natgillin/translations-raw huggingface dataset:
Dosis bør omhyggeligt justeres til den enkelte patient for at holde patienten på den laveste effektive dosis.
Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose.
Behandling med en MAO-hæmmer bør ikke påbegyndes førend 5 uger efter seponering af fluoxetin.
Similarly, at least 5 weeks should elapse after discontinuing fluoxetine treatment before starting a MAOI.
Urogenitalsystem: Vandladningsbesvær, vandladningsfrekvens.
Urogenital system: Urinary retention, urinary frequency
Startdoseringen er 10 mg/dag indgivet som 2,5 ml SÆRNAVN® oral opløsning.
The starting dose is 10mg/day given as 2.5ml of the (Invented name)® liquid formulation.
Det kan være nødvendigt at justere doseringen af insulin eller orale antidiabetika, når behandling med fluoxetin påbegyndes eller seponeres.
Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
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).
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).
Anvendelse til børn og unge under 18 år:
Use in children and adolescents aged 8 to 18 years of age:
- Kontakt din læge eller dit apotek, hvis du har yderligere spørgsmål.
- If you have any further questions, ask your doctor or pharmacist.
Voksne og ældre: 20-60 mg dagligt.
Adults and the elderly: The recommended dose is 20mg daily.
• Hvis du begynder at opleve feber, muskelstivhed eller rysten, ændringer i mentale tilstand så som forvirring, irritabilitet og ekstrem opstemthed.
• 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.
Generelt: Overfølsomhed (f.eks. puritis, udslæt, urticaria, anafylaktiske reaktioner, vasculitis, serumsygdom-lignende reaktioner, angioødem) (se pkt.
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).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver 5 ml indeholder fluoxetinhydrochlorid svarende til 20 mg fluoxetin
STATEMENT OF ACTIVE SUBSTANCE(S) Each 5ml of oral liquid contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine
Der skal foretages nøje individuelle dosisjusteringer for at holde patienten på den laveste effektive dosis.
Dose adjustments should be made carefully, on an individual basis, to maintain the patient at the lowest effective dose.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN <[Se bilag I - Udfyldes nationalt]>
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]>
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL SÆRNAVN® 20 MG ORAL OPLØSNING
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR (Invented name)® 20 mg per 5 ml oral liquid
Anvendelse af anden medicin
NAME OF THE MEDICINAL PRODUCT
LÆGEMIDLETS NAVN SÆRNAVN® 20 mg/5 ml oral opløsning <[Se bilag I - Udfyldes nationalt]> fluoxetinhydrochlorid
NAME OF THE MEDICINAL PRODUCT (Invented name)® 20 mg per 5 ml oral liquid <[See Annex I - To be completed nationally]> fluoxetine hydrochloride
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder fluoxetinhydrochlorid svarende til 20 mg fluoxetin
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) <[Se bilag I - Udfyldes nationalt]>
MARKETING AUTHORISATION NUMBER(S) <[See Annex I - To be completed nationally]>
LÆGEMIDLETS NAVN SÆRNAVN® 20 mg hårde kapsler <[Se bilag I - Udfyldes nationalt]> fluoxetinhydrochlorid
NAME OF THE MEDICINAL PRODUCT (Invented name)® 20 mg hard capsules <[See Annex I - To be completed nationally]> fluoxetine hydrochloride
Her observeredes en forbedring i de primære effektmål (irritabilitet, angst og dysfori).
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).
Diverse: Hårtab, gaben, synsforstyrrelser (f.eks. sløret syn, mydriasis), svedtendens, vasodilatation, ledsmerter, muskelsmerter, postural hypotension, ekkymose.
Miscellaneous: Alopecia, yawn, abnormal vision (e.g., blurred vision, mydriasis), sweating, vasodilatation, arthralgia, myalgia, postural hypotension, ecchymosis.
Du må først tage SÆRNAVN® to uger efter, du er holdt op med at tage en irreversibel MAOhæmmer (for eksempel tranylcypromin).
Treatment with fluoxetine should only be started 2 weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine).
Øvrige indholdsstoffer er benzoesyre, saccharose, glycerol, pebermynte-essens, renset vand.. Produktets udseende og pakningstørrelse <[Udfyldes nationalt]>
Other ingredients are: Benzoic Acid, Sucrose, Glycerin, Mint flavour (containing 0.23% alcohol) and Purified Water.
Risikoen for selvmordsforsøg er forbundet med depression og denne risiko kan vedblive, indtil betydelig bedring indtræder.
This risk persists until significant remission occurs.
Obsessiv-kompulsiv sygdom (OCD):
Obsessive-compulsive disorder
PRODUKTRESUME
Absorption
Produktresuméer, etikettering og indlægssedler fremgår af bilag III.
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.
Indehaveren af markedsføringstilladelsen og fremstiller <[Se bilag I - Udfyldes nationalt]>
Marketing Authorisation Holder and Manufacturer <[See Annex I - To be completed nationally]>
• Hvis du har epilepsi eller tidligere har haft krampeanfald, skal din behandling med SÆRNAVN® overvåges nøje.
• 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.
SÆRNAVN® 20 mg hårde kapsler <[Se bilag I - Udfyldes nationalt]> fluoxetin (som hydrochlorid)
(Invented name)® 20mg hard capsules <[See Annex I - To be completed nationally]> fluoxetine (as hydrochloride)
Stivelse Dimeticon
Dimeticone
<Ikke alle pakningsstørrelser er nødvendigvis markedsført.> 6.6 Særlige forholdsregler ved bortskaffelse og anden håndtering af produktet Ingen særlige forholdsregler.
Nature and contents of container <[To be completed nationally]> Not all pack sizes may be marketed 6.6.
Vægttab: Vægttab kan forekomme hos patienter, der tager fluoxetin.
Weight Loss: Weight loss may occur in patients taking fluoxetine but it is usually proportional to baseline body weight.
Ingen særlige forholdsregler.
Special precautions for disposal No special requirements
• SÆRNAVN® kan tages sammen med mad og drikke.
• You can take (Invented name)® with or without food, whichever you prefer.
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN <[Se bilag I - Udfyldes nationalt]>
NAME OF THE MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]>
Fordeling: Proteinbindingsgraden er ca. 95%.
Fluoxetine is extensively bound to plasma proteins (about 95%) and it is widely distributed (Volume of Distribution: 20 - 40 l/kg).
SÆRNAVN® 20 mg/5 ml oral opløsning <[Se bilag I - Udfyldes nationalt]> fluoxetin (som hydrochlorid)
(Invented name)® 20mg oral liquid <[See Annex I - To be completed nationally]> fluoxetine (as hydrochloride)
Daglig dosis bør generelt ikke overstige 40 mg.
Elderly: Caution is recommended when increasing the dose and the daily dose should generally not exceed 40 mg.
Efter en gennemgang af samtlige oplysninger, der er fremlagt skriftligt og mundtligt af indehaveren af markedsføringstilladelsen,
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.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN <[Se bilag I - Udfyldes nationalt]>
MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]>
• Hvis du tidligere har haft en manisk episode (opstemthed og voldsom uro), skal du være forsigtig med at bruge midler mod depression.
• 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.
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKEETIKET TIL SÆRNAVN® 20 MG ORAL OPLØSNING
PARTICULARS TO APPEAR ON THE BOTTLE CARTONS FOR PROZAC 20 mg per 5 ml oral liquid
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.
Suicide/suicidal thoughts: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Fluoxétine Lilly 20 mg
Fluoxétine Lilly
Når behandling med SÆRNAVN® ikke længere er nødvendig, tilrådes det derfor at seponere behandlingen ved gradvis nedtrapning af dosen (se pkt.
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).
6.5 Emballage (art og indhold) <[Udfyldes nationalt]>
What (Invented name)® looks like and contents of the pack <[To be completed nationally]>
• Obsessiv-kompulsiv sygdom: den anbefalede daglige dosis er 20 mg. Din læge vil vurdere og eventuelt justere din dosis efter 2 ugers behandlingen.
Your doctor will review and adjust your dosage if necessary after 2 weeks of treatment.
Benzoesyre
Benzoic Acid
Spørg din læge eller apotek, hvis du har yderligere spørgsmål om brugen af SÆRNAVN®.
If you have any further questions on the use of (Invented name)®, ask your doctor or pharmacist.
4.2 Dosering og indgivelsesmåde
Posology and method of administration
Kapsler, hårde.
PHARMACEUTICAL FORM Hard capsules.
Dog kan alle psykofarmaka potentielt forringe de motoriske evner samt evnen til at bedømme.
Although fluoxetine has been shown not to affect psychomotor performance in healthy volunteers, any psychoactive drug may impair judgment or skills.
<[Se bilag I - Udfyldes nationalt]>
Sweden: Fontex <[See Annex I - To be completed nationally]>
Indehaver af markedsføringstilladelse Navn
Member State Marketing Authorisation Holder Invented name
Yderligere information om Emgality findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Emgality can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette vil stoppe symptomerne på migræne.
This will stop the symptoms of migraine.
Patienterne kan indsprøjte lægemidlet selv, når de er blevet instrueret i det.
Patients can inject the medicine themselves after being trained.
Det indeholder det aktive stof galcanezumab.
It contains the active substance galcanezumab.
Lægen bør revidere behandlingen efter tre måneder og kun fortsætte den, hvis den er til gavn for patienten.
Doctors should review treatment after 3 months and only continue it if patients benefit from it.
Som for alle lægemidler bliver data vedrørende brug af Emgality løbende overvåget.
As for all medicines, data on the use of Emgality are continuously monitored.
Andre oplysninger om Emgality
Other information about Emgality
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Emgality?
What measures are being taken to ensure the safe and effective use of Emgality?
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Emgality opvejer risiciene, og at det kan godkendes til anvendelse i EU.
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.
Behandlingen bør indledes med injektion af indholdet af to sprøjter (eller penne), efterfulgt en måned senere af enkeltindsprøjtninger givet hver måned.
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.
For mere information om brug af Emgality, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Emgality, see the package leaflet or contact your doctor or pharmacist.
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.
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.
Bivirkninger rapporteret for Emgality vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Emgality are carefully evaluated and any necessary action taken to protect patients.
Et stof kaldet CGRP har vist sig at medvirke til udviklingen af migræne ved at udvide blodkarrene i hjernen.
A substance called CGRP has been shown to be involved in the development of migraine by widening blood vessels in the brain.
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.
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.
En oversigt over Emgality, og hvorfor det er godkendt i EU
An overview of Emgality and why it is authorised in the EU
Emgality udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af migræne.
Emgality can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of migraine.
Emgality indsprøjtes under huden med en fyldt sprøjte eller pen.
Emgality is injected under the skin using a pre-filled syringe or pen.
Emgality er et lægemiddel til forebyggelse af migræne hos voksne, der har migræne mindst fire dage om måneden.
Emgality is a medicine used to prevent migraine in adults who have migraines at least 4 days a month.
Hvad er Emgality, og hvad anvendes det til?
What is Emgality and what is it used for?
Hvorfor blev Emgality godkendt i EU?
Why is Emgality authorised in the EU?
Bivirkningerne ved Emgality anses for at være håndterbare, da de fleste er lette eller moderate.
The side effects seen with Emgality are considered manageable with most being mild or moderate in severity.
Hvilke risici er der forbundet med Emgality?
What are the risks associated with Emgality?
Den fuldstændige liste over bivirkninger og begrænsninger ved Emgality fremgår af indlægssedlen.
For the full list of side effects and restrictions of Emgality, see the package leaflet.
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.
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.
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.
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.
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.
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.
Hvilke fordele viser studierne, at der er ved Emgality?
What benefits of Emgality have been shown in studies?
Hvordan virker Emgality?
How does Emgality work?
Hvordan anvendes Emgality?
How is Emgality used?
Emgality har vist sig at være mere effektivt end placebo til at reducere antallet af dage med migræne.
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.
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).
Overall, Emgality led to 2 fewer days with migraines per month compared with placebo (a dummy treatment).
Dette sammendrag blev sidst ajourført i 07-2007.
This summary was last updated in 07-2007.
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
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.
Andre oplysninger om Gliolan:
Other information about Gliolan:
Virkningerne af Gliolan blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Gliolan were first tested in experimental models before being studied in humans.
Hjernescanningerne blev analyseret af en ekspert, der ikke vidste, om patienterne havde fået Gliolan eller ej.
The brain scans were analysed by an expert who did not know whether the patients had received Gliolan or not.
Men da 5-aminolevulinsyre et naturligt forekommende stof, der i forvejen anvendes til visse andre sygdomme, har firmaet også fremlagt oplysninger fra publikationer.
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.
Det indeholder det aktive stof 5-aminolevulinsyrehydrochlorid (30 mg/ml).
It contains the active substance 5-aminolevulinic acid hydrochloride (30 mg/ml).
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).
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) GLIOLAN EPAR - sammendrag for offentligheden
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) GLIOLAN EPAR summary for the public
Det bør desuden ikke anvendes af patienter med porfyri (manglende evne til at nedbryde porfyriner) eller af gravide.
It should also not be used by patients who have porphyria (an inability to break down porphyrins) or during pregnancy.
Det optages af cellerne i kroppen, hvor det af enzymer omdannes til selvlysende stoffer, hovedsagelig protoporfyrin IX (PPIX).
It is absorbed by cells in the body, where it is converted by enzymes into fluorescent chemicals, particularly protoporphyrin IX (PPIX).
Den anbefalede dosis af Gliolan er 20 mg pr. kg legemsvægt, der gives to til fire timer inden bedøvelsen.
The recommended dose of Gliolan is 20 mg per kilogram body weight, taken two to four hours before the patient is anaesthetised.
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.
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.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Gliolan.
It recommended that Gliolan be given marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Gliolan?
Which measures are being taken to ensure the safe use of Gliolan?
Gliolan pulver opløses i 50 ml postevand af en sygeplejerske eller farmaceut, hvorefter patienten drikker opløsningen.
Gliolan powder should be dissolved in 50 ml tap water by a nurse or pharmacist before the patient drinks the solution.
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).
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).
Den fuldstændige EPAR for Gliolan findes her.
The full EPAR for Gliolan can be found here.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme for Gliolan findes her.
The summary of opinion of the Committee for Orphan Medicinal Products for Gliolan is available here.
De bivirkninger, der oftest ses ved anvendelse af Gliolan, skyldes kombinationen af lægemidlet selv, bedøvelsen og fjernelsen af svulsten.
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.
Hvilken risiko er der forbundet med Gliolan?
What is the risk associated with Gliolan?
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.
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.
Gliolan bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for 5-aminolevulinsyrehydrochlorid eller porfyriner.
Gliolan should not be used in people who may be hypersensitive (allergic) to 5-aminolevulinic acid hydrochloride or porphyrins.
Resultatet af operationen blev sammenlignet for de patienter, der fik Gliolan (og blev opereret under blåt lys), og dem, der ikke fik nogen medicin til at synliggøre svulsten (og blev opereret under sædvanligt hvidt lys).
The outcome of the operation was compared between patients taking Gliolan (operated under blue light) and that of patients who did not take any medicines to improve the visibility of the tumour (operated under normal white light).