natgillin/translations-raw huggingface dataset:
Østrogener øger melatoninniveauerne ved at hæmme den melatoninomsætning, som sker via CYP1A1 og CYP1A2. • CYP1A2- hæmmere såsom quinoloner kan medføre øgede plasmakoncentrationer af melatonin. • Carbamazepin og rifampicin inducerer CYP1A2, hvilket kan medføre nedsatte plasmakoncentrationer af melatonin. • 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.
The combination should be avoided. • Caution should be exercised in patients on 5- or 8-methoxypsoralen (5 and 8-MOP), which increases melatonin levels by inhibiting its metabolism. • Caution should be exercised in patients on cimetidine a CYP2D inhibitor, which increases plasma melatonin levels, by inhibiting its metabolism. • Cigarette smoking may decrease melantonin levels due to induction of CYP1A2. • 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. • CYP1A2 inhibitors such as quinolones may give rise to increased melatonin exposure. • CYP1A2 inducers such as carbamazepine and rifampicin may give rise to reduced plasma concentrations of melatonin. • 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.
• Der bør ikke indtages alkohol sammen med Circadin, da alkohol nedsætter Circadins virkning på søvnen. • Circadin kan forstærke de sedative egenskaber af benzodiazepiner og hypnotika, der ikke indeholder benzodiazepin såsom zalepon, zolpidem og zopiclon.
• Alcohol should not be taken with Circadin, because it reduces the effectiveness of Circadin on sleep. • Circadin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zalepon, zolpidem and zopiclone.
Samtidig indgift af de to stoffer resulterede i en forringet opmærksomhed, hukommelse og koordination sammenlignet med zolpidem indgivet alene.
Concomitant administration resulted in increased impairment of attention, memory and co-ordination compared to zolpidem alone. • Circadin has been co-administered in studies with thioridazine and imipramine, active substances which affect the central nervous system.
3 • I kliniske forsøg er Circadin blevet givet sammen med thioridazin og imipramin, aktive stoffer der påvirker centralnervesystemet.
No clinically significant pharmacokinetic interactions were found in each case.
Der blev ikke observeret klinisk relevante farmakokinetiske interaktioner i disse forsøg.
However, Circadin co-administration resulted in increased feelings of tranquility and difficulty in
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.
3 performing tasks compared to imipramine alone, and increased feelings of “ muzzy- headedness” compared to thioridazine alone.
På grund af manglen på kliniske data bør Circadin ikke bruges til gravide kvinder eller til kvinder, der planlægger graviditet.
In view of the lack of clinical data, use in pregnant women and by women intended to become pregnant is not recommended.
I kliniske forsøg (hvor i alt 1361 patienter tog Circadin, og 1247 patienter tog placebo) rapporterede 37, 0% af de patienter, der fik Circadin, en bivirkning, sammenlignet med 31, 8% af de patienter der fik placebo.
In clinical trials (in which a total of 1361 patients were taking Circadin and 1247 patients were taking placebo), 37.0% of patients receiving Circadin reported an adverse reaction compared with 31.8% taking placebo.
Når man sammenlignede antallet af patienter, der fik bivirkninger per 100 patient- uger, var hyppigheden højere for placebo end for Circadin (8, 21 for placebo over for 3, 17 for Circadin).
3.17 – Circadin).
De mest almindelige bivirkninger hos både de Circadin - og de placebobehandlede grupper var hovedpine, pharyngitis, rygsmerte og asteni, som var almindelige ifølge MedDRA- definitionen.
The most common adverse reactions were headache, pharyngitis, back pain, and asthenia, which were common, by MedDRA definition, in both the Circadin and placebo treated groups.
Følgende bivirkninger blev rapporteret i kliniske forsøg, og de blev defineret som muligvis, sandsynligvis eller med sikkerhed relaterede til behandlingen.
The following adverse reactions were reported in clinical trials and were defined as possibly, probably or definitely related to treatment.
I alt 6, 9% af de forsøgspersoner, der fik Circadin, rapporterede en bivirkning, sammenlignet med 5, 9% af de forsøgspersoner der fik placebo.
A total of 6.9% of subjects receiving Circadin reported an adverse reaction compared with 5.9% of subjects taking placebo.
Kun de bivirkninger, der forekom hos forsøgspersonerne med en tilsvarende eller højere hyppighed end placebo, er medtaget nedenfor.
Only those adverse events occurring in subjects at an equivalent or greater rate than placebo have been included below.
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 estimeres ud fra forhåndenværende data).
Very common (≥ 1/ 10); Common (≥ 1/ 100 to < 1/ 10); Uncommon (≥ 1/ 1,000 to < 1/ 100); Rare (≥ 1/ 10,000 to < 1/ 1,000); Very rare (< 1/ 10,000), Not known (cannot be established from the available data).
Systemorganklasser
System Organ
almindelig Infektioner og parasitære sygdomme
Infections and Infestations
herpes zoster
Herpes zoster
Blod og lymfesystem Metabolisme og ernæring
Blood and Lymphatic System Disorders
leukopeni, trombocytopeni hypertriglyceridæmi
Leukopenia, Thrombocytopenia
Psykiske forstyrrelser
Metabolism and Nutrition Disorders
irritabilitet,
Hypertriglyceridaemia
ændret sindsstemning,
Psychiatric Disorders
nervøsitet, rastløshed, søvnløshed, abnorme drømme
Irritability, Nervousness, Restlessness, Insomnia, Abnormal dreams
aggression, agitation, gråd, tidlig opvågnen, øget libido
Mood altered, Aggression, Agitation, Crying, Early morning awakening, Libido increased
migræne, psykomotorisk hyperaktivitet, svimmelhed, somnolens
Migraine, Psychomotor hyperactivity, Dizziness, Somnolence
hukommelsessvækkelse, opmærksomhedsforstyrrelse, dårlig søvnkvalitet
Memory impairment, Disturbance in attention, Poor quality sleep
nedsat synsskarphed, sløret syn, øget tåresekretion
Visual acuity reduced, Vision blurred, Lacrimation increased
Øre og labyrint Vaskulære sygdomme
Ear and Labyrinth Disorders
positionsvertigo hedeture
Vertigo positional
Mave- tarmkanalen
Vascular Disorders
mavesmerter, forstoppelse, mundtørhed
Abdominal pain, Constipation, Dry mouth
mave- tarmsygdom, mave - tarmforstyrrelse, opkastning, abnorme tarmlyde, flatulens, hypersekretion af spyt, halitose
Gastrointestinal disorder, Gastrointestinal upset, Vomiting, Bowel sounds abnormal, Flatulence, Salivary hypersecretion, Halitosis
Lever og galdeveje
Hepatobiliary Disorders
Hyperbilirubin - æmi
Hyperbilirubinaemia
forhøjet leverenzym, abnorm leverfunktionstest, abnorm laboratorietest
Hepatic enzyme increased, Liver function test abnormal, laboratory test abnormal
hyperhidrose
Hyperhidrosis
eksem, erytem, kløende udslæt, pruritus, tør hud, neglelidelser, natlige svedeture
Eczema, Erythema, Rash pruritic, Pruritus, Dry skin, Nail disorder, Night sweats,
muskelkramper, nakkesmerter
Muscle cramp, Neck pain
priapisme
Priapism
træthed
Fatigue
vægtforøgelse
Weight increased
Der er ikke indberettet tilfælde af overdosering.
5 No case of overdose has been reported.
Melatonin- receptor agonister, ATC- kode:
Melatonin Receptor Agonists, ATC code:
5 Melatonin er et naturligt forekommende hormon, der produceres i pinealkirtlen og strukturelt er relateret til serotonin.
Melatonin is a naturally occurring hormone produced by the pineal gland and is structurally related to serotonin.
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.
Physiologically, melatonin secretion increases soon after the onset of darkness, peaks at 2-4 am and diminishes during the second half of the night.
Melatonin sættes i forbindelse med kontrol af døgnrytmen og tilvænning til lys/ mørke- cyklussen.
Melatonin is associated with the control of circadian rhythms and entrainment to the light-dark cycle.
Virkningsmekanisme Melatonins virkning på MT1, MT2 - og MT3- receptorer menes at bidrage til dens søvnfremmende egenskaber, da disse receptorer (hovedsageligt MT1 og MT2) er involveret i reguleringen af døgnrytmen og søvnen.
Mechanism of action The activity of melatonin at the MT1, MT2 and MT3 receptors 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.
Rationale for brug 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.
Rationale for use 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.
Klinisk effekt 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.
Clinical efficacy 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.
Der var ingen ændringer i søvnmønstret og ingen virkning på REM- søvnens varighed med Circadin- behandling.
There were no modifications of sleep architecture and no effect on REM sleep duration by Circadin.
Der forekom ingen ændringer i funktionsevnen om dagen med 2 mg Circadin- behandling.
Modifications in diurnal functioning did not occur with Circadin 2 mg.
I et forsøg med ambulante patienter med to ugers baseline- indkøringsperiode (placebokontrolleret), en randomiseret, dobbeltblind, placebokontrolleret, parallelgruppe behandlingsperiode på tre uger og to ugers nedtrapningsperiode (placebokontrolleret) var andelen af patienter, der viste en klinisk effekt med hensyn til såvel søvnkvalitet som årvågenhed om morgenen 47% i Circadin- gruppen sammenlignet med 27% i placebo- gruppen.
In an outpatient study with 2 week run-in baseline period with placebo, a randomised, double blind, placebo controlled, parallel group treatment period of 3 weeks and 2 week withdrawal period with placebo, the rate of patients who showed a clinically significant improvement in both quality of sleep and morning alertness was 47% in the Circadin group as compared to 27% in the placebo group.
Desuden forbedredes søvnkvaliteten og årvågenheden om morgenen signifikant i Circadin- gruppen sammenlignet med placebo- gruppen.
In addition, quality of sleep and morning alertness significantly improved with Circadin compared to placebo.
Søvnparametrene vendte gradvist tilbage til baseline uden tilbagefald, der var ingen forøgelse af bivirkninger og ingen forøgelse af abstinenssymptomer.
Sleep variables gradually returned to baseline with no rebound, no increase in adverse events and no increase in withdrawal symptoms.
I et andet forsøg med ambulante patienter med to ugers baseline- indkøringsperiode (placebokontrolleret) og en randomiseret, dobbeltblind, placebokontrolleret, parallelgruppe behandlingsperiode på tre uger var andelen af patienter, der viste en klinisk effekt i såvel søvnkvalitet som årvågenhed om morgenen 26% i Circadin- gruppen sammenlignet med 15% i placebo- gruppen.
In a second outpatient study with two week run in baseline period with placebo and a randomised, double blind, placebo controlled, parallel group treatment period of 3 weeks, the rate of patients who showed a clinically significant improvement in both quality of sleep and morning alertness was 26% in the Circadin group as compared to 15% in the placebo group.
I Circadin- gruppen blev patienternes søvnlatens forkortet med 24, 3 minutter over for 12, 9 minutter i placebo- gruppen.
Circadin shortened patients’ reported
Desuden var patienternes rapporterede søvnkvalitet, antal opvågninger og årvågenhed om morgenen signifikant forbedre i Circadin- gruppen sammenlignet med placebo - gruppen.
6 sleep latency by 24.3 minutes vs 12.9 minutes with placebo.
Livskvaliteten blev betydelig forbedret i 2 mg Circadin- gruppen sammenlignet med placebo.
In addition, patients’ self-reported quality of sleep, number of awakenings and morning alertness significantly improved with Circadin compared to placebo.
5. 2 Farmakokinetiske egenskaber
Quality of life was improved significantly with Circadin 2 mg compared to placebo.
Absorption Absorptionen af oralt indtaget melatonin er fuldstændig hos voksne og kan være nedsat med op til 50% hos ældre.
Absorption The absorption of orally ingested melatonin is complete in adults and may be decreased by up to 50% in the elderly.
2- 8 mg.
The kinetics of melatonin are linear over the range of 2-8 mg.
Biotilgængeligheden er i størrelsesordenen 15%.
Bioavailability is in the order of 15%.
Der er en signifikant førstepassage (first pass) - effekt med en skønnet first pass- metabolisme på 85%.
There is a significant first pass effect with an estimated first pass metabolism of 85%.
6 (Tmax=3, 0t versus Tmax=0, 75t) og lavere peak plasmakoncentration efter fødeindtagelse (Cmax=1020 versus Cmax=1176 pg/ ml).
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).
Distribution In vitro plasmaproteinbindingen af melatonin er cirka 60%.
Distribution The in vitro plasma protein binding of melatonin is approximately 60%.
Circadin binder sig hovedsageligt til albumin, alfa- 1- syre- glykoprotein og high density lipoprotein (HDL).
Circadin is mainly bound to albumin, alpha1-acid glycoprotein and high density lipoprotein.
Metabolisme Eksperimentelle data tyder på, at cytokrom P450- systemet er involveret i melatoninmetabolismen via isoenzymerne CYP1A1, CYP1A2 og muligvis CYP2C19.
Biotransformation Experimental data suggest that isoenzymes CYP1A1, CYP1A2 and possibly CYP2C19 of the cytochrome P450 system are involved in melatonin metabolism.
Hovedmetabolitten er 6- sulfatoxymelatonin (6- S- MT), som er inaktiv.
The principal metabolite is 6- sulphatoxy-melatonin (6-S-MT), which is inactive.
Elimination Terminal halveringstid (t½) er 3, 5- 4 timer.
Elimination Terminal half life (t½) is 3.5-4 hours.
Eliminationen foregår renalt ved udskillelse af metabolitter, heraf 89% som sulfat - og glukoronidkonjugater af 6- hydroxymelatonin og 2% som melatonin (uomdannet stof).
Elimination is by renal excretion of metabolites, 89% as sulphated and glucoronide conjugates of 6-hydroxymelatonin and 2% is excreted as melatonin (unchanged drug).
Køn Cmax hos kvinder er 3- 4 gange højere end hos mænd.
Gender A 3-4-fold increase in Cmax is apparent for women compared to men.
Der er observeret op til 5 gange forskel på Cmax mellem personer af samme køn.
A five-fold variability in Cmax between different members of the same sex has also been observed.
Der er dog ikke fundet farmakodynamiske forskelle mellem mænd og kvinder trods forskelle i melatoninniveauerne.
However, no pharmacodynamic differences between males and females were found despite differences in blood levels.
Ældre Melatonins metabolisme aftager med alderen.
Elderly Melatonin metabolism is known to decline with age.
Der er ved forskellige doser rapporteret højere AUC værdier og Cmax niveauer hos ældre forsøgspersoner sammenlignet med yngre forsøgspersoner, hvilket afspejler den lavere metabolisme af melatonin hos ældre.
Across a range of doses, higher AUC and Cmax levels have been reported in older subjects compared to younger subjects, reflecting the lower metabolism of melatonin in the elderly.
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.
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.
Nedsat nyrefunktion Data fra firmaet tyder på, at melatonin ikke akkumuleres efter gentagen dosering.
Renal impairment Company data indicates that there is no accumulation of melatonin after repeated dosing.
De niveauer, der blev målt i blodet fra patienterne kl.
This finding is compatible with the short half-life of melatonin in humans.
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.
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.
Nedsat leverfunktion Melatonin metaboliseres primært i leveren, og derfor medfører nedsat leverfunktion højere endogene melatoninniveauer.
Hepatic impairment The liver is the primary site of melatonin metabolism and therefore, hepatic impairment results in higher endogenous melatonin levels.
Melatoninniveauerne i plasma hos patienter med cirrose var signifikant forhøjede i dagtimerne.
7 Plasma melatonin levels in patients with cirrhosis were significantly increased during daylight hours.
Patienterne havde en signifikant nedsat total udskillelse af 6- sulfatoxymelatonin sammenlignet med kontrolpersonerne.
Patients had a significantly decreased total excretion of 6-sulfatoxymelatonin compared with controls.
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
No Observed Adverse Effect Level (NOAEL – nul- effekt- niveau) ved 15 mg/ kg/ dag hos rotter svarer til et AUC, som er betragteligt højere (x 15000) end den humane eksponering efter indtagelse af 2 mg Circadin.
The No Observed Adverse Effect Level (NOAEL) at 15 mg/ kg/ day in rats, is equivalent to an AUC which is considerably higher (x 15000) than the human exposure after ingestion of Circadin 2 mg.
7 En karcinogenicitetsundersøgelse af rotter viste ingen relevant eftekt for mennesker.
The carcinogenicity study in the rat did not reveal any effect which may be relevant for humans.
Reproduktionstoksikologiske forsøg i 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.
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.
Hos rotter blev der ved meget høje doser, svarende til cirka 2000 mg/ dag hos mennesker, fundet en mindre påvirkning af den postnatale udvikling.
A slight effect on post-natal growth and viability was found in rats only at very high doses, equivalent to approximately 2000 mg/ day in humans.
Ammoniometakrylat kopolymer type B Kalciumhydrogenfosfat dihydrat Laktosemonohydrat Vandfrit kolloid silica Talkum Magnesiumstearat
Ammonio methacrylate copolymer type B Calcium hydrogen phosphate dihydrate Lactose monohydrate Silica, colloidal anhydrous Talc Magnesium stearate
Tabletterne er pakket i uigennemsigtige PVC/ PVDC- blisterstrips med en bagside af aluminiumsfolie.
The tablets are packed in PVC/ PVDC opaque blister strips with aluminium foil backing.
Pakken består af én blisterstrip med 20 eller 21 tabletter.
The pack consists of one blister strip containing 20 or 21 tablets.
Medicin, der ikke længere skal anvendes, må ikke kastes i afløbet, toilettet eller skraldespanden.
8 Medicines no longer required should not be disposed of via wastewater or the municipal sewage system.
Aflever medicinen til apoteket, eller spørg dit apotek om, hvordan du bortskaffer den i overensstemmelse med gældende regler.
Return them to a pharmacy or ask your pharmacist how to dispose of them in accordance with the national regulations.
RAD Neurim Pharmaceuticals EEC Limited One Forbury Square The Forbury Reading Berkshire RG1 3EB Storbritannien e- mail: neurim@ neurim. com
RAD Neurim Pharmaceuticals EEC Limited One Forbury Square The Forbury Reading Berkshire RG1 3EB United Kingdom e-mail: neurim@neurim. com
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Penn Pharmaceutical Services Ltd Units 23- 24 Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA Storbritannien
Penn Pharmaceutical Services Ltd Units 23-24 Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA UK
Catalent Germany Schorndorf GmbH Steinbeisstrasse 2 D- 73614 Schorndorf Tyskland
Catalent Germany Schorndorf GmbH Steinbeisstrasse 2 D-73614 Schorndorf Germany
Indehaveren af markedsføringstilladelsen skal sikre, at lægemiddelovervågningssystemet er på plads og fungerer, før produktet lanceres på markedet.
The MAH must ensure that the system of pharmacovigilance is in place and functioning prior to placing the product on the market.
Risikostyringssystem
Risk Management System
Indehaveren af markedsføringstilladelsen forpligter sig til at gennemføre den sikkerhedsundersøgelse, der er specificeret i lægemiddelovervågningsplanen.
The MAH commits to performing the study detailed in the Pharmacovigilance Plan.
Endvidere skal en opdateret plan for risikostyring tilvejebringes i henhold til CHMP - vejledningen for risikostyringssystemer vedrørende lægemidler til human brug.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management System for medicinal products for human use.
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER
Each tablet contains 2 mg melatonin.
Indeholder laktosemonohydrat Se yderligere oplysninger i indlægssedlen
Contains lactose monohydrate See leaflet for further information
Depottabletter 20 tabletter 21 tabletter
Prolonged-release tablets 20 tablets 21 tablets
EU/ 1/ 07/ 392/ 001 21 tabletter EU/ 1/ 07/ 392/ 002 20 tabletter
EU/ 1/ 07/ 392/ 001 21 tablets EU/ 1/ 07/ 392/ 002 20 tablets
BLISTER STRIP
BLISTER STRIP
UDLØB:
EXP:
17 INDLÆGSSEDDEL:
17 PACKAGE LEAFLET:
Circadin 2 mg depottabletter Melatonin
Circadin 2 mg prolonged-release tablets Melatonin
- Lægen har ordineret Circadin til dig personligt.
- This medicine has been prescribed for you.