FrancophonIA/ELRC3.0 huggingface dataset:
English: One study assessed the effect of vortioxetine on functional capacity using the University of California San Diego Performance-Based Skills Assessment (UPSA).
Danish: Et studie undersøgte virkningen af vortioxetin på funktionsevnen ved hjælp af testen UPSA.
English: The efficacy of vortioxetine 10 or 20 mg/day was further demonstrated in a 12-week, double-blind, flexible-dose comparative study versus agomelatine 25 or 50 mg/day in patients with MDD.
Danish: Effekten af vortioxetin 10 og 20 mg/dag versus agomelatin 25 og 50 mg/dag blev derudover vist i et 12-ugers dobbeltblindt, sammenlignende studie med fleksibel dosis hos patienter med moderate til svære depressive episoder.
English: - phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines to treat depression called non-selective monoamine oxidase inhibitors); you must not take any of these medicines together with Brintellix.
Danish: - Phenelzin, iproniazid, isocarboxazid, nialamid, tranylcypromin (lægemidler mod depression af typen ikke-selektive MAO-hæmmere); du må ikke tage nogen af disse lægemidler sammen med Brintellix.
English: In the meta-analysis, the overall mean difference to placebo across the studies was statistically significant: -2.3 points (p = 0.007), -3.6 points (p <0.001), and -4.6 points (p <0.001) for the 5, 10, and 20 mg/day doses, respectively; the 15 mg/day dose did not separate from placebo in the meta-analysis, but the mean difference to placebo was -2.6 points.
Danish: I metaanalysen var den samlede gennemsnitsforskel fra placebo statistisk signifikant på tværs af studierne: -2,3 point (p=0,007); -3,6 point (p<0,001) og -4,6 point (p<0,001) for hhv. 5, 10 og 20 mg/dag.
English: 15 mg corresponding to 15 drops.
Danish: 15 mg svarer til 15 dråber.
English: Following a single dose of 10 mg vortioxetine, no impact of mild or moderate hepatic impairment (Child-Pugh Criteria A or B; n=8 per group) was observed on the pharmacokinetics of vortioxetine (changes in AUC were less than 10%).
Danish: Efter en enkelt dosis vortioxetin på 10 mg sås ingen påvirkning af vortioxetins farmakokinetik (ændringer i AUC var under 10 %) ved let til moderat nedsat leverfunktion (Child-Pugh-klasse A eller B; n=8 pr. gruppe).
English: Vortioxetine is extensively metabolised in the liver, primarily through oxidation catalysed by CYP2D6 and to a minor extent CYP3A4/5 and CYP2C9, and subsequent glucuronic acid conjugation.
Danish: Vortioxetin metaboliseres i omfattende grad i leveren og primært gennem oxidation katalyseret af CYP2D6 og i mindre grad af CYP3A4/5 og CYP2C9 og efterfølgende konjugering til glukuronsyre.
English: - taking medicines with a so-called serotonergic effect, such as: - tramadol (a strong pain killer).
Danish: - Hvis du tager lægemidler med såkaldt serotonerg virkning, såsom: Tramadol (mod stærke smerter).
English: Also, no significant inhibitory effect, relative to placebo, on platelet aggregation or pharmacokinetics of acetylsalicylic acid or salicylic acid was observed when acetylsalicylic acid 150 mg/day was co-administered following multiple doses of vortioxetine administration in healthy subjects.
Danish: Der sås heller ingen signifikant hæmmende virkning på trombocytaggregation eller farmakokinetikken af acetylsalicylsyre eller salicylsyre sammenholdt med placebo, når acetylsalicylsyre 150 mg/dag blev administreret til raske forsøgspersoner efter gentagne doser vortioxetin.
English: The lowest effective dose of 5 mg vortioxetine once daily should always be used as the starting dose in patients ≥ 65 years of age.
Danish: Den mindste virksomme dosis på 5 mg vortioxetin en gang dagligt bør altid anvendes som startdosis til patienter ≥ 65 år.
English: Vortioxetine was statistically significantly better than agomelatine as measured by improvement in the MADRS total score and supported by the clinical relevance as demonstrated by the proportions of responders and remitters and improvement in the CGI-I.
Danish: Vortioxetin var statistisk signifikant bedre end agomelatin målt på forbedring i den samlede MADRS-score.
English: The combination of vortioxetine with a weak reversible and non-selective MAOI, such as the antibiotic linezolid, is contraindicated (see section 4.3).
Danish: Reversibel, ikke-selektiv MAO-hæmmer (linezolid) Kombination af vortioxetin med en svag reversibel, ikke-selektiv MAO-hæmmer som antibiotikummet linezolid er kontraindiceret (se pkt.
English: Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS), potentially life-threatening conditions, may occur with vortioxetine.
Danish: Under behandling med vortioxetin kan der forekomme serotonergt syndrom eller malignt neuroleptikasyndrom, som er potentielt livstruende tilstande.
English: Human case reports with medicinal products from the related pharmacological class of antidepressants (SSRIs) have shown an effect on sperm quality that is reversible.
Danish: Der er indberettet tilfælde af reversibel påvirkning af sædkvaliteten hos mennesker for beslægtede antidepressiva (SSRI).
English: How to take Brintellix
Danish: Sådan skal du tage Brintellix
English: Your doctor will make a decision on whether you should stop breast-feeding, or stop using Brintellix taking into account the benefit of breast-feeding for your child, and the benefit of therapy for you
Danish: Din læge vil beslutte, om du skal holde op med at amme, eller om behandlingen med Brintellix skal stoppes, idet der tages hensyn til fordelene ved at dit barn bliver ammet i forhold til fordelene ved, at du bliver behandlet.
English: - sumatriptan and similar medicines with active substance names ending in “triptans” (used to treat migraine).
Danish: Sumatriptan og lignende lægemidler, hvor navnet på det aktive stof ender på “triptan” (mod migræne).
English: Vortioxetine is extensively metabolised in the liver, primarily through oxidation catalysed by CYP2D6 and to a minor extent CYP3A4/5 and CYP2C9 (see section 5.2).
Danish: Vortioxetin metaboliseres i omfattende grad i leveren; primært gennem oxidation katalyseret af CYP2D6 og i mindre grad af CYP3A4/5 og CYP2C9 (se pkt.
English: No inhibitory effect of 40 mg single-dose omeprazole (CYP2C19 inhibitor) was observed on the multiple-dose pharmacokinetics of vortioxetine in healthy subjects.
Danish: Der sås ingen hæmmende virkning af 40 mg omeprazol (CYP2C19-hæmmer) som enkeltdosis på vortioxetins farmakokinetiske egenskaber efter gentagne doser hos raske forsøgspersoner.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Furthermore, vortioxetine, in the dose range of 5-20 mg/day, demonstrated efficacy on the broad range of depressive symptoms (assessed by improvement in all MADRS single-item scores).
Danish: Endvidere blev der vist virkning af vortioxetin på et bredt udvalg af depressive symptomer (vurderet som bedring i scoren for alle de enkelte punkter på MADRS) i dosisområdet 5-20 mg/dag.
English: The maintenance of antidepressant efficacy was demonstrated in a relapse-prevention study.
Danish: Et studie, der undersøgte forebyggelse af recidiv, påviste fastholdelse af den antidepressive effekt.
English: Each drop contains vortioxetine (D,L)-lactate equivalent to 1 mg vortioxetine.
Danish: En dråbe indeholder vortioxetinlactat (D,L) svarende til 1 mg vortioxetin.
English: Brintellix 20 mg/ml oral drops, solution
Danish: Brintellix 20 mg/ml orale dråber, opløsning
English: The lowest effective dose of 5 mg vortioxetine once daily should always be used as the starting dose in patients ≥ 65 years (see section 4.2).
Danish: Den laveste virksomme dosis på 5 mg vortioxetin en gang dagligt bør altid anvendes som startdosis til patienter ≥65 år (se pkt.
English: However, as adverse reactions such as dizziness have been reported, patients should exercise caution when driving or operating hazardous machinery, especially when starting treatment with vortioxetine or when changing the dose.
Danish: Da bivirkninger som svimmelhed er blevet rapporteret, bør patienterne imidlertid udvise forsigtighed, når de fører motorkøretøj eller betjener farlige maskiner - især ved behandlingsstart og dosisændring.
English: The tablet can be taken with or without food.
Danish: Tabletten kan tages alene eller sammen med mad.
English: Each ml of solution contains vortioxetine (D,L)-lactate equivalent to 20 mg vortioxetine.
Danish: En ml opløsning indeholder vortioxetinlactat (D,L) svarende til 20 mg vortioxetin (vortioxetine).
English: The following symptoms may occur in the newborn after maternal use of a serotonergic medicinal product in the later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping.
Danish: Følgende symptomer kan forekomme hos nyfødte, hvis mødre har taget serotonerge lægemidler sidst i graviditeten: vejrtrækningsbesvær, cyanose, apnø, krampeanfald, ustabil temperatur, besvær med at spise, opkastning, hypoglykæmi, hypertoni, hypotoni, hyperrefleksi, tremor, spjætten, irritabilitet, letargi, konstant gråd, døsighed og søvnbesvær.
English: - bupropion (a medicine to treat depression also used to wean from smoking).
Danish: - Bupropion (mod depression og til rygeafvænning).
English: No clinically relevant effect was observed during steady-state lithium exposure following coadministration with multiple doses of vortioxetine in healthy subjects.
Danish: Der sås ingen klinisk relevant effekt efter administration af gentagne doser vortioxetin til raske forsøgspersoner, eksponeret for lithium ved steady state.
English: Package leaflet: Information for the patient Brintellix 20 mg/ml oral drops, solution vortioxetine
Danish: Indlægsseddel: Information til patienten Brintellix 20 mg/ml orale dråber, opløsning
English: No significant effects, relative to placebo, were observed in the levels of sex hormones following co-administration of vortioxetine with a combined oral contraceptive (ethinyl estradiol 30 µg/ levonorgestrel 150 µg).
Danish: Der sås ingen signifikant nedsættelse af den kognitive funktion i forhold til placebo efter samtidig administration af vortioxetin og en enkelt dosis diazepam på 10 mg. Der sås ingen signifikant påvirkning i forhold til placebo af niveauet af kønshormoner efter co-administration af vortioxetin og et oralt kontraceptivum af kombinationstypen (ethinylestradiol 30 µg/ levonorgestrel 150 µg).
English: If you take medicines to treat depression, including Brintellix, during the last 3 months of your pregnancy, you should be aware that the following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties.
Danish: Hvis du tager lægemidler mod depression, herunder Brintellix, i de sidste 3 måneder af graviditeten, skal du være opmærksom på, at følgende symptomer kan forekomme hos den nyfødte: vejrtrækningsbesvær, blålig hud, kramper, ændret kropstemperatur, vanskeligheder med at die, opkastning, lavt blodsukker, stive eller slappe muskler, livlige reflekser, skælven og rysten, irritabilitet, sløvhed, konstant gråd, søvnighed og søvnbesvær.
English: The starting and recommended dose of Brintellix is 10 mg vortioxetine once daily in adults less than 65 years of age.
Danish: Den anbefalede dosis af Brintellix er 10 mg vortioxetin en gang dagligt til voksne under 65 år.
English: Vortioxetine had no effect relative to placebo on body weight, heart rate, or blood pressure in clinical short- and long-term studies.
Danish: I kliniske korttids- eller langtidsstudier påvirkede vortioxetin ikke legemsvægt, hjertefrekvens eller blodtryk i forhold til placebo.
English: The efficacy and safety of vortioxetine have been studied in a clinical programme that included more than 6,700 patients, of whom more than 3,700 were treated with vortioxetine in short-term (≤12 weeks) studies of major depressive disorder (MDD).
Danish: hvoraf over 3.700 blev behandlet med vortioxetin i korttidsstudier (≤12 uger) af moderate til svære depressive episoder.
English: Tell your doctor if you are taking any of the following medicines: - phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines to treat depression called non-selective monoamine oxidase inhibitors) you must not take any of these medicines together with Brintellix.
Danish: Tal med din læge, hvis du tager et af følgende lægemidler: - Phenelzin, iproniazid, isocarboxazid, nialamid, tranylcypromin (lægemidler mod depression af typen ikke-selektive MAO-hæmmere); du må ikke tage nogen af disse lægemidler sammen med
English: Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function [e.g., atypical antipsychotics and phenothiazines, most tricyclic antidepressants, non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (ASA)] (see section 4.5) and in patients with known bleeding tendencies/disorders.
Danish: Forsigtighed tilrådes hos patienter, der tager antikoagulantia og/eller lægemidler med kendt påvirkning af trombocytfunktionen [f.eks. atypiske antipsykotika og phenothiaziner, de fleste tricykliske antidepressiva, non-steroide antiinflammatoriske lægemidler (NSAID), acetylsalicylsyre (ASA)] (se pkt.
English: EU/1/13/891/024 490 film-coated tablets (5 packs of 98x1)
Danish: EU/1/13/891/024 490 filmovertrukne tabletter (5 pakninger a 98 x 1)
English: Titanium dioxide (E171) Iron oxide red (E172)
Danish: Titandioxid (E171) Jernoxid, rød (E172)
English: Multipack containing 126 (9 x 14) and 490 (5 x (98x1)) film-coated tablets.
Danish: Flerstykspakning med 126 (9x14) og 490 (5 x (98x1)) filmovertrukne tabletter.
English: Caution is advised when concomitantly using other medicinal products capable of lowering the seizure threshold [e.g., antidepressants (tricyclics, SSRIs, SNRIs), neuroleptics (phenothiazines, thioxanthenes and butyrophenones), mefloquine, bupropion, tramadol] (see section 4.4).
Danish: Forsigtighed tilrådes ved samtidig brug af andre lægemidler, der kan sænke krampetærsklen [f.eks. antidepressiva (tricykliske, SSRI eller SNRI), antipsykotika (phenothiaziner, thioxanthener og butyrophenoner), mefloquin, bupropion og tramadol](se pkt.
English: - have a severe kidney disease.. - have a severe liver disease or a liver disease called cirrhosis.
Danish: - Hvis du har en alvorlig leversygdom eller leversygdommen cirrose.
English: Each drop contains 1 mg vortioxetine (as (D,L)- lactate)
Danish: En dråbe indeholder 1 mg vortioxetine (som D,L-lactat)
English: In the meta-analyses (ANCOVA, LOCF) of the mean change from baseline in DSST number of correct symbols in all 3 studies, vortioxetine separated from placebo (p<0.05) with a standardised effect size of 0.35.
Danish: Vortioxetin adskilte sig fra placebo (p<0,05) med en standardiseret virkning på 0,35 i meta-analyserne (ANCOVA, LOCF) af den gennemsnitlige ændring fra baseline i DSST antal af korrekte symboler i alle tre studier.
English: Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of antidepressants with serotonergic effect (SSRIs, SNRIs).
Danish: I forbindelse med brug af antidepressiva med serotonerg effekt (SSRI, SNRI) er der indberettet sjældne tilfælde af hyponatriæmi, som formentlig skyldes uhensigtsmæssig produktion af antidiuretisk hormon (SIADH-syndrom).
English: There is no clinical experience with concurrent administration of vortioxetine and ECT, therefore caution is advisable.
Danish: Elektrokonvulsiv terapi (ECT) Der er ingen klinisk erfaring med ECT og samtidig administration af vortioxetin.
English: 14 film-coated tablets 28 film-coated tablets 98 film-coated tablets 56x1 film-coated tablets 98x1 film-coated tablets 100 film-coated tablets 200 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 98 filmovertrukne tabletter 56x1 filmovertrukne tabletter 98x1 filmovertrukne tabletter 100 filmovertrukne tabletter 200 filmovertrukne tabletter
English: - chlorpromazine, chlorprothixene, haloperidol (medicines to treat mental disorders belonging to the group called phenothiazines, thioxanthenes, butyrophenones).
Danish: - Chlorpromazin, chlorprothixen, haloperidol (lægemidler mod psykiske forstyrrelser, som hører til gruppen kaldet phenothiaziner, thioxanthener og butyrophenoner).
English: Dizziness Not known * Serotonin Syndrome
Danish: Serotonergt syndrom
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 98 film-coated tablets 98 x 1 film-coated tablets 100 film-coated tablets 200 film-coated tablets
Danish: 7 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 56 filmovertrukne tabletter 56 x 1 filmovertrukne tabletter 98 filmovertrukne tabletter 98 x 1 filmovertrukne tabletter 100 filmovertrukne tabletter 200 filmovertrukne tabletter
English: - chlorpromazine, chlorprothixene, haloperidol (medicines to treat mental disorders belonging to the group called phenothiazines, thioxanthenes,butyrophenones).
Danish: - Chlorpromazin, chlorprothixen, haloperidon (lægemidler mod psykiske forstyrrelser, som hører til gruppen kaldet phenothiaziner, thioxanthener og butyrophenoner).
English: - The other ingredients are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (type A), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), iron oxide red (E172).
Danish: - Øvrige indholdsstoffer: mannitol (E421), mikrokrystallinsk cellulose, hydroxypropylcellulose, natriumstivelsesglycolat (type A), magnesiumstearat, hypromellose, macrogol 400, titandioxid (E171), rød jernoxid (E172).
English: No effect of multiple doses of acetylsalicylic acid 150 mg/day on the multiple-dose pharmacokinetics of vortioxetine was observed in healthy subjects.
Danish: Hos raske forsøgspersoner observeredes ingen virkning af gentagne doser acetylsalicylsyre 150 mg/dag på farmakokinetikken efter gentagne doser vortioxetin.
English: - The other ingredients are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (type A), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), iron oxide yellow (E172).
Danish: - Øvrige indholdsstoffer: mannitol (E421), mikrokrystallinsk cellulose, hydroxypropylcellulose, natriumstivelsesglycolat (type A), magnesiumstearat, hypromellose, macrogol 400, titandioxid (E171), gul jernoxid (E172).
English: FREQUENCY ADVERSE REACTION
Danish: HYPPIGHED BIVIRKNINGER
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 98 film-coated tablets 98 x 1 film-coated tablets 100 film-coated tablets 200 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 56 filmovertrukne tabletter 56 x 1 filmovertrukne tabletter 98 filmovertrukne tabletter 98 x 1 filmovertrukne tabletter 100 filmovertrukne tabletter 200 filmovertrukne tabletter
English: - The other ingredients are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (type A), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172)
Danish: - Øvrige indholdsstoffer: mannitol (E421), mikrokrystallinsk cellulose, hydroxypropylcellulose, natriumstivelsesglycolat (type A), magnesiumstearat, hypromellose, macrogol 400, titandioxid (E171), gul jernoxid (E172), rød jernoxid (E172).
English: Brintellix 20 mg/ml oral drops, solution vortioxetine
Danish: Brintellix 20 mg/ml orale dråber, opløsning vortioxetine
English: sleepy or very tired, or feeling or being sick; more serious symptoms are fainting, fits or falls) - serotonin syndrome (see section 2) - allergic reactions, that may be serious, causing swelling of the face, lips, tongue or throat,
Danish: Mere alvorlige symptomer er besvimelse, anfald eller fald) - serotonergt syndrom (se punkt 2) - allergiske reaktioner, som kan være alvorlige og forårsage hævelse af ansigt, læber, tunge eller svælg, vejrtræknings- eller synkebesvær og/eller pludseligt blodtryksfald (hvilket forårsager svimmelhed eller omtumlethed) - nældefeber - kraftig eller uforklaret blødning (herunder blå mærker, næseblødning, blødning fra mave/tarm og skede) - udslæt
English: The pack sizes of 56 x 1, 98 x 1 and 490 film-coated tablets are presented in unit dose blister.
Danish: I pakningerne med 56 x 1, 98 x 1 og 490 stk. er de filmovertrukne tabletter pakket i enkeltstyksblistre.
English: What Brintellix is and what it is used for What you need to know before you take Brintellix How to take Brintellix
Danish: Det skal du vide, før du begynder at tage Brintellix Sådan skal du tage Brintellix Bivirkninger
English: Ask your doctor if you are uncertain.
Danish: Er du i tvivl, så spørg lægen.
English: Each drop of solution contains 1 mg vortioxetine (as (D,L)
Danish: En dråbe opløsning indeholder 1 mg vortioxetin (som D,L-lactat).
English: Medicines that increase the risk of fits: - sumatriptan and similar medicines with active substance names ending in “triptans” - tramadol (a strong painkiller).
Danish: Lægemidler, der øger risikoen for kramper: - Sumatriptan og lignende lægemidler, hvor navnet på det aktive stof ender på “triptan”.
English: Brintellix 20 mg film-coated tablets EU/1/13/891/027-035
Danish: Brintellix 20 mg filmovertrukne tabletter EU/1/13/891/027-035
English: However, as adverse reactions such as diziness have been reported, caution is advised during such activities when beginning Brintellix treatment or changing the dose.
Danish: Da da bivirkninger som svimmelhed er blevet rapporteret, bør du dog være forsigtig under disse aktiviteter, når du starter på behandling med Brintellix, og hvis dosis bliver ændret.
English: In the majority of cases, no symptoms or mild symptoms were reported.
Danish: Erfaringen efter markedsføringen vedrører hovedsageligt overdosering på op til 80 mg. I størstedelen af tilfældene blev ingen symptomer eller milde symptomer rapporteret.
English: Co-administration of strong inhibitors of CYP3A4 (such as itraconazol, voriconazole, clarithromycin, telithromycin, nefazodone, conivaptan and many of the HIV protease inhibitors) and inhibitors of CYP2C9 (such as fluconazole and amiodarone) to CYP2D6 poor metabolisers (see section 5.2) has not been investigated specifically, but it is anticipated that it will lead to a more marked increased exposure of vortioxetine in these patients as compared to the moderate effect described above.
Danish: Interaktioner hos patienter med nedsat CYP2D6-metabolisme Samtidig administration af potente CYP3A4-hæmmere (såsom itraconazol, voriconazol, clarithromycin, telithromycin, nefazodon, conivaptan og mange HIV-proteasehæmmere) og CYP2C9hæmmere (såsom fluconazol og amiodaron) til patienter med nedsat CYP2D6-metabolisme (se pkt.
English: However, caution should be exercised when prescribing to elderly patients at doses higher than 10 mg vortioxetine once daily (see section
Danish: Forsigtighed tilrådes derfor ved behandling af patienter ≥ 65 år med doser over 10 mg vortioxetin en gang dagligt (se pkt.
English: Brintellix 15 mg film-coated tablets EU/1/13/891/018-026
Danish: Brintellix 15 mg filmovertrukne tabletter EU/1/13/891/018-026
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172)
Danish: Titandioxid (E171) Jernoxid, rød (E172) Jernoxid, gul (E172)
English: Not known * Anaphylactic reaction
Danish: Ikke almindelig Flushing Ikke kendt*
English: Brintellix 5 mg film-coated tablets EU/1/13/891/001-007
Danish: Brintellix 5 mg filmovertrukne tabletter EU/1/13/891/001-007