FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Attenzjoni hija rrakkomandata meta jintużaw fl-istess waqt prodotti mediċinali oħra li jistgħu jbaxxu l-limitu talaċċessjonijiet [(eż., antidepressanti (triċikliċi, SSRIs, SNRIs), newrolettiċi (phenothiazines, thioxanthenes u butyrophenones), mefloquin, bupropion, tramadol] (ara sezzjoni 4.4).
English: Brintellix 20 mg/ml oral drops, solution vortioxetine
Maltese: Brintellix 20 mg/ml qtar orali, soluzzjoni vortioxetine
English: 15 mg corresponding to 15 drops.
Maltese: 15 mg jikkorrispondu għal 15-il qatra.
English: Vortioxetine separated from placebo statistically with results of 8.0 for vortioxetine versus 5.1 points for placebo (p=0.0003).
Maltese: Vortioxetine ssepara mill-plaċebo b'mod statistiku b'riżultati ta' 8.0 għal vortioxetine kontra 5.1 punti għall-plaċebo
English: Class effect
Maltese: Effett tal-klassi
English: Other medicines and Brintellix
Maltese: Mediċini oħra u Brintellix
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).
Maltese: Ma ġew osservati ebda effetti sinifikanti, meta mqabbel ma' plaċebo, fil-livelli tal-ormoni tas-sess wara l-għoti flimkien ta' vortioxetine ma' kontraċettiv orali kkombinat (ethinyl estradiol 30 µg/ levonorgestrel 150 µg).
English: Each drop of solution contains 1 mg vortioxetine (as (D,L)
Maltese: Kull qatra ta' soluzzjoni fiha 1 mg vortioxetine (bħala (D,L)
English: - chlorpromazine, chlorprothixene, haloperidol (medicines to treat mental disorders belonging to the groups called phenothiazines, thioxanthenes, butyrophenones).
Maltese: - chlorpromazine, chlorprothixene, haloperidol (mediċini biex jiġu kkurati disturbi mentali u li jagħmlu parti mill-gruppi msejjħa phenothiazines, thioxanthenes, butyrophenones).
English: Lundbeck Limited Tel: +44 1908 64 9966
Maltese: Tel: +44 1908 64 9966
English: In clinical short- and long-term placebo-controlled studies, potential discontinuation symptoms were systematically evaluated after abrupt treatment cessation of vortioxetine.
Maltese: Fi studji kliniċi kkontrollati bil-plaċebo fuq perjodu qasir u twil, sintomi potenzjali tat-twaqqif kienu evalwati sistematikament wara twaqqif f'daqqa tal-kura ta' vortioxetine.
English: It belongs to a group of medicines called antidepressants.
Maltese: Jagħmel parti minn grupp ta' mediċini msejħa antidepressanti.
English: However, the 20 mg dose of vortioxetine was associated with an increase in sexual dysfunction (TESD)(see section 5.1) .
Maltese: Iżda, id-doża ta' 20 mg ta' vortioxetine kienet assoċjata ma' żieda fid-disfunzjoni sesswali (TESD, treatment emergent sexual dysfunction)(ara sezzjoni 5.1) .
English: Patients should be monitored for the emergence of signs and symptoms of SS or NMS (see sections 4.3 and 4.5).
Maltese: Il-pazjenti għandhom jiġu ssorveljati għad-dehra ta' sinjali u sintomi ta' SS jew NMS (ara sezzjonijiet 4.3 u 4.5).
English: Not known * Haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding)
Maltese: Mhux magħruf* Emorraġija (inkluż kontużjoni, ekkimosi, epitassi, fsada gastrointestinali jew vaġinali)
English: Therefore, caution should be exercised when treating patients ≥ 65 years of age with doses higher than 10 mg vortioxetine once daily (see sections 4.2, 4.8 and 5.2).
Maltese: Għalhekk wieħed għandu joqgħod attent meta jkun qed jikkura pazjenti ta' età ≥ 65 sena b'dożi ogħla minn 10 mg vortioxetine darba kuljum (ara sezzjonijiet 4.2, 4.8 u 5.2).
English: Target organ toxicity was restricted to kidneys (rats) and liver (mice and rats).
Maltese: Effett tossiku fuq organi mmirati kien limitat għall-kliewi (firien) u l-fwied (ġrieden u firien).
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
Maltese: Informazzjoni minn provi kliniċi wriet riskju akbar ta' mġiba ta' suwiċidju f'adulti li għandhom inqas minn 25 sena b'kondizzjonijiet psikjatriċi li kienu kkurati b'antidepressant.
English: Caution should therefore be exercised (see section 5.2).
Maltese: Għalhekk wieħed għandu joqgħod attent ( ara sezzjoni 5.2).
English: High-density polyethylene (HDPE) tablet container.
Maltese: Kontenitur tal-pilloli magħmul minn polyethylene ta' densità għolja (HDPE - high density polyethylene).
English: Cytochrome P450 substrates
Maltese: Sottostrati taċ-ċitokromju P450
English: CYP2D6 gene types
Maltese: Ġeni tat-tip CYP2D6
English: Vortioxetine is a poor P-gp substrate and inhibitor.
Maltese: Vortioxetine huwa sottostrat u inibitur fqir ta' P-gp.
English: Lundbeck Hellas S.A. Τηλ: +30 210 610 5036
Maltese: Τηλ: +30 210 610 5036
English: No inhibitory effect of 40 mg single-dose omeprazole (CYP2C19 inhibitor) was observed on the multiple-dose pharmacokinetics of vortioxetine in healthy subjects.
Maltese: L-ebda effett impeditorju b'doża unika ta' 40 mg omeprazole (impeditur ta' CYP2C19) ma ġie osservat fil-farmakokinetiċi b'doża multipla ta' vortioxetine f'individwi b'saħħithom.
English: The safety and efficacy of Brintellix in children and adolescents aged less than 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Brintellix fi tfal u adolexxenti b'età inqas minn 18-il sena ma ġewx determinati s'issa.
English: The requirements for submission of periodic safety reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku
English: [outer carton only] PC:
Maltese: [Kartuna ta' barra biss]:
English: The maintenance of antidepressant efficacy was demonstrated in a relapse-prevention study.
Maltese: Manteniment Il-manteniment tal-effikaċja antidepressiva intweriet fi studju ta' prevenzjoni ta' rkadar.
English: Brintellix 20 mg/ml oral drops, solution
Maltese: Brintellix 20 mg/ml qtar orali, soluzzjoni
English: There is limited experience with vortioxetine overdoses above 80 mg.
Maltese: Hemm esperjenza ristretta b'dożi eċċessivi sa 80 mg vortioxetine.
English: Potential for vortioxetine to affect other medicinal products
Maltese: Potenzjal li vortioxetine jaffettwa prodotti mediċinali oħra
English: In studies using the Arizona Sexual Experience Scale (ASEX), the incidence of treatment-emergent sexual dysfunction (TESD) and the ASEX total score showed no clinically relevant difference to placebo in symptoms of sexual dysfunction at the 5 to 15 mg/day doses of vortioxetine.
Maltese: Fi studji li jużaw l-Iskala ta' Esperjenza Sesswali ta' Arizona (ASEX - Arizona Sexual Experience Scale), l-inċidenza ta' disfunzjoni sesswali li tfaċċat waqt il-kura (TESD - treatment-emergent sexual dysfunction) u lpunteġġ totali ta' ASEX ma wrew l-ebda differenza klinikament rilevanti mill-plaċebo fis-sintomi ta' disfunzjoni sesswali fid-dożi ta' vortioxetine ta' 5 sa 15 mg/jum.
English: After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response.
Maltese: Wara li s-sintomi depressivi jgħaddu, kura għal mill-inqas 6 xhur hija rrakkomandata għall konsolidazzjoni tar-rispons antidepressiv.
English: Available data in animals have shown excretion of vortioxetine/ vortioxetine metabolites in milk.
Maltese: Dejta disponibbli fl-annimali wriet li kien hemm eliminazzjoni ta' vortioxetine/metaboliti ta'
English: - sumatriptan and similar medicines with active substance names ending in “triptans” (used to treat migraine).
Maltese: - sumatriptan u mediċini simili bl-ismijiet tas-sustanza attiva li jintemmu bi “triptans”
English: - rifampicin (a medicine to treat tuberculosis and other infections) - carbamazepine, phenytoin (medicines to treat epilepsy or other illness) - Warfarin, dipyridamole, phenprocoumon, low-dose acetylsalicylic acid (blood thinning medicines).
Maltese: - mediċini magħrufa li jikkawża livell baxx ta' sodium - rifampicin (mediċina għall-kura tat-tuberkulożi u infezzjonijiet oħra). - carbamazepine, phenytoin (mediċini għall-kura tal-epilessija jew mard ieħor). - warfarin, dipyridamole, phenprocoumon, doża baxxa ta' acetylsalicylic acid (mediċini li jraqqu d-demm).
English: Perforated unit dose blisters: PVC/PVdC/aluminium.
Maltese: PVC/PVdC/aluminium.
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.
Maltese: Meta vortioxetine ingħata flimkien wara 6 ijiem ta' ketoconazole 400 mg/kuljum (inibitur ta' CYP3A4/5 u ta' P-glycoprotein) jew wara 6 ijiem ta' fluconazole 200 mg (inibitur ta' CYP2C9, CYP2C19 u CYP3A4/5 f'individwi b'saħħithom, kienet osservata żieda ta' 1.3 darbiet u ta' 1.5 darbiet, rispettivament, fl-AUC ta' vortioxetine.
English: Brintellix is not recommended in children and adolescents under 18 years due to lack of information for this age group.
Maltese: Brintellix mhux irrakkomandat fi tfal u adolexxenti b'età inqas minn 18-il sena minħabba nuqqas ta'
English: The efficacy of vortioxetine was demonstrated with at least one dosage group across 9 of the 12 studies, showing at least a 2-point difference to placebo in the Montgomery and Åsberg Depression Rating Scale (MADRS) or Hamilton Depression Rating Scale 24-item (HAM-D24) total score.
Maltese: L-effikaċja ta' vortioxetine intweriet b'għallinqas grupp wieħed ta' dożaġġ fuq firxa ta' 9 studji minn 12, fejn kien hemm għallinqas 2 punti ta' differenza meta mqabbel mal-plaċebo fil-punteġġ totali fl-Iskala ta' Stima tad-Depressjoni ta' Montgomery u Åsberg (MADRS - Montgomery and Åsberg Depression Rating Scale) jew l-Iskala ta' Stima tad-Depressjoni fuq 24 oġġett ta' Hamilton (HAM -D 24 - Hamilton Depression Rating Scale 24-item).
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).
Maltese: Fuq miżuri suġġettivi, vortioxetine ma sseparax mill-plaċebo meta evalwat bl-użu tal-Kwestjonarju dwar il-Funzjoni Konjittiva u Fiżika (Cognitive and Physical Functioning Questionnaire) b'riżultati ta' -8.1 għal vortioxetine kontra -6.9 għallplaċebo (p=0.086).
English: Effects of vortioxetine on the Digit Symbol Substitution Test (DSST), the University of California San Diego Performance-Based Skills Assessment (UPSA) (objective measures) and Perceived Deficits Questionnaire (PDQ) and Cognitive and Physical Functioning Questionnaire CPFQ (subjective measures) scores
Maltese: L-effetti ta' vortioxetine fuq il-punteġġi tat-Test ta' Sostituzzjoni tan-Numri b'Simboli (DSST),talEvalwazzjoni tal-Ħiliet ibbażati fuq l-Imġiba tal-Università ta' Kalifornja f'San Diego (UPSA) (miżuri oġġettivi) u tal-Kwestjonarju dwar Nuqqasijiet Innotati (PDQ) u tal-Kwestjonarju dwar il-Funzjoni Konjittiva u Fiżika (CPFQ) (miżuri suġġettivi).
English: In patients with end-stage renal disease, only a small fraction of vortioxetine was lost during dialysis (AUC and Cmax were 13% and 27% lower, respectively; n=8) following a single 10 mg dose of vortioxetine.
Maltese: F'pazjenti b'mard tal-kliewi tal-aħħar stadju, porzjon żgħir biss ta' vortioxetine kien mitlufa waqt id-dijalisi (AUC u Cmax kienu 13% u 27% inqas, rispettivament; n=8) wara doża waħda ta' 10 mg vortioxetine.
English: Hyponatraemia
Maltese: Hypromellose
English: Blister: Transparent; PVC/PVdC/aluminium blister.
Maltese: Trasparenti; folja tal-PVC/PVdC/aluminju.
English: Doses of 5 to 15 mg showed no difference to placebo.
Maltese: Dożi ta' 5 sa 15 mg ma wrew ebda differenza meta mqabbla ma' plaċebo.
English: Oral drops, solution.
Maltese: U KONTENUT Qtar orali, soluzzjoni
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).
Maltese: Inibitur ta' MAO-A riversibbli u selettiv (moclobemide) Il-taħlita ta' vortioxetine ma' inibitur ta'MAO-A riversibbli u selettiv, bħal moclobemide, huwa kontraindikat (ara sezzjoni 4.3).
English: Pack sizes of 100 and 200 film-coated tablets.
Maltese: Daqsijiet tal-pakkett ta' 100 and 200 pillola miksija b'rita.
English: (p = 0.023) in the study in the elderly.
Maltese: (p=0.0003).
English: Pack sizes of 56 x 1 and 98 x 1 film-coated tablets.
Maltese: Daqsijiet tal-pakkett ta' 56 x 1 u 98 x 1 pilloli miksija b'rita.
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).
Maltese: koma), instabilità awtonomika (eż. takikardija, pressjoni tad-demm mhux stabbli, ipertermija), aberrazzjonijiet newromuskolari (eż., iperriflessija, nuqqas ta' koordinazzjoni) u jew sintomi gastrointestinali (eż., dardir, rimettar, dijarea).
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.
Maltese: Is-sintomi li ġejjin jistgħu jseħħu fit-tarbija tat-twelid wara l-użu matern ta' prodott mediċinali serotonerġiku fl-istadji mwaħħrin tat-tqala: distress respiratorju, ċjanożi, apnea, aċċessjonijiet, instabilità tat-temperatura, diffikultà biex tiekol, rimettar, ipogliċemija, ipertonija, ipotonija, iperriflessija, rogħda, movimenti mhux volontarji, irritabilità, letarġija, biki kostanti, ngħas u diffikultà biex torqod.
English: Seizures
Maltese: Iponatrimja
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.
Maltese: L-esponiment għal vortioxetine żdied bi 2.3 darbiet għall-area under curve (AUC) meta vortioxetine 10 mg/kuljum ingħata flimkien ma' bupropion (inibitur qawwi ta' CYP2D6, 150 mg darbtejn kuljum) għal 14-il ġurnata f'44 individwu f'saħħtu.
English: - The other ingredients are hydroxypropylbetadex, ethanol (96 percent) and purified water
Maltese: - Is-sustanzi l-oħra huma hydroxypropylbetadex, ethanol (96 fil-mija) u ilma ppurifikat.
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).
Maltese: - Is-sustanzi l-oħra huma mannitol (E421), microcystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (tipA), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), iron oxide aħmar (E172).
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)
Maltese: - Is-sustanzi l-oħra huma mannitol (E421), microcystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (tipA), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), iron oxide isfar (E172), iron oxide aħmar (E172).
English: Co-administration of strong CYP3A4/2C9 inhibitors to CYP2D6 poor metabolisers could potentially result in higher exposure (see section 4.5).
Maltese: It-teħid fl-istess ħin ta' inibituri qawwijin ta' CYP3A4/2C9 lil metabolizzaturi dgħajfa , jista' potenzjalment jirriżulta f'espożizzjoni ogħla (ara sezzjoni 4.5).
English: Approximately 2/3 of the inactive vortioxetine metabolites are excreted in the urine and approximately 1/3 in the faeces.
Maltese: Madwar 2/3 tal-metaboliti inattivi ta' vortioxetine jitneħħew fl-awrina u madwar 1/3 fl-ippurgar.
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).
Maltese: L-għoti flimkien ta' prodotti mediċinali b'effett serotonerġiku (eż., tramadol, sumatriptan u triptans oħrajn) jista' jwassal għas-sindrome ta' serotonin (ara sezzjoni 4.4).
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).
Maltese: - Is-sustanzi l-oħra huma mannitol (E421), microcystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (tipA), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), iron oxide isfar (E172).
English: In elderly healthy subjects (aged ≥65 years; n=20), the exposure to vortioxetine increased up to 27% (Cmax and AUC) compared to young healthy control subjects (aged ≤45 years) after multiple doses of
Maltese: F'individwi anzjani (età ≥65 sena; n=20) f'saħħithom, l-esponiment għal vortioxetine żdied sa 27% (Cmax u AUC) meta mqabbel ma' individwi żagħżagħ (età ≤45 sena) f'saħħithom ta' kontroll wara dożi multipli ta'10 mg/kuljum.
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.
Maltese: Pilloli miksija b'rita ta' Brintellix 10 mg huma disponibbli f'pakketti b'folji ta' 7, 14, 28, 56, 56 x 1, 98, 98 x 1, 126 (9x14), 490 (5 x (98x1)) pillola u f'kontenituri tal-pilloli ta' 100 u 200 pillola.
English: The changes in the kidney in rats (glomerulonephritis, renal tubular obstruction, crystalline material in renal tubule) and in the liver of mice and rats (hepatocellular hypertrophy, hepatocyte necrosis, bile duct hyperplasia, crystalline material in bile ducts) were seen at exposures more than 10-fold (mice) and 2-fold (rats) the human exposure at the maximum recommended therapeutic dose of 20 mg/day.
Maltese: It-tibdil fil-kliewi fil-firien (glomerulonefrite, ostruzzjoni tat-tubuli renali, materjal kristallin fit-tubulu renali) u fil-fwied tal-ġrieden u tal-firien (ipertrofija epatoċellulari, nekrożi tal-epatoċita, iperplejżja tal-kanali tal-bili, materjal kristallin fil-kanali tal-bili) dehru f'espożizzjonijiet li kienu aktar minn 10 darbiet (fil-ġrieden) u darbtejn (fil-firien) l-espożizzjoni umana fl-ogħla doża terapewtika rrakkomandata ta' 20 mg/jum.
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.
Maltese: Rapporti minn każijiet umani b'prodotti mediċinali ta' klassi farmakoloġika simili ta' antidipressivi (SSRIs) wrew effett fuq il-kwalità tal-ispema li huwa riversibbli.
English: Hydroxypropylbetadex Ethanol (96 per cent) Purified water
Maltese: Hydroxypropylbetadex
English: Pharmacotherapeutic group: Psychoanaleptics; Other antidepressants, ATC code: N06AX26
Maltese: Antidepressanti oħra, Kodiċi ATC:
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).
Maltese: Użu fl-istess waqt ta' antidepressanti b'effett serotonerġiku u rimedji mill-ħxejjex li fihom St.John's wort (Hypericum perforatum) jista' jwassal għal inċidenza ogħla ta' reazzjonijiet avversi inkluż issindrome ta' serotonin (ara sezzjoni 4.4).
English: Multipack containing 126 (9 x 14) and 490 (5 x (98x1)) film-coated tablets.
Maltese: Pakkett multiplu li fih 126 (9 x 14) u 490 (5 x (98x1)) pillola miksija b'rita.
English: One study assessed the effect of vortioxetine on functional capacity using the University of California San Diego Performance-Based Skills Assessment (UPSA).
Maltese: Ħiliet ibbażati fuq l-Imġiba (UPSA) tal-Università ta' Kalifornja f'San Diego.
English: Pack sizes of 7, 14, 28, 56 and 98 film-coated tablets.
Maltese: Daqsijiet tal-pakkett ta' 7, 14, 28, 56 u 98 pilloli miksija b'rita.
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.
Maltese: L-effikaċja ta' vortioxetine (5-20 mg/jum) f'pazjenti b'MDD ġiet investigata f'studji ta' terminu qasir ikkontrollati bil-plaċebo, 2 magħmulin fl-adulti u wieħed magħmul fl-anzjani.
English: EU/1/13/891/037-038
Maltese: EU/1/13/891/001-007 EU/1/13/891/037-038
English: - sumatriptan and similar medicines to Brintellix with active substance names ending in “triptans” (used to treatmigraine).
Maltese: sumatriptan u mediċini simili bl-ismijiet tas-sustanza attiva li jintemmu bi “triptans” (użati għall-kura tal-emigranja).
English: Interactions in CYP2D6 poor metabolisers
Maltese: Interazzjonijiet f'metabolizzaturi dgħajfin ta' CYP2D6
English: Medicinal products lowering the seizure threshold Antidepressants with serotonergic effect can lower the seizure threshold.
Maltese: Prodotti mediċinali li jbaxxu l-limitu tal-aċċessjonijiet Antidepressanti b'effett serotonerġiku jistgħu jbaxxu l-limitu tal-aċċessjonijiet.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma 'prodotti mediċinali oħra u forom oħra ta 'interazzjoni
English: Brintellix 20 mg tablet vortioxetine
Maltese: Brintellix 20 mg pillola vortioxetine
English: Not known * Hyponatraemia
Maltese: Mhux magħruf* Reazzjoni anafilattika
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Maltese: Ir-reazzjonijiet avversi huma mniżżla bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≤1/10); komuni (≤1/100 sa <1/10); mhux komuni (≤1/1,000 sa <1/100); rari (≤1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
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).
Maltese: Wieħed għandu joqgħod attent meta jkun qed jikkura pazjenti ta' età ≥ 65 sena b'dożi ogħla minn 10 mg vortioxetine darba kuljum li għalihom id-dejta hija limitata (ara sezzjoni 4.4).
English: A meta-analysis of placebo-controlled clinical studies of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo, in patients less than 25 years old.
Maltese: Meta-analiżi ta' studji kliniċi kkontrollati bil-plaċebo ta' antidepressanti f'pazjenti adulti b'disturbi psikjatriċi wrew riskju ogħla ta' mġiba ta' suwiċidju b'antidepressanti meta mqabbel mal-plaċebo, f'pazjenti inqas minn 25 sena.