FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose and timing
Croatian: Doza i vrijeme davanja doze
English: An example is fluvoxamine, which is used to treat depression and obsessive compulsive disorder (OCD).
Croatian: Primjer je fluvoksamin koji se koristi za liječenje depresije i opsesivno-kompulzivnog poremećaja (OKP).
English: Each bottle also contains a 1.5-g silica gel desiccant canister and polyester dunnage.
Croatian: Svaka boca također sadržava spremnik s 1,5 g silika gela kao sredstva za sušenje te jastučić od poliestera.
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.
Croatian: U ispitivanju SET bolesnici iz skupine koja je primala tazimelteon imali su na početku ispitivanja prosječno 195 minuta noćnog sna te 137 minuta drijemanja tijekom dana u 25 % najsimptomatskijih noći odnosno dana.
English: There is limited clinical experience with the effects of an overdose of tasimelteon.
Croatian: Ograničeno je kliničko iskustvo u pogledu učinaka predoziranja tazimelteonom.
English: Each hard capsule contains 20 mg tasimelteon.
Croatian: Svaka tvrda kapsula sadrži 20 mg tazimelteona.
English: The effectiveness of tasimelteon to improve clinical global functioning was evaluated in SET.
Croatian: Učinkovitost tazimelteona u poboljšanju kliničke procjene općeg funkcioniranja ocijenjena je u ispitivanju
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.
Croatian: Bolesnici koji pate od poremećaja cirkadijalnog ritma koji ne traje 24 sata i koji su potpuno slijepi ne mogu vidjeti svjetlost, stoga njihovi tjelesni ritmovi nisu usklađeni s 24-satnim ciklusom što za posljedicu ima razdoblja pospanosti tijekom dana i nemogućnost spavanja noću.
English: HETLIOZ hard capsules contain the azo colouring agent Orange Yellow S (E110), which may cause allergic reactions.
Croatian: Tvrde kapsule lijeka HETLIOZ sadrže azo boju Orange Yellow S (E110), koja može uzrokovati alergijske reakcije.
English: There are no or limited amount of data from the use of tasimelteon in pregnant women.
Croatian: Nema podataka ili su podaci o uporabi tazimelteona u trudnica ograničeni.
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.
Croatian: RESET je bilo randomizirano ispitivanje prekida uzimanja lijeka u 20 bolesnika s poremećajem cirkadijanog ritma koji ne traje 24 sata (medijan dobi od 55 godina), osmišljeno u svrhu procjene održavanja djelotvornosti tazimelteona nakon 12 tjedana.
English: Dysguesia
Croatian: Disgeuzija
English: Daytime sleep on 25% most symptomatic days
Croatian: Dnevni san u 25 % najsimptomatskijih dana
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.
Croatian: Clinical Global Impression of Change, CGI-C) odražava opće društveno, profesionalno i zdravstveno funkcioniranje bolesnika, a ocjenjuje se na skali od 7 vrijednosti koju su ispitivači upotrebljavali za ocjenjivanje poboljšanja stanja bolesnika od početne vrijednosti u pogledu simptoma općeg funkcioniranja, a u čijem se središtu nalazi vrijednost Bez promjene (4),.
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.
Croatian: Incidencija tumora jetre u štakora bila je povećana u mužjaka (adenom i karcinom) i ženki (adenom) pri dozi od 100 i 250 mg/kg/dan; incidencija tumora maternice (adenokarcinom endometrija) i maternice i cerviksa (karcinom skvamoznih stanica) bila je povećana pri dozi od 250 mg/kg/dan.
English: Table 1: Summary of Adverse Drug Reactions System Organ Class
Croatian: Tablica 1: Sažetak nuspojava lijeka Klasifikacija organskih sustava
English: CYP1A2 (35.4%) and CYP3A4 (24.3%) are the major enzymes identified to play a role in the metabolism of tasimelteon.
Croatian: CYP1A2 (35,4%) i CYP3A4 (24,3%) su enzimi za koje je utvrđeno da imaju ulogu u metabolizmu tazimelteona.
English: The no effect dose (50 mg/kg/day) is approximately 25 times the RHD on a mg/m2 basis.
Croatian: Doza bez učinaka (50 mg/kg/dan) jest otprilike 25 puta veća od preporučene doze za ljude na bazi mg/m2.
English: Tasimelteon exposure was increased less than two-fold in subjects with moderate hepatic impairment.
Croatian: Izloženost tazimelteonu povećala se manje nego dvostruko u ispitanika s umjerenim oštećenjem funkcije jetre.
English: Store in the original container and keep the bottle tightly closed in order to protect from moisture and light.
Croatian: Čuvati u originalnom spremniku i držati bocu čvrsto zatvorenom radi zaštite od vlage i svjetlosti.
English: If you stop taking HETLIOZ
Croatian: Ako prestanete uzimati HETLIOZ
English: RESET demonstrated the maintenance of entrainment with tasimelteon treatment compared to placebo withdrawal (aMT6s: 90% vs. 20% and cortisol: 80% vs. 20%).
Croatian: Ispitivanjem RESET dokazalo se održavanje usklađenosti uz liječenje tazimelteonom u usporedbi s prekidom uz placebo (aMT6s: 90 % naspram 20 % i kortizol: 80 % naspram 20 %).
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Croatian: 4.1. Terapijske indikacije
English: See leaflet for further information.
Croatian: Vidjeti Uputu o lijeku za više informacija.
English: The most frequently reported adverse reactions were mostly mild to moderate in severity and transient in nature.
Croatian: Najčešće zabilježene nuspojave bile su uglavnom blagog do umjerenog intenziteta te prolazne.
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).
Croatian: 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).
English: Treatment with tasimelteon resulted in a significant improvement, compared with placebo, for all of these endpoints in SET and RESET (see Table 3).
Croatian: Liječenje tazimelteonom u ispitivanjima SET i RESET rezultiralo je znatnim poboljšanjem u odnosu na placebo za sve te mjere ishoda (vidjeti Tablicu 3).
English: - The active substance is tasimelteon.
Croatian: Djelatna tvar je tazimelteon.
English: Patients were treated for approximately 12 weeks with tasimelteon 20 mg one hour prior to bedtime, at the same time every night.
Croatian: Bolesnici su otprilike 12 tjedana liječeni dozom tazimelteona od 20 mg jedan sat prije spavanja, u isto vrijeme svake večeri.
English: In elderly subjects, tasimelteon exposure increased by approximately two-fold compared to non-elderly adults.
Croatian: Izloženost tazimelteonu u starijih ispitanika povećana je oko dva puta u usporedbi s odraslim osobama koje ne pripadaju starijoj populaciji.
English: - To open the bottle, push the cap down and turn counter-clockwise.
Croatian: Za otvaranje boce pritisnite zatvarač prema dolje i okrenite ga u suprotnom smjeru od smjera kazaljke na satu.
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.
Croatian: 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.
English: Keep out of sight and reach of children.
Croatian: I DOHVATA DJECE Čuvati izvan pogleda i dohvata djece.
English: - The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone K17 and titanium dioxide.
Croatian: Bijela tinta za označavanje sadrži šelak, propilenglikol, natrijev hidroksid, povidon K17 i titanijev dioksid.
English: The recommended dosage of HETLIOZ is 20 mg (1 capsule) per day taken one hour before bedtime, at the same time every night.
Croatian: Preporučena doza lijeka HETLIOZ jest 20 mg (1 kapsula) dnevno koja se uzima jedan sat prije spavanja, svake večeri u isto vrijeme.
English: If you forget to take HETLIOZ
Croatian: Ako ste zaboravili uzeti HETLIOZ
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).
Croatian: 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 %).
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.
Croatian: Non-24 Clinical Response Scale, N24CRS), bili su potrebni za klasifikaciju kliničkog odgovora.
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.
Croatian: 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.
English: Strong CYP3A4 inhibitors (e.g. ketoconazole)
Croatian: Jaki CYP3A4 inhibitori (npr. ketokonazol)
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.
Croatian: 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.
English: Smokers (smoking is a moderate CYP1A2 inducer) Tasimelteon exposure decreased by approximately 40% in smokers, compared to non-smokers (see section
Croatian: Pušači (pušenje umjereno inducira enzim CYP1A2) Izloženost tazimelteonu u pušača smanjila se za otprilike 40 % u usporedbi s nepušačima (vidjeti dio 4.5.).
English: Major metabolites had 13-fold or less activity at melatonin receptors compared to tasimelteon.
Croatian: Glavni metaboliti imali su najmanje 13 puta manju aktivnost na receptorima melatonina u usporedbi s tazimelteonom.
English: Daytime sleep time on 25% most symptomatic days (minutes)(3),(4)
Croatian: Dnevni san u 25 % najsimptomatskijih dana (u minutama) (3),(4)
English: There was no apparent relationship between tasimelteon CL/F and renal function, as measured by either estimated creatinine clearance or eGFR.
Croatian: Nije pronađena vidljiva povezanost između oralnog klirensa tazimelteona i funkcije bubrega mjerenjem procijenjenog klirensa kreatinina ili eGFR-a.
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.
Croatian: 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.
English: See section 4.8 for safety information.
Croatian: Za informacije o sigurnosti primjene vidjeti dio 4.8.
English: HETLIOZ hard capsules contain lactose.
Croatian: Tvrde kapsule lijeka HETLIOZ sadrže laktozu.
English: Race Race does not affect apparent clearance of tasimelteon.
Croatian: Rasa ne utječe na prividni klirens tazimelteona.
English: 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).
Croatian: 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).
English: The active substance in HETLIOZ, tasimelteon, is able to act as a time-keeper for the body rhythms and resets them each day.
Croatian: Djelatna tvar prisutna u lijeku HETLIOZ, tazimelteon, održava tjelesne ritmove i svakoga ih dana ponovno pokreće.
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.
Croatian: 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.
English: Timing of sleep (minutes)(1),(3)
Croatian: (u minutama)(3)
English: Medicinal products that inhibit CYP1A2 and CYP3A4 have been shown to alter the metabolism of tasimelteon in vivo.
Croatian: Pokazalo se da lijekovi koji inhibiraju CYP1A2 i CYP3A4 mijenjaju metabolizam tazimelteona in vivo.
English: Tasimelteon acts as a Dual Melatonin Receptor Agonist (DMRA) with selective agonist activity at the MT1 and MT2 receptors.
Croatian: Tazimelteon djeluje kao dvostruki agonist melatoninskih receptora (DMRA) s aktivnošću selektivnog agonista na receptorima MT1 i MT2.
English: Strong CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin and enoxacin)
Croatian: Jaki CYP1A2 inhibitori (npr. fluvoksamin, ciprofloksacin i enoksacin)
English: No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre (vidjeti dio 5.2.).
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).
Croatian: Ako bolesnici jedu obrok s visokim udjelom masti, preporučuje se pričekati najmanje 2 sata prije uzimanja lijeka HETLIOZ (vidjeti dio 5.2.).
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.
Croatian: 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
English: The peak concentration (Tmax) of tasimelteon occurred approximately 0.5 hours after fasted oral administration.
Croatian: Vršna koncentracija (Tmaks.) tazimelteona postignuta je otprilike 0,5 sati nakon davanja lijeka oralnim putem natašte.
English: Therefore, no dose adjustment is needed in patients with mild or moderate hepatic impairment.
Croatian: Stoga nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre.
English: HETLIOZ contains Orange Yellow S (E110)
Croatian: HETLIOZ sadrži boju Orange Yellow S (E110)
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
Croatian: 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
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.
Croatian: 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.
English: Strong CYP3A4 inducers (e.g. rifampin)
Croatian: Jaki CYP3A4 induktori (npr. rifampicin)
English: Dark blue opaque, hard capsule marked with “VANDA 20 mg” in white ink.
Croatian: Tamnoplava neprozirna tvrda kapsula označena bijelom tintom oznakom „VANDA 20 mg”.
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.
Croatian: 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).
English: It is used to treat Non-24-Hour Sleep-Wake Disorder (Non-24) in adults who are totally blind.
Croatian: Koristi se za liječenje poremećaja cirkadijanog ritma budnosti i spavanja koji ne traje 24 sata, kod odraslih osoba koje su potpuno slijepe.
English: Contains lactose and Orange Yellow S (E110).
Croatian: Sadrži laktozu i boju Orange Yellow S (E110).
English: Aspartate aminotransferase increased, gamma-glutamyl transferase increased
Croatian: Povišene vrijednosti aspartat aminotransferaze, povišene vrijednosti gamaglutamiltransferaze
English: HETLIOZ 20 mg hard capsules tasimelteon
Croatian: HETLIOZ 20 mg tvrde kapsule tazimelteon
English: - The other ingredients are lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate.
Croatian: Ostali su sastojci bezvodna laktoza, mikrokristalična celuloza, umrežena karmelozanatrij, koloidni silicijev dioksid i magnezijev stearat.
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.
Croatian: Najzastupljeniji metaboliti tazimelteona pokazuju manje od jedne desetine afiniteta vezanja ishodišne molekule i za receptore MT1 i receptore MT2.
English: - medicines known to reduce the activity of an enzyme called ‘CYP2C19'.
Croatian: - lijekove koji smanjuju aktivnost enzima pod nazivom „CYP2C19”.
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.
Croatian: CYP1A2 i CYP3A4 su enzimi za koje je utvrđeno da imaju ulogu u metabolizmu tazimelteona, dok manju ulogu ima CYP2C9/C19.
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).
Croatian: 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).
English: HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
Croatian: HETLIOZ je indiciran za liječenje poremećaja cirkadijalnog ritma budnosti i spavanja koji ne traje 24 sata, u potpuno slijepih odraslih osoba.
English: Tasimelteon exhibits a greater affinity for the MT2 as compared to the MT1 receptor.
Croatian: Tazimelteon pokazuje veći afinitet za receptore MT2 u odnosu na receptore MT1.
English: HETLIOZ contains lactose
Croatian: HETLIOZ sadrži laktozu
English: HETLIOZ 20 mg hard capsules
Croatian: HETLIOZ 20 mg tvrde kapsule
English: - medicines called “beta blockers” used to treat high blood pressure and other heart problems.
Croatian: 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.
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.
Croatian: Ispitivanjima SET i RESET ocijenjeno je trajanje i vrijeme nastupa noćnog sna i dnevnih drijemanja putem dnevnika koje su vodili bolesnici.
English: Tasimelteon functions as a DMRA at the MT1 and MT2 receptors.
Croatian: Tazimelteon djeluje kao DMRA na receptorima MT1 i MT2.
English: No dose adjustment is necessary for patients with renal impairment.
Croatian: Nije potrebna prilagodba doze za bolesnike s oštećenjem funkcije bubrega.
English: HETLIOZ contains lactose.
Croatian: HETLIOZ sadrži laktozu.
English: HETLIOZ contains Orange Yellow S (E110) which may cause allergic reactions.
Croatian: Yellow S (E110) koja može izazvati alergijske reakcije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 30-COUNT BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BOCU KOJA SADRŽI 30 TABLETA
English: Dyspepsia, nausea, dry mouth
Croatian: Dispepsija, mučnina,
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
Croatian: - neobičan okus ili promjena okusa - krvne pretrage koje pokazuju promjene u načinu rada jetre (aspartat aminotransferaza i gama glutamiltransferaza)
English: Renal impairment No dose adjustment is recommended for patients with renal impairment (see section 5.2).
Croatian: Ne preporuča se prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2.).
English: - medicines known to reduce the activity of an enzyme called ‘CYP3A4'.
Croatian: - lijekove koji smanjuju aktivnost enzima pod nazivom „CYP3A4”.
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
Croatian: 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.