FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 125 children (2-17.0 years of age, mean age 8.7 +/- 4.15; 96.8% ASD, 3.2% Smith-Magenis syndrome [SMS]) whose sleep failed to improve on behavioural intervention alone were randomized and 112 weeks' results are available.
Maltese: Total ta' 125 tifel u tifla (ta' bejn sentejn u sbatax-il sena, ta' età medja ta' 8.7 +/- 4.15; 96.8 % ASD, 3.2 % is-sindromu ta' Smith-Magenis [SMS]) li l-irqad tagħhom ma tjiebx bl-intervent tal-imġiba waħdu ġew randomized u huma disponibbli 112-il ġimgħa ta' riżultati. 28.8 % tal-pazjenti instab li kellhom l-ADHD qabel il-bidu tal-istudju u 77 % kellhom punteġġ ta' nuqqas ta' attenzjoni/iperattività SDQ anormali (>=7) fil-linja bażi.
English: Melatonin does not induce CYP1A2 or CYP3A enzymes in vitro at supra-therapeutic concentrations.
Maltese: Il-melatonina ma tikkaġunax enżimi ta' CYP1A2 jew CYP3A f'konċentrazzjonijiet supraterapewtiċi in vitro.
English: The study comprises 5 periods: 1) pre-study period (4 weeks), 2) baseline single-blind placebo period (2 weeks), 3) randomized placebo-controlled treatment period (13 weeks), 4) open label treatment period (91 weeks), and 5) single blind run-out period (2 weeks placebo).
Maltese: L-istudju huwa mifrux fuq 5 perjodi: 1) il-perjodu ta' qabel l-istudju (4 ġimgħat), 2) il-perjodu ta' plaċebo single-blind tal-linja bażi (ġimagħtejn), 3) perjodu ta' trattament randomized ikkontrollat minn plaċebo (13-il ġimgħa), 4) perjodu ta' trattament ta' prova miftuħ (91 ġimgħa), u 5) perjodu ta' run-out single blind (ġimagħtejn plaċebo).
English: In adults, following Slenyto 5 mg (1 x 5 mg mini-tablet) administered after food, melatonin concentrations peaked within 3 hours after administration; Cmax (SD) was 3.57 ng/ml (3.64) in plasma.
Maltese: Fl-adulti, wara li Slenyto 5 mg (pillola żgħira ta' 5 mg) ingħata wara l-ikel, il-konċentrazzjonijiet ta' melatonina laħqu l-ogħla livelli fi żmien 3 sigħat mill-għoti; is-Cmax (SD) kien 3.57 ng/ml (3.64) filplażma.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1318/003: 30 prolonged-release tablets (blister pack) EU/1/18/1318/004: 30 prolonged-release tablets (bottle)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1318/003: 30 pillola li jerħu l-mediċina bil-mod (pakkett folji) EU/1/18/1318/004: 30 pillola li jerħu l-mediċina bil-mod (flixkun)
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Maltese: Data mhux klinika ma wriet l-ebda periklu speċjali għall-bnedmin ibbażat fuq studji konvenzjonali ta' farmakoloġija ta' sigurtà, tossiċità ta' doża ripetuta, ġenotossiċità, potenzjal karċinoġeniku, tossiċità għar-riproduzzjoni u żvilupp.
English: • methoxypsoralens (used in the treatment of skin disorders e.g. psoriasis)
Maltese: • methoxypsoralens (użati fit-trattament tad-disturbi tal-ġilda e.ż. il-prorjażi)
English: EU/1/18/1318/001: 60 prolonged-release tablets
Maltese: EU/1/18/1318/001: 60 pillola li jerħu l-mediċina bil-mod
English: Patients (51 from the Slenyto group and 44 from the placebo group, mean age 9 ± 4.24 years, range 2-17.0 years) received open-label Slenyto 2/5 mg according to the double-blind phase dose, for 91 weeks with optional dose adjustment to 2, 5 or 10 mg/day after the first 13 weeks of follow-up period.
Maltese: Il-pazjenti (51 mill-grupp ta' Slenyto u 44 mill-grupp tal-plaċebo, ta' età medja ta' 9 ± 4.24 snin, firxa ta' sentejn-sbatax-il sena) rċivew Slenyto 2/5 mg ta' prova miftuħa skont id-doża tal-fażi double-blind, għal 91 ġimgħa b'aġġustament ta' doża fakultattiva sa 2, 5 jew 10 mg/kuljun wara l-ewwel 13il ġimgħa sal-perjodu ta' segwitu.
English: Slenyto is a medicine that contains the active ingredient, melatonin.
Maltese: Slenyto huwa mediċina li fiha s-sustanza attiva, melatonina.
English: The predominant metabolic flux is through hydroxylation at C6 via the hepatic microsome P-450 system to yield 6-hydroxymelatonin.
Maltese: Il-fluss metaboliku predominanti iseħħ bl-ossidrilazzjoni f'C6 permezz tas-sistema tal-mikrożomu tal-fwied P-450 li tipproduċi 6-hydroxymelatonin.
English: 1 mg strength - The active substance is melatonin.
Maltese: - Is-sustanza attiva hi melatonina.
English: After 13 weeks of double-blind treatment, participants slept on average 57.5 minutes longer at night with Slenyto compared to 9.1 minutes with placebo adjusted mean treatment difference Slenyto-placebo 33.1 minutes in the all Randomized Set; Multiple Imputation (MI) (p=0 .026).
Maltese: Wara 13-il ġimgħa ta' trattament double-blind, il-parteċipanti bħala medja raqdu 57.5 minuti aktar bil-lejl b'Slenyto meta mqabbel ma' 9.1 minuti bi plaċebo differenza ta' trattament medju aġġustat bejn Slenyto u l-plaċebo ta' 33.1 minuti fis-Sett Randomized kollu; Imputazzjoni Multipla (MI) (p=0 .026).
English: Slenyto contains lactose
Maltese: Slenyto fih lactose
English: Pack size: 30 tablets or 60 tablets.
Maltese: Daqs tal-pakkett: 30 pillola jew 60 pillola.
English: Takeda Pharma AB Tel: +46 8 731 28 00 e-mail: infosweden@takeda.com
Maltese: Tel: +46 8 731 28 00 e-mail: infosweden@takeda.com
English: Other medicines and Slenyto
Maltese: Mediċini oħra u Slenyto
English: Two liver-mediated metabolic pathways account for around 90% of melatonin metabolism.
Maltese: Żewġ passaġġi metaboliċi medjati mill-fwied huma responsabbli minn madwar 90 % tal-metaboliżżar tal-melatonina.
English: • fluvoxamine (used for the treatment of depression and obsessive compulsive disorder)
Maltese: • fluvoxamine (użata għat-trattament tad-dipressjoni u d-disturb ossessiv-kompulsiv)
English: DATE OF REVISION OF THE TEXT {DD month YYYY}
Maltese: DATA TA' REVIŻJONI TAT-TEST {JJ xahar SSSS}
English: Each tablet contains 1 mg melatonin.
Maltese: Kull pillola fiha 1 mg melatonina.
English: For the total SDQ score after 13 weeks of double blind treatment, there was a trend to benefit in favour of Slenyto (p=0.077).
Maltese: Għall-punteġġ totali tal-SDQ wara 13-il ġimgħa ta' trattament double-blind, kien hemm xejra ta' benefiċċju favur Slenyto (p=0.077).
English: Table 2: PARENTS WELL BEING (13 weeks Double- blind)
Maltese: TAL-ĠENITURI (13-il ġimgħa Double-blind)
English: 74 patients completed 104 weeks of treatment, 39 completed 2 years and 35 completed 21 months of Slenyto treatment.
Maltese: 74 pazjent lestew 104 ġimgħat ta' trattament, 39 lestew sentejn u 35 lestew 21 xahar ta' trattament b'Slenyto.
English: CYP1A2 inhibitors such as quinolones (ciprofloxacin and norfloxacin) may give rise to increased melatonin exposure.
Maltese: L-inibituri ta' CYP1A2 bħal quinolones (ciprofloxacin and norfloxacin) jistgħu jwasslu għal esponiment akbar għall-melatonina.
English: - The other ingredients are ammonio methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talc, magnesium stearate, carmellose sodium (E466), maltodextrin, glucose monohydrate, lecithin (E322),
Maltese: - L-ingredjenti l-oħra huma ammonio methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talc, magnesium stearate, carmellose sodium (E466), maltodextrin, glucose monohydrate, lecithin (E322), titanium dioxide (E171), iron oxide red (E172) u iron oxide yellow (E172).
English: Prostaglandin synthesis inhibitors (NSAIDs) such as acetylsalicylic acid and ibuprofen, given in the evening may suppress endogenous melatonin levels in the early part of the night by up to 75%.
Maltese: L-inibituri ta' sinteżi prostaglandina (NSAIDs) bħal acetylsalicylic acid u ibuprofen, mogħtija filgħaxija jistgħu jrażżnu l-livelli ta' melatonina endoġena fil-parti bikrija tal-lejl sa massimu ta' 75 %.
English: Iberfar - Indústria Farmacêutica, S.A.
Maltese: Fidia Farmaceutici S.p.A.
English: Both 6hydroxymelatonin and N-acetylserotonin are ultimately conjugated to sulfate and glucoronic acid, and excreted in the urine as their corresponding 6-sulfatoxy and 6-glucoronide derivatives.
Maltese: Kemm 6-hydroxymelatonin kif ukoll Nacetylserotonin fl-aħħar mill-aħħar jiġu kkonjugati mas-sulfat u mal-aċidu glukoroniku, u eliminati mal-awrina bħad-derivattivi korrispondenti tagħhom 6-sulfatoxy u 6-glucoronide.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata f'sezzjoni 6.1.
English: Pharmacotherapeutic group: Psycholeptics, melatonin receptor agonists, ATC code: N05CH01 Mechanism of action
Maltese: Psikolettiċi, agonisti tar-riċettur tal-melatonina, kodiċi ATC:
English: Slenyto 1 mg prolonged-release tablets Slenyto 5 mg prolonged-release tablets melatonin
Maltese: Slenyto 1 mg pilloli li jerħu l-meċina bil-mod Slenyto 5 mg pilloli li jerħu l-mediċina bil-mod melatonina
English: 5 mg strength
Maltese: Qawwa ta' 5 mg
English: Slenyto Placebo
Maltese: Plaċebo
English: The activity of melatonin at the melatonin receptors (MT1, MT2 and MT3) is believed to contribute to its sleep-promoting properties, as these receptors (mainly MT1 and MT2) are involved in the regulation of circadian rhythms and sleep regulation.
Maltese: L-attività tal-melatonina fuq ir-riċetturi tal-melatonina (MT1, MT2 u MT3) hija maħsuba li tikkontribwixxi għall-karatteristiċi tagħha li jistimolaw l-irqad, minħabba li dawn ir-riċetturi (l-aktar MT1 u MT2) huma involuti fir-regolazzjoni tar-ritmi ċirkadjani u r-regolazzjoni tal-irqad.
English: • Tiredness
Maltese: • Stitikezza
English: Melatonin undergoes a fast first hepatic pass metabolism and is metabolised predominantly by CYP1A enzymes, and possibly CYP2C19 of the cytochrome P450 system with elimination half life of ca 40 minutes.
Maltese: Il-melatonina tgħaddi minn metaboliżmu rapidu tal-ewwel passaġġ tal-fwied u hija metabolizzata b'mod predominanti minn enżimi ta' CYP1A, u aktarx ta' CYP2C19 tas-sistema ċitokromu P450 b'half life metabolika ta' madwar 40 minuta.
English: In a clinical trial, there was clear evidence for a transitory pharmacodynamic interaction between melatonin and zolpidem one hour following co-dosing.
Maltese: Fi prova klinika, kien hemm evidenza ċara għal interazzjoni farmakodinamika tranżitorja bejn il-melatonina u ż-zolpidem siegħa wara l-ko-dożaġġ.
English: Melatonin has been co-administered in studies with thioridazine and imipramine, active substances which affect the central nervous system.
Maltese: Il-melatonina ġiet koamministrata fl-istudji ma' thioridazine u imipramine, sustanzi attivi li jaffettwaw is-sistema nervuża ċentrali.
English: (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare
Maltese: Mhux komuni (≥ 1/1 000 sa < 1/100);
English: Patients had a significantly decreased total excretion of 6-sulfatoxymelatonin compared with controls.
Maltese: Ilpazjenti naqqsu b'mod sinifikanti l-eliminazzjoni totali ta' 6-sulfatoxymelatonin meta mqabbel malkontrolli.
English: For social functioning (CGAS), the differences between Slenyto and placebo were small and not statistically significant (Table 1).
Maltese: Għallfunzjonament soċjali (CGAS), id-differenzi bejn Slenyto u l-plaċebo kienu żgħar iżda mhux statistikament sinifikanti (Tabella 1).
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Iberfar Indústria Farmacêutica S.A.,
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur(i) responsabbli mill-ħruġ tal-lott Iberfar Indústria Farmacêutica S.A.,
English: • cimetidine (used in the treatment of stomach problems such as ulcers)
Maltese: • cimetidine (użata fit-trattament ta' problemi tal-istonku bħal ulċeri)
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Il-pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, id-defiċjenza totali ta' lactase jew l-assorbiment ħażin ta' glucose-galactose ma għandhomx jieħdu din il-mediċina. 4.5
English: Hepatic impairment
Maltese: Imġibiet esternalizzanti
English: • Visual impairment
Maltese: • Indeboliment viżiv
English: Available in bottle packs of 60 tablets and blister packs of 30 / 60 tablets.
Maltese: Dawn huma disponibbli f'pakketti bi fliexken ta' 60 pillola u pakketti b'folji ta' 30 / 60 pillola.
English: INFORMATION IN BRAILLE Slenyto 5 mg (only applicable for outer carton, not applicable for bottle label)
Maltese: INFORMAZZJONI BIL-BRAILLE Slenyto ta' 5 mg (applikabbli biss għall-kartuna ta' barra, mhux applikabbli għat-tikketta tal-flixkun)
English: • thioridazine (used for the treatment of schizophrenia)
Maltese: • thioridazine (użata għat-trattament tal-iskiżofrenija)
English: CYP1A2 inducers such as carbamazepine and rifampicin may reduce plasma concentrations of melatonin.
Maltese: L-indutturi ta' CYP1A2 bħall carbamazepine u rifampicin jistgħu jnaqqsu l-konċentrazzjonijiet talplażma tal-melatonina.
English: Slenyto with alcohol
Maltese: Slenyto mal-alkoħol
English: PVC/PVDC opaque blister with aluminium foil backing.
Maltese: Folja opaka tal-PVC/PVDC bil-fojl tal-aluminju fuq wara.
English: The recommended starting dose is 2 mg (two 1-mg tablets) once daily.
Maltese: Id-doża rakkomandata tal-bidu hija 2 mg (żewġ pilloli ta' 1-mg) darba kuljum.
English: Slenyto 2 mg/5 mg treatment resulted in a significant improvement over placebo in the child's externalizing behaviours (hyperactivity/inattention+ conduct scores) as assessed by the Strength and Difficulties Questionnaire (SDQ) after 13 weeks of double-blind treatment (p=0.021).
Maltese: It-trattament b'Slenyto 2 mg/5 mg rriżulta f'titjib sinifikanti meta mqabbel mal-plaċebo fl-imġibiet esternalizzanti tat-tfal (punteġġi tal-iperattività/nuqqas ta' attenzjoni+mġiba) kif ivvalutat millKwestjonarju dwar is-Saħħa u d-Diffikultajiet (SDQ - Strength and Difficulties Questionnaire) wara 13-il ġimgħa ta' trattament double-blind (p=0.021).
English: Randomized placebo-controlled treatment period results (13 weeks) The study met the primary endpoint, demonstrating statistically significant effects of Slenyto 2/5 mg versus placebo on change from baseline in mean Sleep and Nap Diary (SND)-assessed Total Sleep Time (TST) after 13 weeks of double-blind treatment.
Maltese: L-istudju laħaq il-punt aħħari primarju, billi wera b'mod statistiku l-effetti sinifikanti ta' Slenyto 2/5 mg kontra l-plaċebo dwar il-bidla mil-linja bażi f'Ħin Totali ta' Rqad (TST - Total Sleep Time) ivvalutat bid-Djarju tan-Nagħsiet u tal-Irqad (SND - Sleep and Nap Diary) medju wara 13-il ġimgħa ta' trattament double-blind.
English: Flynn Pharma Limited Tel: +44 (0) 1438 727822 e-mail: medinfo@flynnpharma.com
Maltese: (0) 1438 727822 e-mail: medinfo@flynnpharma.com
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: 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 ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Melatonin is a hormone produced naturally by the body.
Maltese: Il-melatonina hija ormon prodott b'mod naturali mill-ġisem.
English: Each tablet contains 5 mg melatonin.
Maltese: Kull pillola fiha 5 mg ta' melatonina.
English: Caution should be exercised in patients on oestrogens (e.g. contraceptive or hormone replacement therapy), which increase melatonin levels by inhibiting its metabolism by CYP1A1 and CYP1A2.
Maltese: Għandha tiġi eżerċitata kawtela f'pazjenti li jkunu qed jirċievu oestrogens (eż. terapija ta' sostituzzjoni tal-ormoni jew kontraċettiva), li jżidu l-livelli ta' melatonina billi jinibixxu l-metaboliżmu tagħha b'CYP1A1 u CYP1A2.
English: *MMRM analysis CI = confidence interval; SDQ = Strength and Difficulties Questionnaire; CGAS = the
Maltese: MMRM tas-CI = intervall tal-fiduċja; SDQ = Kwestjonarju dwar is-Saħħa u d-Diffikultajiet; CGAS (Children's Global Assessment Scale) = l-Iskala ta' Valutazzjoni Globali tat-Tfal; SE = żball standard
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: (only applicable for outer carton, not applicable for bottle label) SN: (only applicable for outer carton, not applicable for bottle label) NN: (only applicable for outer carton, not applicable for bottle label)
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM PC: (applikabbli biss għall-kartuna ta' barra, mhux applikabbli għat-tikketta tal-flixkun) SN:
English: Combination with thioridazine and imipramine should be avoided.
Maltese: Il-kombinazzjoni ta' thioridazine u imipramine għandha tiġi evitata.
English: Frequency not known (reported from use in adults)
Maltese: Frekwenza mhux magħrufa (rrapportat mill-użu fuq l-adulti)
English: The in vitro plasma protein binding of melatonin is approximately 60%.
Maltese: It-twaħħil tal-proteina tal-plażma in vitro tal-melatonina huwa ta' madwar 60 %.
English: Under fasted conditions Cmax was lower (1.73 ng/ml) and tmax was earlier (within 2 hours) with a minor effect on AUC-∞ that was slightly reduced (-14%) as compared to fed state.
Maltese: Taħt kondizzjonijiet ta' sawm, is-Cmax kien aktar baxx (1.73 ng/ml) u tmax kien aktar kmieni (fi żmien sagħtejn) b'effett minuri fuq AUC-∞ li tnaqqas bi ftit (-14 %) meta mqabbel mal-istat alimentat.
English: • imipramine (used for the treatment of depression)
Maltese: • imipramine (użata għat-trattament tad-dipressjoni)
English: If an inadequate response has been observed, the dose should be increased to 5 mg, with a maximal dose of 10 mg.
Maltese: Jekk ikun ġie osservat rispons inadegwat, iddoża għandha tiżdied għal 5 mg, b'doża massima ta' 10 mg.
English: • Periodic Safety Update Reports
Maltese: • Rapporti Perjodiċi AġġornatI dwar is-Sigurtà
English: • Feeling abnormal
Maltese: • Imġiba mhux normali
English: Slenyto is for use in children and adolescents (2 to 18 years old) with autism spectrum disorder (ASD) and/or Smith-Magenis syndrome, a neurogenetic disease (inherited condition affecting the nerves and brain).
Maltese: Slenyto qiegħed biex jintuża fuq tfal u adoloxxenti (ta' bejn is-sentejn u t-18-il sena) b'disturb ġeneralizzat tal-awtiżmu (ASD) u/jew is-sindromu ta' Smith-Magenis, marda newroġenetika (kondizzjoni li tintiret li taffettwa n-nervi u l-moħħ).
English: There was a significant improvement with Slenyto over placebo in Composite Sleep Disturbance Index (CSDI)assessed parent satisfaction in child sleep pattern (p=0 .005) and in caregivers' well-being as assessed by the WHO-5 after 13 weeks of double-blind treatment (p=0.01) (Table 2).
Maltese: Kien hemm titjib sinifikanti b'Slenyto meta mqabbel mal-plaċebo fis-sodisfazzjon tal-ġenituri vvalutat skont l-Indiċi tad-Disturb tal-Irqad Kompost (CSDI - Composite Sleep Disturbance Index) fittendenzi tal-irqad tat-tfal (p=0 .005) u fil-benesseri tal-persuni li jindokraw kif ivvalutaw mill-WHO-5 wara 13-il ġimgħa ta' trattament double-blind (p=0.01) (Tabella 2).
English: The combination should be avoided.
Maltese: Il-kombinazzjoni għandha tiġi evitata.
English: 60 prolonged-release tablets
Maltese: IL-PRODOTT MEDIĊINALI
English: Slenyto 5 mg prolonged-release tablet
Maltese: Pillola Slenyto b'rilaxx prolonat ta' 5 mg
English: • Skin lesion
Maltese: *Analiżi
English: NAME OF THE MEDICINAL PRODUCT Slenyto 1 mg prolonged-release tablets melatonin
Maltese: TAL-PRODOTT MEDIĊINALI Slenyto 1 mg pilloli li jerħu l-mediċina bil-mod melatonina
English: Slenyto 1 mg prolonged-release tablets are pink, film coated, round, biconvex, 3 mm diameter tablets.
Maltese: Slenyto 1 mg pilloli li jerħu l-mediċina bil-mod huma roża, miksija b'rita, tondi, bikonvessi, u b'dijametru ta' 3 mm.
English: Caution should be exercised in patients on cimetidine which is a potent inhibitor of certain cytochrome P450 (CYP450) enzymes, mainly CYP1A2 and thereby increases plasma melatonin levels, by inhibiting its metabolism.
Maltese: Għandha tiġi eżerċitata kawtela f'pazjenti li qed jirċievu cimetidine li hija inibitur b'saħħtu ta' ċerti enżimi ta' ċitokromu P450 (CYP450), l-aktar CYP1A2 u għalhekk iżżid il-livelli ta' melatonina talplażma, billi tinibixxi l-metaboliżmu tagħha.
English: Besides shortening of SL, increase in the longest sleep episode (LSE) = uninterrupted sleep duration compared to placebo was observed.
Maltese: Minbarra t-tnaqqis tal-SL, ġiet osservata żieda fl-episodju tal-itwal raqda (LSE - Longest Sleep episode) = tul tal-irqad mingħajr interruzzjoni meta mqabbel mal-plaċebo.
English: Breastfeeding
Maltese: Varjabbli
English: RAD Neurim Pharmaceuticals EEC SARL Sími: +33 185149776 (FR) Netfang: neurim@neurim.com
Maltese: SARL Sími: +33 185149776 (FR) Netfang: neurim@neurim.com
English: How to take Slenyto
Maltese: X'inhu Slenyto
English: Slenyto 1 mg prolonged-release tablets Pink, film coated, round, biconvex, 3 mm diameter tablets with no imprint.
Maltese: Slenyto 1 mg pilloli li jerħu l-mediċina bil-mod Pilloli roża, miksija b'rita, tondi, bikonvessi b'dijametru ta' 3 mm bl-ebda marka.
English: Frequency categories are defined using the following convention: Very common (≥1/10); Common
Maltese: Komuni ħafna (≥ 1/10); Komuni (≥ 1/100 sa < 1/10);
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1318/002: 60 prolonged-release tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1318/002: 60 pillola li jerħu l-mediċina bil-mod
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma wrewx effett tossiku fuq issistema riproduttiva (ara 5.3).
English: Autoimmune diseases
Maltese: INFECTOPHARM
English: As a precautionary measure, it is preferable to avoid the use of melatonin during pregnancy.
Maltese: Bħala miżura ta' prekawzjoni, huwa preferibbli li jiġi evitat l-użu talmelatonina waqt it-tqala.
English: NAME OF THE MARKETING AUTHORISATION HOLDER RAD Neurim Pharmaceuticals EEC SARL
Maltese: Luxembourg/Luxemburg RAD Neurim Pharmaceuticals EEC
English: For children and adolescents aged 2-18
Maltese: Għal tfal u adoloxxenti ta' bejn is-sentejn u t-18-il sena
English: Slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.
Maltese: Slenyto huwa indikat għat-trattament tal-insomnja fit-tfal u fl-adoloxxenti ta' bejn sentejn u 18-il sena b'Disturb Ġeneralizzat tal-Awtiżmu (ASD) u / jew is-sindromu ta' Smith-Magenis, fejn il-miżuri dwar l-iġjene tal-irqad ma kinux biżżejjed.
English: Melatonin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone.
Maltese: Il-melatonina tista' ssaħħaħ il-karatteristiċi sedattvi ta' benzodiazepines u ipnotiċi mingħajr benzodiazepines, bħal zaleplon, zolpidem u zopiklone.
English: B. PACKAGE LEAFLET
Maltese: Tabella 2: BENESSERI
English: CARTON (BOTTLE AND BLISTER PACKS) AND LABEL (HDPE BOTTLE) - 5 MG
Maltese: U TIKKETTA (FLIXKUN HDPE) - 5
English: Slenyto 5 mg prolonged-release tablets are yellow, film coated, round, biconvex, 3 mm diameter tablets.
Maltese: Slenyto 5 mg pilloli li jerħu l-mediċina bil-mod huma sofor, miksija b'rita, tondi, bikonvessi, u b'dijametru ta' 3 mm.
English: Melatonin's metabolism is mainly mediated by CYP1A enzymes.
Maltese: Il-metaboliżmu tal-melatonina huwa fil-biċċa l-kbira mmedjat mill-enżimi tas-CYP1A.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1318/005: 30 prolonged-release tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1318/005: 30 pillola li jerħu l-mediċina bil-mod
English: RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com
Maltese: SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com
English: Renal impairment
Maltese: Mard awtoimmunitarju
English: NAME OF THE MEDICINAL PRODUCT Slenyto 5 mg prolonged-release tablets melatonin
Maltese: Slenyto 5 mg pilloli li jerħu l-mediċina bil-mod melatonina