FrancophonIA/ELRC3.0 huggingface dataset:
English: Dizziness, sensory disturbances (including paraesthesia or electric shock like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Danish: De almindeligste bivirkninger er svimmelhed, sensoriske forstyrrelser (inklusive paræstesier og følelsen af elektriske stød, især i hovedet), søvnforstyrrelser (inklusive søvnløshed og intense drømme), træthed, søvnighed, opstemthed eller angst, kvalme og/eller opkastning, rysten, hovedpine, myalgi, irritabilitet, diaré, hyperhidrosis og vertigo.
English: Edible white ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171).
Danish: Spiseligt guldblæk: shellac, propylenglycol, stærk ammoniakopløsning, gul jernoxid (E172) Spiseligt hvidt blæk: shellac, propylenglycol, natriumhydroxid, povidon, titandioxid (E171).
English: Dysgeusia Dyskinesia Restless legs syndrome Poor quality sleep
Danish: Myoclonus Akatisi Nervøsitet Koncentrationsbesvær Dysgeusi Dyskinesi Uro i benene Dårlig søvnkvalitet
English: Do not take more than the daily amount of Duloxetine Mylan that has been prescribed for you in one day.
Danish: Du må ikke tage mere Duloxetine Mylan pr. dag, end lægen har ordineret.
English: Orgasm abnormal Abnormal dreams
Danish: Abnorm orgasme
English: Stomatitis Haematochezia Breath odour Microscopic colitis
Danish: Dårlig ånde Mikroskopisk kolitis10
English: The starting and recommended maintenance dose is 60 mg once daily with or without food.
Danish: Startdosering samt den anbefalede vedligeholdelsesdosering er 60 mg en gang dagligt uden hensyntagen til måltider.
English: Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebocontrolled clinical trials.
Danish: Estimeret hyppighed baseret på placebokontrollerede kliniske studier Estimeret hyppighed baseret på rapporterede bivirkninger under overvågning efter markedsføring; ikke observeret i placebokontrollerede kliniske studier.
English: Eosinophilic pneumonia9
Danish: Interstitiel lungesygdom Eosinofil pneumoni
English: The use of Duloxetine Mylan while breast-feeding is not recommended.
Danish: Det anbefales ikke at bruge Duloxetine Mylan, mens du ammer.
English: Concomitant use of Duloxetine Mylan with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Danish: Duloxetine Mylan må ikke anvendes sammen med ikke-selektive, irreversible monoaminoxidasehæmmere (MAO-hæmmere) (se pkt.
English: Gold ink
Danish: Guldblæk
English: Blood pressure increase Flushing
Danish: Vaskulære sygdomme Forhøjet blodtryk
English: Menopausal symptoms
Danish: Ekstrapyramidale symptomer
English: Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine (as hydrochloride)
Danish: Duloxetine Mylan 30 mg hårde enterokapsler Duloxetine Mylan 60 mg hårde enterokapsler duloxetin (som hydrochlorid)
English: Duloxetine Mylan may be taken with or without food.
Danish: Brug af Duloxetine Mylan sammen med mad, drikke og alkohol Duloxetine Mylan kan tages med og uden mad.
English: The starting and recommended maintenance dose is 60 mg daily with or without food.
Danish: Startdosering samt den anbefalede vedligeholdelsesdosering er 60 mg daglig uden hensyntagen til måltider.
English: The 60 mg capsules have an opaque blue cap and opaque yellow body, imprinted in white ink with ‘MYLAN' over ‘DL 60' on both the cap and the body.
Danish: Kapslerne med 60 mg har en uigennemsigtig blå kapseltop og uigennemsigtig gul kapselbund, påtrykt ‘MYLAN' over ‘DL 60'med hvidt blæk både på top og bund.
English: Opaque blue cap and opaque yellow body approximately 21.7 mm, imprinted in white ink with ‘MYLAN' over ‘DL 60' on both the cap and the body.
Danish: Uigennemsigtig blå kapseltop og uigennemsigtig gul kapselbund, cirka 21,7 mm, påtrykt ‘MYLAN' over ‘DL 60'med hvidt blæk både på top og bund.
English: Puh/Tel: +358 20 720 9555
Danish: Suomi/Finland Mylan Finland OY Puh/Tel: +358 20 720 9555
English: Gastrointestinal disorders Nausea
Danish: Opstød Gastritis Dysfagi
English: What Duloxetine Mylan is and what it is used for What you need to know before you take Duloxetine Mylan How to take Duloxetine Mylan Possible side effects
Danish: Det skal du vide, før du begynder at tage Duloxetine Mylan Sådan skal du tage Duloxetine Mylan Bivirkninger
English: Renal impairment: End stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine Cmax and AUC values compared with healthy subjects.
Danish: Nedsat nyrefunktion: Patienter med terminal nyresygdom i dialysebehandling havde et dobbelt så højt duloxetin-Cmaks.
English: Do not take Duloxetine Mylan if you: - are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6) - have liver disease - have severe kidney disease
Danish: • er allergisk over for duloxetin eller et af de øvrige indholdsstoffer i Duloxetine Mylan (angivet i afsnit 6).
English: Hyperglycaemia (reported especially in diabetic patients)
Danish: Metabolisme og ernæring Nedsat appetit Hyperglykæm i (især rapporteret
English: Duloxetine Mylan must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Danish: Duloxetine Mylan må ikke gives til patienter med nedsat leverfunktion på grund af leversygdom (se pkt.
English: Dizziness Lethargy Tremor Paraesthesia
Danish: Svimmelhed Letargi Tremor Paræstesier
English: Galactorrhoea Hyperprolactinaemia Postpartum haemorrhage
Danish: Menopausale symptomer Galaktorré Hyperprolaktin æmi
English: Opaque blue cap and opaque white body approximately 15.9 mm, imprinted in gold ink with ‘MYLAN' over ‘DL 30' on both the cap and the body.
Danish: Uigennemsigtig blå kapseltop og uigennemsigtig hvid kapselbund, cirka 15,9 mm, påtrykt ‘MYLAN' over ‘DL 30'med guldfarvet blæk både på top og bund.
English: Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
Danish: Titandioxid (E171) Gelatine
English: The 30 mg capsules have an opaque blue cap and opaque white body, imprinted in gold ink with ‘MYLAN' over ‘DL 30' on both the cap and the body.
Danish: Kapslerne med 30 mg har en uigennemsigtig blå kapseltop og uigennemsigtig hvid kapselbund, påtrykt ‘MYLAN' over ‘DL 30'med guldfarvet blæk både på top og bund.
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium perforated unit dose blister pack containing 7 x 1, 28 x 1 and 30 x 1 hard gastro-resistant capsules.
Danish: Perforeret enkeltdosisblisterpakning af PVC/PCTFE/Aluminium eller OPA/Aluminium/PVCAluminium med 7 x 1, 28 x 1 og 30 x 1 hårde enterokapsler.
English: How to take Duloxetine Mylan
Danish: Sådan skal du tage Duloxetine Mylan
English: • coughing, wheezing and shortness of breath which may be accompanied by a high temperature
Danish: • symptomer på overgangsalder, unormal mælkeproduktion hos mænd og kvinder hoste, hvæsende vejrtrækning og åndenød, som kan være ledsaget af en høj temperatur kraftig vaginal blødning kort efter fødslen (postpartum blødning)
English: 60 mg capsules Each capsule contains 60 mg of duloxetine (as hydrochloride).
Danish: 60 mg kapsler Hver kapsel indeholder 60 mg duloxetin (som hydrochlorid).
English: Uncommon side effects (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter)
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Duloxetine Mylan indeholder saccharose og natrium Hvis din læge har fortalt dig, at du ikke kan tåle visse sukkerarter, skal du kontakte din læge, inden du tager denne medicin.
English: PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 7 x 1 and 28 x 1 hard gastro-resistant capsules.
Danish: Perforeret enkeltdosisblisterpakning af PVC/PE/PVdC/Aluminium med 7 x 1 og 28 x 1 hårde enterokapsler.
English: 30 mg capsules Each capsule contains 30 mg of duloxetine (as hydrochloride).
Danish: 30 mg kapsler Hver kapsel indeholder 30 mg duloxetin (som hydrochlorid).
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter)
English: BOTTLE LABEL FOR 60 MG HARD GASTRO RESISTANT CAPSULES
Danish: ETIKET TIL FLASKE TIL 60 mg HÅRDE ENTEROKAPSLER
English: If you stop taking Duloxetine Mylan
Danish: Hvis du har taget for meget Duloxetine Mylan
English: 60 mg capsules EU/1/15/1010/011 EU/1/15/1010/012 EU/1/15/1010/013 EU/1/15/1010/014 EU/1/15/1010/015
Danish: 30 mg kapsler EU/1/15/1010/001 EU/1/15/1010/002 EU/1/15/1010/003
English: Serotonin syndrome Convulsion Psychomotor restlessness Extra-pyramidal symptoms
Danish: Serotoninsyndrom Kramper Psykomotorisk uro
English: BLISTER INNER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT CAPSULES, WITHOUT BLUE BOX
Danish: INDRE BLISTERKARTON TIL MULTIPAKNING MED 60 mg HÅRDE ENTEROKAPSLER, UDEN BLÅ BOKS
English: BLISTER CARTON FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Danish: BLISTERKARTON TIL 30 mg HÅRDE ENTEROKAPSLER
English: Interstitial lung disease
Danish: Obstipation Diarré
English: In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label duloxetine 60 mg once daily were randomised to either duloxetine 60 mg once daily or placebo for a further 6-months.
Danish: I et studie med forebyggelse af tilbagefald, hvor patienterne blev randomiserede til enten duloxetin 60 mg eller placebo, efter 12-ugers akut behandling med open-label duloxetin 60 mg én gang dagligt viste duloxetin 60 mg én gang dagligt sig statistisk signifikant bedre end placebo (p=0,004) på den primære parameter, som var forebyggelsen af depressive tilbagefald målt som tid til tilbagefald.
English: BLISTER INNER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT CAPSULES, WITHOUT BLUE BOX
Danish: INDRE BLISTERKARTON TIL MULTIPAKNING MED 30 mg HÅRDE ENTEROKAPSLER, UDEN BLÅ BOKS
English: Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules
Danish: Duloxetine Mylan 30 mg hårde enterokapsler Duloxetine Mylan 60 mg hårde enterokapsler
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium blister pack containing 14, 28, 84, 98 and multipacks containing 98 (2 packs of 49) hard gastro resistant capsules.
Danish: PVC/PCTFE/Aluminium eller OPA/Aluminium/PVC - Aluminium-blisterpakning med 14, 28, 84, 98 og multipakninger med 98 (2 pakninger med 49) hårde enterokapsler.
English: Muscle spasm
Danish: Muskelstivhe d
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium perforated unit dose blister pack containing 28 x 1, 30 x 1 and 100 x 1 hard gastro resistant capsules PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 28 x 1 hard gastro-resistant capsules.
Danish: Perforeret enkeltdosisblisterpakning af PVC/PCTFE/Aluminium eller OPA/Aluminium/PVCAluminium med 28 x 1, 30 x 1 og 100 x 1 hårde enterokapsler.
English: BLISTER CARTON FOR 60 MG HARD GASTRO RESISTANT CAPSULES
Danish: BLISTERKARTON TIL 60 mg HÅRDE ENTEROKAPSLER
English: BLISTER OUTER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT CAPSULES, WITH BLUE BOX
Danish: YDRE BLISTERKARTON TIL MULTIPAKNING MED 60 mg HÅRDE ENTEROKAPSLER, MED BLÅ BOKS
English: Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride).
Danish: Hver kapsel indeholder 30 mg eller 60 mg duloxetin som hydrochlorid.
English: You may be more likely to think like this if you: - have previously had thoughts about killing or harming yourself - are a young adult.
Danish: • tidligere har haft tanker om at begå selvmord eller at gøre skade på dig selv.
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium blister pack containing 7, 14, 28, 98 and multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules.
Danish: PVC/PCTFE/Aluminium eller OPA/Aluminium/PVC - Aluminium-blisterpakning med 7, 14, 28, 98 og multipakninger med 98 (2 pakninger med 49) hårde enterokapsler.
English: BLISTER OUTER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT CAPSULES, WITH BLUE BOX
Danish: YDRE BLISTERKARTON TIL MULTIPAKNING MED 30 mg HÅRDE ENTEROKAPSLER, MED BLÅ BOKS
English: Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine
Danish: Duloxetine Mylan 60 mg hårde enterokapsler duloxetin
English: Haemorrhage
Danish: Muskelsitren
English: Duloxetine Mylan 30 mg hard gastro-resistant capsules duloxetine
Danish: Duloxetine Mylan 30 mg hårde enterokapsler duloxetin
English: PVC/PE/PVdC/Aluminium blister pack containing 7, 14, 28, 49, 98 and multipacks containing 98 (2 packs of 49) hard gastro resistant capsules.
Danish: PVC/PE/PVdC/Aluminium-blisterpakning med 7, 14, 28, 49, 98 og multipakninger med 98 (2 pakninger med 49) hårde enterokapsler.
English: Do not stop taking Duloxetine Mylan, or change your dose, without talking to your doctor.
Danish: Du må kun stoppe behandlingen eller ændre dosis efter aftale med lægen.
English: PVC/PE/PVdC/Aluminium blister pack containing 14, 28, 49, 98 and multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules.
Danish: PVC/PE/PVdC/Aluminium-blisterpakning med 14, 28, 49, 98 og multipakninger med 98 (2 pakninger med 49) hårde enterokapsler.
English: Appetite
Danish: Apati
English: BOTTLE LABEL FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Danish: ETIKET TIL BEHOLDER TIL 30 mg HÅRDE ENTEROKAPSLER
English: Renal and urinary disorders Dysuria
Danish: Infektioner og parasitære sygdomme Laryngitis
English: - are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Duloxetine Mylan') - are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections - are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Mylan')
Danish: • samtidig tager anden medicin, som indeholder duloxetin (se ”Brug af anden medicin sammen med Duloxetine Mylan”).
English: Dermatitis contact Cold sweat Photo-sensitivity reactions
Danish: Nattesved Urticaria Kontaktdermatitis Koldsved Lysfølsmheds -reaktioner Øget tendens til at få blå mærker
English: Hepatic impairment
Danish: Stomatitis Hæmatokeksi
English: Night sweats Urticaria
Danish: Nyrer og urinveje Dysuri
English: Somnolence
Danish: Blødning
English: BOTTLE CARTON FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Danish: KARTON TIL BEHOLDER TIL 30 mg HÅRDE ENTEROKAPSLER
English: In both studies, duloxetine 60 mg once daily and 60 mg twice daily significantly reduced pain compared with placebo.
Danish: Duloxetin blev givet i to forskellige dagsdoser: 60 mg én gang dagligt og 60 mg to gange dagligt.
English: BOTTLE CARTON FOR 60 MG HARD GASTRO RESISTANT CAPSULES
Danish: KARTON TIL BEHOLDER TIL 60 mg HÅRDE ENTEROKAPSLER
English: The effect of duloxetine 60 mg once a day in elderly depressed patients (≥65 years) was specifically examined in a study that showed a statistically significant difference in the reduction of the HAMD17
Danish: I et studie med ældre depressive patienter ( 65 år), som viste en statistisk signifikant forskel i reduktionen i HAMD17-scoren for duloxetinbehandlede patienter sammenlignet med placebo, blev effekten af duloxetin 60 mg en gang dagligt særligt undersøgt.
English: EU/1/15/1010/016 EU/1/15/1010/017 EU/1/15/1010/018 EU/1/15/1010/019 EU/1/15/1010/020 EU/1/15/1010/029 EU/1/15/1010/030 EU/1/15/1010/031 EU/1/15/1010/032 EU/1/15/1010/033 EU/1/15/1010/034 EU/1/15/1010/035 EU/1/15/1010/036 EU/1/15/1010/039 EU/1/15/1010/040 EU/1/15/1010/049 EU/1/15/1010/050 EU/1/15/1010/051 EU/1/15/1010/052 EU/1/15/1010/053 EU/1/15/1010/054
Danish: 60 mg kapsler EU/1/15/1010/011 EU/1/15/1010/012 EU/1/15/1010/013 EU/1/15/1010/014 EU/1/15/1010/015 EU/1/15/1010/016 EU/1/15/1010/017 EU/1/15/1010/018 EU/1/15/1010/019 EU/1/15/1010/020 EU/1/15/1010/029 EU/1/15/1010/030 EU/1/15/1010/031 EU/1/15/1010/032 EU/1/15/1010/033 EU/1/15/1010/034 EU/1/15/1010/035 EU/1/15/1010/036 EU/1/15/1010/039 EU/1/15/1010/040 EU/1/15/1010/049 EU/1/15/1010/050 EU/1/15/1010/051 EU/1/15/1010/052 EU/1/15/1010/053 EU/1/15/1010/054
English: 30 mg capsules EU/1/15/1010/001 EU/1/15/1010/002 EU/1/15/1010/003 EU/1/15/1010/004 EU/1/15/1010/005 EU/1/15/1010/006 EU/1/15/1010/007 EU/1/15/1010/008 EU/1/15/1010/009 EU/1/15/1010/010 EU/1/15/1010/021 EU/1/15/1010/022 EU/1/15/1010/023 EU/1/15/1010/024 EU/1/15/1010/025 EU/1/15/1010/026 EU/1/15/1010/027 EU/1/15/1010/028 EU/1/15/1010/037 EU/1/15/1010/038 EU/1/15/1010/041 EU/1/15/1010/042 EU/1/15/1010/043 EU/1/15/1010/044 EU/1/15/1010/045 EU/1/15/1010/046 EU/1/15/1010/047 EU/1/15/1010/048
Danish: EU/1/15/1010/004 EU/1/15/1010/005 EU/1/15/1010/006 EU/1/15/1010/007 EU/1/15/1010/008 EU/1/15/1010/009 EU/1/15/1010/010 EU/1/15/1010/021 EU/1/15/1010/022 EU/1/15/1010/023 EU/1/15/1010/024 EU/1/15/1010/025 EU/1/15/1010/026 EU/1/15/1010/027 EU/1/15/1010/028 EU/1/15/1010/037 EU/1/15/1010/038 EU/1/15/1010/041 EU/1/15/1010/042 EU/1/15/1010/043 EU/1/15/1010/044 EU/1/15/1010/045 EU/1/15/1010/046 EU/1/15/1010/047 EU/1/15/1010/048
English: The usual dose of Duloxetine Mylan is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Danish: Den anbefalede dosis af Duloxetine Mylan er 60 mg én gang dagligt.
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of duloxetine 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Danish: Hos de patienter, som responderede på 8-ugers akut behandling med 60 mg duloxetin en gang dagligt i et open-label, langtids, ukontrolleret studie, holdt smertereduktionen i yderligere 6 måneder.
English: (see ‘Pregnancy and breast-feeding) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Mylan')
Danish: (monoaminoxidasehæmmer) (se ”Brug af anden medicin sammen med Duloxetine Mylan”).
English: Laryngitis
Danish: Dosering
English: Mydriasis Visual impairment
Danish: Sløret syn Mydriasis Nedsat syn
English: Palpitations
Danish: Epistaxis
English: What Duloxetine Mylan looks like and contents of the pack Duloxetine Mylan is hard gastro-resistant capsule.
Danish: Duloxetine Mylan er en hård enterokapsel.
English: Generalised anxiety disorder
Danish: Generel unormal følelse
English: Hepatic failure Jaundice
Danish: Synkope Hypertension
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL 30 mg HÅRDE ENTEROKAPSLER
English: Excipients
Danish: Perikon
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicants and marketing authorisation holders in the member states
Danish: Liste over lægemidlets navne, lægemiddelformer, styrker, indgivelsesvej samt indehavere af markedsføringstilladelse i medlemsstaterne
English: Ericapark 38
Danish: Consulting Ericapark 38
English: 2403 EG Alphen aan den Rijn
Danish: 2403 EG Alphen aan den Rijn The Netherlands
English: Pharmaceuticals Limited
Danish: Mercury Pharmaceuticals Limited
English: Addiscombe Road, Croydon, Surrey CR0 0XT, United Kingdom
Danish: Addiscombe Road, Croydon, Surrey CR0
English: Concentrate for solution for infusion
Danish: Koncentrat till infusionsvæske, opløsning
English: Belgium Magenta Pharma Consulting
Danish: Magenta Pharma
English: 1 mg/ml (5ml)
Danish: 1 mg/ml (5ml) Injektionsvæske, opløsning
English: Astellas Pharma B.V. Sylviusweg 62
Danish: Sylviusweg 62
English: Belgium
Danish: FRANCE
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Danish: Resultat af en procedure i henhold til artikel 30 i direktiv 2001/83/EF
English: Further treatment can be given under medical supervision.
Danish: Der kan gives yderligere behandling under lægeligt opsyn.
English: The areas harmonised include:
Danish: De harmoniserede afsnit omfatter:
English: The European Commission issued a decision on 30 September 2010.
Danish: Europa-Kommissionen traf en afgørelse den 30 september 2010.
English: The company that markets these medicines is Leo Pharmaceutical Products.
Danish: Den virksomhed, der markedsfører disse lægemidler, er Leo Pharmaceutical Products.
English: What is Daivobet?
Danish: Hvad er Daivobet?
English: The recommended treatment period for the ointment is four weeks.
Danish: Den anbefalede behandlingsperiode for salven er fire uger.
English: Jens Ersbøll (Denmark)
Danish: Jens Ersbøll (Danmark)
English: Daivobet ointment was authorised in some Member States through a mutual recognition procedure and in others through national procedures.
Danish: Daivobet salve blev i nogle medlemsstater godkendt via en gensidig anerkendelsesprocedure og i andre medlemsstater via nationale procedurer.
English: No more than 15 g of the gel or ointment should be used in one day.
Danish: Der bør ikke anvendes mere end 15 g gel eller salve om dagen.
English: Daivobet gel was authorised via a decentralised procedure.
Danish: Daivobet gel blev godkendt via en decentral procedure.
English: Why was Daivobet reviewed?
Danish: Hvorfor blev Daivobet undersøgt igen?
English: Daivobet contains two active substances: calcipotriol and betamethasone.
Danish: Daivobet indeholder to aktive stoffer: calcipotriol og betamethason.
English: It is available as a gel and ointment and is used topically (applied on the skin).
Danish: Det fås som gel og salve, og det anvendes topisk (smøres på huden).
English: The European Medicines Agency has completed a review of Daivobet.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Daivobet.
English: Daivobet is also available in the EU under the trade name Dovobet.
Danish: Daivobet fås også i EU under handelsnavnet Dovobet.
English: On 10 March 2010, Leo Pharmaceutical Products referred Daivobet to the CHMP in order to harmonise the marketing authorisations for the product in the EU.
Danish: Den 10. marts 2010 indbragte Leo Pharmaceutical Products Daivobet for CHMP med henblik på at harmonisere markedsføringstilladelserne for lægemidlet i EU.
English: Because of this, there are some differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.
Danish: Derfor er der nogle forskelle i produktresuméerne, etiketteringen og indlægssedlerne i de lande, hvor lægemidlerne bliver markedsført.
English: The Committee also harmonised a list of contra-indications related to skin conditions, including viral lesions of the skin, fungal or bacterial skin infections, parasitic infections and skin problems caused by tuberculosis or syphilis.
Danish: Udvalget harmoniserede ligeledes en liste over kontraindikationer i forbindelse med hudsygdomme, herunder virale hudlæsioner, svampe- eller bakterieinfektioner, parasitinfektioner og hudproblemer som følge af tuberkulose eller syfilis.
English: Questions and answers on Daivobet and associated names (calcipotriol/betamethasone gel and ointment, 50 micrograms/0.5 mg per g) EMA/CHMP/466386/2010
Danish: Spørgsmål og svar vedrørende Daivobet og tilknyttede navne (calcipotriol/betamethason gel og salve, 50 mikrogram/0,5 mg/g) EMA/CHMP/466386/2010
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Daivobet in the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Daivobet i Den Europæiske Union (EU).
English: Questions and answers on Daivobet and associated names (calcipotriol/betamethasone gel and ointment, 50 micrograms/0.5 mg per g)
Danish: Spørgsmål og svar vedrørende Daivobet og tilknyttede navne (calcipotriol/betamethason gel og salve, 50 mikrogram/0,5 mg/g)