FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Kombinacija vortioksetina z reverzibilnim in selektivnim zaviralcem MAO, kakršen je moklobemid, je kontraindicirana (glejte poglavje 4.3).
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 (see section 4.2).
Slovenian: Pri bolnikih, starih ≥ 65, je kot začetni odmerek vedno treba uporabiti najnižji učinkovit odmerek vortioksetina, ki je 5 mg enkrat na dan (glejte poglavje 4.2).
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).
Slovenian: - Druge sestavine zdravila so manitol (E421), mikrokristalna celuloza, hidroksipropilceluloza, natrijev karboksimetilškrob (vrsta A), magnezijev stearat, hipromeloza, makrogol 400, titanov dioksid (E171), rumeni železov oksid (E172).
English: Blister: Transparent; PVC/PVdC/aluminium blister.
Slovenian: Pretisni omot: prozorni; PVC/PVdC/aluminijski pretisni omot.
English: - chlorpromazine, chlorprothixene, haloperidol (medicines to treat mental disorders belonging to the groups called phenothiazines, thioxanthenes, butyrophenones).
Slovenian: - klorpromazin, klorprotiksen, haloperidol (zdravila za zdravljenje duševnih motenj in pripadajo skupinam imenovanim fenotiazini, tioksanteni, butirofenoni).
English: - chlorpromazine, chlorprothixene, haloperidol (medicines to treat mental disorders belonging to the group called phenothiazines, thioxanthenes, butyrophenones).
Slovenian: - klorpromazin, klorprotiksen, haloperidol (zdravila za zdravljenje duševnih motenj in pripadajo skupinam, imenovanim fenotiazini, tioksanteni, butirofenoni).
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
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 56 filmsko obloženih tablet 98 filmsko obloženih tablet 56 x 1 filmsko obložena tableta 98 x 1 filmsko obložena tableta 100 filmsko obloženih tablet 200 filmsko obloženih tablet
English: Dizziness Not known * Serotonin Syndrome
Slovenian: Serotoninski sindrom
English: - taking medicines with a so-called serotonergic effect, such as: - tramadol (a strong pain killer).
Slovenian: Pred začetkom jemanja zdravila Brintellix se posvetujte z zdravnikom, če: - jemljete zdravila s tako imenovanim serotonergičnim učinkom, kot so: - tramadol (močno sredstvo za lajšanje bolečin).
English: Brintellix 15 mg film-coated tablets Blister: Transparent; PVC/PVdC/aluminium blister.
Slovenian: Brintellix 15 mg filmsko obložene tablete Pretisni omot: prozorni; PVC/PVdC/aluminijski pretisni omot.
English: Brintellix 20 mg film-coated tablets Blister: Transparent; PVC/PVdC/aluminium blister.
Slovenian: Brintellix 20 mg filmsko obložene tablete Pretisni omot: prozorni; PVC/PVdC/aluminijski pretisni omot.
English: Brintellix 20 mg film-coated tablets EU/1/13/891/027-035
Slovenian: Brintellix 20 mg filmsko obložene tablete EU/1/13/891/027-035
English: Brintellix 20 mg tablet vortioxetine
Slovenian: Brintellix 20 mg tableta vortioxetinum
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
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 98 filmsko obloženih tablet 56 x 1 filmsko obložena tableta 98 x 1 filmsko obložena tableta 100 filmsko obloženih tablet 200 filmsko obloženih tablet
English: Brintellix 15 mg film-coated tablets EU/1/13/891/018-026
Slovenian: Brintellix 15 mg filmsko obložene tablete EU/1/13/891/018-026
English: Brintellix 10 mg film-coated tablets Blister: Transparent; PVC/PVdC/aluminium blister.
Slovenian: Brintellix 10 mg filmsko obložene tablete Pretisni omot: prozorni; PVC/PVdC/aluminijski pretisni omot.
English: Ask your doctor if you are uncertain.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom.
English: Brintellix 20 mg film-coated tablets
Slovenian: Brintellix 20 mg filmsko obložene tablete
English: Close monitoring for Serotonin Syndrome is necessary if used concomitantly (see section 4.4).
Slovenian: Pri sočasni uporabi je potrebno skrbno spremljanje bolnika zaradi tveganja za pojav serotoninskega sindroma (glejte poglavje 4.4).
English: Brintellix 5 mg film-coated tablets EU/1/13/891/001-007
Slovenian: Brintellix 5 mg filmsko obložene tablete EU/1/13/891/001-007
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172)
Slovenian: Obloga tablete hipromeloza makrogol 400 titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172)
English: Contact your doctor immediately if your newborn baby has any of these symptoms.
Slovenian: Če se pri novorojenčku pojavi kateri od teh simptomov, takoj obiščite zdravnika.
English: Brintellix 10 mg tablet vortioxetine
Slovenian: Brintellix 10 mg tableta vortioxetinum
English: Brintellix 15 mg tablet vortioxetine
Slovenian: Brintellix 15 mg tableta vortioxetinum
English: 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).
Slovenian: Glede na odziv posameznega bolnika je potrebno razmisliti o prilagoditvi odmerka vortioksetina, če je k zdravljenju z vortioksetinom dodan širok induktor citokroma P450 (npr. rifampicin, karbamazepin, fenitoin) (glejte poglavje 4.5).
English: However, caution should be exercised when prescribing to elderly patients at doses higher than 10 mg vortioxetine once daily (see section 4.4).
Slovenian: Pri odmerkih, višjih od 10 mg vortioksetina enkrat na dan, pa je pri predpisovanju zdravila starejšim bolnikom potrebna previdnost (glejte poglavje 4.4).
English: Brintellix 20 mg/ml oral drops, solution vortioxetine
Slovenian: Brintellix 20 mg/ml peroralne kapljice, raztopina vortioxetinum
English: Brintellix 10 mg film-coated tablets EU/1/13/891/008-017
Slovenian: Brintellix 10 mg filmsko obložene tablete EU/1/13/891/008-017
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.
Slovenian: Prav tako pri sočasni uporabi acetilsalicilne kisline v odmerku 150 mg/dan z večkratnimi odmerki vortioksetina pri zdravih osebah niso opazili, v primerjavi s placebom, pomembnega inhibicijskega učinka na agregacijo trombocitov ali farmakokinetiko acetilsalicilne kisline ali salicilne kisline.
English: 14 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 14 filmsko obložena tableta
English: Depending on individual patient response, a dose adjustment may be considered if a broad cytochrome P450 inducer (e.g., rifampicin, carbamazepine, phenytoin) is added to vortioxetine treatment (see section 4.2).
Slovenian: Glede na odziv posameznega bolnika je potrebno razmisliti o prilagoditvi odmerka, če je k zdravljenju z vortioksetinom dodan širok induktor citokroma P450 (npr. rifampicin, karbamazepin, fenitoin) (glejte poglavje 4.2).
English: The recommended dose of Brintellix is 10 mg vortioxetine taken as one daily dose in adults less than 65 years of age.
Slovenian: Pri odraslih, starih manj kot 65 let, je priporočeni odmerek zdravila Brintellix 10 mg vortioksetina v enkratnem dnevnem odmerku.
English: No significant impairment, relative to placebo, in cognitive function was observed for vortioxetine following co-administration with a single 10 mg dose of diazepam.
Slovenian: Po sočasni uporabi vortioksetina in enkratnega 10 mg odmerka diazepama niso opazili pomembnega poslabšanja kognitivne funkcije v primerjavi s placebom.
English: Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes.
Slovenian: Med zdravljenjem, še posebej po uvedbi zdravljenja in pri vsaki spremembi odmerka, je treba bolnike skrbno nadzirati.
English: Brintellix 10 mg film-coated tablets
Slovenian: Brintellix 10 mg filmsko obložene tablete
English: Brintellix 15 mg film-coated tablets
Slovenian: Brintellix 15 mg filmsko obložene tablete
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Slovenian: Obloga tablete hipromeloza makrogol 400 titanov dioksid (E171) rumeni železov oksid (E172)
English: Each film-coated tablet contains 20 mg vortioxetine (as hydrobromide).
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg vortioksetina (v obliki bromida).
English: Brintellix 5 mg film-coated tablets
Slovenian: Brintellix 5 mg filmsko obložene tablete
English: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 20 mg vortioxetine.
Slovenian: Ena filmsko obložena tableta vsebuje vortioksetinijev bromid v količini, ki ustreza 20 mg vortioksetina (vortioxetinum).
English: How to store Brintellix
Slovenian: Shranjevanje zdravila Brintellix
English: Titanium dioxide (E171) Iron oxide red (E172)
Slovenian: Obloga tablete hipromeloza makrogol 400 titanov dioksid (E171) rdeči železov oksid (E172)
English: Brintellix 10 mg film-coated tablets vortioxetine
Slovenian: Brintellix 10 mg filmsko obložene tablete vortioxetinum
English: 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).
Slovenian: Glede na odziv posameznega bolnika je potrebno razmisliti o nižjem odmerku vortioksetina, če je k zdravljenju z vortioksetinom dodan močan inhibitor CYP2D6 (npr. bupropion, kinidin, fluoksetin, paroksetin) (glejte poglavje 4.2).
English: EU/1/13/891/024 490 film-coated tablets (5 packs of 98x1)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/891/024 490 filmsko obloženih tablet (5 pakiranj po 98 x 1)
English: 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 4.5).
Slovenian: Glede na odziv posameznega bolnika je potrebno razmisliti o nižjem odmerku vortioksetina, če je k zdravljenju z vortioksetinom dodan močan inhibitor CYP2D6 (npr. bupropion, kinidin, fluoksetin, paroksetin) (glejte poglavje 4.5).
English: Brintellix 20 mg film-coated tablets vortioxetine
Slovenian: Brintellix 20 mg filmsko obložene tablete vortioxetinum
English: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 10 mg vortioxetine.
Slovenian: Ena filmsko obložena tableta vsebuje vortioksetinijev bromid v količini, ki ustreza 10 mg vortioksetina (vortioxetinum).
English: The starting and recommended dose of Brintellix is 10 mg vortioxetine once daily in adults less than 65 years of age.
Slovenian: Pri odraslih bolnikih, mlajših od 65 let, je začetni in priporočeni odmerek zdravila Brintellix 10 mg vortioksetina enkrat na dan.
English: Brintellix 15 mg film-coated tablets vortioxetine
Slovenian: Brintellix 15 mg filmsko obložene tablete vortioxetinum
English: Each film-coated tablet contains 10 mg vortioxetine (as hydrobromide).
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg vortioksetina (v obliki bromida).
English: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 15 mg vortioxetine.
Slovenian: Ena filmsko obložena tableta vsebuje vortioksetinijev bromid v količini, ki ustreza 15 mg vortioksetina (vortioxetinum).
English: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5 mg vortioxetine.
Slovenian: Ena filmsko obložena tableta vsebuje vortioksetinijev bromid v količini, ki ustreza 5 mg vortioksetina (vortioxetinum).
English: Brintellix 5 mg film-coated tablets Vortioxetine
Slovenian: Brintellix 5 mg filmsko obložene tablete vortioxetinum
English: 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.
Slovenian: Zdravilo Brintellix filmsko obložene tablete 10 mg so na voljo v pretisnih omotih s 7, 14, 28, 56, 56 x 1, 98, 98 x 1, 126 (9x14), 490 (5 x (98x1)) tabletami in v vsebniku po 100 in 200 tablet.
English: Each film-coated tablet contains 15 mg vortioxetine (as hydrobromide).
Slovenian: Ena filmsko obložena tableta vsebuje 15 mg vortioksetina (v obliki bromida).
English: Each film-coated tablet contains 5 mg vortioxetine (as hydrobromide).
Slovenian: Ena filmsko obložena tableta vsebuje 5 mg vortioksetina (v obliki bromida).
English: CARTON AND LABEL FOR THE TABLET CONTAINER NAME OF THE MEDICINAL PRODUCT
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA IN NALEPKA ZA VSEBNIK ZA TABLETE
English: 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
Slovenian: EU/1/13/891/018 14 filmsko obloženih tablet EU/1/13/891/019 28 filmsko obloženih tablet EU/1/13/891/020 56 filmsko obloženih tablet EU/1/13/891/021 98 filmsko obloženih tablet EU/1/13/891/022 56 x 1 filmsko obložena tableta EU/1/13/891/023 98 x 1 filmsko obložena tableta EU/1/13/891/025 100 filmsko obloženih tablet EU/1/13/891/026 200 filmsko obloženih tablet
English: 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
Slovenian: EU/1/13/891/001 14 filmsko obloženih tablet EU/1/13/891/002 28 filmsko obloženih tablet EU/1/13/891/003 56 x 1 filmsko obložena tableta EU/1/13/891/004 98 x 1 filmsko obložena tableta EU/1/13/891/006 100 filmsko obloženih tablet EU/1/13/891/007 200 filmsko obloženih tablet EU/1/13/891/037 98 filmsko obloženih tablet
English: Brintellix 20 mg/ml oral drops, solution
Slovenian: IME ZDRAVILA Brintellix 20 mg/ml peroralne kapljice, raztopina
English: 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.
Slovenian: Zdravilo Brintellix filmsko obložene tablete 20 mg so na voljo v pretisnih omotih s 14, 28, 56, 56x1, 98, 98x1, 126 (9x14), 490 (5 x (98 x 1)) tabletami in v vsebniku po 100 in 200 tablet.
English: 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.
Slovenian: Zdravilo Brintellix filmsko obložene tablete 15 mg so na voljo v pretisnih omotih s 14, 28, 56, 56 x1, 98, 98 x 1, 490 (5 x (98x1)) tabletami in v vsebniku po 100 in 200 tablet.
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)
Slovenian: natrijev karboksimetilškrob (vrsta A), magnezijev stearat, hipromeloza, makrogol 400, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172).
English: Nervous system disorders
Slovenian: triciklični antidepresivi.
English: 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
Slovenian: EU/1/13/891/008 7 filmsko obloženih tablet EU/1/13/891/009 14 filmsko obloženih tablet EU/1/13/891/010 28 filmsko obloženih tablet EU/1/13/891/011 56 filmsko obloženih tablet EU/1/13/891/012 98 filmsko obloženih tablet EU/1/13/891/013 56 x 1 filmsko obložena tableta EU/1/13/891/014 98 x 1 filmsko obložena tableta EU/1/13/891/016 100 filmsko obloženih tablet EU/1/13/891/017 200 filmsko obloženih tablet
English: Very common Nausea Common
Slovenian: Zelo pogosti
English: Mannitol
Slovenian: Omotica
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).
Slovenian: Pri sočasni uporabi vortioksetina s peroralnimi kontraceptivi (etinilestradiol 30 µg / levonorgestrel 150 µg) niso opazili pomembnega učinka na raven spolnih hormonov v primerjavi s placebom.
English: 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
Slovenian: EU/1/13/891/027 14 filmsko obloženih tablet EU/1/13/891/028 28 filmsko obloženih tablet EU/1/13/891/029 56 filmsko obloženih tablet EU/1/13/891/030 98 filmsko obloženih tablet EU/1/13/891/031 56 x 1 filmsko obložena tableta EU/1/13/891/032 98 x 1 filmsko obložena tableta EU/1/13/891/034 100 filmsko obloženih tablet EU/1/13/891/035 200 filmsko obloženih tablet
English: Orange, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “15” on the other side.
Slovenian: Oranžna filmsko obložena tableta mandljaste oblike (5 x 8,4 mm), z vtisnjeno oznako "TL" na eni strani in "15" na drugi strani.
English: Multipack: 490 (5 packs of 98 x 1) film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Večkratno pakiranje: 490 (5 pakiranj po 98 x 1) filmsko obloženih tablet
English: Red, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “20” on the other side.
Slovenian: Rdeča filmsko obložena tableta mandljaste oblike (5 x 8,4 mm), z vtisnjeno oznako "TL" na eni strani in "20" na drugi strani.
English: For elderly people 65 years of age or older the starting dose is 5 mg vortioxetine taken once daily.
Slovenian: Pri bolnikih, starih ≥ 65 let, je za začetni odmerek treba uporabljati najnižji učinkovit odmerek, 5 mg vortioksetina enkrat na dan.
English: 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)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/891/038 126 filmsko obloženih tablet (9 pakiranj po 14) EU/1/13/891/005 490 filmsko obloženih tablet (5 pakiranj po 98 x 1)
English: latvia@lundbeck.com
Slovenian: Nederland Lundbeck B.V.
English: Yellow, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “10” on the other side.
Slovenian: Rumena filmsko obložena tableta mandljaste oblike (5 x 8,4 mm), z vtisnjeno oznako "TL" na eni strani in "10" na drugi strani.
English: See section 4.
Slovenian: Ottiliavej 9
English: 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)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/891/040 126 filmsko obloženih tablet (9 pakiranj po 14) EU/1/13/891/033 490 filmsko obloženih tablet (5 pakiranj po 98 x 1)
English: Package leaflet: Information for the patient Brintellix 20 mg/ml oral drops, solution vortioxetine
Slovenian: Navodilo za uporabo Brintellix 20 mg/ml peroralne kapljice, raztopina vortioksetin (vortioxetinum)
English: H. Lundbeck A/S
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM H. Lundbeck A/S
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA IN NALEPKA ZA STEKLENICO
English: Pink, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “5” on the other side.
Slovenian: Roza filmsko obložena tableta mandljaste oblike (5 x 8,4 mm), z vtisnjeno oznako "TL" na eni strani in "5" na drugi strani.
English: Red, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “20” on the other side.
Slovenian: Rdeča filmsko obložena tableta (tableta) mandljaste oblike velikosti 5 x 8,4 mm z vtisnjeno oznako "TL" na eni strani in "20" na drugi strani.
English: Orange, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “15” on the other side.
Slovenian: Oranžna filmsko obložena tableta (tableta) mandljaste oblike velikosti 5 x 8,4 mm, z vtisnjeno oznako "TL" na eni strani in "15" na drugi strani.
English: Yellow, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “10” on the other side.
Slovenian: Rumena filmsko obložena tableta (tableta) mandljaste oblike velikosti 5 x 8,4 mm, z vtisnjeno oznako "TL" na eni strani in "10" na drugi strani.
English: 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)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/891/039 126 filmsko obloženih tablet (9 pakiranj po 14) EU/1/13/891/015 490 filmsko obloženih tablet (5 pakiranj po 98 x 1)
English: Pink, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “5” on the other side.
Slovenian: Roza filmsko obložena tableta (tableta) mandljaste oblike velikosti 5 x 8,4 mm, z vtisnjeno oznako "TL" na eni strani in "5" na drugi strani.
English: Multipack: 126 (9 packs of 14) film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Večkratno pakiranje: 126 (9 pakiranj po 14) filmsko obloženih tablet Večkratno pakiranje: 490 (5 pakiranj po 98 x 1) filmsko obloženih tablet
English: Brintellix 5 mg tablet vortioxetine
Slovenian: IME ZDRAVILA Brintellix 5 mg tableta vortioxetinum
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).
Slovenian: Da bi proučili kratkoročno učinkovitost vortioksetina pri odraslih bolnikih (vključno s starejšimi bolniki) z MDD, so izvedli dvanajst dvojno slepih, s placebom nadzorovanih, 6-/8-tedenskih študij s stalnimi odmerki.
English: EU/1/13/891/036 15 ml
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/891/036 15 ml
English: Diarrhoea, Constipation, Vomiting
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA peroralne kapljice, raztopina
English: 21 February 2013
Slovenian: 21. februar 2013
English: It was to be available as tablets (100 mg and 400 mg).
Slovenian: Na voljo naj bi bilo v obliki tablet (100 mg in 400 mg).
English: Medicines containing imatinib are currently approved in the European Union (EU) for the treatment of different types of cancers.
Slovenian: Zdravila, ki vsebujejo imatinib, so trenutno v Evropski uniji (EU) odobrena za zdravljenje različnih vrst raka.
English: The Committee also noted the higher unexplained risk of subdural haemorrhage (a type of bleeding in the brain).
Slovenian: Odbor je prav tako upošteval nepojasnjeno večje tveganje za subduralno krvavitev (vrsto krvavitve v možganih).
English: The main measure of effectiveness was the distance that patients could walk during a six-minute walk test.
Slovenian: Glavno merilo učinkovitosti je bila razdalja, ki so jo bolniki lahko prehodili v 6-minutnem preskusu.
English: Withdrawal of the marketing authorisation application for Ruvise (imatinib) EMA/38204/2013
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Ruvise (imatinib) EMA/38204/2013