FrancophonIA/ELRC3.0 huggingface dataset:
English: Infections, some serious (e.g. pneumonia and bronchitis), have been reported with Zinbryta.
Slovenian: Pri zdravilu Zinbryta so poročali o okužbah, nekaterih resnih (npr. pljučnica in bronhitis).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 150 mg of daclizumab in 1 mL solution for injection.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 150 mg daklizumaba v 1 ml raztopine za injiciranje.
English: Tear here
Slovenian: Odtrgajte tukaj
English: Zinbryta is provided with the needle pre-attached.
Slovenian: Zdravilo Zinbryta je na voljo s pritrjeno injekcijsko iglo.
English: • Common (≥1/100 to <1/10)
Slovenian: • zelo pogosti (≥1/10) • pogosti (≥1/100 do <1/10)
English: Alcohol Wipe
Slovenian: Alkoholni robček
English: Tuberculosis infections have been reported in patients treated with Zinbryta.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Zinbryta, so poročali o primerih okužb s tuberkulozo.
English: Do not use the pen if:
Slovenian: Napolnjenega injekcijskega peresnika ne uporabite, če:
English: Gauze Pad Adhesive Bandage
Slovenian: Nalepka napolnjene injekcijske brizge
English: Lymphadenitis
Slovenian: Limfopenija
English: Adverse reaction
Slovenian: Splošna opozorila
English: Mean number of new T1 Gdenhancing lesions
Slovenian: Povprečno število novih lezij T1, vidnih z gadolinijem
English: Back of Upper Arm
Slovenian: Hrbtna stran nadlahti
English: • dark (tea-coloured) urine
Slovenian: • porumenitev kože ali beločnic • temen urin (barve čaja)
English: • 1 Zinbryta 150 mg Pen (see Figure A) Before Use - Parts of Zinbryta Pen (See Figure A):
Slovenian: • 1 zdravilo Zinbryta 150 mg napolnjen injekcijski peresnik (glejte sliko A)
English: Firmly press and hold down the pen on your injection site.
Slovenian: Napolnjen injekcijski peresnik čvrsto potisnite na mesto injiciranja in ga tako držite.
English: • adhesive bandage or plaster
Slovenian: • lepljivi povoj/obliž
English: Investigations
Slovenian: Ukrepi
English: (Uncommon - may affect up to 1 in 100 people) • Severe inflammation of the liver which might be life-threatening or result in death
Slovenian: (Občasni - pojavijo se lahko pri največ 1 od 100 bolnikov) • bledica
English: Do not pass it on to others.
Slovenian: o Ne zamrzujte.
English: Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen daclizumab
Slovenian: Zinbryta 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zinbryta 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku daklizumab
English: Supplies needed for Zinbryta Pen injection:
Slovenian: Pripomočki, ki so potrebni za injiciranje zdravila Zinbryta napolnjen injekcijski peresnik:
English: This could lock the pen.
Slovenian: Tako se peresnik lahko zaklene.
English: Pack sizes: - Pack containing one 150 mg pre-filled syringe.
Slovenian: Velikosti pakiranja: - Pakiranje z eno 150-mg napolnjeno injekcijsko brizgo.
English: Psychiatric disorders
Slovenian: Psihiatrične motnje depresija*
English: Step 9: Disposing of used Zinbryta Pens
Slovenian: 9. korak: Odstranjevanje uporabljenega zdravila Zinbryta napolnjen injekcijski peresnik
English: Lymphadenopathy†
Slovenian: Limfadenopatija
English: • Do not place Zinbryta back into the refrigerator after warming to room temperature.
Slovenian: • Zdravila Zinbryta ne dajajte nazaj v hladilnik, ko se ogreje na sobno temperaturo.
English: Percentage of patients relapse-free Hazard ratio# * [95% CI]
Slovenian: Odstotek bolnikov brez recidiva Razmerje ogroženosti# * [95 % IZ]
English: Pruritus
Slovenian: Klikanje
English: Colitis has been reported with Zinbryta.
Slovenian: Pri zdravilu Zinbryta so poročali o kolitisu.
English: What Zinbryta is used for
Slovenian: Za kaj uporabljamo zdravilo Zinbryta
English: Pull the needle straight out.
Slovenian: Injekcijsko iglo izvlecite naravnost ven. (Glejte sliko K.)
English: What Zinbryta looks like and contents of the pack Zinbryta is a colourless to slightly yellow, clear to opalescent liquid contained within a syringe/pen.
Slovenian: Zdravilo Zinbryta je brezbarvna do rumenkasta, bistra do opalescentna tekočina v injekcijski brizgi/injekcijskem peresniku.
English: Sustained severe lymphopenia (< 500/mm3), was not observed in clinical studies with Zinbryta.
Slovenian: Med kliničnimi študijami z zdravilom Zinbryta niso opazili trajne hude limfopenije (< 500/mm3), vendar se zaradi previdnosti vsake 3 mesece priporoča pregled celotne krvne slike.
English: • The importance of monitoring the liver function (AST, ALT and total bilirubin levels) at least monthly (or more frequently as clinically indicated) as close as possible before each treatment administration, and for up to six months after the last dose;
Slovenian: • pomembnosti spremljanja delovanja jeter (AST, ALT in raven celotnega bilirubina) vsaj enkrat na mesec (ali pogosteje, če je klinično indicirano) kolikor je mogoče neposredno pred vsako uporabo zdravila in še do šest mesecev po zadnjem odmerku; • obravnavanju bolnikov, ki prejemajo zdravilo Zinbryta, pri katerih se pojavijo znaki in simptomi možne poškodbe jeter, ki vključuje prekinitev zdravljenja, možnost dodatnega zdravljenja in takojšnjo napotitev k hepatologu;
English: Giving your injection Step 5: Remove the Zinbryta Pen cap a.
Slovenian: 5. korak: Odstranite pokrovček z zdravila Zinbryta napolnjen injekcijski peresnik a.
English: An increased incidence of serious colitis (<1%) was reported in patients treated with Zinbryta in clinical studies.
Slovenian: V kliničnih študijah so pri bolnikih, zdravljenih z zdravilom Zinbryta, poročali o povečani incidenci resnega kolitisa (< 1 %).
English: Serious hepatic injury, including fatal cases of autoimmune hepatitis and fulminant liver failure have occurred in patients treated with Zinbryta.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Zinbryta, je prišlo do resnih poškodb jeter, vključno s smrtnimi primeri avtoimunskega hepatitisa in fulminantne odpovedi jeter.
English: If you remove the cap, do not re-cap the pen.
Slovenian: Če ste pokrovček odstranili, napolnjenega injekcijskega peresnika ne smete spet pokriti s pokrovčkom.
English: Zinbryta should be administered with caution to patients with previous or current depressive disorders.
Slovenian: Bolnikom s preteklo ali obstoječo depresivno motnjo je treba zdravilo Zinbryta dajati previdno.
English: Each pre-filled pen contains a pre-filled syringe, containing 150 mg of daclizumab in 1 mL solution for injection.
Slovenian: En napolnjen injekcijski peresnik vsebuje eno napolnjeno injekcijsko brizgo, ki vsebuje 150 mg daklizumaba v 1 ml raztopine za injiciranje.
English: Percentage of patients relapse-free Hazard ratio* [95% CI]
Slovenian: Odstotek bolnikov brez recidiva Razmerje ogroženosti* [95 % IZ]
English: Do not touch or blow on this area again before giving your injection.
Slovenian: Tega predela se do injiciranja več ne dotikajte in ne pihajte po njem.
English: Do not use the Zinbryta pre-filled syringe past the expiry date.
Slovenian: Zdravila Zinbryta napolnjena injekcijska brizga ne uporabljajte po poteku roka uporabnosti.
English: Percent with ≥ 1 Gd enhancing lesion (mean)
Slovenian: Odstotek z lezijami, vidnimi z gadolinijem, ≥ 1 (povprečje)
English: psoriasis)
Slovenian: ekcem, psoriaza)
English: Step 9: Care for your injection site
Slovenian: 9. korak: Nega mesta injiciranja
English: Caution - do not recap the Zinbryta pre-filled syringe.
Slovenian: Pozor - na zdravilo Zinbryta napolnjena injekcijska brizga več ne nameščajte pokrovčka.
English: Hazard ratio* [95% CI]
Slovenian: Razmerje ogroženosti* [95 % IZ]
English: Eczema nummular
Slovenian: IME ZDRAVILA
English: Do not use external heat sources such as hot water to warm Zinbryta pre-filled syringe.
Slovenian: Za ogrevanje zdravila Zinbryta napolnjena injekcijska brizga ne uporabljajte zunanjih virov toplote, kot je topla voda.
English: Note: Do not touch or blow on this area before giving your injection.
Slovenian: Opomba: Tega predela se do injiciranja več ne dotikajte in ne pihajte po njem.
English: Psoriasis
Slovenian: • driska
English: Odds ratio [95% CI]
Slovenian: Razmerje obetov [95 % IZ]
English: 1 pre-filled syringe
Slovenian: 1 napolnjena injekcijska brizga 1 napolnjen injekcijski peresnik
English: Check the medicine window and make sure the Zinbryta medicine is colourless to slightly yellow.
Slovenian: da je zdravilo Zinbryta brezbarvno do rumenkasto.
English: NAME OF THE MEDICINAL PRODUCT Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen
Slovenian: Zinbryta 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zinbryta 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Do not place Zinbryta back into the refrigerator after warming to room temperature.
Slovenian: Zdravila Zinbryta ne dajajte nazaj v hladilnik, ko se ogreje na sobno temperaturo.
English: Patient Card has more information about these side effects.
Slovenian: Več informacij o teh neželenih učinkih najdete na Opozorilni kartici za bolnika.
English: The colitis improved with discontinuation of Zinbryta and standard treatment.
Slovenian: Po prekinitvi uporabe zdravila Zinbryta in s standardnim zdravljenjem se je kolitis popravil.
English: Must not be returned to refrigerator after storage at room temperature.
Slovenian: Po shranjevanju pri sobni temperaturi ne dajajte več nazaj v hladilnik.
English: How to store Zinbryta
Slovenian: Shranjevanje zdravila Zinbryta
English: • Keep Zinbryta pen and all medicines out of reach and sight of children.
Slovenian: • Zdravilo Zinbryta napolnjena injekcijska brizga in vsa zdravila shranjujte nedosegljiva otrokom.
English: Hazard ratio [95% CI]
Slovenian: Razmerje ogroženosti [95 % IZ]
English: If a patient develops signs or symptoms of autoimmune haemolytic anaemia (e.g. pallor, fatigue, dark urine, jaundice, shortness of breath), consider referring to a specialist and discontinuing Zinbryta (see section 4.8).
Slovenian: utrujenost, temen urin, zlatenica, kratka sapa), razmislite o napotitvi k specialistu in ukinitvi zdravila Zinbryta (glejte poglavje 4.8).
English: • The pen is for use under the skin only (subcutaneous).
Slovenian: • Napolnjen injekcijski peresnik je samo za podkožno (subkutano) injiciranje.
English: Do not place Zinbryta pre-filled syringe back into the refrigerator after warming to room temperature.
Slovenian: Zdravila Zinbryta napolnjen injekcijski peresnik ne dajajte nazaj v hladilnik, ko se ogreje na sobno temperaturo.
English: Very Common
Slovenian: pogosti
English: • Check with your doctor, pharmacist or nurse about the right way to throw away the used pen.
Slovenian: • O pravilnem načinu odstranjevanja uporabljenega napolnjenega injekcijskega peresnika se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Step 10: Care for your injection site
Slovenian: 10. korak: Nega mesta injiciranja
English: Each pre-filled syringe contains 150 mg of daclizumab in 1 mL solution for injection.
Slovenian: En napolnjen injekcijski peresnik vsebuje 150 mg daklizumaba v 1 ml raztopine za injiciranje.
English: Instructions overleaf 
Slovenian: Navodilo za uporabo
English: Discontinuation due to skin reactions was 4% in Zinbryta-treated patients.
Slovenian: Zaradi zdravila Zinbryta je zdravljenje prekinilo 4 % bolnikov.
English: • runny nose (rhinitis)
Slovenian: • prehlad (rinitis)
English: Water for injections
Slovenian: Injiciranje zdravila
English: • Check with your doctor, pharmacist or nurse about the right way to throw away the used syringe.
Slovenian: • O pravilnem načinu odstranjevanja uporabljene injekcijske brizge se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Medicine Window
Slovenian: Okno za zdravilo
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: Vodnik za usposabljanje
English: Medicine Visible
Slovenian: Samoinjiciranje zdravila
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ne pričakuje se, da bi se zdravilo Zinbryta presnavljalo z jetrnimi encimi ali z ledvičnim izločanjem.
English: Finger Flange
Slovenian: Držalo za prste
English: Cap
Slovenian: Bat
English: Do not share Zinbryta pre-filled syringe.
Slovenian: Zdravila Zinbryta napolnjena injekcijska igla ne delite z nikomer.
English: Ask your doctor, pharmacist, or nurse for instructions on throwing away used syringes.
Slovenian: Za navodila, kako zavreči uporabljene injekcijske brizge, vprašajte zdravnika, farmacevta ali medicinsko sestro.
English: Oropharyngeal pain†
Slovenian: zelo pogosti nazofaringitis†
English: • Keep this leaflet and the Patient Card. You may need to read them again.
Slovenian: • Navodilo in Opozorilno kartico za bolnika shranite.
English: Weight
Slovenian: Stegno
English: Figure 1: Percentage of patients relapse-free (DECIDE study)
Slovenian: Slika 1: Odstotek bolnikov brez recidiva (študija DECIDE) Delež bolnikov s 24-tedenskim potrjenim napredovanjem prizadetosti
English: Serious hepatic injury including elevations of serum transaminases and fatal cases of autoimmune hepatitis and fulminant liver failure have occurred in patients treated with Zinbryta (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z zdravilom Zinbryta, je prišlo do resnih poškodb jeter, vključno z zvišanjem serumskih transaminaz in smrtnimi primeri avtoimunskega hepatitisa in fulminantne odpovedi jeter
English: • dark urine
Slovenian: • temen urin • kratka sapa
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja dermatitis pogosti alergijski dermatitis pogosti ekcem†
English: Contact your doctor if you think you may have missed a blood test.
Slovenian: Če menite, da ste krvno preiskavo izpustili, se obrnite na zdravnika.
English: Liver function test abnormal
Slovenian: Preiskave nenormalne vrednosti testov delovanja jeter zelo pogosti zmanjšanje števila limfocitov pogosti
English: Laryngitis
Slovenian: Imunogenost
English: This means that symptoms will come back.
Slovenian: To pomeni, da se bodo simptomi ponovno pojavili.
English: - Take the medicine by mouth.
Slovenian: - Zdravilo jemljite skozi usta.
English: Keep the bottle with you so that you can easily describe what you have taken.
Slovenian: Plastenko imejte s seboj, da boste lažje opisali, kaj ste zaužili.
English: Try to take the medicine at the same time every night.
Slovenian: Zdravilo poskusite jemati vsak večer ob istem času.
English: 3 years After first opening of the bottle: 30 days
Slovenian: 3 leta Po prvem odprtju plastenke: 30 dni
English: The safety and efficacy of tasimelteon in children and adolescents aged 0 to 18 years have not been established.
Slovenian: Varnost in učinkovitost tasimelteona pri otrocih in mladostnikih, starih od 0 do 18 let, nista bili dokazani.
English: Respiration, pulse, blood pressure, and other appropriate vital signs should be monitored, and general supportive measures employed.
Slovenian: Spremljati je treba dihanje, srčni utrip, krvni tlak in ostale ustrezne vitalne znake ter uporabiti splošne podporne ukrepe.
English: The size of the capsule is ‘size 1' (dimensions 19.4 x 6.9 mm).
Slovenian: Velikost kapsule je „velikost 1“ (mere 19,4 x 6,9 mm).
English: RESET Study
Slovenian: Študija RESET
English: - Do not use this medicine after the expiry date which is stated on the botttle and the carton.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli.
English: Timing of sleep (minutes)(1),(3)
Slovenian: Čas spanja (v minutah)(1),(3)
English: - It is best to take HETLIOZ on an empty stomach as food can reduce the amount of the medicine that is absorbed into your body.
Slovenian: - Najbolje je, da zdravilo HETLIOZ jemljete na prazen želodec, saj lahko hrana zmanjša količino zdravila, ki se absorbira v vaše telo.
English: <2.0 from the average of Day 112 and Day 183 compared to baseline
Slovenian: <2,0 od povprečja na 112. dan in 183. dan v primerjavi z izhodiščem
English: >30 minutes increase and a standard deviation <2 hours during double-masked phase
Slovenian: >30-minutno podaljšanje in standardni odklon <2 uri med dvojno slepo fazo
English: EXP Use within 30 days after first opening.
Slovenian: Uporabno do: Uporabite v 30 dneh po prvem odprtju.
English: The components of the scale can be found in Table 2.
Slovenian: Sestavni deli lestvice so na voljo v preglednici 2.
English: Very common: may affect more than 1 in 10 people - headache
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov: - glavobol.
English: Some examples include atenolol, metoprolol, and propanolol.
Slovenian: To so na primer atenolol, metoprolol in propanolol.
English: Placebo p-value
Slovenian: Placebo p-vrednost
English: Do not give HETLIOZ to children under the age of 18 years.
Slovenian: Zdravila HETLIOZ ne smete dajati otrokom, mlajšim od 18 let.
English: You are allergic to tasimelteon or any of the other ingredients of this medicine (listed in section 6).
Slovenian: če ste alergični na tasimelteon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Intravenous fluids should be administered as needed.
Slovenian: Po potrebi je treba dovajati intravenske tekočine.
English: N24CRS ≥ 3(2) N24CRS ≥ 2(2)
Slovenian: N24CRS ≥ 2(2)
English: See section 4.8 for safety information.
Slovenian: Za informacije o varnosti glejte poglavje 4.8.
English: This is because HETLIOZ has not been tested in people under 18 years of age and the effects are unknown.
Slovenian: Zdravilo HETLIOZ namreč pri osebah, mlajših od 18 let, ni bilo preskušeno, zato njegovi učinki niso znani.
English: It was rated as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse.
Slovenian: Izboljšanje so ocenjevali z naslednjimi ocenami: 1 = zelo veliko izboljšanje, 2 = veliko izboljšanje, 3 = majhno izboljšanje, 4 = brez spremembe, 5 = majhno poslabšanje, 6 = veliko poslabšanje in 7 = zelo veliko poslabšanje.
English: This reduction in exposure is not considered clinically relevant and therefore no dose adjustment is necessary.
Slovenian: Tolikšno zmanjšanje izpostavljenosti ni klinično pomembno, zato prilagajanje odmerka ni potrebno.
English: B. CONDITIONS OR RESTRICTIONS
Slovenian: POGOJI ALI OMEJITVE
English: As with the management of any overdose, general symptomatic and supportive measures should be used, along with immediate gastric lavage, where appropriate.
Slovenian: Tako kot pri vsakem zdravljenju prevelikega odmerjanja je treba uporabiti splošne simptomatske in podporne ukrepe skupaj z izpiranjem želodca, če je to potrebno.
English: The body controls these rhythms through many pathways including increases and decreases in the production of the hormone melatonin.
Slovenian: Telo te ritme uravnava po številnih poteh, med drugim tudi s povečanjem in zmanjšanjem tvorjenja hormona melatonina.
English: The most frequently reported adverse reactions were mostly mild to moderate in severity and transient in nature.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali, so bili večinoma blagi do zmerni in prehodne narave.
English: - Swallow the capsule whole.
Slovenian: - Kapsulo pogoltnite celo.
English: Subjects with severe renal impairment had a 30% lower CL/F clearance than match controls; however, when variability is taken into account, the different was not significant.
Slovenian: Osebe s hudo okvaro ledvic so imele 30 % manjši očistek CL/F kot primerljive kontrolne osebe, vendar ob upoštevanju variabilnosti ta razlika ni bila pomembna.
English: - medicines called “beta blockers” used to treat high blood pressure and other heart problems.
Slovenian: - zdravila, imenovana „antagonisti adrenergičnih receptorjev beta“, ki se uporabljajo za zdravljenje visokega krvnega tlaka in drugih težav s srcem.
English: Do not stop taking HETLIOZ without talking to your doctor.
Slovenian: Ne prenehajte jemati zdravila HETLIOZ, ne da bi se posvetovali z zdravnikom.
English: Pharmacotherapeutic group: Psycholeptics, melatonin receptor agonists, ATC code: N05CH03
Slovenian: Farmakoterapevtska skupina: psiholeptiki, agonisti melatoninskih receptorjev, oznaka ATC: N05CH03
English: Less than 1% of the dose was excreted in urine as the parent compound.
Slovenian: Manj kot 1 % odmerka se je izločil z urinom v obliki izhodne spojine.
English: The average timing of sleep relative to an individual's desired period for consolidated sleep over at least one circadian period was assessed.
Slovenian: Ocenjevali so povprečen čas spanja glede na posameznikovo želeno obdobje trdnega spanca v najmanj enem cirkadianem obdobju.
English: Potential effect of alcohol on tasimelteon
Slovenian: Možen vpliv alkohola na tasimelteon
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v šestih mesecih po pridobitvi dovoljenja za promet.
English: Foggy feeling in head
Slovenian: - meglen občutek v glavi
English: Repeated once daily dosing with tasimelteon does not result in changes in pharmacokinetic parameters or significant accumulation of tasimelteon.
Slovenian: Ponavljajoče se odmerjanje tasimelteona enkrat na dan ne povzroči sprememb farmakokinetičnih parametrov ali pomembnejšega kopičenja tasimelteona.
English: Take your next dose at the usual time the next day.
Slovenian: Vzemite naslednji odmerek ob običajnem času naslednji dan. Ne vzemite dvojnega odmerka.
English: Adverse reactions leading to discontinuation occurred in 2.3% of tasimelteon-treated patients.
Slovenian: Neželeni učinki, zaradi katerih je bilo treba prekiniti zdravljenje, so se pojavili pri 2,3 % bolnikov, zdravljenih s tasimelteonom.
English: After taking tasimelteon, patients should limit their activity to preparing to go to bed and not use machines because tasimelteon can impair performance of activities requiring complete mental alertness.
Slovenian: Ko bolniki vzamejo tasimelteon, morajo svoje dejavnosti omejiti na pripravo na spanje in ne smejo upravljati strojev, saj lahko tasimelteon zmanjša zmožnost opravljanja dejavnosti, ki zahtevajo popolno umsko pozornost.
English: The mean terminal elimination half-life ± standard deviation of the main metabolites ranges from 1.3 ± 0.5 to 3.7 ± 2.2.
Slovenian: Povprečni končni razpolovni čas izločanja ± standardni odklon glavnih presnovkov znaša od 1,3 ± 0,5 do 3,7 ± 2,2.
English: - Skip the missed dose.
Slovenian: - Izpustite pozabljeni odmerek.
English: It aligns body rhythms with the usual 24-hour day and night cycle and so improve sleep patterns.
Slovenian: Biološke ritme uskladi z običajnim 24-urnim ciklusom dneva in noči ter tako izboljša vzorce spanja.
English: This includes the GABA receptor complex, the binding site for sedative hypnotics, and receptors that bind neuropeptides, cytokines, serotonin, noradrenaline, acetylcholine, and opiates.
Slovenian: Med njimi so kompleks receptorjev GABA, vezavno mesto za sedativne hipnotike, in receptorji, ki vežejo nevropeptide, citokine, serotonin, noradrenalin, acetilholin in opiate.
English: The pharmacokinetics of tasimelteon is linear over doses ranging from 3 to 300 mg (0.15 to 15 times the recommended daily dosage).
Slovenian: Farmakokinetika tasimelteona je linearna pri odmerkih od 3 do 300 mg (0,15- do 15-kratnik priporočenega dnevnega odmerka).
English: Tasimelteon exposure decreased by approximately 40% in smokers compared to non-smokers (see section 5.2).
Slovenian: Izpostavljenost tasimelteonu se je pri kadilcih zmanjšala za približno 40 % v primerjavi z nekadilci (glejte poglavje 5.2).
English: These receptors are thought to be involved in the control of circadian rhythms.
Slovenian: Ta receptorja domnevno sodelujeta pri uravnavanju cirkadianih ritmov.