FrancophonIA/ELRC3.0 huggingface dataset:
English: As with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition, may occur with venlafaxine treatment, particularly with concomitant use of other agents, such as MAO-inhibitors, that may affect the serotonergic neurotransmitter systems (see sections 4.3 and 4.5).
Danish: Som med andre serotonerge midler kan der opstå serotoninsyndrom, en potentielt livstruende tilstand, under behandling med venlafaxin, navnlig ved samtidig brug af andre midler, som f.eks. MAOhæmmere, der kan påvirke de serotonerge neurotransmittersystemer (se pkt.
English: The concomitant use of venlafaxine with serotonin precursors (such as tryptophan supplements) is not recommended (see section 4.4).
Danish: Samtidig brug af venlafaxin og serotoninprækursorer (såsom tryptofantilskud) frarådes (se pkt.
English: The MAH was asked to harmonise Section 4.5 in the Summary of Product Characteristics, for which the following differences between SPCs needed to be evaluated: - monoamine oxidase inhibitors.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at harmonisere afsnit 4.5 i produktresuméet, hvori følgende forskelle mellem produktresuméerne skulle vurderes: - Monoaminooxidase-hæmmere.
English: • If you use other medicines that taken concomitantly with Efexor depot could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”).
Danish: Vær ekstra forsigtig med at tage Efexor Depot - Hvis du tager anden medicin, som sammen med Efexor Depot kan øge risikoen for at udvikle serotoninsyndrom (se afsnittet ”Brug af anden medicin”).
English: Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).
Danish: Symptomerne på serotoninsyndrom kan omfatte: ændringer i mentaltilstand (f.eks. agitation, hallucinationer, koma), autonom ustabilitet (f.eks. takykardi, ustabilt blodtryk, hypertermi), neuromuskulære afvigelser (f.eks. hyperrefleksi, koordinationssvigt) og/eller gastrointestinale symptomer (f.eks. kvalme, opkastning, diaré).
English: • Monoamine oxidase inhibitors (MAOIs: see the section “Before you take Efexor depot”).
Danish: Monoaminooxidasehæmmere (MAO-hæmmere): Se afsnittet ”Det skal du vide, før du begynder at tage Efexor Depot”
English: The efficacy of venlafaxine prolonged-release capsules as a treatment for generalised anxiety disorder (GAD) was established in two 8-week, placebo-controlled, fixed-dose studies (75 to 225 mg/day), one 6-month, placebo-controlled, fixed-dose study (75 to 225 mg/day), and one 6-month, placebo-controlled, flexible-dose study (37.5, 75, and 150 mg/day) in adult outpatients.
Danish: Virkningen af venlafaxin depotkapsler til behandling af generaliseret angst (GAD) hos voksne ambulante patienter er fastslået i to 8-ugers placebo-kontrollerede forsøg med fast dosis (75 til 225 mg/dag), et 6-måneders placebo-kontrolleret forsøg med fast dosis (75 til 225 mg/dag) og et 6måneders placebo-kontrolleret forsøg med fleksibel dosis (37,5, 75 og 150 mg/dag).
English: The most commonly (>1/10) reported adverse reactions in clinical studies were nausea, dry mouth, headache and sweating (including night sweats).
Danish: De mest almindligt indberettede bivirkninger (>1/10) fra kliniske undersøgelser var kvalme, mundtørhed, hovedpine og perspiration (incl.
English: Common: appetite decreased; constipation; vomiting Uncommon: grinding of the teeth; diarrhoea
Danish: • Fordøjelsesforstyrrelser Meget almindelig: Kvalme Almindelig: Nedsat appetit, forstoppelse, opkastning Ikke almindelig: Skæren tænder, diarré
English: The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Danish: Ved behandling af patienter med andre psykiatriske lidelser skal der derfor træffes de samme forholdsregler som dem, der gælder for patienter med større depressiv lidelse.
English: The efficacy of venlafaxine prolonged-release capsules as a treatment for social anxiety disorder was established in four double-blind, parallel-group, 12-week, multi-center, placebo-controlled, flexible-dose studies and one double-blind, parallel-group, 6-month, placebo-controlled, fixed/flexible-dose study in adult outpatients.
Danish: Virkningen af venlafaxin depotkapsler til behandling af socialfobi hos voksne ambulante patienter er fastslået i fire dobbeltblinde, parallel-gruppe-, 12-ugers multicenter, placebo-kontrollerede forsøg med fleksibel dosis og et dobbeltblindt, parallel-gruppe-, 6-måneders placebo-kontrolleret forsøg med fast/fleksibel dosis.
English: Withdrawal symptoms, when treatment is discontinued, are common, particularly if discontinuation is abrupt (see section 4.8).
Danish: Abstinenssymptomer er almindelige ved behandlingsophør, især hvis behandlingen stopper brat (se pkt.
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Efexor depot and associated names (see Annex I).
Danish: Produktresumé, etikettering og indlægsseddel fremgår af bilag III for Efexor depot og tilknyttede navne (se bilag I).
English: Efficacy was also established in one long-term double-blind, placebo-controlled, parallel-group study of the long-term safety, efficacy, and prevention of relapse in adult outpatients who responded to open-label treatment.
Danish: Virkningen med hensyn til langtidssikkerhed, effekt og forebyggelse af tilbagefald blev også fastslået i et langtids-, dobbeltblindt, placebo-kontrolleret parallel-gruppe-forsøg med voksne ambulante patienter, som responderede på åben behandling.
English: Abnormal ejaculation/orgas m (males), Anorgasmia, Erectile dysfunction (impotence), Urination impaired (mostly hesitancy), Menstrual disorders associated with increased bleeding or increased irregular bleeding (e.g., menorrhagia, metrorrhagia), Pollakiuria
Danish: Abnorm sædafgang/orgasme (mænd), anorgasme, erektil dysfunktion (impotens), vandladningsproblemer (ofte startbesvær), menstruationsforstyrrelse r med forøget blødning eller forøget, uregelmæssig blødning (f.eks. menoragi, metroragi), pollakiuria
English: Haematological / Lymphatic
Danish: Blod/lymfe
English: Reversible, non-selective MAOI (linezolid)
Danish: Reversibel, selektiv MAO-hæmmer (moclobemid)
English: Venlafaxine prolonged-release capsules contain spheroids, which release the active substance slowly into the digestive tract.
Danish: Venlafaxin depotkapsler indeholder sfæroider, som frigiver lægemidlet langsomt i mave-tarmkanalen.
English: Efexor depot and associated names (see Annex I) 37.5 mg hard prolonged-release capsules Efexor depot and associated names (see Annex I) 75 mg hard prolonged-release capsules Efexor depot and associated names (see Annex I) 150 mg hard prolonged-release capsules
Danish: Efexor Depot og tilhørende navne (se bilag I) 37.5 mg depotkapsler, hårde Efexor Depot og tilhørende navne (se bilag I) 75 mg depotkapsler, hårde Efexor Depot og tilhørende navne (se bilag I) 150 mg depotkapsler, hårde
English: If you forget to take Efexor depot
Danish: Hvis du har glemt at tage Efexor Depot
English: The efficacy of venlafaxine prolonged-release as a treatment for major depressive episodes was established in two placebo-controlled, short-term studies for 8 and 12 weeks duration, which included a dose range of 75 to 225 mg/day.
Danish: Virkningen af venlafaxin depot til behandling af større depressive episoder blev fastlagt i 2 placebo-kontrollerede, kortvarige forsøg af 8 og12 ugers varighed, med doser fra 75 til 225 mg/dag.
English: the MAH was asked to discuss the risk/benefit for the panic indication in more detail, comparing the safety and efficacy for the 75 mg dose with the suggested 225 mg dose.
Danish: Panikangst: Indehaveren af markedsføringstilladelsen blev anmodet om mere detaljeret analyse af benefit/risk-forholdet for panik-indikationen, hvori sikkerheden og virkningen af dosen på 75 mg sammenlignes med dosen på 225 mg. CHMP var enig med indehaveren af markedsføringstilladelsen om, at patienter kan have nytte af, at dosen individualiseres inden for det effektive doseringsområde fra 75 til 225 mg.
English: It is recommended that a dose of 37.5 mg/day of prolonged-release venlafaxine be used for 7 days.
Danish: Det anbefales at anvende en dosis venlafaxin depotkapsel på 37,5 mg dagligt i 7 dage.
English: These reactions have included tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, and hyperthermia with features resembling neuroleptic malignant syndrome, seizures, and death.
Danish: kvalme, opkastning, flushing, svimmelhed og hypertermi med kendetegn, der ligner neuroleptisk malignt syndrom, kramper og dødsfald.
English: John Wyeth & Brother Ltd trading as Wyeth Laboratories, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH United Kingdom
Danish: John Wyeth & Brother Ltd trading as Wyeth Laboratories, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH Storbritanien
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Efexor depot.
Danish: I de tilfælde hvor patienten er under 18 år, skal du fortælle det til lægen, hvis nogen af de oven for nævnte symptomer udvikler sig eller bliver værre.
English: Common: increase in blood pressure; flushing; palpitations Uncommon: feeling dizzy (particularly when standing up too quickly), fainting, fast heartbeat Not known: decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting
Danish: Almindelig: Forhøjet blodtryk, rødme, hjertebanken Ikke almindelig: Svimmelhed (især, når man rejser sig for hurtigt), besvimelse, hurtigt hjerteslag
English: If you stop taking Efexor depot
Danish: Hvis du holder op med at tage Efexor Depot
English: The recommended starting dose for prolonged-release venlafaxine is 75 mg given once daily.
Danish: Den anbefalede startdosis for venlafaxin depotkapsler er 75 mg 1 gang dagligt.
English: Common: abnormal ejaculation/orgasm (males); lack of orgasm; erectile dysfunction (impotence); menstrual irregularities such as increased bleeding or increased irregular bleeding Uncommon: abnormal orgasm (females)
Danish: • Reproduktive og seksuelle forstyrrelser Almindelig: Abnorm sædafgang/orgasme (mænd), manglende orgasme, erektil dysfunktion (impotens), uregelmæssigheder omkring menstruationen som f.eks. forøget blødning eller forøget, uregelmæssig blødning
English: Diazepam does not appear to affect the pharmacokinetics of either venlafaxine or O-desmethylvenlafaxine.
Danish: Diazepam synes ikke at påvirke hverken venlafaxins eller O-desmethylvenlafaxins farmakokinetik.
English: The MAH was asked to harmonise Section 4.3, for which the following differences between SPCs needed to be evaluated: - Monoamine oxidase inhibitors (MAOIs); - Cardiovascular safety - Uncontrolled hypertension.
Danish: Afsnit 4.3 i produktresuméet - kontraindikationer Indehaveren af markedsføringstilladelsen blev anmodet om at harmonisere afsnit 4.3 i produktresuméet, hvori følgende forskelle mellem produktresuméerne skulle vurderes: - Monoaminooxidasehæmmere (MAO-hæmmere) - Kardiovaskulær sikkerhed - Ukontrolleret hypertension
English: Efectin ER 150 mg cps plg 150 mg Prolonged-release capsules
Danish: Efectin ER 150 mg cps plg 150 mg Depotkapsler
English: Efectin ER 37,5 mg trde kapsules podaljšanim sproščanjem Efectin ER 75 mg trde kapsule s podaljšanim sproščanjem
Danish: Efectin ER 37,5 mg trde kapsule s podaljšanim sproščanjem Efectin ER 75 mg trde kapsule s podaljšanim sproščanjem
English: Common: abnormal dreams; decreased libido; dizziness; increased muscle tonus; insomnia; nervousness; pins and needles; sedation; tremor; confusion; feeling separated (or detached) from yourself and reality
Danish: Almindelig: Unormale drømme, nedsat libido, svimmelhed, øget muskeltonus, søvnløshed, nervøsitet, sovende fornemmelse, mathed, rystelser, forvirring, følelse af at være adskilt fra (uden for) sig selv og virkeligheden
English: Efectin ER 37,5mg cps plg 37.5mg Prolonged-release capsules
Danish: Efectin ER 37,5mg cps plg 37,5mg Depotkapsler
English: The recommended dose for prolonged-release venlafaxine is 75 mg given once daily.
Danish: Den anbefalede dosis for venlafaxin depotkapsler er 75 mg 1 gang dagligt.
English: As the spheroids travel the length of your gastrointestinal tract, venlafaxine is slowly released.
Danish: Mens de bevæger sig ned igennem mave-tarm-kanalen, frigives indholdsstoffet langsomt.
English: Efectin ER 150 mg - Kapseln 150 mg Modified-release capsule, hard
Danish: Efectin ER 150 mg - Kapseln 150 mg Kapsler med modificeret udløsning, hårde
English: Efectin ER 75 mg cps plg 75 mg Prolonged-release capsules
Danish: Efectin ER 75 mg cps plg 75 mg Depotkapsler
English: The efficacy of venlafaxine prolonged-release capsules as a treatment for panic disorder was established in two double-blind, 12-week, multi-center, placebo-controlled studies in adult outpatients with panic disorder, with or without agoraphobia.
Danish: Virkningen af venlafaxin depotkapsler til behandling af panikangst hos voksne ambulante patienter med panikangst med eller uden agorafobi er fastslået i to dobbeltblinde, 12-ugers multicenter, placebo-kontrollerede forsøg.
English: Therefore, even though you may see spheroids in your stools, your dose of venlafaxine has been absorbed.
Danish: Din dosis er derfor optaget i kroppen, selv om du kan se små kugler i afføringen.
English: Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly reported reactions.
Danish: insomni og voldsomme drømme), agitation eller angst, kvalme og/eller opkastning, rysten og hovedpine er de mest almindeligt, indberettede reaktioner.
English: Additionally, it was agreed to clarify in the SPC that dose increments should only be made after a clinical evaluation, and that the lowest effective dose should be maintained, given the risk of dose-related adverse effects.
Danish: Desuden blev det vedtaget at præcisere i produktresuméet, at dosisoptrapninger kun må foretages efter en klinisk vurdering, og at den laveste effektive dosis skal opretholdes af hensyn til risikoen for dosisrelaterede bivirkninger.
English: Additionally, it was clarified in the SPC that dose increments should only be made after a clinical evaluation and that the lowest effective dose should be maintained, given the risk of dose-related adverse effects.
Danish: Desuden blev det præciseret i produktresuméet, at dosisoptrapninger kun må ske efter en klinisk vurdering, og at den laveste effektive dosis skal opretholdes af hensyn til risikoen for dosisrelaterede bivirkninger.
English: Monoamine Oxidase Inhibitors (MAOI)
Danish: Monoaminooxidasehæmmere (MAO-hæmmere)
English: Efectin ER 75 mg - Kapseln 75 mg Modified-release capsule, hard
Danish: Efectin ER 75 mg - Kapseln 75 mg Kapsler med modificeret udløsning, hårde
English: 150 mg Modified Release Capsule
Danish: 150 mg Kapsler med modificeret udløsning Oral anvendelse
English: • If you are allergic to venlafaxine or any of the other ingredients of Efexor depot.
Danish: Tag ikke Efexor Depot - Hvis du er overfølsom (allergisk) over for venlafaxin eller et af de øvrige indholdsstoffer.
English: Not known: a high temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky muscle movements which you can't control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles, which are symptoms of serotonergic syndrome; disorientation and confusion often accompanied by hallucination (delirium); stiffness, spasms and involuntary movements of the muscles; thoughts of harming or killing yourself
Danish: Ikke almindelig: Manglende følelse eller emotion, hallucinationer, ufrivillige muskelbevægelser, ophidselse, svækket koordination og balance Sjælden: En følelse af rastløshed eller manglende evne til at sidde eller stå stille, kramper eller anfald, følelse af at være eksalteret eller euforisk Ikke kendt: Høj temperatur med stive muskler, forvirring eller ophidselse, svedtendens, eller hvis du oplever rykvise muskelbevægelser, som du ikke kan kontrollere.
English: It was also clarified in the SPC that dose increments should only be made after a clinical evaluation and that the lowest effective dose should be maintained, given the risk of doserelated adverse effects.
Danish: Det blev desuden præciseret i produktresuméet, at dosisoptrapninger kun må ske efter en klinisk vurdering, og at den laveste effektive dosis skal opretholdes af hensyn til risikoen for dosisrelaterede bivirkninger.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET Whereas - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling, package leaflet.
Danish: Ud fra følgende betragtninger: - Hensigten med indbringelsen var at harmonisere produktresuméet, etiketteringen og indlægssedlen.
English: FURTHER INFORMATION What Efexor depot contains The active substance is venlafaxine.
Danish: Det aktive indholdsstof er venlafaxin.
English: Efectin ER 37,5 mg - Kapseln 37.5 mg Modified-release capsule, hard
Danish: Efectin ER 37,5 mg - Kapseln 37,5 mg Kapsler med modificeret udløsning, hårde
English: Following the European Commission's request, Section 4.1 of the Summary of Product Characteristics was harmonized to include the following therapeutic indications as worded and described below: - “treatment of major depressive episodes”, with no inclusion of references to associated anxiety, given that the studies designed to investigate the anxiolytic effect of venlafaxine revealed that it is difficult to distinguish anxiety from the concomitant depression disorder;
Danish: - "Behandling af svære depressive episoder", uden henvisninger til hertil knyttet angst, da det af undersøgelserne, der er designet til at se nærmere på den anxiolytiske virkning af venlafaxin, fremgik, at det er vanskeligt at skelne mellem angsten og den samtidige depressionstilstand.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION {DD/MM/YYYY} [To be completed nationally]
Danish: DD/MM/ÅÅÅÅ [Udfyldes nationalt]
English: However, in individual patients not responding to the initial 75 mg/day, increases up to a maximum dose of 225 mg/day may be considered.
Danish: Til enkelte patienter, som ikke responderer på initialdosen på 75 mg dagligt, kan det overvejes at øge dosis op til en maksimal dosis på 225 mg/dag.
English: • Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Danish: - ketoconazol (et svampedræbende lægemiddel) - haloperidol eller risperidon (til behandling af psykiatriske lidelser) - metoprolol (en betablokker til behandling af højt blodtryk og hjerteproblemer)
English: 75 mg Modified Release Capsule
Danish: 75 mg Kapsler med modificeret udløsning Oral anvendelse
English: convulsion, and vomiting.
Danish: Svimmelhed, føleforstyrrelser (inkl.
English: HOW TO TAKE EFEXOR DEPOT
Danish: SÅDAN SKAL DU TAGE EFEXOR DEPOT
English: Mucous membrane bleeding, Prolonged bleeding time, Thrombocytopaenia , Blood dyscrasias, (including agranulocytosis, aplastic anaemia, neutropaenia and pancytopaenia)
Danish: Blødning fra slimhinder, forlænget blødningstid, trombocytopeni, bloddyskrasier, (inkl.
English: • Digestive disorders
Danish: • Urinvejslidelser
English: PHARMACEUTICAL form Hard prolonged-release capsule.
Danish: LÆGEMIDDELFORM Depotkapsel, hård.
English: • Skin disorders
Danish: • Hudlidelser
English: If any of the following happen, do not take more Efexor depot.
Danish: Tag ikke mere Efexor Depot, hvis der opstår noget af det følgende.
English: NAME OF THE MEDICINAL PRODUCT Efexor depot and associated names (see Annex I) 150 mg prolonged-release capsules, hard [See Annex I - To be completed nationally]
Danish: Efexor Depot og tilhørende navne (se bilag I) 150 mg depotkapsler, hårde [Se bilag I - Udfyldes nationalt]
English: NAME OF THE MEDICINAL PRODUCT Efexor depot and associated names (see Annex I) 37.5 mg prolonged-release capsules, hard [See Annex I - To be completed nationally]
Danish: Efexor Depot og tilhørende navne (se bilag I) 37.5 mg depotkapsler, hårde [Se bilag I - Udfyldes nationalt]
English: Patients not responding to the 75 mg/day dose may benefit from dose increases up to a maximum dose of 225 mg/day.
Danish: Patienter, som ikke responderer på dosen på 75 mg dagligt, kan have fordel af forøgelser af dosis op til maksimalt 225 mg dagligt.
English: 75 mg Prolonged-release capsules, hard
Danish: 75 mg Depotkapsler, hårde
English: 150 mg Prolonged-release capsules, hard
Danish: 150 mg Depotkapsler, hårde
English: Efectin ER 150 mg trde kapsules podaljšanim sproščanjem
Danish: EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
English: Effects”), may occur with venlafaxine treatment, particularly when taken with other medicines.
Danish: Serotoninsyndrom, en potentielt livstruende tilstand (se afsnittet ”Bivirkninger”), kan forekomme ved behandling med Efexor Depot, navnlig når det tages sammen med anden medicin.
English: NAME OF THE MEDICINAL PRODUCT Efexor depot and associated names (see Annex I) 75 mg prolonged-release capsules, hard [See Annex I - To be completed nationally]
Danish: Efexor Depot og tilhørende navne (se bilag I) 75 mg depotkapsler, hårde [Se bilag I - Udfyldes nationalt]
English: Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible nonselective MAOI.
Danish: Der skal gå mindst 14 dage efter seponering af behandling med en irreversibel, ikke-selektiv MAOhæmmer, inden behandling med venlafaxin må påbegyndes.
English: Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI.
Danish: Der skal gå mindst 14 dage efter seponering af behandling med en irreversibel MAOhæmmer, inden behandling med venlafaxin må påbegyndes.
English: The following symptoms may be observed in neonates if the mother has used an SSRI/SNRI late in pregnancy: irritability, tremor, hypotonia, persistent crying, and difficulty in sucking or in sleeping.
Danish: Irritabilitet, tremor, hypotoni, vedvarende gråd og besvær med at sutte eller sove.
English: Czech Republic Wyeth-Lederle Pharma GmbH., Storchengasse 1
Danish: Wyeth-Lederle Pharma GmbH., Storchengasse 1
English: Patients not responding to the initial 75 mg/day dose may benefit from dose increases up to a maximum dose of 225 mg/day.
Danish: Patienter, som ikke responderer på startdosen på 75 mg dagligt, kan have fordel af forøgelser af dosis til maksimalt 225 mg dagligt.
English: 37.5 mg Prolonged release-Capsules
Danish: 37,5 mg Depotkapsler
English: NAME OF THE MEDICINAL PRODUCT Efexor depot and associated names (see Annex I) 75 mg prolonged-release capsules [See Annex I - To be completed nationally] Venlafaxine
Danish: Efexor Depot og tilhørende navne (se bilag I) 75 mg depotkapsler [Se bilag I - Udfyldes nationalt]
English: Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Efexor depot in this age group has not yet been demonstrated.
Danish: Dessuden er der - hvad angår vækst, modning samt hjernens og den adfærdsmæssige udvikling - ingen viden om Efexor Depots sikkerhed hos patienter under 18 år, der tager medicinen over længere tid.
English: DATE OF REVISION OF THE TEXT {MM/YYYY [To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN MM/ÅÅÅÅ
English: NAME OF THE MEDICINAL PRODUCT Efexor depot and associated names (see Annex I) 150 mg prolonged-release capsules [See Annex I - To be completed nationally] Venlafaxine
Danish: Efexor Depot og tilhørende navne (se bilag I) 150 mg depotkapsler [Se bilag I - Udfyldes nationalt]