FrancophonIA/ELRC3.0 huggingface dataset:
English: It is possible to switch between the infusion and the oral capsule if needed.
Danish: Der kan efter behov skiftes mellem infusionen og den orale kapsel.
English: A risk management plan has been developed to ensure that Cresemba is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Cresemba anvendes så sikkert som muligt.
English: • certain medicines that enhance the breakdown of isavuconazole in the body (strong inducers of
Danish: • visse lægemidler, der øger nedbrydningen af isavuconazol i kroppen (stærke induktorer af
English: The dosage for the infusions and capsules are the same: 200 mg every 8 hours for the first 48 hours, followed by a 200-mg maintenance dose once a day.
Danish: Dosis til infusion og kapsler er den samme: 6 doser a 200 mg hver 8. time i 48 timer, efterfulgt af en 200 mg vedligeholdelsesdosis én gang dagligt.
English: Other information about Cresemba
Danish: Andre oplysninger om Cresemba
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Cresemba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Cresemba opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What is Cresemba and what is it used for?
Danish: Hvad er Cresemba, og hvad anvendes det til?
English: Why is Cresemba approved?
Danish: Hvorfor blev Cresemba godkendt?
English: What measures are being taken to ensure the safe and effective use of Cresemba?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cresemba?
English: The full EPAR and risk management plan summary for Cresemba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Cresemba findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common side effects with Cresemba (seen in more than 10% of patient studied) were: abnormal liver tests, nausea, vomiting, difficulty breathing, abdominal pain, diarrhea, injection site reactions, headache, low blood potassium and skin rash.
Danish: De hyppigste bivirkninger ved Cresemba (som ses hos mindre end 10 % af patienterne i undersøgelserne) var: abnorme leverprøver, kvalme, opkastning, vejrtrækningsbesvær, mavesmerter, diarré, reaktioner på injektionsstedet, hovedpine, lavt kaliumindhold i blodet og udslæt.
English: It must also not be used in patients with familial short QT syndrome, a heart rhythm problem.
Danish: Det må heller ikke anvendes hos patienter med den arvelige hjerterytmeforstyrrelse kort QT-syndrom.
English: In addition, Cresemba has the advantage that it can be used in patients with reduced kidney function.
Danish: Desuden har Cresemba den fordel, at det kan anvendes hos patienter med nedsat nyrefunktion.
English: Because the number of patients with these diseases is low, they are considered ‘rare', and Cresemba was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 June 2014 (for mucormycosis) and 4 July 2014 (for aspergillosis).
Danish: Da antallet af patienter med disse sygdomme er lavt, betragtes de som "sjældne", og Cresemba blev udpeget som "lægemiddel til sjældne sygdomme" den 4. juni 2014 (til mucormycose) og den 4. juli 2014 (til aspergillose).
English: Cresemba must not be used in patients who are taking any of the following:
Danish: Cresemba må ikke anvendes hos patienter, der får nogen af de nedenstående lægemidler:
English: It is not intended to provide practical advice on how to use Cresemba.
Danish: Det er ikke en praktisk vejledning i, hvordan Cresemba bør anvendes.
English: What are the risks associated with Cresemba?
Danish: Hvilke risici er der forbundet med Cresemba?
English: Without a functional cell membrane, the fungus is killed or prevented from spreading.
Danish: Uden en fungerende cellemembran dør svampene eller kan ikke brede sig.
English: Studies show that survival following treatment with Cresemba is similar to that seen with other treatments.
Danish: Undersøgelserne viser, at overlevelsestiden efter behandling med Cresemba svarer til den, der ses med andre behandlinger.
English: Regarding safety, Cresemba was relatively well tolerated.
Danish: Hvad sikkerheden angår, tåltes Cresemba sædvanligvis godt.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cresemba, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cresemba, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Cresemba isavuconazole
Danish: Cresemba isavuconazol
English: It works by disrupting the formation of ergosterol, an important component of fungal cell membranes.
Danish: Det virker ved at blokere dannelsen af ergosterol, der er en vigtig komponent i svampenes cellemembran.
English: Invasive aspergillosis and mucormycosis are life-threatening infections associated with high mortality.
Danish: Invasiv aspergillose og mucormycose er livstruende infektioner med høj dødelighed.
English: For mucormycosis, Cresemba is used when amphotericin B is inappropriate.
Danish: Ved mucormycose anvendes Cresemba, når amphotericin B er uhensigtsmæssigt.
English: In studies, Cresemba's effect was comparable to that of voriconazole in treating invasive aspergillosis.
Danish: I undersøgelserne var virkningen af Cresemba sammenlignelig med virkningen af voriconazol ved behandling af invasiv aspergillose.
English: Although amphotericin B is the first line treatment for mucormycosis, there is a need for alternative treatments and Cresemba will benefit patients for whom amphotericin B is not appropriate.
Danish: Skønt amphotericin B er førstevalgsbehandling ved mucormycose, er der behov for alternative behandlingsmuligheder, og Cresemba vil være til fordel for patienter, for hvem amphotericin B er uegnet.
English: In a main study of 516 patients with invasive aspergillosis, the mortality rate at 42 days was similar in patients treated with Cresemba (19%) and those treated with another antifungal medicine voriconazole (20%).
Danish: I en hovedundersøgelse med 516 patienter med invasiv aspergillose var dødeligheden efter 42 dage den samme hos patienter, der blev behandlet med Cresemba (19 %), som hos dem, der blev behandlet med et andet svampemiddel (voriconazol) (20 %).
English: For more information about treatment with Cresemba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cresemba, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Cresemba contains the active substance isavuconazole.
Danish: Cresemba indeholder det aktive stof isavuconazol.
English: Cresemba is an antifungal medicine used to treat adults with either of two life-threatening fungal infections: invasive aspergillosis and mucormycosis.
Danish: Cresemba er et svampemiddel, der anvendes til behandling af voksne med en af to livstruende svampeinfektioner: invasiv aspergillose og mucormycose.
English: • high-dose ritonavir (an HIV medicine)
Danish: • ritonavir (et middel mod HIV) i høj dosis
English: How is Cresemba used?
Danish: Hvordan anvendes Cresemba?
English: For practical information about using Cresemba, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Cresemba, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The active substance in Cresemba, isavuconazole, belongs to the ‘triazole' class of antifungal medicines.
Danish: Det aktive stof i Cresemba, isavuconazol, tilhører triazolgruppen af svampemidler.
English: • ketoconazole (an antifungal)
Danish: • ketoconazol (et svampemiddel)
English: What benefits of Cresemba have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Cresemba?
English: For the full list of all side effects reported with Cresemba, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Cresemba fremgår af indlægssedlen.
English: Cresemba is available as a powder used to make a solution for infusion (drip) into a vein and as capsules to be taken by mouth.
Danish: Cresemba fås som et pulver og indgives efter opløsning med drop (ved infusion) i en vene.
English: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (mucormycosis)
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Cresemba findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (invasiv aspergillose) ema.europa.eu/Find medicine/Human medicines/Rare disease designation (mucormycose)
English: Another study included 146 patients, among which 37 patients had mucormycosis and were treated with Cresemba; in patients with mucormycosis the mortality rate after 84 days was 43%, which is similar to rates seen in the published literature for standard treatments with amphotericin-B.
Danish: I en anden hovedundersøgelse deltog 146 patienter med enten invasiv aspergillose eller mucormycose, hvoraf 37 patienter havde mucormycose og blev behandlet med Cresemba.
English: How does Cresemba work?
Danish: Hvordan virker Cresemba?
English: {Name and address} {tel} {fax} {e-mail}
Danish: {Navn og adresse} {tlf} {fax} {email}
English: - Swallow each tablet with a drink of water.
Danish: - Synk hver tablet med et glas vand.
English: The combination should be administered with caution, especially in the elderly.
Danish: Kombinationen skal administreres med forsigtighed, især hos ældre.
English: - Aldosterone antagonists.
Danish: - Aldosteron-antagonister.
English: 2040 / Budaörs Hungary
Danish: 2040 / Budaörs Ungarn
English: In most of the cases the references originate from:
Danish: I de fleste tilfælde stammer referencerne fra:
English: - if you are planning to have an operation (including dental surgery).
Danish: - hvis du planlægger at gennemgå en operation (herunder tandkirurgi).
English: - if you have diabetes.
Danish: - hvis du har diabetes.
English: 1070 Bruxelles Belgium
Danish: 1070 Bruxelles
English: It also makes it easier for your heart to pump blood around your body if you have chronic heart failure.
Danish: Det gør det også lettere for hjertet at pumpe blod rundt i kroppen, hvis du har kronisk hjerteinsufficiens.
English: Taking this medicine - Take one tablet of Vascace each day.
Danish: Sådan tages dette lægemiddel - Tag én tablet Vascace hver dag.
English: This dose should be maintained for about 1 week.
Danish: Denne dosis bør opretholdes i ca. 1 uge.
English: - Vascace may be taken before or after a meal.
Danish: - Vascace kan tages inden eller efter et måltid.
English: Therefore, caution should be exercised in these patients.
Danish: Der skal derfor udvises forsigtighed hos disse patienter.
English: - Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Danish: - Du må ikke tage en dobbeltdosis (to doser på samme tid) som erstatning for en glemt dosis.
English: (a) Summary of the safety profile
Danish: (a) Resumé af sikkerhedsprofilen
English: MedDRA System Organ Class (SOC) and Preferred Terms (PTs) are used where appropriate.
Danish: MedDRA-systemorganklassen (SOC) og foretrukne termer (PT) er anvendt, hvor det er hensigtsmæssigt.
English: Cough is more common in women and non-smokers.
Danish: Hoste forekommer oftere hos kvinder og ikkerygere.
English: If you feel dizzy, do not drive or use any tools or machines.
Danish: Hvis du føler dig svimmel, må du ikke føre motorkøretøj eller bruge værktøj eller maskiner.
English: The following sections were harmonised:
Danish: Følgende punkter blev harmoniseret.
English: These patients also have a higher risk of angioedema.
Danish: Disse patienter har også en højere risiko for angioødem.
English: As this is a single study giving divergent results in this regard, the issue was not further questioned by the CHMP.
Danish: Eftersom dette er en enkelt undersøgelse, der giver divergerende resultater i den henseende, stillede CHMP ikke yderligere spørgsmål til dette emne.
English: Children: Safety and efficacy in children have not been established.
Danish: Børn: Sikkerhed og virkning hos børn er ikke fastlagt.
English: In some cases, reducing the dose may help.
Danish: I nogle tilfælde kan en dosisnedsættelse hjælpe.
English: Other possible side effects:
Danish: Andre mulige bivirkninger:
English: Do not use Vascace after the expiry date which is stated on the pack.
Danish: Brug ikke Vascace efter den udløbsdato, der står på pakningen.
English: Germany: Dynorm
Danish: Tyskland: Dynorm
English: Austria: Inhibace "Roche"
Danish: Østrig: Inhibace ”Roche”
English: Where the patient can tolerate the cough, it may be reasonable to continue treatment.
Danish: Hvis patienten kan tolerere hosten, kan det være fornuftigt at fortsætte behandlingen.
English: (desensitization).
Danish: (desensibilisering).
English: - Insulin or other medicines used to treat diabetes.
Danish: - Insulin eller andre lægemidler til behandling af diabetes.
English: However, always take it around the same time.
Danish: Det skal dog altid tages på omtrent samme tid på dagen.
English: Vascace should be administered once daily.
Danish: Vascace skal indtages én gang dagligt.
English: Maximum plasma concentrations are reached within 2 hours after administration and are directly related to dosage.
Danish: Den maksimale plasmakoncentration nås inden for 2 timer efter administrationen og er direkte relateret til doseringen.
English: Belgium, Bulgaria, Czech Republic, Hungary, Luxembourg, Poland, Spain: Inhibace France: Justor
Danish: Belgien, Bulgarien, Tjekkiet, Ungarn, Luxembourg, Polen, Spanien: Inhibace Frankrig: Justor
English: Do not take Vascace if any of the above apply to you.
Danish: Tag ikke Vascace, hvis et eller flere af ovenstående punkter gælder for dig.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VASCASE AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF VASCACE OG TILKNYTTEDE NAVNE (SE BILAG I)
English: - Tricyclic antidepressants, antipsychotics.
Danish: - Tricykliske antidepressiva, antipsykotika.
English: Routine monitoring of potassium and creatinine is part of normal medical practice for these patients.
Danish: Rutinemæssig monitorering af kalium og kreatinin er en del af den sædvanlige medicinske praksis for disse patienter.
English: This can make it difficult to breathe or swallow.
Danish: Dette kan gøre det svært at trække vejret eller synke.
English: Netherlands: Vascase
Danish: Holland: Vascase
English: - if you have recently been vomiting or have had diarrhoea.
Danish: - hvis du for nylig har kastet op eller har haft diarré.
English: Your doctor will then increase your dose until your blood pressure is under control.
Danish: Lægen vil øge din dosis, indtil dit blodtryk er under kontrol.
English: The dose should always be taken at about the same time of day.
Danish: Dosis bør altid tages på omtrent samme tidspunkt på dagen.
English: - Medicines called ‘non-steroidal anti-inflammatory drugs' (NSAIDs).
Danish: - Medicin kaldet "non-steroide antiinflammatoriske lægemidler" (NSAID'er).
English: These include captopril, enalapril, lisinopril and ramipril.
Danish: Disse omfatter captopril, enalapril, lisinopril og ramipril.
English: Clinical / efficacy studies
Danish: Kliniske studier/effektstudier
English: Greece, Ireland, United Kingdom: Vascace Italy, Portugal: Inibace
Danish: Grækenland, Irland, Storbritannien: Vascace Italien, Portugal: Inibace
English: The long term efficacy of cilazapril (alone or in combination) has also been accepted in the majority of the EU countries.
Danish: Langtidsvirkningen af cilazapril (anvendt alene eller i kombination med et andet lægemiddel) er også blevet godkendt i de fleste EU-lande.
English: Furthermore, the exercise tolerance of these patients increases significantly.
Danish: Motionstolerancen for disse patienter øges også signifikant.
English: 11 avenue Dubonnet 92 400 Courbevoie France
Danish: 11 avenue Dubonnet 92 400 Courbevoie Frankrig
English: All adverse drug reactions (ADRs) listed in the company reference safety information, the Core Data Sheet (CDS) have been included.
Danish: Alle bivirkninger (ADR), som er nævnt i virksomhedens referencesikkerhedsoplysninger, Core Data Sheet (CDS), blev medtaget.
English: The CHMP was of the view that specification (essential or according to updated definition - primary) and the grade (mild or moderate) of the hypertension should be omitted.
Danish: CHMP var af den opfattelse, at specificeringen af hypertension (essentiel eller, ifølge den opdaterede definition, primær) og graden (mild eller moderat) burde udelades.
English: Time of medication intake and meals
Danish: Tidspunkt for indtagelse af medicin og måltider
English: A variant form is angioedema of the intestine, which tends to occur within the first 24-48 hours of treatment.
Danish: En variant er angioødem i tarmen, som sædvanligvis forekommer inden for de første 24-48 timer efter behandling.
English: In a careful literature search, covering the time period up to November 2009, only a single publication was identified, describing a case report of a patient with diabetic nephropathy and cirrhotic ascites.
Danish: Under en omhyggelig litteratursøgning, som dækker tidsperioden frem til november 2009, blev der kun identificeret en enkelt publikation, som beskrev en forsøgsjournal for en patient med diabetisk nefropati og cirrotisk ascites.
English: Vascace is not suitable for people with certain types of heart problem.
Danish: Vascace er ikke egnet til personer med visse typer af hjerteproblemer.
English: The effect is usually not significant in patients with normal renal function.
Danish: Effekten er som regel ikke signifikant hos patienter med normal nyrefunktion.
English: - Lithium (used to treat depression).
Danish: - Lithium (til behandling af depression).
English: However this does not mean that the use of cilazapril would have to be automatically contraindicated in all types of renovascular hypertension.
Danish: Det betyder dog ikke, at brugen af cilazapril automatisk er kontraindiceret til alle former for renovaskulær hypertension.
English: - Low blood pressure.
Danish: - Lavt blodtryk.
English: - Low numbers of all types of white blood cells.
Danish: - Lavt antal af alle typer hvide blodlegemer.
English: Thereafter, the maintenance dose must be adapted to individual tolerability, response and clinical status.
Danish: Herefter skal vedligeholdelsesdosen tilpasses til den individuelle tolerabilitet, respons og kliniske status.
English: This is because some anaesthetics can lower your blood pressure, and it may become too low.
Danish: Årsagen er, at nogle bedøvelsesmidler kan nedsætte dit blodtryk, og det kan blive for lavt.
English: Your doctor will normally advise you to stop taking Vascace before you become pregnant, or as soon as you know you are pregnant, and will advise you to take another medicine instead of Vascace.
Danish: Lægen vil normalt råde dig til at stoppe med at tage Vascace, før du bliver gravid, eller så snart du ved, at du er gravid, Lægen vil desuden råde dig til at tage en anden medicin i stedet for Vascace.
English: Vascace was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Danish: Vascace blev medtaget på den liste over produkter, for hvilke produktresuméerne skulle harmoniseres, som CMD(h) havde udarbejdet i henhold til artikel 30, stk. 2, i direktiv 2001/83/EF med senere ændringer.
English: In general, the heart rate remains unchanged.
Danish: Hjerterytmen forbliver sædvanligvis uændret.
English: Do not take Vascace - if you are allergic (hypersensitive) to cilazapril or any of the other ingredients of Vascace (listed in section 6: Further information).
Danish: Tag ikke Vascace - hvis du er allergisk (overfølsom) over for cilazapril eller et af de øvrige indholdsstoffer i Vascace (anført i afsnit 6: Yderligere oplysninger).
English: Treatment of hypertension
Danish: Behandling af hypertension
English: Therefore the CHMP was of the view that digitalis should not necessarily be mentioned because concomitant therapy with digitalis in general use (as a basic therapy) is not recommended today.
Danish: Derfor var CHMP af den opfattelse, at digitalis ikke nødvendigvis bør nævnes, eftersom samtidig behandling med digitalis til generel brug (som basisbehandling) ikke anbefales i dag.
English: Consideration should be given to using a different type of dialysis membrane or different class of antihypertensive agent in such patients.
Danish: Det skal overvejes at bruge en anden type dialysemembran eller anden klasse af antihypertensiva til disse patienter.
English: - if you have had a stroke or have problems with the blood supply to your brain.
Danish: - hvis du har haft et slagtilfælde eller har problemer med blodtilførslen til hjernen.
English: The following dosage schedules are recommended:
Danish: Følgende doseringsplaner anbefales:
English: Roche Bulgaria EOOD 16, Bvalo pole Str. 1618 / Sofia Bulgaria
Danish: Roche Bulgaria EOOD 16, Bvalo pole Str. 1618 / Sofia Bulgarien
English: Domaniewska 39B 02-672 / Warsaw Poland
Danish: Domaniewska 39B 02-672 / Warsaw Polen
English: It is effective in all degrees of essential hypertension as well as in renal hypertension.
Danish: Det er effektivt ved alle grader af essentiel hypertension samt renal hypertension.
English: Periodic monitoring of leukocyte count is recommended in such patients.
Danish: Periodisk monitorering af leukocyttallet anbefales hos disse patienter.
English: Cilazapril is efficiently absorbed and rapidly converted to the active form, cilazaprilat.
Danish: Cilazapril absorberes effektivt og konverteres hurtigt til den aktive form, cilazaprilat.
English: Common ≥ 1/100 and < 1/10
Danish: ≥ 1/100 og < 1/10
English: Roche Austria GmbH, Engelhorngasse 3, A - 1211 Vienna Austria
Danish: Roche Austria GmbH, Engelhorngasse 3, A - 1211 VienNa Østrig
English: Due to the large variety of possible clinical situations for cirrhotic patients, conditions exist where patients require a carefully supervised treatment with cilazapril.
Danish: På grund af det store antal mulige kliniske situationer for cirrosepatienters vedkommende er der tilstande, hvor patienterne kræver en nøje overvåget behandling med cilazapril.
English: Like all medicines, Vascace can cause side effects, although not everybody gets them.
Danish: Vascace kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: This phenomenon appeared to be more likely to occur during the first weeks of combined treatment and in patients with renal impairment.
Danish: Sandsynligheden for dette fænomen syntes at være større i de første uger af kombinationsbehandlingen og hos patienter med nedsat nyrefunktion.
English: Roche (Hellas) SA 4, Alamanas & Delfon Str. Maroussi 15125
Danish: Grækenland Roche (Hellas) SA 4, AlamaNas & Delfon Str. Maroussi 15125
English: This helps to lower your blood pressure.
Danish: Dette hjælper til at sænke blodtrykket.
English: Ingestion of food immediately prior to Vascace administration delays and reduces absorption to a minor extent which, however, is therapeutically irrelevant.
Danish: Indtagelse af føde umiddelbart inden administration af Vascace forsinker og nedsætter absorptionen i mindre grad, hvilket er terapeutisk irrelevant.
English: Roche Nederland BV Beneluxlaan 2A 3446 GG Woerden Netherlands
Danish: Roche Nederland BV Beneluxlaan 2A 3446 GG Woerden Holland
English: “Limited data are available for overdosage in humans.
Danish: "Der er begrænsede data til rådighed om overdosering hos mennesker.