FrancophonIA/ELRC3.0 huggingface dataset:
English: Oral administration of tasimelteon to rats throughout organogenesis and lactation resulted in persistent reductions in body weight, delayed sexual maturation and physical development, neurobehavioural impairment in offspring at the highest dose tested, andreduced body weight in offspring at the mid-dose tested.
Slovenian: Peroralno dajanje tasimelteona podganam v obdobju organogeneze in laktacije je pri mladičih povzročilo persistentno zmanjšanje telesne mase, zapoznelo spolno dozorevanje in telesni razvoj ter nevrološke vedenjske motnje, kadar je bil uporabljen največji preskušeni odmerek, in zmanjšano telesno maso, kadar je bil uporabljen srednji preskušeni odmerek.
English: Patients treated with tasimelteon experienced an overall improvement in clinical global functioning (CGIC = 2.6) as compared to patients treated with placebo who showed no improvement status (CGI-C = 3.4) compared to the severity of Non-24 at baseline (LS mean difference = -0.8; p=0.0093) (Table 4).
Slovenian: Odziv pri kliničnih merilih splošnega delovanja Pri bolnikih, zdravljenih s tasimelteonom, so opazili splošno izboljšanje splošnega delovanja po kliničnih merilih (CGI-C = 2,6) v primerjavi z bolniki, zdravljenimi s placebom, pri katerih niso opazili nobenega izboljšanja (CGI-C = 3,4) glede na resnost ne-24-urnega ciklusa ob izhodišču (povprečna razlika najmanjših kvadratov = -0,8; p = 0,0093) (preglednica 4).
English: Tasimelteon clearance does not appear to be affected by polymorphisms in these enzymes.
Slovenian: Ni videti, da bi polimorfizmi v teh encimih vplivali na očistek tasimelteona.
English: The peak concentration (Tmax) of tasimelteon occurred approximately 0.5 hours after fasted oral administration.
Slovenian: Najvišje koncentracije (Tmaks) tasimelteona so se pojavile približno 0,5 ure po peroralni uporabi na tešče.
English: Physicians should evaluate patient response to tasimelteon 3 months after treatment initiation utilising a clinician interview to assess their overall functioning with an emphasis on sleep-wake complaints.
Slovenian: Zdravniki morajo tri mesece po začetku zdravljenja oceniti odziv bolnika na tasimelteon, tako da prek pogovora z bolnikom ocenijo njegovo splošno delovanje, pri čemer se morajo osredotočiti predvsem na težave, povezane s ciklusom spanja in budnosti.
English: In SET, tasimelteon entrained circadian rhythms at month 1 at a significantly higher rate than placebo as measured by aMT6s and cortisol (20% vs. 2.6 % and 17.5% vs 2.6% respectively).
Slovenian: V študiji SET je tasimelteon po enem mesecu veliko bolje utiril cirkadiane ritme v primerjavi s placebom, kot so izmerili glede na ravni 6SMT in kortizola (20 % v primerjavi z 2,6 % oziroma 17,5 % v primerjavi z 2,6 %).
English: Tasimelteon has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore caution is recommended when prescribing HETLIOZ to patients with severe hepatic impairment.
Slovenian: Tasimelteona niso proučevali pri bolnikih s hudo okvaro jeter (stadij C po Child-Pughu), zato je pri predpisovanju zdravila HETLIOZ bolnikom s hudo okvaro jeter priporočena previdnost.
English: Clinical response in sleep-wake amount and timing measures SET and RESET evaluated the duration and timing of nighttime sleep and daytime naps via patient-recorded diaries.
Slovenian: Klinični odziv pri merilih, povezanih s količino in časom spanja in budnosti V študijah SET in RESET so ocenjevali trajanje in čas spanja ponoči in dremeža podnevi glede na zapise v dnevnikih bolnikov.
English: HETLIOZ has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore caution is recommended when prescribing HETLIOZ to patients with severe hepatic impairment.
Slovenian: HETLIOZ niso proučevali pri bolnikih s hudo okvaro jeter (stadij C po Child-Pughu), zato je pri predpisovanju zdravila HETLIOZ bolnikom s hudo okvaro jeter priporočena previdnost.
English: Tasimelteon exposure was increased less than two-fold in subjects with moderate hepatic impairment.
Slovenian: Izpostavljenost tasimelteonu se je pri osebah z zmerno okvaro jeter povečala za manj kot dvakrat.
English: - The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone K17 and titanium dioxide.
Slovenian: − Belo črnilo za tisk vsebuje šelak, propilenglikol, natrijev hidroksid, povidon K17 in titanov dioksid.
English: Renal impairment The pharmacokinetic profile of a 20 mg dose of tasimelteon was compared among 8 subjects with severe renal impairment (estimated glomerular filtration rate [eGFR] ≤ 29 mL/min/1.73m2), 8 subjects with end stage renal disease (ESRD) (GFR < 15 mL/min/1.73m2) requiring hemodialysis, and 16 healthy matched controls.
Slovenian: Farmakokinetični profil 20-miligramskega odmerka tasimelteona so primerjali pri osmih osebah s hudo okvaro ledvic (ocenjena hitrost glomerulne filtracije [eGFR] ≤ 29 ml/min/1,73 m2), osmih osebah z boleznijo ledvic v zadnjem stadiju (hitrost glomerulne filtracije < 15 ml/min/1,73 m2), ki so potrebovale hemodializo,
English: Use of tasimelteon should be avoided in combination with rifampin or other CYP3A4 inducers because of a potentially large decrease in tasimelteon exposure with reduced efficacy: the exposure of tasimelteon decreased by approximately 90% when co-administered with rifampin 600 mg (after 11 days of rifampin 600 mg per day).
Slovenian: Uporabi tasimelteona v kombinaciji z rifampinom ali drugimi induktorji CYP3A4 se je treba izogibati, saj obstaja možnost za veliko zmanjšanje izpostavljenosti tasimelteonu in posledično manjšo učinkovitost: pri sočasni uporabi 600 mg rifampina (po 11 dneh uporabe 600 mg rifampina na dan) se je izpostavljenost tasimelteonu zmanjšala za približno 90 %.
English: How to store HETLIOZ 6.
Slovenian: Shranjevanje zdravila HETLIOZ 6.
English: The recommended dosage of HETLIOZ is 20 mg (1 capsule) per day taken one hour before bedtime, at the same time every night.
Slovenian: Priporočeni odmerek zdravila HETLIOZ je 20 mg (1 kapsula) na dan, ki se vzame eno uro pred spanjem,
English: In pregnant rats administered tasimelteon during the period of organogenesis, there were no effects on embryofoetal development.
Slovenian: Pri brejih podganah, ki so jim dajali tasimelteon med obdobjem organogeneze, niso opazili učinkov na razvoj ploda oziroma zarodka.
English: Effects of Tasimelteon 20 mg Treatment on Clinical Response in Non-24 Tasimelteon 20 mg Placebo
Slovenian: Učinki zdravljenja z 20 mg tasimelteona na klinični odziv pri ne-24
English: - The shell of the capsule consists of gelatin, titanium dioxide, Brilliant Blue FCF, Erythrosine, and Orange Yellow S (E110).
Slovenian: − Ovojnica kapsule sestoji iz želatine, titanovega dioksida, briljantno modrega FCF barvila, eritrozina in oranžno rumenega S barvila (E110).
English: HETLIOZ hard capsules contain lactose.
Slovenian: Trde kapsule zdravila HETLIOZ vsebujejo laktozo.
English: Elderly No dose adjustment is recommended for individuals older than 65 years of age (see section 5.2).
Slovenian: Pri osebah, starejših od 65 let, odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Strong CYP3A4 inducers (e.g. rifampin)
Slovenian: Močni zaviralci CYP3A4 (npr. rifampin)
English: Major metabolites had 13-fold or less activity at melatonin receptors compared to tasimelteon.
Slovenian: Glavni presnovki so imeli najmanj trinajstkrat manjšo aktivnost na melatoninskih receptorjih kot tasimelteon.
English: Tasimelteon exposure was increased by approximately 50% when co-administered with ketoconazole 400 mg (after 5 days of ketoconazole 400 mg per day).
Slovenian: Pri sočasni uporabi 400 mg ketokonazola (po petih dneh uporabe 400 mg ketokonazola na dan) se je izpostavljenost tasimelteonu povečala za približno 50 %.
English: HETLIOZ hard capsules contain the azo colouring agent Orange Yellow S (E110), which may cause allergic reactions.
Slovenian: Trde kapsule zdravila HETLIOZ vsebujejo azobarvilo oranžno rumeno S (E110), ki lahko povzroči alergijske reakcije.
English: Table 1: Summary of Adverse Drug Reactions System Organ Class
Slovenian: Preglednica 1: Povzetek neželenih učinkov zdravila
English: Medicinal products that inhibit CYP1A2 and CYP3A4 have been shown to alter the metabolism of tasimelteon in vivo.
Slovenian: Ugotovljeno je bilo, da zdravila, ki zavirajo CYP1A2 in CYP3A4, spremenijo presnovo tasimelteona in vivo.
English: - The active substance is tasimelteon.
Slovenian: − Zdravilna učinkovina je tasimelteon.
English: Tasimelteon and its most abundant metabolites have no appreciable affinity for more than 160 other pharmacologically relevant receptors.
Slovenian: Tasimelteon in njegovi količinsko najpomembnejši presnovki nimajo občutnejše afinitete do več kot 160
English: Because of individual differences in each person's body rhythms, it could take weeks or up to 3 months for an improvement in symptoms to be noticed.
Slovenian: Ker se biološki ritmi posameznikov razlikujejo, lahko traja nekaj tednov ali do tri mesece,
English: Uncommon: may affect up to 1 in 100 people - abnormal or change in taste - blood tests which show changes in the way the liver is working (aspartate aminotransferase and gamma-glutamyl transferase) - increase in daytime urination - nightmares - ringing in the ears - feeling foggy in the head
Slovenian: - nenavaden okus ali spremembe okusa, - preiskave krvi pokažejo spremembe v delovanju jeter (aspartat-aminotransferaza in gama glutamiltransferaza), - pogostejše uriniranje podnevi,
English: Sleep disorder, insomnia, abnormal dreams
Slovenian: nespečnost, nenormalne sanje nočne more
English: - To open the bottle, push the cap down and turn counter-clockwise.
Slovenian: - Plastenko odprete tako, da potisnete zaporko navzdol in jo obrnete v nasprotni smeri urinega kazalca.
English: Dose and timing
Slovenian: Odmerek in časovni razpored odmerjanja
English: If you forget to take HETLIOZ
Slovenian: Če ste pozabili vzeti zdravilo HETLIOZ
English: Date of first authorisation: 3 July 2015
Slovenian: Datum prve odobritve:
English: Smoking (moderate CYP1A2 inducer)
Slovenian: Kajenje (srednje močen induktor CYP1A2)
English: Tasimelteon acts as a Dual Melatonin Receptor Agonist (DMRA) with selective agonist activity at the MT1 and MT2 receptors.
Slovenian: Tasimelteon deluje kot dvojni agonist melatoninskih receptorjev (Dual Melatonin Receptor Agonist - DMRA) s selektivnim agonističnim učinkom na receptorja MT1 in MT2.
English: Caution should be used when administering HETLIOZ in combination with fluvoxamine or other strong CYP1A2 inhibitors, particularly those which also inhibit other enzymes involved in the clearance of HETLIOZ because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions (see section 4.5).
Slovenian: Previdnost je potrebna, kadar se zdravilo HETLIOZ uporablja v kombinaciji s fluvoksaminom ali drugimi močnimi zaviralci CYP1A2, zlasti tistimi, ki zavirajo tudi druge encime, ki sodelujejo pri očistku zdravila HETLIOZ, saj obstaja možnost za veliko povečanje izpostavljenosti tasimelteonu in večje tveganje za neželene učinke (glejte poglavje 4.5).
English: Patients were treated for approximately 12 weeks with tasimelteon 20 mg one hour prior to bedtime, at the same time every night.
Slovenian: Bolniki so približno 12 tednov jemali 20 mg tasimelteona eno uro pred spanjem,
English: The most abundant metabolites of tasimelteon have less than onetenth of the binding affinity of the parent molecule for both the MT1 and MT2 receptors.
Slovenian: Količinsko najpomembnejši presnovki tasimelteona imajo manj kot eno desetino vezavne afinitete matične molekule do receptorjev MT1 in MT2.
English: Strong CYP3A4 inhibitors (e.g. ketoconazole)
Slovenian: Močni zaviralci CYP3A4 (npr. ketokonazol)
English: - The other ingredients are lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate.
Slovenian: − Druge sestavine zdravila so brezvodna laktoza, mikrokristalna celuloza, premreženi natrijev karmelozat, koloidni silicijev dioksid in magnezijev stearat.
English: Daytime sleep on 25% most symptomatic days
Slovenian: Spanje podnevi v 25 % dni z najbolj izraženimi simptomi
English: If you stop taking HETLIOZ
Slovenian: Če ste prenehali jemati zdravilo HETLIOZ
English: The effectiveness of tasimelteon in the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) was established in two randomised, double-masked, placebo-controlled, multicentre, parallel-group studies (SET and RESET) in totally blind patients with Non-24.
Slovenian: Učinkovitost tasimelteona pri zdravljenju motnje ciklusa spanja in budnosti, ki ni usklajen s 24-urnim ciklusom dneva (ne-24-urni ciklus) so dokazali v dveh randomiziranih dvojno slepih s placebom kontroliranih multicentričnih študijah z vzporednimi skupinami (SET in RESET) pri popolnoma slepih bolnikih z ne-24-urnim ciklusom.
English: RESET demonstrated the maintenance of entrainment with tasimelteon treatment compared to placebo withdrawal (aMT6s: 90% vs. 20% and cortisol: 80% vs. 20%).
Slovenian: Študija RESET je pokazala, da se je v skupini, ki je nadaljevala zdravljenje s tasimelteonom, utirjenost ohranila v primerjavi s skupino, ki je prekinila zdravljenje in ga nadaljevala s placebom (6SMT: 90 % v primerjavi z 20 % in kortizol: 80 % v primerjavi z 20 %).
English: Dark blue opaque, hard capsule marked with “VANDA 20 mg” in white ink.
Slovenian: Neprosojna temnomodra trda kapsula z belo oznako „VANDA 20 mg“.
English: If you accidentally take more HETLIOZ than your doctor recommended, contact your doctor at once or contact the nearest hospital for advice.
Slovenian: Če ste vzeli večji odmerek zdravila HETLIOZ, kot bi smeli Če ste pomotoma vzeli večji odmerek zdravila HETLIOZ, kot vam je priporočil zdravnik, se takoj posvetujte z njim ali se oglasite v najbližji bolnišnici.
English: It is used to treat Non-24-Hour Sleep-Wake Disorder (Non-24) in adults who are totally blind.
Slovenian: Uporablja se za zdravljenje motnje ciklusa spanja in budnosti, ki ni usklajen s 24-urnim ciklusom dneva (ne24-urni ciklus), pri odraslih, ki so popolnoma slepi.
English: In rats, the incidence of liver tumours was increased in males (adenoma and carcinoma) and females (adenoma) at 100 and 250 mg/kg/day; the incidence of tumours of the uterus (endometrial adenocarcinoma) and uterus and cervix (squamous cell carcinoma) were increased at 250 mg/kg/day.
Slovenian: (adenom in karcinom) in samicah (adenom), prav tako pa se je pri odmerku 250 mg/kg/dan povečala incidenca tumorjev na maternici (adenokarcinom endometrija) ter maternici in materničnem vratu
English: Contains lactose and Orange Yellow S (E110).
Slovenian: Vsebuje laktozo in oranžno rumeno S barvilo (E110).
English: The pharmacokinetic profile of a 20 mg dose of tasimelteon was compared among 8 subjects with mild hepatic impairment (Child-Pugh Score ≥5 and ≤6 points), 8 subjects with moderate hepatic impairment
Slovenian: Farmakokinetični profil 20-miligramskega odmerka tasimelteona so primerjali pri osmih osebah z blago okvaro jeter (≥ 5 in ≤ 6 točk na Child-Pughovi lestvici), osmih osebah z zmerno okvaro jeter (≥ 7 in ≤ 9 točk na Child-Pughovi lestvici) ter 13 primerljivih zdravih kontrolnih osebah.
English: In animal studies, administration of tasimelteon during pregnancy resulted in developmental toxicity (embryofoetal mortality, neurobehavioural impairment, and decreased growth and development in offspring) at doses greater than those used clinically.
Slovenian: V študijah na živalih so pri uporabi odmerkov tasimelteona, večjih od klinično priporočenih, v obdobju brejosti opazili toksičnost za razvoj (embriofetalno smrt, nevrološke vedenjske motnje ter upočasnjeno rast in razvoj mladičev).
English: Daytime sleep time on 25% most symptomatic days (minutes)(3),(4)
Slovenian: Spanje ponoči v 25 % noči z najbolj izraženimi simptomi (v minutah)(3) Spanje podnevi v 25 % dni z najbolj izraženimi simptomi (v minutah)(3),(4)
English: RESET was a randomised withdrawal trial in 20 patients with Non-24 (median age 55 years) that was designed to evaluate the maintenance of efficacy of tasimelteon after 12-weeks.
Slovenian: urnim ciklusom (mediana starosti 55 let) in ki je bila zasnovana za oceno ohranitve učinkovitosti tasimelteona po 12 tednih.
English: Clinical Response in Non-24-Hour Sleep-Wake Disorder The effectiveness of tasimelteon in the treatment of clinical symptoms, including the circadian sleep-wake cycle and clinical global functioning in patients with Non-24 was established in SET and RESET (Table 3).
Slovenian: Klinični odziv pri motnji ciklusa spanja in budnosti, ki ni usklajen s 24-urnim ciklusom dneva Učinkovitost tasimelteona pri zdravljenju kliničnih simptomov, vključno z izboljšanjem cirkadianega ciklusa spanja in budnosti ter splošnega delovanja po kliničnih merilih, pri bolnikih z ne-24-urnim ciklusom so dokazali v študijah SET in RESET (preglednica 3).
English: SET Study Clinical response (Entrainment + N24CRS
Slovenian: Response Scale - N24CRS).
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.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Hard capsule core Lactose anhydrous Microcrystalline cellulose Croscarmellose sodium Silica, colloidal anhydrous Magnesium sterate
Slovenian: Jedro trde kapsule brezvodna laktoza mikrokristalna celuloza natrijev karmelozat, premreženi silicijev dioksid, koloidni, brezvodni magnezijev stearat
English: No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Potential for other medicinal products to affect tasimelteon CYP1A2 and CYP3A4 are enzymes identified to play a role in the metabolism of tasimelteon, with a minor role for CYP2C9/C19.
Slovenian: CYP1A2 in CYP3A4 sta encima, ki dokazano sodelujeta pri presnovi tasimelteona, medtem ko imata CYP2C9/C19 manjšo vlogo.
English: One HDPE bottle per paperboard carton.
Slovenian: V eni kartonasti škatli je ena plastenka iz HDPE.
English: Caution should be used when administering HETLIOZ in combination with rifampin or other CYP3A4 inducers because of a potentially large decrease in tasimelteon exposure with reduced efficacy (see section
Slovenian: Previdnost je potrebna, kadar se zdravilo HETLIOZ uporablja v kombinaciji z rifampinom ali drugimi induktorji CYP3A4, saj obstaja možnost za veliko zmanjšanje izpostavljenosti tasimelteonu in manjšo učinkovitost (glejte poglavje 4.5).
English: HETLIOZ hard capsules are opaque dark blue printed with “VANDA 20 mg” in white.
Slovenian: Trde kapsule zdravila HETLIOZ so neprozorne, temnomodre in imajo belo oznako „VANDA 20 mg“.
English: Tasimelteon exhibits a greater affinity for the MT2 as compared to the MT1 receptor.
Slovenian: Tasimelteon kaže večjo afiniteto do receptorja MT2 kot do receptorja MT1.
English: There was no increase in tumours at the lowest dose tested in rats, which is approximately 10 times the recommended human doseon a mg/m2 basis.
Slovenian: Pri najmanjšem odmerku, ki so ga preskusili na podganah in je bil približno 10-krat večji od priporočenega odmerka pri človeku na podlagi mg/m2, niso opazili povečanja števila tumorjev.
English: Propylene glycol Sodium hydroxide Povidone K17
Slovenian: Belo črnilo za tisk šelak propilenglikol natrijev hidroksid povidon K17 titanov dioksid
English: HETLIOZ 20 mg hard capsules tasimelteon
Slovenian: HETLIOZ 20 mg trde kapsule tasimelteon
English: CGI-C (LS mean)
Slovenian: CGI-C (povprečje najmanjših kvadratov)
English: HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
Slovenian: Zdravilo HETLIOZ je indicirano za zdravljenje motnje ciklusa spanja in budnosti, ki ni usklajen s 24-urnim ciklusom dneva (ne-24-urni ciklus), pri popolnoma slepih odraslih.
English: HETLIOZ 20 mg hard capsules
Slovenian: HETLIOZ 20 mg trde kapsule
English: Renal impairment No dose adjustment is recommended for patients with renal impairment (see section 5.2).
Slovenian: Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Common: may affect up to 1 in 10 people - change in sleeping pattern - difficulty in sleeping - dizziness - dry mouth - tiredness - indigestion - feeling sick in the stomach - blood tests which show changes in the way the liver is working (alanine aminotransferase) - unusual dreams - sleepiness
Slovenian: - suha usta, - utrujenost, - prebavne motnje, - slabost v želodcu, - preiskave krvi pokažejo spremembe v delovanju jeter (alanin-aminotransferaza),
English: Taking HETLIOZ
Slovenian: Jemanje zdravila HETLIOZ
English: HETLIOZ contains the active substance tasimelteon.
Slovenian: Zdravilo HETLIOZ vsebuje zdravilno učinkovino tasimelteon.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: HETLIOZ contains Orange Yellow S (E110)
Slovenian: Zdravilo HETLIOZ vsebuje barvilo oranžno rumeno S (E110)
English: Therefore, no dose adjustment is needed in patients with mild or moderate hepatic impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter odmerka zato ni treba prilagajati.
English: HETLIOZ contains lactose
Slovenian: Zdravilo HETLIOZ vsebuje laktozo
English: Because symptoms of nighttime sleep disruption and daytime sleepiness are cyclical in patients with Non-24, with severity varying according to the state of alignment of the individual patient's circadian rhythm with the 24-hour day (least severe when fully aligned, most severe when 12 hours out of alignment), efficacy endpoints for nighttime total sleep time and daytime nap duration were based on the 25% of nights with the least nighttime sleep, and the 25% of days with the most daytime nap time.
Slovenian: Glede na to, da se simptomi prebujanja ponoči in zaspanosti podnevi pri bolnikih z ne-24-urnim ciklusom pojavljajo v ciklusih, pri čemer je stopnja izraženosti simptomov odvisna od stanja usklajenosti cirkadianega ritma posameznega bolnika s 24-urnim dnevom (najmanj izraženi so ob popolni usklajenosti, najbolj pa ob
English: Push the cap down and turn counter-clockwise to open the bottle.
Slovenian: Plastenko odprete tako, da potisnete zaporko navzdol in jo obrnete v nasprotni smeri urinega kazalca.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 30-COUNT BOTTLE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PLASTENKO S 30 KAPSULAMI
English: Entrainment in Non-24-Hour Sleep-Wake Disorder
Slovenian: Utirjenje pri motnji ciklusa spanja in budnosti, ki ni usklajen s 24-urnim ciklusom dneva
English: HETLIOZ contains lactose.
Slovenian: Zdravilo HETLIOZ vsebuje laktozo.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR 30-COUNT BOTTLE
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA ZA PLASTENKO S 30 KAPSULAMI
English: Entrainment plus a score ≥3 on this scale, called Non-24 Clinical Response Scale (N24CRS) was required to be classified as a clinical responder.
Slovenian: Za bolnike z odzivom so šteli tisti, pri katerih so zabeležili utirjenje in rezultat ≥ 3 na lestvici, imenovani lestvica za oceno kliničnega odziva bolnikov z ne-24-urnim ciklusom (Non-24 Clinical
English: Titanium dioxide Brilliant Blue FCF Erythrosine
Slovenian: Obloga trde kapsule želatina titanov dioksid briljantno modro FCF eritrozin oranžno rumeno S (E110)
English: Aspartate aminotransferase increased, gamma-glutamyl transferase increased
Slovenian: Preiskave zvišana raven alaninaminotransferaze zvišana raven aspartataminotransferaze, zvišana raven gamaglutamiltransferaze
English: Tasimelteon functions as a DMRA at the MT1 and MT2 receptors.
Slovenian: Tasimelteon deluje kot dvojni agonist melatoninskih receptorjev MT1 in MT2.
English: - medicines known to reduce the activity of an enzyme called ‘CYP3A4'.
Slovenian: - zdravila, ki dokazano zmanjšujejo aktivnost encima, imenovanega „CYP1A2“.