natgillin/translations-raw huggingface dataset:
Duloxetine Mylan hårde enterokapsler indeholder saccharose og natrium.
Duloxetine Mylan hard gastro-resistant capsules contain sucrose and sodium.
Der er blevet rapporteret tilfælde af selvmordstanker og -adfærd under duloxetinbehandling eller tidligt efter behandlingens ophør (se pkt.
Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4).
Doseringer over 60 mg en gang daglig op til maksimaldosis på 120 mg om dagen er evalueret ud fra et sikkerhedsmæssigt perspektiv i kliniske studier.
Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day have been evaluated from a safety perspective in clinical trials.
I kliniske studier er der observeret utilsigtede hændelser ved pludselig afbrydelse af behandlingen hos ca. 45% og 23% af patienterne behandlet med hhv. duloxetin og placebo.
In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with duloxetine and 23% of patients taking placebo.
Bivirkninger kan forekomme hyppigere ved samtidig brug af Duloxetine Mylan og naturlægemidler samt kosttilskud indeholdende perikon (hypericum perforatum).
Adverse reactions may be more common during concomitant use of Duloxetine Mylan and herbal preparations containing St John's wort (Hypericum perforatum).
Hjælpestof, som behandleren skal være opmærksom på Hver kapsel indeholder 62,1 mg saccharose.
Excipient(s) with known effect Each capsule contains 62.1 mg sucrose.
Det skal du vide, før du begynder at tage Duloxetine Mylan
What you need to know before you take Duloxetine Mylan
• Stevens-Johnsons syndrom (en alvorlig lidelse med blærer i huden, munden, øjnene og på kønsorganerne), alvorlige allergiske reaktioner, som kan forårsage hævelse i ansigtet eller halsen (angioødem)
• Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals),
Føler sig syg Varmefølelse Gangforstyrrelse
Feeling hot Gait disturbance
Effekten af duloxetin er vist med den anbefalede faste dosis på 60 mg én gang dagligt i tre ud af tre randomiserede dobbeltblinde, placebokontrollerede studier på voksne akutte ambulante patienter med moderate til svære depressioner.
The efficacy of duloxetine at the recommended dose of 60 mg once a day was demonstrated in three out of three randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
I følgende situationer kan du muligvis ikke anvende Duloxetine Mylan.
The following are reasons why Duloxetine Mylan may not be suitable for you.
• svimmelhed, prikkende følelse som når noget sover eller følelse af elektriske stød (især i hovedet), søvnforstyrrelser (livagtige drømme, mareridt, søvnløshed), træthed, søvnighed, rastløshed eller uro, angst, kvalme eller opkastning, rystelser (tremor), hovedpine, muskelsmerter, irritation, diarré, forøget tendens til at svede eller svimmelhed.
• dizziness, tingling feelings like pins and needles or electric shock like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter)
Rare side effects (may affect up to 1 in 1,000 people)
Ortostatisk hypotension Perifer kuldefornemmelse
Syncope Hypertension Orthostatic hypotension Peripheral coldness
Du bedes henvende dig til din læge, hvis din læge har udskrevet Duloxetine Mylan til en patient under 18 år, og du gerne vil diskutere dette.
If your doctor has prescribed Duloxetine Mylan for a patient under 18 and you want to discuss this, please go back to your doctor.
Tørremidlet må ikke spises.
Do not eat the desiccant.
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.
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.
Spiseligt guldblæk: shellac, propylenglycol, stærk ammoniakopløsning, gul jernoxid (E172) Spiseligt hvidt blæk: shellac, propylenglycol, natriumhydroxid, povidon, titandioxid (E171).
Edible white ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171).
Myoclonus Akatisi Nervøsitet Koncentrationsbesvær Dysgeusi Dyskinesi Uro i benene Dårlig søvnkvalitet
Dysgeusia Dyskinesia Restless legs syndrome Poor quality sleep
Du må ikke tage mere Duloxetine Mylan pr. dag, end lægen har ordineret.
Do not take more than the daily amount of Duloxetine Mylan that has been prescribed for you in one day.
Abnorm orgasme
Orgasm abnormal Abnormal dreams
Dårlig ånde Mikroskopisk kolitis10
Stomatitis Haematochezia Breath odour Microscopic colitis
Startdosering samt den anbefalede vedligeholdelsesdosering er 60 mg en gang dagligt uden hensyntagen til måltider.
The starting and recommended maintenance dose is 60 mg once daily with or without food.
Estimeret hyppighed baseret på placebokontrollerede kliniske studier Estimeret hyppighed baseret på rapporterede bivirkninger under overvågning efter markedsføring; ikke observeret i placebokontrollerede kliniske studier.
Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebocontrolled clinical trials.
Interstitiel lungesygdom Eosinofil pneumoni
Eosinophilic pneumonia9
Det anbefales ikke at bruge Duloxetine Mylan, mens du ammer.
The use of Duloxetine Mylan while breast-feeding is not recommended.
Duloxetine Mylan må ikke anvendes sammen med ikke-selektive, irreversible monoaminoxidasehæmmere (MAO-hæmmere) (se pkt.
Concomitant use of Duloxetine Mylan with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Guldblæk
Gold ink
Vaskulære sygdomme Forhøjet blodtryk
Blood pressure increase Flushing
Ekstrapyramidale symptomer
Menopausal symptoms
Duloxetine Mylan 30 mg hårde enterokapsler Duloxetine Mylan 60 mg hårde enterokapsler duloxetin (som hydrochlorid)
Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine (as hydrochloride)
Brug af Duloxetine Mylan sammen med mad, drikke og alkohol Duloxetine Mylan kan tages med og uden mad.
Duloxetine Mylan may be taken with or without food.
Startdosering samt den anbefalede vedligeholdelsesdosering er 60 mg daglig uden hensyntagen til måltider.
The starting and recommended maintenance dose is 60 mg daily with or without food.
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.
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.
Uigennemsigtig blå kapseltop og uigennemsigtig gul kapselbund, cirka 21,7 mm, påtrykt ‘MYLAN' over ‘DL 60'med hvidt blæk både på top og bund.
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.
Opstød Gastritis Dysfagi
Gastrointestinal disorders Nausea
Det skal du vide, før du begynder at tage Duloxetine Mylan Sådan skal du tage Duloxetine Mylan Bivirkninger
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
Nedsat nyrefunktion: Patienter med terminal nyresygdom i dialysebehandling havde et dobbelt så højt duloxetin-Cmaks.
Renal impairment: End stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine Cmax and AUC values compared with healthy subjects.
• er allergisk over for duloxetin eller et af de øvrige indholdsstoffer i Duloxetine Mylan (angivet i afsnit 6).
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
Metabolisme og ernæring Nedsat appetit Hyperglykæm i (især rapporteret
Hyperglycaemia (reported especially in diabetic patients)
Duloxetine Mylan må ikke gives til patienter med nedsat leverfunktion på grund af leversygdom (se pkt.
Duloxetine Mylan must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Svimmelhed Letargi Tremor Paræstesier
Dizziness Lethargy Tremor Paraesthesia
Menopausale symptomer Galaktorré Hyperprolaktin æmi
Galactorrhoea Hyperprolactinaemia Postpartum haemorrhage
Uigennemsigtig blå kapseltop og uigennemsigtig hvid kapselbund, cirka 15,9 mm, påtrykt ‘MYLAN' over ‘DL 30'med guldfarvet blæk både på top og bund.
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.
Titandioxid (E171) Gelatine
Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
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.
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.
Perforeret enkeltdosisblisterpakning af PVC/PCTFE/Aluminium eller OPA/Aluminium/PVCAluminium med 7 x 1, 28 x 1 og 30 x 1 hårde enterokapsler.
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.
Sådan skal du tage Duloxetine Mylan
How to take Duloxetine Mylan
• 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)
• coughing, wheezing and shortness of breath which may be accompanied by a high temperature
60 mg kapsler Hver kapsel indeholder 60 mg duloxetin (som hydrochlorid).
60 mg capsules Each capsule contains 60 mg of duloxetine (as hydrochloride).
Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter)
Uncommon side effects (may affect up to 1 in 100 people)
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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Perforeret enkeltdosisblisterpakning af PVC/PE/PVdC/Aluminium med 7 x 1 og 28 x 1 hårde enterokapsler.
PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 7 x 1 and 28 x 1 hard gastro-resistant capsules.
30 mg kapsler Hver kapsel indeholder 30 mg duloxetin (som hydrochlorid).
30 mg capsules Each capsule contains 30 mg of duloxetine (as hydrochloride).
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter)
Common side effects (may affect up to 1 in 10 people)
ETIKET TIL FLASKE TIL 60 mg HÅRDE ENTEROKAPSLER
BOTTLE LABEL FOR 60 MG HARD GASTRO RESISTANT CAPSULES
Hvis du har taget for meget Duloxetine Mylan
If you stop taking Duloxetine Mylan
30 mg kapsler EU/1/15/1010/001 EU/1/15/1010/002 EU/1/15/1010/003
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
Serotoninsyndrom Kramper Psykomotorisk uro
Serotonin syndrome Convulsion Psychomotor restlessness Extra-pyramidal symptoms
INDRE BLISTERKARTON TIL MULTIPAKNING MED 60 mg HÅRDE ENTEROKAPSLER, UDEN BLÅ BOKS
BLISTER INNER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT CAPSULES, WITHOUT BLUE BOX
BLISTERKARTON TIL 30 mg HÅRDE ENTEROKAPSLER
BLISTER CARTON FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Obstipation Diarré
Interstitial lung disease
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.
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.
INDRE BLISTERKARTON TIL MULTIPAKNING MED 30 mg HÅRDE ENTEROKAPSLER, UDEN BLÅ BOKS
BLISTER INNER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT CAPSULES, WITHOUT BLUE BOX
Duloxetine Mylan 30 mg hårde enterokapsler Duloxetine Mylan 60 mg hårde enterokapsler
Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules
PVC/PCTFE/Aluminium eller OPA/Aluminium/PVC - Aluminium-blisterpakning med 14, 28, 84, 98 og multipakninger med 98 (2 pakninger med 49) hårde enterokapsler.
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.
Muskelstivhe d
Muscle spasm
Perforeret enkeltdosisblisterpakning af PVC/PCTFE/Aluminium eller OPA/Aluminium/PVCAluminium med 28 x 1, 30 x 1 og 100 x 1 hårde enterokapsler.
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.
BLISTERKARTON TIL 60 mg HÅRDE ENTEROKAPSLER
BLISTER CARTON FOR 60 MG HARD GASTRO RESISTANT CAPSULES
YDRE BLISTERKARTON TIL MULTIPAKNING MED 60 mg HÅRDE ENTEROKAPSLER, MED BLÅ BOKS
BLISTER OUTER CARTON FOR MULTIPACK FOR 60 MG HARD GASTRO RESISTANT CAPSULES, WITH BLUE BOX
Hver kapsel indeholder 30 mg eller 60 mg duloxetin som hydrochlorid.
Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride).
• tidligere har haft tanker om at begå selvmord eller at gøre skade på dig selv.
You may be more likely to think like this if you: - have previously had thoughts about killing or harming yourself - are a young adult.
PVC/PCTFE/Aluminium eller OPA/Aluminium/PVC - Aluminium-blisterpakning med 7, 14, 28, 98 og multipakninger med 98 (2 pakninger med 49) hårde enterokapsler.
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.
YDRE BLISTERKARTON TIL MULTIPAKNING MED 30 mg HÅRDE ENTEROKAPSLER, MED BLÅ BOKS
BLISTER OUTER CARTON FOR MULTIPACK FOR 30 MG HARD GASTRO RESISTANT CAPSULES, WITH BLUE BOX
Duloxetine Mylan 60 mg hårde enterokapsler duloxetin
Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine
Muskelsitren
Haemorrhage
Duloxetine Mylan 30 mg hårde enterokapsler duloxetin
Duloxetine Mylan 30 mg hard gastro-resistant capsules duloxetine
PVC/PE/PVdC/Aluminium-blisterpakning med 7, 14, 28, 49, 98 og multipakninger med 98 (2 pakninger med 49) hårde enterokapsler.
PVC/PE/PVdC/Aluminium blister pack containing 7, 14, 28, 49, 98 and multipacks containing 98 (2 packs of 49) hard gastro resistant capsules.
Du må kun stoppe behandlingen eller ændre dosis efter aftale med lægen.
Do not stop taking Duloxetine Mylan, or change your dose, without talking to your doctor.
PVC/PE/PVdC/Aluminium-blisterpakning med 14, 28, 49, 98 og multipakninger med 98 (2 pakninger med 49) hårde enterokapsler.
PVC/PE/PVdC/Aluminium blister pack containing 14, 28, 49, 98 and multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules.
Apati
Appetite
ETIKET TIL BEHOLDER TIL 30 mg HÅRDE ENTEROKAPSLER
BOTTLE LABEL FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Infektioner og parasitære sygdomme Laryngitis
Renal and urinary disorders Dysuria
• samtidig tager anden medicin, som indeholder duloxetin (se ”Brug af anden medicin sammen med Duloxetine Mylan”).
- 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')
Nattesved Urticaria Kontaktdermatitis Koldsved Lysfølsmheds -reaktioner Øget tendens til at få blå mærker
Dermatitis contact Cold sweat Photo-sensitivity reactions
Stomatitis Hæmatokeksi
Hepatic impairment
Nyrer og urinveje Dysuri
Night sweats Urticaria
Blødning
Somnolence
KARTON TIL BEHOLDER TIL 30 mg HÅRDE ENTEROKAPSLER
BOTTLE CARTON FOR 30 MG HARD GASTRO RESISTANT CAPSULES
Duloxetin blev givet i to forskellige dagsdoser: 60 mg én gang dagligt og 60 mg to gange dagligt.
In both studies, duloxetine 60 mg once daily and 60 mg twice daily significantly reduced pain compared with placebo.
KARTON TIL BEHOLDER TIL 60 mg HÅRDE ENTEROKAPSLER
BOTTLE CARTON FOR 60 MG HARD GASTRO RESISTANT CAPSULES
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.
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
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
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
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
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
Den anbefalede dosis af Duloxetine Mylan er 60 mg én gang dagligt.
The usual dose of Duloxetine Mylan is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
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.
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.
(monoaminoxidasehæmmer) (se ”Brug af anden medicin sammen med Duloxetine Mylan”).
(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')
Dosering
Laryngitis
Sløret syn Mydriasis Nedsat syn
Mydriasis Visual impairment
Epistaxis
Palpitations
Duloxetine Mylan er en hård enterokapsel.
What Duloxetine Mylan looks like and contents of the pack Duloxetine Mylan is hard gastro-resistant capsule.
Generel unormal følelse
Generalised anxiety disorder
Synkope Hypertension
Hepatic failure Jaundice
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL 30 mg HÅRDE ENTEROKAPSLER
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Perikon
Excipients
Liste over lægemidlets navne, lægemiddelformer, styrker, indgivelsesvej samt indehavere af markedsføringstilladelse i medlemsstaterne
List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicants and marketing authorisation holders in the member states
Consulting Ericapark 38
Ericapark 38
Mercury Pharmaceuticals Limited
Pharmaceuticals Limited
Addiscombe Road, Croydon, Surrey CR0
Addiscombe Road, Croydon, Surrey CR0 0XT, United Kingdom
Koncentrat till infusionsvæske, opløsning
Concentrate for solution for infusion
Magenta Pharma
Belgium Magenta Pharma Consulting
1 mg/ml (5ml) Injektionsvæske, opløsning
1 mg/ml (5ml)
Resultat af en procedure i henhold til artikel 30 i direktiv 2001/83/EF
Outcome of a procedure under Article 30 of Directive 2001/83/EC
Der kan gives yderligere behandling under lægeligt opsyn.
Further treatment can be given under medical supervision.
De harmoniserede afsnit omfatter:
The areas harmonised include:
Europa-Kommissionen traf en afgørelse den 30 september 2010.
The European Commission issued a decision on 30 September 2010.
Den virksomhed, der markedsfører disse lægemidler, er Leo Pharmaceutical Products.
The company that markets these medicines is Leo Pharmaceutical Products.
Hvad er Daivobet?
What is Daivobet?
Den anbefalede behandlingsperiode for salven er fire uger.
The recommended treatment period for the ointment is four weeks.
Jens Ersbøll (Danmark)
Jens Ersbøll (Denmark)
Daivobet salve blev i nogle medlemsstater godkendt via en gensidig anerkendelsesprocedure og i andre medlemsstater via nationale procedurer.
Daivobet ointment was authorised in some Member States through a mutual recognition procedure and in others through national procedures.
Der bør ikke anvendes mere end 15 g gel eller salve om dagen.
No more than 15 g of the gel or ointment should be used in one day.
Daivobet gel blev godkendt via en decentral procedure.
Daivobet gel was authorised via a decentralised procedure.
Hvorfor blev Daivobet undersøgt igen?
Why was Daivobet reviewed?
Daivobet indeholder to aktive stoffer: calcipotriol og betamethason.
Daivobet contains two active substances: calcipotriol and betamethasone.
Det fås som gel og salve, og det anvendes topisk (smøres på huden).
It is available as a gel and ointment and is used topically (applied on the skin).
Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Daivobet.
The European Medicines Agency has completed a review of Daivobet.
Daivobet fås også i EU under handelsnavnet Dovobet.
Daivobet is also available in the EU under the trade name Dovobet.
Den 10. marts 2010 indbragte Leo Pharmaceutical Products Daivobet for CHMP med henblik på at harmonisere markedsføringstilladelserne for lægemidlet i EU.
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.