natgillin/translations-raw huggingface dataset:
Desensibilisering Patienter der anvender ACE- hæmmere under desensibiliserende behandling (f. eks. hymenoptera venom) har vedvarende anafylaktiske reaktioner.
Desensitisation Patients receiving ACE inhibitors during desensitisation treatment (e.g. hymenoptera venom) have sustained anaphylactoid reactions.
I de samme patienter har disse reaktioner været undgået, når ACE- hæmmerne midlertidigt blev holdt tilbage, men de kom igen ved utilsigtet udsættelse for ACE- hæmmere.
In the same patients, these reactions have been avoided when ACE inhibitors were temporarily withheld but they have reappeared upon inadvertent re-administration of the medicinal product.
Leversvigt I meget sjældne tilfælde, har ACE- hæmmere været forbundet med et syndrom, der begynder med kolestatisk gulsot eller hepatitis og som udvikler sig til voldsom nekrose og (undertiden) død.
Hepatic failure Very rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant necrosis and (sometimes) death.
Mekanismen bag dette syndrom er ikke klarlagt.
The mechanism of this syndrome is not understood.
Patienter i Zestril behandling der udvikler gulsot eller markant stigning i leverenzymer bør seponere Zestril behandlingen og modtage passende medicinsk opfølgning.
Patients receiving Zestril who develop jaundice or marked elevations of hepatic enzymes should discontinue Zestril and receive appropriate medical follow-up.
Neutropeni/ Agranulocytose Neutropeni/ Agranulocytose, trombocytopeni og anæmi er set hos patienter under ACE- hæmmer behandling.
Neutropenia/ Agranulocytosis Neutropenia/ Agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors.
Hos patienter med normal nyrefunktion og uden andre komplikationer, ses neutropeni sjældent.
In patients with normal renal function and no other complicating factors, neutropenia occurs rarely.
Neutropeni og agranulocytose er reversibelt ved seponering af ACE- hæmmer behandlingen.
Neutropenia and agranulocytosis are reversible after discontinuation of the ACE inhibitor.
Zestril bør administreres med yderste forsigtighed hos patienter med collagen vaskulær sygdom, under immunsuppreserende behandling, i behandling med allopurinol eller procainamid, eller ved kombination af disse omstændigheder, især ved præ- eksisterende nedsat nyrefunktion.
Zestril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function.
Nogle af disse patienter fik alvorlige infektioner og i få tilfælde reagerede de ikke på intensiv antibiotika behandling.
Some of these patients developed serious infections, which in a few instances did not respond to intensive antibiotic therapy.
Hvis Zestril bruges hos denne type patie nter, bør koncentrationen af hvide blodlegemer monitoreres regelmæssigt og patienter bør instrueres i at melde tilbage ved et hvilket som helst tegn på infektion.
If Zestril is used in such patients, periodic monitoring of white blood cell counts is advised and patients should be instructed to report any sign of infection.
Race Andelen af patienter der får angioneurotisk ødem som følge af ACE- hæmmer behandling er større blandt sorte patienter end ikke sorte patienter.
Race Angiotensin converting enzyme inhibitors cause a higher rate of angioedema in black patients than in non-black patients.
Som det også er tilfældet med andre ACE- hæmmere, kan Zestril være mindre effektiv til blodtrykssænkning hos sorte patienter end hos ikke sorte patienter, det kan muligvis skyldes en større hypighed af lav- renin tilstande hos disse patienter.
As with other ACE inhibitors, Zestril may be less effective in lowering blood pressure in black patients than in non-blacks, possibly because of a higher prevalence of low-renin states in the black hypertensive population.
Hoste Hoste har været rapporteret i forbindelse med brug af ACE- hæmmere.
Cough Cough has been reported with the use of ACE inhibitors.
Der er typisk tale om en tør, vedvarende hoste, der forsvinder ved behandlingens ophør.
Characteristically, the cough is non- productive, persistent and resolves after discontinuation of therapy.
ACE- hæmmere induceret hoste bør betragtes som en særskilt diagnose.
ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
Operation/ anæstesi Hos patienter, der gennemgår en større operation eller er i anæstesi med stoffer, der forårsager hypotension, kan Zestril blokere angiotensin- II- danne lsen sekundært til den kompensatoriske reninfrigørelse.
Surgery/Anaesthesia In patients undergoing major surgery or during anaesthesia with agents that produce hypotension, Zestril may block angiotensin II formation secondary to compensatory renin release.
Hvis der opstår hypotension som følge af denne mekanisme, kan der korrigeres med volumenekspansion.
If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
Hyperkaliæmi Stigning i serum kalium har været rapporteret hos patienter i ACE- hæmmer behandling deriblandt Zestril.
Hyperkalaemia Elevations in serum potassium have been observed in some patients treated with ACE inhibitors, including Zestril.
Risikopatienter for udvikling af hyperkaliæmi er patienter med nedsat nyrefunktion, diabetes mellitus, eller dem der samtidig får kalium besparende diuretika, kalium tilskud eller kaliumholdig salt tilskud, eller patienter som tager andre lægemidler som fører til en stigning i serum kalium (f. eks. heparin).
Patients at risk for the development of hyperkalaemia 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 nogen af de ovennævnte lægemidler anses for at være nødvendig, anbefales regelmæssig monitorering af serum kalium (se punkt 4. 5).
If concomitant use of the above-mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).
CPMP/ 423/ 04 Diabetikere
Diabetic patients CPMP/423/04
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Hos diabetikere der behandles peroralt med antidiabetika eller insulin, bør den glycæmiske kontrol monitoreres nøje den første måned af ACE- hæmmer behandlingen (se punkt 4. 5).
In diabetic patients treated with oral antidiabetic agents or insulin, glycaemic control should be closely monitored during the first month of treatment with an ACE inhibitor (see section 4.5)
Lithium Kombinationen af Zestril og lithium kan generelt ikke anbefales (se punkt 4. 5).
Lithium The combination of lithium and Zestril is generally not recommended (see section 4.5).
Graviditet og amning Lisinopril bør ikke anvendes under det første trimester af graviditeten.
Pregnancy and lactation Lisinopril should not be used during the first trimester of pregnancy.
Zestril er kontraindiceret i det andet og tredje trimester af graviditeten (se punkt 4. 3).
Zestril is contraindicated in the second and third trimesters of pregnancy (see section 4.3).
Når graviditeten opdages, bør lisinopril behandlingen ophøre så hurtigt som mu ligt (Se punkt 4. 6).
When pregnancy is detected, lisinopril treatment should be discontinued as soon as possible (see section 4.6).
Brug af lisinopril anbefales ikke under amning.
Use of lisinopril is not recommended during breast-feeding.
4. 5 Interaktioner med andre lægemidler og andre former for interaktioner
4.5 Interaction with other medicinal products and other forms of interaction
Diuretika Når et diuretikum lægges oveni en Zestril behandlingen er den antihypertensive effekt almindeligvis additiv.
Diuretics When a diuretic is added to the therapy of a patient receiving Zestril the antihypertensive effect is usually additive.
Hos patienter, der allerede er i diuretika behandling, og især hos dem, der for nyligt er sat i diuretika behandling, kan der ses et lejlighedsvist svært blodtryksfald, når Zestril adderes.
Patients already on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure when Zestril is added.
Risikoen for symptomatisk hypotension under Zestril behandling kan mindskes ved seponering af diuretikum før behandlingsstart med Zestril (se punkt 4. 4 samt punkt 4. 2).
The possibility of symptomatic hypotension with Zestril can be minimised by discontinuing the diuretic prior to initiation of treatment with Zestril (see section 4.4).
Dog er der i enkelte tilfælde observeret hyperkaliæmi.
Potassium supplements, potassium-sparing diuretics or potassium-containing salt substitutes Although in clinical trials, serum potassium usually remained within normal limits, hyperkalaemia did occur in some patients.
Risikofaktorer for udvikling af hyperkaliæmi inkluderer nyreinsufficiens, diabetes mellitus og samtidig anvendelse af kaliumbesparende diuretika (såsom spironolakton, triamteren eller amilorid), kaliumtilskud eller kaliumholdige salttilskud.
Risk factors for the development of hyperkalaemia include renal insufficiency, diabetes mellitus, and concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene or amiloride), potassium supplements or potassium-containing salt substitutes.
Anvendelsen af kaliumtilskud, kaliumbesparende diuretika eller kaliumholdige salt- tilskud, især hos patienter med nedsat nyrefunktion, kan føre til en signifikant stigning i serumkalium.
The use of potassium supplements, potassium-sparing diuretics or potassium-containing salt substitutes, particularly in patients with impaired renal function, may lead to a significant increase in serum potassium.
Hvis Zestril ordineres sammen med et kaliumtabende diuretikum, kan den diuretika inducerede hypokaliæmi forbedres.
If Zestril is given with a potassium-losing diuretic, diuretic -induced hypokalaemia may be ameliorated.
Lithium Der er rapporteret om reversible stigninger i serum lithium koncentration og toksicitet 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 behandling med thiazid diuretika, kan øge risikoen for lithium toksicitet der allerede er øget p. g. a samtidig behandling med ACE- hæmmere.
Concomitant use of thiazide diuretics may increase the risk of lithium toxicity and enhance the already increased lithium toxicity with ACE inhibitors.
Samtidig behandling med Zestril og lithium er ikke anbefalet, men hvis det er nødvendig bør lithium serum niveauet monitoreres nøje (se punkt 4. 4).
Use of Zestril with lithium is not recommended, but if the combination proves necessary, careful monitoring of serum lithium levels should be performed (see section 4.4).
Nonsteroide antiinflammatoriske stoffer (NSAID) inklusiv acetylsalicylsyre ≥ 3g/ dag Kronisk administration af NSAIDer kan nedsætte den antihypertensive effekt af en ACE- hæmmer.
Non steroidal anti-inflammatory drugs (NSAIDs) including acetylsalicylic acid = 3 G/day Chronic administration of NSAIDs may reduce the antihypertensive effect of an ACE inhib itor.
Nonsteroide anti- inflammatoriske stoffer og ACE- hæmmere udøver en additiv effekt på stigningen af serum kalium, hvilket kan føre til en forværring af nyrefunktionen.
NSAIDs and ACE inhibitors exert an additive effect on the increase in serum potassium and may result in a deterioration of renal function.
Disse virkninger er som regel reversible.
These effects are usually reversible.
I sjældne tilfælde kan der forekomme akut nyresvigt især hos patienter med nedsat nyrefunktion så som ældre eller dehydrerede patie nter.
Rarely, acute renal failure may occur, especially in patients with compromised renal function such as the elderly or dehydrated.
Andre antihypertensiva Samtidig brug af disse lægemidler kan øge Zestrils hypotensive effekt.
Other antihypertensive agents Concomitant use of these agents may increase the hypotensive effects of Zestril.
Samtidig brug af glyceryl trinitrat og andre nitrater eller andre vasodilatatorer, kan sænke blodtrykket yderligere.
Concomitant use with glyceryl trinitrate and other nitrates, or other vasodilators, may further reduce blood pressure.
Tricykliske antidepressiva
Tricyclic antidepressants / Antipsychotics /Anaesthetics
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Samtidig brug af visse bedøvelsesmidler, tricykliske antidepressiva og antipsykotika med ACE - hæmmere kan føre til yderligere blodtrykssænkning (se punkt 4. 4)
Concomitant use of certain anaesthetic medicinal products, tricyclic antidepressants and antipsychotics with ACE inhibitors may result in further reduction of blood pressure (see section 4.4)
Sympatikomimetika Sympatikomimetika kan nedsætte ACE- hæmmernes antihypertensive effekt.
Sympathomimetics Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors.
Antidiabetika Epidemiologiske studier tyder på at samtidig administration af ACE- hæmmere og antidiabetiske lægemidler (insuliner, orale hypoglycæmiske midler) kan føre til en øgning i den blodsukker dæmpe nde effekt med risiko for hypoglycæmi.
Antidiabetics Epidemiological studies have suggested that concomitant administration of ACE inhibitors and antidiabetic medicinal products (insulins, oral hypoglycaemic agents) may cause an increased blood glucose lowering effect with risk of hypoglycaemia.
Dette fænomen ser ud til at være mere sandsynligt under de to første ugers 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.
Acetylsalicylsyre, trombolitika, beta - blokkere og nitrater Zestril kan bruges samtidig med acetylsalicylsyre (ved kardiologiske doser), trombolitika, beta - blokkere og/ eller nitrater.
Acetylsalicylic acid, thrombolytics, beta-blockers, nitrates Zestril may be used concomitantly with acetylsalicylic acid (at cardiologic doses), thrombolytics, beta- blockers and/or nitrates.
Graviditet Zestril bør ikke anvendes under det første trimester af graviditeten.
Pregnancy Zestril should not be used during the first trimester of pregnancy.
Når graviditeten planlægges eller konstateres, bør der skiftes til en alternativ behandling så hurtigt som muligt.
When pregnancy is planned or confirmed the switch to an alternative treatment should be initiated as soon as possible.
Der er ikke udført nogen kontrollerede forsøg med ACE- hæmmere hos mennesker, men i et begrænset antal tilfælde med udsættelse for toksicitet under første trimester, er der ikke set misdannelser, der er i overensstemmelse med human fostertoksic itet som beskrevet nedenfor.
Controlled studies with ACE inhibitors have not been done in humans, but a limited number of cases with first trimester toxicity exposure have not appeared to manifest malformations consistent with human foetotoxicity as described below.
Zestril er kontraindiceret under det andet og tredje trimester af graviditeten (se punkt 4. 3).
Zestril is contraindicated during the second and third trimester of pregnancy (see section 4.3).
Det er kendt at længerevarende anvendelse af ACE- hæmmere under anden og tredje trimester inducere human fostertoksicitet (nedsat nyrefunktion, oligohydramnion, forsinket kranieknogledannelse) og neonatal toksicitet (nyresvigt, hypotension, hyperkaliæmi (se også punkt 5. 3)).
Prolonged ACE inhibitor exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia, see also section 5.3).
Hvis udsættelse for Zestril fra andet trimester har fundet sted tilrådes en ultralydsundersøgelse af nyrefunktion og kranie.
Should exposure to Zestril have occurred from the second trimester of pregnancy, an ultrasound check of renal function and the skull is recommended.
Spædbørn hvis mødre har fået Zestril skal observeres nøje for hypotension, oligouri og hyperkaliæmi.
Infants whose mothers have taken Zestril should be closely observed for hypotension, oliguria and hyperkalaemia.
Zestril der passerer placenta kan med nogen klinisk fordel fjernes fra det neonatale kredsløb ved hjælp af peritonal dialyse og kan teoretisk fjernes ved transfusion.
Zestril, 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 Det vides ikke, om Zestril udskilles i human modermælk.
Lactation It is not known whether Zestril is excreted into human breast milk.
Lisinopril udskilles i modermælken hos rotter.
Lisinopril is excreted into the milk of lactating rats.
Zestril anbefales ikke til ammende mødre.
The use of Zestril is not recommended in women who are breast-feeding.
Ved bilkørsel eller maskinbetjæning bør det tages i betragtning at svimmelhed eller træthed kan forekomme lejlighedsvist.
4.7 Effects on ability to drive and use machines When driving vehicles or operating machines it should be taken into account that occasionally dizziness or tiredness may occur.
Meget almindelig (
4.8 Undesirable effects The following undesirable effects have been observed and reported during treatment with Zestril and other ACE inhibitors with the following frequencies:
≥1%, < 10%), usædvanlig (≥0, 1%,
Very common (≥10%), common (≥1%, < 10%), uncommon (≥0.1, < 1%), rare (≥0.01, < 0.1%), very rare (< 0.01%) including isolated reports.
< 1%), sjælden (≥0, 01%, < 0, 1%), meget sjælden (< 0, 01%) inklusiv isolerede tilfælde.
Blood and the lymphatic system disorders: rare: decreases in haemoglobin, decreases in haematocrit.
Sygdomme i blod og lymfe systemet CPMP/ 423/ 04 Sjælden:
CPMP/423/04
36/ 41 hæmatokrit.
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Lymfeknudesvulster, autoimmun sygdom.
bone marrow depression, anaemia, thrombocytopenia, leucopenia, neutropenia, agranulocytosis (see section 4.4), haemolytic anaemia, lymphadenopathy, autoimmune disease
Stofskiftesygdomme og ernæringsbetingede sygdomme Meget sjælden:
Metabolism and nutrition disorders very rare:
Hypoglycæmi
hypoglycaemia
Sjælden:
Nervous system and psychiatric disorders: common: uncommon: rare:
Humørsvingninger, paræstesi, vertigo, smagsforstyrelser, søvnforstyrelser Mentale forstyrelser
dizziness, headache mood alterations, paraesthesia, vertigo, taste disturbance, sleep disturbances. mental confusion
Usædvanlig:
Cardiac and vascular disorders: common: uncommon:
Ortostatiske manifestationer (herunder hypotension) Myokardieinfarkt eller blodprop i hjernen formentlig som følge af svær hypotension hos høj- risiko patienter (se punkt 4. 4), palpitationer, takykardi, Raynauds fænomen.
Raynaud’s phenomenon
Meget sjældne:
Respiratory, thoracic and mediastinal disorders: common: uncommon: very rare:
Allergisk alveolitis / eosinofil pneumoni.
cough rhinitis bronchospasm, sinusitis, allergic alveolitis/eosinophilic pneumonia
Sjælden:
Gastrointestinal disorders: common: uncommon: rare: very rare:
Mundtørhed Pancreatitis, intestinal angioneurotisk ødem, hepatitis - enten hepatocellulær eller cholestatisk gulsot, leversvigt (50).
diarrhoea, vomiting nausea, abdominal pain and indigestion dry mouth pancreatitis, intestinal angioedema, hepatitis- either hepatocellular or cholestatic, jaundice and hepatic failure (see section 4.4)
Sjælden:
Skin and subcutaneous tissue disorders: uncommon: rare:
Hypersensitivitet/ angioneurotisk ødem i ansigtet, ekstremiteter, læber, tunge, glottis og/ eller larynx (se punkt 4. 4), urticaria, alopecia, psoriasis.
rash, pruritus hypersensitivity/angioneurotic oedema: angioneurotic oedema of the face, extremities, lips, tongue, glottis, and/or larynx (see section 4.4), urticaria, alopecia, psoriasis
Øget svedtendens, pemphigus, toksisk epidermal nekrolyse, Stevens- Johnson´s syndrom og erythema multiforme.
diaphoresis, pemphigus, toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme.
Et syndrom er rapporteret, der kan inkludere en eller flere af følgende symptomer: feber, vaskulitis, myalgia, arthralgi/ arthritis, positiv ANA, forhøjet ESR- værdi, eosinofilia og leukocytose, udslæt, fotosensitivitet eller andre dermatologiske manifestationer.
A symptom complex has been reported which may include one or more of the following: fever, vasculitis, myalgia, arthralgia/arthritis, a positive antinuclear antibodies (ANA), elevated red blood cell sedimentation rate (ESR), eosinophilia and leucocytosis, rash, photosensitivity or other dermatological manifestations may occur.
Meget sjælden:
Renal and urinary disorders: common: rare: very rare:
Oliguri/ anuri
renal dysfunction uraemia, acute renal failure oliguria/anuria
Sjælden:
Reproductive system and breast disorders: uncommon: rare
Impotence Gynækomasti
impotence gynaecomastia
Almene lidelser og reaktioner på indgivelsesstedet Usædvanlige:
General disorders and administration site conditions: uncommon:
Træthed, asteni
fatigue, asthenia
Undersøgelser
CPMP/423/04 Investigations:
Usædvanlig:
©EMEA 2004
CPMP/ 423/ 04 Sjælden:
uncommon:
Stigning af urinstof i serum, serumkreatinin og leverenzymer.
increases in blood urea, increases in serum creatinine, increases in liver enzymes, hyperkalaemia
Hype rkaliæmi.
rare:
37/ 41 ©EMEA 2004 Stigning i serum bilirubin, hyponatræmi.
increases in serum bilirubin, hyponatraemia.
Der findes kun begrænset data vedrørende overdosering hos mennesker.
Limited data are available for overdose in humans.
Symptomer på overdosering med ACE- hæmmere kan være svær hypotension, kredsløbsshock, elektrolytforstyrrelser, nyresvigt, hyperventilering, takykardi, palpitationer, bradykardi, svimmelhed, angst og hoste.
Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough.
Ved overdosering anbefales intravenøs infusion af fysiologisk saltvand.
The recommended treatment of overdose is intravenous infusion of normal saline solution.
I tilfælde af hypotension, bør patienten placeres i liggende position.
If hypotension occurs, the patient should be placed in the shock position.
Hvis det er muligt kan behandling med angiotensin II og/ eller katekolamin overvejes.
If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered.
Ved nylig optagelse, bør det forsøges at fjerne Zestril (f. eks. ved opkast, maveudskyldning, administration af absorbanter og natrium sulfat).
If ingestion is recent, take measures aimed at eliminating Zestril (e.g., emesis, gastric lavage, administration of absorbents and sodium sulphate).
Zestril kan fjernes fra blodomløbet ved hæmodialyse (se punkt 4. 4).
Zestril may be removed from the general circulation by haemodialysis (see section 4.4).
Pacemaker behandling er indiceret i tilfælde af behandlingsresistent bradykardi.
Pacemaker therapy is indicated for therapy-resistant bradycardia.
Vitale tegn, serum- elektrolytter og serum- kreatinin bør monitoreres jævnligt.
Vital signs, serum electrolytes and creatinine concentrations should be monitored frequently.
Angiotensin konverterende enzym hæmmere, ATC kode:
Angiotensin converting enzyme inhibitors, ATC code:
C09A A03
C09A A03
Zestril er en peptidyl dipeptidase hæmmer.
Zestril is a peptidyl dipeptidase inhibitor.
Det hæmmer det angiotensin konverterende enzym (ACE), der katalyserer omdannelsen af angiotensin I til det vasokonstriktoriske peptid, angiotensin II.
It inhibits the angiotensin converting enzyme (ACE) that catalyses the conversion of angiotensin I to the vasoconstrictor peptide, angiotensin II.
Angiotensin II stimulerer endvidere aldosteronsekretionen i binyrebarken.
Angiotensin II also stimulates aldosterone secretion by the adrenal cortex.