FrancophonIA/ELRC3.0 huggingface dataset:
English: Daivobet ointment in tubes of 15 g, 30 g, 60 g, 100 g or 120 g
Danish: Pakningsstørrelser: 15 g, 30 g, 60 g, 100 g og 120 g.
English: Apply Daivobet to the affected area with your fingertips, and rub it in gently - For treatment of the scalp usually an amount between 1 g and 4 g per day is sufficient (4 g corresponds to one teaspoon) - Washing your hair before application of Daivobet is not necessary - In order to achieve optimal effect, it is recommended that the hair is not washed immediately after application of Daivobet.
Danish: Påfør Daivobet på de angrebne steder med fingerspidserne og gnid den forsigtigt ind. - Normalt er 1-4 g om dagen nok til behandling af hårbunden (4 g svarer til en teskefuld).
English: Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g gel [See Annex I - To be completed nationally] calcipotriol/betamethasone
Danish: Daivobet og tilhørende navne (se bilag I) 50 mikrogram/0,5 mg/g gel [Se bilag I - Udfyldes nationalt] calcipotriol/betamethason
English: One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Danish: Et gram salve indeholder 50 mikrogram calcipotriol (som monohydrat) og 0,5 mg betamethason (som dipropionat).
English: Dovobet 50 microgram/g + 0.5 mg/g ointment
Danish: 50 microgram/g + 0.5 mg/g ointment
English: Daivobet 50 míkrógrömm/0 ,5 mg/g hlaup
Danish: 50 míkrógrömm/0,5 mg/g hlaup
English: When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30 % (see section 4.4).
Danish: Kroppens samlede areal behandlet med calcipotriol bør ikke overstige 30 % (se pkt.
English: Keep the bottle in the outer carton in order to protect from light - Discard the bottle with any remaining gel 3 months after first opening.
Danish: Opbevar flasken i yderkartonen beskyttet mod lys.
English: NAME OF THE MEDICINAL PRODUCT Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g gel [See Annex I - To be completed nationally]
Danish: Daivobet og tilhørende navne (se bilag I) 50 mikrogram/0,5 mg/g gel [Se bilag I - Udfyldes nationalt]
English: Topical treatment of mild to moderate “non-scalp” plaque psoriasis vulgaris in adults.
Danish: Topikal behandling af mild til moderat plaque psoriasis på resten af kroppen hos voksne.
English: Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g ointment [See Annex I - To be completed nationally] Calcipotriol/betamethasone
Danish: Daivobet og tilhørende navne (se bilag I) 50 mikrogram/0,5 mg/g salve [Se bilag I - Udfyldes nationalt] calcipotriol/betamethason
English: Daivobet 50 microgramos/g + 0,5 mg/g pomada
Danish: 50 microgramos/g + 0,5 mg/g pomada
English: Another randomised, investigator-blinded clinical study including 312 patients with scalp psoriasis of at least moderate severity according to the IGA investigated use of Daivobet gel once daily compared with Daivonex Scalp solution twice daily for up to 8 weeks.
Danish: Brugen af Daivobet gel én gang dagligt blev sammenlignet med Daivonex kutanopløsning til hårbunden to gange dagligt i op til 8 uger.
English: Polyoxypropylene-15 stearyl ether Castor oil, hydrogenated Butylhydroxytoluene (E321) All-rac-α-tocopherol
Danish: Polyoxypropylen-15-stearylether Ricinusolie, hydrogeneret Butylhydroxytoluen (E321)
English: DAIVOBET 50 µg/g + 0.5 mg/g
Danish: Daivobet ointment 50 μg/g + 0,5 mg/g
English: If you have an allergic reaction, stop taking Daivobet, tell your doctor immediately or go to the casualty department at your nearest hospital - Treatment with this ointment may cause the level of calcium in your blood or urine to increase (usually when too much ointment has been used).
Danish: Hvis du får en allergisk reaktion, skal du stoppe behandlingen med Daivobet og øjeblikkeligt kontakte din læge eller tage på nærmeste skadestue.
English: Dovobet 50 microgram/g + 0.5 mg/g
Danish: 50 microgram/g + 0.5 mg/g
English: Pruritus
Danish: Udslæt
English: STATEMENT OF ACTIVE SUBSTANCE(S) One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et gram gel indeholder 50 mikrogram calcipotriol (som monohydrat) og 0,5 mg betamethason (som dipropionat).
English: United Kingdom LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55
Danish: Storbritannien LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55
English: Polyoxypropylene-15 stearyl ether
Danish: Polyoxypropylen-15-stearylether all-rac-α-tocopherol
English: NAME OF THE MEDICINAL PRODUCT Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g ointment [See Annex I - To be completed nationally]
Danish: Daivobet og tilhørende navne (se bilag I) 50 mikrogram/0,5 mg/g salve [Se bilag I - Udfyldes nationalt]
English: Very common ≥1/10 Common
Danish: Meget almindelig Almindelig
English: DAIVOBET OINTMENT
Danish: Daivobet salve
English: Daivobet ointment
Danish: DAIVOBET SALVE
English: Less serious side effects known to be caused by calcipotriol include the following - Dry skin - Sensitivity of the skin to light resulting in a rash has also been reported - Eczema.
Danish: - Tør hud - Udslæt som følge af, at huden er blevet lysfølsom - Eksem.
English: If you have an allergic reaction, stop taking Daivobet, tell your doctor immediately or go to the casualty department at your nearest hospital - Treatment with this gel may cause the level of calcium in your blood or urine to increase (usually when too much gel has been used).
Danish: - Behandling med denne gel kan give øget kalciumkoncentration i dit blod og din urin (sædvanligvis hvis du har brugt for meget af gelen).
English: The CHMP found that there was no clear statement that this product should not be used there and endorsed the following harmonised wording: “Skin of the face and genitals are very sensitive to corticosteroids.
Danish: CHMP var af den opfattelse, at der ikke var nogen klar information om, at lægemidlet ikke må bruges på de pågældende områder, og CHMP
English: or an increase in pressure inside your eye (signs are eye pain, red eye, decreased or cloudy vision) - Infections (because your immune system, which fights infections, may be suppressed or weakened) - Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet).
Danish: - Infektioner (fordi dit immunsystem, som bekæmper infektioner, kan blive undertrykt eller svækket).
English: Dovobet 50 microgram/g + 0.5 mg/g gel
Danish: 50 microgram/g + 0.5 mg/g gel
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dacogen on 20 September 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dacogen den 20. september 2012.
English: This is a summary of the European public assessment report (EPAR) for Dacogen.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Dacogen.
English: In a 4-week treatment cycle, Dacogen is given daily for the first 5 days.
Danish: Over et fire ugers behandlingsforløb gives Dacogen dagligt de første fem dage.
English: At least 4 treatment cycles are recommended but they can be continued for as long as the AML remains under control.
Danish: Der anbefales mindst fire behandlingsforløb, men de kan fortsættes, så længe som AML stadig holdes under kontrol.
English: The dose is calculated using the patient's height and weight.
Danish: Dosis afhænger af patientens højde og vægt.
English: Dacogen decitabine
Danish: Dacogen decitabin
English: Other information about Dacogen
Danish: Andre oplysninger om Dacogen
English: Patients receiving Dacogen lived for an average of 7.7 months compared with 5.0 months for patients receiving supportive care or treatment with cytarabine.
Danish: De patienter, der fik Dacogen, levede i gennemsnit 7,7 måneder, sammenholdt med 5,0 måneder for patienter, der fik støttende behandling eller behandling med cytarabin.
English: What measures are being taken to ensure the safe and effective use of Dacogen?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Dacogen?
English: Treatment was given for as long as patients benefited from it.
Danish: Behandlingen fortsatte, så længe det var til fordel for patienterne.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dacogen.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Dacogen.
English: These enzymes promote the development and progression of cancer.
Danish: Disse enzymer er ansvarlige for kræftens opståen og udvikling.
English: Treatment with Dacogen should be started under the supervision of a doctor who has experience in the use of chemotherapy.
Danish: Behandling med Dacogen bør indledes under opsyn af en læge med erfaring i at anvende kemoterapi.
English: For more information about treatment with Dacogen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Dacogen, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Because the number of patients with AML is low, the disease is considered ‘rare', and Dacogen was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2006.
Danish: Da antallet af patienter med AML er lavt, betragtes sygdommen som "sjælden", og Dacogen blev udpeget som "lægemiddel til sjældne sygdomme" den 8. juni 2006.
English: If a patient develops certain severe side effects, the doctor may decide to delay or stop Dacogen treatment.
Danish: Hvis patienten får svære bivirkninger, kan lægen beslutte at udsætte eller standse behandlingen med Dacogen.
English: It is used in patients who are not eligible for standard induction chemotherapy (initial treatment with cancer medicines).
Danish: Det anvendes hos patienter, som ikke kan få en traditionel indledende kemoterapi (indledende behandling med kræftlægemidler).
English: The full EPAR for Dacogen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Dacogen findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: There were no major safety concerns with Dacogen and the overall safety profile was similar to that of low-dose cytarabine but some side effects such as infections and neutropenia were more common with Dacogen.
Danish: Der var ingen større sikkerhedsmæssige betænkeligheder forbundet med Dacogen, og den overordnede sikkerhedsprofil svarede til sikkerhedsprofilen af lavdosis cytarabin bortset fra visse bivirkninger såsom infektioner og neutropeni, som var mere almindelige med Dacogen.
English: The main measure of effectiveness was how long the patients lived.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienterne overlevede.
English: As it is not known whether the active substance is excreted in breast milk, in the event that a patient is breastfeeding, they must discontinue breastfeeding if they require treatment with Dacogen.
Danish: Da det ikke vides, om det aktive stof udskilles i modermælk, skal patienter, der ammer, ophøre dermed, hvis de skal behandles med Dacogen.
English: The CHMP noted that the improvement in survival with Dacogen in patients with AML was modest but relevant, as the benefits of current treatments are limited in patients who are not eligible for standard induction chemotherapy.
Danish: CHMP fandt, at forbedringen i overlevelse med Dacogen hos patienter med AML var beskeden, men relevant, idet fordelene ved de nuværende behandlingsmuligheder er begrænsede hos patienter, som ikke kan få en traditionel indledende kemoterapi.
English: The CHMP decided that Dacogen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Dacogen opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Dacogen.
English: Dacogen was compared with either supportive care (any medicine or technique to help patients, excluding cancer medicines or surgery) or low-dose cytarabine (another cancer medicine).
Danish: Dacogen blev sammenlignet med enten støttebehandling (enhver medicin eller teknik, der anvendes til at hjælpe patienterne, bortset fra kræftmedicin og operation) eller lavdosis cytarabin (et andet lægemiddel mod kræft).
English: The active substance in Dacogen, decitabine, is a cytidine deoxynucleoside analogue.
Danish: Det aktive stof i Dacogen, decitabin, er en "cytidindeoxynukleosid-analog".
English: In the body, decitabine is converted into decitabine triphosphate, which is then incorporated into the DNA where it blocks the activity of enzymes called DNA methyltransferases (DNMTs).
Danish: I kroppen omdannes decitabin til decitabintrifosfat, som derefter indbygges i dna, hvor det blokerer enzymerne dna-metyltransferaser (DNMT).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Dacogen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Dacogen findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What is the risk associated with Dacogen?
Danish: Hvilken risiko er der forbundet med Dacogen?
English: Dacogen is used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
Danish: Dacogen anvendes til at behandle patienter, der netop har fået stillet diagnosen akut melodi leukæmi (AML), en kræfttype, der påvirker de hvide blodlegemer.
English: Why has Dacogen been approved?
Danish: Hvorfor blev Dacogen godkendt?
English: For the full list of all restrictions and side effects reported with Dacogen, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og bivirkninger ved Dacogen fremgår af indlægssedlen.
English: Dacogen has been studied in one main study involving 485 adults, who were newly diagnosed with AML but were not eligible for standard induction chemotherapy.
Danish: Dacogen blev undersøgt i en hovedundersøgelse, der omfattede 485 voksne, som netop havde fået stillet diagnosen AML, men som ikke kan få en traditionel indledende kemoterapi.
English: This means that it is similar to cytidine deoxynucleoside, a fundamental component of the DNA (genetic material) of cells.
Danish: Det vil sige, at det ligner cytidindeoxynukleosid, der er en grundlæggende byggesten i cellernes genetiske materiale.
English: Dacogen is given as an infusion into a vein over one hour.
Danish: Dacogen gives i en vene ved en infusion, der varer en time.
English: The most common serious side effects (seen in more than 20% of patients) include pneumonia (lung infection), thrombocytopenia, neutropenia (low blood count of neutrophils, a type of white blood cell), febrile neutropenia (low white blood cell count with fever) and anaemia.
Danish: De hyppigste alvorlige bivirkninger (som optrådte hos flere end 20 % af patienterne) er lungebetændelse, trombocytopeni, neutropeni (for lavt antal neutrofiler, der er en type hvide blodlegemer), febril neutropeni (for lavt antal hvide blodlegemer med feber) og anæmi.
English: By blocking DNMTs, decitabine will prevent the increase of tumour cells and lead to their death.
Danish: Ved at blokere DNMT forhindrer decitabin kræftcellerne i at dele sig, og dermed dør de.
English: Dacogen must not be used in people who are breastfeeding.
Danish: Dacogen må ikke gives til ammende kvinder.
English: The most common side effects with Dacogen (seen in more than 35% of patients) are fever, anaemia (low red blood cell count) and thrombocytopenia (low blood platelet count).
Danish: De hyppigste bivirkninger ved Dacogen (som optrådte hos flere end 35 % af patienterne) er feber, anæmi (for lavt antal røde blodlegemer) og trombocytopeni (for lavt antal blodplader).
English: What is Dacogen?
Danish: Hvad er Dacogen?
English: Dacogen can only be obtained with a prescription.
Danish: Lægemidlet udleveres kun efter recept.
English: It contains the active substance decitabine.
Danish: Dacogen indeholder det aktive stof decitabin.
English: What is Dacogen used for?
Danish: Hvad anvendes Dacogen til?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dacogen have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Dacogen.
English: How has Dacogen been studied?
Danish: Hvordan blev Dacogen undersøgt?
English: Dacogen is a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Dacogen er et pulver, der blandes til en infusionsvæske, opløsning, der gives som drop i en vene.
English: What benefit has Dacogen shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Dacogen?
English: How is Dacogen used?
Danish: Hvordan anvendes Dacogen?
English: How does Dacogen work?
Danish: Hvordan virker Dacogen?
English: Previously known as Zenas.
Danish: Tidligere kendt som Zenas.
English: The name of the medicine was changed to Firdapse on 28 January 2010.
Danish: Lægemidlets navn blev ændret til Firdapse den 28. januar 2010.
English: Firdapse has been authorised under ‘exceptional circumstances'.
Danish: Firdapse er blevet godkendt under "særlige omstændigheder".
English: It is available as tablets (10 mg).
Danish: Det fås som tabletter (10 mg).
English: This document is a summary of the European public assessment report (EPAR) for Firdapse.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Firdapse.
English: A risk management plan has been developed to ensure that Firdapse is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Firdapse anvendes så sikkert som muligt.
English: The recommended starting dose of Firdapse is 15 mg per day, which can be increased by 5 mg every four to five days up to a maximum of 60 mg per day.
Danish: Den anbefalede startdosis af Firdapse er på 15 mg om dagen, som kan øges med 5 mg hver 4. eller 5. dag til maksimalt 60 mg om dagen.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zenas on 23 December 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zenas til EUSA Pharma SAS den 23. december 2009.
English: Firdapse is taken in divided doses, three or four times a day, and a single dose should not be more than 20 mg. Firdapse should be taken with food.
Danish: Firdapse tages i doser fordelt på tre eller fire gange om dagen, og en enkelt dosis bør ikke overstige 20 mg. Firdapse skal tages sammen med mad.
English: Because the number of patients with LEMS is low, the disease is considered ‘rare', and Firdapse was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 December 2002.
Danish: Da antallet af patienter, der lider af LEMS, er lavt, betragtes sygdommen som "sjælden", og Firdapse blev udpeget som "lægemiddel til sjældne sygdomme" den 18. december 2002.
English: A medicine with a narrow therapeutic window can easily cause side effects if given at a dose a little higher than the recommended dose.
Danish: Lægemidler med et snævert terapeutisk indeks kan let give bivirkninger, hvis de gives i en lidt højere dosis end den anbefalede dosis.
English: Because amifampridine-containing medicines have been used in the European Union (EU) for over 20 years, the company presented the results of studies from the scientific literature on amifampridine to support the use of Firdapse.
Danish: Eftersom lægemidler indeholdende amifampridin er blevet anvendt i Den Europæiske Union (EU) i over 20 år, fremlagde virksomheden også resultater af undersøgelser fra den videnskabelige litteratur om amifampridin til støtte for anvendelsen af Firdapse.
English: Firdapse is a medicine that contains the active substance amifampridine.
Danish: Firdapse er et lægemiddel, der indeholder det aktive stof amifampridin.
English: Firdapse amifampridine
Danish: amifampridin
English: The company will ensure that all healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry.
Danish: Virksomheden skal sikre, at alle sundhedsmedarbejdere, som forventes at anvende lægemidlet, får informationer om, hvordan de skal indføre deres patienter i registret.
English: Acetylcholine is released from the nerve endings during a period of ‘depolarisation'.
Danish: Acetylcholin frigives fra nerveenderne under en "depolariseringsperiode".
English: Patients with lower NDS or QMG scores have better muscle function.
Danish: Patienter med lavere NDS- eller QMG-scorer har en bedre muskelfunktion.
English: For more information about treatment with Firdapse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Firdapse, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Treatment with Firdapse should only be started under the supervision of a doctor experienced in treating LEMS.
Danish: Behandling med Firdapse bør kun indledes under overvågning af en læge, som har erfaring med behandling af LEMS.
English: Another study combined data from the two published studies and looked at compound muscle action potential (CMAP).
Danish: I en anden undersøgelse kombinerede man data fra de to offentliggjorte undersøgelser og undersøgte det sammensatte motoriske muskelaktionspotentiale (CMAP).
English: Firdapse is used to treat the symptoms of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Danish: Firdapse anvendes til behandling af symptomerne på Lambert-Eatons myastene syndrom (LEMS) hos voksne.
English: Other information about Firdapse
Danish: Andre oplysninger om Firdapse:
English: What measures are being taken to ensure the safe and effective use of Firdapse?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Firdapse?
English: The company that makes Firdapse will provide further data from studies on cancer in experimental models.
Danish: Den virksomhed, der fremstiller Firdapse, vil tilvejebringe yderligere oplysninger fra undersøgelser af kræft i forsøgsmodeller.
English: CMAP is a measure of electrical activity in muscles.
Danish: CMAP er en skala for den elektriske aktivitet i musklerne.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Firdapse.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Firdapse.
English: It must also not be used with medicines that have a narrow therapeutic window.
Danish: Det må heller ikke anvendes sammen med lægemidler, der har et snævert terapeutisk indeks.