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.
Danish: Der blev randomiseret i alt 125 børn (2-17,0 år, gennemsnitsalder 8,7 +/- 4,15, 96,8 % autismespektrumforstyrrelse (ASD), 3,2 % Smith-Magenis syndrom [SMS]), hvis søvn ikke blev bedre ved adfærdsintervention alene; der foreligger resultater for 112 uger.
English: Endogenous melatonin was measured in human breast milk thus exogenous melatonin is probably secreted into human milk.
Danish: Der er målt endogent melatonin i human mælk; exogent melatonin må derfor forventes at blive udskilt i human mælk.
English: Available in bottle packs of 60 tablets and blister packs of 30 / 60 tablets.
Danish: De fås i flaskepakning med 60 tabletter og blisterpakning med 30/60 tabletter.
English: • Changes in mood
Danish: • Humørændringer
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.
Danish: Opvågningstidspunktet var upåvirket; efter 13 uger var patienternes opvågningstidspunkt forsinket ubetydeligt med 0,09 time (0,215) (5,4 minutter) ved behandling med Slenyto i forhold til placebo.
English: • fluvoxamine (used for the treatment of depression and obsessive compulsive disorder)
Danish: • fluvoxamin (anvendes til behandling af depression og tvangstanker (obsessiv-kompulsiv lidelse)
English: The excretion of the metabolite is completed within 12 hours after ingestion.
Danish: Udskillelsen af metabolitten er fuldstændig inden for 12 timer efter indtagelse.
English: CARTON AND LABEL (HDPE BOTTLE) - 1 MG
Danish: KARTON OG ETIKET (HDPE-FLASKE) - 1 MG
English: No clinical data exist concerning the use of melatonin in individuals with autoimmune diseases.
Danish: Der findes ingen kliniske data om anvendelse af melatonin hos personer med autoimmune sygdomme.
English: • imipramine (used for the treatment of depression)
Danish: • imipramin (anvendes til behandling af depression)
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.
Danish: Melatonin gennemgår hurtig hepatisk first pass-metabolisering, overvejende af CYP1A-enzymer og muligvis CYP2C19 i cytokrom P450-systemet, med en eliminationshalveringstid på ca. 40 minutter.
English: Melatonin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone.
Danish: Melatonin kan øge de sederende egenskaber af benzodiazepiner og andre hypnotika såsom zaleplon, zolpidem og zopiclon.
English: LIST OF EXCIPIENTS Contains lactose monohydrate See leaflet for further information
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactosemonohydrat Yderligere oplysninger fremgår af indlægssedlen
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Det bør ikke anvendes hos patienter med sjældne arvelige problemer bestående i galaktoseintolerans eller glukose-/galaktosemalabsorption.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (BLISTER PACK) - 1 MG
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON (BLISTERPAKNING) - 1 MG
English: • benzodiazepines and non-benzodiazepine hypnotics such as zaleplon, zolpidem and zopiclone
Danish: • sovemidler (benzodiazepiner og ikke-benzodiazepiner såsom zaleplon, zolpidem og zopiclon)
English: *MMRM analysis CI = confidence interval; WHO-5= the World Health Organization Well-Being Index; CSDI =
Danish: * mixed effects model repeated measures (MMRM)-analyse; CI = sikkerhedsinterval; WHO-5 = Verdenssundhedsorganisationens velværeindeks; CSDI = Composite Sleep Disturbance Index; SE = standardfejl
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).
Danish: Behandling med Slenyto, 2 mg/5 mg, medførte en væsentlig bedring i forhold til placebo i barnets eksternaliserende adfærd (score for hyperaktivitet/uopmærksomhed + adfærd), vurderet ved Questionnaire Strength and Difficulties (SDQ), efter 13 ugers dobbeltblind behandling (p = 0,021).
English: Available in bottle and blister packs of 30 tablets.
Danish: De fås i flaske og blisterpakning med 30 tabletter.
English: Concomitant use with fluvoxamine, alcohol, benzodiazepines/non-benzodiazepines hypnotics, thioridazine and imipramine is not recommended (see section 4.5).
Danish: Samtidig brug af fluvoxamin, alkohol, benzodiazepiner/andre hypnotika, thioridazin og imipramin frarådes (se pkt.
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.
Danish: Forsigtighed bør udvises hos patienter, som får østrogener (f.eks. som antikonception eller hormonerstatningsbehandling), da det øger koncentrationen af melatonin ved at hæmme dets metabolisering gennem CYP1A1 og CYP1A2.
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).
Danish: Der var signifikant forbedring med Slenyto i forhold til placebo i Composite Sleep Disturbance Index (CSDI) (sammensat indeks for søvnforstyrrelser) - vurderet tilfredshed hos forældrene i barnets søvnmønster (p = 0,005) og i omsorgspersoners velbefindende, vurderet ved WHO-5, efter 13 ugers dobbeltblind behandling (p = 0,01) (tabel 2).
English: Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du eller dit barn bruger anden medicin eller har gjort det for nylig.
English: You should speak to your doctor before taking/giving Slenyto as its use is not recommended in such cases.
Danish: Tal med lægen før indtagelse af Slenyto, da det frarådes at tage det i sådanne tilfælde.
English: Therefore, melatonin is not recommended for use in patients with autoimmune diseases.
Danish: Det frarådes derfor at anvende melatonin hos patienter med autoimmune sygdomme.
English: At baseline, mean Sleep Latency (SL) was 95.2 minutes in the Slenyto and 98.8 minutes in the placebo group.
Danish: Ved baseline var den gennemsnitlige søvnlatenstid (SL) 95,2 minutter i Slenyto-gruppen og 98,8 minutter i placebogruppen.
English: • thioridazine (used for the treatment of schizophrenia)
Danish: • thioridazin (anvendes til behandling af skizofreni)
English: The tablet should not be broken, crushed or chewed because it will lose the prolonged release properties.
Danish: Tabletterne må ikke deles, knuses eller tygges, da de derved vil miste depot-egenskaberne.
English: The liver is the primary site of melatonin metabolism and therefore, hepatic impairment results in higher endogenous melatonin levels.
Danish: Leveren er det primære organ for metabolisering af melatonin, hvorfor nedsat leverfunktion resulterer i højere koncentration af endogent melatonin.
English: • carbamazepine (used in the treatment of epilepsy)
Danish: • carbamazepin (anvendes til behandling af epilepsi)
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.
Danish: Hvis lægen har fortalt dig, at du eller dit barn ikke tåler visse sukkerarter, skal du kontakte lægen, før du eller dit barn tager dette lægemiddel.
English: Benzodiazepines/non-benzodiazepine hypnotics
Danish: Benzodiazepiner/andre hypnotika
English: Slenyto may cause drowsiness.
Danish: Slenyto kan forårsage døsighed.
English: 60 prolonged-release tablets
Danish: 60 depottabletter
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER STRIP OF 30 TABLETS - 5 MG
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED 30 TABLETTER - 5 MG
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.
Danish: Resultater for den randomiserede, placebo-kontrollerede behandlingsperiode (13 uger) Studiet opfyldte det primære endepunkt, som viste statistisk signifikante virkninger af Slenyto, 2/5 mg, i forhold til placebo ved ændring fra baseline i gennemsnitlig total søvnvarighed beregnet af Sleep and Nap Diary efter 13 ugers dobbeltblind behandling.
English: Pack size: 30 tablets or 60 tablets.
Danish: Pakningsstørrelse: 30 tabletter eller 60 tabletter.
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.
Danish: Ved udgangen af den 13-ugers dobbeltblinde periode steg den gennemsnitlige længste søvnepisode (LSE) med 77,9 minutter i Slenyto-behandlingsgruppen, sammenholdt med 25,5 minutter i placebo-behandlingsgruppen.
English: Other medicines and Slenyto
Danish: Brug af anden medicin sammen med Slenyto
English: CSDI satisfaction Slenyto 1.43(0.175)(1.08,1.78) Placebo 0.71(0.184)(0.34,1.07)
Danish: CSDI-tilfredshed Slenyto 1,43(0,175) [1,08 ; 1,78] Placebo 0,71(0,184) [0,34 ; 1,07]
English: At baseline, mean TST was 457.2 minutes in the Slenyto and 459.9 minutes in the placebo group.
Danish: Ved baseline var den gennemsnitlige totale søvntid (TST) 457,2 minutter i Slenyto-gruppen og 459,9 minutter i placebogruppen.
English: • cimetidine (used in the treatment of stomach problems such as ulcers)
Danish: • cimetidin (anvendes til behandling af maveproblemer såsom sår)
English: 5 mg strength - The active substance is melatonin.
Danish: Styrke 5 mg - Aktivt stof: melatonin.
English: Concomitant use of the following medicinal products is not recommended (see section 4.4):
Danish: Samtidig anvendelse med følgende lægemidler frarådes (se pkt.
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.
Danish: Ved udgangen af den 13-ugers behandlingsperiode faldt børnene i gennemsnit 39,6 minutter hurtigere i søvn med Slenyto og 12,5 minutter hurtigere med placebo; den justerede gennemsnitlige behandlingsforskel var -25,3 minutter i stikprøven bestående af alle randomiserede; MI (p = 0,012), uden at det medførte tidligere opvågnen.
English: 1 mg strength - The active substance is melatonin.
Danish: Styrke 1 mg - Aktivt stof: melatonin.
English: p-value*
Danish: pværdi*
English: INFORMATION IN BRAILLE Slenyto 5 mg (only applicable for outer carton, not applicable for bottle label)
Danish: INFORMATION I BRAILLESKRIFT Slenyto 5 mg (gælder kun for yderkartonen, ikke for flaskeetiketten)
English: Caution should be used when melatonin is administered to patients with renal impairment.
Danish: Forsigtighed bør udvises ved administration af melatonin til patienter med nedsat nyrefunktion.
English: If you or your child suffers from continued drowsiness, you should consult your doctor.
Danish: Hvis du eller dit barn er vedvarende døsig, bør du kontakte lægen.
English: Each prolonged-release tablet contains lactose monohydrate equivalent to 8.86 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver depottablet indeholder lactosemonohydrat svarende til 8,86 mg lactose.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 30 TABLETS - 1 MG
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED 30 TABLETTER - 1 MG
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.
Danish: Hos voksne medførte postprandial administration af Slenyto 5 mg (1 x 5 mg mini-tabletter) inden for 3 timer en Cmax-værdi (SD) af melatonin i plasma på 3,57 ng/ml (3,64).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Slenyto 1 mg prolonged-release tablets
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Slenyto, depottabletter, 1 mg
English: Melatonin has been co-administered in studies with thioridazine and imipramine, active substances which affect the central nervous system.
Danish: Melatonin er blevet koadministreret i studier med de CNS-aktive stoffer thioridazin og imipramin.
English: INFORMATION IN BRAILLE Slenyto 1 mg (only applicable for outer carton, not applicable for bottle label)
Danish: INFORMATION I BRAILLESKRIFT Slenyto 1 mg (gælder kun for yderkartonen, ikke for flaskeetiketten)
English: Each prolonged-release tablet contains lactose monohydrate equivalent to 8.32 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver depottablet indeholder lactosemonohydrat svarende til 8,32 mg lactose.
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).
Danish: Efter 13 ugers dobbeltblindet behandling sov deltagerne gennemsnitligt 57,5 minutter længere om natten med Slenyto i forhold til 9,1 minutter med placebo, og den justerede gennemsnitlige behandlingsforskel Slenyto-placebo var 33,1 minutter i stikprøven af alle randomiserede; multipel imputation (MI) (p = 0,
English: • non-steroidal anti-inflammatory medicines such as aspirin and ibuprofen (used for treating pain and inflammation).
Danish: • nonsteroide antiinflammatoriske lægemidler såsom acetylsalicylsyre og ibuprofen (anvendes til behandling af smerter og inflammation) Disse lægemidler bør undgås, navnlig om aftenen.
English: If you or your child gets any side effects, talk to your doctor or pharmacist.
Danish: Hvis du eller dit barn oplever bivirkninger, bør du tale med lægen eller apoteket.
English: PHARMACEUTICAL FORM AND CONTENTS 30 prolonged-release tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 30 depottabletter
English: • oestrogens (used in contraceptives or hormone replacement therapy)
Danish: • østrogener (anvendes som svangerskabsforebyggende midler eller som hormonerstatningsbehandling)
English: If you or your child takes more Slenyto than you/they should If you/your child has accidentally taken too much medicine, contact the doctor or pharmacist as soon as possible.
Danish: Hvis du eller barnet ved fejl har taget for meget lægemiddel, skal du kontakte lægen eller apoteket snarest muligt.
English: Slenyto contains lactose monohydrate.
Danish: Slenyto indeholder lactosemonohydrat.
English: Published data demonstrate markedly elevated endogenous melatonin levels during daytime hours due to decreased clearance in patients with hepatic impairment (see Section 4.2).
Danish: Hos patienter med nedsat leverfunktion er niveauet af endogent melatonin i dagtimerne markant højere som følge af nedsat clearance, i henhold til publicerede data (se pkt.
English: • Breathlessness/shortness of breath (dyspnoea)
Danish: • Åndenød (dyspnø)
English: EU/1/18/1318/001: 60 prolonged-release tablets
Danish: EU/1/18/1318/001: 60 depottabletter
English: • methoxypsoralens (used in the treatment of skin disorders e.g. psoriasis)
Danish: • methoxpsoralen (anvendes til behandling af hudsygdomme, f.eks. psoriasis)
English: PHARMACEUTICAL FORM AND CONTENTS 60 prolonged-release tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 60 depottabletter
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)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/1/18/1318/003: 30 depottabletter (blisterpakning) EU/1/18/1318/004: 30 depottabletter (flaske)
English: What you need to know before you or your child takes Slenyto
Danish: Det skal du vide, før du eller dit barn begynder at tage Slenyto
English: Pack size: 60 tablets.
Danish: Pakningsstørrelse: 60 tabletter.
English: NAME OF THE MARKETING AUTHORISATION HOLDER RAD Neurim Pharmaceuticals EEC SARL
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN RAD Neurim Pharmaceuticals EEC SARL
English: Therefore, melatonin is not recommended for use in patients with hepatic impairment (see section 5.2).
Danish: Melatonin frarådes derfor anvendt hos patienter med nedsat leverfunktion (se pkt.
English: Pack size: 30 tablets.
Danish: Pakningsstørrelse: 30 tabletter.
English: Crushing and chewing damages the special properties of the tablet and means that they will not work properly.
Danish: Hvis tabletten knuses eller tygges, vil det beskadige dens særlige egenskaber, så den ikke virker korrekt.
English: *MMRM analysis CI = confidence interval; SDQ = Strength and Difficulties Questionnaire; CGAS = the
Danish: *MMRM analyse (mixed effects model repeated measures analysis) (analyse med model for gentagne målinger af blandede effekter); CI = sikkerhedsinterval; SDQ = Strength and Difficulties Questionnaire (spørgeskema vedrørende styrke og vanskeligheder); CGAS = Children's Global Assessment Scale (skala for global vurdering af barnet; SE = standardfejl
English: The rate of participants attaining clinically meaningful responses in TST (increase of 45 minutes from baseline) and/or SL (decrease of 15 minutes from baseline) was significantly higher with Slenyto than with placebo
Danish: Det antal deltagere, der opnåede klinisk meningsfuld respons i total søvntid (TST) (en stigning på 45 minutter fra baseline) og/eller søvnlatenstid SL (et fald på 15 minutter fra baseline) var signifikant højere med Slenyto end med placebo (henholdsvis 68,9 % og 39,3 %; p = 0, 001).
English: How to take Slenyto
Danish: Sådan skal du tage Slenyto
English: What Slenyto contains
Danish: Slenyto indeholder:
English: Children under 2 years old
Danish: Til børn og unge i alderen 2-18 år
English: There is no experience of the use of melatonin in paediatric patients with renal impairment (see Section 4.2).
Danish: Der er ingen erfaringer med anvendelse af melatonin hos pædiatriske patienter med nedsat nyrefunktion (se pkt.
English: There is no experience of the use of melatonin in paediatric patients with liver impairment.
Danish: Der er ikke erfaringer med anvendelse af melatonin hos pædiatriske patienter med nedsat leverfunktion.
English: Fatigue, Hangover
Danish: Træthed, tømmermænd
English: Fluvoxamine
Danish: Fluvoxamin
English: • Feeling abnormal
Danish: • Følelse af at være unormal
English: There is no experience of the use of melatonin in patients with liver impairment.
Danish: Der er ikke erfaringer med anvendelse af melatonin hos patienter med nedsat leverfunktion.
English: In the paediatric population comprising 16 ASD children ages 7-15 years old suffering from insomnia, following Slenyto 2 mg (2 x 1 mg mini-tablets) administration after a standardized breakfast,
Danish: I den pædiatriske population bestående af 16 børn i alderen 7-15 år, der havde autismespektrumforstyrrelse (ASD) og led af søvnløshed, nåede koncentrationen af melatonin efter et standardiseret morgenmåltid sit maksimum 2 timer efter administration af Slenyto, 2 mg (2 x 1 mg mini-tabletter), og forblev efterfølgende forhøjet i 6 timer med en Cmax (SD) på 410 pg/ml (210) i spyt.
English: If you or your child stops taking Slenyto
Danish: Hvis du eller dit barn får for meget Slenyto
English: What Slenyto is
Danish: Hvad er Slenyto?
English: Each tablet contains 5 mg melatonin.
Danish: Hver tablet indeholder 5 mg melatonin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 5 mg melatonin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver depottablet indeholder 5 mg melatonin.
English: Each tablet contains 1 mg melatonin.
Danish: Hver tablet indeholder 1 mg melatonin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 1 mg melatonin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver depottablet indeholder 1 mg melatonin.
English: Fidia Farmaceutici S.p.A. Tel: +39 049 8232355 e-mail: info@fidiapharma.it
Danish: Tel: +39 049 8232355 e-mail: info@fidiapharma.it
English: • Swelling of the face
Danish: • Hævet ansigt
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1318/002: 60 prolonged-release tablets
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/1/18/1318/002: 60 depottabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1318/005: 30 prolonged-release tablets
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/1/18/1318/005: 30 depottabletter
English: Ammonio methacrylate copolymer type B Calcium hydrogen phosphate dihydrate Lactose monohydrate Silica, colloidal anhydrous Talc
Danish: Ammoniummethacrylat-copolymer type B Calciumhydrogenphosphatdihydrat Lactosemonohydrat
English: CGAS
Danish: Social funktion (CGAS)
English: Slenyto 1 mg prolonged-release tablets Slenyto 5 mg prolonged-release tablets melatonin
Danish: Slenyto, depottabletter, 1 mg Slenyto, depottabletter, 5 mg melatonin
English: Slenyto 5 mg prolonged-release tablets are yellow, film coated, round, biconvex, 3 mm diameter tablets.
Danish: Slenyto depottabletter, 5 mg, er gule, filmovertrukne, runde, bikonvekse tabletter med diameter 3 mm.
English: Slenyto contains lactose.
Danish: Slenyto indeholder lactose.
English: NAME OF THE MEDICINAL PRODUCT Slenyto 5 mg prolonged-release tablets melatonin
Danish: LÆGEMIDLETS NAVN Slenyto, depottabletter, 5 mg melatonin
English: Glucose monohydrate Lecithin (E322) Titanium dioxide (E171) Iron oxide yellow (E172)
Danish: Glucosemonohydrat Lecithin (E322) Titaniumdioxid (E171) Jernoxid, gul (E172)
English: You should talk to your doctor before you/your child stops taking Slenyto.
Danish: Hvis du eller dit barn holder op med at tage Slenyto Tal med lægen, før du eller dit barn holder op med at tage Slenyto.
English: Slenyto contains lactose
Danish: Slenyto indeholder lactose
English: NAME OF THE MEDICINAL PRODUCT Slenyto 1 mg prolonged-release tablets melatonin
Danish: LÆGEMIDLETS NAVN Slenyto, depottabletter, 1 mg melatonin
English: Tablet core
Danish: Depottablet.
English: Glucose monohydrate Lecithin (E322) Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172)
Danish: Glucosemonohydrat Lecithin (E322) Titaniumdioxid (E171) Rød jernoxid (E172) Jernoxid, gul (E172)
English: Slenyto 1 mg prolonged-release tablets are pink, film coated, round, biconvex, 3 mm diameter tablets.
Danish: Slenyto depottabletter, 1 mg, er lyserøde, filmovertrukne, runde, bikonvekse tabletter med diameter 3 mm.
English: Ammonio methacrylate copolymer type A Calcium hydrogen phosphate dihydrate Lactose monohydrate Silica, colloidal anhydrous Magnesium stearate
Danish: Ammoniummethacrylat-copolymer type A Calciumhydrogenphosphatdihydrat Lactosemonohydrat
English: Do not break, crush or chew the tablet.
Danish: Tabletterne må ikke deles, knuses eller tygges.
English: Slenyto 5 mg prolonged-release tablets
Danish: Slenyto, depottabletter, 5 mg
English: Each prolonged-release tablet contains 1 mg melatonin.
Danish: Hver depottablet indeholder 1 mg melatonin.
English: Each prolonged-release tablet contains 5 mg melatonin.
Danish: Hver depottablet indeholder 5 mg melatonin.
English: Alcohol
Danish: Rygning
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),
Danish: magnesiumstearat, carmellosenatrium (E466), maltodextrin, glucosemonohydrat, lecithin