FrancophonIA/ELRC3.0 huggingface dataset:
English: Data with 2 mg prolonged release melatonin tablets and data with 1 mg and 5 mg mini-tablets indicate that there is no accumulation of melatonin after repeated dosing.
Slovenian: Podatki za 2 mg tablete melatonina s podaljšanim sproščanjem ter podatki za 1 mg in 5 mg mini tabletke kažejo, da se po ponavljajočem se odmerjanju melatonin ne akumulira.
English: • fluvoxamine (used for the treatment of depression and obsessive compulsive disorder)
Slovenian: • fluvoksaminom (ki se uporablja za zdravljenje depresije in obsesivno kompulzivne motnje);
English: If overdose occurs, drowsiness is to be expected.
Slovenian: Pri prevelikem odmerku se pričakuje zaspanost.
English: - This medicine has been prescribed for you or your child only.
Slovenian: - Zdravilo je bilo predpisano samo vam osebno ali za vašega otroka in ga ne smete dajati drugim.
English: CSDI satisfaction Slenyto 1.43(0.175)(1.08,1.78) Placebo 0.71(0.184)(0.34,1.07)
Slovenian: Zadovoljstvo CSDI Slenyto 1,43 (0,175) (1,08, 1,78) Placebo 0,71 (0,184) (0,34, 1,07)
English: The excretion of the metabolite is completed within 12 hours after ingestion.
Slovenian: Metabolit se izloči v 12 urah po zaužitju.
English: The predominant metabolic flux is through hydroxylation at C6 via the hepatic microsome P-450 system to yield 6-hydroxymelatonin.
Slovenian: Glavna metabolična pot poteka od hidroksilacije pri C6, prek jetrnih mikrosomov sistema P-450 do tvorbe 6-hidroksimelatonina.
English: Melatonin may cause drowsiness, therefore melatonin should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety.
Slovenian: Lahko povzroči zaspanost, zato ga je treba uporabljati previdno, če so učinki zaspanosti lahko povezani s tveganjem za varnost.
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%.
Slovenian: Zaviralci sinteze prostaglandina (nesteroidna protivnetna zdravila), kot sta acetilsalicilna kislina in ibuprofen, ki se dajejo zvečer, lahko v prvem delu noči do 75 % znižajo ravni endogenega melatonina.
English: What Slenyto is and what it is used for What you need to know before you or your child takes Slenyto How to take Slenyto
Slovenian: Kaj je zdravilo Slenyto in za kaj ga uporabljamo Kaj morate vedeti, preden boste vi ali vaš otrok vzeli zdravilo Slenyto Kako jemati zdravilo Slenyto
English: Slenyto should be taken once daily, 0.5-1 hour before bedtime and with or after food.
Slovenian: Zdravilo Slenyto je treba vzeti enkrat na dan, od pol ure do eno uro pred spanjem ter s hrano ali po njej.
English: *MMRM analysis CI = confidence interval; WHO-5= the World Health Organization Well-Being Index; CSDI =
Slovenian: * Analiza MMRM CI = interval zaupanja; WHO-5 = indeks dobrega počutja Svetovne zdravstvene organizacije; CSDI = sestavljeni indeks motenj spanja; SE = standardna napaka
English: Melatonin's metabolism is mainly mediated by CYP1A enzymes.
Slovenian: Na metabolizem melatonina vplivajo večinoma encimi CYP1A.
English: Rua Consiglieri Pedrosa, n.° 121-123 Queluz de Baixo, Barcarena,
Slovenian: Iberfar Indústria Farmacêutica S.A., Rua Consiglieri Pedrosa, n.° 121-123 Queluz de Baixo, Barcarena,
English: • Abnormal behaviour
Slovenian: • nenormalno vedenje
English: • oestrogens (used in contraceptives or hormone replacement therapy)
Slovenian: • estrogeni (ki se uporabljajo za kontracepcijo ali nadomestno hormonsko zdravljenje);
English: Slenyto is for use in the treatment of insomnia.
Slovenian: Zdravilo Slenyto je namenjeno uporabi za zdravljenje nespečnosti.
English: If possible, administration of NSAIDs should be avoided in the evening.
Slovenian: Dajanju nesteroidnih protivnetnih zdravil se je treba zvečer izogibati, če je mogoče.
English: Endogenous melatonin was measured in human breast milk thus exogenous melatonin is probably secreted into human milk.
Slovenian: V materinem mleku je bil izmerjen endogeni melatonin, torej se eksogeni melatonin verjetno izloči v materino mleko.
English: Table 1: CHILD BEHAVIOUR (13 weeks Double-blind)
Slovenian: Preglednica 1: OTROKOVO VEDENJE (13-tedensko dvojno slepo zdravljenje) Spremenljivka Skupina
English: What you need to know before you or your child takes Slenyto
Slovenian: Kaj morate vedeti, preden boste vi ali vaš otrok vzeli zdravilo Slenyto
English: As a precautionary measure, it is preferable to avoid the use of melatonin during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi melatonina bolje izogibati.
English: Efficacy and safety have been assessed in a randomised, placebo-controlled study in children diagnosed with ASDs and neurodevelopmental disabilities caused by Smith-Magenis syndrome who had not shown improvement after standard sleep behavioural intervention.
Slovenian: Učinkovitost in varnost sta bili ocenjeni v randomizirani, s placebom nadzorovani študiji pri otrocih s sindromi avtističnega spektra (ASD) in/ali nepravilnostmi v razvoju živčevja, ki jih je povzročil sindrom Smith-Magenis, pri katerih običajni ukrepi spalnega vedenja niso pokazali izboljšanja.
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.
Slovenian: Randomiziranih je bilo skupno 125 otrok (starih od 2 do 17 let, povprečna starost 8,7 +/- 4,15; 96,8 % z ASD, 3,2 % s sindromom Smith-Magenis [SMS]), pri katerih se spanje samo z vedenjskimi ukrepi ni izboljšalo, rezultati pa so na voljo za 112 tednov.
English: CYP1A2 inducers
Slovenian: Spodbujevalci CYP1A2
English: Besides shortening of SL, increase in the longest sleep episode (LSE) = uninterrupted sleep duration compared to placebo was observed.
Slovenian: Poleg skrajšanja latence uspavanja je bilo v primerjavi s placebom opaženo tudi podaljšanje najdaljše epizode spanja (LSE - longest sleep episode) = neprekinjeno trajanje spanja.
English: If you or your child forgets to take a tablet, it could be taken before going to sleep that night, but after this time, no other tablet should be taken before the next evening.
Slovenian: Če ste vi ali vaš otrok pozabili vzeti zdravilo Slenyto Če vi ali vaš otrok pozabite vzeti tableto, jo lahko vzamete isto noč pred spanjem, vendar po tem do naslednjega večera ne smete vzeti nobene druge tablete.
English: The most frequently reported adverse reactions with Slenyto in clinical studies were somnolence, fatigue, mood swings, headache, irritability, aggression and hangover occurring in 1:100-1:10 children.
Slovenian: V kliničnih študijah so bili najpogosteje navedeni neželeni učinki zdravila Slenyto zaspanost, utrujenost, nihanje razpoloženja, glavobol, razdražljivost, agresivnost in simptomi, podobni simptomom po prekomernem zaužitju alkohola, ki so se pojavili pri 1 od 100 do 1 od 10 otrocih.
English: Fluvoxamine increases melatonin levels (by 17-fold higher AUC and a 12-fold higher serum Cmax) by inhibiting its metabolism by hepatic cytochrome P450 (CYP) isozymes CYP1A2 and CYP2C19.
Slovenian: Fluvoksamin zvišuje ravni melatonina (AUC 17-krat višji, serumska koncentracija Cmax pa 12-krat), saj zavira njegov metabolizem z izocimi jetrnega citokroma P450 (CYP) CYP1A2 in CYP2C19.
English: Available in bottle packs of 60 tablets and blister packs of 30 / 60 tablets.
Slovenian: Na voljo v plastenki po 60 tablet in pretisnih omotih po 30/60 tablet.
English: CYP1A2 inhibitors such as quinolones (ciprofloxacin and norfloxacin) may give rise to increased melatonin exposure.
Slovenian: Zaviralci CYP1A2, kot so kinoloni (ciprofloksacin in norfloksacin), lahko povzročijo povečano izpostavljenost melatoninu.
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.
Slovenian: Pri odraslih, ki so prejeli 5 mg zdravila Slenyto (1 x 5 mg mini tabletko) po hrani, so bile koncentracije melatonina najvišje v treh urah po prejemu; plazemski Cmax (SD) je znašal 3,57 ng/ml (3,64).
English: Melatonin has been co-administered in studies with thioridazine and imipramine, active substances which affect the central nervous system.
Slovenian: V študijah se je melatonin dajal sočasno s tioridazinom in imipraminom, zdravilnima učinkovinama, ki učinkujeta na osrednji živčni sistem.
English: CYP1A2 inducers such as carbamazepine and rifampicin may reduce plasma concentrations of melatonin.
Slovenian: Spodbujevalci CYP1A2, kot sta karbomazepin in rifampicin, lahko zmanjšajo plazemske koncentracije melatonina.
English: The following adverse reactions (frequency unknown) have been reported with off-label use of the adult formulation, 2 mg prolonged-release melatonin tablets: epilepsy, visual impairment, dyspnoea, epistaxis, constipation, decreased appetite, swelling face, skin lesion, feeling abnormal, abnormal behaviour and neutropenia.
Slovenian: Pri neodobreni uporabi zdravila za odrasle, 2 mg tablete melatonina s podaljšanim sproščanjem, so poročali o naslednjih neželenih učinkih (pogostost neznana): epilepsija, poslabšanje vida, dispneja, epistaksa, zaprtost, zmanjšan tek, zabuhel obraz, kožna lezija, nenormalno počutje, nenormalno vedenje in nevtropenija.
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.
Slovenian: Previdnost je potrebna pri bolnikih, ki jemljejo estrogene (npr. za kontracepcijo ali nadomestno hormonsko zdravljenje), saj zvišujejo ravni melatonina z zaviranjem njegovega metabolizma z encimi CYP1A1 in CYP1A2.
English: Rua Consiglieri Pedrosa, n.° 121-123 Queluz de Baixo Barcarena
Slovenian: Iberfar - Indústria Farmacêutica, S.A. Rua Consiglieri Pedrosa, n.° 121-123 Queluz de Baixo Barcarena
English: Plasma melatonin levels in patients with cirrhosis were significantly increased during daylight hours.
Slovenian: Podnevi so bile plazemske ravni melatonina pri bolnikih s cirozo bistveno povišane.
English: Wake up time was unaffected; after 13 weeks, patients' wake up time was delayed insignificantly by 0.09 hour (0.215) (5.4 minutes) with Slenyto compared to placebo treatment.
Slovenian: Čas prebujanja se ni spremenil; po 13 tednih je bil čas prebujanja bolnikov, ki so prejemali zdravilo Slenyto, zanemarljivo poznejši za 0,09 ure (0,215) (5,4 minute) kot pri bolnikih, ki so prejemali placebo.
English: The site of biotransformation is the liver.
Slovenian: Biotransformacija poteka v jetrih.
English: (only applicable for outer carton, not applicable for bottle label)
Slovenian: (Uporablja se samo za zunanjo škatlo, ne uporablja se za nalepko na plastenki.)
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).
Slovenian: Zdravilo Slenyto se uporablja pri otrocih in mladostnikih (starih od 2 do 18 let) z motnjami avtističnega spektra (ASD) in/ali sindromom Smith-Magenis, nevrogenetsko boleznijo (dedna bolezen, ki prizadene živčevje in možgane).
English: 3 years (PVC/PVDC blister and HDPE bottle)
Slovenian: 3 leta (pretisni omot PVC/PVDC in plastenka HDPE)
English: • cimetidine (used in the treatment of stomach problems such as ulcers)
Slovenian: • cimetidinom (ki se uporablja za zdravljenje želodčnih težav, kot so razjede želodca);
English: Therefore, when CYP1A2 inducers and melatonin are both given, dose adjustment may be required.
Slovenian: Pri dajanju spodbujevalcev CYP1A2 in melatonina je zato morda treba prilagoditi odmerek.
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.
Slovenian: Rezultati obdobja odprtega zdravljenja (91 tednov) Bolniki (51 iz skupine z zdravilom Slenyto in 44 iz skupine s placebom, povprečna starost 9 ± 4,24 leta, razpon 2-17,0 leta) so 91 tednov odprto prejemali 2 mg/5 mg zdravila Slenyto v skladu z odmerkom dvojno slepe faze, z možnostjo prilagoditve odmerka na 2,5 mg ali 10 mg/dan po prvih 13 tednih nadaljevalnega obdobja.
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.
Slovenian: Zdravilo Slenyto je indicirano za zdravljenje nespečnosti pri otrocih in mladostnikih, starih od 2 do 18 let, s sindromom avtističnega spektra (ASD) in/ali sindromom Smith-Magenis, pri katerih ukrepi spalne higiene niso bili zadostni.
English: Each prolonged-release tablet contains lactose monohydrate equivalent to 8.86 mg lactose.
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje monohidrat laktoze, ki ustreza 8,86 mg laktoze.
English: • imipramine (used for the treatment of depression)
Slovenian: • imipraminom (ki se uporablja za zdravljenje depresije).
English: Read all of this leaflet carefully before you or your child starts taking this medicine because it contains important information.
Slovenian: Preden vi ali vaš otrok začnete jemati zdravilo, natančno preberite navodilo, ker vsebuje za vas ali vašega otroka pomembne informacije!
English: By the end of the 13-week double-blind period, the mean LSE increased on average by 77.9 minutes in the Slenyto treated group, compared to 25.5 minutes in the placebo-treated group.
Slovenian: Do konca 13-tedenskega dvojno slepega obdobja se je povprečni LSE v skupini, zdravljeni z zdravilom Slenyto, podaljšal povprečno za 77,9 minute, v skupini, ki je prejemala placebo, pa za 25,5 minute.
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.
Slovenian: Previdnost je potrebna pri bolnikih, ki jemljejo cimetidin, ki je močan zaviralec nekaterih encimov iz skupine citokromov P450 (CYP450), predvsem encima CYP1A2, saj se zaradi zaviranja njegovega metabolizma zvišajo plazemske ravni melatonina.
English: There is no experience of the use of melatonin in paediatric patients with renal impairment (see Section 4.2).
Slovenian: Izkušenj z uporabo melatonina pri pediatričnih bolnikih z ledvično okvaro ni (glejte poglavje 4.2).
English: If you or your child has been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Če je zdravnik vam ali vašemu otroku povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo.
English: By the end of the 13-week treatment period, children fell asleep on average 39.6 minutes faster with Slenyto and 12.5 minutes faster with placebo adjusted mean treatment difference -25.3 minutes in the all Randomized Set; MI( p=0.012) without causing earlier wakeup time.
Slovenian: Do konca 13-tedenskega obdobja zdravljenja so otroci povprečno zaspali 39,6 minute hitreje z zdravilom Slenyto in 12,5 minute s placebom, prilagojena povprečna razlika v zdravljenju -25,3 minute v celotni randomizirani skupini; MI(p = 0,012), kar ni povzročilo zgodnejšega časa prebujanja.
English: • carbamazepine (used in the treatment of epilepsy)
Slovenian: • karbamazepinom (ki se uporablja za zdravljenje epilepsije);
English: Each prolonged-release tablet contains lactose monohydrate equivalent to 8.32 mg lactose.
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje monohidrat laktoze, ki ustreza 8,32 mg laktoze.
English: PHARMACEUTICAL FORM AND CONTENTS 30 prolonged-release tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 tablet s podaljšanim sproščanjem
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.
Slovenian: Melatonin se hitro presnovi med prvim prehodom v jetrih, presnavljajo pa ga v glavnem encimi CYP1A, lahko tudi CYP2C19 iz sistema citokromov P450, pri čemer znaša razpolovni čas izločanja približno 40 minut.
English: HDPE bottles closed with induction sealed polypropylene caps.
Slovenian: Plastenke iz polietilena visoke gostote (HDPE) z indukcijsko zapečatenimi polipropilenskimi zaporkami.
English: The liver is the primary site of melatonin metabolism and therefore, hepatic impairment results in higher endogenous melatonin levels.
Slovenian: Jetrna okvara Melatonin se presnavlja predvsem v jetrih, zato ima jetrna okvara za posledico višje ravni endogenega melatonina.
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.
Slovenian: Rezultati randomiziranega obdobja zdravljenja, nadzorovanega s placebom (13 tednov) Študija je dosegla glavni cilj, saj je dokazala statistično pomembne učinke zdravila Slenyto 2 mg/5 mg v primerjavi s placebom, saj se je povprečni dnevnik spanja in dremanja - ocenjeni skupni čas spanja (TST - Total Sleep Time) po 13 tednih dvojno slepega zdravljenja glede na izhodišče spremenil.
English: At baseline, mean Sleep Latency (SL) was 95.2 minutes in the Slenyto and 98.8 minutes in the placebo group.
Slovenian: V skupini z zdravilom Slenyto je znašala izhodiščna povprečna latenca uspavanja (SL - Sleep Latency) 95,2 minute, v skupini s placebom pa 98,8 minute.
English: *MMRM analysis CI = confidence interval; SDQ = Strength and Difficulties Questionnaire; CGAS = the
Slovenian: * Analiza MMRM CI = interval zaupanja; SDQ = vprašalnik prednosti in težav; CGAS = lestvica za celovito presojo otrok (Children's Global Assessment Scale); SE = standardna napaka
English: 28.8% patients were diagnosed with ADHD before study initiation and 77% had abnormal SDQ hyperactivity/inattention score (>=7) at baseline.
Slovenian: Pred začetkom študije je bila pri 28,8 % bolnikih ugotovljena motnja aktivnosti in pozornosti (ADHD), 77 % bolnikov pa je imelo na začetku študije zaradi hiperaktivnosti in pomanjkljive pozornosti neobičajno oceno, določeno na podlagi vprašalnika SDQ (Streght and Difficulties Questionnaire) (>= 7).
English: Beta-blockers
Slovenian: Beta zaviralci
English: PHARMACEUTICAL FORM AND CONTENTS 60 prolonged-release tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 60 tablet s podaljšanim sproščanjem
English: (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare
Slovenian: Neželeni učinki so navedeni po skupinah organskih sistemov v skladu z MedDRA in po pogostosti pojavljanja.Skupine pogostosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Tell your doctor or pharmacist before using Slenyto if you or your daughter:
Slovenian: Pred uporabo zdravila Slenyto obvestite zdravnika ali farmacevta, če ste vi ali vaša hči:
English: • Feeling abnormal
Slovenian: • nenormalno počutje
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.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Slenyto contains lactose monohydrate.
Slovenian: Zdravilo Slenyto vsebuje monohidrat laktoze.
English: The recommended starting dose is 2 mg (two 1-mg tablets) once daily.
Slovenian: Zdravilo Slenyto je na voljo v dveh jakostih: 1 mg in 5 mg. Priporočeni začetni odmerek je 2 mg (dve 1 mg tableti) enkrat dnevno.
English: Available in bottle and blister packs of 30 tablets.
Slovenian: Na voljo v plastenki in pretisnih omotih po 30 tablet.
English: Do not break, crush or chew the tablet.
Slovenian: Tablete ne smete prelomiti, zdrobiti ali žvečiti.
English: Clearance of the active substance is expected within 12 hours after ingestion.
Slovenian: Zdravilna učinkovina se predvidoma odstrani v 12 urah po zaužitju.
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).
Slovenian: Po 13-tedenskem dvojno slepem zdravljenju se je skupna ocena na podlagi vprašanja SDQ nagibala v korist zdravila Slenyto (p = 0,077).
English: INFORMATION IN BRAILLE Slenyto 1 mg
Slovenian: Slenyto 1 mg
English: • Breathlessness/shortness of breath (dyspnoea)
Slovenian: • zasoplost/kratka sapa (dispneja)
English: At baseline, mean TST was 457.2 minutes in the Slenyto and 459.9 minutes in the placebo group.
Slovenian: V skupini z zdravilom Slenyto je bil izhodiščni povprečni TST 457,2 minute, v skupini s placebom pa 459,9 minute.
English: If you or your child suffers from continued drowsiness, you should consult your doctor.
Slovenian: Če ste vi ali vaš otrok nenehno zaspani, se posvetujte z zdravnikom.
English: Each tablet contains 1 mg melatonin.
Slovenian: Ena tableta vsebuje 1 mg melatonina.
English: • Sudden onset of sleep
Slovenian: • nenaden spanec
English: Therefore, melatonin is not recommended for use in patients with autoimmune diseases.
Slovenian: Uporaba melatonina zato pri bolnikih z avtoimunskimi boleznimi ni priporočljiva.
English: Each tablet contains 5 mg melatonin.
Slovenian: Ena tableta vsebuje 5 mg melatonina.
English: EU/1/18/1318/001: 60 prolonged-release tablets
Slovenian: EU/1/18/1318/001: 60 tablet s podaljšanim sproščanjem
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).
Slovenian: Po 13 tednih dvojno slepega zdravljenja so udeleženci z zdravilom Slenyto ponoči spali povprečno 57,5 minute dlje, udeleženci s placebom pa 9,1 minute, pri čemer je znašala razlika med prilagojenima povprečjema zdravljenja z zdravilom Slenyto in s placebom 33,1 minute v celotni randomizirani skupini; večkratno vstavljanje manjkajočih vrednosti (MI) (p = 0,026).
English: Pack size: 60 tablets.
Slovenian: Velikost pakiranja: 60 tablet.
English: INFORMATION IN BRAILLE Slenyto 5 mg (only applicable for outer carton, not applicable for bottle label)
Slovenian: PODATKI V BRAILLOVI PISAVI Slenyto 5 mg (Uporablja se samo za zunanjo škatlo, ne uporablja se za nalepko na plastenki.)
English: There is no experience of the use of melatonin in paediatric patients with liver impairment.
Slovenian: Izkušenj z uporabo melatonina pri pediatričnih bolnikih z jetrno okvaro ni.
English: Pack size: 30 tablets.
Slovenian: Velikost pakiranja: 30 tablet.
English: INFORMATION IN BRAILLE Slenyto 1 mg (only applicable for outer carton, not applicable for bottle label)
Slovenian: PODATKI V BRAILLOVI PISAVI Slenyto 1 mg (uporablja se samo za zunanjo škatlo, ne uporablja se za nalepko na plastenki.)
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).
Slovenian: Po 13-tedenskem dvojno slepem zdravljenju z zdravilom Slenyto 2 mg/5 mg se je otrokovo eksternalizirano vedenje bistveno bolj izboljšalo kot pri placebu (ocena glede hiperaktivnosti/pomanjkljive pozornosti + vedenja), kot je določeno na podlagi vprašalnika prednosti in težav (SDQ) (p = 0,021).