FrancophonIA/ELRC3.0 huggingface dataset:
English: Agomelatine inhibits neither CYP1A2 in vivo nor the other CYP450 in vitro.
Maltese: Agomelatine ma jimpedixxix la CYP1A2 in vivo lanqas CYP450 oħrajn in vitro.
English: Valdoxan contains the active ingredient agomelatine.
Maltese: Valdoxan fih is-sustanza attiva agomelatine.
English: Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) (see section 4.5).
Maltese: Użu flimkien ta' impedituri qawwija CYP1A2 (bħal fluvoxamine, ciprofloxacin) (ara sezzjoni 4.5). 4.4
English: One person having ingested 2,450 mg agomelatine, recovered spontaneously without cardiovascular and biological abnormalities.
Maltese: Persuna waħda li belgħet 2,450 mg agomelatine, irkuprat b'mod spontaneju mingħajr anormalitajiet kardjovaskulari u bijoloġiċi.
English: Gastrointestinal Disorders
Maltese: Disturbi gastro-intestinali Komuni
English: Increased ALT and/or AST (in clinical trials, increases >3 times the upper limit of the normal range for ALT and/or AST were seen in 1.2% of patients on agomelatine 25 mg daily and 2.6 % on agomelatine 50 mg daily vs. 0.5% on placebo).
Maltese: Żidiet fl-ALT u/jew fl-AST (fi provi kliniċi, dehru żidiet >3 darbiet mill-ogħla limitu tal-firxa normali għal ALT u/jew AST f'1.2 % tal-pazjenti fuq agomelatine 25 mg kuljum u f'2.6 % fuq agomelatine 50 mg kuljum kontra 0.5 % fuq plaċebo)
English: Pharmacotherapeutic group: Psychoanaleptics, other antidepressants, ATC-code: N06AX22 Mechanism of action
Maltese: Psikoanalettiċi, antidippressanti oħra, kodiċi ATC:
English: Hepatic impairment Agomelatine is contraindicated in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Maltese: Indeboliment tal-fwied Agomelatine huwa kontraindikat f'pazjenti b'disturbi fil-fwied (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Adverse reactions are listed below using the following convention: very common (≥1/10); common (≥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 mniżżlin hawn taħt u jsegwu din il-konvenzjoni: komuni ħafna ( ≥ 1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1000 sa 1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Film-coating
Maltese: Żieda fil-piż*
English: A placebo-controlled 8-week trial of agomelatine 25-50mg/day in elderly depressed patients (≥ 65 years, N=222, of which 151 on agomelatine) demonstrated a statistically significant difference of 2.67 points on HAM-D total score, the primary outcome.
Maltese: Prova fuq 8 ġimgħat ikkontrollata bi plaċebo ta' agomelatine 25-50 mg/kuljum fuq pazjenti anzjani biddipressjoni (≥ 65 sena, N = 222, li minnhom 151 kienu fuq agomelatine) uriet differenza statistikament sinifikanti ta' 2.67 punti fuq il-punteġġ totali ta' HAM-D, ir-riżultat primarju.
English: Switching therapy from SSRI/SNRI antidepressant to agomelatine Patients may experience discontinuation symptoms after cessation from an SSRI/ SNRI antidepressant.
Maltese: Il-qlib tat-terapija minn antidipressanti SSRI/SNRI għal agomelatine Il-pazjenti jistgħu jesperjenzaw sintomi ta' diskontinwazzjoni wara l-waqfien minn antidipressant SSRI/ SNRI.
English: Anpharm Przedsiebiorstwo Farmaceutyczne S.A. 03-236 Warszawa ul.
Maltese: 03-236 Warszawa
English: Agomelatine did not show proconvulsive properties at ip doses up to 128 mg/kg in mice and rats.
Maltese: Agomelatine ma weriex karatteristiċi prokonvulżivi f'dożi intraperitoneal sa 128 mg/kg fil-ġrieden u fil-firien.
English: Following oral administration, agomelatine is rapidly metabolised mainly via hepatic CYP1A2; CYP2C9 and CYP2C19 isoenzymes are also involved but with a low contribution.
Maltese: Wara amministrazzjoni orali, agomelatine jiġi metabolizzat b'mod mgħaġġel l-iktar permezz ta' CYP1A2 epatiku; isoenżimi CYP2C9 u CYP2C19 huma wkoll involuti imma b'kontribuzzjoni baxxa.
English: Tinnitus*
Maltese: Tinnite*
English: Combination of agomelatine with oestrogens (moderate CYP1A2 inhibitors) results in a several fold increased exposure of agomelatine.
Maltese: Użu flimkien t'agomelatine ma' estroġeni (impedituri moderati CYP1A2) jirriżulta f'diversi drabi iżjed esponiment t'agomelatine.
English: Calendar packs containing 14, 28, 56, 84 and 98 film-coated tablets.
Maltese: Kaxxi tal-kartun ippakkjati f'folji tal-aluminju/PVC Il-pakketti tal-kalendarju fihom 14, 28, 56, 84 u 98 pilloli miksija b'rita.
English: - Uncommon side effects (may affect up to 1 in 100 people): migraine, pins and needles in the fingers and toes (paraesthesia), blurred vision, restless legs syndrome (a disorder that is characterized by an uncontrollable urge to move the legs), ringing in the ears, excessive sweating (hyperhidrosis), eczema, pruritus, urticaria (hives), agitation, irritability, restlessness, aggressive behaviour, nightmares, mania/hypomania (see also under “Warnings and precautions” in section 2), suicidal thoughts or behaviour,confusion, weight decreased.
Maltese: - Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): emigranja, tniggiż fisswaba' tal-idejn u s-saqajn (paraesthesia), vista mċajpra, sindrome ta' irrikwietezza tas-saqajn (disturb li huwa kkaratterizzat minn urġenza inkontrollabbli li ċċaqlaq saqajk), ċempil fil-widnejn, togħroq ħafna (iperidrożi), ekżema, prurite, urtikarja (ħorriqija), aġitazzjoni, irritabilità, irrekwitezza, imġiba aggressiva, ħolm ikrah, manija/ipomanija (ara wkoll taħt “Twissijiet u prekawzjonijiet” f'sezzjoni 2), ħsibijiet u mġiba suwiċidali, konfużjoni, tnaqqis fil-piż.
English: The pooled analysis of trials using the Arizona Sexual Experience Scale (ASEX) showed that agomelatine was not associated with sexual dysfunction.
Maltese: Ġabra ta' provi analizzati permezz tal-Iskala Sesswali Arizona (ASEX) urew li agomelatine ma kienx assoċjat ma' disfunzjoni sesswali.
English: Valdoxan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Valdoxan fih inqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment “mingħajr sodium”.
English: Valdoxan contains lactose
Maltese: Valdoxan fih lactose
English: In a pharmacokinetic study in elderly patients (≥ 65 years), it was showed that at a dose of 25 mg the mean AUC and mean Cmax were about 4-fold and 13-fold higher for patients ≥ 75 years old compared to patients < 75 years old.
Maltese: Fi studju farmakokinetiku fuq pazjenti anzjani (≥ 65 sena), intwera li f'doża ta' 25 mg l-AUC medju u sCmax medju kienu madwar 4 darbiet u 13-il darba ogħla għall-pazjenti ≥ 75 sena meta mqabbla ma'
English: United Kingdom Servier Laboratories Ltd
Maltese: Servier Laboratories (Ireland) Ltd.
English: The incidence of relapse during the 6-months double-blind follow up period was 22% and 47% for agomelatine and placebo, respectively.
Maltese: L-inċidenza li l-marda terġa' titfaċċa waqt is-6 xhur segwiti doubleblind kienet 22% u 47% għal agomelatine u plaċebo, rispettivament.
English: The percentage of patients with at least one discontinuation symptom one week after the SSRI/SNRI treatment stop, was lower in the long tapering group (gradual cessation of the previous SSRI/SNRI within 2 weeks) than in the short tapering group (gradual cessation of the previous SSRI/SNRI within 1 week) and in the abrupt substitution group (abrupt cessation): 56.1%, 62.6 % and 79.8% respectively.
Maltese: (waqfien gradwali tal-SSRI/SNRI preċedenti fi żmien ġimgħa) u fil-grupp ta' sostituzzjoni f'daqqa (waqfien f'daqqa): 56.1%, 62.6 % u 79.8% rispettivament.
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: In rodents, a marked induction of CYP2B and a moderate induction of CYP1A and CYP3A were seen from 125 mg/kg/day whereas in monkeys the induction was slight for CYP2B and CYP3A at 375 mg/kg/day.
Maltese: F'annimali li jgerrmu, induzzjoni qawwija ta' CYP2B u induzzjoni moderata ta' CYP1A u CYP3A dehru minn 125 mg/kg/kuljum waqt li fix-xadini, l-induzzjoni kienet ftit għal CYP2B u CYP3A bi
English: Primary endpoint was change in HAMD-17 score from baseline.
Maltese: Punt ta' tmiem primarju kien bidla fil punteġġ HAMD-17 mil-linja bażi.
English: Patients responding to 8/10-weeks of acute treatment with open-label agomelatine 25-50 mg once daily were randomised to either agomelatine 25-50 mg once daily or placebo for further 6-months.
Maltese: Il-pazjenti li rrispondew għall-kura akuta ta' 8/10 ġimgħat b'agomelatine open-label 25-50 mg darba kuljum kienu randomizzati għal jew agomelatine 25-50 mg darba kuljum jew plaċebo għal 6 xhur oħra.
English: Confusional state*
Maltese: Stat ta' konfużjoni*
English: Akathisia*
Maltese: Akatiżja*
English: The frequencies have not been corrected for placebo.
Maltese: Il-frekwenzi ma ġewx irregolati għal plaċebo.
English: No improvement was observed in very elderly patients (≥75 years, N= 69, of which 48 on agomelatine).
Maltese: Ma ġie osservat l-ebda titjib f'pazjenti anzjani ħafna (≥ 75 sena, N = 69, li minnhom 48 kienu fuq agomelatine).
English: Surveillance of the liver function (see also section 2):
Maltese: Sorveljanza tal-funzjoni tal-fwied (ara wkoll sezzjoni 2):
English: No relevant modification in agomelatine pharmacokinetic parameters in patients with severe renal impairment has been observed.
Maltese: L-ebda modifikazzjoni relevanti f'parametri farmakokinetiċi ta' agomelatine f'pazjenti b'disturbi fil-kliewi serji ma ġiet osservata.
English: Tel: +371 67502039
Maltese: SIA Servier Latvia Tel: +371 67502039
English: Hallucinations*
Maltese: Alluċinazzjonijiet *
English: Consequently, co-administration of Valdoxan with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.
Maltese: korriment tal-fwied u interazzjonijiet ma' inibituri qawwijin tas-CYP1A2 (eż. fluvoxamine, ciprofloxacin);
English: The efficacy and safety of agomelatine in major depressive episodes have been studied in a clinical programme including 7,900 patients treated with agomelatine.
Maltese: Effikaċja klinika u sigurtà L-effikaċja u s-sigurtà ta' agomelatine f'episodji dipressivi maġġuri ġew studjati fi programm kliniku li jinkludi 7900 pazjent ikkurati b'agomelatine.
English: Each film-coated tablet contains 61.8 mg lactose (as monohydrate) For the full list of excipients, see section 6.1.
Maltese: Kull pillola miksija b'rita fiha 61.8 mg lactose (bħala monohydrate).
English: No effect is documented in patients ≥75 years.
Maltese: Ma ġie ddokumentat l-ebda effett f'pazjenti ≥ 75 sena.
English: Safety pharmacology studies showed no effect of agomelatine on hERG (human Ether à-go-go Related Gene) current or on dog Purkinje cells action potential.
Maltese: Studji tas-sigurtà farmakoloġika ma wrew l-ebda effett t'agomelatine fuq hERG (Ether à-go-go Ġene Uman Relatat) kurrenti jew fuq l-azzjoni potenzjali taċ-ċelloli tal-kelb Purkinje.
English: Excretion is mainly (80%) urinary and in the form of metabolites, whereas unchanged compound recovery in urine is negligible.
Maltese: L-eskrezzjoni hija l-iktar fl-awrina (80%) u permezz ta' sustanzi tal-metaboliżmu, filwaqt li l-forma mhux mibdula miġbura fl-awrina hija negliġibbli.
English: Valdoxan 25 mg film-coated tablets agomelatine
Maltese: Valdoxan 25 mg pilloli agomelatine
English: What is in this leaflet:
Maltese: Jista' jkun hemm xi raġunijiet għala Valdoxan ma jkunx jaqbel miegħek:
English: No relevant modification of pharmacokinetic parameters in patients with severe renal impairment has been observed (n=8, single dose of 25 mg), but caution should be exercised in patients with severe or moderate renal impairment as only limited clinical data are available in these patients (see section 4.2).
Maltese: L-ebda modifikazzjoni relevanti tal-parametri farmakokinetiċi f'pazjenti b'indeboliment tal-kliewi sever ma ġiet osservata (n=8, doża waħda ta' 25 mg) imma għandha tingħata attenzjoni f'pazjenti li għandhom indeboliment tal-kliewi sever jew moderat minħabba li l-informazzjoni klinika pprovduta hija limitata f'dawn il-pazjenti (ara sezzjoni 4.2).
English: In the therapeutic dose-range, agomelatine systemic exposure increases proportionally with dose.
Maltese: Fil-livell tad-doża terapewtika l-esponiment sistemiku għall-agomelatine jiżdied proporzjonalment maddoża.
English: Smoking induces CYP1A2 and has been shown to decrease the bioavailability of agomelatine, especially in heavy smokers (> 15 cigarettes/day) (see section 5.2).
Maltese: It-tipjip jinduċi CYP1A2 u ntwera li jnaqqas il-bijodisponibilità ta' agomelatine, b'mod speċjali f'dawk li jpejpu ħafna (≥ 15-il sigarett/kuljum) (ara sezzjoni 5.2).
English: During your treatment with Valdoxan :
Maltese: Matul il-kura tiegħek b'Valdoxan:
English: Hyperhidrosis Eczema Pruritus* Urticaria*
Maltese: • Gwida dwar l-iskema ta' monitoraġġ epatiku
English: You should not take Valdoxan together with certain medicines (see also under “Do not take Valdoxan” in section 2): fluvoxamine (another medicine used in the treatment of depression), ciprofloxacin (an antibiotic) can modify the expected dose of agomelatine in your blood.
Maltese: M'għandekx tieħu Valdoxan flimkien ma' ċertu mediċini (ara wkoll taħt ‘Tiħux Valdoxan' f'sezzjoni 2): fluvoxamine (mediċina oħra użata biex tikkura d-dipressjoni), ciprofloxacin (antibijotiku) jistgħu jbiddlu ddoża mistennija ta' agomelatine fid-demm tiegħek.
English: 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: .1 Proprjetajiet farmakodinamiċi
English: Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure.
Maltese: Prodotti mediċinali li għandhom interazzjoni ma' dawn l-isoenżimi jistgħu jnaqqsu jew iżidu il bijodisponibilità t'agomelatine. Fluvoxamine, impeditur ta'CYP1A2 qawwi u ta' CYP2C9 moderat jimpedixxi b'mod ċar il-metaboliżmu t'agomelatine u jirriżulta għal żieda ta' 60 darba (livell 12-412) għall-effetti t'agomelatine.
English: Hepatic impairment (i.e. cirrhosis or active liver disease) or transaminases exceeding 3 X upper limit of normal (see sections 4.2 and 4.4).
Maltese: Disturbi fil-fwied (i.e. ċirrożi jew marda attiva fil-fwied) jew transaminażi ta' aktar minn 3 X il-limitu ta' fuq tan-normal (ara sezzjonijiet 4.2 u 4.4).
English: These effects are usually mild to moderate and disappear spontaneously within a few days.
Maltese: Dawn l-effetti huma normalment ħfief għal moderati u jgħibu spontanjament fi ftit jiem.
English: Agomelatine has no abuse potential as measured in healthy volunteer studies on a specific visual analogue scale or the Addiction Research Center Inventory (ARCI) 49 check-list.
Maltese: Agomelatine ma weriex xi abbuż potenzjali meta mkejjel fi studji fuq voluntiera b'saħħithom fuq skala analogu viżwali speċifika jew fid-49 lista tal-Inventarju taċ-Ċentru tar-Riċerka fuq id-Dipendenza (ARCI).
English: What Valdoxan looks like and contents of the pack Valdoxan 25 mg film-coated tablets (tablet) are oblong, orange-yellow with a blue imprint of ‘company logo'
Maltese: Kif jidher Valdoxan u l-kontenut tal-pakkett Valdoxan 25 mg pilloli miksija b'rita (pillola) huma rettangolari, oranġjo fl-isfar bil-logo tal-kumpanija mnaqqax bil-blu fuq naħa minnhom.
English: Jaundice*
Maltese: Rimettar*
English: Responder rate analysis favoured agomelatine.
Maltese: Analiżi tar-rata ta' rispons iffavorixxiet lill-agomelatine.
English: Therefore, agomelatine should not be used by patients in this age group (see sections 4.4 and 5.1).
Maltese: Għaldaqstant, agomelatine ma għandux jintuża minn pazjenti f'dan il-grupp ta' età (ara sezzjonijiet 4.4 u 5.1).
English: The efficacy and safety of agomelatine (25 to 50mg/day) have been established in elderly depressed patients (< 75years).
Maltese: Anzjani L-effikaċja u s-sigurtà ta' agomelatine (25 sa 50 mg/kuljum) ġew stabbiliti f'pazjenti anzjani bid dipressjoni (< 75 sena).
English: Therefore, agomelatine will not modify exposure to medicinal products metabolised by CYP 450.
Maltese: Għalhekk, agomelatine ma jimmodifikax l-effetti ta' prodotti mediċinali oħra metabolizzati b'CYP 450.
English: While there was no specific safety signal in the 800 patients treated in combination with oestrogens, caution should be exercised when prescribing agomelatine with other moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) until more experience has been gained (see section 4.4).
Maltese: Filwaqt li ma kienx hemm ebda sinjal speċifiku ta' sigurtà fit-800 pazjent ikkurati bl-użu flimkien ma' estroġeni, kawtela għandha tingħata meta jiġi preskritt agomelatine ma' impedituri CYP1A2 moderati oħra (eż. propranolol, enoxacine) sakemm tinkiseb iktar esperjenza (ara sezzjoni 4.4).
English: Agitation and related symptoms* (such as irritability and restlessness) Aggression*
Maltese: Ħsibijiet jew imġiba suwiċidali (ara sezzjoni 4.4) Aġitazzjoni u sintomi relatati* (bħal irritabilità u irrekwitezza) Aggressjoni *
English: In a specific sexual dysfunction comparative trial with remitted depressed patients, there was a numerical trend (not statistically significant) towards less sexual emergent dysfunction than venlafaxine for Sex Effects Scale (SEXFX) drive arousal or orgasm scores on agomelatine.
Maltese: Fi prova komparattiva speċifika fuq disfunzjoni sesswali f'pazjenti li ma baqgħux ibatu bid-dipressjoni, kien hemm trend numerikali (mhux statistikament sinifikanti) lejn inqas disfunzjoni sesswali b'agomelatine minn b'venlafaxine għall-impulsi sesswali u orgażmi mkejla b'punti miksuba fl-Iskala tal-Effetti Sesswali
English: Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet with blue imprint of company logo on one side.
Maltese: Pillola rettangolari oranġjo fl-isfar, twila 9.5 mm, wiesgħa 5.1 mm miksija b'rita bil-logo tal-kumpanija mnaqqax bil-blu fuq naħa minnhom.
English: Other medicinal products
Maltese: Prodotti mediċinali oħra
English: Valdoxan 25 mg film-coated tablets are available in calendar blisters.
Maltese: Valdoxan 25 mg pilloli miksija b'rita huma disponibbli f'folji b'kalendarju.
English: ‐ the increase in serum transaminases exceeds 3 X upper limit of normal.
Maltese: • Kontraindikazzjoni f'pazjenti bi transaminażi li taqbeż 3 darbiet il-limitu ta' fuq tan-normal;
English: The major metabolites, hydroxylated and demethylated agomelatine, are not active and are rapidly conjugated and eliminated in the urine.
Maltese: Is-sustanzi maġġuri li joħorġu fil-metaboliżmu, agomelatine hydroxylated u demethylated, mhumiex attivi u jikkonjugaw mill-ewwel u jiġu eliminati mal-awrina.
English: Depression is a continuing disturbance of mood that interferes with everyday life.
Maltese: Id-dipressjoni hija taħwid kontinwu tal-burdata li tinterferixxi mal-ħajja ta' kuljum.
English: Tolerability of agomelatine in elderly patients was comparable to that seen in the younger adults.
Maltese: It-tollerabilità ta' agomelatine f'pazjenti anzjani kienet komparabbli ma' dik li dehret f'adulti iżgħar.
English: Potential interactions affecting agomelatine
Maltese: Interazzjonijiet li potenzjalment jaffettwaw agomelatine
English: The below table gives the adverse reactions observed from placebo-controlled and active-controlled clinical trials.
Maltese: It-tabella ta' hawn taħt tagħti r-reazzjonijiet avversi osservati minn provi kliniċi kkontrollati bi plaċebo u bis sustanza attiva.
English: Servier Laboratories (Ireland) Ltd. Tel: +353 (0)1 663 8110
Maltese: United Kingdom Servier Laboratories Ltd Tel: +44 (0)1753 666409
English: The Physician's guide to prescribing should contain the following key messages: The need to inform patients about the potential risk of transaminases elevations,the risk of liver injury and interactions with potent CYP 1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin); The need to perform liver function tests in all patients before starting treatment and periodically thereafter around three, six (end of acute phase), twelve and twenty four weeks (end of maintenance phase), and thereafter when clinically indicated; The need to perform liver function tests at the same frequency as at treatment initiation in all patients where the dosage is increased; Guidance in case of clinical symptoms of hepatic dysfunction; Guidance in case of liver function test abnormality; Caution should be exercised when therapy is administered to patients with pretreatment elevated transaminases (> the upper limit of the normal ranges and < 3 times the upper limit of the normal range); Caution should be exercised when therapy is prescribed for patients with hepatic injury risk factors e.g. obesity/overweight/non-alcoholic fatty liver disease, diabetes, alcohol use disorder and /or substantial alcohol intake or concomitant medicinal products associated with risk of hepatic injury; Contra-indication in patients with hepatic impairment (i.e. cirrhosis or active liver disease); Contraindication in patients with transaminases exceeding 3 X upper limit of normal; Contra-indication in patients receiving concomitantly potent CYP1A2 inhibitors.
Maltese: • Għandha tiġi eżerċitata l-kawtela meta tingħata terapija (b'riċetta ta' tabib) għall-pazjenti b'fatturi ta' riskju ta' korriment tal-fwied eż. obeżità/piż eċċessiv/mard tal-fwied xaħmi mhux alkoħoliku, dijabete, disturb fl-użu tal-alkoħol u/jew teħid sostanzjali ta' alkoħol jew prodotti mediċinali fl-istess ħin assoċjati ma' riskju ta' korriment tal-fwied;
English: In vivo, agomelatine does not induce CYP450 isoenzymes.
Maltese: L-effett potenzjali t'agomelatine fuq prodotti mediċinali oħra In vivo, agomelatine ma jinduċix isoenżimi CYP450.
English: A battery of in vitro and in vivo standard genotoxicity assays concludes to no mutagenic or clastogenic potential of agomelatine.
Maltese: Numru ta' kejl ġenotossiku li jintużaw is-soltu in vitro u in vivo ikkonkludew li agomelatine m'għandux potenzjal mutaġeniku u klastoġeniku.
English: Treatment should be discontinued if transaminases exceed 3 X upper limit of normal (see sections 4.3 and 4.4).
Maltese: Il-kura għandha titwaqqaf jekk it-transaminażi taqbeż 3 darbiet il-limitu ta' fuq tan-normal (ara sezzjonijiet 4.3 u 4.4).
English: The requirements for submission of periodic safety update 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 biex jiġu ppreżentati 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 lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: At the end of treatment (over 6 or 8 weeks), significant efficacy of agomelatine 25-50 mg was demonstrated in 6 out of the ten short-term double-blind placebo-controlled trials.
Maltese: Fl-aħħar tal-kura (tul 6 sa 8 ġimgħat), effikaċja sinifikanti t'agomelatine 25 u 50 mg intweriet fis-6 minn għaxar provi double-blind li saru f'perjodu ta' żmien qasir ikkontrollati bi plaċebo.
English: No dose adjustment is required in relation to age (see section 5.2).
Maltese: Ma hemm l-ebda ħtieġa ta' aġġustament fid-doża relatata mal-età (ara sezzjoni 5.2).
English: Anxiety Abnormal dreams*
Maltese: Ħolm mhux normali*
English: Valdoxan is for oral use.
Maltese: Valdoxan huwa għall-użu orali.
English: Agomelatine has shown an antidepressant-like effect in animal models of depression (learned helplessness test, despair test, chronic mild stress) as well as in models with circadian rhythm desynchronisation and in models related to stress and anxiety.
Maltese: Agomelatine wera xebh ta' effett antidippressiv f'mudelli t'annimali b'dipressjoni (test nuqqas ta' ħeġġa mgħallma, test disperazzjoni, stress mhux qawwi kroniku) flimkien ukoll f'mudelli b'ritmu ċirkadjan disinkronizzat u f'mudelli relatati ma' stress u anzjetà.