FrancophonIA/ELRC3.0 huggingface dataset:
English: However, in patients with impaired renal function and/or in patients taking potassium supplements (including salt substitutes) or potassiumsparing diuretics, and especially aldosterone antagonists, hyperkalemia can occur.
Danish: Hos patienter med nedsat nyrefunktion og/eller patienter, som tager kaliumtilskud (herunder salterstatninger) eller kaliumbesparende diuretika, især aldosteron-antagonister, kan der dog forekomme hyperkaliæmi.
English: Hypersensitivity/angioedema
Danish: Overfølsomhed/angioødem
English: Preventive measures include withdrawing or temporarily withholding diuretics, beginning therapy with very small doses of ACE inhibitors, and cautious dose titration.
Danish: Forebyggende foranstaltninger omfatter seponering eller midlertidig afbrydelse af diuretika, iværksættelse af behandling med meget små doser ACE-hæmmere samt forsigtig dosistitrering.
English: 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 cannot be excluded.
Danish: Epidemiologisk evidens vedrørende risikoen for teratogenicitet efter eksponering for ACE-hæmmere under første trimester af graviditeten er ikke entydig, dog kan en lille øgning i risikoen ikke udelukkes.
English: Rarely, neutropenia and agranulocytosis have been associated with ACE inhibitors, especially in patients with renal failure or collagen vascular disease, and those receiving immunosuppressive therapy.
Danish: Neutropeni og agranulocytose er i sjældne tilfælde blevet forbundet med ACE-hæmmere, især hos patienter med nyreinsufficiens eller kollagen vaskulær sygdom og patienter, som får immunsuppressiv behandling.
English: As recommended by the CHMP, the MAH has added an additional warning concerning the use of cilazapril in patients with high grade renal artery stenosis with renal impairment to the subsection entitled `Renal impairment' in section 4.4.
Danish: Som anbefalet af CHMP, har indehaveren af markedsføringstilladelsen tilføjet en yderligere advarsel med hensyn til brugen af cilazapril hos patienter med high-grade nyrearteriestenose, der har nedsat nyrefunktion, i underpunktet om "Nedsat nyrefunktion" i punkt 4.4.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
Danish: Der er rapporteret reversible stigninger i lithiumkoncentrationen i serum og toksicitet ved samtidig administration af lithium og ACE-hæmmere.
English: The warning concerning anaphylaxis in dialysis patients receiving ACE inhibitors is discussed under a separate subheading in Section 4.4, “Anaphylaxis”.
Danish: Advarslen om anafylaksi hos dialysepatienter, der får ACE-hæmmere, er medtaget i et separat underpunkt i punkt 4.4, "Anafylaksi".
English: Headache is a commonly reported adverse event, although the incidence of headache is greater in patients receiving placebo than in those receiving ACE inhibitors.
Danish: Hovedpine er en almindelig rapporteret bivirkning, selvom hyppigheden af hovedpine er større hos patienter, som får placebo end hos dem, som får ACE-hæmmere.
English: Low-density lipoproteins (LDL) apheresis: Patients receiving ACE inhibitors during LDL apheresis with dextran sulphate have experienced life-threatening anaphylaxis.
Danish: Aferese af lavdensitetslipoproteiner (LDL): Patienter, som får ACE-hæmmere under LDL-aferese med dextransulfat, har oplevet livstruende anafylakse.
English: Myocardial ischaemia, angina pectoris, tachycardia, palpitations Rare
Danish: Myokardieiskæmi, angina pectoris, takykardi, hjertebanken Sjælden
English: At-risk patients should start treatment with cilazapril under medical supervision, with a low initial dose and careful titration.
Danish: Patienter i risikogruppen bør påbegynde behandlingen med cilazapril under lægeligt opsyn ved en lav initial dosis og forsigtig titrering.
English: (Invented) name
Danish: SærNavn Navn
English: Specific dosing recommendation for renovascular hypertension has been covered by the dosing instructions for patients with impaired renal function in this section 4.2.
Danish: Den specifikke doseringsanbefaling for renovaskulær hypertension er medtaget i doseringsinstruktionerne for patienter med nedsat nyrefunktion i punkt 4.2.
English: Cilazapril belongs to the family of angiotensin converting enzyme (ACE) inhibitors.
Danish: Cilazapril tilhører gruppen af angiotensinkonverterende enzymhæmmere (ACE-hæmmere).
English: Angioedema due to ACE inhibitors can present as recurrent episodes of facial swelling, which resolves on withdrawal, or as acute oropharyngeal edema and airways obstruction, which requires emergency treatment, and may be life-threatening.
Danish: Angioødem forårsaget af ACE-hæmmere kan komme til udtryk som tilbagevendende episoder med ansigtshævelse, som fortager sig efter seponering, eller som akut orofaryngealt ødem og luftvejsobstruktion, som kræver akut behandling, og som kan være livstruende.
English: Hepatic impairment: In patients with liver cirrhosis increased plasma concentrations and reduced plasma and renal clearance were observed, with a greater effect on cilazapril than on its active metabolite cilazaprilat.
Danish: Nedsat leverfunktion: Hos patienter med levercirrose blev der observeret øget plasmakoncentration og nedsat plasmaclearence og renal clearance med en større effekt på cilazapril end dets aktive metabolit cilazaprilat.
English: If you are not sure, talk to your doctor or pharmacist before taking Vascace.
Danish: Hvis du er usikker, skal du tale med lægen eller apoteket, inden du tager Vascace.
English: Pacemaker therapy is indicated for therapy-resistant bradycardia.
Danish: Pacemakerbehandling er indiceret ved behandlingsresistent bradykardi.
English: Angiotensin converting enzyme inhibitors, as a class, have been shown to induce adverse effects on the late foetal development, resulting in foetal death and congenital effects, in particular affecting the skull.
Danish: Angiotensinkonverterende enzymhæmmere har som lægemiddelklasse vist sig at fremkalde uønskede effekter på den sene fosterudvikling, hvilket har medført fosterdød og medfødte effekter, især på kraniet.
English: 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 section 4.4).
Danish: Tricykliske antidepressiva/antipsykotika/anæstetika/narkotika Samtidig brug af visse anæstetika, tricykliske antidepressiva og antipsykotika med ACE-hæmmere kan medføre yderligere blodtryksfald (se pkt.
English: Chronic heart failure - The usual starting dose is 0.5 mg per day.
Danish: Kronisk hjerteinsufficiens - Den sædvanlige startdosis er 0,5 mg pr. dag.
English: ACE inhibitors have established renoprotective effects, but can cause reversible impairment of renal function in the setting of reduced renal perfusion, whether due to bilateral renal artery stenosis, severe congestive heart failure, volume depletion, hyponatraemia or high dosages of diuretics, and in those receiving treatment with NSAIDs.
Danish: ACE-hæmmere har bekræftet renoprotektiv virkning, men kan forårsage reversibel nedsættelse af nyrefunktionen ved nedsat nyreperfusion, uanset om det er forårsaget af bilateral renal arteriestenose, alvorlig kongestiv hjerteinsufficiens, volumenudtømning, hyponatriæmi eller høje doser diuretika, og hos patienter i behandling med NSAID'er.
English: In patients with chronic heart failure, the renin-angiotensin-aldosterone and sympathetic nervous systems are generally activated, leading to enhanced systemic vasoconstriction and promotion of sodium and water retention.
Danish: Hos patienter med kronisk hjerteinsufficiens er renin-angiotensin-aldosteron-systemet og det sympatiske nervesystem generelt aktiveret, hvilket medfører forstærket systemisk vasokonstriktion og øget natrium- og væskeretention.
English: Hyperkalaemia, hyponatraemia, proteinuria, nephrotic syndrome, nephritis Reproductive and breast disorders
Danish: Hyperkaliæmi, hyponatriæmi, proteinuri, nefrotisk syndrom, nephritis Det reproduktive system og mammae
English: The most frequent drug-attributable adverse events observed in patients taking ACE inhibitors are cough, skin rash and renal dysfunction.
Danish: De mest almindelige lægemiddelrelaterede bivirkninger, som er observeret hos patienter, som tager ACE-hæmmere, er hoste, udslæt og nyredysfunktion.
English: Potassium-sparing diuretics should be used with caution in patients receiving ACE inhibitors, and serum potassium and renal function should be monitored.
Danish: Kaliumbesparende diuretika bør bruges med forsigtighed hos patienter, som får ACE-hæmmere, og serumkalium og nyrefunktionen skal monitoreres.
English: As with other ACE inhibitors, the blood pressure-lowering effect of Vascace in black patients may be less pronounced than in non-blacks.
Danish: I lighed med andre ACE-hæmmere kan den blodtrykssænkende effekt af Vascace være mindre udtalt hos sorte patienter end hos andre patienter.
English: Epidemiological studies have suggested that concomitant administration of ACE inhibitors and antidiabetic medicines (insulins, oral hypoglycemic agents) may cause an increased blood-glucoselowering effect with risk of hypoglycemia.
Danish: Epidemiologiske forsøg tyder på, at samtidig adminstration af ACE-hæmmere og antidiabetika (insuliner, perorale hypoglykæmiske midler) kan medføre en øget blodglukosesænkende effekt med risiko for hypoglykæmi.
English: Potassium sparing diuretics (e.g. spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
Danish: Kaliumbesparende diuretika (for eksempel spironolacton, triamteren eller amilorid), kaliumtilskud eller salterstatninger med kalium kan medføre signifikante stigninger af serumkalium.
English: Concomitant use of ACE inhibitors and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Danish: Samtidig anvendelse af ACE-hæmmere og NSAIDer kan medføre en øget risiko for forværring af nyrefunktionen, inklusive mulig akut nyreinsufficiens og en øgning af serumkalium, især hos patienter med allerede eksisterende dårlig nyrefunktion.
English: Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, salt and/or volume depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood pressure following the initial dose.
Danish: Patienter med et stærkt aktiveret renin-angiotensin-aldosteronsystem (navnlig salt- og/eller volumendepletering, kardial dekompensation eller svær hypertension) kan opleve et for kraftigt fald i blodtrykket efter initialdosen.
English: Lupus-like syndrome (symptoms may include vasculitis, myalgia, arthralgia/arthritis, positive antinuclear antibodies, increased erythrocyte sedimentation rate, eosinophilia and leukocytosis) Nervous system disorders
Danish: Lupus-lignende syndrom (symptomerne kan omfatte vasculitis, myalgi, artralgi/artritis, positive antinukleære antistoffer, forhøjet blodsænkning (erythrocyte sedimentation rate), eosinofili og leukocytose)
English: This belongs to a group of medicines called ‘ACE inhibitors' (Angiotensin Converting Enzyme Inhibitors).
Danish: Det tilhører gruppen af medicin, som kaldes "ACE-hæmmere" (angiotensinkonverterende enzymhæmmere).
English: Rare (affects less than 1 in 1'000 people)
Danish: Sjælden (forekommer hos færre end 1 ud af 1.000 behandlede)
English: In these patients, treatment should be started under close medical supervision with low doses and careful dose titration.
Danish: Hos disse patienter bør behandlingen indledes under nøje lægeligt opsyn med lave doser og omhyggelig dosistitrering.
English: Should exposure to ACE inhibitors have occurred from the second trimester of pregnancy, ultrasound examination of renal function and skull is recommended.
Danish: Hvis der har været eksponering for ACE-hæmmere fra det andet trimester af graviditeten, anbefales en ultralydsundersøgelse af nyrefunktionen og kraniet.
English: In patients with renal impairment, the dosage of cilazapril should be adjusted according to creatinine clearance (see section 4.2).
Danish: Hos patienter med nedsat nyrefunktion bør doseringen af cilazapril justeres i henhold til kreatininclearance (se pkt.
English: Reduced doses are required for patients with renal impairment depending on their creatinine clearance.
Danish: Nedsatte doser er nødvendige til patienter med nedsat nyrefunktion, afhængigt af deres kreatininclearance.
English: Section 4.3 - Contra-indications
Danish: Punkt 4.3 - Kontraindikationer
English: Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Danish: Prækliniske data viser ingen særlig risiko for mennesker baseret på konventionelle studier af almen farmakologi, toksicitet ved gentagen dosis, genotoksicitet og karcinogent potentiale.
English: “Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Danish: "Prækliniske data viser ingen særlig risiko for mennesker baseret på konventionelle undersøgelser af generel farmakologi, toksicitet ved gentagen dosering, genotoksicitet og karcinogenicitet.
English: This can be avoided by temporarily withholding ACE inhibitor therapy prior to each apheresis.
Danish: Dette kan undgås ved at afbryde behandlingen med ACE-hæmmer midlertidigt inden hver aferese.
English: In such patients a lower starting dose (0.5mg) is recommended and the initiation of treatment should take place under medical supervision.
Danish: Til disse patienter anbefales en lavere startdosis (0,5 mg), og behandlingen bør indledes under lægeligt opsyn.
English: Surgery/anaesthesia
Danish: Operation/anæstesi
English: Psoriaform dermatitis, psoriasis (exacerbation), lichen planus, exfoliative dermatitis, urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous pemphigoid, pemphigus, Karposi's sarcoma, vasculitis/purpura, photosensitivity reactions, alopecia, onycholysis Musculoskeletal and connective tissue disorders Uncommon
Danish: Psoriaform dermatitis, psoriasis (forværret), lichen planus, eksfoliativ dermatitis, nældefeber, erythema multiforme, Stevens-Johnson-syndrom, toksisk epidermal nekrolyse, bulløs pemphigoid, pemfigus, Karposis sarkom, vasculitis/purpura, lysfølsomhedsreaktioner, alopeci, onykolyse Knogler, led, muskler og bindevæv
English: Member State EU Marketing Authorisation Holder
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Alle hjælpestoffer er anført under pkt.
English: The following effects may happen: feeling dizzy or light-headed, shallow breathing, cold clammy skin, being unable to move or speak and a slow heart beat.
Danish: Tag pakningen med. Følgende kan forekomme: Svimmelhed eller følelse af ørhed, overfladisk vejrtrækning, kold og klam hud, at være ude af stand til at bevæge sig eller tale og langsom hjerterytme
English: When driving and operating machines, it should be taken into account that occasionally dizziness and fatigue may occur, especially when starting therapy (see sections 4.4 and 4.8).
Danish: I forbindelse med bilkørsel og betjening af maskiner skal der tages højde for, at der lejlighedsvis kan forekomme svimmelhed og træthed, især ved starten af behandlingen (se pkt.
English: Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Medmindre fortsat behandling med ACE-hæmmere anses for nødvendig, skal patienter, som planlægger graviditet, skiftes over til andre antihypertensive behandlinger, som har en fastslået sikkerhedsprofil for brug ved graviditet.
English: The MAH's response refers to the results achieved by other ACE inhibitors stating the beneficial therapeutic effect for patients with chronic heart failure.
Danish: I svaret fra indehaveren af markedsføringstilladelsen henvises der til de resultater, der er opnået med andre ACE-hæmmere, og det anføres, at de har haft en gavnlig terapeutisk virkning hos patienter med kronisk hjerteinsufficiens.
English: Administration of ACE inhibitors to patients with diabetes may potentiate the blood glucose-lowering effect of oral hypoglycaemic agents or insulin, especially in patients with renal impairment.
Danish: Administration af ACE-hæmmere til patienter med diabetes kan forstærke den blodglucosesænkende effekt af perorale hypoglykæmiske stoffer eller insulin, især hos patienter med nedsat nyrefunktion.
English: Cerebral ischaemia, transient ischaemic attack, ischaemic stroke Peripheral neuropathy
Danish: Cerebral iskæmi, transitorisk iskæmisk attak, iskæmisk slagtilfælde Perifer neuropati
English: Take special care with Vascace
Danish: Vær ekstra forsigtig med at tage Vascace
English: The recommended starting dose in these patients is 0.5 mg once daily.”
Danish: Den anbefalede startdosis til disse patienter er 0,5 mg én gang dagligt."
English: indometacin and ibuprofen.
Danish: Disse omfatter aspirin, indometacin og ibuprofen.
English: The following list of adverse reactions is derived from clinical trials and post-marketing data in association with cilazapril and/or other ACE inhibitors.
Danish: Følgende liste over bivirkninger stammer fra kliniske forsøg og post marketing-data i forbindelse med cilazapril og/eller andre ACE-hæmmere.
English: “No clinical trials have been carried out which prove the effect of cilazapril on morbidity and mortality in heart failure.”
Danish: "Der er ikke foretaget nogen kliniske undersøgelser, som viser cilazaprils virkning på morbiditet og mortalitet ved hjerteinsufficiens."
English: Hypertension: The initial dose is 1 mg/day.
Danish: Hypertension: Den initiale dosis er 1 mg/dag.
English: The harmonised list of undesirable effects was derived from clinical trials and post-marketing data in association with cilazapril and/or other ACE inhibitors.
Danish: Den harmoniserede liste over bivirkninger stammede fra kliniske undersøgelser og data efter markedsføringen i forbindelse med cilazapril og/eller andre ACE-hæmmere.
English: Anaesthetic agents with blood pressure lowering effects can cause hypotension in patients receiving ACE inhibitors.
Danish: Anæstetika med blodtrykssænkende effekt kan medføre hypotension hos patienter, som får ACEhæmmere.
English: These developmental anomalies are thought to be partly due to a direct action of ACE inhibitors on the foetal renin-angiotensin system and partly due to ischaemia resulting from maternal hypotension and decreases in foetal-placental blood flow and oxygen/nutrients delivery to the foetus.
Danish: Disse udviklingsabnormiteter menes delvist at skyldes en direkte virkning af ACE-hæmmere på fostrets renin-angiotensin-system og delvist iskæmi som følge af maternel hypotension og fald i den føtale-placentale blodgennemstrømning og forsyningen af ilt/næringsstoffer til fostret.
English: Very common ≥ 1/10
Danish: Der er følgende hyppighedskategorier: Meget almindelig ≥ 1/10 Almindelig
English: Abnormal liver function test (including transaminases, bilirubin, alkaline phosphatase, gamma GT) Cholestatic hepatitis with or without necrosis
Danish: Unormal leverfunktionstest (herunder transaminaser, bilirubin, basisk fosfatase, gamma-GT) Kolestatisk hepatitis med eller uden nekrose
English: Common (affects less than 1 in 10 people)
Danish: Almindelig (forekommer hos færre end 1 ud af 10 behandlede)
English: Therefore, there is no recommendation for administration of cilazapril to children.”
Danish: Derfor anbefales det ikke at give cilazapril til børn."
English: ACE inhibitors block the action of angiotensin converting enzyme and by doing so, the production of Angiotensin II which is a potent vasoconstrictor peptide will also be decreased.
Danish: ACE-hæmmere hæmmer virkningen af angiotensinkonverterende enzym, hvilket også nedsætter produktionen af angiotensin II, som er et kraftigt vasokonstriktorpeptid.
English: Renal impairment: In patients with renal impairment, higher plasma concentrations of cilazaprilat are observed than in patients with normal renal function, since drug clearance is reduced when creatinine clearance is lower.
Danish: Nedsat nyrefunktion: Hos patienter med nedsat nyrefunktion observeres der højere plasmakoncentrationer af cilazaprilat end hos patienter med normal nyrefunktion, da lægemiddelclearance er nedsat ved lavere kreatininclearance.
English: These developmental anomalies are thought to be partly due to a direct action of ACE inhibitors on the foetal renin-angiotensin system and partly due to ischaemia resulting from maternal hypotension and decreases in foetal-placental blood flow and oxygen/nutrients delivery to the foetus.”
Danish: Det menes, at disse udviklingsmisdannelser skyldes dels ACE-hæmmernes direkte virkning på det føtale renin-angiotensinsystem og dels iskæmi som følge af moderens hypotension samt en reduktion af den føtale-placentale blodgennemstrømning og tilførslen af ilt og næringsstoffer til fosteret."
English: A lower starting dose of 0.5 mg once daily is recommended in such patients and the initiation of treatment should take place under medical supervision.
Danish: En lavere startdosis på 0,5 mg én gang dagligt anbefales til disse patienter, og behandlingen skal igangsættes under lægeligt opsyn.
English: “Hypertension: The initial dose is 1 mg/day.
Danish: "Hypertension: Initialdosen er 1 mg/dag.
English: Exposure to ACE inhibitor therapy 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).
Danish: Eksponering for ACE-hæmmere under andet og tredje trimester medfører kendt human føtotoksicitet (nedsat nyrefunktion, oligohydramnion, forsinket forbening af kraniet) og neonatal toksicitet (nyreinsufficiens, hypotension, hyperkaliæmi).
English: - Any medicines used to treat high blood pressure.
Danish: - Medicin mod forhøjet blodtryk.
English: For cirrhotic patients with ascites however, cilazapril is not recommended.
Danish: Hos patienter med ascites anbefales cilazapril ikke.
English: - if you are on a diet to control how much salt (sodium) you take in. - if you are planning to have treatment to reduce your allergy to bee or wasp stings
Danish: - hvis du planlægger at få behandling for at mindske din allergi over for bi- eller hvepsestik
English: The recommended starting dose in these patients is 0.5 mg once daily.
Danish: Den anbefalede startdosis hos disse patienter er 0,5 mg én gang dagligt.
English: Vascace is indicated for the treatment of hypertension.
Danish: Vascace er indiceret til behandling af hypertension.
English: Potassium sparing diuretics, potassium supplements or potassium-containing salt substitutes Although serum potassium usually remains within normal limits, hyperkalaemia may occur in some patients treated with cilazapril.
Danish: Kaliumbesparende diuretika, kaliumtilskud eller salterstatninger med kalium Hyperkaliæmi kan forekomme hos nogle patienter, som behandles med cilazapril, selvom serumkalium normalt forbliver inden for normale værdier.
English: If indicated, cilazaprilat, the active form of cilazapril, may be removed from the general circulation by haemodialysis (see section 4.4).”
Danish: Hvis det er indiceret, kan cilazaprilat, som er den aktive form af cilazapril, fjernes fra det systemiske kredsløb ved hjælp af hæmodialyse (se punkt 4.4)."
English: “Vascace is indicated for the treatment of hypertension.”
Danish: "Vascace er indiceret til behandling af hypertension."