natgillin/translations-raw huggingface dataset:
• if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Comtess);
• če jemljete določene antidepresive (povprašajte svojega zdravnika ali farmacevta, ali lahko jemljete svoje zdravilo proti depresiji skupaj z zdravilom Comtess);
What Comtess is and what it is used for
Kaj je zdravilo Comtess in za kaj ga uporabljamo
EU/1/98/082/001 30 film-coated tablets EU/1/98/082/002 60 film-coated tablets EU/1/98/082/003 100 film-coated tablets EU/1/98/082/005 175 film-coated tablets
EU/1/98/082/001 30 filmsko obloženih tablet EU/1/98/082/002 60 filmsko obloženih tablet EU/1/98/082/003 100 filmsko obloženih tablet EU/1/98/082/005 175 filmsko obloženih tablet
The safety and efficacy of Comtess in children below age 18 have not been established.
Varnost in učinkovitost zdravila Comtess pri otrocih, starih do 18 let, nista bili dokazani.
If you stop taking Comtess Do not stop taking Comtess unless your doctor tells you to.
Če ste prenehali jemati zdravilo Comtess Ne prekinite jemanja zdravila Comtess, razen če vam to naroči vaš zdravnik.
Do not use Comtess during pregnancy or if you are breast-feeding.
Ne jemljite zdravila Comtess v nosečnosti ali če dojite.
If you experience such effects at the start of treatment with Comtess you should contact your doctor who may decide to adjust your dosage of levodopa.
Če pri vas pride od takih učinkov na začetku zdravljenja z zdravilom Comtess, morate obvestiti zdravnika, ki se bo morda odločil, da vam prilagodi odmerjanje levodope.
Other medicines and Comtess
Druga zdravila in zdravilo Comtess
What you need to know before you take Comtess
Kaj morate vedeti, preden boste vzeli zdravilo Comtess
There are large intra- and interindividual variations in the absorption of entacapone.
V absorpciji entakapona so velike intra- in interindividualne variacije.
If you forget to take Comtess
Če ste pozabili vzeti zdravilo Comtess
Comtess in association with levodopa may have a major influence on the ability to drive and use machines.
Comtess ima skupaj z levodopo pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
Do not take Comtess
Ne jemljite zdravila Comtess
What Comtess is and what it is used for What you need to know before you take Comtess How to take Comtess
Kaj je zdravilo Comtess in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Comtess Kako jemati zdravilo Comtess Možni neželeni učinki
If you forget to take the Comtess tablet with your levodopa dose, you should continue the treatment by taking the next Comtess tablet with your next levodopa dose.
Če pozabite vzeti tableto Comtess s svojim odmerkom levodope, nadaljujte zdravljenje tako, da vzamete naslednjo tableto Comtess z naslednjim odmerkom levodope.
White high-density polyethylene (HDPE) bottles with white tamper proof polypropylene (PP) closures containing 30, 60, 100 or 175 tablets.
Bele stekleničke iz polietilena visoke gostote (HDPE), z belim polipropilenskim (PP) pokrovčkom, odpornim proti nepooblaščenemu odpiranju, v katerih je po 30, 60, 100 ali 175 tablet.
When Comtess is given at higher doses:
Pri uporabi višjih odmerkov zdravila Comtess:
comtess 200 mg [carton only]
comtess 200 mg [samo na škatli]
If you take more Comtess than you should In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.
Če ste vzeli večji odmerek zdravila Comtess, kot bi smeli Če ste vzeli prevelik odmerek, se takoj posvetujte z zdravnikom, farmacevtom ali najbližjo bolnišnico.
• dizziness, tiredness, increased sweating, fall ;
• omotičnost, utrujenost, povečano znojenje, padec;
General characteristics of the active substance Absorption
Splošne značilnosti zdravilne učinkovine Absorpcija
Comtess may make it harder for you to digest iron.
Zdravilo Comtess lahko oteži prebavljanje železa.
As Comtess tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.
Ker boste tablete Comtess jemali skupaj z drugimi zdravili z levodopo, skrbno preberite tudi njihova navodila za uporabo.
Comtess tablets contain entacapone and are used together with levodopa to treat Parkinson's disease.
Tablete Comtess vsebujejo entakapon in jih uporabljamo skupaj z levodopo za zdravljenje Parkinsonove bolezni.
The recommended dose of Comtess is one 200 mg tablet with each levodopa dose.
Priporočeni odmerek zdravila Comtess je ena 200-miligramska tableta z vsakim odmerkom levodope.
Suddenly stopping Comtess and other medicines to treat Parkinson´s disease may result in unwanted side effects.
Nenadna prekinitev zdravljenja z zdravilom Comtess in drugimi zdravili za Parkinsonovo bolezen lahko povzroči neželene učinke.
Comtess is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations).
Zdravilo Comtess se jemlje skupaj z zdravili, ki vsebujejo levodopo (bodisi pripravki levodope/karbidope bodisi pripravki levodope/benserazida).
Comtess has no effect on relieving the symptoms of Parkinson's disease unless taken with levodopa.
Zdravilo Comtess ne lajša simptomov Parkinsonove bolezni, če ga bolnik ne vzame skupaj z levodopo.
Usually side effects caused by Comtess are mild to moderate.
Neželeni učinki, ki jih povzroča zdravilo Comtess, so navadno blagi do zmerni.
Comtess aids levodopa in relieving the symptoms of Parkinson's disease.
Zdravilo Comtess pomaga levodopi pri lajšanju simptomov Parkinsonove bolezni.
How to take Comtess
Kako jemati zdravilo Comtess
What Comtess contains - The active substance is entacapone.
Kaj vsebuje zdravilo Comtess - Zdravilna učinkovina je entakapon.
Your doctor may advise you to slowly discontinue the treatment with Comtess and other medicines to treat Parkinson's disease.
Zdravnik vam bo morda svetoval, da zdravilo Comtess in druga zdravila za Parkinsonovo bolezen prenehate jemati postopoma.
However, the experience of the clinical use of entacapone with several medicinal products, including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e.g. catecholstructured compounds: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine,
Vendar so izkušnje s klinično uporabo entakapona z več zdravili, med drugim z zaviralci MAO-A, tricikličnimi antidepresivi, zaviralci ponovnega privzema noradrenalina, kot so desipramin, maprotilin in venlafaksin, in zdravili, ki jih presnavlja COMT (na primer spojine s kateholno skupino: rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-metildopa, apomorfin in paroksetin), še omejene.
In addition, Comtess taken with levodopa may make you feel very drowsy, or cause you to sometimes suddenly fall asleep.
Poleg tega lahko zdravilo Comtess, ki ga vzamete skupaj z levodopo, povzroči hudo zaspanost ali povzroči, da včasih nenadoma zaspite.
Comtess 200 mg film-coated tablets
Comtess 200 mg filmsko obložene tablete
• Comtess taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep;
• poredko se lahko zgodi, da zaradi zdravila Comtess, ki ga jemljete z levodopo, postanete čez dan izredno zaspani, lahko tudi povzroči, da nenadoma zaspite;
Comtess taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Comtess, ki ga jemljete skupaj z levodopo, vam lahko zniža krvni tlak, zaradi česar se vam lahko stemni pred očmi ali postanete omotični.
Comtess contains soya lecithin.
Zdravilo Comtess vsebuje sojin lecitin
Talk to your doctor or pharmacist before taking Comtess:
Pred začetkom jemanja zdravila Comtess se posvetujte z zdravnikom ali farmacevtom:
What Comtess looks like and contents of the pack Comtess 200 mg film-coated tablets are brownish-orange, oval tablets with "COMT" engraved on one side.
Comtess 200 mg filmsko obložene tablete so rjavkastooranžne, ovalne tablete z vtisnjenim napisom “COMT” na eni strani.
Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Comtess in association with levodopa (see section 4.4).
Motnje pri obvladovanju impulzov: Pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravili, kot je zdravilo Comtess v povezavi z levodopo, lahko pride do patološkega hazardiranja, povečanega libida, hiperseksualnosti, kompulzivnega zapravljanja ali nakupovanja, prenajedanja ali kompulzivnega prenajedanja (glejte poglavje 4.4).
Comtess taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep.
Zdravilo Comtess, ki ga vzamete skupaj z levodopo, lahko povzroča zaspanost ali povzroči, da včasih nenadoma zaspite.
Comtess 200 mg film-coated tablets entacapone
Comtess 200 mg filmsko obložene tablete entakapon
Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Comtess in association with levodopa.
Bolnike in njihove skrbnike je treba opozoriti, da pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravili, kot je zdravilo Comtess v povezavi z levodopo, lahko pride do vedenjskih simptomov, ki so znak motenj pri obvladovanju impulzov, kar vključuje patološko hazardiranje, povečan libido, hiperseksualnost, kompulzivno zapravljanje ali nakupovanje, prenajedanje in kompulzivno prenajedanje.
The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Comtess.
Najvišji priporočeni odmerek je 10 tablet na dan, t.j.
Experience with Comtess in patients under 18 years is limited.
Izkušenj z uporabo zdravila Comtess pri bolnikih, ki so stari manj kot 18 let, je malo, zato uporabe zdravila Comtess pri otrocih in mladostnikih ni mogoče priporočati.
How to store Comtess
Shranjevanje zdravila Comtess
Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Comtess and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Do nje lahko pride zlasti pri nenadni prekinitvi zdravljenja z zdravilom Comtess in drugimi zdravili za Parkinsonovo bolezen oziroma pri nenadnem znižanju odmerka teh zdravil.
The dose of other medicines to treat Parkinson's disease may need to be adjusted when you start taking Comtess.
Morda bo ob uvedbi zdravila Comtess potrebno prilagoditi odmerke drugih zdravil za Parkinsonovo bolezen.
3 years
3 let
This dosage may be continued for up to thirteen weeks.
S tem odmerkom se lahko nadaljuje do trinajst tednov.
Terminal half life (t½) is 3.5-4 hours.
Končna razpolovna doba (t½) je 3,5-4 ure.
Patients were re-randomised at 3 weeks.
Bolniki so bili pri 3 tednih ponovno randomizirani.
These medicines include:
Med ta zdravila spadajo:
- If you have been told you suffer from an autoimmune disease (where the body is ‘attacked' by its own immune system).
• če so vam povedali, da imate avtoimunsko bolezen (kjer telo »napada« njegov lastni imunski sistem).
• Presence of red blood cells in the urine
• prisotnost rdečih krvničk v urinu
The clinical relevance of the finding is unknown.
Klinični pomen te ugotovitve ni znan.
The safety and efficacy of Circadin in children aged 0 to 18 years has not yet been established.
Varnost in učinkovitost zdravila Circadin pri otrocih, starih 0 do 18 let, še nista bili dokazani.
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).
Zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do <1/10); občasni (≥ 1/1.000 do <1/100); redki (≥ 1/10.000 do <1/1.000); zelo redki (<1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
It is also associated with a hypnotic effect and increased propensity for sleep.
Povezuje se tudi s hipnotičnimi učinki in povečano nagnjenostjo k spanju.
35039 Marburg
35039 Marburg Nemčija
Do not use this medicine after the expiry date which is stated on the carton (EXP).
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli (EXP).
Do not store above 25°C.
Shranjujte pri temperature do 25°C.
The study showed that the benefit observed after 3 weeks is maintained for up to 3 months but failed the primary analysis set at 6 months.
Študija je pokazala, da se koristi, opažene po 3 tednih, ohranijo do 3 mesece, vendar pa ni prestala niza primarnih analiz pri 6 mesecih.
The combination should be avoided.
Izogibajte se tej kombinaciji.
Do not give this medicine to children between the ages of 0 to 18 years as it has not been tested and its effects are unknown.
Ne dajajte tega zdravila otrokom do 18 leta starosti, ker preskusov niso izvedli in učinki niso znani.
If you forget to take your tablet, take another as soon as you remember, before going to sleep, or wait until it is time to take your next dose, then go on as before.
Če ste pozabili vzeti tableto, jo vzemite takoj, ko se spomnite, preden greste spat, ali pa počakajte do naslednjega odmerka, nato pa nadaljujte kot običajno.
- If you suffer from liver or kidney problems.
• če imate težave z jetri ali ledvicami.
The carcinogenicity study in the rat did not reveal any effect which may be relevant for humans.
Študija kancerogenosti pri podganah ni pokazala nikakršnih učinkov, ki bi lahko bili pomembni pri ljudeh.
• Loss of consciousness or fainting
• izguba zavesti in omedlevica
Bioavailability is in the order of 15%.
Biološka uporabnost je približno 15 %.
However, no pharmacodynamic differences between males and females were found despite differences in blood levels.
Vendar pa farmakodinamičnih razlik med moškimi in ženskami kljub različnih ravneh v krvi niso zaznali.
• Vertigo (a feeling of dizziness or “spinning”)
• vertigo (občutek omotice ali vrtoglavice)
‘Primary' means that the insomnia does not have any identified cause, including any medical, mental or environmental cause.
»Primarna« pomeni, da vzrok za nespečnost, vključno s karšnim koli medicinskim, duševnim ali okoljskim razlogom, ni pojasnjen.
Frequency not known: (cannot be established from the available data)
Neznana pogostnost: (ni mogoče oceniti iz razpoložljivih podatkov)
The absorption of orally ingested melatonin is complete in adults and may be decreased by up to 50% in the elderly.
Absorpcija peroralno zaužitega melatonina pri odraslih je popolna in se lahko zmanjša za do 50 % pri starejših.
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.
Rahel učinek na rast in sposobnost preživetja po rojstvu se je pokazal pri podganah samo pri zelo visokih odmerkih, ki ustrezajo približno 2000 mg/dni pri ljudeh.
Date of latest renewal: 20 April 2012
Datum prve odobritve: 29. junij 2007 Datum zadnjega podaljšanja: 20. april 2012
A 3-4-fold increase in Cmax is apparent for women compared to men.
Pri ženskah je povečanje Cmax 3-4-kratno v primerjavi z moškimi.
EU/1/07/392/001 21 tablets EU/1/07/392/002 20 tablets EU/1/07/392/003 30 tablets EU/1/07/392/004 7 tablets
EU/1/07/392/001 21 tablet EU/1/07/392/002 20 tablet EU/1/07/392/003 30 tablet EU/1/07/392/004 7 tablet
Do not take Circadin if you are pregnant, think you may be pregnant, trying to become pregnant or breast-feeding.
Ne jemljite zdravila Circadin, če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev.
This finding is compatible with the short half-life of melatonin in humans.
Ta ugotovitev je združljiva s kratko razpolovno dobo melatonina pri ljudeh.
The blisters are then packed in cardboard boxes.
Pretisni omoti so pakirani v kartonaste škatle.
Tablets should be swallowed whole to maintain prolonged release properties.
Tablete je treba pogoltniti cele, da se ohrani njihovo podaljšano sproščanje.
If induction occurs, this can give rise to reduced plasma concentrations of concomitantly administered medicinal products.
Če se indukcija pojavi, lahko to privede do znižane plazemske koncentracije zdravil, ki se dajejo sočasno.
DATE OF REVISION OF THE TEXT {DD month YYYY}
DATUM ZADNJE REVIZIJE BESEDILA {DD. mesec LLLL}
- If you have been told by your doctor that you have an intolerance to some sugars.
• če vam je vaš zdravnik povedal, da ne prenašate nekaterih sladkorjev.
− Thioridazine (for the treatment of schizophrenia) and imipramine (for the treatment of depression).
- tioridazin (za zdravljenje shizofrenije) in imipramin (za zdravljenje depresije).
Tmax occurs after 3 hours in a fed state.
Tmax se pojavi po 3 urah na poln želodec.
Circadin tablets should not be crushed or cut in half.
Tablet Circadin ne drobite in ne režite na pol.
The principal metabolite is 6-sulphatoxy-melatonin (6-S-MT), which is inactive.
Najpomembnejši metabolit je 6-sulfatoksimelatonin (6-S-MT), ki ni aktiven.
In a clinical trial, there was clear evidence for a transitory pharmacodynamic interaction between Circadin and zolpidem one hour following co-dosing.
V kliničnem preskušanju so se pokazali jasni znaki prehodnih farmakodinamičnih interakcij med zdravilom Circadin in zolpidemom eno uro po hkratnem dajanju.
There is a significant first pass effect with an estimated first pass metabolism of 85%.
Učinek prvega prehoda je pomemben z oceno presnove prvega prehoda 85 %.
Older People
Starejši
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.
Predvideva se, da aktivnost melatonina pri receptorjih MT1, MT2 in MT3 prispeva k lastnostim, ki spodbujajo spanje, saj ti receptorji (pretežno MT1 in MT2) sodelujejo pri uravnavanju cirkadianega ritma in uravnavanju spanja.
An additional randomised clinical trial (n=600) compared the effects of Circadin and placebo for up to six months.
V dodatnem randomiziranem kliničnem preskušanju (n = 600) so primerjali učinke zdravila Circadin in placeba v obdobju do šest mesecev.
• Reduced blood platelets, which increases risk of bleeding or bruising
• zmanjšano število trombocitov, kar povečuje tveganje za pojav krvavitev ali modric
The recommended dose is 2 mg once daily, 1-2 hours before bedtime and after food.
Priporočeni odmerek je 2 mg enkrat dnevno, 1-2 uri pred spanjem in po hrani.
The use of Circadin is not known to cause any withdrawal effects after treatment completion.
Ni znano, da bi uporaba zdravila Circadin povzročala kakršne koli odtegnitvene učinke po končanju zdravljenja.
The study demonstrated improvements in sleep latency, quality of sleep and morning alertness, with no withdrawal symptoms and rebound insomnia.
Študija je pokazala izboljšanje latence spanja, kakovosti spanja in jutranje budnosti brez odtegnitvenih simptomov in povratne nespečnosti.
Do not take Circadin - if you are allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na melatonin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
Pri tej populaciji je morda primernejša uporaba drugih farmacevtskih oblik/jakosti.
Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
You should swallow the tablet whole.
Pogoltnite celo tableto.
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.
Obstajajo podatki iz živalskih modelov, vključno z glodavci, ovcami, govedom in primati, ki nakazujejo prenos melatonina na zarodek preko placente ali v mleko.
Therefore the product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety.
Zato je treba zdravilo jemati previdno, če so učinki zaspanosti povezani s tveganjem za varnost.
The in vitro plasma protein binding of melatonin is approximately 60%.
In vitro vezava melatonina na proteine plazme je približno 60 %.
At 3 months, about an extra 10% of responders were seen in the Circadin treated group.
Pri 3 mesecih so v skupini, zdravljeni z zdravilom Circadin opazili dodatnih približno 10 % oseb, ki se je odzivalo.
The kinetics of melatonin are linear over the range of 2-8 mg.
Kinetika melatonina je linearna v razponu med 2-8 mg.
France e-mail: regulatory@neurim.com
Francija e-pošta: regulatory@neurim.com
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.
Zaradi vloge melatonina pri uravnavanju spanja in cirkadianega ritma in s starostjo povezanim zmanjšanjem proizvodnje endogenega melatonina, lahko melatonin učinkovito izboljša kakovost spanja, še zlasti pri bolnikih s primarno nespečnostjo, starih več kot 55 let.
If you stop taking Circadin
Če ste prenehali jemati Circadin
In addition, there were fewer dropouts in the active treatment group (9 patients; 15.0%) compared to the placebo group (21 patients; 32.3%).
Tudi upad udeležencev je bil v skupini zdravljenja z učinkovino manjši (9 bolnikov; 15,0 %) v primerjavi s skupino s placebom (21 bolnikov; 32,3 %).
Circadin shortened patients' reported sleep latency by 24.3 minutes vs 12.9 minutes with placebo.
Bolniki, ki so jim zmanjšali odmerek zdravila Circadin, so poročali o latentnosti uspavanja 24,3 minute v primerjavi z 12,9 minutami s placebom.
Pharmacotherapeutic group: Psycholeptics, melatonin receptor agonists, ATC code: N05CH01
Farmakoterapevtska skupina: psiholeptiki, agonisti receptorjev melatonina, oznaka ATC: N05CH01
Another medicine containing melatonin may be more appropriate for administration to children between the ages of 2 to 18 - please ask your doctor or pharmacist for advice.
Pri otrocih, starih od 2 do 18 let, je morda primernejša uporaba drugega zdravila, ki vsebuje melatonin - posvetujte se z zdravnikom ali farmacevtom.
For melatonin, no clinical data on exposed pregnancies are available.
Za melatonin ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
Do not drink alcohol before, during or after taking Circadin, because it reduces the effectiveness of Circadin.
Pred, med ali po jemanju zdravila Circadin ne pijte alkohola, ker ta zmanjšuje učinkovitost zdravila Circadin.
Concomitant administration resulted in increased impairment of attention, memory and co-ordination compared to zolpidem alone.
Hkratno dajanje je vplivalo na poslabšanje pozornosti, spominskih funkcij in koordinacije v primerjavi z dajanjem samega zolpidema.
SPECIAL STORAGE CONDITIONS Do not store above 25ºC.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25ºC.
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).
Izločanje poteka z izločanjem metabolitov skozi ledvice, 89 % kot sulfatni in glukoronidni konjugati 6-hidroksimelatonina in 2 % se izloča kot melatonin (nespremenjena zdravilna učinkovina).
Company data indicates that there is no accumulation of melatonin after repeated dosing.
Podatki družbe kažejo, da se melatonin ne akumulira s ponavljajočimi odmerki.
• Cigarette smoking may decrease melatonin levels due to induction of CYP1A2.
• Kajenje cigaret lahko zniža ravni melatonina zaradi indukcije CYP1A2.