FrancophonIA/ELRC3.0 huggingface dataset:
English: Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
Danish: Det kan være nødvendigt at justere doseringen af insulin eller orale antidiabetika, når behandling med fluoxetin påbegyndes eller seponeres.
English: A lower or less frequent dose (e.g. 20 mg every second day) should be considered in patients with hepatic impairment (see 5.2 Pharmacokinetic properties), or in patients where concomitant medication has the potential for interaction with (Invented name)® (see 4.5 Interactions).
Danish: Hos patienter med leverfunktionsnedsættelse bør en lavere eller mindre hyppig dosis (f.eks. 20 mg hver 2. dag) overvejes (se pkt 5.2 Farmakokinetiske egenskaber).
English: Use in children and adolescents aged 8 to 18 years of age:
Danish: Anvendelse til børn og unge under 18 år:
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: - Kontakt din læge eller dit apotek, hvis du har yderligere spørgsmål.
English: Adults and the elderly: The recommended dose is 20mg daily.
Danish: Voksne og ældre: 20-60 mg dagligt.
English: • start to experience fever, muscle stiffness or tremor, changes in your mental state like confusion, irritability and extreme agitation; you may suffer from the so called serotonin syndrome or neuroleptic malignant syndrome.
Danish: • Hvis du begynder at opleve feber, muskelstivhed eller rysten, ændringer i mentale tilstand så som forvirring, irritabilitet og ekstrem opstemthed.
English: Body as a whole: Hypersensitivity (e.g. pruritis, rash, urticaria, anaphylactoid reaction, vasculitis, serum sickness-like reaction, angioedema) (see ‘Contraindications' and ‘Warnings'), chills, serotonin syndrome, photosensitivity, very rarely Toxic Epidermal Necrolysis (Lyell syndrome).
Danish: Generelt: Overfølsomhed (f.eks. puritis, udslæt, urticaria, anafylaktiske reaktioner, vasculitis, serumsygdom-lignende reaktioner, angioødem) (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 5ml of oral liquid contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver 5 ml indeholder fluoxetinhydrochlorid svarende til 20 mg fluoxetin
English: Dose adjustments should be made carefully, on an individual basis, to maintain the patient at the lowest effective dose.
Danish: Der skal foretages nøje individuelle dosisjusteringer for at holde patienten på den laveste effektive dosis.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]>
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN <[Se bilag I - Udfyldes nationalt]>
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR (Invented name)® 20 mg per 5 ml oral liquid
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL SÆRNAVN® 20 MG ORAL OPLØSNING
English: NAME OF THE MEDICINAL PRODUCT
Danish: Anvendelse af anden medicin
English: NAME OF THE MEDICINAL PRODUCT (Invented name)® 20 mg per 5 ml oral liquid <[See Annex I - To be completed nationally]> fluoxetine hydrochloride
Danish: LÆGEMIDLETS NAVN SÆRNAVN® 20 mg/5 ml oral opløsning <[Se bilag I - Udfyldes nationalt]> fluoxetinhydrochlorid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder fluoxetinhydrochlorid svarende til 20 mg fluoxetin
English: MARKETING AUTHORISATION NUMBER(S) <[See Annex I - To be completed nationally]>
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) <[Se bilag I - Udfyldes nationalt]>
English: NAME OF THE MEDICINAL PRODUCT (Invented name)® 20 mg hard capsules <[See Annex I - To be completed nationally]> fluoxetine hydrochloride
Danish: LÆGEMIDLETS NAVN SÆRNAVN® 20 mg hårde kapsler <[Se bilag I - Udfyldes nationalt]> fluoxetinhydrochlorid
English: In the first study of continuous 20 mg daily dosing for 6 cycles, improvement was observed in the primary efficacy parameter (irritability, anxiety and dysphoria).
Danish: Her observeredes en forbedring i de primære effektmål (irritabilitet, angst og dysfori).
English: Miscellaneous: Alopecia, yawn, abnormal vision (e.g., blurred vision, mydriasis), sweating, vasodilatation, arthralgia, myalgia, postural hypotension, ecchymosis.
Danish: Diverse: Hårtab, gaben, synsforstyrrelser (f.eks. sløret syn, mydriasis), svedtendens, vasodilatation, ledsmerter, muskelsmerter, postural hypotension, ekkymose.
English: Treatment with fluoxetine should only be started 2 weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine).
Danish: Du må først tage SÆRNAVN® to uger efter, du er holdt op med at tage en irreversibel MAOhæmmer (for eksempel tranylcypromin).
English: Other ingredients are: Benzoic Acid, Sucrose, Glycerin, Mint flavour (containing 0.23% alcohol) and Purified Water.
Danish: Øvrige indholdsstoffer er benzoesyre, saccharose, glycerol, pebermynte-essens, renset vand.. Produktets udseende og pakningstørrelse <[Udfyldes nationalt]>
English: This risk persists until significant remission occurs.
Danish: Risikoen for selvmordsforsøg er forbundet med depression og denne risiko kan vedblive, indtil betydelig bedring indtræder.
English: Obsessive-compulsive disorder
Danish: Obsessiv-kompulsiv sygdom (OCD):
English: Absorption
Danish: PRODUKTRESUME
English: The CHMP recommended the granting of the variation of the Marketing Authorisations for which the Summaries of Product Characteristics, Labelling and Package Leaflets are set out in Annex III and under the conditions set out in Annex IV.
Danish: Produktresuméer, etikettering og indlægssedler fremgår af bilag III.
English: Marketing Authorisation Holder and Manufacturer <[See Annex I - To be completed nationally]>
Danish: Indehaveren af markedsføringstilladelsen og fremstiller <[Se bilag I - Udfyldes nationalt]>
English: • have epilepsy or have had a fit in the past; if you have a fit (seizure) or experience an increase in seizure frequency, contact your doctor immediately, the use of fluoxetine might need to be discontinued.
Danish: • Hvis du har epilepsi eller tidligere har haft krampeanfald, skal din behandling med SÆRNAVN® overvåges nøje.
English: (Invented name)® 20mg hard capsules <[See Annex I - To be completed nationally]> fluoxetine (as hydrochloride)
Danish: SÆRNAVN® 20 mg hårde kapsler <[Se bilag I - Udfyldes nationalt]> fluoxetin (som hydrochlorid)
English: Dimeticone
Danish: Stivelse Dimeticon
English: Nature and contents of container <[To be completed nationally]> Not all pack sizes may be marketed 6.6.
Danish: <Ikke alle pakningsstørrelser er nødvendigvis markedsført.> 6.6 Særlige forholdsregler ved bortskaffelse og anden håndtering af produktet Ingen særlige forholdsregler.
English: Weight Loss: Weight loss may occur in patients taking fluoxetine but it is usually proportional to baseline body weight.
Danish: Vægttab: Vægttab kan forekomme hos patienter, der tager fluoxetin.
English: Special precautions for disposal No special requirements
Danish: Ingen særlige forholdsregler.
English: • You can take (Invented name)® with or without food, whichever you prefer.
Danish: • SÆRNAVN® kan tages sammen med mad og drikke.
English: NAME OF THE MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]>
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN <[Se bilag I - Udfyldes nationalt]>
English: Fluoxetine is extensively bound to plasma proteins (about 95%) and it is widely distributed (Volume of Distribution: 20 - 40 l/kg).
Danish: Fordeling: Proteinbindingsgraden er ca. 95%.
English: (Invented name)® 20mg oral liquid <[See Annex I - To be completed nationally]> fluoxetine (as hydrochloride)
Danish: SÆRNAVN® 20 mg/5 ml oral opløsning <[Se bilag I - Udfyldes nationalt]> fluoxetin (som hydrochlorid)
English: Elderly: Caution is recommended when increasing the dose and the daily dose should generally not exceed 40 mg.
Danish: Daglig dosis bør generelt ikke overstige 40 mg.
English: Having considered the overall submitted data provided by the MAH in writing and in the oral explanation, the CHMP recommended the granting of the variation to the terms of the Marketing Authorisations for which the Summaries of Product Characteristics, labelling and package leaflets.
Danish: Efter en gennemgang af samtlige oplysninger, der er fremlagt skriftligt og mundtligt af indehaveren af markedsføringstilladelsen,
English: MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]>
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN <[Se bilag I - Udfyldes nationalt]>
English: • have suffered from mania in the past; if you have a manic episode, contact your doctor immediately, the use of fluoxetine might need to be discontinued.
Danish: • Hvis du tidligere har haft en manisk episode (opstemthed og voldsom uro), skal du være forsigtig med at bruge midler mod depression.
English: PARTICULARS TO APPEAR ON THE BOTTLE CARTONS FOR PROZAC 20 mg per 5 ml oral liquid
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKEETIKET TIL SÆRNAVN® 20 MG ORAL OPLØSNING
English: Suicide/suicidal thoughts: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Danish: Selvmord/selvmordstanker: Depression er forbundet med en øget risiko for selvmordstanker For antidepressiva gælder generelt, at der kan gå nogle uger før patienten opnår en bedring.
English: Fluoxétine Lilly
Danish: Fluoxétine Lilly 20 mg
English: It is therefore advised that when (Invented name)® treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see section 4.2 Posology and Method of Administration and section 4.4 Special warnings and precautions for use).
Danish: Når behandling med SÆRNAVN® ikke længere er nødvendig, tilrådes det derfor at seponere behandlingen ved gradvis nedtrapning af dosen (se pkt.
English: What (Invented name)® looks like and contents of the pack <[To be completed nationally]>
Danish: 6.5 Emballage (art og indhold) <[Udfyldes nationalt]>
English: Your doctor will review and adjust your dosage if necessary after 2 weeks of treatment.
Danish: • Obsessiv-kompulsiv sygdom: den anbefalede daglige dosis er 20 mg. Din læge vil vurdere og eventuelt justere din dosis efter 2 ugers behandlingen.
English: Benzoic Acid
Danish: Benzoesyre
English: If you have any further questions on the use of (Invented name)®, ask your doctor or pharmacist.
Danish: Spørg din læge eller apotek, hvis du har yderligere spørgsmål om brugen af SÆRNAVN®.
English: Posology and method of administration
Danish: 4.2 Dosering og indgivelsesmåde
English: PHARMACEUTICAL FORM Hard capsules.
Danish: Kapsler, hårde.
English: Although fluoxetine has been shown not to affect psychomotor performance in healthy volunteers, any psychoactive drug may impair judgment or skills.
Danish: Dog kan alle psykofarmaka potentielt forringe de motoriske evner samt evnen til at bedømme.
English: Sweden: Fontex <[See Annex I - To be completed nationally]>
Danish: <[Se bilag I - Udfyldes nationalt]>
English: Member State Marketing Authorisation Holder Invented name
Danish: Indehaver af markedsføringstilladelse Navn
English: Further information on Emgality can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Emgality findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This will stop the symptoms of migraine.
Danish: Dette vil stoppe symptomerne på migræne.
English: Patients can inject the medicine themselves after being trained.
Danish: Patienterne kan indsprøjte lægemidlet selv, når de er blevet instrueret i det.
English: It contains the active substance galcanezumab.
Danish: Det indeholder det aktive stof galcanezumab.
English: Doctors should review treatment after 3 months and only continue it if patients benefit from it.
Danish: Lægen bør revidere behandlingen efter tre måneder og kun fortsætte den, hvis den er til gavn for patienten.
English: As for all medicines, data on the use of Emgality are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Emgality løbende overvåget.
English: Other information about Emgality
Danish: Andre oplysninger om Emgality
English: What measures are being taken to ensure the safe and effective use of Emgality?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Emgality?
English: The European Medicines Agency therefore decided that Emgality's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Emgality opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Treatment should be started with the injection of the content of 2 syringes (or pens), followed a month later by single injections given every month.
Danish: Behandlingen bør indledes med injektion af indholdet af to sprøjter (eller penne), efterfulgt en måned senere af enkeltindsprøjtninger givet hver måned.
English: For more information about using Emgality, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Emgality, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The active substance of Emgality, galcanezumab, is a monoclonal antibody (a type of protein) designed to attach to and block CGRP, thereby helping blood vessels to return to their normal size.
Danish: Det aktive stof i Emgality, galcanezumab, er et monoklonalt antistof (en type protein), der er designet til at binde sig til CGRP og blokere det, så blodkarrene kan få deres normale størrelse igen.
English: Side effects reported with Emgality are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Emgality vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: A substance called CGRP has been shown to be involved in the development of migraine by widening blood vessels in the brain.
Danish: Et stof kaldet CGRP har vist sig at medvirke til udviklingen af migræne ved at udvide blodkarrene i hjernen.
English: The most common side effects with Emgality (which may affect more than 1 in 10 people) are reactions at the site of injection such as pain, redness, itching, bruising or swelling.
Danish: De hyppigste bivirkninger ved Emgality (som kan forekomme hos mere end 1 ud af 10 personer) er reaktioner på injektionsstedet, såsom smerter, rødme, kløe, blå mærker eller hævelse.
English: An overview of Emgality and why it is authorised in the EU
Danish: En oversigt over Emgality, og hvorfor det er godkendt i EU
English: Emgality can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of migraine.
Danish: Emgality udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af migræne.
English: Emgality is injected under the skin using a pre-filled syringe or pen.
Danish: Emgality indsprøjtes under huden med en fyldt sprøjte eller pen.
English: Emgality is a medicine used to prevent migraine in adults who have migraines at least 4 days a month.
Danish: Emgality er et lægemiddel til forebyggelse af migræne hos voksne, der har migræne mindst fire dage om måneden.
English: What is Emgality and what is it used for?
Danish: Hvad er Emgality, og hvad anvendes det til?
English: Why is Emgality authorised in the EU?
Danish: Hvorfor blev Emgality godkendt i EU?
English: The side effects seen with Emgality are considered manageable with most being mild or moderate in severity.
Danish: Bivirkningerne ved Emgality anses for at være håndterbare, da de fleste er lette eller moderate.
English: What are the risks associated with Emgality?
Danish: Hvilke risici er der forbundet med Emgality?
English: For the full list of side effects and restrictions of Emgality, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Emgality fremgår af indlægssedlen.
English: In two studies involving 1,784 patients who had migraines between 4 and 14 days a month, those treated with Emgality had 4 or 5 fewer days with migraines per month, compared with 2 to 3 fewer days for patients on a placebo injection.
Danish: I to studier med 1.784 patienter, som led af migræne i mellem fire og fjorten dage om måneden, havde de patienter, der fik Emgality, fire eller fem færre dage med migræne om måneden sammenlignet med to til tre dage færre for patienter, der fik en placeboindsprøjtning.
English: In a third study of 1,117 patients who had migraines for more than 15 days a month on average (chronic migraine), those treated with Emgality had on average around 5 fewer days with migraines per month compared with around 3 fewer days for patients on placebo.
Danish: I et andet studie med 1.117 patienter, der i gennemsnit led af migræne i mere end 15 dage om måneden (kronisk migræne), havde de patienter, der fik Emgality, i gennemsnit fem færre dage med migræne om måneden sammenholdt med ca. tre færre dage hos de patienter, der fik placebo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emgality have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Emgality.
English: What benefits of Emgality have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Emgality?
English: How does Emgality work?
Danish: Hvordan virker Emgality?
English: How is Emgality used?
Danish: Hvordan anvendes Emgality?
English: Emgality was shown to be more effective than placebo at reducing the number of days of migraine, although the size of the effect is limited particularly for patients with chronic migraine.
Danish: Emgality har vist sig at være mere effektivt end placebo til at reducere antallet af dage med migræne.
English: Overall, Emgality led to 2 fewer days with migraines per month compared with placebo (a dummy treatment).
Danish: Emgality har i tre hovedstudier vist sig at være effektivt til at reducere antallet af dage, som patienterne lider af migræne i. Samlet set gav Emgality to færre dage med migræne om måneden sammenlignet med placebo (en uvirksom behandling).
English: This summary was last updated in 07-2007.
Danish: Dette sammendrag blev sidst ajourført i 07-2007.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Gliolan to m e d a c Gesellschaft für klinische Spezialpräparate mbH on 7 September 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Gliolan til m e d a c Gesellschaft für klinische Spezialpräparate mbH den 7. september
English: Other information about Gliolan:
Danish: Andre oplysninger om Gliolan:
English: The effects of Gliolan were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Gliolan blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The brain scans were analysed by an expert who did not know whether the patients had received Gliolan or not.
Danish: Hjernescanningerne blev analyseret af en ekspert, der ikke vidste, om patienterne havde fået Gliolan eller ej.
English: However, because 5-aminolevulinic acid is a naturally occurring substance which is already used in some other conditions, the company also presented data from the published literature.
Danish: Men da 5-aminolevulinsyre et naturligt forekommende stof, der i forvejen anvendes til visse andre sygdomme, har firmaet også fremlagt oplysninger fra publikationer.
English: It contains the active substance 5-aminolevulinic acid hydrochloride (30 mg/ml).
Danish: Det indeholder det aktive stof 5-aminolevulinsyrehydrochlorid (30 mg/ml).
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om grundlaget for CHMP's anbefalinger, kan du læse den faglige drøftelse (der ligeledes er en del af denne EPAR).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) GLIOLAN EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) GLIOLAN EPAR - sammendrag for offentligheden
English: It should also not be used by patients who have porphyria (an inability to break down porphyrins) or during pregnancy.
Danish: Det bør desuden ikke anvendes af patienter med porfyri (manglende evne til at nedbryde porfyriner) eller af gravide.
English: It is absorbed by cells in the body, where it is converted by enzymes into fluorescent chemicals, particularly protoporphyrin IX (PPIX).
Danish: Det optages af cellerne i kroppen, hvor det af enzymer omdannes til selvlysende stoffer, hovedsagelig protoporfyrin IX (PPIX).
English: The recommended dose of Gliolan is 20 mg per kilogram body weight, taken two to four hours before the patient is anaesthetised.
Danish: Den anbefalede dosis af Gliolan er 20 mg pr. kg legemsvægt, der gives to til fire timer inden bedøvelsen.
English: After six months, 20.5% of the patients given Gliolan were still alive without progression, compared with 11.0% of those who did not receive the medicine.
Danish: Efter seks måneder var 20,5 % af de patienter, der havde fået Gliolan, stadig i live uden fremadskriden af sygdommen, sammenholdt med 11,0 % af dem der ikke havde fået Gliolan.
English: It recommended that Gliolan be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Gliolan.
English: Which measures are being taken to ensure the safe use of Gliolan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Gliolan?
English: Gliolan powder should be dissolved in 50 ml tap water by a nurse or pharmacist before the patient drinks the solution.
Danish: Gliolan pulver opløses i 50 ml postevand af en sygeplejerske eller farmaceut, hvorefter patienten drikker opløsningen.
English: The side effects seen most commonly (in more than 1 patient in 10) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leukocytosis (high levels of leukocytes, a type of white blood cell) and increased levels of liver enzymes in the blood (bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and amylase).
Danish: De almindeligste bivirkninger (som ses hos flere end 1 ud af 10 patienter), er blodmangel, for lavt antal blodplader, for højt antal hvide blodlegemer og forhøjet indhold i blodet af stoffer fra leveren (bilirubin og enzymerne alaninaminotransferase, aspartataminotransferase, gammaglutamyltransferase og amylase).
English: The full EPAR for Gliolan can be found here.
Danish: Den fuldstændige EPAR for Gliolan findes her.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Gliolan is available here.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme for Gliolan findes her.
English: The most common side effects seen with Gliolan are due to a combination of the medicine itself, as well as anaesthesia and the removal of the tumour.
Danish: De bivirkninger, der oftest ses ved anvendelse af Gliolan, skyldes kombinationen af lægemidlet selv, bedøvelsen og fjernelsen af svulsten.
English: What is the risk associated with Gliolan?
Danish: Hvilken risiko er der forbundet med Gliolan?
English: The Committee for Medicinal Products for Human Use (CHMP) noted that surgical treatment for malignant glioma should aim to remove as much of the tumour as possible while sparing healthy brain tissue.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konstaterede, at det ved kirurgisk behandling af ondartet gliom bør tilstræbes at fjerne så meget svulstvæv som muligt og samtidig skåne det sunde hjernevæv.