FrancophonIA/ELRC3.0 huggingface dataset:
English: However, caution should be exercised when vortioxetine is combined with oral anticoagulants or antiplatelet medicinal products due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction (see section 4.4).
Danish: Der bør dog udvises forsigtighed, når vortioxetin kombineres med orale antikoagulantia eller trombocythæmmende lægemidler, da den potentielle risiko for blødninger, der kan henføres til en farmakodynamisk interaktion (se pkt.
English: What you need to know before you take Brintellix Do not take Brintellix:
Danish: Det skal du vide, før du begynder at tage Brintellix Tag ikke Brintellix:
English: Brintellix can be taken with or without food.
Danish: Brintellix kan tages alene eller sammen med mad.
English: CARTON AND LABEL FOR BOTTLE NAME OF THE MEDICINAL PRODUCT
Danish: ÆSKE OG ETIKET TIL FLASKE LÆGEMIDLETS NAVN
English: The dose may be increased by your doctor to a maximum of 20 mg vortioxetine per day or lowered to a minimum of 5 mg vortioxetine per day depending on your response to treatment.
Danish: Lægen kan øge din dosis til højst 20 mg vortioxetin om dagen eller nedsætte den til mindst 5 mg vortioxetin om dagen afhængigt af, hvordan du reagerer på behandlingen.
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 på noget tidspunkt får tanker om selvmord eller om at gøre skade på dig selv, skal du straks kontakte din læge eller en skadestue.
English: Discontinuation of vortioxetine should be considered in patients with symptomatic hyponatraemia and appropriate medical intervention should be instituted.
Danish: Det bør overvejes at seponere vortioxetin hos patienter med symptomatisk hyponatriæmi og iværksætte passende intervention.
English: Contents of the pack and other information What Brintellix contains
Danish: Pakningsstørrelser og yderligere oplysninger Brintellix indeholder:
English: Vortioxetine did not increase the incidence of insomnia or somnolence relative to placebo.
Danish: Vortioxetin øgede ikke forekomsten af insomni eller døsighed sammenlignet med placebo.
English: - Based upon the review of a signal for rash, a plausible temporal relationship was concluded in several post-marketing cases reported (74% of reported time to onset was within one week and 93% was within one month), including cases with positive de- or re-challenge (respectively 135 and 8 cases).
Danish: - På baggrund af gennemgangen af et signal om udslæt blev det konkluderet, at der var en plausibel tidsmæssig sammenhæng i adskillige indberettede tilfælde efter markedsføringen (symptomdebut inden for en uge i 74 % af de indberettede tilfælde og inden for én måned i 93 % af tilfældene), herunder tilfælde med positiv dechallenge (udslættet forsvandt efter seponering/dosisreduktion) eller rechallenge (udslættet vendte tilbage efter genoptagelse af behandling) (henholdsvis 135 og 8 tilfælde).
English: Not known: frequency cannot be estimated from available data - low levels of sodium in the blood (the symptoms may include feeling dizzy, weak, confused,
Danish: Ikke kendt: hyppigheden kan ikke estimeres ud fra forhåndenværende data - lave niveauer af natrium i blodet (symptomerne kan omfatte, at man føler sig svimmel, svag, forvirret, søvnig eller meget træt, eller får kvalme eller opkasninger.
English: Patients (and caregivers of patients) should be alerted to 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 omsorgspersoner) skal informeres om nødvendigheden af overvågning for forekomst af en hvilken som helst klinisk forværring, selvmordsrelateret adfærd eller selvmords-tanker samt unormal adfærd og om, at de straks skal søge læge, hvis disse symptomer opstår.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER FOR TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL TABLETTER
English: Angioedema, Urticaria Rash
Danish: Angioødem, Urticaria Udslæt
English: The efficacy of vortioxetine is supported by the pooled responder analysis, in which the proportion of responders ranged from 46% to 49% for vortioxetine versus 34% for placebo (p <0.01; NRI analysis).
Danish: Effekten af vortioxetin er understøttet af den poolede respondentanalyse, hvor procentdelen af responderende varierede fra 46 % til 49 % for vortioxetin i forhold til 34 % for placebo (p<0,01); NRI-analyse).
English: Brintellix with alcohol
Danish: Brug af Brintellix sammen med alkohol
English: - carbamazepine, phenytoin (medicines to treat epilepsy or other illness).
Danish: - Carbamazepin, phenytoin (mod epilepsi eller anden sygdom).
English: Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily or decreased to a minimum of 5 mg vortioxetine once daily.
Danish: Afhængigt af den enkelte patients respons kan denne dosis øges til maksimalt 20 mg vortioxetin en gang dagligt eller nedsættes til mindst 5 mg vortioxetin en gang dagligt.
English: - rifampicin (a medicine to treat tuberculosis and other infections).
Danish: - Rifampicin (mod tuberkulose og andre infektioner).
English: Talk to your doctor or pharmacist before taking Brintellix if you:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Brintellix:
English: Brintellix contains ethanol.
Danish: Brintellix indeholder ethanol
English: Pack sizes of 100 and 200 film-coated tablets.
Danish: Pakninger a 100 og 200 filmovertrukne tabletter.
English: Make sure your midwife and/or doctor know you are on Brintellix.
Danish: Fortæl din jordemoder og/eller læge, at du tager Brintellix.
English: - moclobemide (a medicine to treat depression).
Danish: - Moclobemid (mod depression).
English: oral drops, solution 15 ml
Danish: Orale dråber, opløsning 15 ml
English: However, by recommended patient usage vortioxetine is considered to pose negligible risk to the aquatic and terrestrial environment (see section
Danish: Ved den anbefalede brug til patienter anses vortioxetin imidlertid at udgøre en ubetydelig risiko for vandmiljøet og landmiljøet (se pkt.
English: The effect seen with vortioxetine was a 4.7 point difference to placebo in MADRS total score at Week 8 (MMRM analysis).
Danish: Effekten af vortioxetin sammenlignet med placebo afveg med 4,7 point på totalscore på MADRS i uge 8 (MMRM-analyse).
English: Available data in animals have shown excretion of vortioxetine/ vortioxetine metabolites in milk.
Danish: De tilgængelige data fra dyrestudier viser, at vortioxetin/dets metabolitter udskilles i mælk.
English: Patients in remission after an initial 12-week open-label treatment period with vortioxetine were randomised to vortioxetine 5 or 10 mg/day or placebo and observed for relapse during a double-blind period of at least 24 weeks (24 to 64 weeks).
Danish: Patienter i remission efter en initial 12-ugers periode med åben behandling med vortioxetin blev randomiseret dobbeltblindet til vortioxetin 5 eller 10 mg/dag eller placebo og observeret for recidiv i en periode på mindst 24 uger (24 til 64 uger).
English: However, there have been reports of enhanced effects when antidepressants with serotonergic effect have been given together with lithium or tryptophan; therefore, concomitant use of vortioxetine with these medicinal products should be undertaken with caution.
Danish: Der foreligger dog rapporter om forstærket virkning, hvis der samtidig gives antidepressiva med serotonerg virkning og lithium eller tryptophan, og forsigtighed tilrådes derfor ved samtidig brug af vortioxetin og disse lægemidler.
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 og patienter, der udviser en signifikant grad af selvmordstanker eller selvmordsforsøg inden behandling, har større risiko for selvmordstanker eller for at forsøge at begå selvmord og bør følges tæt under behandlingen.
English: Microcrystalline cellulose Hydroxypropylcellulose Sodium starch glycolate (type A) Magnesium stearate
Danish: Mikrokrystallinsk cellulose Hydroxypropylcellulose Natriumstivelsesglycolat (type A) Magnesiumstearat
English: Following dosages several fold higher than the therapeutic dose range, events of seizure and serotonin syndrome have been reported.
Danish: Efter doseringer, der er mange gange højere end det terapeutiske dosisområde, er tilfælde af krampeanfald og serotonergt syndrom blevet rapporteret.
English: Following multiple dosing of 5, 10, or 20 mg/day, mean Cmax values of 9 to 33 ng/mL were observed.
Danish: Efter gentagne doser på 5, 10 eller 20 mg/dag sås gennemsnitsværdier for Cmax på 9-33 ng/ml.
English: [outer carton only]
Danish: [kun ydre æske]
English: The reactions were usually temporary and did not lead to cessation of therapy.
Danish: Bivirkningerne var sædvanligvis forbigående og medførte ikke, at behandlingen blev afbrudt.
English: Bleeding abnormalities, such as ecchymoses, purpura and other haemorrhagic events, such as gastrointestinal or gynaecological bleeding, have been reported rarely with the use of antidepressants with serotonergic effect, including vortioxetine .
Danish: Blødningsforstyrrelser såsom ekkymose, purpura og andre blødningshændelser såsom gastrointestinal eller gynækologisk blødning er blevet indberettet i sjældne tilfælde i forbindelse med brug af antidepressiva med serotonerg virkning, herunder vortioxetin.
English: CYP2D6 gene types
Danish: CYP2D6-genotyper
English: Vortioxetine had no effect on rat fertility, mating performance, reproductive organs, or sperm morphology and motility.
Danish: Vortioxetin påvirkede ikke rotters fertilitet, parringsadfærd, reproduktionsorganer eller sædmorfologi og -motilitet.
English: Vortioxetine should be used with caution in patients with a history of mania/hypomania and should be discontinued in any patient entering a manic phase.
Danish: Vortioxetin bør anvendes med forsigtighed til patienter med mani/hypomani i anamnesen og seponeres, hvis patienten er på vej ind i en manisk fase.
English: The efficacy of vortioxetine was demonstrated with at least one dosage group across 9 of the 12 studies, showing at least a 2-point difference to placebo in the Montgomery and Åsberg Depression Rating Scale (MADRS) or Hamilton Depression Rating Scale 24-item (HAM-D24) total score.
Danish: Vortioxetins virkning blev påvist med mindst én dosisgruppe i 9 af de 12 studier, som viste en forskel på mindst 2 point i forhold til placebo på MADRS-skalaen (Montgomery and Åsberg Depression Rating Scale) eller den samlede score på Hamiltons depressionsskala med 24 punkter (HAM-D24).
English: It is expected that the ingredients of Brintellix will pass into breast milk.
Danish: Det aktive stof i Brintellix forventes at gå over i mælken.
English: Vortioxetine was not teratogenic in rats or rabbits, but reproductive toxicity in terms of effects on foetal weight and delayed ossification were seen in the rat at exposures more than 10-fold the human exposure at the maximum recommended therapeutic dose of 20 mg/day.
Danish: Vortioxetin var ikke teratogent hos rotter og kaniner, men der er set reproduktionstoksicitet i form af påvirkning af fostervægt og forsinket ossifikation hos rotter ved eksponering for mere end 10 gange den humane eksponering ved den maksimale anbefalede terapeutiske dosis på 20 mg/dag.
English: Lot See embossed stamp.
Danish: Lot Se præget stempel.
English: Following a single dose of 10 mg vortioxetine, renal impairment estimated using the Cockcroft-Gault formula (mild, moderate, or severe; n=8 per group) caused modest exposure increases (up to 30%), compared to healthy matched controls.
Danish: Efter en enkelt dosis vortioxetin på 10 mg forårsagede nedsat nyrefunktion - estimeret i henhold til Cockcroft-Gault-formlen (let, moderat eller svær; n=8 pr. gruppe) - moderate stigninger i eksponeringen (op til 30 %) sammenlignet med raske, matchende kontrolpersoner.
English: This syndrome may be associated with hallucinations, involuntary twitching, accelerated heartbeat, high blood pressure, fever, nausea and diarrhoea.
Danish: Dette syndrom kan være forbundet med hallucinationer, ufrivillige trækninger, hurtig puls, højt blodtryk, feber, kvalme og diaré.
English: Ingestion of vortioxetine in clinical trials in the dose range of 40 mg to 75 mg has caused an aggravation of the following adverse reactions: nausea, postural dizziness, diarrhoea, abdominal discomfort, generalised pruritus, somnolence and flushing.
Danish: Indtagelse af vortioxetin i kliniske studier inden for dosisområdet 40 mg -75 mg har medført forstærkning af følgende bivirkninger: kvalme, postural svimmelhed, diaré, abdominalgener, generaliseret pruritus, døsighed og flushing.
English: Epidemiological data suggest that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).
Danish: Epidemiologiske data tyder på, at brug af SSRI-antidepressiva under graviditet, især sidst i graviditeten, kan øge risikoen for persisterende pulmonal hypertension hos den nyfødte (PPHN).
English: The film-coated tablets can be taken with or without food.
Danish: De filmovertrukne tabletter kan tages med eller uden samtidig fødeindtagelse.
English: If this happens to your baby, you should contact your midwife and/or doctor immediately.
Danish: Hvis dette sker for dit barn, så kontakt straks din jordemoder eller læge.
English: When adjusting for the change in MADRS the total score in the meta-analysis of the same studies showed that vortioxetine separated from placebo (p<0.05) with a standardised effect size of 0.24.
Danish: Når der justeredes for ændring på MADRS, viste den samlede score i meta-analyserne af de samme studier, at vortioxetin adskilte sig fra placebo (p<0,05) med en standardiseret virkning på
English: Each bottle contains 15 ml Brintellix oral drops, solution.
Danish: En flaske indeholder 15 ml Brintellix orale dråber, opløsning.
English: For doses of 20 mg vortioxetine once daily, the incidences of nausea and constipation were higher in patients aged ≥65 years (42% and 15%, respectively) than in patients aged <65 years (27% and 4%, respectively)(see section 4.4).
Danish: Ved doser på 20 mg vortioxetin en gang dagligt var forekomsten af kvalme og obstipation højere hos patienter ≥65 år (henholdsvis 42 % og 15 %) end hos patienter <65 år (henholdsvis 27 % og 4 %) (se pkt.
English: In a pre- and post-natal study in rats, vortioxetine was associated with increased pup mortality, reduced bodyweight gain, and delayed pup development at doses that did not result in maternal toxicity and with associated exposures similar to those achieved in humans following administration of vortioxetine 20 mg/day (see section 4.6).
Danish: I et præ- og postnatalt studie hos rotter blev vortioxetin sat i forbindelse med øget mortalitet hos afkommet, nedsat vægtstigning og forsinket udvikling af afkommet ved doser, der ikke medførte toksicitet hos moderdyret, og resulterede i eksponeringer svarende til niveauet hos mennesker efter administration af vortioxetin 20 mg/dag (se pkt.
English: In studies using the Arizona Sexual Experience Scale (ASEX), the incidence of treatment-emergent sexual dysfunction (TESD) and the ASEX total score showed no clinically relevant difference to placebo in symptoms of sexual dysfunction at the 5 to 15 mg/day doses of vortioxetine.
Danish: I studier, der anvendte ASEX-skalaen (Arizona Sexual Experience Scale), sås ingen klinisk relevant forskel i forekomsten af seksuel dysfunktion opstået under behandlingen (TESD), og ASEX-totalscoren viste ingen klinisk relevant forskel i symptomerne på seksuel dysfunktion ved en vortioxetindosis på 5-15 mg/dag i forhold til placebo.
English: Vortioxetine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible non-selective MAOI.
Danish: Vortioxetin må ikke initieres før mindst 14 dage efter seponering af en irreversibel ikke-selektiv MAO-hæmmer.
English: A no-effect level for convulsions was established with a corresponding safety margin of 5 considering the maximum recommended therapeutic dose of 20 mg/day.
Danish: Der blev påvist et dosisniveau uden effekt på tendensen til krampeanfald med en sikkerhedsmargin på 5 ved den maksimale anbefalede terapeutiske dosis på 20 mg/dag.
English: These findings were mainly attributed to rodent-specific vortioxetine-related crystalline material obstruction of the renal tubules and the bile ducts, respectively, and considered of low risk to humans.
Danish: Disse fund blev især tilskrevet obstruktion af henholdsvis nyretubuli og galdegange forårsaget af gnaverspecifikke vortioxetin-relateret krystallinske forbindelser, og risikoen anses for at være lav hos mennesker.
English: A meta-analysis of placebo-controlled clinical studies of antidepressants 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 metaanalyse af placebokontrollerede kliniske studier med antidepressiva hos voksne patienter med psykiatriske lidelser viste en øget risiko for selvmordsrelateret adfærd hos patienter under 25 år, der blev behandlet med antidepressiva, sammenlignet med placebo.
English: - The other ingredients are hydroxypropylbetadex, ethanol (96 percent) and purified water
Danish: - Øvrige indholdsstoffer: Hydroxypropylbetadex, ethanol (96 %) og renset vand.
English: In elderly healthy subjects (aged ≥65 years; n=20), the exposure to vortioxetine increased up to 27% (Cmax and AUC) compared to young healthy control subjects (aged ≤45 years) after multiple doses of
Danish: Hos ældre forsøgspersoner (i alderen ≥65 år; n=20) steg eksponeringen for vortioxetin med op til 27 % (Cmax og AUC) i forhold til hos unge raske kontrolpersoner (i alderen ≤45 år) efter gentagne doser på
English: In patients with end-stage renal disease, only a small fraction of vortioxetine was lost during dialysis (AUC and Cmax were 13% and 27% lower, respectively; n=8) following a single 10 mg dose of vortioxetine.
Danish: Hos patienter med nyresygdom i terminalfasen gik kun en lille andel af vortioxetin tabt under dialyse (AUC og Cmax var henholdsvis 13 % og 27 % lavere; n=8) efter en enkelt dosis vortioxetin på 10 mg. Dosisjustering er ikke nødvendig (se pkt.
English: If you stop taking Brintellix
Danish: Hvis du holder op med at tage Brintellix
English: Brintellix 20 mg/ml [outer carton only]
Danish: Brintellix 20 mg/ml [kun ydre æske]
English: The risk of SS or NMS is increased with concomitant use of serotonergic-active substances (including triptans), medicinal products that impair the metabolism of serotonin (including MAOIs), antipsychotics, and other dopamine antagonists.
Danish: Risikoen for disse syndromer øges ved samtidig anvendelse af serotonerge stoffer (herunder triptaner), lægemidler, der hæmmer serotonins metabolisme (herunder MAO-hæmmere), antipsykotika og andre dopaminantagonister.
English: Read the package leaflet before use Oral use
Danish: Læs indlægssedlen inden brug
English: Vortioxetine must be discontinued for at least 14 days before starting treatment with an irreversible non-selective MAOI (see section 4.3).
Danish: Vortioxetin skal seponeres mindst 14 dage før start på behandling med en irreversibel, ikke-selektiv MAO-hæmmer (se pkt.
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
Danish: Kliniske studier har vist, at der var en øget risiko for selvmordsrelateret adfærd hos voksne under 25 år med psykiatriske lidelser, der blev behandlet med antidepressiv medicin.
English: The reactions were usually transient and did not generally lead to cessation of therapy.
Danish: Bivirkningerne var sædvanligvis forbigående og medførte normalt ikke seponering.
English: If you forget to take Brintellix
Danish: Hvis du har glemt at tage Brintellix
English: The changes in the kidney in rats (glomerulonephritis, renal tubular obstruction, crystalline material in renal tubule) and in the liver of mice and rats (hepatocellular hypertrophy, hepatocyte necrosis, bile duct hyperplasia, crystalline material in bile ducts) were seen at exposures more than 10-fold (mice) and 2-fold (rats) the human exposure at the maximum recommended therapeutic dose of 20 mg/day.
Danish: Forandringer i nyrerne hos rotter (glomerulonefritis, obstruktion af nyretubuli, krystallinsk materiale i nyretubuli) og i leveren hos mus og rotter (hepatocellulær hypertrofi, hepatocytnekrose, galdevejshyperplasi, krystallinsk materiale i galdegange) forekom ved eksponeringer over 10 gange (mus) og 2 gange (rotter) den humane eksponering ved den maksimale anbefalede terapeutiske dosis på 20 mg/dag.
English: Close monitoring for serotonin syndrome is necessary if used concomitantly (see section 4.4).
Danish: Tæt monitorering for serotonergt syndrom er nødvendig ved samtidig brug (se pkt.
English: Other medicines and Brintellix
Danish: Brug af anden medicin sammen med Brintellix
English: - lithium (a medicine to treat depression and mental disorders) or tryptophan.
Danish: - Lithium (mod depression og psykiske forstyrrelser) eller tryptophan.
English: Data on the use of Brintellix in elderly patients with major depressive episodes are limited.
Danish: Der foreligger begrænsede data om anvendelse af Brintellix til ældre patienter med moderate til svære depressive episoder.
English: Caution should therefore be exercised (see section 5.2).
Danish: Forsigtighed tilrådes (se pkt.
English: CARTON AND LABEL FOR THE TABLET CONTAINER NAME OF THE MEDICINAL PRODUCT
Danish: ÆSKE OG ETIKET TIL TABLETBEHOLDEREN LÆGEMIDLETS NAVN
English: Haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding)
Danish: Blødning (herunder kontusion, ekkymose, epistaxis, gastrointestinal eller vaginal blødning)
English: - medicines known to cause low sodium level.
Danish: - Lægemidler, der er kendt for at nedsætte blodets indhold af natrium.
English: Brintellix is used to treat major depressive episodes in adults.
Danish: Brintellix bruges til behandling af moderate til svære depressive episoder hos voksne.
English: - The active substance is vortioxetine.
Danish: - Aktivt stof: vortioxetin.
English: The plasma concentration of vortioxetine was approximately two times higher in CYP2D6 poor metabolisers than in extensive metabolisers.
Danish: Plasmakoncentrationen af vortioxetin var ca. dobbelt så høj hos patienter med nedsat CYP2D6metabolisme i forhold til patienter med normal metabolisme.
English: After first opening the drops should be used within 8 weeks.
Danish: Dråberne skal anvendes inden for 8 uger efter anbrud.
English: Vortioxetine separated from placebo statistically with results of 8.0 for vortioxetine versus 5.1 points for placebo (p=0.0003).
Danish: Vortioxetin adskilte sig fra placebo statistisk set med et resultat på 8,0 point for vortioxetin i forhold til 5,1 point for placebo (p=0,0003).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE FOLDEETIKET PÅ FLERSTYKSPAKNINGER PAKKET I FOLIE (MED BLÅ BOKS)
English: Brintellix should not be used during pregnancy unless the doctor says it is absolutely necessary.
Danish: Hvis du er gravid, må du kun tage Brintellix, hvis lægen har sagt, at det er absolut nødvendigt.
English: Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS)
Danish: Serotonergt syndrom eller malignt neuroleptikasyndrom
English: Vortioxetine has not shown any clinically significant effect on ECG parameters, including the QT, QTc, PR and QRS intervals, in patients with MDD.
Danish: Vortioxetin har ikke vist klinisk signifikant påvirkning af EKG-parametre, herunder QT-, QTc-, PRog QRS-intervallet, hos patienter med moderate til svære depressive episoder.