FrancophonIA/ELRC3.0 huggingface dataset:
English: The rate of melatonin absorption and Cmax following Circadin 2 mg oral administration is affected by food.
Danish: Hastigheden af absorptionen af melatonin og Cmax efter oral administration af 2 mg Circadin påvirkes af fødeindtagelse.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Circadin.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apoteket, før du tager Circadin.
English: The blisters are then packed in cardboard boxes.
Danish: Blisterpakningerne er derefter pakket i papæsker.
English: Physiologically, melatonin secretion increases soon after the onset of darkness, peaks at 2-4 am and diminishes during the second half of the night.
Danish: Fysiologisk øges melatoninsekretionen kort tid efter mørkets frembrud og når sit maksimum ved 2-4 tiden om natten og falder i løbet af anden halvdel af natten.
English: The following adverse reactions were reported in clinical trials and from post-marketing spontaneous reporting.
Danish: Følgende bivirkninger blev rapporteret i kliniske forsøg og findes fra spontant rapportering efter markedsføringen.
English: Circadin has moderate influence on the ability to drive and use machines.
Danish: Circadin påvirker i moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
English: An additional randomised clinical trial (n=600) compared the effects of Circadin and placebo for up to six months.
Danish: Yderligere et randomiseret klinisk forsøg (n=600) sammenlignede effekten af Circadin og placebo i op til seks måneder.
English: The carcinogenicity study in the rat did not reveal any effect which may be relevant for humans.
Danish: En karcinogenicitetsstudie af rotter viste ingen relevant effekt for mennesker.
English: The principal metabolite is 6-sulphatoxy-melatonin (6-S-MT), which is inactive.
Danish: Hovedmetabolitten er 6-sulfatoxymelatonin (6-S-MT), som er inaktiv.
English: Tmax occurs after 3 hours in a fed state.
Danish: Tmax optræder tre timer efter fødeindtagelse.
English: There are data in animal models including rodents, sheep, bovine and primates that indicate maternal transfer of melatonin to the foetus via the placenta or in the milk.
Danish: Der foreligger data fra forsøgsdyr herunder gnavere, får, køer og primater, som tyder på overførsel af melatonin fra moderdyret til fostret via placenta eller i mælken.
English: Do not take Circadin - if you are allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Circadin - hvis du er allergisk over for melatonin eller et af de øvrige indholdsstoffer i denne medicin
English: The recommended dose is 2 mg once daily, 1-2 hours before bedtime and after food.
Danish: Den anbefalede dosis er 2 mg én gang daglig, 1-2 timer inden sengetid og efter indtagelse af mad.
English: Melatonin is a naturally occurring hormone produced by the pineal gland and is structurally related to serotonin.
Danish: Melatonin er et naturligt forekommende hormon, der produceres i pinealkirtlen og strukturelt er relateret til serotonin.
English: Therefore the product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety.
Danish: Derfor bør produktet anvendes med forsigtighed, hvis døsigheden kan indebære en sikkerhedsrisiko.
English: The tablets are packed in PVC/PVDC opaque blister strips with aluminium foil backing.
Danish: Tabletterne er pakket i uigennemsigtige PVC/PVDC-blisterstrips med en bagside af aluminiumsfolie.
English: Pharmacotherapeutic group: Psycholeptics, melatonin receptor agonists, ATC code: N05CH01
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, melatonin-receptor-agonister, ATC-kode: N05CH01
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.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Circadin tablets should not be crushed or cut in half.
Danish: Circadin-tabletter må ikke knuses eller deles i to dele.
English: Across a range of doses, higher AUC and Cmax levels have been reported in older patients compared to younger patients, reflecting the lower metabolism of melatonin in the elderly.
Danish: Der er ved forskellige doser rapporteret højere AUC værdier og Cmax niveauer hos ældre patienter sammenlignet med yngre patienter, hvilket afspejler den lavere metabolisme af melatonin hos ældre.
English: Sleep variables gradually returned to baseline with no rebound, no increase in adverse reactions and no increase in withdrawal symptoms.
Danish: Søvnparametrene vendte gradvist tilbage til baseline uden tilbagefald, der var ingen forøgelse af bivirkninger og ingen forøgelse af abstinenssymptomer.
English: Endogenous melatonin was measured in human breast milk thus exogenous melatonin is probably secreted into human milk.
Danish: Endogen melatonin blev målt i human brystmælk, så eksogen melatonin udskilles sandsynligvis i human mælk.
English: The active substance of Circadin, melatonin, belongs to a natural group of hormones produced by the body.
Danish: Det aktive stof i Circadin, melatonin, hører til en naturlig gruppe af hormoner, som kroppen selv danner.
English: Plasma melatonin levels in patients with cirrhosis were significantly increased during daylight hours.
Danish: Melatoninniveauerne i plasma hos patienter med cirrose var signifikant forhøjede i dagtimerne.
English: - Smoking may make Circadin less effective, because the components of tobacco smoke can increase the breakdown of melatonin by the liver.
Danish: - Rygning kan gøre circadin mindre effektivt, fordi indholdsstofferne i tobaksrøg kan øge leverens nedbrydning af melatonin.
English: Nervous system disorders were more common in the active group with 42% patients, compared to 23% in the placebo group, mainly driven by somnolence and headache more frequent in the active group.
Danish: Lidelser i nervesystemet var mere almindelige hos den aktive gruppe med 42 % patienter, sammenlignet med 23 % i placebogruppen, hovedsagelig som følge af somnolens og hovedpine, der forekom oftere i den aktive gruppe.
English: • Severe chest pain due to angina
Danish: • Alvorlige brystsmerter på grund af angina
English: The recommended dose is one Circadin tablet (2 mg) taken daily by mouth, after food, 1-2 hours before bedtime.
Danish: Den anbefalede dosis er én Circadin-tablet (2 mg) taget daglig gennem munden, efter mad, 1-2 timer inden sengetid.
English: Because of the role of melatonin in sleep and circadian rhythm regulation, and the age related decrease in endogenous melatonin production, melatonin may effectively improve sleep quality particularly in patients who are over 55 with primary insomnia.
Danish: På grund af den rolle melatonin spiller i reguleringen af søvn og døgnrytme og det aldersrelaterede fald i den endogene melatoninproduktion, kan melatonin effektivt forbedre søvnkvaliteten, og dette gælder især hos patienter over 55 år, der lider af primær søvnløshed.
English: Melatonin metabolism is known to decline with age.
Danish: Melatonins metabolisme aftager med alderen.
English: Circadin may cause drowsiness, therefore the product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety.
Danish: Circadin kan medføre døsighed, og derfor skal produktet anvendes med forsigtighed, hvis det er muligt at virkningerne af døsighed kan være forbundet med en sikkerhedsrisiko.
English: The levels assessed in the blood of the patients at 23:00 (2 hours after administration) following 1 and 3 weeks of daily administration were 411.4 ± 56.5 and 432.00 ± 83.2 pg/ml respectively, and are similar to those found in in healthy volunteers following a single dose of Circadin 2 mg.
Danish: De niveauer, der blev målt i blodet fra patienterne kl. 23:00 (2 timer efter administration) efter én og tre ugers daglig administration, var henholdsvis 411,4 ± 56,5 og 432,00 ± 83,2 pg/ml, og det svarer til det, der ses hos raske frivillige efter en enkelt dosis Circadin 2 mg.
English: Company data indicates that there is no accumulation of melatonin after repeated dosing.
Danish: Data fra firmaet tyder på, at melatonin ikke akkumuleres efter gentagen dosering.
English: There was also a reduction in sleep latency with active treatment (61 minutes) compared to placebo (77 minutes) after 13 weeks of double-blind treatment, without causing earlier wake-up time.
Danish: Der var også en reduktion i søvnlatenstid med aktiv behandling (61 minutter) sammenlignet med placebo (77 minutter) efter 13 ugers dobbeltblind behandling, uden at det medførte tidligere opvågningstid.
English: Concomitant administration resulted in increased impairment of attention, memory and co-ordination compared to zolpidem alone.
Danish: Samtidig indgift af de to stoffer resulterede i en forringet opmærksomhed, hukommelse og koordination sammenlignet med zolpidem indgivet alene.
English: Elimination is by renal excretion of metabolites, 89% as sulphated and glucoronide conjugates of 6-hydroxymelatonin and 2% is excreted as melatonin (unchanged active substance).
Danish: Eliminationen foregår renalt ved udskillelse af metabolitter, heraf 89 % som sulfat- og glukoronidkonjugater af 6-hydroxymelatonin og 2 % som melatonin (uomdannet aktivt stof).
English: Circadin is mainly bound to albumin, alpha1-acid glycoprotein and high density lipoprotein.
Danish: Circadin binder sig hovedsageligt til albumin, surt alfa1-glykoprotein og high-density lipoprotein (HDL).
English: Only those adverse reactions reported during clinical trials occurring in patients at an equivalent or greater rate than placebo have been included below.
Danish: Kun de bivirkninger, der blev rapporteret under kliniske forsøg, og som forekom hos patienter med en tilsvarende eller højere hyppighed end placebo, er medtaget nedenfor.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER STRIP
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS STRIP
English: In view of the lack of clinical data, use in pregnant women and by women intending to become pregnant is not recommended.
Danish: På grund af manglen på kliniske data bør Circadin ikke bruges til gravide kvinder eller til kvinder, der planlægger graviditet.
English: This finding is compatible with the short half-life of melatonin in humans.
Danish: Dette er i overensstemmelse med melatonins korte halveringstid hos mennesker.
English: • Alcohol should not be taken with Circadin, because it reduces the effectiveness of Circadin on sleep.
Danish: • Der bør ikke indtages alkohol sammen med Circadin, da alkohol nedsætter Circadins virkning på søvnen.
English: • Circadin has been co-administered in studies with thioridazine and imipramine, active substances which affect the central nervous system.
Danish: • I kliniske forsøg er Circadin blevet givet sammen med thioridazin og imipramin, aktive stoffer der påvirker centralnervesystemet.
English: Cmax levels around 500 pg/ml in adults (18-45) versus 1200 pg/ml in elderly (55-69); AUC levels around 3,000 pg*h/mL in adults versus 5,000 pg*h/mL in the elderly.
Danish: Cmax niveauer på omkring 500 pg/ml hos voksne (18-45 år) versus 1200 pg/ml hos ældre (55-69 år); AUC niveauer på omkring 3.000 pg*t/ml hos voksne versus 5.000 pg*t/ml hos ældre.
English: The study demonstrated improvements in sleep latency, quality of sleep and morning alertness, with no withdrawal symptoms and rebound insomnia.
Danish: Forsøget viste forbedringer i søvnlatens, søvnkvalitet og årvågenhed om morgenen uden abstinenssymptomer og rebound insomni.
English: No clinically significant pharmacokinetic interactions were found in each case.
Danish: Der blev ikke observeret klinisk relevante farmakokinetiske interaktioner i disse forsøg.
English: The kinetics of melatonin are linear over the range of 2-8 mg.
Danish: Melatonins kinetik er lineær ved dosering i området: 2-8 mg.
English: If you experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately:
Danish: Hvis du oplever nogen af følgende alvorlige bivirkninger, skal du ophøre med at tage medicinen og omgående kontakre din læge.
English: The presence of food delayed the absorption of the melatonin resulting in a later (Tmax=3.0 h versus Tmax=0.75 h) and lower peak plasma concentration in the fed state (Cmax=1020pg/ml versus Cmax=1176 pg/ml).
Danish: Fødeindtagelse forsinkede absorptionen af melatonin, hvilket resulterede i en senere (Tmax=3,0t versus Tmax=0,75t) og lavere peak plasmakoncentration efter fødeindtagelse (Cmax=1020 versus Cmax=1176 pg/ml).
English: Quality of life was improved significantly with Circadin 2 mg compared to placebo.
Danish: Livskvaliteten blev betydelig forbedret i 2 mg Circadin-gruppen sammenlignet med placebo.
English: White to off-white, round, biconvex tablets
Danish: Hvide til næsten hvide, runde, bikonvekse tabletter
English: Hypersensitivity reaction, swelling of mouth or tongue, swelling of the skin and abnormal milk secretion.
Danish: Overfølsomhedsreaktion, hævelse af mund eller tunge, hævelse af huden og unormalt mælkesekret.
English: There were no modifications of sleep architecture and no effect on REM sleep duration by Circadin.
Danish: Der var ingen ændringer i søvnmønstret og ingen virkning på REM-søvnens varighed med Circadin-behandling.
English: The pack consists of one blister strip containing 7, 20 or 21 tablets, or two blister strips containing 15 tablets each (30 tablets).
Danish: Pakken består af én blisterstrip med 7, 20 eller 21 tabletter eller to blisterstrips med hver 15 tabletter (30 tabletter).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis din læge har fortalt dig, at der er visse sukkertyper, du ikke kan tåle, bør du kontakte din læge, før du tager dette lægemiddel.
English: If overdose occurs, drowsiness is to be expected.
Danish: Ved overdosering kan der forekomme døsighed.
English: Published data demonstrates markedly elevated endogenous melatonin levels during daytime hours due to decreased clearance in patients with hepatic impairment.
Danish: Publicerede data påviser markant forhøjede endogene melatoninniveauer i dagtimerne på grund af nedsat elimination af melatonin hos patienter med nedsat leverfunktion.
English: • Cigarette smoking may decrease melatonin levels due to induction of CYP1A2.
Danish: • Cigaretrygning kan nedsætte melatoninniveauerne via induktion af CYP1A2.
English: Circadin shortened patients' reported sleep latency by 24.3 minutes vs 12.9 minutes with placebo.
Danish: I Circadin-gruppen blev patienternes søvnlatens forkortet med 24,3 minutter over for 12,9 minutter i placebo-gruppen.
English: In clinical trials (in which a total of 1,931 patients were taking Circadin and 1,642 patients were taking placebo), 48.8% of patients receiving Circadin reported an adverse reaction compared with 37.8% taking placebo.
Danish: I kliniske forsøg (hvor i alt 1.931 patienter tog Circadin, og 1.642 patienter tog placebo) rapporterede 48,8 % af de patienter, der fik Circadin, en bivirkning sammenlignet med 37,8 % af de patienter, der fik placebo.
English: Comparing the rate of patients with adverse reactions per 100 patient weeks, the rate was higher for placebo than Circadin (5.743- placebo vs. 3.013- Circadin).
Danish: Når man sammenlignede antallet af patienter, der fik bivirkninger per 100 patient-uger, var hyppigheden højere for placebo end for Circadin (5.743 for placebo over for 3.013 for Circadin).
English: • There is a large amount of data in the literature regarding the effect of adrenergic agonists/antagonists, opiate agonists/antagonists, antidepressant medicinal products, prostaglandin inhibitors, benzodiazepines, tryptophan and alcohol, on endogenous melatonin secretion.
Danish: • Der findes omfattende dokumentation i litteraturen vedrørende virkningen af adrenerge agonister/antagonister, opiatagonister/antagonister, antidepressiva, prostaglandinhæmmere, benzodiazepiner, tryptofan og alkohol på den endogene sekretion af melatonin.
English: • Circadin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone.
Danish: • Circadin kan forstærke de sedative egenskaber af benzodiazepiner og hypnotika, der ikke indeholder benzodiazepin såsom zaleplon, zolpidem og zopiclon.
English: Rare: (may affect up to 1 in 1000 people)
Danish: Sjældne: (kan forekomme hos op til 1 ud af 1000 personer)
English: If you suffer from continued drowsiness, then you should consult your doctor.
Danish: Hvis du lider af vedvarende døsighed, skal du spørge din læge til råds.
English: A 3-4-fold increase in Cmax is apparent for women compared to men.
Danish: Cmax hos kvinder er 3-4 gange højere end hos mænd.
English: Circadin has been administered at 5 mg daily doses in clinical trials over 12 months without significantly changing the nature of the adverse reactions reported.
Danish: Circadin administreret i daglige doser på 5 mg over 12 måneder, og der er ikke observeret ændringer i arten af de registrerede bivirkninger.
English: In reproductive toxicology, oral administration of melatonin in pregnant female mice, rats or rabbits did not result in adverse effects on their offspring, measured in terms of foetal viability, skeletal and visceral abnormalities, sex ratio, birthweight and subsequent physical, functional and sexual development.
Danish: Reproduktionstoksikologiske studier af dyr, hvor melatonin blev givet oralt til drægtige hunmus, rotter eller kaniner, resulterede ikke i skadelige virkninger på deres afkom, målt som fostrets levedygtighed, skeletale og viscerale abnormiteter, kønsratio, fødselsvægt og efterfølgende fysiske, funktionelle og seksuelle udvikling.
English: Sites responsible for Batch Release in the EEA:
Danish: Fremstillerne ansvarlige for batchfrigivelse i EEA:
English: Each carton of tablets contains one blister strip of 7, 20 or 21 tablets, or alternatively in a carton containing two blister strips of 15 tablets each (30 tablet pack).
Danish: Hver æske indeholder en blisterstrip med 7, 20 eller 21 tabletter eller alternativt to blisterstrips med hver 15 tabletter (i alt 30 tabletter i æsken).
English: In clinical trials a total of 9.5% of patients receiving Circadin reported an adverse reaction compared with 7.4% of patients taking placebo.
Danish: I kliniske forsøg rapporterede i alt 9,5 % af de patienter, der fik Circadin, en bivirkning sammenlignet med 7,4 % af de patienter, der fik placebo.
English: Vertigo positional, vertigo
Danish: Øre og labyrint positionsvertigo, vertigo
English: Uncommon: (may affect up to 1 in 100 people) • Chest pain
Danish: Ikke almindelige: (kan forekomme hos op til 1 ud af 100 personer) • Brystsmerter
English: If you have accidentally taken too much of your medicine, contact your doctor or pharmacist as soon as possible.
Danish: Hvis du er kommet til at tage for meget medicin, skal du hurtigst muligt kontakte din læge eller apoteket.
English: Visual acuity reduced, vision blurred, lacrimation increased
Danish: Øjne nedsat synsskarphed, sløret syn, øget tåresekretion
English: The use of Circadin is not known to cause any withdrawal effects after treatment completion.
Danish: Brugen af Circadin menes ikke at give abstinenser efter, at behandlingen er afsluttet.
English: Circadin is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Danish: Circadin er indiceret til monoterapi ved korttidsbehandling af primær søvnløshed kendetegnet ved dårlig søvnkvalitet hos patienter i alderen 55 år eller derover.
English: Melatonin is associated with the control of circadian rhythms and entrainment to the light-dark cycle.
Danish: Melatonin sættes i forbindelse med kontrol af døgnrytmen og tilvænning til lys/mørke-cyklussen.
English: Circadin may cause drowsiness.
Danish: Circadin kan medføre døsighed.
English: • Feeling your heartbeat
Danish: • Følelse af hjertebanken
English: Sími: +354 535 7000
Danish: Simi: +354 535 7000
English: Modifications in diurnal functioning did not occur with Circadin 2 mg.
Danish: Der forekom ingen ændringer i funktionsevnen om dagen med 2 mg Circadin-behandling.
English: INFORMATION IN BRAILLE Circadin 2 mg
Danish: INFORMATION I BRAILLESKRIFT Circadin 2 mg
English: If you experience any of the following non-serious side effects contact your doctor and/or seek medical advice:
Danish: Hvis du oplever nogen af følgende ikke-alvorlige bivirkninger, børf du kontakte din læge og/eller sæge lægehjælp:
English: If you stop taking Circadin
Danish: Hvis du holder op med at tage Circadin
English: LIST OF EXCIPIENTS Contains lactose monohydrate See leaflet for further information
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactosemonohydrat Se yderligere oplysninger i indlægssedlen
English: However, Circadin 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.
Danish: Der blev imidlertid, når produkterne blev givet sammen, set en øget fornemmelse af ro og vanskelighed ved at udføre opgaver sammenlignet med imipramin indgivet alene samt en øget fornemmelse af omtågethed sammenlignet med thioridazin indgivet alene.
English: Other medicines and Circadin
Danish: Brug af anden medicin sammen med Circadin
English: What Circadin contains - The active substance is melatonin.
Danish: Circadin indeholder: - Aktivt stof/aktive stoffer: melatonin.
English: − Fluvoxamine (used for the treatment of depression and obsessive compulsive disorder), psoralens (used in the treatment of skin disorders e.g. psoriasis), cimetidine (used in the treatment of stomach problems such as ulcers), quinolones and rifampicin (used in the treatment of bacterial infections), oestrogens (used in contraceptives or hormone replacement therapy) and carbamazepine (used in the treatment of epilepsy).
Danish: - Fluvoxamin (bruges til behandling af depression og obsessiv-kompulsiv tilstand OCD), psoralener (anvendes til behandling af hudproblemer, fx psoriasis), cimetidin (brugs til behandling af maveproblemer, som fx mavesår), quinoloner og rifampicin (bruges til behandling af bakterieinfektioner), østrogener (bruges i præventionsmidler eller hormonsubstitutionsbehandling) og carbamazepin (bruges til behandling af epilepsi).
English: Uncommon: (may affect up to 1 in 100 people)
Danish: Ikke almindelige: (kan forekomme hos op til 1 ud af 100 personer)
English: If you forget to take Circadin
Danish: Hvis du har glemt at tage Circadin
English: Circadin contains lactose.
Danish: Circadin indeholder lactose.
English: NAME OF THE MARKETING AUTHORISATION HOLDER RAD Neurim Pharmaceuticals EEC SARL
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN RAD Neurim Pharmaceuticals EEC Limited
English: Administration of daily doses of up to 300 mg of melatonin without causing clinically significant adverse reactions have been reported in the literature.
Danish: I litteraturen er der rapporteret daglige doser på op til 300 mg melatonin, uden at dette har medført klinisk betydende bivirkninger.
English: In clinical trials, where patients suffering from primary insomnia received Circadin 2 mg every evening for 3 weeks, benefits were shown in treated patients compared to placebo in sleep latency (as measured by objective and subjective means) and in subjective quality of sleep and daytime functioning (restorative sleep) with no impairment of vigilance during the day.
Danish: I kliniske forsøg hvor patienter, der led af primær søvnløshed, blev behandlet med 2 mg Circadin hver aften i tre uger, blev der registreret effekt hos de behandlede patienter sammenlignet med placebo med hensyn til søvnlatens (målt objektivt og subjektivt) samt med hensyn til den subjektive søvnkvalitet og funktionsevne om dagen (udhvilende søvn) uden forringelse af årvågenhed om dagen.