FrancophonIA/ELRC3.0 huggingface dataset:
English: Also, you must wait at least 7 days after you stop taking Efexor before you take any irreversible MAOI (see also the sections “Serotonin syndrome” and “Taking other medicines”).
Danish: Du skal desuden vente i mindst 7 dage, efter at du er holdt med at tage Efexor, før du tager en MAO-hæmmer (se også afsnittene ”Serotoninsyndrom” og ”Brug af anden medicin”).
English: It is recommended that venlafaxine immediate-release tablets be taken with food, at approximately the same time each day.
Danish: Det anbefales at tage venlafaxin tabletter til umiddelbar udløsning sammen med mad på omtrent samme tidspunkt hver dag.
English: Clinically relevant increases in serum cholesterol were recorded in 5.3% of venlafaxine-treated patients and 0.0% of placebo-treated patients treated for at least 3 months in placebo-controlled clinical trials.
Danish: Der blev registreret klinisk relevante stigninger i serumkolesterol hos 5,3 % af de venlafaxinbehandlede patienter og 0,0 % af de placebobehandlede patienter, som blev behandlet i mindst 3 måneder i placebo-kontrollerede kliniske forsøg.
English: Thoughts of suicide and worsening of your depression or anxiety disorder
Danish: Tanker om selvmord eller forværring af din depression eller angst.
English: Venlafaxine increased the risperidone AUC by 50%, but did not significantly alter the pharmacokinetic profile of the total active moiety (risperidone plus 9-hydroxyrisperidone).
Danish: Venlafaxin øgede AUC for risperidon med 50 %, men ændrede ikke den farmakokinetiske profil signifikant for den totale aktive del (risperidon plus 9-hydroxyrisperidon).
English: Approximately 87% of a venlafaxine dose is recovered in the urine within 48 hours as either unchanged venlafaxine (5%), unconjugated ODV (29%), conjugated ODV (26%), or other minor inactive metabolites (27%).
Danish: Omtrent 87 % af en venlafaxindosis genfindes i urinen inden for 48 timer som enten uændret venlafaxin (5 %), ukonjugeret ODV (29 %), konjugeret ODV (26 %) eller andre underordnede inaktive metabolitter (27 %).
English: In general, the adverse reaction profile of venlafaxine (in placebo-controlled clinical trials) in children and adolescents (ages 6 to 17) was similar to that seen for adults.
Danish: Generelt var venlafaxins bivirkningsprofil (i placebo-kontrollerede kliniske forsøg) hos børn og unge (i alderen 6 til 17 år) den samme som hos voksne.
English: Erythema multiforme, Toxic epidermal necrolysis, StevensJohnson syndrome, Pruritus, Urticaria
Danish: Erythema multiforme, toksisk epidermal nekrolyse, Stevens-Johnsonssyndrom, pruritus, urticaria
English: A pharmacokinetic study with haloperidol has shown a 42% decrease in total oral clearance, a 70% increase in AUC, an 88% increase in Cmax, but no change in half-life for haloperidol.
Danish: Et farmakokinetisk forsøg med haloperidol har vist et fald på 42 % i total oral clearance, en stigning på 70 % i AUC, en stigning på 88 % i Cmax, men ingen ændring i halveringstid for haloperidol.
English: The extent to which the finding of an increased risk of fatal outcomes can be attributed to the toxicity of venlafaxine in overdosage, as opposed to some characteristics of venlafaxine-treated patients, is not clear.
Danish: I hvor høj grad fundet af en forhøjet risiko for dødelig udgang kan tilskrives venlafaxins toksicitet ved overdosering i modsætning til en række karakteristika hos patienter, som behandles med venlafaxin, er ikke klart.
English: Postural hypotension, Syncope, Tachycardia
Danish: Postural hypotension, synkope, takykardi
English: Severe adverse reactions have been reported in patients who have recently been discontinued from an MAOI and started on venlafaxine, or have recently had venlafaxine therapy discontinued prior to initiation of an MAOI.
Danish: Der er rapporteret alvorlige bivirkninger hos patienter, som for nylig har fået seponeret en MAOhæmmer og er begyndt på venlafaxin, eller som for nylig har fået seponeret en venlafaxinbehandling før iværksættelse af en MAO-hæmmer.
English: 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens, Greece
Danish: 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athen, Grækenland
English: Aggression may occur in a small number of patients who have received antidepressants, including venlafaxine.
Danish: Aggression kan forekomme hos et lille antal patienter, som har fået antidepressiva, herunder venlafaxin.
English: Abrupt discontinuation should be avoided.
Danish: Pludseligt behandlingsstop bør undgås.
English: As with adults, decreased appetite, weight loss, increased blood pressure, and increased serum cholesterol were observed (see section
Danish: Ligesom hos voksne sås der nedsat appetit, vægttab, forhøjet blodtryk og forhøjet serumkolesterol (se pkt.
English: Therefore, caution is advised if a patient's therapy includes a CYP3A4 inhibitor and venlafaxine concomitantly.
Danish: Derfor tilrådes forsigtighed, når en patients behandling omfatter en CYP3A4-hæmmer og venlafaxin samtidig.
English: Rash, Alopecia
Danish: Udslæt, alopeci
English: Generally, these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
Danish: Generelt er disse symptomer selvbegrænsende og går over i løbet af 2 uger, men hos nogle patienter kan de dog vare længere (2-3 måneder eller mere).
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDEL FREMLAGT AF EMEA
English: • If you use other medicines that taken concomitantly with Efexor could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”).
Danish: • Hvis du tager anden medicin, som sammen med Efexor kan øge risikoen for at udvikle serotoninsyndrom (se afsnittet ”Brug af anden medicin”)
English: Reversible, non-selective MAOI (linezolid)
Danish: Reversibel, ikke-selektiv MAO-hæmmer (linezolid)
English: Steady-state concentrations of venlafaxine and ODV are attained within 3 days of oral multiple-dose therapy.
Danish: Steady state-koncentrationer af venlafaxin og ODV nås inden for 3 dages behandling med multiple orale doser.
English: Suicide-related behaviours (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Danish: I kliniske undersøgelser blev selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) hyppigere set hos børn og unge, som blev behandlet med antidepressiva end hos dem, som blev behandlet med placebo.
English: • If you are allergic to venlafaxine or any of the other ingredients of Efexor.
Danish: • Hvis du er overfølsom (allergisk) over for venlafaxin eller et af de øvrige indholdsstoffer.
English: Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Danish: Patienter med selvmordsrelaterede hændelser i anamnesen eller patienter, som udviser en signifikant grad af selvmordstanker, før de påbegynder behandlingen, har større risiko for selvmordstanker eller selvmordsforsøg og skal overvåges nøje under behandlingen.
English: A new study report was provided which concluded that the use of venlafaxine was not associated with an excess risk of sudden cardiac death compared with the SSRIs fluoxetine and citalopram or dusolepin in patients with depression or anxiety.
Danish: Der blev fremlagt en ny undersøgelsesrapport, som konkluderede, at anvendelse af venlafaxin ikke var forbundet med en merrisiko for pludselig hjertedød sammenlignet med SSRI'erne fluoxetin og citalopram eller dusolepin hos patienter med depression eller angst.
English: • Psychiatric problems, such as hyperactivity and euphoria
Danish: • Psykiatriske problemer, såsom hyperaktivitet og opstemthed.
English: Close supervision of patients, and in particular those at high risk, should accompany drug therapy, especially in early treatment and following dose changes.
Danish: Den medicinske behandling bør følges af tæt overvågning af patienterne, i særdeleshed højrisikopatienter, især i begyndelsen af behandlingen og efter dosisændringer.
English: Concomitant use of CYP3A4 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, voriconazole, posaconazole, ketoconazole, nelfinavir, ritonavir, saquinavir, telithromycin) and venlafaxine may increase levels of venlafaxine and O-desmethylvenlafaxine.
Danish: Samtidig brug af CYP3A4-hæmmere (f.eks. atazanavir, clarithromycin, indinavir, itraconazol, voriconazol, posaconazol, ketokonazol, nelfinavir, ritonavir, saquinavir, telithromycin) og venlafaxin kan øge niveauet af venlafaxin og O-desmethylvenlafaxin.
English: In the harmonized text of Section 4.4 it is indicated that non-selective MAOIs should not be given concomitantly, and that reversible, selective MAOIs such as moclobemide are not recommended in combination with venlafaxine, due to the risk of serotonin syndrome.
Danish: I den harmoniserede tekst under afsnit 4.4 anføres det, at non-selektive MAO-hæmmere ikke må gives samtidigt, og at reversible selektive MAO-hæmmere, såsom moclobemid, ikke anbefales i kombination med venlafaxin som følge af risikoen for serotoninsyndrom.
English: Reduced fertility was observed in a study in which both male and female rats were exposed to ODV.
Danish: Nedsat fertilitet blev observeret i et forsøg, hvor både han- og hunrotter blev eksponeret for ODV.
English: When equal daily doses of venlafaxine are administered as either an immediate-release tablet or prolonged-release capsule, the prolonged-release capsule provides a slower rate of absorption, but the same extent of absorption compared with the immediate-release tablet.
Danish: Når der administreres lige store daglige doser venlafaxin som enten tabletter til umiddelbar udløsning eller som depotkapsler, giver depotkapslen en langsommere absorption, men samme grad af absorption som tabletten til umiddelbar udløsning.
English: Do not take Efexor
Danish: Tag ikke Efexor
English: Controlled clinical studies in children and adolescents with major depressive disorder failed to demonstrate efficacy and do not support the use of venlafaxine in these patients (see sections 4.4 and
Danish: Kontrollerede kliniske undersøgelser med børn og unge med større depressive lidelser kunne ikke påvise effekt og understøtter ikke brugen af venlafaxin til disse patienter (se pkt.
English: Serotonin syndrome may occur with the concomitant use of venlafaxine and lithium (see Serotonin syndrome).
Danish: Lithium Serotoninsyndrom kan forekomme ved samtidig brug af venlafaxin og lithium (se Serotoninsyndrom).
English: The clinical relevance of this finding in hypertensive patients is unknown.
Danish: Den kliniske relevans af dette fund hos hypertensive patienter er ikke kendt.
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: Der er set følgende symptomer hos nyfødte, hvor moderen har anvendt en SSRI/SNRI sent i graviditeten: Irritabilitet, tremor, hypotoni, vedvarende gråd og besvær med at sutte eller sove.
English: Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE).
Danish: Længerevarende behandling kan også være relevant for at forebygge nye anfald af større depressive episoder.
English: There are limited data in patients with severe hepatic impairment.
Danish: Der er begrænsede data for patienter med svært nedsat leverfunktion.
English: Venlafaxine
Danish: Venlafaxin
English: Very common Affects more than 1 user in 10 Common
Danish: Meget almindelig Påvirker flere end 1 ud af 10 patienter Almindelig
English: Patients not responding to the initial 75 mg/day dose may benefit from dose increases up to a maximum dose of 375 mg/day.
Danish: Patienter, som ikke responderer på startdosen på 75 mg dagligt, kan have fordel af forøgelser af dosis op til en maksimal dosis på 375 mg dagligt.
English: Your doctor will advise you on how you should gradually discontinue Efexor treatment.
Danish: Din læge fortæller dig, hvordan du gradvist skal holde op med Efexor-behandlingen.
English: • Haloperidol or risperidone (to treat psychiatric conditions)
Danish: • haloperidol eller risperidon (til behandling af psykiatriske lidelser)
English: Following treatment with a reversible MAO-inhibitor, a shorter withdrawal period than 14 days may be used before initiation of venlafaxine treatment.
Danish: Efter behandling med en reversibel MAO-hæmmer kan en kortere aftrapningsperiode end 14 dage tillades, før behandling med venlafaxin sættes i gang.
English: What Efexor is and what is used for Before you take Efexor How to take Efexor Possible side effects How to store Efexor Further information
Danish: Efexors virkning og hvad du skal bruge det til Det skal du vide, før du begynder at tage Efexor Sådan skal du tage Efexor Bivirkninger
English: Psychomotor restlessness was also added to the table of adverse drug reactions.
Danish: Psykomotorisk rastløshed blev også føjet til skemaet over lægemiddelbivirkninger.
English: In vitro studies revealed that venlafaxine has virtually no affinity for opiate or benzodiazepine sensitive receptors.
Danish: In vitro-forsøg viste, at venlafaxin så godt som ikke har nogen affinitet for opiater eller benzodiazepinfølsomme receptorer.
English: Cases of hyponatraemia and/or the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion may occur with venlafaxine.
Danish: Der kan forekomme tilfælde af hyponatriæmi og/eller Inappropriate Antidiuretic Hormone secretion (SIADH) i forbindelse med venlafaxin.
English: Musculoskeletal
Danish: Muskoloskeletalt
English: Withdrawal symptoms seen on discontinuation of venlafaxine: based on a proposed text for the SPC for Selective Serotonin Reuptake Inhibitors (SSRIs) / Selective Norepinephrine Reuptake Inhibitors (SNRIs) (Sections 4.2, 4.4, and 4.8) reviewed by the Pharmacovigilance Working Party, it was agreed to incorporate this text into the harmonised SPC.
Danish: Abstinenssymptomer set ved seponering af venlafaxin: På basis af en påtænkt tekst til produktresumméet for selektive serotoningenoptagelseshæmmere (SSRI'er)/selektive noraldrenalingenoptagelseshæmmere (SNRI'er) (afsnit 4.2, 4.4 og 4.8) gennemgået af arbejdsgruppen vedrørende lægemiddelovervågning blev det vedtaget, at medtage denne tekst i det harmoniserede produktresumé.
English: Generally, these events are mild to moderate and are self-limiting; however, in some patients, they may be severe and/or prolonged.
Danish: Generelt er disse tilfælde milde til moderate og er selvbegrænsende, men hos nogle patienter kan de dog være alvorlige og/eller vare længere tid.
English: The MAH did not agree with the PhVWP/CMD(h) agreed SPC wording for all antidepressants for Section 4.8, since suicidal ideation is not considered an adverse reaction in adult patients, but agreed to comply with the mandated class labelling.
Danish: Indehaveren af markedsføringstilladelsen var ikke enig i den af PhVWP/CMD(h) godkendte tekst til produktresuméet for alle antidepressiva til afsnit 4.8, da selvmordstanker ikke anses for en bivirkning hos voksne patienter, indehaveren indvilligede dog i at overholde den obligatoriske klassemærkning.
English: Efexor has been included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Danish: Efexor er optaget på listen over produkter til harmonisering af produktresumé, der er opstillet af koordinationsgruppen for gensidig anerkendelse og decentrale procedurer - humanmedicinske anliggender (CMD(h)), i overensstemmelse med artikel 30, stk. 2, i direktiv 2001/83/EF, med senere ændringer.
English: SPC Section 4.4 - Special Warnings and Precautions for Use The MAH was asked to harmonize Section 4.4, for which the following differences between SPCs needed to be evaluated: - the mentioning of reports of aggression in relation to starting and discontinuing treatment; - treatment of children and adolescents under the age of 18, which was recommended by the CHMP in 2005 to be included in Section 4.4 of the SPC (Commission Decision of 19-VIII-2005); With regards to the aggression reports, it was agreed to introduce a wording to indicate that aggression may occur in patients receiving venlafaxine, under initiation, dose changes and discontinuation of treatment.
Danish: Afsnit 4.4 i produktresuméet - særlige advarsler og forsigtighedsregler vedrørende brugen Indehaveren af markedsføringstilladelsen blev anmodet om at harmonisere afsnit 4.4, hvori følgende forskelle mellem produktresuméerne skulle vurderes: - Omtalen af indberetninger om aggression i relation til indledning og ophør af behandling - Behandling af børn og unge under 18 år, som CHMP i 2005 anbefalede medtaget i afsnit 4.4 i produktresuméet (Kommissionens beslutning af 19. august 2005) Med hensyn til de indberettede tilfælde af aggression enedes man om at indføre en tekst for at angive, at aggression kan forekomme under indledning, dosisændringer og seponering af behandling hos patienter, der får venlafaxin.
English: Ketoconazole (CYP3A4 inhibitor)
Danish: Ketoconazol (CYP3A4-hæmmer)
English: A pharmacokinetic study with ketoconazole in CYP2D6 extensive (EM) and poor metabolisers (PM) resulted in higher AUC of venlafaxine (70% and 21% in CYP2D6 PM and EM subjects, respectively) and O-desmethylvenlafaxine (33% and 23% in CYP2D6 PM and EM subjects, respectively) following administration of ketoconazole.
Danish: Et farmakokinetisk forsøg med ketoconazol til personer med god metaboliseringsevne (GM) og ringe metaboliseringsevne (RM) af CYP2D6 gav en højere AUC for venlafaxin (henholdsvis 70 % og 21 % hos CYP2D6 GM-patienter og CYP2D6 RM-patienter) og O-desmethylvenlafaxin (henholdsvis 33 % og 23 % hos CYP2D6 GM-patienter og CYP2D6 RM-patienter) efter administration af ketoconazol.
English: In dialysis patients, venlafaxine elimination half-life was prolonged by about 180% and clearance reduced by about 57% compared to normal subjects, while ODV elimination half-life was prolonged by about 142% and clearance reduced by about 56%.
Danish: Hos dialysepatienter blev eliminationshalveringstiden for venlafaxin forlænget med ca. 180 % og clearance reduceret med ca. 57 % i forhold til raske forsøgspersoner, mens elimineringshalveringstiden for ODV blev forlænget med ca. 142 % og clearance blev reduceret med ca. 56 %.
English: It is recommended that patients with raised intraocular pressure or patients at risk for acute narrow-angle glaucoma (angle-closure glaucoma) be closely monitored.
Danish: Det anbefales nøje at overvåge patienter med forhøjet intraokulært tryk eller patienter, som har risiko for akut snævervinklet glaukom (vinkelblokglaukom).
English: Efexor is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs).
Danish: Efexor er et antidepressivum, som tilhører en gruppe medicin, der kaldes serotonin- og noradrenalinepinefrin-reuptake-hæmmere (SNRI'er).
English: The SPC was amended according to the CHMP position.
Danish: Produktresuméet blev ændret i overensstemmelse med CHMP's opfattelse.
English: • If you have a history of low sodium levels in your blood (hyponatraemia).
Danish: • Hvis du har eller har haft et lavt natriumindhold i blodet (hyponatriæmi).
English: Venlafaxine undergoes extensive hepatic metabolism.
Danish: Venlafaxin gennemgår en omfattende hepatisk metabolisering.
English: Discontinuation of treatment
Danish: Seponering af behandling
English: The MAH was of the view that a contraindication in patients with uncontrolled hypertension was not warranted.
Danish: Som følge heraf var CHMP enig i, at en kontraindikation for patienter med ukontrolleret hypertension ikke var berettiget.
English: Venlafaxine has virtually no affinity for rat brain muscarinic, cholinergic, H1-histaminergic or α1-adrenergic receptors in vitro.
Danish: Venlafaxin har så godt som ingen affinitet for muskarine, kolinerge, H1-histaminerge eller α1-adrenerge receptorer in vitro.
English: Efexor should normally not be used for children and adolescents under 18 years.
Danish: Efexor må normalt ikke anvendes til børn og unge under 18 år.
English: Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome with symptoms such as agitation, tremor and hyperthermia.
Danish: Samtidig behandling med irreversible monoaminooxidase-hæmmere (MAO-hæmmere) er kontraindiceret på grund af risikoen for serotoninsyndrom med agitation, tremor og hypertermi.
English: This has been reported under initiation, dose changes and discontinuation of treatment.
Danish: Dette er set ved behandlingsstart, dosisændringer samt ved behandlingsophør.
English: However, the CHMP considered that only non-selective, irreversible MAOIs should be contraindicated and that a strong warning in Section 4.4 and Section 4.5 of the SPC should be sufficient for the reversible MAOIs.
Danish: CHMP mente dog, at kun non-selektive irreversible MAOhæmmere skal være kontraindicerede, og at en kraftig advarsel i afsnit 4.4 og afsnit 4.5 i produktresuméet burde være tilstrækkeligt for reversible MAO-hæmmere.
English: Use in children and adolescents under 18 years of age
Danish: Brug til børn og unge under 18 år
English: The SPC was amended to reflect the CHMP position.
Danish: Produktresuméet blev ændret, så det afspejler CHMP's opfattelse.
English: Mania/hypomania may occur in a small proportion of patients with mood disorders who have received antidepressants, including venlafaxine.
Danish: Mani/hypomani kan forekomme hos en lille andel af patienter med affektive sindslidelser, som har fået antidepressiva, herunder også venlafaxin.
English: Apathy, Hallucinations, Myoclonus, Agitation, Impaired coordination and balance
Danish: Apati, hallucinationer, myokloni, agitation, svækket koordination og balance
English: • Eye problems, such as blurred vision, dilated pupils
Danish: • Øjenproblemer, såsom sløret syn, udvidede pupiller.
English: Because of inter-individual variability in clearance in these patients, individualisation of dosage may be desirable.
Danish: På grund af den interindividuelle forskel i clearance hos disse patienter kan det være ønskeligt med individuel dosering.
English: As with other serotonin reuptake inhibitors (SSRIs/SNRIs), discontinuation symptoms may occur in the newborns if venlafaxine is used until or shortly before birth.
Danish: Som med andre serotonin-reuptake-hæmmere (SSRI'er/SNRI'er) kan der forekomme seponeringssyndrom hos nyfødte, hvis venlafaxin anvendes indtil eller indtil kort tid før fødslen.
English: Caution should be exercised in patients whose underlying conditions might be compromised by increases in blood pressure, e.g., those with impaired cardiac function.
Danish: Der skal udvises forsigtighed hos patienter, hvis underliggende sygdomme kan forværres af en stigning i blodtrykket, f.eks. patienter med nedsat hjertefunktion.
English: Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.
Danish: Oplysninger fra kliniske undersøgelser har vist en øget risiko for selvmordsadfærd hos unge mennesker (under 25 år) med psykiatriske lidelser i behandling med et antidepressivum.
English: General supportive and symptomatic measures are recommended; cardiac rhythm and vital signs must be monitored.
Danish: Hjerterytme og vitale tegn skal monitoreres.