FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with HETLIOZ in one or more subsets of the paediatric population who are totally blind with Non-24.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom HETLIOZ za eno ali več podskupin popolnoma slepe pediatrične populacije z ne-24-urnim ciklusom.
English: What you need to know before you take HETLIOZ 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo HETLIOZ 3.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tasimelteon therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja s tasimelteonom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: The recommended dose is one capsule every night, taken one hour before you go to bed.
Slovenian: Kakšen je priporočeni odmerek Priporočeni odmerek je ena kapsula vsak večer, ki jo vzamete eno uro pred spanjem.
English: Timing of sleep
Slovenian: Čas spanja
English: Patients should be instructed to initiate HETLIOZ treatment without regard to circadian phase.
Slovenian: Bolnikom je treba naročiti, naj zdravljenje z zdravilom HETLIOZ začnejo ne glede na fazo cirkadianega ritma.
English: The effectiveness of tasimelteon to improve clinical global functioning was evaluated in SET.
Slovenian: Učinkovitost tasimelteona pri izboljšanju splošnega delovanja po kliničnih merilih so ocenili v študiji SET.
English: There are no data on the effects of tasimelteon on human fertility.
Slovenian: Podatkov o učinkih tasimelteona na plodnost pri človeku ni.
English: The most common adverse reactions (>3%) during clinical trials were headache (10.4%), somnolence (8.6%), nausea (4.0%), and dizziness (3.1%).
Slovenian: Najpogostejši neželeni učinki (> 3 %) med kliničnimi preskušanji so bili glavobol (10,4 %), somnolenca (8,6 %), navzea (4,0 %) in omotica (3,1 %).
English: - Store in the original container and keep tightly closed in order to protect from moisture and light.
Slovenian: - Shranjujte v originalnem vsebniku in tesno zaprto za zagotovitev zaščite pred vlago in svetlobo.
English: Each bottle has a child-resistant cap and contains 30 hard capsules.
Slovenian: Vsaka plastenka ima za otroke varno zaporko in vsebuje 30 trdih kapsul.
English: As a precautionary measure, it is preferable to avoid the use of tasimelteon during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi tasimelteona bolje izogibati.
English: Analyses of entrainment at month 7 in a subset of patients demonstrated that 59% of tasimelteon-treated patients entrained by month 7 indicating that response to treatment may take weeks or months for some patients to respond.
Slovenian: Analize utirjenja v sedmem mesecu pri podskupini bolnikov so pokazale, da se je cirkadiani ritem pri 59 % bolnikov, ki so prejemali tasimelteon, utiril do 7. meseca, kar kaže na to, da se nekateri bolniki odzovejo šele po več tednih ali mesecih.
English: Hard capsules should be swallowed whole.
Slovenian: Trde kapsule je treba pogoltniti cele.
English: Contents of the pack and other information What HETLIOZ contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo HETLIOZ
English: The observed mean elimination half-life for tasimelteon is 1.3 ± 0.4 hours.
Slovenian: Povprečni opaženi razpolovni čas izločanja tasimelteona je bil 1,3 ± 0,4 ure.
English: Race Race does not affect apparent clearance of tasimelteon.
Slovenian: Rasa Rasa ne vpliva na navidezni očistek tasimelteona.
English: This type of medicine is called a “melatonin agonist” that acts as a regulator of daily body rhythms.
Slovenian: To vrsto zdravila imenujemo „agonist melatoninskih receptorjev“, ki uravnava dnevne biološke ritme.
English: Assessment
Slovenian: Ocena
English: (1) Higher numbers indicates improvement (2) Sensitivity Analysis (3) P-value was based on analysis of covariance model, units are LS mean minutes (4) Lower numbers indicates improvement (5) Post-hoc analysis
Slovenian: (2) Analiza občutljivosti (3) p-vrednost je temeljila na analizi kovariančnega modela, enote so povprečne minute, izračunane z metodo najmanjših kvadratov (4) Nižje številke pomenijo izboljšanje (5) Naknadna analiza
English: During SET, patient diaries were recorded for an average of 88 days during screening and 133 days during randomisation.
Slovenian: Med študijo SET so bolniki opažanja v dnevnik zapisovali povprečno 88 dni med presejalnim obdobjem in 133 dni med randomizacijo.
English: Tasimelteon may cause somnolence.
Slovenian: Tasimelteon lahko povzroči somnolenco.
English: There was no apparent relationship between tasimelteon CL/F and renal function, as measured by either estimated creatinine clearance or eGFR.
Slovenian: Očitne povezave med očistkom po peroralni uporabi (CL/F) in delovanjem ledvic, izmerjenim glede na ocenjeni očistek kreatinina ali eGFR, ni bilo.
English: Therefore, your doctor may ask you to take HETLIOZ for up to 3 months before checking if it is working for you.
Slovenian: HETLIOZ jemljite do tri mesece, preden bo preveril, ali pri vas deluje.
English: In sighted people, the change in light levels between day and night helps to synchronise internal body rhythms, including feeling sleepy at night and being active during the day.
Slovenian: Pri ljudeh, ki vidijo, sprememba jakosti svetlobe med dnevom in nočjo pomaga sinhronizirati notranje biološke ritme, ki vključujejo zaspanost ponoči in aktivnost podnevi.
English: It is unknown whether tasimelteon/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se tasimelteon/presnovki izločajo v materino mleko.
English: The Clinical Global Impression of Change (CGI-C) is a reflection of the general social, occupational, and health functioning of the patient and is evaluated on a 7-point scale, centered at No Change (4), that investigators used to rate the patients' improvement from baseline in symptoms of global functioning.
Slovenian: Splošen klinični vtis o spremembi (Clinical Global Impression of Change - CGI-C) odraža splošno družbeno, poklicno in telesno delovanje bolnika ter se ovrednoti na 7-stopenjski lestvici s srednjo stopnjo brez spremembe (4), ki jo raziskovalci uporabljajo za ocenjevanje izboljšanja simptomov, povezanih s splošnim delovanjem bolnikov, od izhodišča.
English: Patients in whom the calculated time of peak melatonin level (melatonin acrophase) occurred at approximately the same time of day (in contrast to the expected daily delay) during the run-in phase were randomised to receive placebo or continue daily treatment with tasimelteon 20 mg for 8 weeks.
Slovenian: Bolnike, pri katerih so se največje koncentracije melatonina (akrofaza melatonina) med uvajalnim obdobjem pojavljale ob približno istem času dneva (v nasprotju s pričakovanim dnevnim zamikom), so randomizirali tako, da so bodisi prejemali placebo bodisi še osem tednov nadaljevali vsakodnevno zdravljenje z 20 mg tasimelteona.
English: The mean overall exposure of tasimelteon was approximately 1.6-fold greater in female than in male subjects.
Slovenian: Povprečna skupna izpostavljenost tasimelteonu je bila približno 1,6-krat večja pri ženskah kot pri moških.
English: The mean absolute oral bioavailability of tasimelteon is 38%.
Slovenian: Povprečna absolutna biološka uporabnost tasimelteona po peroralni uporabi je 38-odstotna.
English: Because of individual differences in each person's body rhythms, it could take weeks or months for you to notice an improvement in your symptoms.
Slovenian: Ker se biološki ritmi posameznikov razlikujejo, lahko traja nekaj tednov ali mesecev, preden boste opazili izboljšanje simptomov.
English: The pharmacokinetics of tasimelteon and its metabolites did not change with repeated daily dosing.
Slovenian: Farmakokinetika tasimelteona in njegovih presnovkov se pri ponavljajočem se dnevnem odmerjanju ne spremeni.
English: Following oral administration of radiolabeled tasimelteon, 80% of total radioactivity was excreted in urine and approximately 4% in feces, resulting in a mean recovery of 84%.
Slovenian: Po peroralni uporabi radioaktivno označenega tasimelteona se je 80 % skupne radioaktivnosti izločilo z urinom in približno 4 % z blatom, kar pomeni, da je povprečni izkoristek znašal 84 %.
English: Metabolism of tasimelteon consists primarily of oxidation at multiple sites and oxidative dealkylation resulting in opening of the dihydrofuran ring followed by further oxidation to give a carboxylic acid.
Slovenian: Presnova tasimelteona poteka predvsem z oksidacijo na več mestih in oksidativno dealkilacijo, ki povzročita odprtje dihidrofuranskega obroča, čemur sledita nadaljnja oksidacija in nastanek karboksilne kisline.
English: Each bottle also contains a 1.5-g silica gel desiccant canister and polyester dunnage.
Slovenian: Vsaka plastenka vsebuje tudi sušilno sredstvo iz 1,5 g silikagela in varovalno oblogo iz poliestra.
English: > 45 min improvement in both nighttime and daytime sleep (%)(5)
Slovenian: > 45-minutno izboljšanje spanja ponoči in podnevi (%)(5)
English: The apparent oral volume of distribution at steady state of tasimelteon in young healthy subjects is approximately 59 - 126 L. At therapeutic concentrations, tasimelteon is about 88.6 - 90.1% bound to proteins.
Slovenian: Navidezni volumen porazdelitve tasimelteona v stanju dinamičnega ravnovesja po peroralni uporabi je pri mladih zdravih osebah približno 59-126 l. Pri terapevtskih koncentracijah se približno 88,6-90,1 % tasimelteona veže na beljakovine.
English: - If HETLIOZ is not taken every night, the body rhythms will lose alignment with the usual 24-hour day and night cycle again.
Slovenian: - Če zdravila HETLIOZ ne boste jemali vsak večer, bodo biološki ritmi ponovno postali neusklajeni z običajnim 24-urnim ciklusom dneva in noči.
English: After taking HETLIOZ, you should get ready to go to bed and only carry out activities that you would normally do before going to bed.
Slovenian: Ko vzamete zdravilo HETLIOZ, se pripravite za spanje in opravljajte samo tiste dejavnosti, ki bi jih tudi sicer opravljali pred spanjem.
English: If you become pregnant while taking HETLIOZ, consult your doctor immediately as it is recommended not to take HETLIOZ while you are pregnant or breast feeding.
Slovenian: Če zanosite med jemanjem zdravila HETLIOZ, se takoj posvetujte z zdravnikom, saj jemanje zdravila HETLIOZ med nosečnostjo in dojenjem ni priporočljivo.
English: Excipient(s) with known effect: Each hard capsule contains 183.25 mg of lactose (as anhydrous) and 0.03 mg of Orange Yellow S (E110).
Slovenian: Pomožne snovi z znanim učinkom: ena trda kapsula vsebuje 183,25 mg laktoze (brezvodne) in 0,03 mg barvila oranžno rumeno S (E110).
English: Therefore, tasimelteon should be taken without food; if patients eat a high-fat meal, it is recommended to wait at least 2 hours before taking tasimelteon.
Slovenian: Tasimelteon je zato treba jemati brez hrane - če bolniki zaužijejo obrok z visoko vsebnostjo maščob, je priporočljivo, da počakajo vsaj dve uri, preden vzamejo tasimelteon.
English: While haemodialysis was effective at clearing tasimelteon and the majority of its major metabolites in patients with renal impairment, it is not known if hemodialysis will effectively reduce exposure in the case of overdose.
Slovenian: Hemodializa je učinkovito odstranila tasimelteon in večino njegovih presnovkov pri bolnikih z okvaro ledvic, vendar ni znano, ali bi učinkovito zmanjšala izpostavljenost ob prevelikem odmerjanju.
English: The master body clock regulates the circadian rhythms of hormones including melatonin and cortisol and aligns/synchronises the physiological processes of the sleep-wake cycle and metabolic and cardiovascular homeostasis.
Slovenian: Glavna biološka ura uravnava cirkadiane ritme hormonov, med katerimi sta tudi melatonin in kortizol, ter uskladi/sinhronizira fiziološke procese ciklusa spanja in budnosti ter presnovno in kardiovaskularno ravnovesje.
English: >45 minutes increase in average nighttime sleep duration
Slovenian: >45-minutno podaljšanje povprečnega trajanja spanja ponoči
English: After taking HETLIOZ, patients should limit their activity to preparing for going to bed.
Slovenian: Ko bolniki vzamejo zdravilo HETLIOZ, morajo svoje dejavnosti omejiti na pripravo na spanje.
English: Store in the original container and keep the bottle tightly closed in order to protect from moisture and light.
Slovenian: Shranjujte v originalnem vsebniku in imejte plastenko tesno zaprto za zagotovitev zaščite pred vlago in svetlobo.
English: High density polyethylene (HDPE) bottle containing 30 hard capsules with polypropylene child-resistant closures containing polypropylene resin induction seals.
Slovenian: Plastenka iz polietilena visoke gostote (HDPE), ki vsebuje 30 trdih kapsul, z za otroke varno zaporko iz polipropilena, ki vsebuje indukcijsko tesnilo iz polipropilenske smole.
English: In SET, patients in the tasimelteon group had, at baseline, an average 195 minutes of nighttime sleep and 137 minutes of daytime nap time on the 25% of most symptomatic nights and days, respectively.
Slovenian: V študiji SET so pri bolnikih v skupini s tasimelteonom ob izhodišču zabeležili povprečno 195 minut spanja ponoči in 137 minut dremeža podnevi v 25 % noči oziroma dni z najbolj izraženimi simptomi.
English: Patients with Non-24 who are totally blind cannot see light, so their body rhythms shift out of alignment with the 24-hour world, resulting in periods of feeling sleepy during the day and the inability to sleep at night.
Slovenian: Bolniki z ne-24-urnim ciklusom, ki so popolnoma slepi, ne morejo videti svetlobe, zato njihovi biološki ritmi niso usklajeni s 24-urnim dnevom, kar povzroči obdobja zaspanosti podnevi in nespečnosti ponoči.
English: The most frequent adverse reactions leading to discontinuation were: somnolence (0.23%), nightmare (0.23%), and headache (0.17%).
Slovenian: so bili: somnolenca (0,23 %), nočne more (0,23 %) in glavobol (0,17 %).
English: CYP2C9 (18.8%) and CYP2C19 (15.1%) also contribute to the metabolism of tasimelteon.
Slovenian: K presnovi tasimelteona prispevata tudi CYP2C9 (18,8 %) in CYP2C19 (15,1 %).
English: Other medicines and HETLIOZ
Slovenian: Druga zdravila in zdravilo HETLIOZ
English: Both studies demonstrated the ability of tasimelteon to entrain the master body clock in patients with Non-24 and RESET demonstrated that continued daily dosing of tasimelteon is necessary to maintain entrainment.
Slovenian: Obe študiji sta pokazali, da tasimelteon lahko utiri glavno biološko uro pri bolnikih z ne-24-urnim ciklusom, študija RESET pa tudi, da je za ohranitev utirjenosti potrebno stalno dnevno odmerjanje tasimelteona.
English: This is deemed even more important for strong CYP1A2 inhibitors also inhibiting other enzymes involved in the clearance of HETLIOZ (e.g. fluvoxamine and ciprofloxacin).
Slovenian: To je še pomembnejše pri močnih zaviralcih CYP1A2, ki zavirajo tudi druge encime, ki sodelujejo pri očistku zdravila HETLIOZ (npr. fluvoksamin in ciprofloksacin).
English: When administered with a high-fat meal, the Cmax of tasimelteon was 44% lower than when administered in a fasted state, and the median Tmax was delayed by approximately 1.75 hours.
Slovenian: Po zaužitju tasimelteona skupaj z obrokom z visoko vsebnostjo maščob je bila njegova Cmaks za 44 % manjša kot po zaužitju na tešče, mediana Tmaks pa se je podaljšala za približno 1,75 ure.
English: An example is omeprazole, which is used to treat hearburn and gastroesophageal reflux disease (GERD).
Slovenian: To je na primer omeprazol, ki se uporablja za zdravljenje zgage in gastroezofagealne refluksne bolezni (GERB);
English: Treatment with tasimelteon resulted in a significant improvement, compared with placebo, for all of these endpoints in SET and RESET (see Table 3).
Slovenian: Zdravljenje s tasimelteonom je v študijah SET in RESET povzročilo pomembno izboljšanje v primerjavi s placebom pri vseh omenjenih opazovanih dogodkih (glejte preglednico 3).
English: Dyspepsia, nausea, dry mouth
Slovenian: Bolezni prebavil dispepsija, navzea, suha usta
English: The following terms and frequencies are applied and presented by MedDRA System Organ Class: Very common (≥1/10); Common (≥1/100 to <1/10);
Slovenian: Uporabljeni so naslednji izrazi in pogostnosti, ki so razvrščeni glede na organske sisteme po MedDRA: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do <1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000).
English: On some psychomotor test measures (intoxication, drunk, alertness/drowsiness, balance platform test), there was a trend towards greater effects of tasimelteon plus ethanol versus ethanol alone, but the effects were not deemed significant.
Slovenian: Pri določenih merilih za preverjanje psihomotoričnih sposobnosti (vinjenost, pijanost, budnost/dremavost, preskus ravnotežja na plošči) so opazili večje učinke pri uporabi tasimelteona v kombinaciji z etanolom kot pri uporabi samo etanola, vendar ti niso bili ocenjeni kot pomembni.
English: What you need to know before you take HETLIOZ Do not take HETLIOZ if
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo HETLIOZ Ne jemljite zdravila HETLIOZ:
English: During RESET, patient diaries were recorded for an average of 57 days during the run-in phase and 59 days during the randomised-withdrawal phase.
Slovenian: Med študijo RESET so bolniki opažanja v dnevnik zapisovali povprečno 57 dni med uvajalnim obdobjem in 59 dni med randomizirano fazo prekinitve zdravljenja.
English: Tasimelteon is a circadian regulator that resets the master body clock in the suprachiasmatic nucleus (SCN).
Slovenian: Tasimelteon je regulator cirkadianega ritma, ki ponovno nastavi glavno biološko uro v suprakiazmalnem jedru (SKJ).
English: If you eat a high-fat meal close to the time you would normally take the medicine, it is best to wait 2 hours before taking HETLIOZ.
Slovenian: Če zaužijete obrok z visoko vsebnostjo maščob približno takrat, ko bi morali vzeti zdravilo, je najbolje, da počakate dve uri, preden vzamete zdravilo HETLIOZ.
English: Reproductive and developmental toxicity studies showed that oestrous cycles were prolonged in rats treated with high doses of tasimelteon, with no effect on mating performance or male fertility, and only a marginal effect on female fertility.
Slovenian: Študije o vplivu na sposobnost razmnoževanja in razvoja so pokazale, da so se pri podganah, zdravljenih z velikimi odmerki tasimelteona, podaljšali estrusni ciklusi, niso pa pokazale vpliva na uspešnost parjenja ali plodnost samcev in samo zanemarljiv vpliv na plodnost samic.
English: What HETLIOZ is and what it is used for 2.
Slovenian: Kaj je zdravilo HETLIOZ in za kaj ga uporabljamo 2.
English: Nightmare
Slovenian: - nočne more,
English: In SET, 84 patients with Non-24 (median age 54 years) were randomised to receive tasimelteon 20 mg or placebo, one hour prior to bedtime, at the same time every night for up to 6 months.
Slovenian: V študiji SET so 84 bolnikov z ne-24-urnim ciklusom (mediana starosti 54 let) randomizirali tako, da so do šest mesecev prejemali bodisi 20 mg tasimelteona bodisi placebo eno uro pred spanjem, vsak večer ob istem času.
English: Each hard capsule contains 20 mg tasimelteon.
Slovenian: Ena trda kapsula vsebuje 20 mg tasimelteona.
English: The active substance in HETLIOZ, tasimelteon, is able to act as a time-keeper for the body rhythms and resets them each day.
Slovenian: Zdravilna učinkovina v zdravilu HETLIOZ, tasimelteon, lahko deluje kot vzdrževalec bioloških ritmov, ki jih vsak dan ponovno nastavi.
English: HETLIOZ should be taken without food; if patients eat a high-fat meal, it is recommended to wait at least 2 hours before taking HETLIOZ (see section 5.2).
Slovenian: Zdravilo HETLIOZ je treba jemati brez hrane - če bolniki zaužijejo obrok z visoko vsebnostjo maščob, je priporočljivo, da počakajo vsaj dve uri, preden vzamejo zdravilo HETLIOZ (glejte poglavje 5.2).
English: Threshold of Response
Slovenian: Prag za potrditev odziva
English: There are no or limited amount of data from the use of tasimelteon in pregnant women.
Slovenian: Podatkov o uporabi tasimelteona pri nosečnicah ni oziroma so omejeni.
English: The following side effects may happen with this medicine.
Slovenian: Pri tem zdravilu se lahko pojavijo naslednji neželeni učinki:
English: If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking HETLIOZ.
Slovenian: Če karkoli od navedenega velja za vas (ali če niste prepričani), se pred jemanjem zdravila HETLIOZ
English: HETLIOZ is intended for chronic use.
Slovenian: Zdravilo HETLIOZ je namenjeno za dolgotrajno uporabo.
English: CYP1A2 (35.4%) and CYP3A4 (24.3%) are the major enzymes identified to play a role in the metabolism of tasimelteon.
Slovenian: CYP1A2 (35,4%) in CYP3A4 (24,3%) sta encima, ki dokazano sodelujeta pri presnovi tasimelteona.
English: Tasimelteon is extensively metabolised.
Slovenian: Tasimelteon se obsežno presnavlja.
English: In elderly subjects, tasimelteon exposure increased by approximately two-fold compared to non-elderly adults.
Slovenian: Pri starejših osebah je bila izpostavljenost tasimelteonu približno dvakrat večja kot pri ostalih odraslih.
English: What HETLIOZ is and what it is used for
Slovenian: Kaj je zdravilo HETLIOZ in za kaj ga uporabljamo
English: HETLIOZ contains Orange Yellow S (E110) which may cause allergic reactions.
Slovenian: Zdravilo HETLIOZ vsebuje oranžno rumeno S (E110), ki lahko povzroči alergijske reakcije.
English: In a study of 28 healthy volunteers, a single dose of ethanol (0.6 g/kg for women and 0.7 g/kg for men) was co-administered with a 20 mg dose of tasimelteon.
Slovenian: V študiji, v kateri je sodelovalo 28 zdravih prostovoljcev, so sočasno z 20-miligramskim odmerkom tasimelteona uporabili tudi enkraten odmerek etanola (0,6 g/kg pri ženskah in 0,7 g/kg pri moških).
English: No evidence of carcinogenic potential was observed in mice; the highest dose tested is approximately 75 times the RHD of 20 mg/day, on a mg/m2 basis.
Slovenian: Pri miših niso opazili nobenih znakov karcinogenega potenciala, pri čemer je bil največji preskušeni odmerek približno 75-krat večji od priporočenega odmerka pri človeku 20 mg/dan na podlagi mg/m2.
English: SET and RESET assessed entrainment of the master body clock as measured by aMT6s and cortisol.
Slovenian: V študijah SET in RESET so ocenjevali utirjenje glavne biološke ure, ki so ga merili glede na ravni 6SMT in kortizola.
English: There is limited clinical experience with the effects of an overdose of tasimelteon.
Slovenian: Klinične izkušnje z učinki prevelikega odmerjanja tasimelteona so omejene.
English: The following are adverse reactions that were reported in tasimelteon-treated adult patients, derived from patient trials in 1772 patients treated with tasimelteon.
Slovenian: Preglednica z neželenimi učinki V nadaljevanju so navedeni neželeni učinki, o katerih so poročali pri odraslih bolnikih, zdravljenih s tasimelteonom, iz preskušanj, v katerih je sodelovalo 1772 bolnikov, ki so prejemali tasimelteon.
English: The efficacy of tasimelteon may be reduced in patients with concomitant administration of beta adrenergic receptor antagonists.
Slovenian: Pri bolnikih, ki sočasno uporabljajo antagoniste adrenergičnih receptorjev beta, je lahko zmanjšana učinkovitost tasimelteona.
English: What HETLIOZ looks like and contents of the pack
Slovenian: Izgled zdravila HETLIOZ in vsebina pakiranja
English: The no effect dose (50 mg/kg/day) is approximately 25 times the RHD on a mg/m2 basis.
Slovenian: Odmerek, pri katerem ni učinka (50 mg/kg/dan), je približno 25-krat večji od priporočenega odmerka pri človeku na podlagi mg/m2.
English: Due to the overall inter-subject variability of tasimelteon, this increase is not clinically meaningful and dose adjustment is not recommended.
Slovenian: Zaradi splošne interindividualne variabilnosti tasimelteona ta večja izpostavljenost ni klinično pomembna,