natgillin/translations-raw huggingface dataset:
ACE- hæmmerinduceret hoste bør betragtes som en del af den differentierede diagnose af hoste.
ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
Operation/ anæstesi Hos patienter der gennemgår større operation eller er i anæstesi med lægemidler, der forårsager hypotension, blokerer enalapril angiotensin II dannelsen sekundært til den kompensatoriske reninfrigørelse.
Surgery/ Anesthesia In patients undergoing major surgery or during anesthesia with agents that produce hypotension, enalapril blocks angiotensin II formation secondary to compensatory renin release.
Hvis der opstår hypotension som følge af denne mekanisme kan den korrigeres med væskevolumenekspansion.
If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
Hyperkaliæmi Der er set forhøjede koncentrationer af serumkalium hos nogle patienter behandlet med ACE - hæmmere, inklusiv enalapril.
Hyperkalemia Elevations in serum potassium have been observed in some patients treated with ACE inhibitors, including enalapril.
Patienter med risiko for udvikling af hyperkaliæmi inkluderer patienter med nyreinsufficiens, diabetes mellitus, eller de, som anvender kaliumbesparende diuretika, kaliumsupplement eller salterstatninger som indeholder kalium; eller de patienter som indtager andre lægmidler i forbindelse med forhøjelser i serumkalium (f. eks. heparin).
Patients at risk for the development of hyperkalemia include those with renal insufficiency, diabetes mellitus, or those using concomitant potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes; or those patients taking other drugs associated with increases in serum potassium (e. g. heparin).
Hvis samtidig brug af ovenstående lægemidler vurderes nødvendig, anbefales regelmæssig kontrol af serumkalium.
If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended.
Lithium Kombination af lithium og enalapril anbefales generelt ikke (se 4. 5 Interaktion med andre lægemidler og andre former for interaktion).
Lithium The combination of lithium and enalapril is generally not recommended (see 4.5 Interaction with other medicinal products and other forms of interaction).
Laktose < RENITEC > indeholder mindre end 200 mg laktose pr. tablet.
Lactose< Renitec > contains less than 200 mg of lactose per tablet.
CPMP/ 3175/ 03
CPMP/ 3175/ 03 Paediatric Use
2 måneder (se også 4. 2 Dosering og indgivelsesmåde, 5. 1 Farmakodynamiske egenskaber og 5. 2 Farmakokinetiske egenskaber). < RENITEC > anbefales ikke til børn med andre indikationer end hypertension.
(Also see 4.2 Posology and method of administration, 5.1 Pharmacodynamic properties, and 5.2 Pharmacokinetic properties. )< Renitec > is not recommended in children in other indications than hypertension.
< RENITEC > anbefales ikke til nyfødte eller til pædiatriske patienter med glomerulær filtrations - hastighed < 30 ml/ min/ 1, 73 m2, da dette ikke er undersøgt (se 4. 2 Dosering og indgivelsesmåde).
(See 4.2 Posology and method of administration.)
Graviditet og amning Enalapril bør ikke anvendes i graviditetens første trimester. < RENITEC > er kontraindiceret i andet og tredie trimester af graviditeten (se 4. 3 Kontraindikationer).
Pregnancy and lactation Enalapril should not be used during the first trimester of pregnancy .< Renitec > is contraindicated in the second and third trimesters of pregnancy (see 4 .3 Contraindications).
Når graviditet erkendes bør enalapril - behandling ophøre hurtigst muligt (se 4. 6 Graviditet og amning).
When pregnancy is detected, enalapril treatment should be discontinued as soon as possible (see 4.6 Pregnancy and lactation).
Brug af enalapril anbefales ikke under amning.
Use of enalapril is not recommended during breast feeding.
Etniske forskelle Som med andre ACE- hæmmere er enalapril tilsyneladende mindre effektiv til nedsættelse af blodtrykket hos negroide personer end andre personer, muligvis på grund af en højere prævalens af lavreninstatus i den negroide hypertensive befolkning.
Ethnic differences As with other angiotensin converting enzyme inhibitors, enalapril is apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of a higher prevalence of low-renin states in the black hypertensive population.
Kaliumbesparende diuretika eller kaliumsupplementer ACE- hæmmere svækker diuretisk induceret kaliumtab.
Potassium sparing diuretics or potassium supplements ACE inhibitors attenuate diuretic induced potassium loss.
Kaliumbesparende diuretika (f. eks. spironolacton, triamteren eller amilorid), kaliumsupplementer eller kaliumholdige salterstatninger kan føre til signifikante øgninger i serumkalium.
Potassium sparing diuretics (e. g. spironolactone, triamterene or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
Hvis samtidig anvendelse er indikeret på grund af påvist hypokaliæmi er det vigtigt at de anvendes med forsigtighed og med hyppig kontrol af serumkalium (se 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
If concomitant use is indicated because of demonstrated hypokalemia they should be used with caution and with frequent monitoring of serum potassium (see 4.4 Special warnings and special precautions for use).
Diuretika (thiazid - eller loop- diuretika) Tidligere behandling med højdosis diuretika kan resultere i volumendepletering og risiko for hypotention når enalpril behandling initieres (se 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
Diuretics (thiazide or loop diuretics) Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with enalapril (see 4.4 Special warnings and special precautions for use).
De hypotensive effekter kan reduceres ved seponering af diuretika, ved at øge volumen eller saltindtaget eller ved at initiere behandling med en lav dosis enalapril.
The hypotensive effects can be reduced by discontinuation of the diuretic, by increasing volume or salt intake or by initiating therapy with a low dose of enalapril.
Andre antihypertensive lægemidler Samtidig brug af disse lægemidler kan øge den hypotensive effekt af enalapril.
Other antihypertensive agents Concomitant use of these agents may increase the hypotensive effects of enalapril.
Samtidig brug med nitroglycerin og andre nitrater eller andre vasodilatorer kan nedsætte blodtrykket yderligere.
Concomitant use with nitroglycerine and other nitrates, or other vasodilators, may further reduce blood pressure.
Lithium Der er rapporteret reversible forhøjelser i serumlithiumkoncentrationer og toxicitet ved samtidig brug af lithium og ACE- hæmmere.
Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
Samtidig brug af thiaziddiuretika og ACE- hæmmer kan yderligere øge lithiumkoncentrationen og forøge risikoen for lithiumtoxicitet.
Concomitant use of thiazide diuretics may further increase lithium levels and enhance the risk of lithium toxicity with ACE inhibitors.
Brug af enalapril sammen med lithium anbefales ikke, men hvis kombinationen er nødvendig bør kontrol af serumlithiumkoncentration udføres (se 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
Use of enalapril with lithium is not recommended, but if the combination proves necessary, careful monitoring of serum lithium levels should be performed (see 4.4 Special warnings and special precautions for use).
Tricykliske antidepressiva/ antipsykotika/ anæstetika/ narkotika Samtidig brug af visse anæstesiprodukter, tricykliske antidepressiva og antipsykotika sammen med ACE- hæmmere kan resultere i yderligere reduktion af blodtrykket (se 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
Tricyclic antidepressants/ Antipsychotics/ Anesthetics/ Narcotics Concomitant use of certain anesthetic medicinal products, tricyclic antidepressants and antipsychotics with ACE inhibitors may result in further reduction of blood pressure (see 4.4 Special warnings and special precautions for use).
Non- steroide anti- inflammatoriske lægemidler (NSAIDs) Kronisk administration af NSAIDs kan reducere den antihypertensive effekt af ACE- hæmmere.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Chronic administration of NSAIDs may reduce the antihypertensive effect of an ACE inhibitor.
CPMP/ 3175/ 03 Sympatomimetika
CPMP/ 3175/ 03
Sympatomimetika kan reducere ACE- hæmmeres antihypertensive effekt.
Sympathomimetics Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors.
Antidiabetika Epidemiologiske studier antyder at samtidig administration af ACE- hæmmere og antidiabetika (insulin, orale hypoglykæmiske midler) kan give en øget blodglucose nedsættende effekt med risiko for hypoglykæmi.
Antidiabetics Epidemiological studies have suggested that concomitant administration of ACE inhibitors and antidiabetic medicines (insulins, oral hypoglycemic agents) may cause an increased blood-glucose- lowering effect with risk of hypoglycemia.
Dette fænomen synes mest sandsynligt i de første uger af kombinationsbehandling og hos patienter med nedsat nyrefunktion.
This phenomenon appeared to be more likely to occur during the first weeks of combined treatment and in patients with renal impairment.
Alkohol Alkohol forstærker ACE- hæmmeres hypotensive effekt.
Alcohol Alcohol enhances the hypotensive effect of ACE inhibitors.
Acetylsalicylsyre, thrombolytika og β- blokkere Enalapril kan uden risiko administreres samtidig med acetylsalicylsyre (i cardiologiske doser), thrombolytika og β- blokkere.
Acetyl salicylic acid, thrombolytics and β -blockers Enalapril can be safely administered concomitantly with acetyl salicylic acid (at cardiologic doses), thrombolytics and β -blockers.
Graviditet Enalapril bør ikke anvendes i første trimester af graviditeten.
Pregnancy Enalapril should not be used during the first trimester of pregnancy.
Når graviditet planlægges eller bekræftes bør skift til anden behandling initieres strakt.
When a pregnancy is planned or confirmed the switch to an alternative treatment should be initiated as soon as possible.
Kontrollerede undersøgelser med ACE- hæmmere er ikke udført med mennesker, men et begrænset antal tilfælde med eksponering i første trimester har ikke vist sig at give misdannelser i overensstemmelse med human føtotoxicitet som beskrevet nedenfor.
Controlled studies with ACE inhibitors have not been done in humans, but a limited number of cases with first trimester exposure have not appeared to manifest malformations consistent with human fetotoxicity as described below.
Enalapril er kontraindiceret i andet og tredje trimester af graviditeten.
Enalapril is contraindicated during the second and third trimesters of pregnancy.
Det er kendt at forlænget eksponering for enalapril i andet og tredje trimester inducerer human fototoxicitet (nedsat nyrefunktion, oligohydramniose, kranieforbeningsretardering) og neonatal toxicitet (nyresvigt, hypotension, hyperkaliæmi) (se også 5. 3 Prækliniske sikkerhedsdata).
(Also see 5.3 Preclinical safety data.)
Har der været ekponering for enalapril i andet og tredie trimester af graviditeten anbefales ultralydsscanning af nyrefunktion og kranium.
Should exposure to enalapril have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Børn, hvis mødre har taget < RENITEC > under graviditeten, bør observeres tæt for hypotension, oliguri og hyperkaliæmi.
Infants whose mothers have taken< Renitec > should be closely observed for hypotension, oliguria and hyperkalemia.
Enalapril, som passerer placenta, kan fjernes fra det neonatale kredsløb ved peritonealdialyse med nogen klinisk effekt og kan i teorien fjernes ved udskiftningstransfusion.
Enalapril, which crosses the placenta, has been removed from the neonatal circulation by peritoneal dialysis with some clinical benefit, and theoretically may be removed by exchange transfusion.
Amning Enalapril og enalaprilmaleat udskilles i modermælk, men deres effekt på det ammende barn er ikke påvist.
Lactation Enalapril and enalaprilat are excreted in breast milk but their effect on the nursing infant has not been determined.
Derfor anbefales brug af enalapril ikke under amning.
Consequently, use of enalapril is not recommended if breast-feeding.
Når der føres motorkøretøj eller betjenes maskiner, bør patienten være opmærksom på, at svimmelhed og ørhed kan opstå.
When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur.
Uønskede virkninger rapporteret for enalapril omfatter:
Undesirable effects reported for enalapril include:
CPMP/ 3175/ 03 Metabolisme og ernæring:
CPMP/ 3175/ 03 Blood and the lymphatic system disorders:
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Hypoglykæmi (se 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen, Diabetespatienter)
uncommon: anemia (including aplastic and hemolytic) rare: neutropenia, decreases in hemoglobin, decreases in hematocrit, thrombocytopenia, agranulocytosis, bone marrow depression, pancytopenia, lymphadenopathy, autoimmune diseases
Hovedpine, depression Mindre hyppige:
Metabolism and nutrition disorders: uncommon: hypoglycemia (see 4.4 Special warnings and special precautions for use, Diabetic patients)
Abnorme drømme, søvnforstyrrelser
Nervous system and psychiatric disorders: common: headache, depression uncommon: confusion, somnolence, insomnia, nervousness, paresthesia, vertigo rare: dream abnormality, sleep disorders
Sløret syn
Eye disorders: very common: blurred vision
Orthostatisk hypotention, palpitationer Sjældne:
Cardiac and vascular disorders: very common: dizziness common: hypotension (including orthostatic hypotension), syncope, myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients (see 4.4 Special warnings and special precautions for use), chest pain, rhythm disturbances, angina pectoris, tachycardia uncommon: orthostatic hypotension, palpitations rare:
Raynaud' s fænomen
Raynaud’ s phenomenon
Pulmonære infiltrater, rhinitis, allergisk alveolitis, eosinofilisk pneumoni
Respiratory, thoracic and mediastinal disorders: very common: cough common: dyspnea uncommon: rhinorrhea, sore throat and hoarseness, bronchospasm/ asthma rare: pulmonary infiltrates, rhinitis, allergic alveolitis/ eosinophilic pneumonia
Stomatitis/ aphtous ulcera, glossitis
Gastrointestinal disorders: very common: nausea, common: diarrhea, abdominal pain, taste alteration uncommon: ileus, pancreatitis, vomiting, dyspepsia, constipation, anorexia, gastric irritations, dry mouth, peptic ulcer rare: stomatitis/ aphthous ulcerations, glossitis
Erythema multiform, Stevens- Johnson syndrom, exfoliativ dermatitis, toxisk epidermisk nekrolyse, pemphigus, erythroderma
Hepatobiliary disorders: rare: hepatic failure, hepatitis – either hepatocellular or cholestatic, hepatitis including necrosis, cholestasis (including jaundice) Skin and subcutaneous tissue disorders: common: rash, hypersensitivity/ angioneurotic edema: angioneurotic edema of the face, extremities, lips, tongue, glottis and/ or larynx has been reported (see 4.4 Special warnings and special precautions for use) uncommon: diaphoresis, pruritus, urticaria, alopecia rare: erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma
Feber, serositis, vaskulitis, myalgi/ myositis, arthralgi/ arthritis, positiv ANA, forhøjet ESR, eosinofili og leukocytose.
A symptom complex has been reported which may include some or all of the following: fever, serositis, vasculitis, myalgia/ myositis, arthralgia/ arthritis, a positive ANA, elevated ESR, eosinophilia, and leukocytosis.
Udslæt, fotosensitivitet eller andre dermatologiske manifestationer kan forekomme.
Rash, photosensitivity or other dermatologic manifestations may occur.
Oliguria
Renal and urinary disorders: uncommon: renal dysfunction, renal failure, proteinuria rare: oliguria
CPMP/ 3175/ 03
CPMP/ 3175/ 03 Reproductive system and breast disorders: uncommon: impotence rare: gynecomastia
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Muskelkramper, rødmen, tinnitus, ubehag, feber
General disorders and administration site conditions: very common: asthenia common: fatigue uncommon: muscle cramps, flushing, tinnitus, malaise, fever
Forhøjede leverenzymtal, forhøjelser i serumbilirubin
Investigations: common: hyperkalemia, increases in serum creatinine uncommon: increases in blood urea, hyponatremia rare: elevations of liver enzymes, elevations of serum bilirubin
Der er begrænsede data med hensyn til overdosering hos mennesker.
Limited data are available for overdosage in humans.
6 timer efter indtagelse af tabletter samtidig med blokade af renin- angiotensinsystemet og stupor.
The most prominent features of overdosage reported to date are marked hypotension, beginning some six hours after ingestion of tablets, concomitant with blockade of the renin-angiotensin system, and stupor.
Symptomer forbundet med overdosis af ACE - hæmmere kan omfatte cirkulatorisk shock, elektrolytforstyrrelser, nyresvigt, hyperventilation, tachykardi, palpitationer, bradykardi, svimmelhed, angst og hoste.
Symptoms associated with overdosage of ACE inhibitors may include circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.
Der er rapporteret serumenalaprilatniveauer 100 og 200 gange højere end normalt set efter terapeutiske doser efter indtagelse af henholdsvis 300 mg og 440 mg enalapril.
Serum enalaprilat levels 100- and 200-fold higher than usually seen after therapeutic doses have been reported after ingestion of 300 mg and 440 mg of enalapril, respectively.
Anbefalet behandling af overdosering er intravenøs infusion af saltvandsopløsning.
The recommended treatment of overdosage is intravenous infusion of normal saline solution.
Hvis hypotension opstår bør patienten placeres i shockposition.
If hypotension occurs, the patient should be placed in the shock position.
Behandling med angiotensin II infusion og/ eller intravenøse catecholaminer kan også overvejes.
If available, treatment with angiotensin II infusion and/ or intravenous catecholamines may also be considered.
Hvis indtagelse er sket fornylig bør der tages forholdsregler med henblik på at eliminere enalaprilmaleat (f. eks. opkastning, udpumpning, administration af absorbenter og natriumsulfat).
If ingestion is recent, take measures aimed at eliminating enalapril maleate (e. g., emesis, gastric lavage, administration of absorbents, and sodium sulphate).
Enalaprilat kan fjernes fra det systemiske kredsløb ved hæmodialyse (se 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen, Hæmodialysepatienter).
Enalaprilat may be removed from the general circulation by hemodialysis.
Pacemakerterapi er indikeret til terapiresistent bradykardi.
(See 4.4 Special warnings and special precautions for use, Hemodialysis Patients.) Pacemaker therapy is indicated for therapy-resistant bradycardia.
Vitale tegn, serumelektrolytter og kreatininkoncentrationer bør kontrolleres fortløbende.
Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.
ATC- kode:
Angiotensin converting enzyme inhibitors, ATC Code:
C09A A02
C09A A02
< RENITEC > (enalaprilmaleat) er maleatsaltet af enalapril, et derivat af to aminosyrer, L- alanine og L - proline.
< Renitec > (enalapril maleate) is the maleate salt of enalapril, a derivative of two amino-acids, L- alanine and L-proline.
Angiotensinkonverterende enzymer (ACE) er en peptidyldipeptidase som katalyserer konverteringen af angiotensin I til pressorsubstansen angiotensin II.
Angiotensin converting enzyme (ACE) is a peptidyl dipeptidase which catalyzes the conversion of angiotensin I to the pressor substance angiotensin II.
Efter absorption hydrolyseres enalapril til enalaprilat som hæmmer ACE.
After absorption, enalapril is hydrolyzed to enalaprilat, which inhibits ACE.
Hæmning af ACE resulterer i nedsat plasmaangiotensin II, som medfører øget plasmareninaktivitet (pga. fjernelse af negativ feed back fra reninfrigørelse) og nedsat aldosteronsekretion.
Inhibition of ACE results in decreased plasma angiotensin II, which leads to increased plasma renin activity (due to removal of negative feedback of renin release), and decreased aldosterone secretion.
ACE er identisk med kinase II.
ACE is identical to kininase II.
Dermed blokerer < RENITEC > nedbrydning af bradykinin, et potent vasodepressorpeptid.
Thus< Renitec > may also block the degradation of bradykinin, a potent vasodepressor peptide.
Administration af < RENITEC > til patienter med hypertension reducerer både liggende og stående blodtryk uden at øge hjertefrekvensen signifikant.
However, the role that this plays in the therapeutic effects of< Renitec > remains to be elucidated.
Pludselig seponering af < RENITEC > er ikke associeret med en hurtig stigning i blodtrykket.
While the mechanism through which< Renitec > lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, < Renitec > is antihypertensive even in patients with low-renin hypertension.
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Effektiv inhibering af ACE- aktiviteten indtræder typisk 2- 4 timer efter oral administration af enkeltdosis enalapril.
Effective inhibition of ACE activity usually occurs 2 to 4 hours after oral administration of an individual dose of enalapril.
Begyndende reduktion i blodtryk ses sædvanligvis efter 1 time med maksimal reduktion 4- 6 timer efter administration.
Onset of antihypertensive activity was usually seen at one hour, with peak reduction of blood pressure achieved by 4 to 6 hours after administration.
Varigheden af effekten er dosisrelateret.
The duration of effect is dose-related.
Ved anbefalede doser bibeholdes den antihypertensive og hæmodynamiske effekt i mindst 24 timer.
However, at recommended doses, antihypertensive and hemodynamic effects have been shown to be maintained for at least 24 hours.
I hæmodynamiske undersøgelser med patienter med essentiel hypertension er sænkning af blodtrykket associeret med reduktion af den perifere arteriemodstand og en stigning i det kardielle output samt lille eller ingen ændring i hjertefrekvens.
In hemodynamic studies in patients with essential hypertension, blood pressure reduction was accompanied by a reduction in peripheral arterial resistance with an increase in cardiac output and little or no change in heart rate.
Efter indtagelse af < RENITEC > sås der øgning i renal blodgennemstrømning, og den glomerulære filtrationsrate forblev uændret.
Following administration of< Renitec > there was an increase in renal blood flow; glomerular filtration rate was unchanged.
Der sås ingen tegn på natrium - eller væskeretention.
There was no evidence of sodium or water retention.
Hos patienter med forudgående lav filtrationshastighed blev denne typisk øget.
However, in patients with low pretreatment glomerular filtration rates, the rates were usually increased.
I kliniske undersøgelser af kortere varighed med diabetikere og ikke- diabetikere med nyresygdom sås fald i albuminuri, urinudskillelse af IgG og totalprotein i urinen efter administration af enalapril.
In short term clinical studies in diabetic and nondiabetic patients with renal disease, decreases in albuminuria and urinary excretion of IgG and total urinary protein were seen after the administration of enalapril.
Ved samtidig administration med thiaziddiuretika er effekten af < RENITEC > som minimum additiv. < RENITEC > kan reducere eller forebygge udvikling af thiazidinduceret hypokaliæmi.
When given together with thiazide-type diuretics, the blood pressure-lowering effects of< Renitec > are at least additive. < Renitec > may reduce or prevent the development of thiazide-induced hypokalemia.