FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients.
Danish: Ventrikelskylning kan være indiceret, hvis den udføres kort tid efter indtagelse eller hos symptomatiske patienter.
English: • Monoamine oxidase inhibitors (MAOIs: see the section “Before you take Efexor”).
Danish: • Monoaminooxidasehæmmere (MAO-hæmmere): Se afsnittet ”Det skal du vide, før du begynder at tage Efexor”
English: The most commonly reported events in overdose include tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis, convulsion, and vomiting.
Danish: De mest almindeligt rapporterede hændelser ved overdosering omfatter: takykardi, ændringer i bevidsthedsniveauet (fra somnolens til koma), mydriasis, kramper og opkastning.
English: • Nervous system disorders
Danish: • Nervesystemet
English: The safety and efficacy of venlafaxine therapy in combination with weight loss agents, including phentermine, have not been established.
Danish: Der er ikke dokumentation for sikkerhed og virkning af venlafaxinbehandling kombineret med vægttabsmedicin, herunder også fentermin.
English: Not known: slight changes in blood levels of liver enzymes; decrease in blood sodium levels; itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); confusion, excessive water intake (known as SIADH); abnormal breast milk production
Danish: Ikke kendt: Lette ændringer i blodets indhold af leverenzymer, nedsat natriumniveau i blodet, kløen, gul hud eller øjne, mørk urin, forkølelseslignende symptomer, som kan være symptom på betændelse i leveren (hepatitis), forvirring, overdreven indtagelse af vand (kendt som SIADH), unormal produktion af modermælk
English: Uncommon: altered taste sensation; ringing in the ears (tinnitus) Not known: severe eye pain and decreased or blurred vision
Danish: Ikke almindelig: Ændret smagsfornemmelse, ringen for ørerne Ikke kendt: Alvorlige smerter i øjnene og nedsat eller sløret syn
English: Efexor and associated names (see Annex I) 25 mg tablets Efexor and associated names (see Annex I) 37.5 mg tablets Efexor and associated names (see Annex I) 50 mg tablets Efexor and associated names (see Annex I) 75 mg tablets
Danish: Efexor og tilhørende navne (se bilag I) 25 mg tabletter Efexor og tilhørende navne (se bilag I) 37.5 mg tabletter Efexor og tilhørende navne (se bilag I) 50 mg tabletter Efexor og tilhørende navne (se bilag I) 75 mg tabletter
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 med serotoninprækursorer (såsom tryptofantilskud) frarådes (se pkt.
English: Cyprus
Danish: Kypern
English: Serum cholesterol increased, Weight loss
Danish: Forhøjet serumkolesterol , vægttab
English: Appetite decreased (anorexia), Constipation, Vomiting
Danish: Nedsat appetit (anoreksi), forstoppelse, opkastning
English: Following the administration of venlafaxine prolonged-release capsules, peak plasma concentrations of venlafaxine and ODV are attained within 5.5 hours and 9 hours, respectively.
Danish: Efter administration af venlafaxin depotkapsler nås de højeste plasmakoncentrationer af venlafaxin og ODV inden for henholdsvis 5,5 timer og 9 timer.
English: For example, venlafaxine immediate-release tablets 37.5 mg twice daily may be switched to venlafaxine prolonged-release capsules 75 mg once daily.
Danish: F.eks. kan venlafaxin-tabletter til umiddelbar udløsning 37,5 mg to gange dagligt skiftes til venlafaxin depotkapsler 75 mg 1 gang dagligt.
English: In some cases, severely elevated blood pressure requiring immediate treatment has been reported in postmarketing experience.
Danish: I nogle tilfælde er der efter markedsføring rapporteret om alvorlige tilfælde af forhøjet blodtryk, der kræver omgående behandling.
English: Uncommon: lack of feeling or emotion; hallucinations; involuntary movement of the muscles; agitation; impaired coordination and balance
Danish: Ikke almindelig: Manglende følelse eller emotion, hallucinationer, ufrivillige muskelbevægelser, ophidselse, svækket koordination og balance
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 MAOinhibitors, 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: For patients that require haemodialysis and in patients with severe renal impairment (GFR < 30 ml/min), the dose should be reduced by 50%.
Danish: Til patienter i hæmodialyse og patienter med svært nedsat nyrefunktion (GFR < 30 ml/min.)
English: There are limited data in patients with severe hepatic impairment (see section 4.2).
Danish: Der er begrænsede data for patienter med svært nedsat leverfunktion (se også pkt.
English: • Heart or circulation disorders
Danish: • Hjerte- eller kredsløbslidelser
English: As with other serotonin-reuptake inhibitors, venlafaxine should be used cautiously in patients predisposed to bleeding, including patients on anticoagulants and platelet inhibitors.
Danish: Som med andre serotonin-reuptake-hæmmere skal venlafaxin anvendes med forsigtighed til patienter, som er disponeret for blødning, herunder patienter i behandling med antikoagulantia og trombocythæmmere.
English: Particularly, the following adverse reactions were observed in paediatric patients: abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis, and myalgia.
Danish: Specielt sås følgende bivirkninger hos pædiatriske patienter: abdominalsmerter, agitation, dyspepsi, ekkymose, næseblod og myalgi.
English: Withdrawal symptoms seen on discontinuation of venlafaxine
Danish: Abstinenssymptomer ved seponering af venlafaxin
English: The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.
Danish: Symptomerne på mulig overdosering kan være hurtigt hjerteslag, ændringer i bevidsthedsniveau (varierende fra søvnighed til koma), sløret syn, kramper eller anfald og opkastning.
English: Hypotension, QT prolongation, Ventricular fibrillation, Ventricular tachycardia (including torsade de pointes)
Danish: Hypotension, QTforlængelse, ventrikelflimren, ventrikulær takykardi (inkl.
English: Efexor sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heart beat; slight changes in blood levels or liver enzymes, sodium or cholesterol.
Danish: Efexor kan give bivirkninger, som du måske ikke bemærker, såsom blodtryksstigniner eller unormal puls, lette ændringer i blodets indhold af leverenzymer, natrium eller kolesterol.
English: Metoprolol did not alter the pharmacokinetic profile of venlafaxine or its active metabolite, O-desmethylvenlafaxine.
Danish: Metoprolol ændrede ikke den farmakokinetiske profil af venlafaxin eller dets aktive metabolit, O-desmethylvenlafaxin.
English: Caution should be exercised with co-administration of venlafaxine and metoprolol.
Danish: Der skal udvises forsigtighed ved samtidig administration af venlafaxin og metoprolol.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and Address} {tel} {fax} {e-mail}
Danish: Indehaveren af markedsføringstilladelsen og fremstiller [Se bilag I - Udfyldes nationalt] {Navn og adresse} {tlf} {fax} {email}
English: Venlafaxine also weakly inhibits dopamine uptake.
Danish: Venlafaxin hæmmer også svagt dopamingenoptag.
English: Caution should be exercised with co-administration of venlafaxine and imipramine.
Danish: Der skal udvises forsigtighed ved samtidig administration af venlafaxin og imipramin.
English: In vitro and in vivo studies indicate that venlafaxine is a weak inhibitor of CYP2D6.
Danish: In vitro- og in vivo-forsøg viser, at venlafaxin er en svag hæmmer af CYP2D6.
English: However, due to inter-individual variability in clearance, individualisation of dosage may be desirable.
Danish: På grund af den interindividuelle forskel i clearance hos disse patienter kan det dog være ønskeligt med individuel dosering.
English: • Medicines containing sibutramine (used for weight loss)
Danish: • medicin med sibutramin (anvendes til vægttab)
English: Abnormal dreams, Decreased libido, Dizziness, Increased muscle tonus (hypertonia), Insomnia, Nervousness, Paresthesia, Sedation, Tremor, Confusion, Depersonalisation
Danish: Abnorme drømme, nedsat libido, svimmelhed, forøget muskeltonus (hypertoni), søvnløshed, nervøsitet, paræstesi, sedation, tremor, forvirring, depersonalisati on
English: The efficacy of venlafaxine immediate-release as a treatment for major depressive episodes was demonstrated in five randomised, double-blind, placebo-controlled, short-term trials ranging from 4 to 6 weeks duration, for doses up to 375 mg/day.
Danish: Virkningen af venlafaxin med umiddelbar udløsning til behandling af større depressive episoder blev fastlagt i 5 randomiserede, dobbeltblinde, placebo-kontrollerede, kortvarige forsøg af 4 til 6 ugers varighed, med doser op til 375 mg/dag.
English: Akathisia/psychomotor restlessness
Danish: Akatisi/psykomotorisk rastløshed
English: Cardiovascular
Danish: Kardiovaskulær
English: SPC Section 4.8 - Undesirable effects
Danish: Afsnit 4.8 i produktresuméet - bivirkninger
English: Reversible, selective MAO-A inhibitor (moclobemide) Due to the risk of serotonin syndrome, the combination of venlafaxine with a reversible and selective MAOI, such as moclobemide, is not recommended.
Danish: På grund af risikoen for serotoninsyndrom kan kombinationen af venlafaxin og en reversibel og selektiv MAO-hæmmer, som f.eks. moclobemid, ikke anbefales.
English: Affects 1 to 10 users in 100
Danish: Påvirker 1 til 10 patienter ud af 100
English: Abnormality of accommodation, Mydriasis, Visual disturbance,
Danish: Abnorm akkommodatio n, mydriasis, synsforstyrrelse
English: - 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: Mydriasis may occur in association with venlafaxine.
Danish: Mydriasis kan forekomme i forbindelse med venlafaxin.
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 and associated names (see Annex I).
Danish: Produktresumé, etikettering og indlægsseddel fremgår af bilag III for Efexor og tilknyttede navne (se bilag I).
English: United Kingdom John Wyeth & Brother Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH United Kingdom
Danish: Storbritanien John Wyeth & Brother Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH Storbritanien
English: The human relevance of this finding is unknown.
Danish: Den humane relevans af dette fund kendes ikke.
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 og 12 ugers varighed, med doser fra 75 til 225 mg/dag.
English: However, caution should be exercised in treating the elderly (e.g., due to the possibility of renal impairment, the potential for changes in neurotransmitter sensitivity and affinity occurring with aging).
Danish: Det anses ikke for nødvendigt med specifikke dosisjusteringer af venlafaxin alene på grundlag af patientens alder. Der skal dog udvises forsigtighed ved behandling af ældre (f.eks. på grund af muligheden for nedsat nyrefunktion og potentielle ændringer i neurotransmitter-følsomhed og affinitet, som optræder med alderen).
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: Almindelig: Abnorm sædafgang/orgasme (mænd), manglende orgasme, erektil dysfunktion (impotens), uregelmæssigheder omkring menstruationen som f.eks. forøget blødning eller forøget, uregelmæssig blødning
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 almindeligt indberettede bivirkninger (>1/10) fra kliniske undersøgelser var kvalme, mundtørhed, hovedpine og perspiration (incl.
English: SPC Section 4.1 - Therapeutic Indications
Danish: 4.1 Terapeutiske indikationer
English: Important information about some of the ingredients of Efexor
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Efexor [Udfyldes nationalt]
English: Mean ± SD plasma half-lives of venlafaxine and ODV are 5±2 hours and 11±2 hours, respectively.
Danish: Venlafaxins og ODVs middel ± SD plasma-halveringstid er henholdsvis 5 ±2 timer og 11 ±2 timer.
English: Take special care with Efexor
Danish: Vær ekstra forsigtig med at tage Efexor
English: Plasma concentrations of venlafaxine are higher in CYP2D6 poor metabolisers than extensive metabolisers.
Danish: Personer med god og ringe CYP2D6-metaboliseringsevne Plasmakoncentrationerne af venlafaxin er højere hos personer, som har en ringe CYP2D6metaboliseringsevne end hos personer, som har en god metaboliseringsevne.
English: Venlafaxine must not be used in combination with irreversible non-selective MAOIs.
Danish: Irreversible, ikke-selektive MAO-hæmmere Venlafaxin må ikke anvendes i kombination med irreversible, ikke-selektive MAO-hæmmere (se pkt.
English: Haematological/ Lymphatic
Danish: Blod/lymfe
English: Affects 1 to 10 users in 10,000
Danish: Påvirker 1 til 10 patienter ud af 10.000
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION {DD/MM/YYYY} [To be completed nationally]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt] DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN DD/MM/ÅÅÅÅ [Udfyldes nationalt]
English: After immediate-release venlafaxine administration, the peak plasma concentrations of venlafaxine and ODV occur in 2 and 3 hours, respectively.
Danish: Efter administration af venlafaxin til umiddelbar udløsning forekommer de højeste plasmakoncentrationer af venlafaxin og ODV efter henholdsvis 2 og 3 timer.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Efexor.
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: 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: As with all antidepressants, venlafaxine should be introduced with caution in patients with a history of convulsions, and concerned patients should be closely monitored.
Danish: Som med alle antidepressiva skal behandling med venlafaxin iværksættes med forsigtighed hos patienter med kramper i anamnesen, og de pågældende patienter skal overvåges nøje.
English: [To be completed nationally] 6.6 Special precautions for disposal No special requirements.
Danish: 6.6 Regler for destruktion og anden håndtering Ingen særlige forholdsregler.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: • Medicines containing tramadol (a pain-killer)
Danish: • medicin med tramadol (et smertestillende middel)
English: It is therefore advised that when venlafaxine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
Danish: Der tilrådes derfor gradvis ophør med aftrapning af dosis, når behandling med venlafaxin ikke længere er nødvendig (se pkt.
English: Uncommon: weight gain
Danish: Ikke almindelig: Vægtøgning
English: Not known: skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
Danish: Ikke kendt: Hududslæt, som kan føre til alvorlig blæredannelse og afskalning af huden, kløe, let udslæt
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: Metabolic/ Nutritional
Danish: Stofskifte/ ernæring
English: The MAH was asked to harmonize 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: 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: As with other antidepressants, venlafaxine should be used cautiously in patients with a history of aggression.
Danish: Som med andre antidepressiva skal venlafaxin anvendes med forsigtighed hos patienter med aggression i anamnesen.
English: • Nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits
Danish: • Nerveproblemer, såsom svimmelhed, sovende fornemmelse, bevægelsesforstyrrelse, kramper eller anfald.
English: Other reported events include electrocardiographic changes (e.g., prolongation of QT interval, bundle branch block, QRS prolongation), ventricular tachycardia, bradycardia, hypotension, vertigo, and death.
Danish: forlængelse af QT-intervallet, grenblok, QRS-forlængelse), ventrikulær takykardi, bradykardi, hypotension, vertigo og dødsfald.
English: Given that strong warnings recommending the monitoring of blood pressure for all patients prior to the initiation of treatment were included in Section 4.4, the CHMP agreed that a contraindication in patients with uncontrolled hypertension was not warranted.
Danish: De kraftige advarsler med anbefaling af overvågning af blodtryk hos alle patienter forud for indledning af behandling blev indført i afsnit 4.4.
English: Complete side effect listing
Danish: Fuldstændig liste over bivirkninger
English: Food does not affect the bioavailability of venlafaxine and ODV.
Danish: Mad påvirker ikke venlafaxins og ODVs biotilgængelighed.
English: Abnormal liver function tests, Hyponatraemia, Hepatitis, Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH), Prolactin increased
Danish: Abnorme leverfunktionsprøver, hyponatriæmi, hepatitis, (SIADH), øget prolaktin
English: FURTHER INFORMATION What Efexor contains The active substance is venlafaxine.
Danish: Det aktive indholdsstof er venlafaxin.
English: Venlafaxine did not affect the pharmacokinetics of imipramine and 2-OH-imipramine.
Danish: Venlafaxin påvirkede ikke imipramins og 2-OH-imipramins farmakokinetik.
English: *In pooled clinical trials, the incidence of headache was 30.3% with venlafaxine versus 31.3% with placebo.
Danish: * I sammenlagte kliniske undersøgelser var incidensen af hovedpine 30,3 % for venlafaxin mod 31,3 % for placebo ** Der er rapporteret om suicidale forestillinger og suicidal adfærd under behandling med venlafaxin eller tidligt efter behandlingsophør (se pkt.
English: In this leaflet:
Danish: Efexor indeholder:
English: Blood pressure should be reviewed periodically, after initiation of treatment and after dose increases.
Danish: Efter påbegyndelse af behandling og efter dosisforhøjelser bør blodtrykket kontrolleres regelmæssigt.
English: Diazepam does not appear to affect the pharmacokinetics of either venlafaxine or O-desmethylvenlafaxine.
Danish: Diazepam synes ikke at påvirke hverken venlafaxins eller Odesmethylvenlafaxins farmakokinetik.
English: Not known: swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)
Danish: Almindelig: Svækkelse (asteni), kuldegysninger Ikke almindelig: Overfølsomhed over for sollys Ikke kendt: Opsvulmet ansigt eller tunge, stakåndethed eller vejrtrækningsbesvær, ofte med udslæt på huden (dette kan være en alvorlig allergisk reaktion)
English: It is recommended that venlafaxine should be discontinued for at least 7 days before starting treatment with a reversible MAOI (see section 4.4).
Danish: Det anbefales at seponere venlafaxin i mindst 7 dage, før behandling med en reversibel MAO-hæmmer sættes i gang (se pkt.
English: 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/orga sme (mænd), anorgasme, erektil dysfunktion (impotens), vandladningspr oblemer (ofte startbesvær), menstruationsfo rstyrrelser med forøget blødning eller forøget, uregelmæssig blødning (f.eks. menoragi, metroragi), pollakiuria
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: As with other antidepressants, venlafaxine should be used cautiously in patients with a history or family history of bipolar disorder.
Danish: Som med andre antidepressiva skal venlafaxin anvendes med forsigtighed hos patienter med bipolær affektiv sindslidelse i anamnesen eller den familiære anamnese.
English: • Chest tightness, wheezing, trouble swallowing or breathing
Danish: • Trykken for brystet, hvæsende åndedræt, problemer med at synke eller åndedrætsproblemer.
English: Dizziness, sensory disturbances (including paraethesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, headache and flu syndrome are the most commonly reported reactions.
Danish: insomni og voldsomme drømme), agitation eller angst, kvalme og/eller opkastning, rysten, hovedpine og influenzasyndrom er de mest almindelige, indberettede reaktioner.
English: • Serotonin syndrome, a potentially life-threatening condition (see the section “Possible Side
Danish: • Serotoninsyndrom: Serotoninsyndrom, en potentielt livstruende tilstand (se afsnittet ”Bivirkninger”), kan forekomme ved behandling med Efexor, navnlig når det tages sammen med anden medicin.