natgillin/translations-raw huggingface dataset:
CYP1A2 (35.4%) and CYP3A4 (24.3%) are the major enzymes identified to play a role in the metabolism of tasimelteon.
CYP1A2 (35,4%) i CYP3A4 (24,3%) su enzimi za koje je utvrđeno da imaju ulogu u metabolizmu tazimelteona.
The no effect dose (50 mg/kg/day) is approximately 25 times the RHD on a mg/m2 basis.
Doza bez učinaka (50 mg/kg/dan) jest otprilike 25 puta veća od preporučene doze za ljude na bazi mg/m2.
Tasimelteon exposure was increased less than two-fold in subjects with moderate hepatic impairment.
Izloženost tazimelteonu povećala se manje nego dvostruko u ispitanika s umjerenim oštećenjem funkcije jetre.
Store in the original container and keep the bottle tightly closed in order to protect from moisture and light.
Čuvati u originalnom spremniku i držati bocu čvrsto zatvorenom radi zaštite od vlage i svjetlosti.
If you stop taking HETLIOZ
Ako prestanete uzimati HETLIOZ
RESET demonstrated the maintenance of entrainment with tasimelteon treatment compared to placebo withdrawal (aMT6s: 90% vs. 20% and cortisol: 80% vs. 20%).
Ispitivanjem RESET dokazalo se održavanje usklađenosti uz liječenje tazimelteonom u usporedbi s prekidom uz placebo (aMT6s: 90 % naspram 20 % i kortizol: 80 % naspram 20 %).
CLINICAL PARTICULARS 4.1 Therapeutic indications
4.1. Terapijske indikacije
See leaflet for further information.
Vidjeti Uputu o lijeku za više informacija.
The most frequently reported adverse reactions were mostly mild to moderate in severity and transient in nature.
Najčešće zabilježene nuspojave bile su uglavnom blagog do umjerenog intenziteta te prolazne.
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).
Treba izbjegavati primjenu tazimelteona u kombinaciji s rifampicinom ili drugim CYP3A4 induktorima zbog mogućeg velikog smanjenja izloženosti tazimelteonu sa smanjenom djelotvornosti: izloženost tazimelteonu smanjila se za otprilike 90 % kad je primijenjen istodobno s rifampicinom od 600 mg (nakon 11 dana uzimanja rifampicina od 600 mg dnevno).
Treatment with tasimelteon resulted in a significant improvement, compared with placebo, for all of these endpoints in SET and RESET (see Table 3).
Liječenje tazimelteonom u ispitivanjima SET i RESET rezultiralo je znatnim poboljšanjem u odnosu na placebo za sve te mjere ishoda (vidjeti Tablicu 3).
- The active substance is tasimelteon.
Djelatna tvar je tazimelteon.
Patients were treated for approximately 12 weeks with tasimelteon 20 mg one hour prior to bedtime, at the same time every night.
Bolesnici su otprilike 12 tjedana liječeni dozom tazimelteona od 20 mg jedan sat prije spavanja, u isto vrijeme svake večeri.
In elderly subjects, tasimelteon exposure increased by approximately two-fold compared to non-elderly adults.
Izloženost tazimelteonu u starijih ispitanika povećana je oko dva puta u usporedbi s odraslim osobama koje ne pripadaju starijoj populaciji.
- To open the bottle, push the cap down and turn counter-clockwise.
Za otvaranje boce pritisnite zatvarač prema dolje i okrenite ga u suprotnom smjeru od smjera kazaljke na satu.
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.
U miševa nije primijećen kancerogeni potencijal; najviša ispitana doza jest otprilike 75 puta veća od preporučene doze za ljude od 20 mg/dan na bazi mg/m2.
Keep out of sight and reach of children.
I DOHVATA DJECE Čuvati izvan pogleda i dohvata djece.
- The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone K17 and titanium dioxide.
Bijela tinta za označavanje sadrži šelak, propilenglikol, natrijev hidroksid, povidon K17 i titanijev dioksid.
The recommended dosage of HETLIOZ is 20 mg (1 capsule) per day taken one hour before bedtime, at the same time every night.
Preporučena doza lijeka HETLIOZ jest 20 mg (1 kapsula) dnevno koja se uzima jedan sat prije spavanja, svake večeri u isto vrijeme.
If you forget to take HETLIOZ
Ako ste zaboravili uzeti HETLIOZ
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).
U ispitivanju SET tazimelteon je uskladio cirkadijalni ritam tazimelu prvom mjesecu u znatno većoj mjeri nego placebo, mjereno prema aMT6s i kortizolu (20 % naspram 2,6 % te 17,5 % naspram 2,6 %).
Entrainment plus a score ≥3 on this scale, called Non-24 Clinical Response Scale (N24CRS) was required to be classified as a clinical responder.
Non-24 Clinical Response Scale, N24CRS), bili su potrebni za klasifikaciju kliničkog odgovora.
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.
Oba su ispitivanja dokazala sposobnost tazimelteona da uskladi ritam glavnog tjelesnog sata u bolesnika s poremećajem cirkadijalnog ritma koji ne traje 24 sata, a ispitivanje RESET pokazalo je da je kontinuirano dnevno doziranje tazimelteona nužno za održavanje usklađenog ritma.
Strong CYP3A4 inhibitors (e.g. ketoconazole)
Jaki CYP3A4 inhibitori (npr. ketokonazol)
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.
U ispitivanjima provedenima na životinjama primjena tazimelteona tijekom trudnoće rezultirala je razvojnom toksičnošću (embriofetalnom smrtnošću, neurobihevioralnim poremećajem te smanjenim rastom i razvojem potomaka) kod uzimanja doza većih od onih koje se upotrebljavaju klinički.
Smokers (smoking is a moderate CYP1A2 inducer) Tasimelteon exposure decreased by approximately 40% in smokers, compared to non-smokers (see section
Pušači (pušenje umjereno inducira enzim CYP1A2) Izloženost tazimelteonu u pušača smanjila se za otprilike 40 % u usporedbi s nepušačima (vidjeti dio 4.5.).
Major metabolites had 13-fold or less activity at melatonin receptors compared to tasimelteon.
Glavni metaboliti imali su najmanje 13 puta manju aktivnost na receptorima melatonina u usporedbi s tazimelteonom.
Daytime sleep time on 25% most symptomatic days (minutes)(3),(4)
Dnevni san u 25 % najsimptomatskijih dana (u minutama) (3),(4)
There was no apparent relationship between tasimelteon CL/F and renal function, as measured by either estimated creatinine clearance or eGFR.
Nije pronađena vidljiva povezanost između oralnog klirensa tazimelteona i funkcije bubrega mjerenjem procijenjenog klirensa kreatinina ili eGFR-a.
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.
HETLIOZ nije ispitivan na bolesnicima s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) i stoga se preporuča oprez prilikom propisivanja lijeka HETLIOZ bolesnicima s teškim oštećenjem funkcije jetre.
See section 4.8 for safety information.
Za informacije o sigurnosti primjene vidjeti dio 4.8.
HETLIOZ hard capsules contain lactose.
Tvrde kapsule lijeka HETLIOZ sadrže laktozu.
Race Race does not affect apparent clearance of tasimelteon.
Rasa ne utječe na prividni klirens tazimelteona.
In pregnant rabbits administered tasimelteon during the period of organogenesis, embryolethality and embryofoetal toxicity (reduced foetal body weight and delayed ossification) were observed at the highest dose tested (200 mg/kg/day).
U gravidnih kunića koji su tijekom organogeneze primali tazimelteon, smrtnost embrija i embriofetalna toksičnost (smanjena tjelesna težina fetusa i zakašnjela osifikacija) primijećene su pri najvišoj ispitanoj dozi (200 mg/kg/dan).
The active substance in HETLIOZ, tasimelteon, is able to act as a time-keeper for the body rhythms and resets them each day.
Djelatna tvar prisutna u lijeku HETLIOZ, tazimelteon, održava tjelesne ritmove i svakoga ih dana ponovno pokreće.
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.
Peroralno davanje tazimelteona štakorima u razdoblju organogeneze i laktacije rezultiralo je trajnim smanjenjima tjelesne težine, zakašnjelim spolnim sazrijevanjem i fizičkim razvojem, neurobihevioralnim oštećenjem u mladunaca u najvišoj ispitanoj dozi te smanjenom tjelesnom težinom u mladunaca u srednjoj ispitanoj dozi.
Timing of sleep (minutes)(1),(3)
(u minutama)(3)
Medicinal products that inhibit CYP1A2 and CYP3A4 have been shown to alter the metabolism of tasimelteon in vivo.
Pokazalo se da lijekovi koji inhibiraju CYP1A2 i CYP3A4 mijenjaju metabolizam tazimelteona in vivo.
Tasimelteon acts as a Dual Melatonin Receptor Agonist (DMRA) with selective agonist activity at the MT1 and MT2 receptors.
Tazimelteon djeluje kao dvostruki agonist melatoninskih receptora (DMRA) s aktivnošću selektivnog agonista na receptorima MT1 i MT2.
Strong CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin and enoxacin)
Jaki CYP1A2 inhibitori (npr. fluvoksamin, ciprofloksacin i enoksacin)
No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2).
Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre (vidjeti dio 5.2.).
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).
Ako bolesnici jedu obrok s visokim udjelom masti, preporučuje se pričekati najmanje 2 sata prije uzimanja lijeka HETLIOZ (vidjeti dio 5.2.).
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.
Farmakokinetički profil doze tazimelteona od 20 mg uspoređen je među 8 ispitanika s teškim oštećenjem funkcije bubrega (procijenjena stopa glomerularne filtracije [eGFR] ≤ 29 mL/min/1,73 m2), 8 ispitanika sa završnim stadijem bolesti bubrega (GFR < 15 mL/min/1,73 m2) kojima je potrebna hemodijaliza, te 16
The peak concentration (Tmax) of tasimelteon occurred approximately 0.5 hours after fasted oral administration.
Vršna koncentracija (Tmaks.) tazimelteona postignuta je otprilike 0,5 sati nakon davanja lijeka oralnim putem natašte.
Therefore, no dose adjustment is needed in patients with mild or moderate hepatic impairment.
Stoga nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre.
HETLIOZ contains Orange Yellow S (E110)
HETLIOZ sadrži boju Orange Yellow S (E110)
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
Potreban je oprez prilikom primjene lijeka HETLIOZ u kombinaciji s rifampicinom ili drugim CYP3A4 induktorima zbog mogućeg velikog smanjenja izloženosti tazimelteonu i smanjene djelotvornosti (vidjeti dio
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.
U ispitivanju SET 84 bolesnika s poremećajem cirkadijalnog ritma koji ne traje 24 sata (medijan dobi od 54 godine) randomizirana su u skupine koje su primale tazimelteon od 20 mg ili placebo, jedan sat prije spavanja, u isto vrijeme svake večeri najviše 6 mjeseci.
Strong CYP3A4 inducers (e.g. rifampin)
Jaki CYP3A4 induktori (npr. rifampicin)
Dark blue opaque, hard capsule marked with “VANDA 20 mg” in white ink.
Tamnoplava neprozirna tvrda kapsula označena bijelom tintom oznakom „VANDA 20 mg”.
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.
U ispitivanju u kojem je sudjelovalo 28 zdravih dobrovoljaca, uz dozu tazimelteona od 20 mg istodobno je primijenjena i jedna doza etanola (0,6 g/kg za žene i 0,7 g/kg za muškarce).
It is used to treat Non-24-Hour Sleep-Wake Disorder (Non-24) in adults who are totally blind.
Koristi se za liječenje poremećaja cirkadijanog ritma budnosti i spavanja koji ne traje 24 sata, kod odraslih osoba koje su potpuno slijepe.
Contains lactose and Orange Yellow S (E110).
Sadrži laktozu i boju Orange Yellow S (E110).
Aspartate aminotransferase increased, gamma-glutamyl transferase increased
Povišene vrijednosti aspartat aminotransferaze, povišene vrijednosti gamaglutamiltransferaze
HETLIOZ 20 mg hard capsules tasimelteon
HETLIOZ 20 mg tvrde kapsule tazimelteon
- The other ingredients are lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate.
Ostali su sastojci bezvodna laktoza, mikrokristalična celuloza, umrežena karmelozanatrij, koloidni silicijev dioksid i magnezijev stearat.
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.
Najzastupljeniji metaboliti tazimelteona pokazuju manje od jedne desetine afiniteta vezanja ishodišne molekule i za receptore MT1 i receptore MT2.
- medicines known to reduce the activity of an enzyme called ‘CYP2C19'.
- lijekove koji smanjuju aktivnost enzima pod nazivom „CYP2C19”.
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.
CYP1A2 i CYP3A4 su enzimi za koje je utvrđeno da imaju ulogu u metabolizmu tazimelteona, dok manju ulogu ima CYP2C9/C19.
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).
Odgovor u mjerama kliničke procjene općeg funkcioniranja Bolesnicima liječenima tazimelteonom općenito se poboljšala klinička procjena općeg funkcioniranja (rezultat CGI-C = 2,6) u usporedbi s bolesnicima liječenima placebom, u kojih nije bilo vidljivog poboljšanja (rezultat CGI-C = 3,4) u usporedbi s težinom poremećaja cirkadijanog ritma koji ne traje 24 sata na početku ispitivanja (srednja vrijednost razlike dobivena metodom najmanjih kvadrata = -0,8; p = 0,0093) (Tablica 4).
HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
HETLIOZ je indiciran za liječenje poremećaja cirkadijalnog ritma budnosti i spavanja koji ne traje 24 sata, u potpuno slijepih odraslih osoba.
Tasimelteon exhibits a greater affinity for the MT2 as compared to the MT1 receptor.
Tazimelteon pokazuje veći afinitet za receptore MT2 u odnosu na receptore MT1.
HETLIOZ contains lactose
HETLIOZ sadrži laktozu
HETLIOZ 20 mg hard capsules
HETLIOZ 20 mg tvrde kapsule
- medicines called “beta blockers” used to treat high blood pressure and other heart problems.
Primjer je omeprazol koji se upotrebljava za liječenje žgaravice i gastroezofagealne refluksne bolesti (GERB). - lijekove koji se nazivaju „beta blokatori”, a koriste se za liječenje visokog krvnog tlaka i ostalih srčanih problema.
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.
Ispitivanjima SET i RESET ocijenjeno je trajanje i vrijeme nastupa noćnog sna i dnevnih drijemanja putem dnevnika koje su vodili bolesnici.
Tasimelteon functions as a DMRA at the MT1 and MT2 receptors.
Tazimelteon djeluje kao DMRA na receptorima MT1 i MT2.
No dose adjustment is necessary for patients with renal impairment.
Nije potrebna prilagodba doze za bolesnike s oštećenjem funkcije bubrega.
HETLIOZ contains lactose.
HETLIOZ sadrži laktozu.
HETLIOZ contains Orange Yellow S (E110) which may cause allergic reactions.
Yellow S (E110) koja može izazvati alergijske reakcije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 30-COUNT BOTTLE
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BOCU KOJA SADRŽI 30 TABLETA
Dyspepsia, nausea, dry mouth
Dispepsija, mučnina,
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
- neobičan okus ili promjena okusa - krvne pretrage koje pokazuju promjene u načinu rada jetre (aspartat aminotransferaza i gama glutamiltransferaza)
Renal impairment No dose adjustment is recommended for patients with renal impairment (see section 5.2).
Ne preporuča se prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2.).
- medicines known to reduce the activity of an enzyme called ‘CYP3A4'.
- lijekove koji smanjuju aktivnost enzima pod nazivom „CYP3A4”.
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
Farmakokinetički profil doze tazimelteona od 20 mg tazimeluspoređen je među 8 ispitanika s blagim oštećenjem funkcije jetre (Child-Pugh rezultat ≥ 5 i ≤ 6 bodova), 8 ispitanika s umjerenim oštećenjem funkcije jetre (Child-Pugh rezultat ≥ 7 i ≤ 9 bodova) te 13 zdravih odgovarajućih kontrola.
Caution should be used when administering tasimelteon in combination with fluvoxamine or other strong CYP1A2 inhibitors such as ciprofloxacin and enoxacin because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions: the AUC0-inf and Cmax of tasimelteon increased by 7-fold and 2-fold, respectively, when co-administered with fluvoxamine 50 mg (after 6 days of fluvoxamine 50 mg per day).
inhibitorima kao što su ciprofloksacin i enoksacin zbog mogućeg velikog povećanja izloženosti tazimelteonu i većeg rizika od nuspojava: AUC0-inf povećao se 7 puta, a Cmax tazimelteona 2 puta kada su primijenjeni istodobno s fluvoksaminom od 50 mg (nakon 6 dana uzimanja fluvoksamina od 50 mg dnevno).
It may harm them, even if their signs of illness are the same as yours.
Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki vašima.
HETLIOZ hard capsules are opaque dark blue printed with “VANDA 20 mg” in white.
HETLIOZ tvrde kapsule neprozirne su i tamnoplave boje označene bijelom tintom oznakom „VANDA 20 mg”.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR 30-COUNT BOTTLE
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA ZA BOCU KOJA SADRŽI 30 TABLETA
Date of first authorisation: 3 July 2015
Datum prvog odobrenja:
Package leaflet: Information for the patient HETLIOZ 20 mg hard capsules
Uputa o lijeku: Informacija za bolesnika HETLIOZ 20 mg tvrde kapsule tazimelteon
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).
Učinkovitost tazimelteona u liječenju kliničkih simptoma, uključujući cirkadijani ciklus budnosti i spavanja i kliničku procjenu općeg funkcioniranja u bolesnika s poremećajem cirkadijalnog ritma koji ne traje 24 sata, utvrđena je ispitivanjima SET i RESET (Tablica 3).
SET Study Clinical response (Entrainment + N24CRS
Klinički odgovor (usklađivanje + N24CRS N24CRS ≥ 3(2)
How to take HETLIOZ
Kako uzimati HETLIOZ
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.
Klinička djelotvornost i sigurnost Učinkovitost tazimelteona u liječenju poremećaja cirkadijanog ritma budnosti i spavanja koji ne traje 24 sata utvrđena je u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja s usporednim skupinama (SET i RESET) na potpuno slijepim bolesnicima s poremećajem cirkadijalnog ritma koji ne traje
Hard capsule shell Gelatin
Ovojnica tvrde kapsule Želatina
> 45 min improvement in both nighttime and daytime sleep (%)(5)
> 45-minutno poboljšanje u noćnom i dnevnom snu (%)(5) Vrijeme nastupa sna (u minutama)(1),(3) Ispitivanje RESET
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).
CYP1A2 inhibitorima, naročito onima koji inhibiraju i druge enzime uključene u klirensu lijeka HETLIOZ zbog mogućeg velikog povećanja izloženosti tazimelteonu i većeg rizika od nuspojava (vidjeti dio 4.5.).
Hard capsule core Lactose anhydrous Microcrystalline cellulose Croscarmellose sodium Silica, colloidal anhydrous Magnesium sterate
Umrežena karmelozanatrij Silicijev dioksid, koloidni bezvodni Magnezijev stearat
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
- mučnina u želucu - krvne pretrage koje pokazuju promjene u načinu rada jetre (alanin aminotransferaza) - neobični snovi
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.
Pri terapijskim koncentracijama, tazimelteon se veže za bjelančevine otprilike 88,6 - 90,1 %.
RESET Study
Ispitivanje SET
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Prilogu V.
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.
Tazimelteon nije ispitan u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C); stoga je pri propisivanju lijeka
Pollakiuria
Propilenglikol
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.
koje su otprilike 10 puta više od preporučene doze za ljude na bazi mg/m2.
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).
Smatra se da je to još važnije za jake CYP1A2 inhibitore koji inhibiraju i druge enzime uključene u klirensu lijeka
How HETLIOZ works
Kako djeluje HETLIOZ
How to store HETLIOZ
Kako čuvati HETLIOZ
Effects of Tasimelteon 20 mg Treatment on Clinical Response in Non-24 Tasimelteon 20 mg Placebo
Tablica 3: Učinak liječenja tazimelteonom u dozi od 20 mg na klinički odgovor bolesnika s poremećajem cirkadijanog ritma koji ne traje 24 sata
Taking HETLIOZ
Uzimanje lijeka HETLIOZ
This includes: - medicines known to reduce the activity of an enzyme called ‘CYP1A2'.
- lijekove koji smanjuju aktivnost enzima pod nazivom „CYP1A2”.
HETLIOZ contains the active substance tasimelteon.
HETLIOZ sadrži djelatnu tvar tazimelteon.