FrancophonIA/ELRC3.0 huggingface dataset:
English: The antibiotic linezolid is a weak reversible and non-selective MAOI and should not be given to patients treated with venlafaxine (see section 4.4).
Danish: Antibiotikummet linezolid er en svag, reversibel og ikke-selektiv MAO-hæmmer og må ikke gives til patienter i behandling med venlafaxin (se pkt.
English: Effect of other medicinal products on venlafaxine
Danish: Andre lægemidlers virkning på venlafaxin
English: When there is a risk of aspiration, induction of emesis is not recommended.
Danish: Fremkaldelse af opkastning anbefales ikke, når der er en risiko for aspiration.
English: • Feeling nervous or anxious, dizziness, throbbing sensations, sudden reddening of the skin and/or a warm feeling
Danish: • Følelse af nervøsitet eller angst, svimmelhed, dunkende fornemmelse, pludselig rødme af huden og/eller en varm fornemmelse.
English: Patients treated with venlafaxine immediate-release tablets may be switched to venlafaxine prolonged-release capsules at the nearest equivalent daily dosage.
Danish: Patienter, som behandles med venlafaxin tabletter til umiddelbar udløsning, kan skifte til venlafaxin depotkapsler på den nærmeste tilsvarende daglige dosis.
English: • Medicines containing linezolid, an antibiotic (used to treat infections)
Danish: • medicin med linezolid, et antibiotikum til behandling af infektioner
English: More rarely, Efexor may reduce the function of platelets in your blood, leading to an increased risk of bruising or bleeding.
Danish: I mere sjældne tilfælde kan Efexor reducere funktionen af trombocytter i blodet, hvilket forhøjer risikoen for blå mærker eller blødning.
English: In Child-Pugh A (mildly hepatically impaired) and Child-Pugh B (moderately hepatically impaired) subjects, venlafaxine and ODV half-lives were prolonged compared to normal subjects.
Danish: Hos forsøgspersoner med Child-Pugh A (let nedsat leverfunktion) og Child-Pugh B (moderat nedsat leverfunktion) blev halveringstiden for venlafaxin og ODV forlænget i forhold til raske forsøgspersoner.
English: Following review, chills, confusion, depersonalisation, headache, menstrual disorders, palpitations and pollakiuria were included in this table.
Danish: Efter gennemgangen blev kulderystelser, konfusion, depersonalisering, hovedpine, uregelmæssig menstruation, palpitationer og pollakiuria medtaget i dette skema.
English: In patients with mild and moderate hepatic impairment, in general a 50% dose reduction should be considered.
Danish: Anvendelse til patienter med nedsat leverfunktion Til patienter med mildt til moderat nedsat leverfunktion bør en dosisreduktion på 50% generelt overvejes.
English: Venlafaxine and ODV exhibit linear kinetics over the dose range of 75 mg to 450 mg/day.
Danish: Venlafaxin og ODV udviser lineær kinetik gennem dosisintervallet fra 75 mg til 450 mg dagligt.
English: The MAH was asked to identify differences between the listed adverse events in the nationally approved SPCs and the MAH's CDS, and to organise Section 4.8 according to the MedDRA system organ class.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at identificere forskellene mellem de anførte bivirkninger i de nationalt godkendte produktresuméer og indehaverens CDS (Core Data Sheet) og om at organisere afsnit 4.8 i overensstemmelse med MedDRA-systemets organklasser.
English: This exposure was approximately 1 to 2 times that of a human venlafaxine dose of 375 mg/day.
Danish: Denne eksponering var ca. 1-2 gange højere end en human venlafaxindosis på 375 mg dagligt.
English: It is therefore advised that venlafaxine should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient's needs (see section 4.2).
Danish: Det tilrådes derfor, at venlafaxin aftrappes gradvist over en periode på flere uger eller måneder ved behandlingsophør, alt afhængig af patientens behov (se pkt.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Serum cholesterol
Danish: Serumkolesterol
English: Not known: reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding; blood disorders which may lead to an increased risk of infection
Danish: Ikke kendt: Nedsat antal trombocytter i blodet, hvilket fører til øget risiko for blå mærker eller blødning, blodforstyrrelser, som kan medføre øget risiko for infektion
English: • Products containing St. John's Wort (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression)
Danish: • produkter med perikon (også kaldet hypericum perforatum, et naturlægemiddel eller urtemedicin, som bruges til at behandle mild depression)
English: • Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
Danish: • Kraftigt udslæt, kløe eller nældefeber (hævede pletter i rød eller bleg hud, der ofte klør).
English: Venlafaxine and its metabolites are excreted primarily through the kidneys.
Danish: Venlafaxin og dens metabolitter udskilles hovedsageligt via nyrerne.
English: Preclinical studies have shown that venlafaxine and its major metabolite, O-desmethylvenlafaxine (ODV), are inhibitors of serotonin and noradrenaline reuptake.
Danish: Prækliniske undersøgelser har vist, at venlafaxin og dets hovedmetabolit, O-desmethylvenlafaxin (ODV), hæmmer serotonin og noradrenalin genoptag.
English: Discontinuation of venlafaxine (particularly when abrupt) commonly leads to withdrawal symptoms.
Danish: Behandlingsophør med venlafaxin (specielt hvis behandlingen ophører brat) medfører almindeligvis abstinenssymptomer.
English: In clinical trials, adverse events seen on treatment discontinuation (tapering and post-tapering) occurred in approximately 35% of patients treated with venlafaxine and 17% of patients taking placebo.
Danish: I kliniske undersøgelser opstod bivirkninger ved behandlingsophør (aftrapning og postaftrapning) hos ca. 31% af patienterne, som blev behandlet med venlafaxin, og hos 17% af patienterne, som fik placebo.
English: DATE OF REVISION OF THE TEXT MM/YYYY [To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN MM/ÅÅÅÅ [Udfyldes nationalt]
English: Dose-related increases in blood pressure have been commonly reported with venlafaxine.
Danish: Der er hyppigt rapporteret om dosisrelaterede stigninger i blodtrykket i forbindelse med behandling med venlafaxin.
English: When stopping treatment with venlafaxine, the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Danish: Når behandling med venlafaxin stoppes, bør dosis reduceres gradvist over en periode på mindst en til to uger for at reducere risikoen for abstinensreaktioner (se pkt.
English: A meta-analysis of placebocontrolled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Danish: En meta-analyse af placebokontrollerede kliniske forsøg med antidepressiva til voksne patienter med psykiatriske lidelser viste en øget risiko for selvmordsadfærd hos patienter under 25 år i behandling med antidepressiva sammenlignet med placebo.
English: Common: appetite decreased; constipation; vomiting Uncommon: grinding of the teeth; diarrhoea
Danish: Almindelig: Nedsat appetit, forstoppelse, opkastning Ikke almindelig: Skæren tænder, diarré
English: Tablet [To be completed nationally]
Danish: Tablet [Udfyldes nationalt]
English: • Products containing tryptophan (used for problems such as sleep and depression)
Danish: • produkter med tryptofan (anvendes mod søvnproblemer og depression)
English: The usual recommended starting dose is 75 mg per day in divided doses, two or three times a day.
Danish: Den normalt anbefalede startdosis er 75 mg dagligt fordelt på 2 eller 3 doser om dagen.
English: Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcomes compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants.
Danish: Offentliggjorte, retrospektive forsøg rapporterer, at overdosering af venlafaxin kan være forbundet med en forhøjet risiko for dødelig udgang i forhold til det, der ses med SSRI-antidepressiva, men lavere end for tricykliske antidepressiva.
English: Following the European Commission's request, Section 4.1 of the Summary of Product Characteristics was harmonised 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: Afsnit 4.1 i produktresuméet - Terapeutiske indikationer Efter Europa-Kommissionens anmodning blev afsnit 4.1 i produktresuméet harmoniseret, så følgende terapeutiske indikationer blev medtaget således som formuleret og beskrevet herunder: - "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: Venlafaxine is extensively metabolised, primarily to the active metabolite, O-desmethylvenlafaxine (ODV).
Danish: Venlafaxin metaboliseres i omfattende grad, primært til den aktive metabolit, O-desmethylvenlafaxin (ODV).
English: Hypersensitivity to the active substance or to any of the excipients.
Danish: Overfølsomhed over for aktive indholdsstof eller over for et eller flere af hjælpestofferne.
English: The MAH completed both the assessment of urinary disorders and of occurrence of gastrointestinal haemorrhage and agreed to add them to the adverse reaction table.
Danish: Indehaveren af markedsføringstilladelsen gennemførte vurderingen af urinvejssygdomme og forekomsten af gastrointestinal blødning og indvilligede i at føje dem til skemaet over bivirkninger.
English: In postmarketing experience, fatal cardiac arrhythmias have been reported with the use of venlafaxine, especially in overdose.
Danish: Efter markedsføring er der indberetninger om dødelig hjertearytmi ved brug af venlafaxin, specielt ved overdosering.
English: Dry mouth is reported in 10% of patients treated with venlafaxine.
Danish: Der er rapporteret om mundtørhed hos 10% af patienterne, som er i behandling med venlafaxin.
English: The MAH was of the view that all MAOIs should be contraindicated with venlafaxine.
Danish: Indehaveren af markedsføringstilladelsen var af den opfattelse, at alle MAO-hæmmere skulle være kontraindicerede sammen med venlafaxin.
English: • Ketoconazole (an antifungal medicine)
Danish: • ketoconazol (et svampedræbende lægemiddel)
English: • Muscle disorders Not known: unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
Danish: • Knogler, led og muskler Ikke kendt: Uforklarlige muskelsmerter, ømhed eller slaphed (rhabdomyolyse)
English: Frequency cannot be estimated from the available data • Blood disorders
Danish: Hyppigheden kan ikke fastsættes ud fra forhåndenværende data
English: Efexor should be taken with food (see section 3 “HOW TO TAKE EFEXOR”).
Danish: Brug af Efexor sammen med mad og drikke Efexor skal tages sammen med mad (se afsnit 3 ”Sådan skal du tage Efexor”).
English: Efexor should not be used in the treatment of children and adolescents under the age of 18 years.
Danish: Efexor bør ikke anvendes til behandling af børn og unge under 18 år.
English: Venlafaxine was not mutagenic in a wide range of in vitro and in vivo tests.
Danish: Venlafaxin var ikke mutagent i en lang række in vitro- og in vivo-test.
English: In paediatric clinical trials the adverse reaction suicidal ideation was observed.
Danish: I kliniske pædiatriske forsøg blev tanker om selvmord observeret som bivirkning.
English: Weight gain
Danish: Vægtforøgelse
English: If any of the following happen, do not take more Efexor.
Danish: Tag ikke mere Efexor, hvis der opstår noget af det følgende.
English: SPC Section 4.2 - Posology and Method of Administration The MAH was asked to harmonize the following posology texts in the SPC: - limitations of treatment duration of the maximum daily dose of 375mg to 4 weeks; - differences in maximum recommended daily dose.
Danish: Afsnit 4.2 i produktresuméet - Dosering og indgivelsesmåde Indehaveren af markedsføringstilladelsen blev anmodet om at harmonisere den følgende doseringstekst i produktresuméet: - Begrænsninger af behandlingsvarighed til 4 uger for den maksimale daglige dosis på 375 mg - Forskelle i anbefalet maksimal daglig dosis.
English: There was a dose-dependent increase of 2-OH-desipramine AUC by 2.5 to 4.5-fold when venlafaxine 75 mg to 150 mg daily was administered.
Danish: Der var en dosisafhængig stigning i AUC for 2−OH−desipramin på 2,5 til 4,5 gange ved administration af venlafaxin 75 mg til 150 mg dagligt.
English: Not known: severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)
Danish: Ikke kendt: Alvorlige mave- eller rygsmerter (hvilket kan tyde på alvorlige problemer i tarmen, leveren eller bugspytkirtlen)
English: Common: weight loss; increased cholesterol
Danish: Almindelig: Vægttab, forhøjet kolesterol
English: Hypertension, Vasodilatation (mostly hot flashes/flushes), Palpitations
Danish: Hypertension, vasodilatation (fortrinsvis hedestigninger /rødmen), hjertebanken
English: Caution should be exercised in patients whose underlying conditions might be compromised by increases in heart rate.
Danish: Der skal udvises forsigtighed hos patienter, hvis underliggende sygdomme kan forværres af en stigning i hjertefrekvensen.
English: Venlafaxine has not been evaluated in patients with a recent history of myocardial infarction or unstable heart disease.
Danish: Venlafaxin er ikke vurderet hos patienter med myokardieinfarkt eller ustabil hjertesygdom i den nylige anamnese.
English: In one longer-term study, adult outpatients who had responded during an 8-week open trial on venlafaxine prolonged-release (75, 150, or 225 mg) were randomised to continuation of their same venlafaxine prolonged-release dose or to placebo, for up to 26 weeks of observation for relapse.
Danish: I et længerevarende forsøg blev voksne ambulante patienter, som under et 8-ugers åbent forsøg havde responderet på venlafaxin depot (75, 150, eller 225 mg, hver morgen), randomiseret til enten at fortsætte på den samme venlafaxin depot-dosis eller til placebo med henblik på op til 26 ugers observation for recidiv.
English: If you forget to take Efexor
Danish: Hvis du har glemt at tage Efexor
English: In vitro and in vivo studies indicate that venlafaxine is metabolised to a minor, less active metabolite, N-desmethylvenlafaxine, by CYP3A4.
Danish: In vitro- og in vivoforsøg viser, at venlafaxin metaboliseres til en underordnet, mindre aktiv metabolit, N-desmethylvenlafaxin, af CYP3A4.
English: Ecchymosis, Gastrointestinal haemorrhage
Danish: Blodudtrædning, gastrointestinal blødning
English: The MAH wished to maintain that all MAOIs should be contraindicated whereas the CHMP considered that only non-selective, irreversible MAOIs should be contraindicated and that a strong warning in Section 4.5 of the SPC should be sufficient for the reversible MAOIs.
Danish: Indehaveren af markedsføringstilladelsen ønskede at fastholde, at alle MAO-hæmmere skulle være kontraindicerede, mens CHMP mente, at kun non-selektive irreversible MAO-hæmmere skulle være kontraindicerede, og at en kraftig advarsel i afsnit 4.5 i produktresuméet burde være tilstrækkelig for de reversible MAO-hæmmere.
English: • Treatment withdrawal (see the section “HOW TO TAKE EFEXOR, If you stop taking Efexor”)
Danish: • Abstinenser (se afsnittet ”Sådan skal du tage Efexor, Hvis du holder op med at tage Efexor”).
English: • Triptans (used for migraine)
Danish: • triptaner (anvendes mod migræne)
English: Vandral 37,5 mg comprimidos Vandral 50 mg comprimidos Vandral 75 mg comprimidos *[Please note that not all listed products and strengths may be available.]
Danish: Vandral 75 mg comprimidos *[Bemærk: Det er ikke sikkert, at alle nævnte produkter og styrker er tilgængelige]
English: Mean ± SD plasma steady-state clearances of venlafaxine and ODV are 1.3±0.6 L/h/kg and 0.4±0.2 L/h/kg, respectively.
Danish: Middel ± SD plasma steady state clearance for venlafaxin og ODV er henholdsvis 1,3 ±0,6 l/t/kg og 0,4 ±0,2 l/t/kg.
English: Use in patients with hepatic impairment: it was agreed to recommend in the SPC the individualization of dosage to overcome clearance variability between patients with hepatic impairment.
Danish: Anvendelse til patienter med nedsat leverfunktion: Der var enighed om i produktresuméet at anbefale individualisering af dosis for at komme ud over clearance-afvigelighed mellem patienter med nedsat leverfunktion.
English: If you stop taking Efexor
Danish: Hvis du holder op med at tage Efexor
English: Signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
Danish: Tegn og symptomer på serotoninsyndrom kan omfatte en kombination af følgende: Rastløshed, hallucinationer, manglende koordination, hurtig puls, forhøjet kropstemperatur, hurtige ændringer i blodtrykket, overaktive reflekser, diarré, koma, kvalme, opkastning.
English: Age and gender Subject age and gender do not significantly affect the pharmacokinetics of venlafaxine and ODV.
Danish: Alder og køn Forsøgspersonens alder og køn påvirker ikke i signifikant grad venlafaxins og ODVs farmakokinetik.
English: Akathisia/ Psychomotor restlessness, Convulsion, Manic reaction
Danish: Akatisi/ psykomotorisk rastløshed , kramper, manisk reaktion
English: • Medicines containing moclobemide, a reversible MAOI (used to treat depression)
Danish: • medicin med moclobemid, en reversibel MAO-hæmmer til behandling af depression
English: Dosage adjustment is necessary in patients with severe renal impairment and in patients that require haemodialysis (see section 4.2).
Danish: Det er nødvendigt at justere dosis til patienter med svært nedsat leverfunktion og til patienter, som kræver hæmodialyse (se pkt.
English: As with other serotonergic agents, serotonin syndrome may occur with venlafaxine treatment, particularly with concomitant use of other agents that may affect the serotonergic neurotransmitter system (including triptans, SSRIs, SNRIs, lithium, sibutramine, tramadol, or St. John's Wort [Hypericum perforatum]), with medicinal agents which impair metabolism of serotonin (including MAOIs), or with serotonin precursors (such as tryptophan supplements).
Danish: Som med andre serotonerge midler kan der opstå serotoninsyndrom under behandling med venlafaxin, navnlig ved samtidig brug af andre midler, der kan påvirke de serotonerge neurotransmittersystemer (herunder også triptaner, SSRI'er, SNRI'er, lithium, sibutramin, tramadol eller perikum [Hypericum perforatum]), med lægemidler, der hæmmer metabolismen af serotonin (herunder også MAOhæmmere), eller med serotoninprækursorer (såsom tryptofantilskud).
English: In vitro and in vivo studies indicate that venlafaxine is biotransformed to its major active metabolite, ODV, by CYP2D6.
Danish: In vitro- og in vivo-forsøg viser, at venlafaxin biotransformeres til dens aktive hovedmetabolit, ODV, af CYP2D6.
English: Venlafaxine has no effects on the pharmacokinetics and pharmacodynamics of diazepam and its active metabolite, desmethyldiazepam.
Danish: Venlafaxin har ingen virkning på diazepams farmakokinetik og farmakodynamik og dets aktive metabolit, desmethyldiazepam.
English: The recommended starting dose of immediate-release venlafaxine is 75 mg/day in two or three divided doses taken with food.
Danish: Den anbefalede startdosis for venlafaxin til umiddelbar udløsning er 75 mg dagligt fordelt på to eller tre doser, der indtages sammen med mad.
English: Not known: coughing, wheezing, shortness of breath and a high temperature, which are symptoms of inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia)
Danish: Ikke kendt: Hoste, hvæsen, stakåndethed og høj temperatur, hvilket er symptomer på en betændelseslignende tilstand (inflammation) i lungerne i forbindelse med en stigning i antallet af hvide blodlegemer (pulmonær eosinophili)
English: These reactions have included tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, and hyperthermia with features resembling neuroleptic malignant syndrome, seizures, and death.
Danish: Disse reaktioner har omfattet: tremor, myoklonus, diaforese, kvalme, opkastning, flushing, svimmelhed og hypertermi med kendetegn, der ligner neuroleptisk malignt syndrom, kramper og dødsfald.
English: Very common: dry mouth; headache
Danish: Meget almindelig: Mundtørhed, hovedpine
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 Ikke kendt: Fald i blodtrykket, unormalt, hurtigt eller uregelmæssigt hjerteslag, som kan føre til besvimelse
English: United Kingdom
Danish: Storbritanien
English: In a second longer-term study, the efficacy of venlafaxine in prevention of recurrent depressive episodes for a 12-month period was established in a placebo-controlled double-blind clinical trial in adult outpatients with recurrent major depressive episodes who had responded to venlafaxine treatment (100 to 200 mg/day, on a b.i.d.
Danish: I et andet længerevarende forsøg blev virkningen af venlafaxin til forebyggelse af nye anfald af depressive episoder i en 12-måneders periode fastslået i et placebo-kontrolleret, dobbeltblindt klinisk forsøg med voksne ambulante patienter med tilbagevendende større depressive episoder, som havde responderet på venlafaxinbehandling (100 til 200 mg dagligt, to gange dagligt) under den sidste depressionsepisode.
English: Common: difficulties passing urine; increased frequency in urination Uncommon: inability to pass urine
Danish: Almindelig: Problemer med at lade vandet, hyppigere vandladning Ikke almindelig: Ude af stand til at lade vandet
English: Uncommon: bruising; black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding
Danish: Ikke almindelig: Blå mærker, sort, tjæreagtig afføring (faeces) eller blod i afføringen, hvilket kan være tegn på indre blødning
English: Some patients may experience symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely, electric shock sensations, weakness, sweating, seizures or flu-like symptoms.
Danish: Nogle patienter kan opleve symptomer såsom træthed, svimmelhed, uklarhed, hovedpine, søvnløshed, mareridt, mundtørhed, appetitløshed, kvalme, diarré, nervøsitet, agitation, konfusion, ringen for ørerne, prikken i huden eller sjældent følelse af elektrisk stød, svækkelse, sveden, kramper eller influenza-lignende symptomer.
English: Venlafaxine and its active metabolite, O-desmethylvenlafaxine, are excreted in breast milk.
Danish: Venlafaxin og dets aktive metabolit, O-desmethylvenlafaxin, udskilles i modermælken.
English: Very common: sweating (including night sweats) Uncommon: rash; abnormal hair loss
Danish: Meget almindelig: Svedtendenser (også nattesved) Ikke almindelig: Udslæt, unormalt hårtab