FrancophonIA/ELRC3.0 huggingface dataset:
English: Following a single dose of 10 mg vortioxetine, renal impairment estimated using the Cockcroft-Gault formula (mild, moderate, or severe; n=8 per group) caused modest exposure increases (up to 30%), compared to healthy matched controls.
Maltese: Wara doża waħda ta' 10 mg vortioxetine, indeboliment renali stmat skont il-formula ta' CockcroftGault (ħafif, moderat, jew sever; n=8 kull grupp) ikkawża żidiet modesti (sa 30%) fl-esponiment, meta mqabbel ma' kontrolli mqabbla f'saħħithom.
English: Haemorrhage
Maltese: Aċċessjonijiet
English: Following dosages several fold higher than the therapeutic dose range, events of seizure and serotonin syndrome have been reported.
Maltese: Wara dożaġġi diversi drabi ogħla mill-firxa tad-doża terapewtika, ġew irrapportati każijiet ta' puplesija bis-sindrome ta' serotonin.
English: Potential for other medicinal products to affect vortioxetine
Maltese: Potenzjal li prodotti mediċinali oħra jaffettwaw vortioxetine
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 productfrom related pharmacological classes of antidepressants (SSRIs or TCAs).
Maltese: Studji epidemoloġiċi, magħmula l-iżjed f'pazjenti ta' età ta' 50 sena jew iżjed, wrew żieda fir-riskju ta' ksur tal-għadam f'pazjenti li jirċievu prodott mediċinali minn klassijiet farmakoloġiċi simili ta' antidipressivi (SSRIs jew TCAs).
English: For the 20 mg/day dose, an increase in TESD was seen compared to placebo (an incidence difference of 14.2%, 95% CI [1.4, 27.0]).
Maltese: Għad-doża ta' 20 mg/jum, dehret żieda fit-TESD meta mqabbel ma' plaċebo (differenza fl-inċidenza ta' 14.2%, 95% CI
English: The mechanism of action of vortioxetine is thought to be related to its direct modulation of serotonergic receptor activity and inhibition of the serotonin (5-HT) transporter.
Maltese: Il-mekkaniżmu ta' azzjoni ta' vortioxetine huwa maħsub li huwa relatat mal-modulazzjoni dirett talattività tar-riċettur serotonerġiku u l-inibizzjoni tat-trasportatur ta' serotonin (5-HT).
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.
Maltese: Brintelix intwera li jnaqqas il-firxa wiesgħa ta' sintomi depressivi, inkluż dwejjaq, tensjoni minn ġewwa (tħossok ansjuż), disturbi fl-irqad (tnaqqis fl-irqad), aptit imnaqqas, diffikultà biex tikkonċentra, tħossok li ma inti xejn, telf ta' interess fl-attivitajiet favoriti, tħoss li battejt.
English: 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.
Maltese: Pilloli miksija b'rita ta' Brintellix 5 mg huma disponibbli f'pakketti b'folji ta' 14, 28, 56x1, 98, 98x1, 126 (9x14), 490 (5x(98x1)) pilloli u f'kontenituri tal-pilloli ta' 100 u 200 pillola.
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
Maltese: EU/1/13/891/027 14 pillola miksijin b'rita EU/1/13/891/028 28 pillola miksijin b'rita EU/1/13/891/029 56 pillola miksijin b'rita EU/1/13/891/030 98 pillola miksijin b'rita EU/1/13/891/031 56 x 1 pilloli miksijin b'rita EU/1/13/891/032 98 x 1 pilloli miksijin b'rita
English: Multipack: 126 (9 packs of 14) film-coated tablets.
Maltese: Pakketti multipli: 126 (9 pakketti ta' 14) pillola miksijin b'rita.
English: There was no clinically relevant difference to placebo in the incidence or nature of the discontinuation symptoms after either short-term (6-12 weeks) or long-term (24-64 weeks) treatment with vortioxetine.
Maltese: Ma kien hemm l-ebda differenza klinikament rilevanti mill-plaċebo fl-inċidenza jew fin-natura tas-sintomi tat-twaqqif wara kura fuq perjodu qasir (6-12-il ġimgħa) jew perjodu twil (24-64 ġimgħa) ta' vortioxetine.
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).
Maltese: Saru tnax-il studji double-blind, ikkontrollati bil-plaċebo, ta' 6/8 ġimgħat b'doża fissa biex tiġi investigata l-effikaċja fuq żmien qasir ta' vortioxetine f'MDD fl-adulti (inklużi l-anzjani).
English: A risk to the breastfeeding child cannot be excluded.
Maltese: Riskju għat-tarbija li qed terda' ma jistax jiġi eskluż.
English: Film-coated tablet (tablet)
Maltese: Kisja tal-pillola
English: The recommended dose of Brintellix is 10 mg vortioxetine taken as one daily dosein adults less than 65 years of age.
Maltese: Id-doża tal-bidu u dik irrakkomandata ta' Brintellix hija ta' 10 mg vortioxetine darba kuljum fl-adulti ta' età inqas minn 65 sena.
English: Brintellix 15 mg tablet vortioxetine
Maltese: Brintellix 15 mg pillola vortioxetine
English: EXP (MM-YYYY) See embossed stamp.
Maltese: Sinjali ta' doża eċċessiva huma sturdament,
English: The mean 5-HT transporter occupancy in the raphe nuclei was approximately 50% at 5 mg/day, 65% at 10 mg/day and increased to above 80% at 20 mg/day.
Maltese: 65% b'10 mg/kuljum u żdiedet għal aktar minn 80% b'20 mg/kuljum.
English: Each bottle contains 15 ml Brintellix oral drops, solution.
Maltese: Kull flixkun fih 15 ml ta' Brintellix qtar orali, soluzzjoni.
English: Brintellix 5 mg tablet vortioxetine
Maltese: Brintellix 5 mg pillola vortioxetine
English: Brintellix 10 mg tablet vortioxetine
Maltese: Brintellix 10 mg pillola vortioxetine
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Maltese: Depressjoni hija assoċjata ma' riskju akbar ta' ħsibijiet ta' suwiċidju, ħsara lill-persuna nnifisha u suwiċidju (avvenimenti relatati ma' suwiċidju).
English: A no-effect level for convulsions was established with a corresponding safety margin of 5 considering the maximum recommended therapeutic dose of 20 mg/day.
Maltese: Livell ta' bla effett għall-konvulżjonijiet ġie stabbilit b'marġni ta' sigurtà li jikkorrispondi għal 5 b'konsiderazzjoni tad-doża terapewtika massima rrakkomandata ta' 20 mg/kuljum.
English: Cytochrome P450 inducers
Maltese: Inibituri taċ-ċitokromju P450
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.
Maltese: Meta doża waħda ta' 20 mg vortioxetine ingħatat flimkien wara 10 ġranet ta' rifampicin 600 mg/kuljum (induttur b'firxa wiesa' tal-isozimi CYP) f'individwi b'saħħithom, kien osservat tnaqqis ta' 72% fl-AUC ta' vortioxetine.
English: Multipack containing 490 (5 x (98x1)) film-coated tablets.
Maltese: Pakkett multiplu li fih 490 (5 x (98x1)) pillola miksija b'rita.
English: Vortioxetine had no effect on rat fertility, mating performance, reproductive organs, or sperm morphology and motility.
Maltese: Vortioxetine ma kellu l-ebda effett fuq il-fertilità , tgħammir, organi riproduttivi, jew fuq il morfoloġija u l-motilità tal-isperma fil-firien.
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)).
Maltese: Pazjenti b'depressjoni severa jew b'depressjoni u livelli għolja ta' sintomi ta' ansjetà F'pazjenti depressi b'mod sever (punteġġ totali ta' MADRS fil-linja bażi ta' ≥30) u f'pazjenti depressi b'livell għoli ta' sintomi ta' ansjetà (punteġġ totali ta' HAM-A fil-linja bażi ta' ≥20) vortioxetine ukoll wera effikaċja fl-istudji fuq perjodu qasir fl-adulti (il-medja tad-differenza in ġenerali mill-plaċebo filpunteġġ totali
English: - mefloquine (a medicine to prevent and treatmalaria).
Maltese: tramadol (mediċina qawwija kontra l-uġigħ).
English: Package leaflet: Information for the patient Brintellix 20 mg/ml oral drops, solution vortioxetine
Maltese: Informazzjoni għall-pazjent Brintellix 20 mg/ml qtar orali, soluzzjoni
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.
Maltese: Fl-istudju b'doża fissa, double-blind, ikkontrollat bil-plaċebo ta' 8 ġimgħat fuq pazjenti anzjani biddipressjoni (età ≥65 sena, n=452, li minnhom 156 kienu fuq vortioxetine), , vortioxetine 5 mg/kuljum kien superjuri għall-plaċebo kif imkejjel mit-titjib fil-punteġġi totali ta' MADRS u HAM-D24..
English: Following a single dose of 10 mg vortioxetine, no impact of mild or moderate hepatic impairment (Child-Pugh Criteria A or B; n=8 per group) was observed on the pharmacokinetics of vortioxetine (changes in AUC were less than 10%).
Maltese: Wara doża waħda ta' 10 mg vortioxetine, ma kien osservat l-ebda impatt ta' indeboliment epatiku ħafif jew moderat (Kriterji Child-Pugh A jew B; n=8 kull grupp) fuq il-farmakokinetika ta' vortioxetine (bidliet fl-AUC kienu anqas minn 10%).
English: EU/1/13/891/024 490 film-coated tablets (5 packs of 98x1)
Maltese: EU/1/13/891/015 490 pillola miksijin b'rita (5 pakketti ta' 98x1)
English: Co-administration of strong inhibitors of CYP3A4 (such as itraconazol, voriconazole, clarithromycin, telithromycin, nefazodone, conivaptan and many of the HIV protease inhibitors) and inhibitors of CYP2C9 (such as fluconazole and amiodarone) to CYP2D6 poor metabolisers (see section 5.2) has not been investigated specifically, but it is anticipated that it will lead to a more marked increased exposure of vortioxetine in these patients as compared to the moderate effect described above.
Maltese: (bħal itraconazol, voriconazole, clarithromycin, telitromycin, nefazodone, conivaptan u ħafna mill-inibituri tal-protease tal-HIV) u inibituri ta' CYP2C9 (bħal fluconazole u amiodarone) lil metabolizzaturi dgħajfin ta' CYP2D6 (ara sezzjoni 5.2)
English: 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).
Maltese: tiġi kkunsidrata jekk inibitur qawwi ta' CYP2D6 (eż., bupropion, quinidine, fluoxetine, paroxetine) jiżdied mal-kura ta' vortioxetine (ara sezzjoni 4.2).
English: Bleeding abnormalities, such as ecchymoses, purpura and other haemorrhagic events, such as gastrointestinal or gynaecological bleeding, have been reported rarely with the use of antidepressants with serotonergic effect, including vortioxetine .
Maltese: Anormalitajiet ta' fsada, bħal eċċimosi, purpura u avvenimenti emorraġiċi oħra, bħall-fsada gastrointestinali jew ġinekoloġika kienu rrappurtati b'mod rari bl-użu ta' antidippressanti b'effett serotonerġiku, inkluż vortioxetine.
English: In the meta-analyses (ANCOVA, LOCF) of the mean change from baseline in DSST number of correct symbols in all 3 studies, vortioxetine separated from placebo (p<0.05) with a standardised effect size of 0.35.
Maltese: Fil-meta-analiżi (ANCOVA, LOCE) tal-bidla medja mil-linja bażi fid-DSST tan-numru ta' simboli korretti f'kull wieħed mit-tliet studji, vortioxetine ssepara millplaċebo (p<0.05) b'daqs ta' effett istandardizzat ta' 0.35.
English: Angioedema, Urticaria Rash
Maltese: Stitikezza, Rimettar
English: The plasma concentration of vortioxetine was approximately two times higher in CYP2D6 poor metabolisers than in extensive metabolisers.
Maltese: Il-konċentrazzjoni ta' vortioxetine fil-plażma kienet madwar darbtejn ogħla f'metabolizzaturi dgħajfa ta' CYP2D6 milli f'metabolizzaturi estensivi.
English: Not known*
Maltese: Tista'
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.
Maltese: Vortioxetine kien superjuri (p=0.004) għallplaċebo fil-kejl tar-riżultat primarju, iż-żmien sa rikaduta ta' MDD, bi proporzjon ta' periklu ta' 2.0; b'hekk, ir-riskju ta' rikaduta kien darbtejn ogħla fil-grupp tal-plaċebo milli fil-grupp ta' vortioxetine.
English: Sexual dysfunction
Maltese: Disfunzjoni sesswali
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 98 film-coated tablets 98 x 1 film-coated tablets 100 film-coated tablets 200 film-coated tablets
Maltese: Aqra l-fuljett ta' tagħrif qabel l-użu. 28 pillola miksijin b'rita 56 pillola miksijin b'rita 56 x 1 pilloli miksijin b'rita 98 pillola miksijin b'rita 98 x 1 pilloli miksijin b'rita
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.
Maltese: Ukoll, ma kien osservat l-ebda effett inibitorju sinifikanti, mqabbel mal-plaċebo, fuq l-aggregazzjoni tal-plejtlits jew il-farmakokinetika ta' acetylsalicylic acid jew salicylic acid meta acetylsalicylic acid 150 mg/kuljum ingħata flimkien wara l-għoti ta' dożi multipli ta' vortioxetine f'individwi b'saħħithom.
English: Brintellix is for oral use.
Maltese: Brintellix huwa għall-użu orali.
English: Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS), potentially life-threatening conditions, may occur with vortioxetine.
Maltese: Sindrome ta' Serotonin (SS - Serotonin syndrome) jew Sindrome Newrolettiku Malinn (NMS), kondizzjonijiet b'potenzjal ta' periklu għall-ħajja, jistgħu jseħħu b'vortioxetine.
English: The pack sizes of 56 x 1, 98 x 1 and 490 film-coated tablets are presented in unit dose blister.
Maltese: Id-daqsijiet tal-pakketti ta' 56 x 1, 98 x 1 u 490 pillola miksija b'rita ssibhom f'folji b'doża waħda.
English: 98 x 1 film-coated tablets.
Maltese: Pilloli miksijin b'rita 98 x 1 pilloli.
English: Vortioxetine has not been studied in patients with severe hepatic impairment and caution should be exercised when treating these patients (see section 4.4).
Maltese: Vortioxetine ma ġiex studjat f'pazjenti b'indeboliment epatiku sever u għandu jkun hemm attenzjoni meta jkunu qed jiġu kkurati dawn il-pazjenti (ara sezzjoni 4.4).
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
Maltese: EU/1/13/891/001 14 pillola miksijin b'rita EU/1/13/891/002 28 pillola miksijin b'rita EU/1/13/891/003 56 pillola miksijin b'rita EU/1/13/891/004 56 x 1 pilloli miksijin b'rita
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
Maltese: 14 pillola miksijin b'rita 28 pillola miksijin b'rita 56 pillola miksijin b'rita 56 x 1 pilloli miksijin b'rita 98 pillola miksijin b'rita 98 x 1 pilloli miksijin b'rita
English: - Based upon the review of a signal for rash, a plausible temporal relationship was concluded in several post-marketing cases reported (74% of reported time to onset was within one week and 93% was within one month), including cases with positive de- or re-challenge (respectively 135 and 8 cases).
Maltese: - Ibbażat fuq ir-reviżjoni ta' sinjal għal raxx, relazzjoni temporali plawsibbli kienet konkluża f'diversi każijiet wara t-tqegħid fis-suq irrappurtati (74% tal-ħin irrappurtat sal-bidu kien fi żmien ġimgħa u 93% kien fi żmien xahar), inklużi każijiet b'de- jew re-challenge pożittiv (135 u 8 każijiet rispettivament).
English: 15 ml in an amber glass bottle (type III) and screw cap (polypropylene) with dropper (LDpolyethylene), (child-resistant closure).
Maltese: 15 ml fi flixkun tal-ħġieġ lewn l-ambra (tip III) b'għatu tal-kamin (polypropylene) bi dropper (LD
English: Epidemiological data suggest that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).
Maltese: Dejta epidemjoloġika tissuġġerixxi li l-użu ta' SSRIs fit-tqala, speċjalment tard fit-tqala, jista' jżid ir riskju ta' pressjoni pulmonari għolja persistenti fit-tarbija tat-twelid (PPHN - persistent pulmonary hypertension in the newborn).
English: Fits are a potential risk with medicines used to treat depression.
Maltese: Aċċessjonijiet huma riskju potenzjali ta' mediċini wżati għall-kura tad-depressjoni.
English: Vortioxetine is extensively metabolised in the liver, primarily through oxidation catalysed by CYP2D6 and to a minor extent CYP3A4/5 and CYP2C9 (see section 5.2).
Maltese: Vortioxetine huwa metabolizzat b'mod estensiv fil-fwied primarjament permezz tal-ossidazzjoni kkatalizzata minn CYP2D6 u f'miżura inqas minn CYP3A4/5 u CYP2C9 (ara sezzjoni 5.2).
English: Vortioxetine is extensively metabolised in the liver, primarily through oxidation catalysed by CYP2D6 and to a minor extent CYP3A4/5 and CYP2C9and subsequent glucuronic acid conjugation.
Maltese: Vortioxetine huwa metabolizzat b'mod estensiv fil-fwied primarjament permezz tal-ossidazzjoni kkatalizzata minn CYP2D6 u f'miżura inqas minn CYP3A4/5 u CYP2C9 u konjugazzjoni sussegwenti ma' glucuronic acid.
English: Pack sizes of 14, 28, 56 and 98 film-coated tablets.
Maltese: Daqsijiet tal-pakkett ta' 14, 28, 56 u 98 pilloli miksija b'rita.
English: No effect of multiple doses of acetylsalicylic acid 150 mg/day on the multiple-dose pharmacokinetics of vortioxetine was observed in healthy subjects.
Maltese: Ma kien osservat l-ebda effett ta' dożi multipli ta' acetylsalicylic acid 150 mg/kuljum fuq ilfarmakokinetika ta' dożi multipli ta' vortioxetine 10 mg/kuljum fi 28 individwu f'saħħtu.
English: Post-marketing experience mainly concerns vortioxetine overdoses of up to 80 mg.
Maltese: Esperjenza ta' wara t-tqegħid fis-suq jikkonċerna dożi eċċessivi sa 80 mg ta' vortioxedine.
English: Each film-coated tablet contains 20 mg vortioxetine (as hydrobromide).
Maltese: Kull pillola miksija b'rita fiha 20 mg vortioxetine (bħala hydrobromide).
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
Maltese: 0001) fiż-2 studji fl-adulti u Δ =
English: Each film-coated tablet contains 20 mg vortioxetine (as hydrobromide)
Maltese: Kull pillola miksija b'rita fiha 20 mg vortioxetine (bħala hydrobromide)
English: - phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines to treat depression called non-selective monoamine oxidase inhibitors); you must not take any of these medicines together with Brintellix.
Maltese: Għid lit-tabib tiegħek jekk qed tieħu xi waħda mill-mediċini li ġejjin: - phenelzine, iproniazid, isocarboxazid, nialamidetranylcypromine (mediċini biex jikkuraw id depressjoni msejħa inibituri mhux selettivi ta' monoamine oxidase); m'għandekx tieħu kwalunkwe minn dawn il-mediċini ma' Brintellix.
English: Fertility studies in male and female rats showed no effect of vortioxetine on fertility, sperm quality or mating performance (see section 5.3).
Maltese: Studji dwar il-fertilità f'firien maskili u femminili ma wrew l-ebda effett ta' vortioxetine fuq il fertilità, kwalità ta' sperma jew it-tgħammir (ara sezzjoni 5.3).
English: In a thorough QTc study in healthy subjects at doses up to 40 mg daily, no potential for the prolongation of the QTc interval was observed.
Maltese: 40 mg kuljum, ma kien osservat l-ebda potenzjal għal titwil tal-intervall QTc.
English: Vortioxetine must be discontinued for at least 14 days before starting treatment with an irreversible non-selective MAOI (see section 4.3).
Maltese: Vortioxetine għandu jitwaqqaf għal mill-inqas 14-il ġurnata qabel ma tinbeda l-kura b'MAOI irriversibbli u mhux selettiv (ara sezzjoni 4.3).
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.
Maltese: Prodotti mediċinali kontra l-koagulazzjoni tad-demm u kontra l-plejtlits Ma kienu osservati l-ebda effetti sinifikanti mqabbla mal-plaċebo fil-valuri tal-INR, prothrombin jew R-/S-warfarin fil-plażma wara l-għoti ta' dożi multipli ta' vortioxetine flimkien ma' dożi stabbli ta' warfarin f'indivdwi b'saħħithom.
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.
Maltese: Minħabba r-riskju tas-sindrome ta' serotonin, vortioxetine huwa kontraindikat fi kwalunkwe taħlita ma' MAOIs irriversibbli u mhux selettivi.
English: Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function [e.g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (ASA)] (see section 4.5) and in patients with known bleeding tendencies/disorders.
Maltese: Attenzjoni hija rrakkomandata f'pazjenti li jieħdu sustanzi kontra il-koagulazzjoni tad-demm u/jew prodotti mediċinali magħrufa li jaffettwaw il-funzjoni tal-plejtlits [eż., antipsikotiċi atipiċi u phenothiazines, il-biċċa l-kbira tal-antidepressanti triċikliċi, mediċini anti infjammatorji mhux sterojdi (NSAIDs - non-steroidal anti-inflammatory drugs), acetylsalicylic acid(ASA)] (ara sezzjoni 4.5) u f'pazjenti magħrufa li għandhom tendenzi/disturbi ta' fsada.
English: Multipack: 490 (5 packs of 98 x 1) film-coated tablets.
Maltese: Pakketti multipli: 490 (5 pakketti ta' 98 x 1) pillola miksijin b'rita.
English: Each film-coated tablet contains 10 mg vortioxetine (as hydrobromide)
Maltese: Kull pillola miksija b'rita fiha 10 mg vortioxetine (bħala hydrobromide)
English: Taking these medicines together with Brintellix may increase the risk of serotonin syndrome.
Maltese: It-teħid ta' dawn il-mediċini flimkien ma' Brintellix jista' jżid ir-riskju tas-sindromu ta' serotonin.
English: Patients in remission after an initial 12-week open-label treatment period with vortioxetine were randomised to vortioxetine 5 or 10 mg/day or placebo and observed for relapse during a double-blind period of at least 24 weeks (24 to 64 weeks).
Maltese: Pazjenti f'remissjoni wara l-perjodu ta' kura tal-bidu ta' 12-il ġimgħa open-label b'vortioxetine kienu randomised għal vortioxetine 5 jew 10 mg/kuljum jew plaċebo u osservati għal rikaduta waqt perjodu double-blind ta' mill-inqas 24 ġimgħa (24 sa 64 ġimgħa).
English: Multipacks: 490 (5 packs of 98 x 1) film-coated tablets.
Maltese: Pakketti multipli: 490 ( 5 pakketti ta' 98 x 1) pillola miksijin b'rita.
English: Pink, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “5” on the other side.
Maltese: Pillola miksija b'rita ta' lewn roża, forma ta' lewża (5 x 8.4 mm) imnaqqxa b'“TL ”fuq naħa waħda u “5 ”fuq in-naħa l-oħra.
English: Brintellix oral drops, solution, are available in 20 ml amber glass bottle including screw cap with dropper (child-resistant closure).
Maltese: Brintellix qtar orali, soluzzjoni, huma disponibbli fi flixken tal-ħġieġ ta' 20 ml lewn l-ambra li jinkludi għatu tal-kamin bi dropper (għeluq li jirreżisti l-ftuħ mit-tfal).