natgillin/translations-raw huggingface dataset:
Aktiviteten af melatonin ved melatonin-receptorerne (MT1, MT2 og MT3) antages at bidrage til dets søvnfremmende egenskaber, da disse receptorer (hovedsagelig MT1 og MT2) er involveret i reguleringen af døgnrytmen og søvn.
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.
• quinoloner (f.eks. ciprofloxacin og norfloxacin) og rifampicin (anvendes til behandling af bakterielle infektioner)
• quinolones (for example ciprofloxacin and norfloxacin) and rifampicin (used in the treatment of bacterial infections)
Der ses 3-4 gange højere Cmax hos kvinder end hos mænd.
A 3-4-fold increase in Cmax is apparent for women compared to men.
In vitro-plasmaproteinbindingen af melatonin er ca. 60 %.
The in vitro plasma protein binding of melatonin is approximately 60%.
Kombination med thioridazin og imipramin bør undgås.
Combination with thioridazine and imipramine should be avoided.
Præpubertale børn og unge voksne metaboliserer melatonin hurtigere end voksne.
Prepubertal children and young adults metabolize melatonin faster than adults.
Effekten af melatonin på nyfødte/spædbørn kendes ikke.
The effect of melatonin on newborns/infants is unknown.
Tabel 1: Gruppen vedrørende BØRNS ADFÆRD (13 ugers dobbeltblind)
Table 1: CHILD BEHAVIOUR (13 weeks Double-blind)
Patienten bør overvåges med jævne mellemrum (mindst hver 6. måned) for at kontrollere, at Slenyto stadig er den bedst egnede behandling.
The patient should be monitored at regular intervals (at least every 6 months) to check that Slenyto is still the most appropriate treatment.
Fortæl det til lægen, hvis du eller dit barn begynder at ryge eller holder op med at ryge under behandlingen.
Please tell your doctor if you or your child starts or stops smoking during treatment.
Du eller dit barn bør kontrolleres af lægen med jævne mellemrum (hver 6. måned anbefales) for at sikre, at Slenyto stadig er den rigtige behandling for dig/barnet.
You or your child should be monitored by your doctor at regular intervals (recommended every 6 months) to check that Slenyto is still the right treatment for you/them.
Effekten af enhver grad af nedsat nyrefunktion på farmakokinetikken af melatonin er ikke undersøgt.
The effect of any stage of renal impairment on melatonin pharmacokinetics has not been studied.
Når tabletterne er blandet i sådanne fødevarer, skal de gives straks og ikke henstå eller opbevares, da dette kan påvirke den måde, tabletterne virker på.
If the tablets are mixed with these foods, they should be given immediately and not left or stored, as this may affect the way the tablets work.
Hvis en tablet glemmes, kan den tages, før patienten går i seng samme aften, men efter dette tidspunkt bør der ikke gives endnu en tablet før næste planlagte dosis.
If a tablet is forgotten, it could be taken before the patient goes to sleep that night, but after this time, no other tablet should be given before the next scheduled dose.
To hepatisk medierede metaboliseringsveje tegner sig for omkring 90 % af melatonins metabolisering.
Two liver-mediated metabolic pathways account for around 90% of melatonin metabolism.
Eksternaliserende adfærd
Externalizing behaviours
Slenyto fås i to styrker: 1 mg og 5 mg.
Slenyto is available in two strengths: 1 mg and 5 mg.
Interaktioner mellem melatonin og andre aktive stoffer kan derfor forekomme som følge af deres virkning på CYP1Aenzymerne.
Therefore, interactions between melatonin and other active substances as a consequence of their effect on CYP1A enzymes is possible.
Dato for første markedsføringstilladelse: 20. september 2018
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2018
Clearance af det aktive stof forventes afsluttet inden for 12 timer efter indtagelse.
Clearance of the active substance is expected within 12 hours after ingestion.
Prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagen dosering, genotoksicitet, karcinogent potentiale eller reproduktions- og udviklingstoksicitet.
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.
Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slenyto er til oral brug.
Slenyto is for oral use.
Betablokkere kan undertrykke frigivelsen af endogent melatonin om natten og bør derfor administreres om morgenen.
Beta-blockers may supress the night-time release of endogenous melatonin and thus should be administered in the morning.
Hvis tabletterne er blandet i mad eller drikke, skal de indtages straks; blandingen må ikke opbevares.
If the tablets are mixed with food or drink, they should be taken immediately and the mixture not stored.
Det skal besluttes, om amning skal ophøre, eller behandlingen med Slenyto seponeres/undlades, under hensyntagen til fordelene ved amning for barnet og den terapeutiske fordel for kvinden.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from melatonin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Forbedringerne i total søvntid (TST), søvnlatens (SL) og varighed af uafbrudt søvn (LSE, længste søvnepisode), der sås i dobbeltblindfasen, var vedvarende i hele den 39 ugers opfølgningsperiode.
The improvements in total sleep time (TST), sleep latency (SL) and duration of uninterrupted sleep (LSE; longest sleep episode) seen in the double blind-phase were maintained throughout the 39 weeks' follow up period.
• ammer eller planlægger at amme.
• is breast-feeding or planning to breast-feed.
Lægemidlet bør derfor anvendes med forsigtighed, hvis virkningerne af døsighed forventes at kunne medføre en sikkerhedsrisiko (se pkt.
Therefore the medicinal product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety (see section 4.7).
Rygning er kendt for at inducere metabolisering gennem CYP1A2; hvis en patient holder op med at ryge eller begynder at ryge under behandling med melatonin, kan dosisjustering være nødvendig.
Smoking is known to induce CYP1A2 metabolism, therefore if patients stop or start smoking during treatment with melatonin, dose adjustment may be required.
De hyppigst indberettede bivirkninger med Slenyto i kliniske studier var somnolens, træthed, humørsvingninger, hovedpine, irritabilitet, aggression og tømmermænd, der forekom hos 1:100-1:10 børn.
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.
Da melatonin imidlertid hovedsagelig elimineres via metabolisering i leveren, og da metabolitten 6-SMT er inaktiv, forventes nedsat nyrefunktion ikke at påvirke clearance af melatonin.
However as melatonin is mainly eliminated via liver metabolism, and the metabolite 6SMT is inactive, renal impairment is not expected to influence clearance of melatonin.
Lægen kan muligvis afgøre, at du eller dit barn bør holde op med at tage dette lægemiddel.
The doctor may want you/your child to stop taking this medicine.
Foruden kortere SL sås en stigning i den længste søvnepisode (LSE) = uafbrudt søvnvarighed i forhold til placebo.
Besides shortening of SL, increase in the longest sleep episode (LSE) = uninterrupted sleep duration compared to placebo was observed.
Data med 2 mg depottabletter af melatonin og data med 1 mg og 5 mg minitabletter viser, at der ikke forekommer akkumulering af melatonin efter gentagen dosering.
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.
Ved overdosering må forventes døsighed.
If overdose occurs, drowsiness is to be expected.
Navnlig medfører det øget risiko for bivirkninger at tage Slenyto sammen med følgende lægemidler, eller det kan påvirke den måde, som Slenyto eller det andet lægemiddel virker på:
In particular, taking Slenyto with the following medicines can increase the risk of side effects, or it can affect the way that Slenyto or the other medicine works:
Den anbefalede startdosis er 2 mg Slenyto.
The recommended starting dose is 2 mg of Slenyto.
ENTYDIG IDENTIFIKATOR - 2D STREGKODE Der er anført en 2D-stregkode, som indeholder den entydige identifikator.
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Samtidige anvendelser, der frarådes
Concomitant use not recommended
HDPE-flaske med induktionsforseglet polypropylenlåg.
HDPE bottles closed with induction sealed polypropylene caps.
I studier hos både voksne og unge dyr var melatonin uden effekt på fertiliteten hos hanner og hunner (se pkt.
In studies performed in both adult and juvenile animals, melatonin had no effect on male or female fertility (see section 5.3).
(gælder kun for yderkartonen, ikke for flaskeetiketten)
(only applicable for outer carton, not applicable for bottle label)
Gruppe Justerede behandlingsmiddelværdier (SE) [95% CI]
Group Adjusted treatment means (SE) [95% CI]
Justerede behandlingsmiddelværdier (SE) [95 % CI]
Adjusted treatment means (SE) [95% CI]
Den anden, mindre betydende, metaboliseringsvej er 5-demethylering, der resulterer i den fysiologiske melatonin-precursor N-acetylserotonin.
The second, less significant, pathway is 5-demethylation to yield a physiological melatonin precursor, N-acetylserotonin.
• Anfald (epilepsi)
• Fits (epilepsy)
For den samlede SDQ-score efter 13 ugers dobbeltblindbehandling var der tendens til fordel for Slenyto (p = 0,077).
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).
Den justerede estimerede behandlingsforskel var 43,2 minutter i stikprøven af alle randomiserede (MI, p = 0,039).
The adjusted estimated treatment differences were 43.2 minutes in the all Randomized Set (MI, p=0 .039).
Der foreligger ingen data om anvendelse af melatonin hos gravide kvinder.
There are no data from the use of melatonin in pregnant women.
melatonin går muligvis over i modermælk; lægen vil derfor afgøre, om du/din datter bør amme under behandlingen med melatonin.
It is possible that melatonin is passed into human breast milk, therefore your doctor will decide whether you or your daughter should breastfeed whilst taking melatonin.
28,8 % af patienterne blev diagnosticeret med ADHD før initiering af studiet, og 77 % havde ved baseline unormal (> = 7) score for hyperaktivitet/uopmærksomhed i henhold til Strength and Difficulties Questionnaire (SDQ).
28.8% patients were diagnosed with ADHD before study initiation and 77% had abnormal SDQ hyperactivity/inattention score (>=7) at baseline.
Både 6-hydroxymelatonin og N-acetylserotonin konjugeres til sidst til sulfat og glucuronsyre og udskilles i urinen som de tilsvarende 6-sulfatoxy- og 6-glucuronidderivater.
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.
Melatonin bindes hovedsagelig til albumin, alpha1-syre glykoprotein og højdensitetslipoprotein.
Melatonin is mainly bound to albumin, alpha1-acid glycoprotein and high density lipoprotein.
Tabletterne synkes hele og må IKKE deles, knuses eller tygges.
The tablets should be swallowed whole and NOT broken, crushed or chewed.
Eliminationen finder sted ved renal udskillelse af metabolitterne, 89 % som sulfaterede og glucuroniderede konjugater af 6-hydroxymelatonin (over 80 % som 6-sulfatoxymelatonin), og 2 % udskilles som uændret aktivt melatonin).
Elimination is by renal excretion of metabolites, 89% as sulfated and glucoronide conjugates of 6-hydroxymelatonin (over 80% as 6-sulfatoxy melatonin) and 2% is excreted as melatonin (unchanged active substance).
• Abnorm adfærd
• Abnormal behaviour
Plasmakoncentrationen af melatonin hos patienter med cirrose var ikke signifikant øget ved dagslys.
Plasma melatonin levels in patients with cirrhosis were significantly increased during daylight hours.
Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs webside http://www.ema.europa.eu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slenyto er et lægemiddel, der indeholder det aktive stof melatonin.
Slenyto is a medicine that contains the active ingredient, melatonin.
Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
This leaflet was last revised in { month/YYYY}.
Følgende bivirkninger (hyppighed ukendt) er indberettet ved ikke godkendt anvendelse af formuleringen til voksne, 2 mg melatonin-depottabletter: epilepsi, synsnedsættelse, dyspnø, epistaxis, obstipation, nedsat appetit, hævet ansigt, hudforandringer, unormal følelse, unormal adfærd og neutropeni.
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.
Tabletter kan kommes i madvarer som yoghurt, appelsinjuice eller is for at gøre det lettere at synke dem og opnå bedre compliance.
Tablets can be put into food such as yoghurt, orange juice or ice-cream to facilitate swallowing and improve compliance.
INFORMATION I BRAILLESKRIFT Slenyto 1 mg
INFORMATION IN BRAILLE Slenyto 1 mg
Slenyto anvendes til behandling af søvnløshed.
Slenyto is for use in the treatment of insomnia.
Den dominerende metaboliseringsvej er hydroxylering ved C6 via det hepatiske mikrosom-P-450-system, der resulterer i 6-hydroxymelatonin.
The predominant metabolic flux is through hydroxylation at C6 via the hepatic microsome P-450 system to yield 6-hydroxymelatonin.
• Pludselig falden i søvn
• Sudden onset of sleep
Farmakoterapeutisk klassifikation: Psykoleptika, melatoninreceptoragonister, ATC-kode: N05CH01 Virkningsmekanisme
Pharmacotherapeutic group: Psycholeptics, melatonin receptor agonists, ATC code: N05CH01 Mechanism of action
Melatonin inducerer ikke enzymerne CYP1A2 eller CYP3A in vitro ved supraterapeutiske koncentrationer.
Melatonin does not induce CYP1A2 or CYP3A enzymes in vitro at supra-therapeutic concentrations.
Metaboliseringen af melatonin formidles hovedsagelig af CYP1A-enzymer.
Melatonin's metabolism is mainly mediated by CYP1A enzymes.
Tabel 2: FORÆLDRES VELBEFINDENDE (13 ugers dobbeltblind)
Table 2: PARENTS WELL BEING (13 weeks Double- blind)
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Døsighed
4.4 Special warnings and precautions for use
30 måneder (blister af PVC/PVDC) 18 måneder (HDPE-flaske)
30 months (PVC/PVDC blister) 18 months (HDPE bottle)
I fastende tilstand var Cmax lavere (1,73 ng/ml), og tmax var tidligere (inden for 2 timer), mens AUC-∞ var let reduceret (-14 %) i forhold til postprandial tilstand.
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.
Filmovertræk Carmellosenatrium (E466) Maltodextrin
Carmellose sodium (E466) Maltodextrin
- føler dig/sig døsig (se afsnittet under "Trafik- og arbejdssikkerhed").
- feels drowsy (see section below on “Driving and using machines”).
Kombination med benzodiazepiner og andre hypnotika bør undgås.
Combination with benzodiazepines and non-benzodiazepine hypnotics should be avoided.
Forsigtighed bør udvises hos patienter, der får 5- eller 8-methoxypsoralen (5 eller 8-MOP), som øger koncentrationen af melatonin ved at hæmme dets metabolisering.
Caution should be exercised in patients on 5- or 8-methoxypsoralen (5 or 8-MOP), which increases melatonin levels by inhibiting its metabolism.
Koadministration af melatonin førte til øget følelse af afslappethed og vanskelighed ved at udføre opgaver i forhold til imipramin alene, og øget omtågethed i forhold til thioridazin alene.
However, melatonin co-administration resulted in increased feelings of tranquility and difficulty in performing tasks compared to imipramine alone, and increased feelings of “muzzyheadedness” compared to thioridazine alone.
• betablokkere (anvendes til kontrol af blodtrykket).
• beta-blockers (used to control blood pressure).
Melatonin kan forårsage døsighed.
Melatonin may cause drowsiness.
Melatonin kan forårsage døsighed og skal derfor anvendes med forsigtighed, især hvor døsighedens grad kan være forbundet med en sikkerhedsrisiko.
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.
Hæmmere af prostaglandinsyntesen (NSAID) såsom acetylsalicylsyre og ibuprofen, der gives om aftenen, kan undertrykke endogene koncentrationer af melatonin i den første del af natten med op til 75 %.
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%.
De hele tabletter kan kommes i fødevarer såsom yoghurt, appelsinjuice eller is for at gøre det lettere at synke dem.
The whole tablets can be put into food like yoghurt, orange juice or ice-cream to help with swallowing.
Uigennemsigtig blister af PVC/PVDC med underlag af aluminiumfolie.
PVC/PVDC opaque blister with aluminium foil backing.
I ingen af tilfældene fandtes farmakokinetiske interaktioner af betydning.
No clinically significant pharmacokinetic interactions were found in each case.
3 år (blister af PVC/PVDC og HDPE-flaske)
3 years (PVC/PVDC blister and HDPE bottle)
Studiet omfatter 5 faser: 1) en forberedende fase (4 uger), 2) en baseline enkeltblind placebofase (2 uger), 3) en randomiseret placebokontrolleret behandlingsfase (13 uger), 4) en åben behandlingsfase (91 uger) og 5) en enkeltblind udløbsfase (2 ugers placebo).
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).
CYP1A2-hæmmere som quinoloner (ciprofloxacin og norfloxacin) kan medføre øget eksponering for melatonin.
CYP1A2 inhibitors such as quinolones (ciprofloxacin and norfloxacin) may give rise to increased melatonin exposure.
Hvis du eller dit barn har glemt at tage Slenyto Hvis du eller dit barn glemmer at tage en tablet, kan den tages før sengetid samme aften, men efter dette tidspunkt bør der ikke tages endnu en tablet før næste aften.
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.
Biotransformationen finder sted i leveren.
The site of biotransformation is the liver.
ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC: (gælder kun for yderkartonen, ikke for flaskeetiketten) SN: (gælder kun for yderkartonen, ikke for flaskeetiketten) NN: (gælder kun for yderkartonen, ikke for flaskeetiketten)
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)
Hyppighedskategorierne er angivet med følgende konvention: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1 000 til < 1/100), sjælden (≥ 1/10 000 til < 1/1 000); meget sjælden (< 1/10 000), ikke kendt (kan ikke beregnes af de foreliggende data).
(≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare