FrancophonIA/ELRC3.0 huggingface dataset:
English: Summary of the safety profile The most common adverse reaction was nausea.
Danish: Resumé af sikkerhedsprofilen Den hyppigste bivirkning var kvalme.
English: Brintellix should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus.
Danish: Brintellix bør kun gives til gravide kvinder, hvis de forventede fordele for moderen opvejer de mulige risici for fosteret.
English: Approximately 2/3 of the inactive vortioxetine metabolites are excreted in the urine and approximately 1/3 in the faeces.
Danish: Ca. 2/3 af vortioxetins inaktive metabolitter udskilles i urinen og ca. 1/3 i fæces.
English: Taking these medicines together with Brintellix may increase the risk of serotonin syndrome.
Danish: Når disse lægemidler tages sammen med Brintellix, kan det øge risikoen for serotonergt syndrom.
English: - have low sodium level in the blood.
Danish: - Hvis du har et lavt indhold af natrium i blodet.
English: This multimodal activity is considered responsible for the antidepressant and anxiolytic-like effects and the improvement of cognitive function, learning and memory observed with vortioxetine in animal studies.
Danish: Denne multimodale aktivitet anses for at være ansvarlig for vortioxetins antidepressive og anxiolytikalignende virkning og den forbedring af den kognitive funktion, indlæring og hukommelse, som er observeret i dyrestudier af vortioxetin.
English: If no drops come out, the bottle can be tapped lightly to start the flow.
Danish: Hvis der ikke kommer dråber ud, kan flasken tappes let for at starte dråberne.
English: Vortioxetine is highly bound to plasma proteins (98 to 99%) and the binding appears to be independent of vortioxetine plasma concentrations.
Danish: Vortioxetin bindes med høj affinitet til plasmaproteiner (98-99 %), og bindingen synes at være uafhængig af vortioxetins plasmakoncentration.
English: Continue to take Brintellix even if it takes some time before you feel any improvement in your condition.
Danish: Bliv ved med at tage Brintellix, selv om der går noget tid, før du mærker, at du får det bedre.
English: Management of overdose should consist of treating clinical symptoms and relevant monitoring.
Danish: Overdosering bør håndteres med behandling af de kliniske symptomer og passende monitorering.
English: Based on results from conventional 2-year carcinogenicity studies in mice or rats, vortioxetine is not considered to pose a risk of carcinogenicity in humans.
Danish: Ud fra resultaterne fra konventionelle toårige karcinogenicitetsstudier hos mus og rotter anses vortioxetin ikke for at indebære en risiko for karcinogenicitet hos mennesker.
English: Co-administration resulted in a higher incidence of adverse reactions when bupropion was added to vortioxetine than when vortioxetine was added to bupropion.
Danish: Co-administration resulterede i en højere forekomst af bivirkninger, når bupropion blev føjet til vortioxetin, end når vortioxetin blev føjet til bupropion.
English: In the dedicated study in elderly, vortioxetine was also effective in these patients.
Danish: I studiet kun med ældre var vortioxetin også virksomt hos disse patienter.
English: No dose adjustment is needed.
Danish: Dosisjustering er ikke nødvendig.
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 måske være en hjælp at tale med en ven eller pårørendeom, at du er deprimeret eller angst, og bede dem om at læse denne indlægsseddel.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for vortioxetine, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for vortioxetin er CHMP nået frem til følgende videnskabelige konklusioner:
English: Although no studies have investigated the association of PPHN with vortioxetine treatment, this potential risk cannot be ruled out taking into account the related mechanism of action (increase in serotonin concentrations).
Danish: Selv om ingen studier har undersøgt forbindelsen mellem PPHN og behandling med vortioxetin, kan en potentiel risiko ikke udelukkes i betragtning af den beslægtede virkningsmekanisme (øgning af serotoninkoncentrationer).
English: Nausea was usually mild or moderate and occurred within the first two weeks of treatment.
Danish: Kvalme var sædvanligvis let eller moderat og indtrådte i løbet af de første to behandlingsuger.
English: Do not use this medicine after the expiry date that is stated on the packaging after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Target organ toxicity was restricted to kidneys (rats) and liver (mice and rats).
Danish: Toksicitet i målorganer var begrænset til nyrer (rotter) og lever (mus og rotter).
English: The most frequently reported symptoms were nausea and vomiting.
Danish: De hyppigst rapporterede symptomer var kvalme og opkastning.
English: Limited data are available for patients with severe renal impairment.
Danish: Der foreligger begrænsede data for patienter med svært nedsat nyrefunktion.
English: In clinical studies, sexual dysfunction was assessed using the Arizona Sexual Experience Scale (ASEX).
Danish: I de kliniske studier blev seksuel dysfunktion vurderet ved hjælp af ASEX-skalaen (Arizona Sexual Experience Scale).
English: These included salivation (rat and dog), pupil dilatation (dog), and two incidences of convulsions in dogs in the general toxicity study programme.
Danish: De omfatter spytflåd (rotte og hund), pupildilatation (hund) og to tilfælde af kramper hos hunde i det generelle toksicitetsstudieprogram.
English: Very common: may affect more than 1 in 10 people - nausea
Danish: Meget almindelige: kan berøre flere end 1 ud af 10 personer - kvalme
English: These symptoms could be due to either discontinuation effects or excess serotonergic activity.
Danish: Disse symptomer kan enten skyldes abstinenssymptomer eller overdreven serotonerg aktivitet.
English: The mechanism of action of vortioxetine is thought to be related to its direct modulation of serotonergic receptor activity and inhibition of the serotonin (5-HT) transporter.
Danish: Vortioxetins virkningsmekanisme menes at hænge sammen med dets direkte modulering af serotonerg receptoraktivitet og hæmning af serotonin- (5-HT-) transportøren.
English: In humans, two positron emission tomography (PET) studies have been conducted using 5-HT transporter ligands (11C-MADAM or 11C-DASB) to quantify the 5-HT transporter occupancy in the brain across different dose levels.
Danish: Hos mennesker er der udført to studier med positron-emissiontomografi (PET-studier) med 5-HTtransportørligander (11C-MADAM eller 11C-DASB) for at kvantificere 5-HT-transportørbindingen i hjernen ved forskellige dosisniveauer.
English: The major metabolite of vortioxetine is pharmacologically inactive.
Danish: Vortioxetins primære metabolit er farmakologisk inaktiv.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V.
English: The safety and efficacy of Brintellix in children and adolescents aged less than 18 years have not been established.
Danish: Brintellix' sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: An increased risk of bone fractures has been observed in patients taking this type of medicines.
Danish: Der er set en øget risiko for knoglebrud hos patienter, der tager denne type medicin.
English: Additionally, the class warning on haemorrhage should be updated, to add that haemorrhage has been reported with vortioxetine as well.
Danish: Derudover bør klasseadvarslen vedrørende blødning opdateres, således at det bliver tilføjet, at blødning også er blevet indberettet med vortioxetin.
English: However, the precise contribution of the individual targets to the observed pharmacodynamic profile remains unclear and caution should be applied when extrapolating animal data directly to man.
Danish: Det er dog endnu uafklaret, hvorledes påvirkningen af den enkelte receptor bidrager til den observerede farmakodynamiske profil, og der bør udvises forsigtighed med at ekstrapolere data direkte fra dyr til mennesker.
English: In general, the observed side effects were mild to moderate and occurred within the first two weeks of treatment.
Danish: De observerede bivirkninger var generelt lette til moderate og indtrådte i løbet af de første to ugers behandling.
English: In a thorough QTc study in healthy subjects at doses up to 40 mg daily, no potential for the prolongation of the QTc interval was observed.
Danish: I et omfattende studie af QTc-intervallet hos raske forsøgspersoner, der fik doser på op til 40 mg dagligt, blev der ikke observeret potentiale for forlængelse af QTc-intervallet.
English: Thoughts of suicide and worsening of your depression
Danish: Selvmordstanker og forværring af din depression eller angst
English: Class effect
Danish: Klasseeffekt
English: Environmental risk assessment studies have shown that vortioxetine has the potential to be persistent, bioaccumulative and toxic to the environment (risk to fish).
Danish: Miljørisikovurderingsstudier har vist, at vortioxetin har potentiale til at være persistent, bioakkumulerende og toksisk for miljøet (skadeligt for fisk).
English: You may be more likely to think like this if you: - have previously had thoughts about killing or harming yourself.
Danish: Du kan have øget risiko for sådanne tanker: - Hvis du tidligere har haft selvmordstanker eller tanker om at gøre skade på dig selv.
English: Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes.
Danish: Tæt overvågning, især af patienter i højrisikogruppe, bør ledsage den medicinske behandling særlig ved behandlingsstart og efter dosisændring.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE SOM INTERMEDIÆR PAKNING/ DEL AF FLERSTYKSPAKNING (UDEN BLÅ BOKS)
English: Have the container and any remaining tablets available.
Danish: Medbring beholderen og resten af tabletterne.
English: If this occurs, treatment with vortioxetine should be discontinued immediately and symptomatic treatment should be initiated.
Danish: Hvis disse symptomer opstår, skal behandlingen med vortioxetin afbrydes med det samme og symptomatisk behandling indledes.
English: The mean 5-HT transporter occupancy in the raphe nuclei was approximately 50% at 5 mg/day, 65% at 10 mg/day and increased to above 80% at 20 mg/day.
Danish: Den gennemsnitlige binding af 5-HT-transportører i raphe nuclei var ca. 50 % ved 5 mg/dag, 65 % ved 10 mg/dag, mens de steg til over 80 % ved 20 mg/dag.
English: There is limited experience with vortioxetine overdoses above 80 mg.
Danish: Der er begrænset erfaring med overdosering af vortioxetin over 80 mg.
English: - The review of a signal for anaphylactic reaction reported a total of 40 post-marketing cases, including seven where causality with vortioxetine treatment was considered possible.
Danish: - Ved gennemgangen af et signal om anafylaktiske reaktioner blev der fundet i alt 40 tilfælde efter markedsføringen, herunder syv tilfælde, som blev vurderet at have en mulig årsagssammenhæng med vortioxetinbehandling.
English: Effects of vortioxetine on the Digit Symbol Substitution Test (DSST), the University of California San Diego Performance-Based Skills Assessment (UPSA) (objective measures) and Perceived Deficits Questionnaire (PDQ) and Cognitive and Physical Functioning Questionnaire CPFQ (subjective measures) scores
Danish: Virkningen af vortioxetin bedømt ud fra scoringen i DSST (the Digit Symbol Substitution Test) og UPSA (the University of California San Diego Performance-Based Skills Assessment) (objektive mål) og ud fra scoringen i spørgeskemaerne PDQ (the Perceived Deficits Questionnaire) og CPFQ (the Cognitive and Physical Functioning Questionnaire) (subjektive mål)
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Danish: Eftersom en bedring af depressionen måske ikke ses før efter flere ugers behandling, bør patienten følges tæt, indtil der kan ses bedring.
English: Vortioxetine was not genotoxic in a standard battery of in vitro and in vivo tests.
Danish: Vortioxetin var ikke genotoksisk i en standardrække af in vitro- og in vivo-tests.
English: On the basis of the scientific conclusions for vortioxetine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing vortioxetine is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for vortioxetine er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder vortioxetine forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: The pharmacokinetics are linear and time independent in the dose range studied (2.5 to 60 mg/day).
Danish: Farmakokinetikken er lineær og uafhængig af tid i det undersøgte dosisinterval (2,5 til 60 mg/dag).
English: Administration of vortioxetine in the general toxicity studies in mice, rats and dogs was mainly associated with CNS-related clinical signs.
Danish: I de generelle toksicitetsstudier var administration af vortioxetin til mus, rotter og hunde især forbundet med CNS-relaterede kliniske symptomer.
English: The bottle must be turned completely upside down.
Danish: Flasken skal drejes helt om.
English: For the 20 mg/day dose, an increase in TESD was seen compared to placebo (an incidence difference of 14.2%, 95% CI [1.4, 27.0]).
Danish: Ved en dosis på 20 mg/dag sås en stigning i TESD i forhold til placebo (en forskel i forekomsten på 14,2 %, 95 % CI [1,4; 27,0]).
English: Please tell your doctor if you are taking any of the medicines above, since your doctor needs to know if you already are at risk for seizure.
Danish: Fortæl din læge, hvis du tager et af lægemidlerne nævnt ovenfor - lægen har brug for at vide, om du i forvejen har risiko for at få krampeanfald.
English: There was no clinically relevant difference to placebo in the incidence or nature of the discontinuation symptoms after either short-term (6-12 weeks) or long-term (24-64 weeks) treatment with vortioxetine.
Danish: Der var ingen klinisk relevant forskel i forhold til placebo i forekomsten eller arten af seponeringssymptomer efter hverken korttidsbehandling (6-12 uger) eller langtidsbehandling (24-64 uger) med vortioxetin.
English: - have a severe kidney disease.
Danish: - Hvis du har en alvorlig nyresygdom.
English: EXP (MM-YYYY) See embossed stamp.
Danish: EXP (MM-ÅÅÅÅ) Se præget stempel.
English: Do not stop taking Brintellix without talking with your doctor.
Danish: Du må ikke stoppe behandlingen med Brintellix uden først at tale med din læge.
English: Pharmacotherapeutic group: Psychoanaleptics; Other antidepressants, ATC-code: N06AX26
Danish: Farmakoterapeutisk klassifikation: Psykoanaleptika: Andre antidepressiva, ATC-kode: N06AX26
English: No clinically significant changes were observed in hepatic or renal assessments in clinical studies.
Danish: Der blev ikke observeret klinisk signifikante ændringer i lever- eller nyrefunktionen i kliniske studier.
English: This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Danish: Dette lægemiddel indeholder en mindre mængde ethanol (alkohol), mindre end 100 mg pr. dosis.
English: The effect in the individual studies was supported by the meta-analysis (MMRM) of the mean change from baseline in MADRS total score at Week 6/8 in the short-term, placebo-controlled studies in adults.
Danish: Effekten i de enkelte studier blev understøttet af metaanalysen (MMRM) af gennemsnitsændringen fra baseline i den samlede MADRS-score i uge 6/8 i de kortvarige, placebokontrollerede studier hos voksne.
English: Brintellix is not recommended for the treatment of depression in patients aged less than 18 years since the safety and efficacy of vortioxetine have not been established in this age group (see section 4.2).
Danish: Brintellix anbefales ikke til behandling af depression hos patienter under 18 år, da vortioxetins sikkerhed og virkning hos denne aldersgruppe ikke er klarlagt (se pkt.
English: Combining this medicine with alcohol is not advisable.
Danish: Dette lægemiddel bør ikke kombineres med alkohol.
English: There are limited data from the use of vortioxetine in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af vortioxetin til gravide kvinder.
English: EXP {MM-YYYY} When opened, use within 8 weeks
Danish: EXP {MM-ÅÅÅÅ} Anvendes inden for 8 uger efter anbrud
English: Have the bottle and any remaining solution available.
Danish: Medbring flasken og resten af opløsningen.
English: Hydroxypropylbetadex Ethanol (96 per cent) Purified water
Danish: Hydroxypropylbetadex Ethanol (96 %) Renset vand
English: This was supported by clinical relevance as demonstrated by the proportions of responders and remitters and the improvement in the Clinical Global Impression - Global Improvement (CGI-I) score.
Danish: Den kliniske relevans af dette blev yderligere understøttet af andelen med respons eller remission og forbedret score på CGI-I (Clinical Global Impression - Global Improvement).
English: Nonclinical data indicate that vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter, leading to modulation of neurotransmission in several systems, including predominantly the serotonin but probably also the norepinephrine, dopamine, histamine, acetylcholine, GABA and glutamate systems.
Danish: Prækliniske data indikerer, at vortioxetin er en 5-HT3-, 5-HT7- og 5-HT1D-receptorantagonist, en partiel 5-HT1B-receptoragonist, en 5-HT1A-receptoragonist og en hæmmer af 5-HT-transportøren, hvilket fører til modulering af flere neurotransmittersystemer, herunder primært det serotonerge, men muligvis også det noradrenerge, dopaminerge, histaminerge, acetylcholinerge, GABAerge og glutaminerge system.
English: Contains ethanol
Danish: Indeholder ethanol
English: - Based upon the role of serotonin on haemostasis, the mechanism of action of vortioxetine and 63 post-marketing cases retrieved from a signal for haemorrhage with possible causality with vortioxetine, it was considered that haemorrhage should be included as an adverse drug reaction in the product information of vortioxetine.
Danish: - På baggrund af serotonins rolle for hæmostasen, votioxetins virkningsmekanisme og 63 tilfælde efter markedsføringen, som er udledt fra et signal om blødning med mulig årsagssammenhæng med vortioxetin, blev det vurderet, at blødning bør inkluderes som bivirkning i produktinformationen for vortioxetin.
English: Brintellix is not recommended in children and adolescents under 18 years due to lack of information for this age group.
Danish: Børn og unge under 18 år bør ikke få Brintellix på grund af manglende oplysninger om brug til denne aldersgruppe.
English: - tramadol (a strong painkiller).
Danish: - Tramadol (mod stærke smerter).
English: In clinical short- and long-term placebo-controlled studies, potential discontinuation symptoms were systematically evaluated after abrupt treatment cessation of vortioxetine.
Danish: I kliniske, placebokontrollerede korttids- og langtidsstudier blev potentielle seponeringssymptomer systematisk evalueret efter abrupt seponering af vortioxetin.
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Danish: Bivirkninger er anført nedenfor i henhold til følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til < 1/100), sjælden (≥1/10.000 til <1/1.000),
English: Potential for vortioxetine to affect other medicinal products
Danish: Vortioxetins potentielle påvirkning af andre lægemidler
English: In clinical studies in children and adolescents treated with other antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour, anger) were more frequently observed than in those treated with placebo.
Danish: I kliniske studier med børn og unge, der blev behandlet med andre antidepressiva, forekom selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (især aggression, trodsighed og vrede) hyppigere i behandlingsgruppen end i placebogruppen.
English: - quinidine (a medicine to treat heart rhythm disorders).
Danish: - Quinidin (til at behandle forstyrrelser i hjertets rytme).
English: It is expected that vortioxetine will be excreted into human milk (see section 5.3).
Danish: Det forventes, at vortioxetin udskilles i human mælk (se pkt.
English: In accordance with the half-life, the accumulation index is 5 to 6 based on AUC0-24h following multiple doses of 5 to 20 mg/day.
Danish: I overensstemmelse med halveringstiden er akkumuleringsindekset 5-6, baseret på AUC0-24h efter gentagne doser på 5-20 mg/dag.
English: 15 ml in an amber glass bottle (type III) and screw cap (polypropylene) with dropper (LDpolyethylene), (child-resistant closure).
Danish: 15 ml i en ravfarvet glasflaske (type III) og skruelåg (polypropylen) med dråbetæller (LDpolyethylen), (børnesikret lukning).
English: Vortioxetine is a poor P-gp substrate and inhibitor.
Danish: Vortioxetin er et svagt P-gp-substrat og en svag Pgp-hæmmer.
English: Due to the risk of serotonin syndrome, vortioxetine is contraindicated in any combination with irreversible non-selective MAOIs.
Danish: På grund af risikoen for serotonergt syndrom er vortioxetin kontraindiceret i enhver kombination med irreversible ikke-selektive MAO-hæmmere.
English: Clear, nearly colourless to yellowish solution.
Danish: Klar, næsten farveløs til gullig opløsning.
English: Common: may affect up to 1 in 10 people - diarrhoea, constipation, vomiting - dizziness - itching of the whole body - abnormal dreams
Danish: Almindelige: kan berøre op til 1 ud af 10 personer - diaré, forstoppelse, opkastning - svimmelhed - kløe over hele kroppen - unormale drømme
English: In juvenile toxicity studies in rats, all vortioxetine treatment-related findings were consistent with those noted in adult animals.
Danish: I toksicitetsstudier hos juvenile rotter stemte alle fund relateret til behandling med vortioxetin overens med fundene hos voksne dyr.
English: - mefloquine (a medicine to prevent and treat malaria).
Danish: - Mefloquin (til at forebygge og behandle malaria).
English: Caution should be exercised in patients at risk, such as the elderly, patients with cirrhosis of the liver or patients concomitantly treated with medicinal products known to cause hyponatraemia.
Danish: Forsigtighed tilrådes hos patienter i risikogruppe såsom ældre, patienter med levercirrose eller patienter, der er i samtidig behandling med lægemidler, der kan forårsage hyponatriæmi.
English: Potential for other medicinal products to affect vortioxetine
Danish: Andre lægemidlers potentielle påvirkning af vortioxetin
English: Brintellix contains the active substance vortioxetine.
Danish: Brintellix indeholder det aktive stof vortioxetin.
English: This medicinal product contains small amounts of ethanol, less than 100 mg per dose.
Danish: Dette lægemiddel indeholder en mindre mængde ethanol, mindre end 100 mg pr. dosis.
English: The incidence of self-reported adverse sexual reactions was low and similar to placebo in clinical short- and long-term studies with vortioxetine.
Danish: Forekomsten af selvindberettede seksuelle bivirkninger var lav og sammenlignelig med placebo i kliniske korttids- og langtidsstudier med vortioxetin.