FrancophonIA/ELRC3.0 huggingface dataset:
English: Zinbryta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with any other DMT is contraindicated or otherwise unsuitable (see section 4.4).
Maltese: Zinbryta hu indikat għall-kura ta' pazjenti adulti b'sklerożi multipla li tirkadi u tbatti li kellhom rispons inadegwat għal mill-inqas żewġ terapiji li jimmodifikw il-marda (DMTs, disease modifying therapies) u li għalihom it-trattament b'kwalunkwe DMT ieħor hu kontraindikat jew inkella mhux adattat (ara sezzjoni 4.4).
English: In addition, there was a statistically significant effect on 24 week confirmed disability progression in Zinbryta treated patients with a hazard ratio 0.24 [95% CI: 0.09, 0.63].
Maltese: Barra minn hekk, kien hemm effett statistikament sinifikanti fuq il-progressjoni tal-marda kkonfermata sostnuta għal mill-inqas 24 ġimgħa f'pazjenti kkurati b'Zinbryta bi proporzjon ta' periklu ta' 0.24 [95% CI: 0.09, 0.63]. Id-doża ta' 300 mg ma pprovdietx benefiċċju addizzjonali fuq id-doża ta' 150 mg.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 150 mg of daclizumab in 1 mL Each pre-filled pen contains 150 mg of daclizumab in 1 mL
Maltese: Kull pinna mimlija għal-lest fiha siringa mimlija għal-lest, li fiha 150 mg ta' daclizumab f' 1 mL ta' soluzzjoni għall-injezzjoni.
English: Very common
Maltese: rikombinanti.
English: Zinbryta is for subcutaneous use.
Maltese: Zinbryta jiġi injettat kull xahar.
English: Detailed instructions for injecting Zinbryta are given in section 7, Instructions for injecting Zinbryta.
Maltese: 7, Istruzzjonijiet biex tinjetta Zinbryta.
English: If a patient develops clinical signs or symptoms suggestive of hepatic dysfunction (e.g. unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine), it is recommended to promptly measure serum transaminases, discontinue treatment with Zinbryta, as appropriate, and promptly refer the patient to a hepatologist.
Maltese: Il-pazjenti għandhom jiġu infurmati dwar ir-riskju ta' ħsara fil-fwied, il-ħtieġa għal monitoraġġ perjodiku, u jiġu mwissija dwar sinjali jew sintomi li jissuġġerixxu disfunzjoni tal-fwied.Jekk pazjent jiżviluppa sinjali jew sintomi kliniċi li jissuġġerixxu disfunzjoni epatika (eż., dardir inspegabbli, rimettar, uġigħ addominali, għeja, anoreksja, jew suffejra u/jew awrina skura), hu rakkomandat li tkejjel fil-pront it-transaminases fis-serum, twaqqaf il-kura b'Zinbryta, kif xieraq, u tirreferi l-pazjent immedjatament għand epatoloġista.
English: 1 pre-filled pen.
Maltese: Tagħmlux fil-friża.
English: Expiry Date
Maltese: DATA TA ' SKADENZA
English: If you are over 55 your doctor may still prescribe Zinbryta.
Maltese: Jekk għandek aktar minn 55 sena, it-tabib tiegħek jista' xorta jagħtik riċetta għal Zinbryta.
English: The MAH shall ensure that in each EU MS where Zinbryta is marketed, all prescribers are provided with an educational package, aiming at preventing and/or minimising the risk of serious hepatic injury (potentially life threatening or fatal) and informing the patients about the unpredictability of these events and containing the following elements:
Maltese: L-MAH għandu jiżgura li f'kull Stat Membru tal-UE fejn Zinbryta jitpoġġa fis-suq, il-persuni kollha li jagħtu riċetta għandhom jiġu pprovduti b'pakkett edukattiv, li għandu l-għan li jipprevjeni u/jew jimminimizza r-riskju ta' ħsara serja tal-fwied (potenzjalment ta' theddida għall-ħajja jew fatali), u li jinforma lill-pazjenti dwar l-imprevedibbiltà ta' dawn l-avvenimenti u li jkun fih l-elementi li ġejjin:
English: Key effects of this IL-2 pathway modulation potentially related to the therapeutic effects of daclizumab in MS include selective antagonism of activated T-cell responses, and expansion of immunoregulatory CD56bright natural killer (NK) cells, which have been shown to selectively decrease activated T-cells.
Maltese: (NK - natural killer) CD56bright immunoregulatorji, li ntwera li jnaqqsu b'mod selettiv ċelluli T attivati.
English: Hepatic injury
Maltese: • Tkun skaduta.
English: Additional supplies which are not included in the pack (See Figure B):
Maltese: Provvisti addizzjonali li mhumiex inklużi fil-pakkett (ara Figura B):
English: # Hazard ratio for the risk of relapse.
Maltese: *Tnaqqis relattiv fir-riskju ta' rikaduta
English: NAME OF THE MEDICINAL PRODUCT Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen daclizumab
Maltese: Informazzjoni għall-utent Zinbryta 150 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: The Hepatic Risk Management Guide for Physicians should inform HCPs about:
Maltese: Tużax din il-mediċina jekk tinnota li:
English: Supplies needed for your Zinbryta injection • Zinbryta pre-filled syringe
Maltese: Provvisti meħtieġa għall-injezzjoni tal-Pinna Zinbryta
English: In two 9 month studies conducted in cynomolgus monkeys daclizumab was subcutaneously administered at bi-weekly doses of 10-200 mg/kg.
Maltese: F'żewġ studji li damu 9 xhur, li saru fuq xadini cynomolgus, daclizumab ingħata taħt il-ġilda f'dożi kull ġimagħtejn ta' 10-200 mg/kg.
English: Seborrhoeic dermatitis†
Maltese: Il-ġilda titqaxxar
English: Folliculitis
Maltese: Pożoloġija
English: • stomach pain
Maltese: • demm fl-ippurgar
English: Zinbryta should be administered with caution to patients with previous or current depressive disorders.
Maltese: Zinbryta għandu jingħata b'kawtela lill-pazjenti b'disturbi depressivi fil-passat jew kurrenti.
English: Total NK cell counts increased approximately 1.5-fold as a result of the change in CD56bright NK cells.
Maltese: żdied b'madwar 1.5 darbiet b'riżultat tal-bidla fiċ-ċelluli CD56bright NK. Effikaċja klinika u sigurtà
English: Percentage of patients relapse-free Hazard ratio* [95% CI]
Maltese: MRI scans ta' kull xahar) Proporzjon tal-medja leżjoni[95% CI]
English: In MS, the body's immune system causes inflammation which damages the protective sheath (called myelin) around the nerves in the central nervous system (including the brain and spinal cord).
Maltese: Fil-marda tal-MS, is-sistema immuni tal-ġisem tikkawża infjammazzjoni li tagħmel ħsara lis-saff protettiv (imsejjaħ myelin) li hemm madwar in-nervaturi fis-sistema nervuża ċentrali (li tinkludi l moħħ u s-sinsla tad-dahar).
English: • If needed, Zinbryta may be stored in the closed original carton without refrigeration up to 30°C for up to 30 days.
Maltese: • Jekk ikun meħtieġ, Zinbryta jista' jinħażen fil-kartuna oriġinali magħluqa mingħajr refriġerazzjoni f'temperatura sa 30°C għal sa 30 jum.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zinbryta 150 mg injection daclizumab
Maltese: Il-prodott mediċinali m'għandux jintuża jekk:
English: Clinical endpoints Number of patients Annualised relapse rate Rate ratio [95% CI]
Maltese: Numru ta ' pazjenti Rata ta' rikaduti annwalizzata* Proporzjon tar-rata * [95% CI]
English: Zinbryta has had very little testing in people older than 55 years old.
Maltese: Sar ftit ħafna ttestjar b'Zinbryta f'nies li jkollhom aktar minn 55 sena.
English: Pull the pen cap straight off and set it aside (See Figure E).
Maltese: Iġbed l-għatu tal-pinna dritt 'il fuq u poġġih fil-ġenb (Ara Figura E).
English: • skin rashes, including inflamed, irritated, itchy, dry or peeling skin (dermatitis, eczema,
Maltese: (dermatite, ekżema, psorjasi)
English: • the syringe/pen is cracked or broken
Maltese: • is-siringa/pinna tkun imxaqqa jew miksura
English: *Hazard ratio for the risk of relapse #MRI analyses used evaluable dataset for each endpoint; T1 Gd-enhancing: MRI intensive population
Maltese: T1 jidhru aħjar bil-Gd : popolazzjoni b‘MRI intensiv
English: Following subcutaneous administration of daclizumab 150 mg every 4 weeks, steady-state serum daclizumab concentrations were achieved by the 4th dose and daclizumab accumulated to a level approximately 2.5-fold compared to a single dose.
Maltese: Wara l-għoti taħt il-ġilda ta' daclizumab 150 mg kull 4 ġimgħat, il-konċentrazzjonijiet ta' daclizumab serum fl-istat fiss inkisbu sar-4 doża, u daclizumab akkumula għal livell ta' madwar 2.5 darbiet meta mqabbel ma' doża waħda.
English: psoriasis)
Maltese: (medja)
English: 48155 Münster Germany
Maltese: 48155 Münster
English: 30 hard capsules
Maltese: 30 kapsula iebsa
English: See section 4.8 for safety information.
Maltese: Ara sezzjoni 4.8 għal informazzjoni dwar is-sigurtà.
English: Alanine aminotransferase increased
Maltese: Żieda f'alanine aminotransferase
English: Timing of sleep (minutes)(1),(3)
Maltese: Ħin tal-irqad (minuti)(1),(3)
English: CGI-C (LS mean)
Maltese: CGI-C (LS medju)
English: Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
Maltese: (>1/100 sa <1/10), Mhux komuni (>1/1,000 sa <1/100), Rari (>1/10,000 sa <1/1,000), Rari ħafna
English: SET Study Clinical response (Entrainment + N24CRS
Maltese: Studju SET Rispons kliniku (Regolazzjoni + N24CRS
English: Reproductive toxicology
Maltese: Tossiċità riproduttiva
English: Hard capsule core Lactose anhydrous Microcrystalline cellulose Croscarmellose sodium Silica, colloidal anhydrous Magnesium sterate
Maltese: Qalba tal-kapsula iebsa Lactose anhydrous Microcrystalline cellulose Croscarmellose sodium Silica, colloidal anhydrous Magnesium sterate
English: Difference p-value
Maltese: Differenza valur-p
English: Aspartate aminotransferase increased, gamma-glutamyl transferase increased
Maltese: Żieda fl-aspartate aminotransferase, żieda fil gamma-glutamyl transferase
English: The size of the capsule is ‘size 1' (dimensions 19.4 x 6.9 mm).
Maltese: Id-daqs tal-kapsula huwa ‘daqs 1' (dimensjonijiet 19.4
English: The mean absolute oral bioavailability of tasimelteon is 38%.
Maltese: Il-bijodisponibbilità orali assoluta medja ta' tasimelteon hija 38%.
English: Tasimelteon is extensively metabolised.
Maltese: Tasimelteon jiġi metabolizzat b'mod estensiv.
English: Beta blockers
Maltese: Imblokkaturi beta
English: Placebo p-value
Maltese: Plaċebo valur-p
English: Table 1: Summary of Adverse Drug Reactions System Organ Class
Maltese: Tabella 1: Sommarju tar-Reazzjonijiet Avversi tal-Mediċini Sistema talKlassifika tal-Organi
English: CYP2C9 (18.8%) and CYP2C19 (15.1%) also contribute to the metabolism of tasimelteon.
Maltese: CYP2C9 (18.8%) u CYP2C19 (15.
English: CYP1A2 (35.4%) and CYP3A4 (24.3%) are the major enzymes identified to play a role in the metabolism of tasimelteon.
Maltese: CYP1A2 (35,4%) u CYP3A4 (24,3%) huma enzimi identifikati li għandhom rwol fil-metaboliżmu ta' tasimelteon.
English: Some examples include atenolol, metoprolol, and propanolol.
Maltese: Xi eżempji jinkludu atenolol, metoprolol, u propanolol.
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.
Maltese: Il-profil farmakokinetiku ta' doża ta' 20 mg ta' tasimelteon ġie mqabbel fost 8 suġġetti b'indeboliment renali sever (rata stmata ta' filtrazzjoni glomerulari \[eGFR] ≤ 29 mL/min/1.73m2), 8 suġġetti b'mard renali flaħħar stadju (ESRD) (GFR < 15 mL/min/1.73m2) li jeħtieġu emodijalisi, u 16-il kontroll b'saħħitom imqabblin.
English: - The active substance is tasimelteon.
Maltese: − Is-sustanza attiva hija tasimelteon.
English: RESET demonstrated the maintenance of entrainment with tasimelteon treatment compared to placebo withdrawal (aMT6s: 90% vs. 20% and cortisol: 80% vs. 20%).
Maltese: RESET wera l-manteniment tar-regolazzjoni bil-kura b'tasimelteon meta mqabbel mal-plaċebo tal-irtirar (aMT6s: 90% vs. 20% u kortisol: 80% vs. 20%).
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.
Maltese: L-effikaċja ta' tasimelteon fil-kura ta' Disturb Irqad-Qawmien Mhux għal 24 Siegħa (Non-24) ġiet stabbilita f'żewġ studji randomizzati, double-masked, ikkontrollati bi plaċebo, multiċentriċi, bi gruppi paralleli (SET u RESET) f'pazjenti kompletament għomja b'Non-24.
English: An example is fluvoxamine, which is used to treat depression and obsessive compulsive disorder (OCD).
Maltese: Eżempju fluvoxamine, li jintuża għall-kura ta' dipressjoni u ta' disturb ossessiv kompulsiv (OCD).
English: Strong CYP3A4 inducers (e.g. rifampin)
Maltese: Indutturi tas-CYP3A4 b'saħħithom (eż. rifampin)
English: It was rated as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse.
Maltese: Ġiet ikklassifikata bħala: 1 = imtejba ħafna; 2 = imtejba sew; 3 = imtejba ftit; 4 = ebda bidla; 5 = ftit agħar; 6 = agħar; jew 7 = ħafna agħar.
English: The observed mean elimination half-life for tasimelteon is 1.3 ± 0.4 hours.
Maltese: L-eliminazzjoni osservata tal-medja tal-half-life għal tasimelteon huwa 1.3 ± 0.4 sigħat.
English: Tasimelteon exposure was increased by approximately 50% when co-administered with ketoconazole 400 mg (after 5 days of ketoconazole 400 mg per day).
Maltese: ketoconazole (wara 5 ijiem ta' 400 mg ketoconazole kuljum).
English: <2.0 from the average of Day 112 and Day 183 compared to baseline
Maltese: <2.0 mill-medja ta' Jum 112 u Jum 183 meta mqabbel mal-linja bażi
English: HETLIOZ is intended for chronic use.
Maltese: HETLIOZ huwa intiż għal użu kroniku.
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).
Maltese: Pazjenti kkurati b'tasimelteon esperjenzaw titjib ġenerali fil-funzjonament kliniku globali (CGI-C = 2.6) meta mqabbel ma' pazjenti kkurati bi plaċebo li ma wrew ebda stat ta' titjib (CGI-C = 3.4) meta mqabbel mas-severità tal-linja bażi ta' Non-24 (differenza medja tal-LS = -0.8; p=0.0093) (Tabella 4).
English: Potential effect of alcohol on tasimelteon
Maltese: Effett potenzjali tal-alkoħol fuq tasimelteon
English: HETLIOZ 20 mg hard capsules tasimelteon
Maltese: HETLIOZ 20 mg kapsuli ibsin tasimelteon
English: There is limited clinical experience with the effects of an overdose of tasimelteon.
Maltese: Hemm esperjenza klinika limitata bl-effetti ta' doża eċċessiva ta' tasimelteon.
English: - The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone K17 and titanium dioxide.
Maltese: − L-inka bajda tal-istampar fiha shellac, propylene glycol, sodium hydroxide, povidone K17 u titanium dioxide.
English: Tasimelteon acts as a Dual Melatonin Receptor Agonist (DMRA) with selective agonist activity at the MT1 and MT2 receptors.
Maltese: Agonist (DMRA) b'attività agonista selettiva fir-riċetturi MT1 u MT2.
English: Strong CYP3A4 inhibitors (e.g. ketoconazole)
Maltese: Inibituri tas-CYP3A4 b'saħħithom (eż. ketoconazole)
English: The mean terminal elimination half-life ± standard deviation of the main metabolites ranges from 1.3 ± 0.5 to 3.7 ± 2.2.
Maltese: L-eliminazzjoni terminali medja tal-half-life ± devjazzjoni standard tal-firxiet ewlenin tal-metaboliti minn 1.3 ± 0.5 sa 3.7 ±
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.
Maltese: Fi studju ta 28 voluntiera b'saħħithom, doża waħda ta' etanol (0.6 g/kg għan-nisa u 0.7 g/kg għall-irġiel) ngħatat flimkien ma' doża ta' 20 mg ta' tasimelteon.
English: Taking HETLIOZ
Maltese: Tiħux HETLIOZ jekk
English: >30 minutes increase and a standard deviation <2 hours during double-masked phase
Maltese: >żieda ta' 30 minuta u devjazzjoni standard ta' <sagħtejn waqt il-fażi double-masked
English: HETLIOZ contains Orange Yellow S (E110)
Maltese: HETLIOZ fih Orange Yellow S (E110)
English: - Swallow the capsule whole.
Maltese: - Ibla l-kapsula sħiħa.
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.
Maltese: Fil-firien, l-inċidenza ta' tumuri talfwied ġiet miżjuda fl-irġiel (adenoma u karċinoma) u fin-nisa (adenoma) b'100 u 250 mg/kg/ġurnata; linċidenza ta' tumuri tal-utru (adenokarċinoma endometrijali) u utru u ċerviċi (karċinoma taċ-ċelloli skwamużi) żdiedu b'250 mg/kg/ġurnata.
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
Maltese: (1) Numri ogħla jindikaw titjib (2) Analiżi tas-Sensittività (3) Il-valur-p kien ibbażat fuq l-analiżi ta' mudell ta' kovarjanza, l-unitajiet huma minuti medji LS (4) Numri iżgħar jindikaw titjib (5) Analiżi post-hoc
English: Daytime sleep time on 25% most symptomatic days (minutes)(3),(4)
Maltese: Ħin ta' rqad matul il-ġurnata f'25% talġranet l-iktar sintomatiċi (minuti)(3),(4)
English: >45 minutes increase in average nighttime sleep duration
Maltese: >nuqqas ta' 45 minuta fil-medja tat-tul ta' rqad matul il-jum
English: Pharmacotherapeutic group: Psycholeptics, melatonin receptor agonists, ATC code: N05CH03
Maltese: Psikolettiċi, agonisti tar-riċettur tal-melatonina, kodiċi ATC:
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.
Maltese: F'SET, ilpazjenti fil-grupp ta' tasimelteon kellhom, fil-linja bażi, medja ta' 195 minuta ta' ħin ta' rqad matul il-lejl u 137 minuta ta' ħin ta' rqad matul il-ġurnata f'25% tal-iljieli u ġranet l-iktar sintomatiċi, rispettivament.
English: Tasimelteon is a circadian regulator that resets the master body clock in the suprachiasmatic nucleus (SCN).
Maltese: Tasimelteon huwa regolatur ċirkadjan li jibda mill-ġdid l-arloġġ ewlieni tal-ġisem fin-nukleu suprakjażmatiku (SCN - suprachiasmatic nucleus).
English: - medicines known to increase the activity of an enzyme called ‘CYP3A4'.
Maltese: - mediċini magħrufin li jnaqqsu l-attività ta' enzima msejħa ‘CYP3A4'.
English: The pharmacokinetics of tasimelteon is linear over doses ranging from 3 to 300 mg (0.15 to 15 times the recommended daily dosage).
Maltese: Il-farmakokinetiċi ta' tasimelteon huma lineari fuq dożi li jvarjaw minn 3 sa 300 mg (0.15 sa 15-il darba iddożaġġ ta' kuljum rakkomandat).
English: The no effect dose (50 mg/kg/day) is approximately 25 times the RHD on a mg/m2 basis.
Maltese: Id-doża ta' ebda effett (50 mg/kg/ġurnata) hija bejn wieħed u ieħor 25 darba l-RHD fuq bażi ta' mg/m2.
English: The peak concentration (Tmax) of tasimelteon occurred approximately 0.5 hours after fasted oral administration.
Maltese: Il-konċentrazzjoni massima (Tmax) ta' tasimelteon intlaħqet bejn wieħed u ieħor 0.5 siegħa wara amministrazzjoni orali sajma.
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).
Maltese: L-użu ta' tasimelteon għandu jiġi evitat flimkien ma' rifampin jew indutturi tas-CYP3A4 oħrajn b'saħħithom minħabba tnaqqis potenzjalment kbir fl-esponiment ta' tasimelteon b'effikaċja mnaqqsa: l-esponiment ta' tasimelteon tnaqqas b'bejn wieħed u ieħor 90% meta mogħtija flimkien ma' 600 mg ta' rifampin (wara 11-il jum ta' 600 mg rifampin kuljum).
English: HETLIOZ hard capsules are opaque dark blue printed with “VANDA 20 mg” in white.
Maltese: HETLIOZ kapsuli ibsin huma blu skur opaki stampati b'”VANDA 20 mg” bl-abjad.
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).
Maltese: Kull kapsula iebsa fiha 183.25 mg ta' lattosju (bħala anidru) u 0.03 mg ta' Oranġjo Isfar S (E110).
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.
Maltese: CYP1A2 u CYP3A4 huma enzimi identifikati li għandhom rwol fil-metaboliżmu ta' tasimelteon, bi rwol minuri għal CYP2C9/C19.
English: How to store HETLIOZ 6.
Maltese: Kif taħżen HETLIOZ 6.
English: Dyspepsia, nausea, dry mouth
Maltese: Fertilità, tqala u treddigħ
English: HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
Maltese: HETLIOZ huwa indikat għall-kura ta' Disturb Irqad-Qawmien Mhux għal 24 siegħa (Non-24) fl-adulti kompletament għomja.
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%.
Maltese: Wara amministrazzjoni orali ta' tasimelteon radjutikkettat, 80% tar-radjazzjoni totali ġiet imneħħija fl-awrina u bejn wieħed u ieħor 4% fl-ippurgar, u dan jirriżulta f'irkupru medju ta' 84%.
English: 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).
Maltese: Inibituri CYP1A2 b'saħħithom (eż. fluvoxamine, ciprofloxacin u enoxacin) Għandha tingħata attenzjoni meta jingħata tasimelteon flimkien ma' fluvoxamine jew ma' inibituri CYP1A2 oħrajn b'saħħithom minħabba żieda potenzjalment kbira fl-esponiment għal tasimelteon u riskju miżjud ta' reazzjonijiet avversi: l-AUC0-inf u Cmax ta' tasimelteon żdied b'7 darbiet u darbtejn rispettivament, meta mogħti fl-istess ħin ma' fluvoxamine 50 mg (wara 6 ijiem ta' fluvoxamine 50 mg kuljum).
English: HETLIOZ 20 mg hard capsules
Maltese: HETLIOZ 20 mg kapsuli ibsin
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
Maltese: Il-profil farmakokinetiku ta' doża ta' 20 mg ta' tasimelteon tqabbel fost 8 suġġetti b'indeboliment tal-fwied ħafif (Punteġġ Child-Pugh ≥5 u ≤6 punti), 8 suġġetti b'indeboliment tal-fwied moderat (Punteġġ Child-Pugh ≥7 u ≤9 punti), u 13-il kontroll b'saħħithom imqabblin.
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).
Maltese: Fil-fniek tqal li ngħataw tasimelteon waqt il-perjodu ta' organoġenesi, embrijuletalità u tossiċità embrijufetali (tnaqqis fil-piż tal-ġisem fetali u ossifikazzjoni mwaħħra) ġew osservati fl-ogħla doża ttestjata (200 mg/kg/ġurnata).
English: The efficacy of tasimelteon may be reduced in patients with concomitant administration of beta adrenergic receptor antagonists.
Maltese: L-effikaċja ta' tasimelteon tista' titnaqqas f'pazjenti b'amministrazzjoni konkomitanti ta' antagonisti tar riċetturi beta adrenerġiċi.