FrancophonIA/ELRC3.0 huggingface dataset:
English: - Potassium supplements (including salt substitutes) or potassium-sparing diuretics.
Danish: - Kaliumtilskud (inklusive salterstatninger) eller kaliumbesparende diuretika.
English: “Patients with renal impairment: Reduced dosages are required for patients with renal impairment, depending on their creatinine clearance (see section 4.4).
Danish: "Patienter med nedsat nyrefunktion: Nedsatte doser er nødvendige til patienter med nedsat nyrefunktion, afhængigt af deres kreatininclearance (se punkt 4.4).
English: Desensitization: Anaphylactic reactions can occur in patients undergoing desensitization therapy with wasp or bee venom while receiving an ACE inhibitor.
Danish: Desensibilisering: Anafylaktiske reaktioner kan opstå hos patienter, som gennemgår desensibiliseringsbehandling med hvepse- eller bigift, mens de behandles med en ACE-hæmmer.
English: Chronic heart failure: In patients with chronic heart failure, clearance of cilazaprilat is correlated with creatinine clearance.
Danish: Kronisk hjerteinsufficiens: Hos patienter med kronisk hjerteinsufficiens korrelerer clearance af cilazaprilat med kreatininclearance.
English: Renal impairment and acute renal failure are more likely in patients with severe heart failure, renal artery stenosis, pre-existing renal disorders or volume depletion (see section 4.4).
Danish: Der er større risiko for nedsat nyrefunktion og akut nyreinsufficiens hos patienter med alvorlig hjerteinsufficiens, renal arteriestenose, præeksisterende nyresygdomme eller volumenudtømning (se pkt.
English: Severe reactions:
Danish: Alvorlige bivirkninger:
English: The signs include bruising easily and nose bleeds.
Danish: Tegnene omfatter tendens til blodudtrædninger og næseblod.
English: Single cases of liver function disorders, such as increased values of liver function tests (transaminases, bilirubin, alkaline phosphatase, gamma GT) and cholestatic hepatitis with or without necrosis have been reported.
Danish: Der er rapporteret enkelte tilfælde af lidelser relateret til leverfunktionen som f.eks. forhøjede leverværdier ved leverfunktionstest (transaminaser, bilirubin, basisk fosfatase, gamma-GT) og kolestatisk hepatitis med eller uden nekrose.
English: HOW TO TAKE VASCACE
Danish: SÅDAN SKAL DU TAGE VASCACE
English: The posolgy recommendation for cilazapril in chronic heart failure is based on effects on symptomatic improvement, rather than on data showing that cilazapril reduces morbidity and mortality in this patient group (see section 5.1).”
Danish: Den maksimale daglige dosis for disse patienter er 5,0 mg. Doseringsanbefalingen for cilazapril ved kronisk hjerteinsufficiens er baseret på virkningerne på symptomforbedringen snarere end på data, der viser, at cilazapril reducerer morbiditet og mortalitet hos denne patientgruppe (se punkt 5.1)."
English: The usual starting dose of Vascace is then 0.5 mg per day.
Danish: Den sædvanlige startdosis af Vascace er dernæst 0,5 mg pr. dag.
English: Elderly with chronic heart failure: The recommended starting dose of Vascace 0.5 mg must be strictly followed.
Danish: Ældre med kronisk hjerteinsufficiens: Den anbefalede startdosis for Vascace 0,5 mg skal følges nøje.
English: - the scope of the referral was the harmonisation of the Summary of Products Characteristics, labelling and package leaflet.
Danish: - formålet med indbringelsen var at harmonisere produktresuméet, etiketteringen og indlægssedlen,
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 udført kliniske forsøg, som fastslår virkningen af cilazapril på morbiditet og mortalitet ved hjerteinsufficiens.
English: Muscle cramps, myalgia, arthralgia
Danish: Muskelkramper, myalgi, artralgi
English: Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough.
Danish: Symptomer i forbindelse med overdosering af ACE-hæmmere kan omfatte hypotension, kredsløbschok, elektrolytforstyrrelser, nyreinsufficiens, hyperventilation, takykardi, palpitationer, bradykardi, svimmelhed, angst og hoste.
English: When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Danish: Når graviditeten konstateres, skal behandling med ACE-hæmmere øjeblikkeligt ophøre, og alternativ behandling skal om nødvendigt igangsættes.
English: Hypotension contributes further to a reduction in renal perfusion (see section 4.4 `Hypotension').
Danish: Hypotension bidrager yderligere til et fald i nyreperfusionen (se pkt.
English: Excessive lowering of blood pressure may increase the chance of heart attack or stroke in certain patients - Increased heart rate - Feeling weak - Pains in the chest - Breathing problems, including shortness of breath and tightness in the chest - A runny or blocked nose and sneezing (rhinitis) - Dry or swollen mouth - Lack of appetite - Change in the way things taste - Diarrhoea and vomiting - Skin rash (which may be severe) - Muscle cramps or pain in your muscles or joints - Impotence
Danish: Stort blodtryksfald kan øge risikoen for hjertetilfælde eller slagtilfælde hos visse patienter - Øget hjertefrekvens - Følelse af afkræftethed - Smerter i brystet - Vejrtrækningsproblemer, herunder stakåndethed og strammende fornemmelse i brystet - Løbende næse, stoppet næse og nysen (rhinitis) - Tør eller hævet mund - Manglende appetit - Ændret smagssans - Diarré og opkastning
English: Liver cirrhosis: In patients with liver cirrhosis (but without ascites) who require therapy for hypertension, cilazapril should be dosed with great caution not exceeding 0.5 mg/day accompanied by a careful monitoring of the blood pressure, because significant hypotension may occur.
Danish: Levercirrose: Hos patienter med levercirrose (men uden ascites), som har behov for behandling for hypertension, bør cilazapril doseres med stor forsigtighed og ikke overstige 0,5 mg/dag ledsaget af nøje monitorering af blodtrykket, da der kan forekomme signifikant hypotension.
English: Uncommon (affects less than 1 in 100 people)
Danish: Ikke almindelig (forekommer hos færre end 1 ud af 100 behandlede)
English: - Your doctor will then increase the dose - the usual maintenance dose is between 1 mg and
Danish: - Din læge vil dernæst øge dosis - den sædvanlige vedligeholdelsesdosis er 1 mg - 2,5 mg pr.
English: 6.6 Special precautions for disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Vascace is indicated for the treatment of chronic heart failure.
Danish: Vascace er indiceret til behandling af kronisk hjerteinsufficiens.
English: Considering the data from cilazapril trials conducted as part of the clinical development program for Vascace, the published data on the therapeutic effect of ACE inhibitors on CHF, and the Guidelines of the European Society of Cardiology, the CHMP agreed with the following wording proposed by the MAH for this indication:
Danish: På baggrund af dataene fra cilazaprilundersøgelser, der blev foretaget som led i det kliniske udviklingsprogram for Vascace, de offentliggjorte data om ACE-hæmmeres terapeutiske virkning på
English: The signs include severe pain in the stomach which spreads to your back - Changes in the way your liver or kidneys work (shown in blood and urine tests) - Liver problems such as hepatitis (inflammation of the liver) or liver damage - Severe skin reactions including blistering or peeling of skin - Increased sensitivity to light - Hair loss (which may be temporary) - Loosening or separation of a nail from its bed - Breast enlargement in men
Danish: - Ømhed i tungen - betændelse i bugspytkirtlen (pancreatitis) Tegnene omfatter alvorlige smerter i maven, som breder sig til ryggen - Ændringer i lever- eller nyrefunktion (ses i blod- og urinprøver) - Leverproblemer som f.eks. hepatitis (leverbetændelse) eller leverskade - Alvorlige hudreaktioner, herunder dannelse af blister eller afskalning af huden - Øget lysfølsomhed - Hårtab (som kan være midlertidigt) - Løsning af negl fra neglelejet - Brystforstørrelse hos mænd
English: The special dosage recommendation should thus be followed in chronic heart failure patients with impaired renal function.”
Danish: Den særlige dosisanbefaling bør således følges hos patienter, der både har kronisk hjerteinsufficiens og nedsat nyrefunktion."
English: Thus, dosage adjustments beyond those recommended for patients with impaired renal function (see section 4.2) should not be necessary.
Danish: Dosisjusteringer ud over dem, der anbefales for patienter med nedsat nyrefunktion (se pkt.
English: The special dosage recommendation should thus be followed in chronic heart failure patients with impaired renal function.
Danish: Den særlige doseringsanbefaling bør derfor følges hos patienter med kronisk hjerteinsufficiens med nedsat nyrefunktion.
English: Results from clinical trials showed that clearance of cilazaprilat was correlated with creatinine clearance in patients with chronic heart failure.
Danish: Resultater fra kliniske forsøg viste, at clearance af cilazaprilat korrelerede med kreatininclearance hos patienter med kronisk hjerteinsufficiens.
English: In patients with liver cirrhosis (but without ascites) who require therapy for hypertension, cilazapril should be initiated at a lower 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 lavere dosis og med stor forsigtighed, da der kan forekomme signifikant hypotension (se pkt.
English: Hyperkalaemia is most likely to occur in patients with renal impairment and those taking potassium sparing diuretics or potassium supplements.
Danish: Risikoen for hyperkaliæmi er størst hos patienter med nedsat nyrefunktion og patienter, som tager kaliumbesparende diuretika eller kaliumtilskud.
English: - Gold compounds (used to treat rheumatoid arthritis).
Danish: - Guldforbindelser (bruges til at behandle leddegigt).
English: “Vascace is indicated for the treatment of chronic heart failure.”
Danish: "Vascace er indiceret til behandling af kronisk hjerteinsufficiens."
English: The usual dose range of Vascace is 2.5 to 5.0 mg once daily.
Danish: Det normale dosisinterval for Vascace er 2,5-5,0 mg én gang dagligt.
English: Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy.
Danish: Der er rapporteret sjældne tilfælde af nitritoide reaktioner (symptomerne omfatter ansigtsrødmen, kvalme, opkastning og hypotension) hos patienter, der får injektioner med guldforbindelser (natriumaurothiomalat) og samtidig behandling med ACE-hæmmere.
English: The signs include feeling tired, pale skin, fast or uneven heart beat (palpitations), and feeling short of breath.
Danish: Tegnene omfatter træthed, bleghed, hurtig eller ujævn hjerterytme (hjertebanken) og stakåndethed.
English: “Liver cirrhosis: In patients with liver cirrhosis (but without ascites) who require therapy for hypertension, cilazapril should be dosed with great caution not exceeding 0.5 mg/day accompanied by a careful monitoring of the blood pressure, because significant hypotension may occur.”
Danish: "Levercirrose: Hos patienter med levercirrose (men uden ascites), som kræver behandling af hypertension, skal cilazapril doseres med stor forsigtighed og med en maksimal dosis på 0,5 mg dagligt, ledsaget af omhyggelig monitorering af blodtrykket, eftersom der kan opstå signifikant hypotension."
English: “Elderly with hypertension: Treatment with Vascace should be initiated with a dose between 0.5 and 1.0 mg once daily.
Danish: "Ældre med hypertension: Behandling med Vascace bør initieres med en dosis på mellem 0,5 og 1,0 mg én gang dagligt.
English: Angioedema (may involve the face, lips, tongue, larynx or gastrointestinal tract) (see section 4.4) Rare
Danish: Angioødem (kan involvere ansigtet, læberne, tungen, strubehovedet eller mavetarmkanalen) (se pkt.
English: First-dose hypotension is most likely to occur in patients whose renin-angiotensin-aldosterone system is activated, such as in renovascular hypertension or other causes of renal hypoperfusion, sodium or volume depletion, or previous treatment with other vasodilators.
Danish: Hypotension i forbindelse med første dosis er mest sandsynlig hos patienter med et aktiveret renin-angiotensinaldosteron-system, f.eks. ved renovaskulær hypertension eller andre årsager til renal hypoperfusion,
English: 1995;10 (4):221-227) raised the question of whether the once daily dosing schedule in hypertension is sufficient, no further discussion of the results of this study in comparison with the other studies conducted with cilazapril was provided by the MAH.
Danish: hvorvidt en doseringsplan med én daglig dosis er tilstrækkelig ved hypertension, fremlagde indehaveren af markedsføringstilladelsen ingen yderligere redegørelse for resultaterne af denne undersøgelse sammenlignet med de andre undersøgelser, der er foretaget af cilazapril.
English: Elderly with hypertension: Treatment with Vascace should be initiated with a dose between 0.5 and 1.0 mg once daily.
Danish: Ældre personer med hypertension: Behandling med Vascace bør påbegyndes ved en dosis mellem 0,5 og 1,0 mg én gang dagligt.
English: Renal impairment, acute renal failure (see section 4.4), blood creatinine increased, blood urea increased
Danish: 4.4), forhøjet blodkreatinin, forhøjet urinkvælstof
English: BEFORE YOU TAKE VASCACE
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE VASCACE
English: “Chronic heart failure: Therapy with Vascace should be initiated at a recommended starting dose of 0.5 mg once daily under close medical supervision.
Danish: "Kronisk hjerteinsufficiens: Behandling med Vascace bør initieres med en anbefalet startdosis på 0,5 mg én gang dagligt under nøje lægeligt opsyn.
English: Chronic heart failure: Therapy with Vascace should be initiated at a recommended starting dose of 0.5 mg once daily under close medical supervision.
Danish: Kronisk hjerteinsufficiens: Behandling med Vascace bør påbegyndes ved en anbefalet startdosis på 0,5 mg én gang dagligt under nøje lægeligt opsyn.
English: The posology recommendation for cilazapril in chronic heart failure is based on effects on symptomatic improvement, rather than on data showing that cilazapril reduces morbidity and mortality in this patient group (see section 5.1).
Danish: Den maksimale daglige dosis for disse patienter er 5,0 mg. Anbefalingerne for dosering af cilazapril ved kronisk hjerteinsufficiens er baseret på effekten på symptomatisk forbedring, snarere end på data, der viser at cilazapril reducerer morbiditet og mortalitet hos denne patientgruppe (se pkt.
English: Hypersensitivity to cilazapril or any components of the product, or to other ACE inhibitors
Danish: Overfølsomhed over for cilazapril eller over for et eller flere af hjælpestofferne eller over for andre ACE-hæmmere.
English: The use of ACE inhibitors such as cilazapril is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Danish: Brugen af ACE-hæmmere såsom cilazapril er kontraindiceret under det andet og tredje trimester af gradiviteten (se punkt 4.3 og 4.4).
English: United Kingdom Roche Products Ltd 6 Falcon Way, Shire Park Welwyn Garden City / AL7
Danish: Storbritannien Roche Products Ltd 6 Falcon Way, Shire Park Welwyn Garden City / AL7 1TW
English: It was also recommended by the CHMP that in patients with liver cirrhosis (but without ascites), cilazapril should be initiated at a lower dose since significant hypotension could occur, and in patients with ascites, cilazapril should not be recommended.
Danish: CHMP anbefalede ligeledes, at cilazapril initieres ved en lavere dosis hos patienter med levercirrose (men uden ascites), eftersom der er risiko for signifikant hypotension.
English: 1 mg once daily
Danish: 1 mg én gang dagligt
English: What Vascace is and what it is used for Before you take Vascace How to take Vascace Possible side effects How to store Vascace Further information
Danish: Det skal du vide, før du begynder at tage Vascace Sådan skal du tage Vascace Bivirkninger
English: Haemodialysis: Anaphylaxis has occurred in patients dialysed with high flux membranes (e.g. AN 69) receiving ACE inhibitors.
Danish: Hæmodialyse: Anafylakse er forekommet hos patienter i dialyse med high flux-membraner (f.eks.
English: For patients with impaired liver function the CHMP agreed with the following wording proposed by the MAH:
Danish: For patienter med nedsat leverfunktion godkendte CHMP følgende ordlyd, som indehaveren af markedsføringstilladelsen havde foreslået.
English: Inhibace "Roche" 0,5 mg - Filmtabletten
Danish: Inhibace "Roche" 0,5 mgFilmtabletten
English: If indicated, cilazaprilat, the active form of cilazapril, may be removed from the general circulation by haemodialysis (see section 4.4).
Danish: På indikation kan cilazaprilat, den aktive form af cilazapril, fjernes fra kredsløbet via hæmodialyse (se pkt.
English: “The use of ACE inhibitors such as cilazapril is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: "Brugen af ACE-hæmmere såsom cilazapril anbefales ikke under det første trimester af gradiviteten (se punkt 4.4).
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 graviditet (se pkt.
English: When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Danish: Når der konstateres graviditet, skal behandling med ACE-hæmmere straks stoppes, og hvis det er relevant, skal anden behandling igangsættes (se pkt.
English: Inhibace "Roche" 2,5 mg - Filmtabletten
Danish: Inhibace "Roche" 2,5 mgFilmtabletten
English: Respiratory, thoracic and mediastinal disorders Common
Danish: Luftveje, thorax og mediastinum
English: Taking into account the recommendation of the CHMP, the following wording proposed by the MAH was agreed:
Danish: På baggrund af CHMP's anbefaling godkendtes følgende ordlyd, som indehaveren af markedsføringstilladelsen havde foreslået:
English: FURTHER INFORMATION What Vascace contains - The active substance in Vascace is cilazapril.
Danish: - Det aktive stof i Vascace er cilazapril.
English: Patients with renal impairment: Reduced dosages are required for patients with renal impairment, depending on their creatinine clearance (see section 4.4).
Danish: Patienter med nedsat nyrefunktion: Nedsættelse af dosis er påkrævet hos patienter med nedsat nyrefunktion, afhængigt af deres kreatininclearance (se pkt.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name}
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt] {Navn}
English: “Hypersensitivity to cilazapril or any components of the product, or to other ACE inhibitors History of angioedema associated with previous ACE inhibitor therapy Hereditary or idiopathic angioedema
Danish: Angioødem i anamnesen i forbindelse med tidligere behandling med en ACE-hæmmer Hereditært eller idiopatisk angioødem
English: History of angioedema associated with previous ACE inhibitor therapy
Danish: Angioødem i anamnesen i forbindelse med tidligere behandling med ACE-hæmmer.
English: The use of ACE inhibitors such as cilazapril is contraindicated during the second and third trimester of pregnancy (see section 4.3 and 4.4).
Danish: Brug af ACE-hæmmere såsom cilazapril er kontraindiceret under det andet og tredje trimester af graviditet (se pkt.
English: 2.5 mg once daily
Danish: 2,5 mg én gang dagligt
English: (It is also better to avoid Vascace in early pregnancysee the sections on ‘Pregnancy' and ‘Breast-feeding'.)
Danish: - hvis du er gravid og mere end 3 måneder henne (det er også bedst at undgå Vascace tidligt i graviditeten - se afsnit om "Graviditet" og "Amning").
English: - It does not matter what time of day you take Vascace.
Danish: - Du kan tage Vascace på et hvilket som helst tidspunkt på dagen.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL
English: - If you have liver cirrhosis without ascites, your doctor will not give you a dose of more than
Danish: - Hvis du har levercirrose uden væskeophobning i maveregionen (ascites), vil din læge ikke give dig en større dosis end 0,5 mg per dag, og lægen vil monitorere dit blodtryk omhyggeligt.
English: Serum potassium
Danish: Serumkalium
English: (anemia, neutropenia, agranulocytosis and thrombocytopenia) - A type of severe allergic reaction (anaphylaxis) - Cerebral ischaemia, transient ischaemic attack, ischaemic stroke (may occur if blood pressure becomes too low) - Myocardial infarction (may occur if blood pressure becomes too low) - Irregular heartbeat - Interstitial lung disease - A disorder resembling systemic lupus erythematosus - Pins and needles or numbness in the hands or feet - Wheezing - A feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis).
Danish: - En type alvorlig allergisk reaktion (anafylakse) - Lammelser, talebesvær, bevidstløshed pga. blodprop i hjernen (cerebral iskæmi, transitorisk iskæmisk attak, iskæmisk slagtilfælde kan forekomme hvis blodtrykket bliver for lavt).
English: Taking into account the recommendation of the CHMP, the following wording was agreed by the MAH:
Danish: På baggrund af anbefalingen fra CHMP's arbejdsgruppe vedrørende lægemiddelovervågning accepterede indehaveren af markedsføringstilladelsen følgende ordlyd:
English: Pharmaceutical Form
Danish: Styrke Lægemiddelform Indgivelsesvej
English: Second and third trimesters of pregnancy (see sections 4.4. and 4.6)
Danish: Andet og tredje trimester af graviditet (se pkt.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally]
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer [Udfyldes nationalt]
English: - if you are on kidney dialysis.
Danish: - hvis du er i nyredialyse.
English: It is available as tablets (2.5, 5, 7.5, 10, 15 and 20 mg) and as ‘orodispersible' tablets (5, 10, 15 and 20 mg).
Danish: Det fås som tabletter (2,5, 5, 7,5, 10, 15 og 20 mg) og som smeltetabletter (5, 10, 15 og 20 mg).
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Danish: Den fuldstændige EPAR for referencelægemidlerne findes også på agenturets websted.
English: Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain.
Danish: Dets nøjagtige virkningsmekanisme kendes ikke, men det bindes til flere receptorer på overfladen af nervecellerne i hjernen.
English: The full EPAR for Olanzapine Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Olanzapin Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Olanzapine Teva.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Olanzapin Teva.
English: Two medicines are bioequivalent when produce the same levels of the active substance in the body.
Danish: To lægemidler er bioækvivalente, når de producerer den samme mængde af det aktive stof i kroppen).