celler i den glatte muskulatur.
Angiotensin II also stimulates smooth muscle cell proliferation.
In vitro og in vivo blokerer losartan og dets farmakologisk aktive carboxylsyremetabolit E- 3174 alle fysiologisk relevante virkninger af angiotensin- II, uafhængig af kilde eller syntesevej.
In vitro and in vivo losartan and its pharmacologically active carboxylic acid metabolite E-3174 block all physiologically relevant actions of angiotensin II, regardless of the source or route of its synthesis.
Af denne grund finder ingen potensering af bradykinin- medierede virkninger sted.
Consequently, there is no potentiation of undesirable bradykinin- mediated effects.
Under administration af losartan leder fjernelse af angiotensin- II’ s negative feed- back på reninsekretionen til øget plasmareninaktivitet (PRA).
33 During administration of Losartan, removal of the angiotensin II negative feedback on renin secretion leads to increased plasma renin activity (PRA).
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 plasma aldosterone concentration are maintained, indicating effective angiotensin II receptor blockade.
Efter seponering af losartan faldt PRA og angiotensin- II- værdierne inden for tre dage til værdierne ved baseline.
After discontinuation of Losartan, PRA and angiotensin II values fell within three days to the baseline values.
Hypertensionsundersøgelser I kontrollerede kliniske undersøgelser, hvor losartan blev administreret én gang dagligt til patienter med mild til moderat essentiel hypertension, opnåedes statistisk signifikant reduktion af systolisk og diastolisk blodtryk.
Both Losartan and its principal active metabolite have a far greater affinity for the AT1-receptor than for the AT2-receptor.
Blodtryksmåling 24 timer efter dosering i forhold til 5- 6 timer efter dosering viste
The active metabolite is 10- to 40- times more active than Losartan on a weight for weight basis.
28 reduktion af blodtrykket i løbet af 24 timer; den naturlige døgnrytme blev bibeholdt.
Measurements of blood pressure 24 hours post-dose relative to 5 – 6 hours post-dose demonstrated blood pressure reduction over 24 hours; the natural diurnal rhythm was retained.
Losartan er lige effektiv hos mænd og kvinder samt hos yngre (< 65 år) og ældre hypertensive patienter.
Losartan is equally effective in males and females, and in younger (below the age of 65 years) and older hypertensive patients.
LIFE- undersøgelsen LIFE (The Losartan Intervention For Endpoint Reduction In Hypertension) var en randomiseret, trippelblindet, aktiv kontrolleret undersøgelse foretaget hos 9193 hypertensive patienter i alderen 55 til 80 år med EKG- diagnosticeret hypertrofi af venstre ventrikel.
LIFE-Study The Losartan Intervention For Endpoint Reduction in Hypertension [LIFE] study was a randomised, triple-blind, active-controlled study in 9193 hypertensive patients aged 55 to 80 years with ECG- documented left-ventricular hypertrophy.
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.
Andre antihypertensiva, undtagen ACE- hæmmere, angiotensin II- antagonister eller beta- blokkere, 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.
Race I LIFE- undersøgelsen havde de negroide patienter, der havde fået behandling med losartan, større risiko for at blive ramt af det primære sammensatte effektmål, dvs. en kardiovaskulær hændelse (f. eks. hjerteinfarkt, kardiovaskulær død) og især stroke, end de negroide patienter, som blev behandlet med atenolol.
Race In the LIFE-Study black patients treated with Losartan had a higher risk of suffering the primary combined endpoint, i. e. a cardiovascular event (e. g. cardiac infarction, cardiovascular death) and especially stroke, than the black patients treated with atenolol.
Derfor var de resultater, der sås for losartan sammenlignet med atenolol i LIFE - undersøgelsen med hensyn til kardiovaskulær morbiditet/ mortalitet, ikke gældende for negroide patienter med hypertension og hypertrofi af venstre ventrikel.
Therefore the results observed with losartan in comparison with atenolol in the LIFE study with regard to cardiovascular morbidity/ mortality do not apply for black patients with hypertension and left ventricular hypertrophy.
RENAAL- undersøgelsen RENAAL- undersøgelsen (The Reduction of Endpoints in NIDDM with the Angiotensin II Receptor Antagonist Losartan) var en kontrolleret, klinisk verdensomspændende undersøgelse med 1513 type 2- diabetikere med proteinuri, med eller uden hypertension.
34 RENAAL-Study The Reduction of Endpoints in NIDDM with the Angiotensin II Receptor Antagonist Losartan RENAAL study was a controlled clinical study conducted worldwide in 1513 Type 2 diabetic patients with proteinuria, with or without hypertension.