FrancophonIA/ELRC3.0 huggingface dataset:
English: The main combination effects were the attenuation of thiazide induced potassium loss and decreased motoric activity at high doses in monkeys.
Danish: Den primære effekt af kombinationen var lavere thiazid-induceret kaliumtab og formindsket motorisk aktivitet ved høje doser hos aber.
English: Vascace Plus is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Vascace Plus anbefales ikke tidligt i graviditeten og må ikke tages, hvis du er mere end 3 måneder henne, da det kan forårsage alvorlig skade på barnet, hvis det bruges efter 3. måned af graviditeten.
English: Cholestyramine/colestipol Cholestyramine and colestipol reduce the absorption of hydrochlorothiazide.
Danish: Colestyramin/colestipol Colestyramin og colestipol nedsætter absorptionen af hydrochlorthiazid.
English: Angioedema has been associated with ACE inhibitors, with a reported incidence of 0.1-0.5%.
Danish: Angioødem har været rapporteret ved behandling med ACE-hæmmere med en incidens på 0,1-0,5 %.
English: Medicinal products that could induce torsades de pointes Due to the risk of hypokalemia hydrochlorothiazide should be administered with caution when a patient is simultaneously being treated with medicinal products that could induce torsades de pointes such as:
Danish: Lægemidler som kan inducere torsades de pointes På grund af risikoen for hypokaliæmi skal hydrochlorthiazid administreres med forsigtighed, når en patient samtidig er i behandling med lægemidler, som kan inducere torsades de pointes såsom:
English: - Steroid medicines (such as hydrocortisone, prednisolone and dexamethasone) or other medication which suppress the immune system.
Danish: - Steroider (såsom hydrocortison, prednisolon og dexamethason) eller andre lægemidler, som undertrykker immunsystemet.
English: For cilazaprilat, the volume of distribution has been determined to be approximately 0.5 to 0.7 l/kg.
Danish: Fordeling Distributionsvolumen for cilazaprilat er blevet bestemt til ca. 0,5-0,7 l/kg.
English: These changes were demonstrated to be reversible and are a consequence of exaggerated pharmacodynamic activity of cilazapril occurring only at high multiples of the therapeutic human doses.
Danish: Disse ændringer er reversible og er konsekvensen af voldsom farmakodynamisk aktivitet af cilazapril, som kun forekommer ved doser, som er mange gange højere end de terapeutiske doser hos mennesker.
English: The antihypertensive effects of cilazapril and hydrochlorothiazide in the combination are additive resulting in a higher percentage of hypertensive patients responding satisfactorily as well as in a greater blood pressure reduction than to either component administered alone.
Danish: Den antihypertensive effekt af cilazapril og hydrochlorthiazid i kombinationen er additiv og resulterer i en højere procentdel af hypertensive patienter, som responderer tilfredsstillende, samt en større reduktion af blodtrykket, end hvis de aktive stoffer bliver administreret alene.
English: In patients with liver cirrhosis increased plasma concentrations and reduced plasma and renal clearance were observed.
Danish: Hos patienter med levercirrose blev der observeret øget plasmakoncentration og nedsat plasmaclearance og renal clearance.
English: You must tell your doctor if you think you are (or might become) pregnant.
Danish: Du skal fortælle din læge, hvis du tror, at du er (eller kan blive) gravid.
English: Cilazapril is efficiently absorbed after oral administration of Vascace Plus and rapidly converted by ester cleavage to the active form, cilazaprilat.
Danish: Cilazapril absorberes effektivt efter oral administration af Vascace Plus og omdannes hurtigt ved esterspaltning til den aktive form, cilazaprilat.
English: Diuretics (thiazide or loop diuretics)
Danish: Diuretika (thiazid eller loop-diuretikum)
English: Elimination Cilazaprilat is eliminated unchanged by the kidneys, with an effective half-life of about 9 hours.
Danish: Elimination Cilazaprilat udskilles uomdannet via nyrerne med en effektiv halveringstid på omkring 9 timer.
English: However, in patients with impaired renal function and/or in patients taking potassium supplements (including salt substitutes), hyperkalemia can occur.
Danish: Hos patienter med nedsat nyrefunktion og/eller patienter, som tager kaliumtilskud (herunder salterstatninger), kan der dog forekomme hyperkaliæmi.
English: Blood problems reported with ACE inhibitors and thiazide-type diuretics include: - Low numbers of red blood cells (anaemia).
Danish: Bivirkninger i blodet i forbindelse med brug af ACE-hæmmere og thiazid-diuretika omfatter: - Lavt antal røde blodlegemer (anæmi).
English: Vascace Plus is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see the sections on ‘Pregnancy' and ‘Breastfeeding').
Danish: Vascace Plus anbefales ikke tidligt i graviditeten og må ikke tages, hvis du er mere end 3 måneder henne i graviditeten, da det kan forårsage alvorlig skade på barnet, hvis det bruges på dette tidspunkt (se afsnittene om "Graviditet" og "Amning").
English: The risk of angioedema appears to be greater in black-skinned than non black-skinned patients.
Danish: Risikoen for angioødem synes at være større hos sorte patienter end hos ikke-sorte.
English: Non-depolarizing muscle relaxants
Danish: Ikke-polariserende muskelrelaksantia
English: The dose of Vascace Plus is one tablet (5.0 mg cilazapril and 12.5 mg hydrochlorothiazide) administered once daily.
Danish: Dosis af Vascace Plus er én tablet (5,0 mg cilazapril og 12,5 mg hydrochlorthiazid) én gang dagligt.
English: Administration of cilazapril and hydrochlorothiazide in the presence of food delays cilazaprilat Tmax by 1.5 hours and reduces Cmax by 24%.
Danish: Administration af cilazapril og hydrochlorthiazid samtidig med føde forsinker cilazaprilats Tmax med 1,5 timer og reducerer Cmax med 24 %.
English: In clinical studies, the efficacy and tolerability of cilazapril and hydrochlorothiazide administered concomitantly was similar in both elderly and younger hypertensive patients, although pharmacokinetic data show that clearance of both components in elderly patients was reduced (see section 5.2).
Danish: Kliniske studier viste, at virkning og tolerabilitet af cilazapril og hydrochlorthiazid ved samtidig administration var ens hos ældre og yngre patienter med hypertension, selvom farmakokinetiske data viser, at clearance af begge komponenter var reduceret hos ældre patienter (se pkt.
English: Should exposure to ACE inhibitor 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-hæmmer fra det andet trimester af graviditeten, anbefales ultralydsundersøgelse af nyrefunktionen og kraniet.
English: At-risk patients should start treatment with cilazapril under medical supervision, with a low initial dose and careful titration.
Danish: Patienter i risikogruppe bør påbegynde behandling med cilazapril under lægeligt opsyn og med en lav initialdosis og forsigtig dosistitrering.
English: In patients with renal artery stenosis, activation of the renin-angiotensin-aldosterone system helps to maintain renal perfusion by causing constriction of the efferent arteriole.
Danish: Hos patienter med nyrearteriestenose hjælper aktivering af renin-angiotensin-aldosteron-systemet til at opretholde renal perfusion ved at fremkalde konstriktion af den efferente arteriole.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines: - Any medicines used to treat high blood pressure.
Danish: Du skal i særdeleshed fortælle det til din læge eller på apoteket, hvis du tager følgende medicin: - Anden medicin mod forhøjet blodtryk.
English: ACE inhibitors should not be initiated during pregnancy.
Danish: Behandling med ACE-hæmmer bør ikke påbegyndes under graviditet.
English: Use of cilazapril with lithium is not recommended, but if the combination proves necessary, careful monitoring of serum lithium levels should be performed.
Danish: Anvendelse af cilazapril sammen med lithium anbefales ikke, og hvis kombinationen anses for nødvendig, skal lithiumkoncentrationen monitoreres omhyggeligt.
English: Hydrochlorothiazide is eliminated largely unchanged by the kidney, with a half-life of 7 to 11 hours.
Danish: Hydrochlorthiazid udskilles i stor udstrækning uomdannet via nyrerne med en halveringstid på 7-11 timer.
English: Hence, blockade of angiotensin II formation, and possibly also an increase in the formation of bradykinin, causes efferent arteriolar vasodilation resulting in a reduction in glomerular filtration pressure.
Danish: Blokering af dannelsen af angiotensin II og muligvis også en øget produktion af bradykinin fremkalder efferent arteriolær vasodilatation, hvilket medfører et fald i det glomerulære filtrationstryk.
English: It increases the urinary excretion of sodium and chloride and, to a lesser degree, the excretion of potassium and magnesium, thus increasing diuresis and exerting an anti-hypertensive effect.
Danish: Det øger udskillelsen af natrium og chlorid i urinen og i mindre grad udskillelsen af kalium og magnesium og øger derved diuresen og udøver en antihypertensiv effekt.
English: Vascace Plus and associated names (see Annex I) 5 mg/12.5 mg film-coated tablets [See Annex I - To be completed nationally]
Danish: Vascace Plus og relaterede navne (Se bilag I) 5 mg/12,5 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt]
English: In patients not responding to 5 mg cilazapril given as monotherapy, the addition of hydrochlorothiazide at a low dose of 12.5 mg once daily substantially improves the response to treatment.
Danish: Hos patienter, som ikke responderer på 5 mg cilazapril administreret som monoterapi, bliver behandlingsresponset forbedret betydeligt ved tillæg af hydrochlorthiazid i en lav dosis på 12,5 mg én gang daglig.
English: Studies performed with Vascace Plus have demonstrated that the combination of cilazapril and hydrochlorothiazide administered once daily at various doses reduces systolic and diastolic blood pressure compared to placebo 24 hours after dosing, to an extent that is both statistically significant and clinically meaningful.
Danish: Studier udført med Vascace Plus har vist, at sammenlignet med placebo reducerer kombinationen af cilazapril og hydrochlorthiazid administreret én gang daglig i forskellige doser det systoliske og diastoliske blodtryk 24 timer efter dosering i et omfang, som både er statistisk signifikant og klinisk relevant.
English: Similar caution should be taken for patients with angina pectoris or cerebrovascular disease, in whom hypotension can cause myocardial or cerebral ischaemia.
Danish: Der skal udvises lignende forsigtighed hos patienter med angina pectoris eller cerebrovaskulær sygdom, da hypotension kan medføre myokardieiskæmi eller cerebral iskæmi hos disse patienter.
English: When driving and operating machines, it should be taken into account that occasionally dizziness and fatigue may occur during treatment with Vascace Plus (see sections 4.4 and 4.8).
Danish: I forbindelse med bilkørsel og betjening af maskiner skal der tages højde for, at der kan forekomme lejlighedsvis svimmelhed og træthed under behandlingen med Vascace Plus (se pkt.
English: The findings included increased plasma urea and creatinine values, and thickening of the glomerular arterioles, occasionally in association with hyperplasia of the juxtaglomerular cells.
Danish: Disse fund inkluderer øget plasma-carbamid og plasma-kreatinin og fortykkelse af de glomerulære arterioler, sommetider forbundet med hyperplasi i de juxtaglomerulære celler.
English: Tell your doctor if you are breastfeeding or about to start breastfeeding.
Danish: Fortæl din læge, hvis du ammer eller skal til at påbegynde amning.
English: The use of ACE inhibitors such as cilazapril is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: Brug af ACE-hæmmere såsom cilazapril anbefales ikke under det første trimester af graviditeten (se pkt.
English: 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 cilazapril.
Danish: Den hypotensive effekt kan reduceres ved seponering af det pågældende diuretikum, ved at øge volumen eller saltindtaget eller ved at påbegynde behandlingen med en lav cilazaprildosis.
English: Adverse reactions that were not observed during Vascace Plus clinical trials but have been reported in association with monotherapy with either component or with other ACE inhibitors or thiazide diuretics, or derived from post-marketing case reports, are classified as `uncommon' (<1/100).
Danish: Bivirkninger, som ikke blev observeret i kliniske forsøg med Vascace Plus, men som er rapporteret i forbindelse med monoterapi med de aktive stoffer eller med andre ACE-hæmmere eller thiazid-diuretika, eller som stammer fra post marketing-rapporter, er klassificeret som ”ikke almindelige” (< 1/100).
English: The bioavailability of cilazaprilat from oral cilazapril approximates 60% based on urinary recovery data.
Danish: Biotilgængeligheden af cilazaprilat fra oral cilazapril er ca. 60 % baseret på urindata.
English: The signs may include: - Sudden swelling of the face, throat, lips or mouth.
Danish: Symptomerne kan omfatte: - Pludselig hævelse af ansigtet, halsen, læberne eller munden.
English: In case of dehydration induced by hydrochlorothiazide, there is an increased risk of acute renal impairment, in particular when larger doses of iodine containing contrast media are administered.
Danish: I tilfælde af dehydrering induceret af hydrochlorthiazid er der en øget risiko for akut forringelse af nyrefunktionen, især hvis der administreres store doser iodholdigt kontrastmiddel.
English: If renal failure occurs, treatment should be discontinued.
Danish: Hvis der opstår nyreinsufficiens, skal behandlingen seponeres.
English: Non-steroidal anti-inflammatory medicinal products (NSAIDs) including aspirin  3 g/day When ACE inhibitors are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Danish: Non-steroide antiinflammatoriske lægemidler (NSAID'er) herunder acetylsalicylsyre ≥ 3 g/døgn Når ACE-hæmmere administreres samtidig med ikke-steroide anitinflammatoriske lægemidler (for eksempel acetylsalicylsyre i antiinflammatoriske doseringsregimer, COX-2 hæmmere og ikkeselektive NSAIDer) kan den antihypertensive virkning nedsættes.
English: Hydrochlorothiazide is a thiazide diuretic which acts as fluid-expelling and blood pressure-lowering agent by inhibition of substances which increase the tubular re-absorption of sodium in the cortical diluting segment.
Danish: Hydrochlorthiazid er et thiazid-diuretikum, som virker vanddrivende og blodtrykssænkende ved at hæmme de stoffer, som øger den tubulære reabsorption af natrium i det kortikale fortyndende segment.
English: It works by making your blood vessels relax and widen.
Danish: Medicinen virker ved at afslappe og udvide dine blodkar.
English: Patients who develop jaundice or marked elevations of hepatic enzymes should discontinue Vascace Plus and receive appropriate medical follow-up.
Danish: Patienter, som udvikler gulsot eller markant forhøjede leverenzymer, skal stoppe behandlingen med Vascace Plus og have passende medicinsk opfølgning.
English: The signs include increased number of infections, for example in your mouth, gums, throat and lungs.
Danish: Symptomerne omfatter hyppigere infektioner, f.eks. i munden, tandkødet, halsen og lungerne.
English: Hypotension contributes further to a reduction in renal perfusion (see section 4.4 `Hypotension').
Danish: Hypotension bidrager yderligere til et fald i den renale perfusion (se pkt.
English: - if you are on kidney dialysis.
Danish: - hvis du er i dialyse.
English: Renal hydrochlorothiazide clearance is proportionally related to creatinine clearance.
Danish: Renal clearance af hydrochlorthiazid er proportional med kreatininclearance.
English: Your doctor will normally advise you to stop taking Vascace Plus before you become pregnant, or as soon as you know you are pregnant, and will advise you to take another medicine instead of Vascace Plus.
Danish: Lægen vil normalt råde dig til at stoppe med at tage Vascace Plus, før du bliver gravid, eller så snart du ved, at du er blevet gravid.
English: ACE inhibitors can cause hyperkalemia due to suppression of aldosterone.
Danish: ACE-hæmmere kan forårsage hyperkaliæmi på grund af suppression af aldosteron.
English: Concomitant use of thiazide diuretics may increase the risk of lithium toxicity and enhance the already increased risk of lithium toxicity with ACE inhibitors.
Danish: Samtidig anvendelse af thiazid-diuretika kan øge risikoen for lithiumtoksicitet og forstærke den allerede øgede risiko for lithiumtoksicitet ved ACEhæmmere.
English: In patients with liver cirrhosis (but without ascites) who require therapy for hypertension, cilazapril should be initiated at a low dose and with great caution because significant hypotension may occur (see section 4.2).
Danish: Hos patienter med levercirrose (men uden ascites), som har behov for antihypertensiv behandling, skal behandling med cilazapril påbegyndes ved en lav dosis og med stor forsigtighed, da der kan forekomme signifikant hypotension (se pkt.
English: - if you undergo LDL apheresis with dextrane sulphate.
Danish: - hvis du får LDL-aferese med dextransulfat.
English: The use of thiazides in patients with cirrhosis may precipitate hepatic encephalopathy resulting from minor changes in fluid and electrolyte balance.
Danish: Anvendelse af thiazider til patienter med cirrose kan forårsage hepatisk encefalopati på grund af mindre ændringer i væske- og elektrolytbalancen.
English: If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Vascace Plus.
Danish: Hvis et eller flere af ovenstående punkter gælder for dig, eller hvis du er i tvivl, skal du spørge lægen eller på apoteket, inden du tager Vascace Plus.
English: Important information about some of the ingredients of Vascace Plus Vascace Plus contains lactose, which is a type of sugar.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Vascace Plus Vascace Plus indeholder lactose.
English: Therefore, Vascace Plus is not recommended for patients with severe renal impairment (see section 4.3).
Danish: Vascace Plus anbefales derfor ikke til patienter med alvorligt nedsat nyrefunktion (se pkt.
English: Glucose levels should be carefully monitored during initiation of treatment with each component of Vascace Plus.
Danish: Glucosekoncentrationen skal monitoreres omhyggeligt under igangsættelse af behandling med hvert aktivt stof i Vascace Plus.
English: Concomitant use of anticholinergics (e.g. atropine, biperiden) may increase the bioavailability of hydrochlorothiazide due to reduced gastrointestinal mobility and decreased gastric emptying.
Danish: Samtidig anvendelse af antikolinerge lægemidler (f.eks. atropin, biperiden) kan øge biotilgængeligheden af hydrochlorthiazid pga. nedsat gastrointestinal mobilitet og nedsat gastrisk tømningshastighed.
English: Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see sections 4.3 and 4.4).
Danish: Spædbørn, hvis mødre har taget ACE-hæmmer, skal monitoreres omhyggeligt for hypotension (se pkt.
English: Hypotension should be treated by placing the patient supine and volume expansion.
Danish: Hypotension skal behandles ved at anbringe patienten i rygleje og ved iværksættelse af volumenekspansion.
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with cilazapril (see section 4.4).
Danish: Tidligere behandling med høje doser diuretika kan medføre volumendepletion og risiko for hypotension ved påbegyndelse af behandling med cilazapril (se pkt.
English: Simultaneous administration of hydrochlorothiazide together with vitamin D or with calcium salts may potentiate the rise in serum calcium.
Danish: Samtidig administration af hydrochlorthiazid og D-vitamin eller calciumsalte kan forøge stigningen i serumcalcium.
English: - Cytotoxic drugs (e.g. methotrexate, cyclophosphamide).
Danish: - Cytotoksiske lægemidler (f.eks. methotrexat, cyclophosphamid).
English: This results in elevated plasma concentrations of hydrochlorothiazide, which decrease more slowly than in subjects with normal renal function.
Danish: Dette resulterer i forhøjede plasmakoncentrationer af hydrochlorthiazid, som aftager langsommere end hos patienter med normal nyrefunktion.
English: The combination of cilazapril and hydrochlorothiazide caused no relevant signs of a mutagenic potential for the case of therapeutic treatment.
Danish: Kombinationen af cilazapril og hydrochlorthiazid forårsagede ingen relevante tegn på mutagent potentiale ved terapeutisk behandling.
English: The following list of adverse reactions is derived from clinical trials and post-marketing data, and includes adverse drug reactions seen in patients receiving treatment with cilazapril and/or other ACE inhibitors alone, hydrochlorothiazide and/or other thiazide-type diuretics alone, and in those receiving combined therapy.
Danish: Nedenstående liste over bivirkninger stammer fra kliniske forsøg og post marketing-data og inkluderer bivirkninger set hos patienter, som er blevet behandlet med cilazapril og/eller andre ACE-hæmmere alene, hydrochlorthiazid og/eller andre thiazid-diuretika alene og hos patienter, som har fået kombinationsbehandling.
English: The use of this agent increases plasma renin activity and aldosterone secretion resulting in a decrease in serum potassium.
Danish: Behandling med dette lægemiddel øger reninaktiviteten i plasma og aldosteronsekretionen, hvilket resulterer i et fald i serumkalium.
English: Treatment-related adverse events resulting in treatment withdrawal occur in around 0.1% of patients receiving thiazide monotherapy.
Danish: Behandlingsrelaterede bivirkninger, der resulterer i seponering af behandlingen, forekommer hos omkring 0,1 % af de patienter, som får thiazid-monoterapi.
English: You may feel dizzy while taking Vascace Plus.
Danish: Du kan blive svimmel, mens du tager Vascace Plus.
English: • Some antipsychotics (e.g. thioridazine, chlorpromazine, trifluoperazine, sulpiride, tiapride,
Danish: • Visse antipsykotika (f.eks. thioridazin, chlorpromazin, trifluoperazin, sulpirid, tiaprid,
English: Some biochemical and metabolic abnormalities associated with thiazide diuretics appear to be attenuated by the co-administration of cilazapril.
Danish: Nogle biokemiske og metaboliske abnormiteter forbundet med thiaziddiuretika synes at blive svækket ved samtidig administration med cilazapril.
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 administration af ACE-hæmmere og antidiabetika (insuliner, orale hypoglykæmiske midler) kan medføre en øget blodglucosesænkende effekt med risiko for hypoglykæmi.
English: The events of cerebral ischaemia, transient ischaemic attack and ischaemic stroke reported rarely in association with ACE inhibitors may be related to hypotension in patients with underlying cerebrovascular disease.
Danish: Cerebral iskæmi, transitorisk iskæmisk attak og iskæmisk apopleksi, som i sjældne tilfælde er rapporteret i forbindelse med ACE-hæmmere, kan være relateret til hypotension hos patienter med underliggende cerebrovaskulær sygdom.
English: Hypersensitivity (angioedema, anaphylaxis), lupus-like syndrome Metabolism and nutrition disorders
Danish: Overfølsomhed (angioødem, anafylaksi), lupus-lignende syndrom Metabolisme og ernæring