FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro, vortioxetine did not show any relevant potential for inhibition or induction of cytochrome P450 isozymes (see section 5.2).
Danish: In vitro udviste vortioxetin ikke relevant potentiale på hæmning eller induktion af CYP-isoenzymer (se pkt.
English: - selegiline, rasagiline (medicines to treat Parkinson's disease).
Danish: - Selegilin, rasagilin (mod Parkinsons sygdom).
English: Vortioxetine-related material was distributed to the milk of lactating rats (see section 4.6).
Danish: Vortioxetin-relaterede forbindelser blev udskilt i mælken hos diegivende rotter (se pkt.
English: When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Brintellix may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish.
Danish: Når medicin som Brintellix tages under graviditeten, især i de sidste 3 måneder af graviditeten, kan det øge risikoen for en alvorlig tilstand med forhøjet tryk i lungekredsløbet hos den nyfødte (kaldet persisterende pulmonal hypertension hos den nyfødte (PPHN)).
English: - warfarin, dipyridamole, phenprocoumon, low-dose acetylsalicylic acid (blood thinning medicines).
Danish: - Warfarin, dipyridamol, phenprocoumon, lav dosis af acetylsalicylsyre (blodfortyndende medicin).
English: Based on the above, it was considered that anaphylactic reaction should be included as an adverse drug reaction in the product information of vortioxetine.
Danish: - På baggrund af ovenstående blev det vurderet, at anafylaktiske reaktioner bør inkluderes som bivirkning i produktinformationen for vortioxetin.
English: Perforated unit dose blisters: PVC/PVdC/aluminium.
Danish: Perforeret enkeltstyksblister: PVC/PVdC/aluminium.
English: Fertility studies in male and female rats showed no effect of vortioxetine on fertility, sperm quality or mating performance (see section 5.3).
Danish: Fertilitetsstudier af vortioxetin hos han- og hunrotter viste ingen påvirkning af fertilitet, sædkvalitet eller parringsadfærd (se pkt.
English: Patients with severe depression or with depression and high levels of anxiety symptoms In severely depressed patients (baseline MADRS total score ≥30) and in depressed patients with a high level of anxiety symptoms (baseline HAM-A total score ≥20) vortioxetine also demonstrated efficacy in the short-term studies in adults (the overall mean difference to placebo in MADRS total score at Week 6/8 ranged from 2.8 to 7.3 points and from 3.6 to 7.3 points, respectively,(MMRM analysis)).
Danish: Patienter med svær depression eller med depression og mange angstsymptomer Hos patienter med svær depression (baseline MADRS-totalscore ≥30) og hos patienter med depression og mange angstsymptomer (baseline HAM-A-totalscore ≥20) udviste vortioxetin også effekt i korttidsstudierne hos voksne (den samlede gennemsnitsforskel fra placebo i MADRS totalscore i uge 6/8 afveg med henholdsvis 2,8-7,3 point og 3,6-7,3 point (MMRM-analyse)).
English: If no drops come out, tap the bottle lightly to start the flow.
Danish: Hvis der ikke kommer nogen dråber ud af flasken, skal du banke forsigtigt på den.
English: Only negligible amounts of vortioxetine are excreted in the faeces.
Danish: Der udskilles kun ubetydelige mængder vortioxetin i fæces.
English: The exposure to vortioxetine increased 2.3-fold for area under the curve (AUC) when vortioxetine 10 mg/day was co-administered with bupropion (a strong CYP2D6 inhibitor 150 mg twice daily) for 14 days in healthy subjects.
Danish: Eksponeringen for vortioxetin steg med faktor 2,3 målt som areal under kurven (AUC) ved samtidig administration af vortioxetin 10 mg/dag og bupropion (en potent CYP2D6-hæmmer) 150 mg to gange dagligt i 14 dage hos raske forsøgspersoner.
English: Turn the bottle completely upside down.
Danish: Vend bunden i vejret på flasken.
English: If you have taken any of these medicines, you will need to wait 14 days before you start taking Brintellix.
Danish: Hvis du har taget et af disse lægemidler, skal der gå 14 dage, før du begynder at tage Brintellix.
English: Brintellix 5 mg film-coated tablets Brintellix 10 mg film-coated tablets Brintellix 15 mg film-coated tablets Brintellix 20 mg film-coated tablets
Danish: Brintellix 5 mg filmovertrukne tabletter Brintellix 10 mg filmovertrukne tabletter Brintellix 15 mg filmovertrukne tabletter Brintellix 20 mg filmovertrukne tabletter
English: 20 mg corresponding to 20 drops.
Danish: 20 mg svarer til 20 dråber.
English: High-density polyethylene (HDPE) tablet container.
Danish: Tabletbeholder af højdensitets-polyethylen (HDPE).
English: If the combination proves necessary, the added medicinal product should be given with minimum dosage and under close clinical monitoring for serotonin syndrome (see section 4.4).
Danish: Hvis kombination er nødvendig, skal det tillagte lægemiddel gives i mindste dosering og under tæt klinisk monitorering for serotonergt syndrom (se pkt.
English: Consequently, it was concluded that rash should be included as an adverse drug reaction in the product information of vortioxetine.
Danish: Det blev derfor konkluderet, at udslæt bør inkluderes som bivirkning i produktinformationen for vortioxetin.
English: Twelve double-blind, placebo-controlled, 6/8-week, fixed-dose studies have been conducted to investigate the short-term efficacy of vortioxetine in MDD in adults (including the elderly).
Danish: Der blev udført 12 dobbeltblindede, placebokontrollerede 6- eller 8-ugers studier med fast dosering for at undersøge vortioxetins korttidseffekt på moderate til svære depressive episoder hos voksne (herunder ældre).
English: Brintellix has been shown to reduce the broad range of depressive symptoms, including sadness, inner tension (feeling anxious), sleep disturbances (reduced sleep), reduced appetite, difficulty in concentrating, feelings of worthlessness, loss of interest in favourite activities, feeling of being slowed down.
Danish: Det er vist, at Brintelix reducerer en lang række depressive symptomer, herunder tristhed, indre spænding (ængstelse), søvnforstyrrelser (nedsat søvn), nedsat appetit, koncentrationsbesvær, manglende selvværd, manglende lyst til at gøre det, du bedst kan lide samt en fornemmelse af at fungere langsommere.
English: Overdose signs could be dizziness, nausea, diarrhoea, stomach discomfort, itching of the whole body, sleepiness and flushing.
Danish: Symptomer på overdosering kan være svimmelhed, kvalme, diaré, mavegener, kløe over hele kroppen, søvnighed og ansigtsrødme.
English: The oral drops can be taken with or without food.
Danish: De orale dråber kan tages med eller uden samtidig fødeindtagelse.
English: Serotonin Syndrome symptoms include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, uncoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).
Danish: Symptomerne på et serotonergt syndrom omfatter ændringer i mental tilstand (f.eks. agitation, hallucinationer, koma), autonom ustabilitet (f.eks. takykardi, labilt blodtryk, hypertermi), neuromuskulære forstyrrelser (f.eks. hyperrefleksi, manglende koordination) og/eller gastrointestinale symptomer (f.eks. kvalme, opkastning, diaré).
English: Co-administration of strong CYP3A4/2C9-inhibitors to CYP2D6 poor metabolisers could potentially result in higher exposure (see section 4.5).
Danish: Co-administration af potente CYP3A4/2C9-hæmmere til patienter med nedsat CYP2D6-metabolisme kan potentielt resultere i højere eksponering (se pkt.
English: (DSST), ranging from Δ = 1.75 (p = 0.019) to 4.26 (p <0.0001) in the 2 studies in adults and Δ = 2.79
Danish: Vortioxetin havde statistisk signifikant virkning sammenlignet med placebo i DSST fra Δ= 1,75 (p = 0,019) til 4,26 (p <0,0001) i de to studier med voksne og Δ= 2,79 (p = 0,023) i studiet med ældre.
English: Brintellix oral drops, solution, are available in 20 ml amber glass bottle including screw cap with dropper (child-resistant closure).
Danish: Brintellix orale dråber, opløsning, udleveres i 20 ml ravfarvede glasflasker med skruelåg og dråbetæller (børnesikret lukning).
English: When a single dose of 20 mg vortioxetine was co-administered following 10 days of rifampicin 600 mg/day (a broad inducer of CYP isozymes) in healthy subjects, a 72% decrease in AUC of vortioxetine was observed.
Danish: Når en enkelt dosis på 20 mg vortioxetin blev tilføjet efter administration af rifampicin (en bred induktor af CYP-isoenzymer) 600 mg/dag i 10 dage til raske forsøgspersoner, observeredes en formindskelse på 72 % i AUC for vortioxetin.
English: - linezolid (a medicine to treat bacterial infections) .
Danish: - Linezolid (mod infektioner, der skyldes bakterier).
English: Uncommon: may affect up to 1 in 100 people - flushing - night sweats
Danish: Ikke almindelige: kan berøre op til 1 ud af 100 personer - ansigtsrødme - natlige svedeture
English: Following intake of dosages several times higher than the prescribed dose, fits (seizures) and a rare condition called serotonin syndrome have been reported.
Danish: Efter indtag af doser, der er mange gange større end den ordinerede dosis, er der rapporteret om krampeanfald og en sjælden sygdom, der hedder serotonergt syndrom.
English: Depending on individual patient response, a lower dose of vortioxetine may be considered if a strong inhibitor of CYP3A4 or CYP2C9 is co-administered in CYP2D6 poor metabolisers.
Danish: Afhængigt af den enkelte patients respons kan det overvejes at give en lavere dosis vortioxetin, hvis en stærk hæmmer af CYP3A4 eller CYP2C9 administreres samtidigt til patienter med nedsat CYP2D6-metabolisme.
English: For elderly people 65 years of age or older, the starting dose is 5 mg vortioxetine taken once daily.
Danish: Til ældre på 65 år eller derover er startdosis 5 mg vortioxetin en gang dagligt.
English: In the 8-week double-blind, placebo-controlled, fixed-dose study in elderly depressed patients (aged ≥65 years, n=452, 156 of whom were on vortioxetine), vortioxetine 5 mg/day was superior to placebo as measured by improvement in the MADRS and HAM-D24 total scores.
Danish: Ældre I det 8-ugers dobbeltblindede, placebokontrollerede studie med fast dosering hos ældre depressive patienter (i alderen ≥65 år, n=452, hvoraf 156 fik vortioxetin) var vortioxetin 5 mg/dag superior i forhold til placebo målt som bedring af totalscore på MADRS og HAM-D24.
English: Multipack: 126 (9 packs of 14) film-coated tablets.
Danish: Flerstykspakning: 126 (9 pakninger a 14) filmovertrukne tabletter.
English: The efficacy of vortioxetine (5-20 mg/day) in patients with MDD has been investigated in 2 adult and 1 elderly short-term, placebo-controlled studies.
Danish: Virkningen af vortioxetin (5-20 mg dagligt) på patienter med moderate til svære depressive episoder er blevet undersøgt i to placebokontrollerede korttidsstudier med voksne og ét med ældre.
English: Therefore, vortioxetine should be introduced cautiously in patients who have a history of seizures or in patients with unstable epilepsy (see section 4.5).
Danish: Derfor bør behandling med vortioxetin indledes med forsigtighed hos patienter med krampeanfald i anamnesen eller med ustabil epilepsi (se pkt.
English: - have had fits (seizures).
Danish: - Hvis du har haft kramper.
English: Elderly patients For doses ≥10 mg vortioxetine once daily, the withdrawal rate from the studies was higher in patients aged ≥65 years.
Danish: Ved doser ≥10 mg vortioxetin en gang dagligt var seponeringsraten i studierne højere for patienter ≥65 år.
English: The safety and tolerability of vortioxetine have been established in short- and long-term studies across the dose range of 5 to 20 mg/day.
Danish: Vortioxetins sikkerhed og tolerabilitet er påvist i dosisområdet 5-20 mg/dag i både korttids- og langtidsstudier.
English: Irreversible, selective MAO-B inhibitor (selegiline, rasagiline) Although a lower risk of serotonin syndrome is expected with selective MAO-B inhibitors than with MAO-A inhibitors, the combination of vortioxetine with irreversible MAO-B inhibitors, such as selegiline or rasagiline should be administered with caution.
Danish: Irreversible, selektive MAO-B-hæmmere (selegilin, rasagilin) Selv om risikoen for serotonergt syndrom forventes at være lavere med selektive MAO-B-hæmmere end med MAO-A-hæmmere, skal der udvises forsigtighed ved kombination af vortioxetin og irreversible MAO-B-hæmmere såsom selegilin og rasagilin.
English: Grounds for the variation to the terms of the Marketing Authorisation(s)
Danish: Begrundelser for ændring af betingelserne for markedsføringstilladelsen
English: - if you are taking other medicines known for depression as non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors.
Danish: - hvis du tager anden medicin mod depression af typen ikke-selektive MAO-hæmmere eller selektive MAO-A-hæmmere.
English: Lundbeck Eesti AS Tel: + 372 605 9350
Danish: Lundbeck EestiAS Tel: + 372 605 9350
English: Your doctor will treat you cautiously if you have a history of fits or have unstable fit disorders/epilepsy.
Danish: Din læge vil være forsigtig med at behandle dig, hvis du tidligere har haft kramper eller lider af ustabile kramper/epilepsi.
English: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving a medicinal product from related pharmacological classes of antidepressants (SSRIs or TCAs).
Danish: Epidemiologiske studier hovedsageligt udført hos patienter på 50 år og opefter, viser en forøget risiko for knoglebrud hos patienter i behandling med farmakologisk beslægtede antidepressiva (SSRI'er eller TCA'er).
English: No dose adjustment is needed (see section 4.2).
Danish: Dosisjustering er ikke nødvendig (se pkt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies in major depressive disorder with vortioxetine in children and adolescents aged 7 to 18 years (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med vortioxetin hos børn i alderen 7-18 år ved moderate til svære depressive episoder (se pkt.
English: CYP3A4 inhibitors and CYP2C9, and CYP2C19 inhibitors When vortioxetine was co-administered following 6 days of ketoconazole 400 mg/day (a CYP3A4/5 and P-glycoprotein inhibitor) or following 6 days of fluconazole 200 mg/day (a CYP2C9, CYP2C19, and CYP3A4/5 inhibitor) in healthy subjects, a 1.3-fold and 1.5-fold increase, respectively, in vortioxetine AUC was observed.
Danish: CYP3A4-hæmmere, CYP2C9-hæmmere og CYP2C19-hæmmere Når vortioxetin blev tilføjet efter administration af ketoconazol (en CYP3A4/5- og P-glykoproteinhæmmer) 400 mg/dag i 6 dage eller af fluconazol (en CYP2C9-, CYP2C19- og CYP3A4/5-hæmmer) 200 mg/dag i 6 dage til raske forsøgspersoner, observeredes en stigning på henholdsvis faktor 1,3 og 1,5 i AUC for vortioxetin.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Brintellix treatment taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Brintellix seponeres/undgås, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Lundbeck Austria GmbH Tel: +43 1 266 91 08
Danish: Lundbeck AustriaGmbH Tel: +43 1 266 91 08
English: Medicinal products lowering the seizure threshold Antidepressants with serotonergic effect can lower the seizure threshold.
Danish: Antidepressiva med serotonerg virkning kan sænke krampetærsklen.
English: After stopping Brintellix, you must allow 14 days before taking any of these medicines.
Danish: Når du er stoppet med at tage Brintellix, skal der gå 14 dage, før du begynder at tage et af disse lægemidler.
English: - fluoxetine, paroxetine and other medicines to treat depression called SSRI/SNRIs, tricyclics.
Danish: - Fluoxetin, paroxetin og andre midler mod depression af typerne SSRI/SNRI og tricykliske lægemidler.
English: Seizures are a potential risk with antidepressants.
Danish: Antidepressiva indebærer en potentiel risiko for krampeanfald.
English: No inhibitory or inducing effect of vortioxetine was observed in the drug-drug interaction studies for the CYP isozymes CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4/5 (see section 4.5).
Danish: Der blev ikke observeret hæmmende eller inducerende virkning af vortioxetin på CYP-isoenzymerne CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 eller CYP3A4/5 (se pkt.
English: In CYP2D6 ultra-rapid metabolisers, the plasma concentration of vortioxetine 10 mg/day were between those obtained in extensive metabolisers at 5 mg/day and 10 mg/day.
Danish: Hos patienter med ultrahurtig CYP2D6-metabolisme lå plasmakoncentrationen ved vortioxetin 10 mg/dag mellem de plasmakoncentrationer, som blev opnået med henholdsvis 5 mg/dag og 10 mg/dag hos patienter med hurtig CYP2D6-metabolisme.
English: The European Medicines Agency has waived the obligation to submit the results of studies in major depressive disorder with vortioxetine in children aged less than 7 years (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med vortioxetin hos børn under 7 år ved moderate til svære depressive episoder (se pkt.
English: Diarrhoea, Constipation, Vomiting
Danish: Diaré, obstipation, opkastning
English: No effect of food on the pharmacokinetics was observed (see section 4.2).
Danish: Fødeindtagelse påvirkede ikke farmakokinetikken (se pkt.
English: Treatment should be discontinued in any patient who develops seizures or for whom there is an increase in seizure frequency.
Danish: Behandlingen skal seponeres hos patienter, der udvikler krampeanfald, eller som får en øget anfaldsfrekvens.
English: Pack sizes of 56 x 1 and 98 x 1 film-coated tablets.
Danish: Pakninger a 56 x 1 og 98 x 1 filmovertrukne tabletter.
English: Anticoagulants and antiplatelet medicinal products No significant effects, relative to placebo, were observed in INR, prothrombin or plasma R-/S-warfarin values following co-administration of multiple doses of vortioxetine with stable doses of warfarin in healthy subjects.
Danish: Antikoagulantia og trombocythæmmende lægemidler Der sås ingen signifikante påvirkninger sammenholdt med placebo af INR, protrombin eller plasma R-/S-warfarin efter administration af gentagne doser vortioxetin sammen med stabile doser warfarin hos raske forsøgspersoner.
English: Depending on individual patient response, a dose adjustment may be considered (see section 4.2).
Danish: Justering af dosis kan overvejes afhængigt af den enkelte patients respons (se pkt.
English: Concomitant use with nonselective monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (see section 4.5).
Danish: Samtidig anvendelse af ikke-selektive monoaminoxidasehæmmere (MAO-hæmmere) eller selektive MAO-A-hæmmere (se pkt.
English: - St John's wort (hypericum perforatum)(a medicine to treat depression).
Danish: - Perikon (Hypericum perforatum) (et naturlægemiddel mod depression).
English: - have a tendency to bleed or bruise easily.
Danish: - Hvis du let kommer til at bløde eller let får blå mærker.
English: 98 x 1 film-coated tablets.
Danish: 98 x 1 filmovertrukne tabletter.
English: Caution is advised when treating patients ≥ 65 years of age with doses higher than 10 mg vortioxetine once daily for which data are limited (see section 4.4).
Danish: Forsigtighed tilrådes ved behandling af patienter ≥ 65 år med doser over 10 mg vortioxetin en gang dagligt, da der kun foreligger begrænsede data for dette (se pkt.
English: 5 mg corresponding to 5 drops.
Danish: 5 mg svarer til 5 dråber.
English: Pruritus, including pruritus generalised
Danish: Pruritus, herunder generaliseret pruritus Ikke almindelig Natlige svedudbrud Ikke kendt*
English: Each drop contains 4.25 mg of ethanol.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: En dråbe indeholder 4,25 mg ethanol.
English: In one study, vortioxetine was superior to placebo on subjective measures, evaluated using the Perceived Deficits Questionnaire with results of -14.6 for vortioxetine and -10.5 for placebo (p=0.002).
Danish: I et studie var vortioxetin bedre end placebo på subjektive mål vurderet vha. PDQ med resultater på14,6 for vortioxetin og -10,5 for placebo (p=0,002).
English: Following multiple doses of vortioxetine, no inhibitory effect was observed in healthy subjects for the cytochrome P450 isozymes CYP2C19 (omeprazole, diazepam), CYP3A4/5 (ethinyl estradiol, midazolam), CYP2B6 (bupropion), CYP2C9 (tolbutamide, S-warfarin), CYP1A2 (caffeine) or CYP2D6 (dextromethorphan).
Danish: Efter gentagne doser vortioxetin til raske forsøgspersoner sås der ikke hæmmende virkninger på CYPisoenzymerne CYP2C19 (omeprazol, diazepam), CYP3A4/5 (ethinylestradiol, midazolam), CYP2B6 (bupropion), CYP2C9 (tolbutamid, S-warfarin), CYP1A2 (caffein) eller CYP2D6 (dextromethorphan).
English: Co-administration of medicinal products with serotonergic effect (e.g., tramadol, sumatriptan and other triptans) may lead to Serotonin Syndrome (see section 4.4).
Danish: Samtidig behandling med serotonerge lægemidler (f.eks. tramadol, sumatriptan og andre triptaner) kan medføre serotonergt syndrom (se pkt.
English: Medicines that increase the risk of fits: - sumatriptan and similar medicines with active substance names ending in “triptans”.
Danish: Lægemidler, der øger risikoen for krampeanfald: - Sumatriptan og lignende lægemidler, hvor navnet på det aktive stof ender på “triptan”.
English: 10 mg corresponding to 10 drops.
Danish: 10 mg svarer til 10 dråber.
English: Concomitant use of antidepressants with serotonergic effect and herbal remedies containing St. John's wort (Hypericum perforatum) may result in a higher incidence of adverse reactions including Serotonin Syndrome (see section 4.4).
Danish: Samtidig brug af antidepressiva med serotonerg virkning og naturlægemidler, der indeholder perikon (Hypericum perforatum), kan medføre en øget forekomst af bivirkninger inklusive serotonergt syndrom (se pkt.
English: Vortioxetine did not separate from placebo on subjective measures when evaluated using the Cognitive and Physical Functioning Questionnaire with results of -8.1 for vortioxetine versus -6.9 for placebo (p=0.086).
Danish: Vortioxetin adskilte sig ikke fra placebo på subjektive mål vurderet vha. CPFQ med et resultat på -8,1 for vortioxetin og -6,9 for placebo (p=0,086).
English: Vortioxetine has not been studied in patients with severe hepatic impairment and caution should be exercised when treating these patients (see section 5.2).
Danish: Vortioxetin er ikke undersøgt hos patienter med svært nedsat leverfunktion, og forsigtighed tilrådes ved behandling af disse patienter (se pkt.
English: Reversible, selective MAO-A inhibitor (moclobemide) The combination of vortioxetine with a reversible and selective MAO-A inhibitor, such as moclobemide, is contraindicated (see section 4.3).
Danish: Reversibel, selektiv MAO-A-hæmmer (moclobemid) Kombination af vortioxetin med en reversibel og selektiv MAO-A-hæmmer som moclobemid er kontraindiceret (se pkt.
English: Vortioxetine was superior (p=0.004) to placebo on the primary outcome measure, the time to relapse of MDD, with a hazard ratio of 2.0; that is, the risk of relapse was two times higher in the placebo group than in the vortioxetine group.
Danish: Vortioxetin var bedre (p=0,004) end placebo, hvad angår det primære effektmål, tid til recidiv af moderat til svære depressiv episode, med en hazard ratio på 2,0.
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.