natgillin/translations-raw huggingface dataset:
- Hvis du har en alvorlig leversygdom eller leversygdommen cirrose.
- have a severe kidney disease.. - have a severe liver disease or a liver disease called cirrhosis.
En dråbe indeholder 1 mg vortioxetine (som D,L-lactat)
Each drop contains 1 mg vortioxetine (as (D,L)- lactate)
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.
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.
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).
Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of antidepressants with serotonergic effect (SSRIs, SNRIs).
Elektrokonvulsiv terapi (ECT) Der er ingen klinisk erfaring med ECT og samtidig administration af vortioxetin.
There is no clinical experience with concurrent administration of vortioxetine and ECT, therefore caution is advisable.
14 filmovertrukne tabletter 28 filmovertrukne tabletter 98 filmovertrukne tabletter 56x1 filmovertrukne tabletter 98x1 filmovertrukne tabletter 100 filmovertrukne tabletter 200 filmovertrukne tabletter
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
- Chlorpromazin, chlorprothixen, haloperidol (lægemidler mod psykiske forstyrrelser, som hører til gruppen kaldet phenothiaziner, thioxanthener og butyrophenoner).
- chlorpromazine, chlorprothixene, haloperidol (medicines to treat mental disorders belonging to the group called phenothiazines, thioxanthenes, butyrophenones).
Serotonergt syndrom
Dizziness Not known * Serotonin Syndrome
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
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
- Chlorpromazin, chlorprothixen, haloperidon (lægemidler mod psykiske forstyrrelser, som hører til gruppen kaldet phenothiaziner, thioxanthener og butyrophenoner).
- chlorpromazine, chlorprothixene, haloperidol (medicines to treat mental disorders belonging to the group called phenothiazines, thioxanthenes,butyrophenones).
- Øvrige indholdsstoffer: mannitol (E421), mikrokrystallinsk cellulose, hydroxypropylcellulose, natriumstivelsesglycolat (type A), magnesiumstearat, hypromellose, macrogol 400, titandioxid (E171), rød jernoxid (E172).
- 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).
Hos raske forsøgspersoner observeredes ingen virkning af gentagne doser acetylsalicylsyre 150 mg/dag på farmakokinetikken efter gentagne doser vortioxetin.
No effect of multiple doses of acetylsalicylic acid 150 mg/day on the multiple-dose pharmacokinetics of vortioxetine was observed in healthy subjects.
- Øvrige indholdsstoffer: mannitol (E421), mikrokrystallinsk cellulose, hydroxypropylcellulose, natriumstivelsesglycolat (type A), magnesiumstearat, hypromellose, macrogol 400, titandioxid (E171), gul jernoxid (E172).
- 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).
HYPPIGHED BIVIRKNINGER
FREQUENCY ADVERSE REACTION
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
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
- Øvrige indholdsstoffer: mannitol (E421), mikrokrystallinsk cellulose, hydroxypropylcellulose, natriumstivelsesglycolat (type A), magnesiumstearat, hypromellose, macrogol 400, titandioxid (E171), gul jernoxid (E172), rød jernoxid (E172).
- 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)
Brintellix 20 mg/ml orale dråber, opløsning vortioxetine
Brintellix 20 mg/ml oral drops, solution vortioxetine
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
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,
I pakningerne med 56 x 1, 98 x 1 og 490 stk. er de filmovertrukne tabletter pakket i enkeltstyksblistre.
The pack sizes of 56 x 1, 98 x 1 and 490 film-coated tablets are presented in unit dose blister.
Det skal du vide, før du begynder at tage Brintellix Sådan skal du tage Brintellix Bivirkninger
What Brintellix is and what it is used for What you need to know before you take Brintellix How to take Brintellix
Er du i tvivl, så spørg lægen.
Ask your doctor if you are uncertain.
En dråbe opløsning indeholder 1 mg vortioxetin (som D,L-lactat).
Each drop of solution contains 1 mg vortioxetine (as (D,L)
Lægemidler, der øger risikoen for kramper: - Sumatriptan og lignende lægemidler, hvor navnet på det aktive stof ender på “triptan”.
Medicines that increase the risk of fits: - sumatriptan and similar medicines with active substance names ending in “triptans” - tramadol (a strong painkiller).
Brintellix 20 mg filmovertrukne tabletter EU/1/13/891/027-035
Brintellix 20 mg film-coated tablets EU/1/13/891/027-035
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.
However, as adverse reactions such as diziness have been reported, caution is advised during such activities when beginning Brintellix treatment or changing the dose.
Erfaringen efter markedsføringen vedrører hovedsageligt overdosering på op til 80 mg. I størstedelen af tilfældene blev ingen symptomer eller milde symptomer rapporteret.
In the majority of cases, no symptoms or mild symptoms were reported.
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.
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.
Forsigtighed tilrådes derfor ved behandling af patienter ≥ 65 år med doser over 10 mg vortioxetin en gang dagligt (se pkt.
However, caution should be exercised when prescribing to elderly patients at doses higher than 10 mg vortioxetine once daily (see section
Brintellix 15 mg filmovertrukne tabletter EU/1/13/891/018-026
Brintellix 15 mg film-coated tablets EU/1/13/891/018-026
Titandioxid (E171) Jernoxid, rød (E172) Jernoxid, gul (E172)
Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172)
Ikke almindelig Flushing Ikke kendt*
Not known * Anaphylactic reaction
Brintellix 5 mg filmovertrukne tabletter EU/1/13/891/001-007
Brintellix 5 mg film-coated tablets EU/1/13/891/001-007
4.2), og der skal udvises forsigtighed ved ordination af doser over 10 mg vortioxetin en gang dagligt til ældre patienter (se pkt.
However, caution should be exercised when prescribing to elderly patients at doses higher than 10 mg vortioxetine once daily (see section 4.4).
Vedrørende bivirkninger, se pkt.
For information on undesirable effects, see section 4.8.
Brintellix 10 mg filmovertrukne tabletter EU/1/13/891/008-017
Brintellix 10 mg film-coated tablets EU/1/13/891/008-017
Flerstykspakning med 490 (5 x (98x1)) filmovertrukne tabletter.
Multipack containing 490 (5 x (98x1)) film-coated tablets.
Lægemidler mod depression er forbundet med en risiko for at få kramper.
Fits are a potential risk with medicines used to treat depression.
Brintellix 5 mg filmovertrukne tabletter Blister: Transparent PVC/PVdC/Al-blister Pakninger a 14, 28 og 98 filmovertrukne tabletter.
Brintellix 15 mg film-coated tablets Blister: Transparent; PVC/PVdC/aluminium blister.
Brintellix 20 mg filmovertrukne tabletter
Brintellix 20 mg film-coated tablets
Behandlingen bør afbrydes hos patienter, der oplever kramper eller får kramper hyppigere end normalt.
Treatment should be discontinued in any patient who develops fits or where there is an increase in the frequency of fits.
Afhængigt af den enkelte patients respons kan det overvejes at justere dosis af vortioxetin, hvis en bred CYP-induktor (f.eks. rifampicin, carbamazepin, phenytoin) føjes til behandling med vortioxetin (se pkt.
Depending on individual patient response, a dose adjustment of vortioxetine may be considered if a broad cytochrome P450 inducer (e.g., rifampicin, carbamazepine, phenytoin) is added to vortioxetine treatment (see section 4.5).
Efter co-administration af en enkeltdosis af vortioxetin på 20 mg eller 40 mg og en enkeltdosis ethanol (0,6 g/kg) til raske forsøgspersoner observeredes ingen påvirkning af hverken vortioxetins eller ethanols farmakokinetik eller signifikant nedsættelse af kognitiv funktion sammenholdt med placebo.
No effect on the pharmacokinetics of vortioxetine or ethanol and no significant impairment, relative to placebo, in cognitive function were observed when vortioxetine in a single dose of 20 mg or 40 mg was co-administered with a single dose of ethanol (0.6 g/kg) in healthy subjects.
Flerstykspakning: 490 (5 pakninger a 98 x 1) filmovertrukne tabletter.
Multipack: 490 (5 packs of 98 x 1) film-coated tablets.
Ved doser på 5-15 mg sås ingen afvigelser fra placebo, hvorimod en dosis på 20 mg vortioxetin var forbundet med en højere frekvens af seksuel dysfunktion (TESD) (se pkt.
However, the 20 mg dose of vortioxetine was associated with an increase in sexual dysfunction (TESD)(see section 5.1) .
Brintellix 20 mg filmovertrukne tabletter Blister: Transparent PVC/PVdC/Al-blister Pakninger a 14, 28, 56 og 98 filmovertrukne tabletter.
Brintellix 20 mg film-coated tablets Blister: Transparent; PVC/PVdC/aluminium blister.
Brintellix 10 mg filmovertrukne tabletter
Brintellix 10 mg film-coated tablets
Brintellix 15 mg filmovertrukne tabletter
Brintellix 15 mg film-coated tablets
En filmovertrukket tablet indeholder vortioxetinhydrobromid svarende til 20 mg vortioxetin (vortioxetine).
Each film-coated tablet contains vortioxetine hydrobromide equivalent to 20 mg vortioxetine.
Brintellix 5 mg filmovertrukne tabletter
Brintellix 5 mg film-coated tablets
Brintellix 10 mg filmovertrukne tabletter vortioxetine
Brintellix 10 mg film-coated tablets vortioxetine
Indlægsseddel: Information til patienten Brintellix 20 mg filmovertrukne tabletter
Package leaflet: Information for the patient Brintellix 20 mg film-coated tablets vortioxetine
Brintellix 20 mg filmovertrukne tabletter vortioxetine
Brintellix 20 mg film-coated tablets vortioxetine
Vortioxetin (vortioxetine)
ECT (electroconvulsive therapy)
En filmovertrukket tablet indeholder 20 mg vortioxetine (som hydrobromid).
Each film-coated tablet contains 20 mg vortioxetine (as hydrobromide).
En filmovertrukket tablet indeholder vortioxetinhydrobromid svarende til 10 mg vortioxetin (vortioxetine).
Each film-coated tablet contains vortioxetine hydrobromide equivalent to 10 mg vortioxetine.
15 mg/dag administrationen adskilte sig ikke fra placebo i metaanalysen, men gennemsnitsforskellen fra placebo var -2,6 point.
Doses of 5 to 15 mg showed no difference to placebo.
Brintellix 15 mg filmovertrukne tabletter vortioxetine
Brintellix 15 mg film-coated tablets vortioxetine
Indlægsseddel: Information til patienten Brintellix 10 mg filmovertrukne tabletter
Package leaflet: Information for the patient Brintellix 10 mg film-coated tablets vortioxetine
Afhængigt af den enkelte patients respons kan det overvejes at give en lavere dosis vortioxetin ved tilføjelse af potente CYP2D6-hæmmere (f.eks. bupropion, quinidin, fluoxetin, paroxetin) til behandling med vortioxetin (se pkt.
Depending on individual patient response, a lower dose of vortioxetine may be considered if strong CYP2D6 inhibitor (e.g., bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment (see section 4.2).
En filmovertrukket tablet indeholder vortioxetinhydrobromid svarende til 15 mg vortioxetin (vortioxetine).
Each film-coated tablet contains vortioxetine hydrobromide equivalent to 15 mg vortioxetine.
En filmovertrukket tablet indeholder vortioxetinhydrobromid svarende til 5 mg vortioxetin (vortioxetine).
Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5 mg vortioxetine.
Indlægsseddel: Information til patienten Brintellix 15 mg filmovertrukne tabletter
Package leaflet: Information for the patient Brintellix 15 mg film-coated tablets vortioxetine
Brintellix filmovertrukne tabletter 20 mg fås i blisterpakninger med 14, 28, 56, 56x1, 98, 98x1, 126 (9x14), 490 (5x(98x1)) tabletter samt i beholdere med 100, 200 tabletter.
Brintellix film-coated tablets 20 mg are available in blister packs of 14, 28, 56, 56x1, 98, 98x1, 126 (9x14), 490 (5x(98x1)) tablets and in tablet containers of 100, 200 tablets.
Indlægsseddel: Information til patienten Brintellix 5 mg filmovertrukne tabletter
Package leaflet: Information for the patient Brintellix 5 mg film-coated tablets vortioxetine
Orange, mandelformet (5 x 8,4 mm) filmovertrukket tablet præget med “TL” på den ene side og “15” på den anden side.
Orange, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “15” on the other side.
Rød, mandelformet (5 x 8,4 mm) filmovertrukket tablet præget med “TL” på den ene side og “20” på den anden side.
Red, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “20” on the other side.
Brintellix filmovertrukne tabletter 10 mg fås i blisterpakninger med 7, 14, 28, 56, 56 x 1, 98, 98 x 1 eller 126 (9x14), 490 (5 x (98x1)) tabletter samt i beholdere med 100 eller 200 tabletter.
Brintellix film-coated tablets 10 mg are available in blister packs of 7, 14, 28, 56, 56 x 1, 98, 98 x 1, 126 (9x14), 490 (5 x (98x1)) tablets and in tablet containers of 100 and 200 tablets.
Brintellix 5 mg filmovertrukne tabletter vortioxetine
Brintellix 5 mg film-coated tablets Vortioxetine
Rød, mandelformet 5 x 8,4 mm filmovertrukket tablet (tablet) præget med “TL” på den ene side og “20” på den anden side.
Red, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “20” on the other side.
Orange, mandelformet 5 x 8,4 mm filmovertrukket tablet (tablet) præget med “TL” på den ene side og “15” på den anden side.
Orange, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “15” on the other side.
EU/1/13/891/01814 filmovertrukne tabletter EU/1/13/891/019 28 filmovertrukne tabletter EU/1/13/891/020 56 filmovertrukne tabletter EU/1/13/891/021 98 filmovertrukne tabletter EU/1/13/891/022 56 x 1 filmovertrukne tabletter EU/1/13/891/023 98 x 1 filmovertrukne tabletter EU/1/13/891/025 100 filmovertrukne tabletter EU/1/13/891/026 200 filmovertrukne tabletter
EU/1/13/891/018 14 film-coated tablets EU/1/13/891/019 28 film-coated tablets EU/1/13/891/020 56 film-coated tablets EU/1/13/891/021 98 film-coated tablets EU/1/13/891/022 56x1 film-coated tablets EU/1/13/891/023 98x1 film-coated tablets EU/1/13/891/025 100 film-coated tablets EU/1/13/891/026 200 film-coated tablets
En filmovertrukket tablet indeholder 10 mg vortioxetine (som hydrobromid).
Each film-coated tablet contains 10 mg vortioxetine (as hydrobromide).
EU/1/13/891/001 14 filmovertrukne tabletter EU/1/13/891/002 28 filmovertrukne tabletter EU/1/13/891/003 56 x 1 filmovertrukne tabletter EU/1/13/891/004 98 x 1 filmovertrukne tabletter EU/1/13/891/006 100 filmovertrukne tabletter EU/1/13/891/007 200 filmovertrukne tabletter EU/1/13/891/037 98 filmovertrukne tabletter
EU/1/13/891/001 14 film-coated tablets EU/1/13/891/002 28 film-coated tablets EU/1/13/891/003 56 x 1 film-coated tablets EU/1/13/891/004 98 x 1 film-coated tablets EU/1/13/891/006 100 film-coated tablets EU/1/13/891/007 200 film-coated tablets EU/1/13/891/037 98 film-coated tablets
Brintellix filmovertrukne tabletter 15 mg fås i blisterpakninger med 14, 28, 56, 56 x 1, 98, 98 x 1 eller 490 (5 x (98x1)) tabletter samt i beholdere med 100 eller 200 tabletter.
Brintellix film-coated tablets 15 mg are available in blister packs of 14, 28, 56, 56 x 1, 98, 98 x 1, 490 (5 x (98x1)) tablets and in tablet containers of 100 and 200 tablets.
Gul, mandelformet 5 x 8,4 mm filmovertrukket tablet (tablet) præget med “TL” på den ene side og “10” på den anden side.
Yellow, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “10” on the other side.
Indgivelsesmåde
AUTHORISATION
Patienterne bør kontrolleres for symptomer på serotonergt syndrom og malignt neuroleptikasyndrom (se pkt.
Patients should be monitored for the emergence of signs and symptoms of SS or NMS (see sections 4.3 and 4.5).
Brintellix filmovertrukne tabletter 5 mg fås i blisterpakninger med 14, 28, 98, 56x1, 98x1, 126 (9x14), 490 (5x (98x1)) tabletter samt i beholdere med 100 eller 200 tabletter.
Brintellix film-coated tablets 5 mg are available in blister packs of 14, 28, 98, 56x1, 98x1, 126 (9x14) 490 (5x(98x1)) tablets and in tablet containers of 100 and 200 tablets.
CYP-induktorer
Gastrointestinal disorders
EU/1/13/891/02714 filmovertrukne tabletter EU/1/13/891/028 28 filmovertrukne tabletter EU/1/13/891/029 56 filmovertrukne tabletter EU/1/13/891/030 98 filmovertrukne tabletter EU/1/13/891/031 56 x 1 filmovertrukne tabletter EU/1/13/891/032 98 x 1 filmovertrukne tabletter EU/1/13/891/034 100 filmovertrukne tabletter EU/1/13/891/035 200 filmovertrukne tabletter
EU/1/13/891/027 14 film-coated tablets EU/1/13/891/028 28 film-coated tablets EU/1/13/891/029 56 film-coated tablets EU/1/13/891/030 98 film-coated tablets EU/1/13/891/031 56x1 film-coated tablets EU/1/13/891/032 98x1 film-coated tablets EU/1/13/891/034 100 film-coated tablets EU/1/13/891/035 200 film-coated tablets
EU/1/13/891/038 126 filmovertrukne tabletter (9 pakninger a 14) EU/1/13/891/005 490 filmovertrukne tabletter (5 pakninger a 98 x 1)
EU/1/13/891/038 126 film-coated tablets (9 packs of 14) EU/1/13/891/005 490 film-coated tablets (5 packs of 98x1)
Flerstykspakning: 490 (5 pakninger a 98 x1) filmovertrukne tabletter.
Multipack: 490 (5 packs of 98x1) film-coated tablets.
Lyserød, mandelformet (5 x 8,4 mm) filmovertrukket tablet præget med “TL” på den ene side og “5” på den anden side.
Pink, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “5” on the other side.
Brintellix 10 mg filmovertrukne tabletter Blister: Transparent PVC/PVdC/Al-blister Pakninger a 7, 14, 28, 56 og 98 filmovertrukne tabletter.
Brintellix 10 mg film-coated tablets Blister: Transparent; PVC/PVdC/aluminium blister.
Du må ikke tage Brintellix, hvis du ammer.
Brintellix is not to be used during breast-feeding.
EU/1/13/891/0087 filmovertrukne tabletter EU/1/13/891/009 14 filmovertrukne tabletter EU/1/13/891/010 28 filmovertrukne tabletter EU/1/13/891/011 56 filmovertrukne tabletter EU/1/13/891/012 98 filmovertrukne tabletter EU/1/13/891/013 56 x 1 filmovertrukne tabletter EU/1/13/891/014 98 x 1 filmovertrukne tabletter EU/1/13/891/016 100 filmovertrukne tabletter EU/1/13/891/017 200 filmovertrukne tabletter
EU/1/13/891/008 7 film-coated tablets EU/1/13/891/009 14 film-coated EU/1/13/891/010 28 film-coated tablets EU/1/13/891/011 56 film-coated tablets EU/1/13/891/012 98 film-coated tablets EU/1/13/891/013 56x1 film-coated tablets EU/1/13/891/014 98x1 film-coated tablets EU/1/13/891/016 100 film-coated tablets EU/1/13/891/017 200 film-coated tablets
Lyserød, mandelformet 5 x 8,4 mm filmovertrukket tablet (tablet) præget med “TL” på den ene side og “5” på den anden side.
Pink, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “5” on the other side.
Gul, mandelformet (5 x 8,4 mm) filmovertrukket tablet præget med “TL” på den ene side og “10” på den anden side.
Yellow, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “10” on the other side.
En filmovertrukket tablet indeholder 5 mg vortioxetine (som hydrobromid).
Each film-coated tablet contains 5 mg vortioxetine (as hydrobromide).
En filmovertrukket tablet indeholder 15 mg vortioxetine (som hydrobromid).
Each film-coated tablet contains 15 mg vortioxetine (as hydrobromide).
EU/1/13/891/040126 filmovertrukne tabletter (9 pakninger a 14) EU/1/13/891/033 490 filmovertrukne tabletter (5 pakninger a 98 x 1)
EU/1/13/891/040 126 film-coated tablets (9 packs of 14) EU/1/13/891/033 490 film-coated tablets (5 packs of 98x1)
EU/1/13/891/039126 filmovertrukne tabletter (9 pakninger a 14) EU/1/13/891/015 490 filmovertrukne tabletter (5 pakninger a 98 x 1)
EU/1/13/891/039 126 film-coated tablets (9 packs of 14) EU/1/13/891/015 490 film-coated tablets (5 packs of 98x1)
Hvis du har taget for meget Brintellix
If you take more Brintellix than you should
Afhængigt af den enkelte patients respons kan det overvejes at give en lavere dosis vortioxetin ved samtidig behandling med potente CYP2D6-hæmmere (f.eks. bupropion, quinidin, fluoxetin, paroxetin) (se pkt.
Depending on individual patient response, a lower dose of vortioxetine may be considered if a strong CYP2D6 inhibitor (e.g., bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment (see section 4.2).
Det var hensigten, at det skulle leveres som tabletter (100 mg og 400 mg).
It was to be available as tablets (100 mg and 400 mg).
Hvad er Ruvise?
What is Ruvise?
Ansøgeren fremlagde data fra én hovedundersøgelse, hvori der deltog 202 patienter med PAH.
The applicant presented data from one main study involving 202 patients with PAH.
Udvalget var betænkeligt ved, at den gavnlige virkning af imatinib ved PAH ikke var tilstrækkeligt bevist.
The Committee was concerned that a beneficial effect of imatinib in PAH had not been sufficiently demonstrated.
Hvis du deltager i en klinisk undersøgelse med Ruvise og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Det forventedes anvendt hos patienter, der fortsat har symptomer, selv om de er i behandling med mindst to særlige lægemidler mod PAH.
It was expected to be used in patients who still have symptoms despite being treated with at least two medicines specific for PAH.