FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to take Vascace - If you forget to take a dose, skip the missed dose.
Danish: Hvis du har glemt at tage Vascace - Hvis du glemmer at tage en dosis, skal du springe den glemte dosis over.
English: No rapid increase in blood pressure has been observed after abrupt withdrawal of Vascace.
Danish: Der er ikke observeret nogen hurtig blodtryksstigning efter pludselig seponering af Vascace.
English: Roche S.p.A Via G.B Stucchi 110 20052/Monza Italy
Danish: Roche S.p.A Via G.B Stucchi 110 20052/Monza Italien
English: - the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: - produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen havde foreslået, blev vurderet på baggrund af den fremsendte dokumentation og den faglige drøftelse i udvalget,
English: As food intake has no clinically significant influence on absorption, Vascace can be administered before or after a meal.
Danish: Da indtagelse af føde ikke har nogen klinisk signifikant indvirkning på absorptionen, kan Vascace indtages før eller efter et måltid.
English: If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered.
Danish: Hvis det er tilgængeligt, kan behandling med angiotensin II-infusion og/eller intravenøse katekolaminer også overvejes.
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Vascase and associated names (see Annex I).
Danish: har CHMP anbefalet ændringen af de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Vascace og tilknyttede navne (se bilag I).
English: Additional ADRs listed in local SPCs but not in the CDS have been included if appropriate references could be identified.
Danish: Yderligere bvirkninger, som er nævnt i lokale produktresuméer, men ikke i CDS, blev medtaget, hvis der var tilstrækkelige referencer.
English: - Sympathomimetics.
Danish: - Sympatomimetika.
English: Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.
Danish: Vitale tegn, serumelektrolytter og kreatininkoncentrationer skal monitoreres løbende.
English: If possible, diuretic therapy should be discontinued temporarily.
Danish: Hvis det er muligt, bør diuretisk behandling afbrydes midlertidigt.
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 data fra urin.
English: - Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets
Danish: - Blodprøver viser et fald i antallet af røde blodlegemer, hvide blodlegemer eller blodplader
English: Cilazaprilat is eliminated unchanged by the kidneys, with an effective half-life of 9 hours after once daily dosing with Vascace.
Danish: Cilazaprilat udskilles uændret af nyrerne med en effektiv halveringstid på 9 timer efter dosering én gang dagligt med Vascace.
English: EXPIRY DATE [To be completed nationally] EXP {MM YYYY}
Danish: UDLØBSDATO [Udfyldes nationalt] EXP {MM YYYY}
English: These conditions can co-exist, particularly in severe heart failure.
Danish: Disse tilstande kan forekomme samtidig, især ved alvorlig hjerteinsufficiens.
English: Section 4.4 - Special warnings and precautions for use With a few exceptions, the scientific basis for the proposed text in Section 4.4 is provided by reviews of adverse effects of ACE inhibitors found in the following texts: Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions 2006 and the Martindale: The Complete Drug Reference 36.
Danish: Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen Med nogle få undtagelser bygger det videnskabelige grundlag for den foreslåede tekst i punkt 4.4 på gennemgangen af utilsigtede hændelser i forbindelse med ACE-hæmmere, der er nævnt i følgende tekster: Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions 2006 and the Martindale: The Complete Drug Reference 36.
English: Roche Pharma AG Emil-Barell-Strasse 1 79639/Grenzach Germany
Danish: Roche Pharma AG Emil-Barell-Strasse 1 79639/Grenzach Tyskland
English: - if you have a collagen vascular disease.
Danish: - hvis du har kollagen vaskulær sygdom.
English: The antihypertensive effect of Vascace is maintained during long-term therapy.
Danish: Den antihypertensive virkning af Vascace opretholdes under langtidsbehandling.
English: Roche Farma S.A. Eucalipto n° 33 28016 / Madrid Spain
Danish: Roche Farma S.A. Eucalipto n° 33 28016 / Madrid Spanien
English: Important information about some of the ingredients of Vascace Vascace contains lactose, which is a type of sugar.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Vascace Vascace indeholder lactose, som er en type sukker.
English: An additive effect may be observed when cilazapril is administered in combination with other antihypertensive agents.
Danish: Der kan observeres en additiv effekt, når cilazapril administreres i kombination med andre antihypertensiva.
English: The recommended treatment of overdosage is intravenous infusion of sodium chloride 9 mg/ml (0.9%) solution.
Danish: Den anbefalede behandling af overdosering er intravenøs infusion af natriumkloridopløsning 9 mg/ml (0,9 %).
English: Table 1: Recommended dosage schedule for patients with renal impairment Creatinine clearance
Danish: Tabel 1: Anbefalet doseringsplan for patienter med nedsat nyrefunktion Kreatininclearance
English: Check with your doctor or pharmacist before taking Vascace - if you have a heart problem.
Danish: Tal med lægen eller apoteket, inden du tager Vascace - hvis du har et hjerteproblem.
English: Limited data are available for overdosage in humans.
Danish: Der foreligger kun begrænsede data for overdosering hos mennesker.
English: Although the study by Carlsen et al (Carlsen JE, Buchmann M, Hoeglund C, Pellinen T, Honkanen T, Soerensen OH, et al. 24-hour antihypertensive effect of oral cilazapril?
Danish: Selv om undersøgelsen af Carlsen et al (Carlsen JE, Buchmann M, Hoeglund C, Pellinen T, Honkanen T, Sørensen OH, et al., 24-hour antihypertensive effect of oral cilazapril?
English: This is because Vascace can affect the way some medicines work.
Danish: Grunden er, at Vascace kan påvirke den måde, hvorpå noget medicin virker.
English: It may be resumed later if required.
Danish: Diuretika kan genoptages senere, hvis det er nødvendigt.
English: Since the submission of the original documentation no additional studies were conducted by Roche in patients with impaired liver function.
Danish: Efter fremsendelsen af den originale dokumentation foretog Roche ingen yderligere undersøgelser af patienter med nedsat leverfunktion.
English: The haemodynamic and clinical effects occur promptly and persist.
Danish: De hæmodynamiske og kliniske effekter opstår øjeblikkeligt og persisterer.
English: If concomitant use is indicated because of demonstrated hypokalaemia they should be used with caution and with frequent monitoring of serum potassium.
Danish: Hvis samtidig anvendelse er indiceret på grund af påvist hypokaliæmi skal de anvendes med forsigtighed og med hyppig monitorering af serumkalium.
English: The efficacy of cilazapril in the treatment of hypertension has been documented in several clinical trials sponsored by Roche.
Danish: Virkningen af cilazapril til behandling af hypertension er blevet dokumenteret i adskillige kliniske undersøgelser sponsoreret af Roche.
English: N.V. Roche S.A. Rue Dante 75
Danish: Roche S.A. Rue Dante 75
English: Angioedema has been associated with ACE inhibitors, with a reported incidence of 0.1-0.5%.
Danish: Angioødem har været forbundet med ACE-hæmmere med en rapporteret incidens på 0,1-0,5 %.
English: - Low numbers of platelets in your blood.
Danish: - Lavt antal blodplader i blodet.
English: - If you have problems with your kidneys, or if you are elderly, your doctor may give you a lower dose.
Danish: - Hvis du har problemer med nyrerne, eller hvis du er ældre, kan din læge give dig en lavere dosis.
English: Accordingly these results can be extrapolated also for cilazapril, where the beneficial effects of ACE inhibitors in CHF can be considered as a class effect.
Danish: Tilsvarende kan disse resultater også ekstrapoleres for cilazapril, hvor ACE-hæmmeres gavnlige virkninger på CHF kan betragtes som en klassevirkning.
English: If you take more Vascace than you should, or if someone else takes your Vascace tablets, talk to a doctor or go to a hospital straight away.
Danish: Hvis du tager flere Vascace tabletter, end du skal, eller hvis en anden person tager dine Vascace tabletter, skal du straks tale med en læge eller henvende dig på et hospital.
English: Estimates of frequency are based on the proportion of patients reporting each adverse reaction during cilazapril clinical trials that included a total combined population of 7171 patients.
Danish: Estimater af hyppighederne er baseret på andelen af patienter, som rapporterede hver bivirkning under kliniske forsøg med cilazapril, som omfattede en samlet kombineret population på 7.171 patienter.
English: However it is also very well known that ACE inhibitors may have serious impact on the renal function, especially in the case of reduced renal perfusion.
Danish: Det er dog også særdeles velkendt, at ACE-hæmmere kan have en alvorlig indvirkning på nyrefunktionen, navnlig i tilfælde af nedsat renal perfusion.
English: The antihypertensive effect of Vascace is usually apparent within the first hour after administration, with maximum effect observed between 3 and 7 hours after dosing.
Danish: Den antihypertensive virkning af Vascace ses som regel inden for den første time efter administration, med en maksimal virkning 3-7 timer efter dosering.
English: No clinically significant interactions were observed when cilazapril and digoxin, nitrates, coumarin anticoagulants, and H2 receptor blockers were concomitantly administered.
Danish: Der blev ikke observeret nogen klinisk signifikante interaktioner, når cilazapril og digoxin, nitrater, coumarin antikoagulantia og H2-receptorblokkere blev administreret samtidig.
English: The demographic data justifies the efficacy in patients of various age, gender, and weight with mild to moderate primary hypertension.
Danish: De demografiske data bekræfter virkningen hos patienter med forskellig alder, køn og vægt, der lider af mild til moderat primær hypertension.
English: However, racial differences in response are no longer evident when Vascace is administered in combination with hydrochlorothiazide.
Danish: Der ses dog ikke længere nogen racemæssige forskelle i respons, når Vascace adminstreres i kombination med hydrochlorothiazid.
English: In some patients blood pressure reduction may diminish towards the end of the dosage interval.
Danish: Hos nogle patienter kan blodtryksfaldet mindskes mod slutningen af doseringsintervallet.
English: Uncommon ≥ 1/1,000 and < 1/100
Danish: Ikke almindelig ≥ 1/1.000 og < 1/100
English: Blood pressure should be assessed, and dosage adjusted individually in accordance with the blood pressure response.
Danish: Blodtrykket bør måles, og doseringen bør justeres individuelt ud fra blodtryksresponsen.
English: This is more likely to happen when you first start treatment.
Danish: Sandsynligheden for dette er størst ved starten af behandlingen.
English: Nevertheless, as there are no outcome studies to provide a definite beneficial dose for the majority of patients, and since the MAH has not been able to provide a better dosing guide based e.g. on pharmacokinetic/pharmacodynamic data, the following wording proposed by the MAH, was considered to be acceptable by the CHMP.
Danish: Eftersom der ikke er nogen resultatundersøgelser, som viser en bestemt gavnlig dosis til de fleste patienter, og eftersom indehaveren af markedsføringstilladelsen ikke har kunnet give en bedre doseringsvejledning baseret på f.eks. farmakokinetiske/farmakodynamiske data, var CHMP dog af den opfattelse, at følgende ordlyd, som indehaveren af markedsføringstilladelsen havde foreslået, var acceptabel.
English: Vascace is used to treat the following: - High blood pressure (hypertension) - Chronic (long-term) heart failure.
Danish: Vascace bruges til at behandle følgende: - Forhøjet blodtryk (hypertension) - Kronisk (langvarig) hjertesvigt.
English: Treatment-related adverse events severe enough to stop treatment occur in less than 5% of patients receiving ACE inhibitors.
Danish: Behandlingsrelaterede bivirkninger, der er alvorlige nok til at stoppe behandlingen, forekommer hos mindre end 5 % af patienter, som får ACE-hæmmere.
English: - If you are already taking a diuretic (‘water tablets'), your doctor may tell you to stop taking it about 3 days before you start taking Vascace.
Danish: - Hvis du allerede tager et diuretikum (vanddrivende medicin), kan lægen bede dig om at stoppe med at tage det ca. 3 dage inden, du begynder at tage Vascace.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: Hvis du har yderligere spørgsmål om brugen af denne medicin, skal du spørge din læge eller på apoteket.
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 med lithium anbefales ikke, men hvis kombinationen anses for nødvendig, skal en grundig monitorering af lithiumkoncentrationen udføres.
English: Vascace is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Vascace anbefales ikke til mødre, som ammer, og lægen vil muligvis vælge en anden behandling til dig, hvis du ønsker at amme, især hvis dit spædbarn er nyfødt eller for tidligt født.
English: If this dose has been well tolerated it may be increased in weekly intervals and according to the clinical status of the patient to 1.0 mg or 2.5 mg.
Danish: Hvis denne dosis er veltolereret, kan den med ugentlige intervaller og i henhold til patientens kliniske status øges til 1,0 mg eller 2,5 mg.
English: For patients with impaired renal function, the dosing recommendations were based on data from a number of Roche studies and published clinical trials.
Danish: Til patienter med nedsat nyrefunktion var doseringsanbefalingerne baseret på data fra en række Roche-undersøgelser og offentliggjorte kliniske undersøgelser.
English: Blood problems reported with ACE inhibitors include: - Low numbers of red blood cells (anaemia).
Danish: Blodproblemer i forbindelse med brug af ACE-hæmmere, omfatter: - Lavt antal røde blodlegemer (anæmi).
English: Reflex tachycardia is not induced, although small, clinically insignificant alterations of heart rate may occur.
Danish: Der opstår ikke reflekstakykardi, selvom der dog kan forekomme små, klinisk insignifikante ændringer i hjerterytmen.
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction The most important possible interactions (PK, PD or toxic) have been included in the harmonized label, since these drugs are frequently co-prescribed with cilazapril or other ACE inhibitors and scientific rationale is available.
Danish: Punkt 4.5 - Interaktion med andre lægemidler og andre former for interaktion De vigtigste mulige interaktioner (farmakokinetiske, farmakodynamiske eller toksiske) er blevet medtaget i den harmoniserede etikettering, eftersom disse lægemidler ofte ordineres sammen med cilazapril eller andre ACE-hæmmere, og et videnskabeligt rationale er tilgængeligt.
English: If you have a severe reaction called angioedema, stop taking Vascace and see a doctor straight away.
Danish: Hvis du oplever en alvorlig reaktion kaldet angioødem, skal du stoppe med at tage Vascace og straks søge læge.
English: Vascace and associated names (see Annex I) 0.5 mg film-coated tablets Vascace and associated names (see Annex I) 1 mg film-coated tablets Vascace and associated names (see Annex I) 2.5 mg film-coated tablets Vascace and associated names (see Annex I) 5 mg film-coated tablets [See Annex I - To be completed nationally]
Danish: Vascace og tilhørende navne (Se bilag I) 0,5 mg filmovertrukne tabletter Vascace og tilhørende navne (Se bilag I) 1 mg filmovertrukne tabletter Vascace og tilhørende navne (Se bilag I) 2,5 mg filmovertrukne tabletter Vascace og tilhørende navne (Se bilag I) 5 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt]
English: The CHMP was of the view that it should be mentioned that the angiotensin escape phenomenon (renin-angiotensin system activation and increased activity in sympathetic system) can occur (and was observed) in patients treated with ACE inhibitors as monotherapy (Roig e, et al Eur.
Danish: CHMP var af den opfattelse, at det burde nævnes, at angiotensin escape-fænomenet (aktivering af renin-angiotensinsystemet og øget aktivitet i det sympatetiske system) kan optræde (og blev observeret) hos patienter behandlet med ACE-hæmmere som monoterapi (Roig e, et al Eur.
English: The dosing recommendation follows the “dosing by symptomatic relief” principle, which is not the current clinical practice.
Danish: Dosisanbefalingen følger princippet om "dosering efter symptomlindring", som ikke er almindelig klinisk praksis.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines: - Diuretics (‘water tablets') - see ‘High blood pressure (hypertension)' in section 3 on ‘How to take Vascace'.
Danish: Du skal i særdeleshed fortælle det til din lægen eller apoteket, hvis du tager følgende medicin: - Diuretika (vanddrivende medicin) - se "Forhøjet blodtryk (hypertension)" i afsnit 3: Sådan skal du tage Vascace.
English: - Steroide medicines (such as hydrocortisone, prednisolone and dexamethasone) or other medication which suppress the immune system.
Danish: - Steroider (som f.eks. hydrokortison, prednisolon og dexamethason) eller andre lægemidler, som undertrykker immunsystemet.
English: The CHMP was of the view that renovascular hypertension should not be included as an independent indication, as the MAH was unable to substantiate it with their own clinical data.
Danish: CHMP var af den opfattelse, at renovaskulær hypertension ikke burde medtages som en uafhængig indikation, eftersom indehaveren af markedsføringstilladelsen ikke var i stand til at underbygge den med sine egne kliniske data.
English: Also some medicines can affect the way Vascace works.
Danish: Noget medicin kan også påvirke den måde, hvorpå Vascace virker.
English: Treatment of chronic heart failure (CHF)
Danish: Behandling af kronisk hjerteinsufficiens (CHF)
English: No data on overall survival, cardiovascular morbidity, frequency of CV hospitalisation of patients treated with cilazapril for CHF have been presented.
Danish: Der er ikke fremlagt nogen data for samlet overlevelse, kardiovaskulær morbiditet og hyppigheden af kardiovaskulær hospitalsindlæggelse af patienter behandlet med cilazapril for CHF.
English: Lactose intolerance
Danish: Laktoseintolerans
English: Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Danish: Patienterne skal være tilstrækkeligt hydrerede, og der skal overvejes at monitorere nyrefunktionen efter påbegyndelse af den samtidige behandling og regelmæssigt derefter.
English: If hypotension occurs, the patient should be placed in the shock position.
Danish: Hvis der opstår hypotension, bør patienten placeres i chokstilling.
English: Owing to the presence of lactose monohydrate, patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: På grund af tilstedeværelsen af laktosemonohydrat må patienter med hereditær galaktoseintolerans, Lapp-laktase-mangel eller glukose-galaktose-malabsorption ikke tage dette lægemiddel.
English: Always take Vascace exactly as prescribed.
Danish: Tag altid Vascace nøjagtigt efter lægens anvisning.
English: The dosing schedule of once daily, administered before or after a meal as proposed by the MAH was considered to be approvable by the CHMP.
Danish: Doseringsplanen med én daglig dosis, der gives før eller efter et måltid, som foreslået af indehaveren af markedsføringstilladelsen, blev anset for at kunne godkendes af CHMP.
English: Cilazapril must be stopped before the start of desensitization therapy, and should not be replaced by a β- blocker.
Danish: Behandling med cilazapril skal stoppes inden påbegyndelse af desensibiliseringsbehandling og bør ikke erstattes af en betablokker.
English: Vascace is not recommended for use in children.
Danish: Vascace anbefales ikke til børn.
English: - if you are allergic (hypersensitive) to other ACE inhibitor medicines.
Danish: - hvis du er allergisk (overfølsom) over for andre ACE-hæmmere.
English: Vascace induces a reduction of both supine and standing systolic and diastolic blood pressure, usually with no orthostatic component.
Danish: Vascace inducerer et fald i det systoliske og diastoliske blodtryk ved både liggende og stående stilling, som regel uden nogen ortostatisk komponent.
English: Pharmacotherapeutic group: ACE inhibitor, ATC code: C09AA08
Danish: Farmakoterapeutisk klassifikation: ACE-hæmmer, ATC-kode: C09AA08
English: The signs include increased number of infections, for example in your mouth, gums, throat and lungs.
Danish: Tegnene omfatter øget antal infektioner, f.eks. i munden, tandkødet, halsen og lungerne.
English: At recommended doses, the effect of Vascace in hypertensive patients and in patients with chronic heart failure is maintained for up to 24 hours.
Danish: Ved de anbefalede doser opretholdes virkningen af Vascace hos hypertensive patienter og patienter med kronisk hjerteinsufficiens i op til 24 timer.
English: - The other ingredient(s) is (are)...
Danish: - Øvrige indholdsstoffer er….
English: Gold
Danish: Guld
English: This may make you feel weak, dizzy or light-headed, and may lead to blurred vision and fainting.
Danish: Dette kan få dig til at føle dig svag, svimmel eller ør i hovedet og kan medføre sløret syn og besvimelse.
English: Taking Vascace with food and drink Tell your doctor or pharmacist if you are taking food supplements that contain potassium.
Danish: Brug af Vascace sammen med mad og drikke Fortæl lægen eller apoteket, hvis du tager kosttilskud, som indeholder kalium.
English: Excess sweating, flushing, asthenia, sleep disorder (c) Description of selected adverse events
Danish: Øget svedafsondring, rødme, asteni, søvnforstyrrelse (c) Beskrivelse af udvalgte bivirkninger
English: - if you undergo LDL apheresis with dextrane sulphate.
Danish: - hvis du får foretaget LDL-aferese med dextransulfat.
English: - Your doctor will then increase your dose until your blood pressure is under control - the usual maintenance dose is between 2.5 mg and 5 mg per day.
Danish: - Din læge vil dernæst øge din dosis, indtil dit blodtryk er under kontrol - den sædvanlige vedligeholdelsesdosis er 2,5 - 5 mg pr. dag.
English: Vascace 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 anbefales ikke under tidlig graviditet 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 efter 3. måned af graviditeten.