FrancophonIA/ELRC3.0 huggingface dataset:
English: Use in children and adolescents under the age of 18 years: it was agreed that “Venlafaxine is not recommended for use in children and adolescents”.
Danish: Anvendelse til børn og unge under 18 år: Der var enighed om: "Det anbefales ikke at anvende Venlafaxin til børn og unge".
English: Your doctor should decide whether you can take Efexor with other medicines.
Danish: Din læge afgør, om du kan tage Efexor sammen med anden medicin.
English: Mania/hypomania
Danish: Mani/hypomani
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med sjældne, arvelige problemer med galaktoseintolerans, Lapp-laktase-mangel eller glukose-galaktose malabsorption bør ikke anvende dette lægemiddel.
English: If any of these conditions apply to you, please talk with your doctor before taking Efexor.
Danish: Hvis nogen af disse forhold passer på dig, skal du tale med din læge, før du tager Efexor.
English: Special Senses
Danish: Særlige sanser
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour, and to seek medical advice immediately if these symptoms present.
Danish: Patienter og deres omsorgsgivere skal være opmærksomme på behovet for at monitorere enhver klinisk forværring, selvmordsadfærd eller -tanker og usædvanlige ændringer i opførsel, og de skal omgående søge lægelig rådgivning, hvis disse symptomer viser sig.
English: You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.
Danish: Det kan være, du synes, det er en hjælp at fortælle en i familien eller en nær ven, at du har en depression eller en angstlidelse, og bede dem læse denne indlægsseddel.
English: If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Danish: Hvis du har tanker om af skade dig selv eller slå dig selv ihjel, skal du straks kontakte din læge eller tage på hospitalet.
English: If you miss a dose, take it as soon as you remember.
Danish: Hvis du glemmer at tage en dosis, skal du tage den hurtigst muligt.
English: Taking an irreversible MAOI together with other medicines, including Efexor, can cause serious or even life-threatening side effects.
Danish: Hvis du tager en irreversibel MAO-hæmmer sammen med anden medicin, herunder også Efexor, kan det give alvorlige eller endda livstruende bivirkninger.
English: Efexor passes into breast milk.
Danish: Efexor kan gå over i modermælken.
English: In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during the current episode.
Danish: I de fleste tilfælde er den anbefalede dosis til forebyggelse af ny større depressiv episode den samme, som anvendes ved den igangværende episode.
English: If you experience any of these or other symptoms that are troublesome, ask your doctor for further advice.
Danish: Hvis du oplever et af disse eller andre symptomer, der er generende, skal du bede din læge om råd.
English: The dose can be raised by your doctor gradually and, if needed, even up to a maximum dose of 375 mg daily for depression.
Danish: Denne dosis kan gradvist øges af lægen, og hvis det er nødvendigt, helt op til en maksimal dosis på 375 mg dagligt ved depression.
English: Forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit.
Danish: Forceret diurese, dialyse, hæmoperfusion og udskiftningstransfusion vil sandsynligvis ikke have nogen effekt.
English: The mechanism of venlafaxine's antidepressant action in humans is believed to be associated with its potentiation of neurotransmitter activity in the central nervous system.
Danish: Venlafaxins antidepressive virkningsmekanisme hos mennesker menes at være forbundet med dets potensering af neurotransmitteraktiviteten i centralnervesystemet.
English: • If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
Danish: • Hvis du har problemer med øjnene, såsom visse typer grøn stær (forhøjet tryk i øjet).
English: Do not stop taking Efexor without talking to your doctor (see the section “If you stop taking Efexor”).
Danish: Du må ikke holde op med at tage Efexor uden først at tale med din læge (se afsnittet ”Hvis du holder op med at tage Efexor”).
English: Such complications can arise immediately upon delivery.
Danish: Disse komplikationer kan opstå straks efter fødslen.
English: Venlafaxine is not indicated for weight loss alone or in combination with other products.
Danish: Venlafaxin er ikke indiceret ikke til vægttab alene eller i kombination med andre produkter.
English: Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation (see section 4.4).
Danish: På grund af risikoen for dosisrelaterede bivirkninger bør dosisforøgelser kun ske efter klinisk vurdering (se pkt.
English: Major depressive episodes
Danish: Major Depression
English: Cardiac disease and risk of arrhythmia
Danish: Hjertesygdom og risiko for arytmi
English: In postmarketing experience, overdose with venlafaxine was reported predominantly in combination with alcohol and/or other medicinal products.
Danish: Ved erfaringerne efter markedsføring blev overdosering med venlafaxin fortrinsvis rapporteret i kombination med alkohol og/eller andre lægemidler.
English: If your baby has these symptoms when it is born and you are concerned, contact your doctor and/or midwife who will be able to advise you.
Danish: Hvis dit barn har disse symptomer, når det fødes, og du er bekymret, skal du kontakte din læge og/eller jordemoder, som vil kunne rådgive dig.
English: Use in patients with renal impairment: it was agreed that the individualisation of the dosage may be desirable, and this concept was introduced in the text for harmonisation.
Danish: Anvendelse til patienter med nedsat nyrefunktion: Der var enighed om, at individualisering af dosis kan være ønskelig, og dette begreb blev indført i teksten til harmonisering.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product (and its associated names), the European Commission notified the CHMP/EMEA Secretariat of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Danish: Som følge af de divergerende nationale beslutninger, der er truffet af medlemsstaterne vedrørende godkendelsen af ovennævnte lægemiddel (og tilknyttede navne), har Europa-Kommissionen anmodet CHMP/EMEA-sekretariatet om en officiel indbringelse i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, for at få afhjulpet forskellene mellem de nationalt godkendte produktresuméer og derved harmonisere de divergerende produktresuméer i hele EU.
English: The risk of withdrawal symptoms may be dependent on several factors, including the duration and dose of therapy and the rate of dose reduction.
Danish: Risikoen for abstinenssymptomer kan være afhængig af flere faktorer, herunder behandlingsvarighed og dosering og af hastigheden ved dosisreduktion.
English: Furthermore, a statement was included in the harmonized SPC to highlight that controlled studies in children did not demonstrate efficacy of venlafaxine in the “major depressive disorder” indication.
Danish: Endvidere blev der medtaget en erklæring i det harmoniserede produktresumé for at påpege, at kontrollerede undersøgelser af børn ikke påviste effekt af venlafaxin til indikationen "major depression".
English: CARTON/BOTTLE/TABLET CONTAINER
Danish: KARTON/DÅSE/TABLETBEHOLDER
English: SPC Section 4.5 - Interaction with other medicinal products and other forms of interaction
Danish: Afsnit 4.5 i produktresuméet - interaktion med andre lægemidler og andre former for interaktion
English: Tell your doctor immediately, or go to the casualty department at your nearest hospital:
Danish: Fortæl det straks til lægen, eller tag til nærmeste skadestue.
English: Get medical care right away if you think serotonin syndrome is happening to you.
Danish: Søg straks læge, hvis du tror, du er ved at få serotoninsyndrom.
English: • Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Danish: • metoprolol (en betablokker til behandling af højt blodtryk og hjerteproblemer)
English: No specific antidotes for venlafaxine are known.
Danish: Der kendes ingen specifikke antidoter til venlafaxin.
English: However, a recommendation to exercise caution in treating elderly patients, to use the lowest effective dose and to monitor carefully elderly patients when an increase in the dose is required was also included in the harmonized SPC.
Danish: Dog blev en anbefaling om at udvise forsigtighed ved behandling af ældre patienter, at bruge den laveste effektive dosis og at overvåge ældre patienter omhyggeligt, når en dosisøgning er nødvendig, også medtaget i det harmoniserede produktresumé.
English: • Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines containing lithium
Danish: • medicin til behandling af depression, f.eks. SNRI, SSRI'er, tricyklisk medicin eller medicin med lithium
English: Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Muenster Germany
Danish: Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Münster Tyskland
English: Very common: nausea
Danish: Meget almindelig: Kvalme
English: • If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
Danish: • Hvis du eller nogen i din familie tidligere har eller har haft mani eller bipolær affektiv sindslidelse (følelse af at være eksalteret eller euforisk).
English: WHAT EFEXOR IS AND WHAT IT IS USED FOR
Danish: EFEXORS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
English: You should avoid alcohol while you are taking Tradename.
Danish: Undgå at drikke alkohol, mens du tager Efexor.
English: The risk of using venlafaxine in combination with other CNS-active substances has not been systematically evaluated.
Danish: Risikoen ved at anvende venlafaxin i kombination med andre CNS-aktive stoffer er ikke vurderet systematisk.
English: Although no change in dosage is necessary for patients with glomerular filtration rate (GFR) between 30-70 ml/minute, caution is advised.
Danish: Selv om det ikke er nødvendigt med dosisjustering til patienter med glomerulær filtrationshastighed (GFR) mellem 30-70 ml/min., anbefales forsigtighed.
English: It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.
Danish: Man forstår endnu ikke til bunds, hvordan antidepressiva virker, men de kan hjælpe ved at øge niveauet af serotonin og noradrenalin i hjernen.
English: The oral clearance of both venlafaxine and ODV was reduced.
Danish: Både clearance for oralt venlafaxin og ODV blev reduceret.
English: Call your doctor or pharmacist immediately if you take more than the amount of Efexor prescribed by your doctor.
Danish: Kontakt lægen eller apoteket straks, hvis du tager mere Efexor, end du har fået ordineret af lægen.
English: Therefore, you should discuss the matter with your doctor, and he/she will decide whether you should stop breast-feeding or stop the therapy with Efexor.
Danish: Du skal derfor diskutere det med din læge, og han/hun vil beslutte, om du bør holde op med at amme eller stoppe behandlingen med Efexor.
English: The lowest effective dose should always be used, and patients should be carefully monitored when an increase in the dose is required.
Danish: Der skal altid anvendes lavest mulige dosis, og patienterne skal overvåges omhyggeligt, hvis en øgning af dosis er nødvendig.
English: Always take Efexor exactly as your doctor has told you.
Danish: Tag altid Efexor nøjagtigt efter lægens anvisning.
English: Concomitant administration of venlafaxine and metoprolol to healthy volunteers in a pharmacokinetic interaction study for both medicinal products resulted in an increase of plasma concentrations of metoprolol by approximately 30-40% without altering the plasma concentrations of its active metabolite, α-hydroxymetoprolol.
Danish: Samtidig administration af venlafaxin og metoprolol til raske frivillige i et farmakokinetisk interaktionsforsøg med begge lægemidler gav en stigning i metoprolols plasmakoncentrationer på ca. 30-40 % uden at ændre plasmakoncentrationerne af dets aktive metabolit, a-hydroxymetoprolol.
English: Major Depressive Episodes: the CHMP considered that the maximum dose of 375mg/day Efexor is safe and effective in a long term perspective and recommended that it is approved without duration limitations in the harmonised SPC.
Danish: Svære depressive episoder: CHMP mente, at en maksimal dosis Efexor på 375 mg/dag er sikker og effektiv ved langtidsbehandling og anbefalede, at den godkendes uden tidsbegrænsninger i det harmoniserede produktresumé.
English: A pharmacokinetic study with indinavir has shown a 28% decrease in AUC and a 36% decrease in Cmax for indinavir.
Danish: Et farmakokinetisk forsøg med indinavir har påvist et fald på 28 % i AUC og et fald på 36 % i Cmax for indinavir.
English: Abnormal bleeding
Danish: Abnorm blødning
English: The efficacy and safety of venlafaxine for other indications in children and adolescents under the age of 18 have not been established.
Danish: Virkning og sikkerhed ved brug af venlafaxin til andre indikationer hos børn og unge under 18 år er ikke fastslået.
English: Abnormal orgasm (females), Urinary retention
Danish: Abnorm orgasme (kvinder), urinretention
English: In addition, these conditions may be co-morbid with major depressive disorder.
Danish: Derudover kan disse lidelser være komorbide med en større depressiv lidelse.
English: Do not start or stop taking any medicines, including those bought without a prescription, natural and herbal remedies, before checking with your doctor or pharmacist.
Danish: Du må ikke begynde eller holde op med at tage medicin, ej heller medicin, som ikke er købt på recept, samt naturlægemidler, før du har spurgt din læge eller apoteket.
English: • If you have a history of high blood pressure.
Danish: • Hvis du har eller har haft højt blodtryk.
English: A large degree of intersubject variability was noted.
Danish: Der sås en høj grad af variabilitet mellem forsøgspersonerne.
English: Because the total exposure (AUC) of venlafaxine and ODV is similar in poor and extensive metabolisers, there is no need for different venlafaxine dosing regimens for these two groups.
Danish: Eftersom den totale eksponering (AUC) for venlafaxin og ODV er den samme hos personer med en god og personer med en ringe metaboliseringsevne, er der ikke behov for forskellige dosisregimer for venlafaxin for disse to grupper.
English: The volume of distribution for venlafaxine at steady-state is 4.4±1.6 L/kg following intravenous administration.
Danish: Venlafaxins fordelingsvolumen ved steady state er 4,4 ±1,6 l/kg efter intravenøs administration.
English: Treatment should be discontinued in any patient who develops seizures.
Danish: Behandlingen skal ophøre hos alle patienter, som udvikler kramper.
English: Some newborns exposed to venlafaxine late in the third trimester have developed complications requiring tube-feeding, respiratory support or prolonged hospitalisation.
Danish: Nogle nyfødte, som har været udsat for venlafaxin sent i tredje trimester, har udviklet komplikationer, der kræver respirationsstøtte, sondeernæring eller forlænget indlæggelse.
English: It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain.
Danish: Det menes, at personer, som er deprimerede og/eller angste, har et lavere niveau af serotonin og noradrenalin i hjernen.
English: This group of medicines is used to treat depression and other conditions, such as anxiety disorders.
Danish: Det er en gruppe medicin, der anvendes til at behandle depression og andre lidelser, såsom angstlidelser.
English: Venlafaxine and ODV are minimally bound at therapeutic concentrations to human plasma proteins (27% and 30%, respectively).
Danish: Venlafaxin og ODV binder sig minimalt til humane plasmaproteiner ved terapeutiske koncentrationer (henholdsvis 27 % og 30 %).
English: Therefore, a decision to continue/discontinue breast-feeding or to continue/discontinue therapy with Efexor should be made, taking into account the benefit of breast-feeding to the child and the benefit of Efexor therapy to the woman.
Danish: Der skal derfor træffes en beslutning om, hvorvidt amningen skal fortsætte/ophøre, eller behandlingen med Efexor skal fortsætte/seponeres, idet der tages højde for fordelene for barnet ved amning og fordelene for kvinden ved behandlingen med Efexor.
English: Tell your doctor if you become pregnant, or you are trying to become pregnant.
Danish: Du skal straks fortælle det til din læge, hvis du bliver gravid eller har planer om at blive gravid.
English: At least 92% of venlafaxine is absorbed following single oral doses of immediate-release venlafaxine.
Danish: Mindst 92 % venlafaxin absorberes efter enkelte orale doser venlafaxin til umiddelbar udløsning.
English: Venlafaxine and ODV are very similar with respect to their overall action on neurotransmitter reuptake and receptor binding.
Danish: Venlafaxin og ODV er meget ens med hensyn til deres samlede virkning på neurotransmitter-genoptag og receptorbinding.
English: Venlafaxine has been shown not to increase the impairment of mental and motor skills caused by ethanol.
Danish: Det er påvist, at venlafaxin ikke øger den svækkelse af de mentale og motoriske færdigheder, der forårsages af ethanol.
English: If you have liver or kidney problems, talk to your doctor, since your dose of Efexor may need to be different.
Danish: Hvis du har lever- eller nyreproblemer, skal du tale med din læge, fordi din Efexor-dosis eventuelt skal ændres.
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Danish: For patienter, som udvikler disse symptomer, kan en dosisøgning være skadelig.
English: The use of venlafaxine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Danish: Brugen af venlafaxin er sat i forbindelse med udviklingen af akatisi karakteriseret ved en subjektiv ubehagelig eller generende rastløshed og behov for at bevæge sig, ofte ledsaget af manglende evne til at sidde eller stå stille.
English: Use in elderly patients: based on published data raising the possibility of renal impairment and the potential for changes in neurotransmitter sensitivity and affinity with aging, a new wording for use in elderly patients was agreed in the SPC.
Danish: Anvendelse til ældre patienter: På basis af de offentliggjorte data, der rejser spørgsmålet om muligheden for nedsat nyrefunktion og potentielle ændringer i neurotransmitterfølsomhed og sammenhæng med aldring, enedes man om en ny formulering for anvendelse til ældre patienter i produktresuméet.
English: This should be taken into account in patients treated with haloperidol and venlafaxine concomitantly.
Danish: Der skal tages højde for dette hos patienter, som behandles samtidig med haloperidol og venlafaxin.
English: Prescriptions for venlafaxine should be written for the smallest quantity of the medicinal product consistent with good patient management in order to reduce the risk of overdose.
Danish: Venlafaxin skal ordineres i den mindste mængde af lægemidlet, der er i overensstemmelse med god patientbehandling, for at reducere risikoen for overdosering.
English: • If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding.
Danish: • Hvis du har tendens til at få blå mærker eller til nemt at bløde (tidligere blødningslidelser), eller hvis du tager anden medicin, der kan øge blødningsrisikoen.
English: Animal studies regarding reproductive toxicity have found in rats a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation.
Danish: Dyreforsøg vedrørende reproduktionstoksicitet har hos rotter påvist et fald i ungernes vægt, en stigning i antallet af dødfødte unger og en stigning i dødsfald blandt ungerne i løbet af de første 5 dages laktation.
English: Suicide/suicidal thoughts or clinical worsening
Danish: Selvmord/selvmordstanker eller klinisk forværring
English: Venlafaxine did not inhibit CYP1A2, CYP2C9, or CYP3A4.
Danish: Venlafaxin hæmmer ikke CYP1A2, CYP2C9 eller CYP3A4.
English: The risk of skin and mucous membrane bleeding, including gastrointestinal haemorrhage, may be increased in patients taking venlafaxine.
Danish: Risikoen for blødninger fra hud og slimhinder, herunder gastrointestinal blødning, kan forhøjes hos patienter, som tager venlafaxin.
English: Pulmonary eosinophilia
Danish: Pulmonal eosinofili
English: Effect of venlafaxine on other medicinal products
Danish: Venlafaxins virkning på andre lægemidler
English: Epidemiological studies have shown that venlafaxinetreated patients have a higher burden of suicide risk factors than SSRI patients.
Danish: Epidemiologiske forsøg har påvist, at patienter, som behandles med venlafaxin, har en større byrde af selvmordsrisikofaktorer end SSRI-patienter.
English: Consequently, caution is advised when venlafaxine is taken in combination with other CNS-active substances.
Danish: Derfor tilrådes forsigtighed, når venlafaxin tages i kombination med andre CNS-aktive stoffer.
English: Studies with venlafaxine in rats and mice revealed no evidence of carcinogenesis.
Danish: Forsøg med venlafaxin til rotter og mus viste ingen evidens for karcinogenese.
English: Therefore, any patient receiving venlafaxine should be cautioned about their ability to drive or operate hazardous machinery.
Danish: Derfor skal patienter, som får venlafaxin, tilrådes at udvise forsigtighed, når det gælder evnen til at føre motorkøretøj eller betjene farlige maskiner.
English: Venlafaxine and its active metabolite reduce β-adrenergic responsiveness after both acute (single dose) and chronic administration.
Danish: Venlafaxin og dets aktive metabolit reducerer den β-adrenerge modtagelighed efter både akut (enkeltdosis) og kronisk administration.
English: These effects occurred at 30 mg/kg/day, 4 times the human daily dose of 375 mg of venlafaxine (on an mg/kg basis).
Danish: Disse virkninger indtraf ved 30 mg/kg/dag, 4 gange den humane daglige dosis på 375 mg venlafaxin (på en mg/kg basis).
English: Generally, these symptoms are mild to moderate; however, in some patients they may be severe in intensity.
Danish: Generelt er disse symptomer milde til moderate, men hos nogle patienter kan de være alvorlige i deres intensitet.
English: If concomitant treatment of venlafaxine with an SSRI, an SNRI or a serotonin receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Danish: Hvis samtidig behandling med venlafaxin og en SSRI, en SNRI eller en receptoragonist (triptan) er klinisk berettiget, tilrådes det at overvåge patienten nøje, navnlig under iværksættelse af behandlingen og forhøjelser af dosis.
English: • If you have a history of heart problems.
Danish: • Hvis du har eller har haft hjerteproblemer.
English: The potential benefit should be weighed against the risk in the treatment of patients with severe hepatic impairment.
Danish: Den potentielle fordel bør opvejes mod risikoen ved behandling af patienter med svært nedsat leverfunktion.
English: If you are taking Efexor during pregnancy, let your midwife and/or doctor know as your baby might have some symptoms when it is born.
Danish: Hvis du tager Efexor, når du er gravid, skal du fortælle det til din jordemoder og/eller læge, da dit barn kan have symptomer, når det fødes.