FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use the Zinbryta pre-filled syringe past the expiry date.
Croatian: Nemojte koristiti Zinbryta napunjenu štrcaljku nakon isteka roka valjanosti.
English: • If you do forget a dose, and it is within 2 weeks of your missed dose, inject as soon as you can. Then carry on as normal, sticking to your usual injection day.
Croatian: • Ako zaboravite primijeniti dozu, a prošlo je manje od 2 tjedna od propuštene doze, injicirajte je čim prije možete.
English: External heat sources such as hot water must not be used to warm Zinbryta.
Croatian: Za zagrijavanje Zinbryte ne smiju se koristiti vanjski izvori topline, kao što je vruća voda.
English: In clinical studies Zinbryta increased the incidence of skin reactions [18% vs 13% (placebo); 37% vs 19% (interferon beta-1a (intramuscular))] and serious skin reactions [<1% vs 0% (placebo); 2% vs <1% (interferon beta-1a (intramuscular))] compared to placebo and interferon beta-1a (intramuscular).
Croatian: (placebo); 37% naspram 19% (interferon beta-1a (intramuskularno))] i ozbiljnih kožnih reakcija [<1% naspram 0% (placebo); 2% naspram <1% (interferon beta-1a (intramuskularno))] u usporedbi s placebom i interferonom beta-1a (intramuskularno).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 150 mg of daclizumab in 1 mL solution for injection.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena štrcaljka sadrži 150 mg daklizumaba u 1 ml otopine za injekciju.
English: Nasopharyngitis†
Croatian: Nazofaringitis†
English: Lymphadenopathy†
Croatian: Limfadenopatija†
English: Step 8: Disposing of the used Zinbryta Pre-filled Syringe
Croatian: Nakon injekcije 8. korak: Odlaganje iskorištene Zinbryta napunjene štrcaljke
English: Patient Card has more information about these side effects.
Croatian: Više informacija o ovim nuspojavama se nalazi u Kartici za bolesnika.
English: Autoimmune haemolytic anaemia was reported in < 1% of patients treated with Zinbryta in clinical studies.
Croatian: Autoimuna hemolitična anemija zabilježena je u kliničkim ispitivanjima u < 1% bolesnika liječenih
English: Liver problems: (Common - may affect up to 1 in 10 people)
Croatian: Problemi s jetrom: (Često - mogu se javiti u manje od 1 na 10 osoba)
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
Croatian: Jedna napunjena štrcaljka sadrži 150 mg daklizumaba u 1 ml Jedna napunjena brizgalica sadrži 150 mg daklizumaba u 1 ml
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1107/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1107/002
English: • Check with your doctor, pharmacist or nurse about the right way to throw away the used pen.
Croatian: • Pitajte svog liječnika, ljekarnika ili medicinsku sestru za ispravan način bacanja iskorištenih brizgalica.
English: Percentage of patients relapse-free Hazard ratio# * [95% CI]
Croatian: Postotak bolesnika bez relapsa Omjer hazarda* [95% CI]
English: Daclizumab has not been studied in patients with hepatic impairment.
Croatian: Daklizumab nije ispitivan u bolesnika s oštećenjem bubrega.
English: Do not use the Zinbryta pre-filled syringe if the liquid is cloudy, or has floating particles in it. o You might see air bubbles in the Zinbryta medicine.
Croatian: Nemojte koristiti Zinbryta napunjenu štrcaljku ako je tekućina zamućena ili ako sadrži plutajuće čestice.
English: Step 1: Remove the pen from the fridge a. Remove the pen from the carton in the fridge 30 minutes before giving your injection to allow it to warm to room temperature.
Croatian: Izvadite brizgalicu iz kutije u hladnjaku 30 minuta prije injiciranja kako bi se ugrijala na sobnu temperaturu.
English: Laryngitis
Croatian: Laringitis
English: • Acknowledgment Form.
Croatian: • Obrazac potvrde o upoznatosti s rizikom.
English: Note: Do not rest the pen on the injection site until you are ready to inject.
Croatian: Ne naslanjajte brizgalicu na mjesto injiciranja sve dok niste spremni na injiciranje.
English: Exfoliative rash
Croatian: Eksfolijativni osip
English: Study design Treatment
Croatian: Dizajn ispitivanja
English: • Prior to treatment (re)start, confirmation of: o A discussion between the physician and the patient about the risk of serious and potentially fatal hepatic injury and the unpredictable nature of such reactions and about the possibility of having to switch treatment in case of levels of ALT or AST > 3 times the ULN; o Patient understanding of the risk information provided; o Receipt of a copy of the acknowledgement form; o Receipt of the Patient Card;
Croatian: o da je liječnik upoznao bolesnika s rizikom od ozbiljnog i potencijalno smrtonosnog oštećenja jetre i o nepredvidljivosti takvih reakcija te o mogućoj potrebi promjene liječenja u slučaju da vrijednosti ALT-a ili AST-a budu > 3 puta GGN
English: • Inform patients about the unpredictable risk of serious and potentially fatal hepatic injury at any time during treatment and up to several month after treatment;
Croatian: Vodič za liječnike o zbrinjavanju rizika za jetru treba liječnike upozoriti na: • nepredvidljivi rizik od ozbiljnog i potencijalno smrtonosnog oštećenja jetre u bilo kojem trenutku liječenja i do nekoliko mjeseci nakon zadnje doze
English: Hazard ratio* [95% CI]
Croatian: Omjer stopa* [95% CI]
English: Serious liver problems can occur both early after starting treatment with Zinbryta, any time during treatment and several months after discontinuing treatment.
Croatian: Zinbrytom, u bilo kojem trenutku tijekom liječenja, a također i nekoliko mjeseci nakon prekida liječenja.
English: Tear here
Croatian: Pokidati ovdje
English: • Keep Zinbryta pen and all medicines out of reach and sight of children.
Croatian: Zinbryta brizgalicu i sve lijekove čuvajte izvan pogleda i dohvata djece.
English: Serious hepatic injury, including fatal cases of autoimmune hepatitis and fulminant liver failure have occurred in patients treated with Zinbryta.
Croatian: U bolesnika liječenih Zinbrytom pojavila su se ozbiljna oštećenja jetre uključujući slučajeve autoimunog hepatitisa i fulminantnog zatajenja jetre sa smrtnim ishodom.
English: Pharyngitis
Croatian: Faringitis
English: Tuberculosis infections have been reported in patients treated with Zinbryta.
Croatian: U bolesnika liječenih Zinbrytom zabilježene su tuberkulozne infekcije.
English: • Uncommon (≥1/1,000 to <1/100)
Croatian: • manje često (≥1/1000 i <1/100)
English: How to store Zinbryta
Croatian: Kako primjenjivati Zinbrytu
English: Sodium succinate Succinic acid Sodium chloride Polysorbate 80
Croatian: 6.1 Popis pomoćnih tvari natrijev sukcinat sukcinatna kiselina natrijev klorid polisorbat 80 voda za injekcije
English: Do not place Zinbryta back into the refrigerator after warming to room temperature.
Croatian: Ne stavljajte Zinbrytu natrag u hladnjak nakon zagrijavanja na sobnu temperaturu.
English: Referring patients who develop symptoms of colitis (e.g. abdominal pain, fever, prolonged diarrhoea) to a specialist is advisable (see section 4.8).
Croatian: bol u abdomenu, vrućicu, dugotrajni proljev) specijalistu (vidjeti dio 4.8).
English: Infections, some serious (e.g. pneumonia and bronchitis), have been reported with Zinbryta.
Croatian: Pri liječenju Zinbrytom prijavljene su infekcije od kojih su neke ozbiljne (npr. upala pluća i bronhitis).
English: Adverse reaction
Croatian: Potkožna primjena
English: • The unpredictable risk of serious and potentially fatal hepatic injury at any time during treatment and up to several months after the last dose;
Croatian: • upoznati bolesnike s nepredvidljivim rizikom od ozbiljnog i potencijalno smrtonosnog oštećenja jetre, u bilo kojem trenutku tijekom liječenja te do nekoliko mjeseci nakon liječenja • upoznati bolesnike s potrebom praćenja funkcije jetre tijekom liječenja i do 6 mjeseci nakon zadnje doze lijeka Zinbryta • poučiti bolesnike o važnosti:
English: • Do not place Zinbryta back into the refrigerator after warming to room temperature.
Croatian: • Ne vraćajte Zinbrytu u hladnjak nakon što se zagrijala na sobnu temperaturu.
English: Medicine Visible
Croatian: NAČIN PRIMJENE LIJEKA
English: Supplies needed for Zinbryta Pen injection:
Croatian: Pribor za injiciranje Zinbryta brizgalicom:
English: Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen daclizumab
Croatian: Zinbryta 150 mg otopina za injekciju u napunjenoj štrcaljki Zinbryta 150 mg otopina za injekciju u napunjenoj brizgalici daklizumab
English: The other ingredients are sodium succinate, succinic acid, sodium chloride, polysorbate 80, water for injections (see section 2 ‘Zinbryta contains a small amount of sodium').
Croatian: Ostali sastojci su natrijev sukcinat, sukcinatna kiselina, natrijev klorid, polisorbat 80, voda za injekcije
English: Each pre-filled pen contains a pre-filled syringe, containing 150 mg of daclizumab in 1 mL solution for injection.
Croatian: Jedna napunjena brizgalica sadrži napunjenu štrcaljku koja sadrži 150 mg daklizumaba u 1 ml otopine za injekciju.
English: Injecting yourself
Croatian: Samostalno davanje injekcije
English: Percent prior DMT use (%)
Croatian: Postotak prethodne upotrebe terapije koja modificira tijek bolesti (%)
English: Step 10: Care for your injection site
Croatian: 10. korak: Njega mjesta injiciranja
English: Step 9: Care for your injection site
Croatian: 9. korak: Njega mjesta injiciranja
English: Eczema nummular
Croatian: Broj bolesnika
English: Odds ratio [95% CI]
Croatian: Omjer stopa [95% CI]
English: Percentage with 24 weeks confirmed disability progression
Croatian: Progresijomonesposobljenosti tijekom 24 tjedna
English: Rash maculopapular
Croatian: Makulopapularni osip
English: Lymphadenitis
Croatian: Limfopenija
English: There was limited exposure in patients over 55 years of age in clinical studies with daclizumab.
Croatian: U kliničkim ispitivanjima s daklizumabom bila je ograničena izloženost u bolesnika starijih od
English: Pack sizes: - Pack containing one 150 mg pre-filled pen.
Croatian: - Pakiranje sadrži jednu napunjenu brizgalicu od 150 mg.
English: Zinbryta is not expected to undergo metabolism by hepatic enzymes or renal elimination.
Croatian: Zinbryte putem jetrenih enzima niti eliminacija putem bubrega.
English: Folliculitis
Croatian: Limfadenitis
English: • gauze pad
Croatian: • jastučić gaze
English: Each pre-filled syringe contains 150 mg of daclizumab in 1 mL solution for injection.
Croatian: Jedna napunjena brizgalica sadrži 150 mg daklizumaba u 1 ml otopine za injekciju.
English: Percentage with 12 weeks confirmed disability progression
Croatian: Postotak s potvrđenom progresijom onesposobljenosti tijekom 12 tjedana Omjer hazarda [95% CI]
English: Instructions overleaf 
Croatian: Prijavljivanje nuspojava
English: • It is expired.
Croatian: • rok valjanosti je istekao
English: Mean number of new T1 Gdenhancing lesions
Croatian: Srednji broj novih lezija imbibiranih gadolinijem na T1-mjerenoj snimci
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
Croatian: Zinbryta 150 mg otopina za injekciju u napunjenoj štrcaljki Zinbryta 150 mg otopina za injekciju u napunjenoj brizgalici
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
Croatian: Uputa o lijeku: Informacije za korisnika Zinbryta 150 mg otopina za injekciju u napunjenoj štrcaljki Zinbryta 150 mg otopina za injekciju u napunjenoj brizgalici daklizumab
English: and C. If your blood test shows that you have some liver problems, your doctor will decide whether to start Zinbryta - at least monthly blood tests during treatment, as close as possible before each dose of
Croatian: Ako pretraga krvi pokaže da imate neke tegobe s jetrom, liječnik će odlučiti smijete li započeti liječenje Zinbrytom.
English: It is essentially ‘sodium-free' and can be used by patients on a sodium-restricted diet.
Croatian: Ovaj lijek sadrži 0,14 mmola natrija po dozi, tj. zanemarive količine natrija i mogu ga koristiti bolesnici na dijeti s ograničenim unosom natrija.
English: Eczema†
Croatian: Ekcem†
English: Oropharyngeal pain†
Croatian: Orofaringealna bol†
English: Your
Croatian: DJECE
English: • your skin or the whites of your eyes turn yellow
Croatian: • koža ili bjeloočnice požute • tamna (boje čaja) mokraća
English: Time on study (weeks) Average number of patients at risk
Croatian: Prosječan broj bolesnika pod rizikom
English: Glass Barrel
Croatian: Stakleni cilindar
English: Excipient related considerations
Croatian: Početne značajke
English: Lesion mean ratio [95% CI]
Croatian: Srednji omjer lezija [95% CI]
English: Do not place Zinbryta pre-filled syringe back into the refrigerator after warming to room temperature.
Croatian: Zinbryta napunjenu štrcaljku natrag u hladnjak nakon zagrijavanja na sobnu temperaturu.
English: • The pen is for use under the skin only (subcutaneous).
Croatian: • Brizgalica je namijenjena samo za ubrizgavanje lijeka potkožno (supkutano).
English: • If you see blood at your injection site, wipe it off with the gauze pad and apply an adhesive bandage or plaster.
Croatian: • Ako vidite krv na mjestu injiciranja,
English: This medicinal product contains 0.14 mmol sodium per dose.
Croatian: Jedna doza Zinbryte sadrži 0,14 mmola natrija, tj. zanemarive količine natrija te lijek mogu koristiti osobe na dijeti s ograničenim unosom natrija.
English: Disposal
Croatian: Cijepljenje
English: Clinical endpoints Number of patients Annualised relapse rate* Rate ratio* [95% CI]
Croatian: Postotak bolesnika bez relapsa Omjer hazarda # * [95% CI]
English: This means that symptoms will come back.
Croatian: To znači da će se simptomi vratiti.
English: Take your next dose at the usual time the next day.
Croatian: Uzmite svoju sljedeću dozu u uobičajeno vrijeme sljedećeg dana.
English: Keep the bottle with you so that you can easily describe what you have taken.
Croatian: Imajte bocu uza sebe kako biste lakše mogli opisati što ste uzeli.
English: 3 years After first opening of the bottle: 30 days
Croatian: 3 godine Nakon prvog otvaranja boce: 30 dana.
English: Try to take the medicine at the same time every night.
Croatian: Nastojte uzimati lijek svake večeri u isto vrijeme.
English: - This medicine has been prescribed for you only.
Croatian: Ovaj je lijek propisan samo vama.
English: This leaflet was last revised in Other sources of information
Croatian: Ova uputa je zadnji puta revidirana u Drugi izvori informacija
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži za vas važne podatke.
English: Do not give HETLIOZ to children under the age of 18 years.
Croatian: Nemojte davati HETLIOZ djeci mlađoj od 18 godina.
English: The size of the capsule is ‘size 1' (dimensions 19.4 x 6.9 mm).
Croatian: Veličina kapsule jest „veličina 1” (dimenzije 19,4 x 6,9 mm).
English: Very common: may affect more than 1 in 10 people - headache
Croatian: Vrlo česte: mogu se pojaviti u više od 1 na 10 osoba - glavobolja
English: - Take the medicine by mouth.
Croatian: - Uzmite lijek na usta.
English: One HDPE bottle per paperboard carton.
Croatian: Jedna HDPE boca po kartonskoj kutiji.
English: The safety and efficacy of tasimelteon in children and adolescents aged 0 to 18 years have not been established.
Croatian: Sigurnost i djelotvornost tazimelteona u djece i adolescenata u dobi od 0 do 18 godina još nije ustanovljena.
English: Beta blockers
Croatian: Beta blokatori
English: This is because HETLIOZ has not been tested in people under 18 years of age and the effects are unknown.
Croatian: Razlog tomu je činjenica da HETLIOZ nije ispitan na osobama mlađima od 18 godina i učinci su nepoznati.
English: Do not stop taking HETLIOZ without talking to your doctor.
Croatian: Nemojte prestati uzimati HETLIOZ bez prethodnog razgovora sa svojim liječnikom.
English: Contents of the pack and other information What HETLIOZ contains
Croatian: Sadržaj pakiranja i druge informacije Što HETLIOZ sadrži
English: Respiration, pulse, blood pressure, and other appropriate vital signs should be monitored, and general supportive measures employed.
Croatian: Potrebno je pratiti disanje, puls, krvni tlak i druge odgovarajuće vitalne znakove te poduzeti opće potporne mjere.
English: N24CRS ≥ 3(2) N24CRS ≥ 2(2)
Croatian: N24CRS ≥ 2(2)
English: - It is best to take HETLIOZ on an empty stomach as food can reduce the amount of the medicine that is absorbed into your body.
Croatian: Najbolje je uzeti HETLIOZ na prazan želudac jer hrana može smanjiti količinu lijeka koja se apsorbira u tijelo.
English: A risk to the breast-fed child cannot be excluded.
Croatian: Ne može se isključiti rizik za dijete koje se doji.
English: Some examples include atenolol, metoprolol, and propanolol.
Croatian: Neki primjeri uključuju atenolol, metoprolol i propanolol.
English: - Swallow the capsule whole.
Croatian: - Progutajte cijelu kapsulu.
English: Placebo p-value
Croatian: Placebo p-vrijednost
English: Therefore, your doctor may ask you to take HETLIOZ for up to 3 months before checking if it is working for you.
Croatian: Stoga vas liječnik može zatražiti da uzimate HETLIOZ tijekom razdoblja do tri mjeseca prije nego što provjeri njegovo djelovanje na vas.
English: EXP Use within 30 days after first opening.
Croatian: Rok valjanosti Upotrijebiti u roku od 30 dana od prvog otvaranja.
English: >30 minutes increase and a standard deviation <2 hours during double-masked phase
Croatian: > 30-minutno produljenje i standardna devijacija < dva sata tijekom dvostruko slijepe faze
English: What HETLIOZ is and what it is used for
Croatian: Što je HETLIOZ i za što se koristi
English: These receptors are thought to be involved in the control of circadian rhythms.
Croatian: Smatra se da su ti receptori uključeni u kontrolu cirkadijalnog ritma.
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.
Croatian: Skala je rangirana na sljedeći način: 1 = jako poboljšano; 2 = uvelike poboljšano; 3 = minimalno poboljšano; 4 = bez promjene; 5 = minimalno pogoršano; 6 = uvelike pogoršano ili 7 = jako pogoršano.
English: This reduction in exposure is not considered clinically relevant and therefore no dose adjustment is necessary.
Croatian: Ovakvo smanjenje izloženosti ne smatra se klinički značajnim i stoga prilagodba doze nije potrebna.
English: What HETLIOZ looks like and contents of the pack
Croatian: Kako HETLIOZ izgleda i sadržaj pakiranja
English: Contents of the pack and other information
Croatian: 6. Sadržaj pakiranja i druge informacije
English: <2.0 from the average of Day 112 and Day 183 compared to baseline
Croatian: < 2,0 od prosjeka na 112. i 183. dan u odnosu na početnu vrijednost
English: The body controls these rhythms through many pathways including increases and decreases in the production of the hormone melatonin.
Croatian: Tijelo kontrolira te ritmove na različite načine, uključujući povećanjem i smanjenjem proizvodnje hormona melatonina.
English: Each bottle has a child-resistant cap and contains 30 hard capsules.
Croatian: Svaka boca ima sigurnosni zatvarač za djecu i sadrži 30 tvrdih kapsula.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.
English: Phenolic glucuronidation is the major phase II metabolic route.
Croatian: Fenolska glukuronidacija jest glavni metabolički put faze II.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim problemima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcije glukoze-galaktoze ne smiju uzimati ovaj lijek.
English: This type of medicine is called a “melatonin agonist” that acts as a regulator of daily body rhythms.
Croatian: Ova vrsta lijeka naziva se „agonist melatoninskih receptora” koji djeluje kao regulator dnevnih tjelesnih ritmova.
English: Less than 1% of the dose was excreted in urine as the parent compound.
Croatian: Manje od 1 % doze izlučeno je u urin kao ishodišni spoj.
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
Croatian: (1) Veće brojke ukazuju na poboljšanje (2) Analiza osjetljivosti (3) P-vrijednost temeljila se na analizi modela kovarijance, jedinice su srednje vrijednosti dobivene metodom najmanjih kvadrata u minutama (4) Niže brojke ukazuju na poboljšanje (5) Analiza post-hoc
English: Pharmacotherapeutic group: Psycholeptics, melatonin receptor agonists, ATC code: N05CH03
Croatian: Farmakoterapijska skupina: psiholeptici, agonisti melatoninskih receptora, ATK oznaka: N05CH03
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet prvo periodičko izvješće o neškodljivosti za ovaj lijek dostavlja unutar 6 mjeseci nakon dobivanja odobrenja.
English: Hard capsules should be swallowed whole.
Croatian: Tvrde kapsule potrebno je progutati cijele.
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.
Croatian: Nakon uzimanja lijeka HETLIOZ trebate se pripremiti za odlazak na spavanje i obavljati samo one aktivnosti koje biste obično obavljali prije odlaska na spavanje.
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.
Croatian: Ako zatrudnite dok uzimate HETLIOZ, odmah se obratite svom liječniku jer se ne preporučuje uzimanje lijeka HETLIOZ za vrijeme trudnoće ili dojenja.
English: Other medicines and HETLIOZ
Croatian: Drugi lijekovi i HETLIOZ
English: Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
Croatian: < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000).
English: - Do not use this medicine after the expiry date which is stated on the botttle and the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji.
English: Subjects with severe renal impairment had a 30% lower CL/F clearance than match controls; however, when variability is taken into account, the different was not significant.
Croatian: Ispitanici s teškim oštećenjem funkcije bubrega imali su 30 % niži oralni klirens od odgovarajućih kontrola; međutim, kada se u obzir uzme varijabilnost, razlika nije bila znatna.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Prilogu V.
English: Intravenous fluids should be administered as needed.
Croatian: Potrebno je primijeniti inatravenske tekućine prema potrebi.
English: The efficacy of tasimelteon may be reduced in patients with concomitant administration of beta adrenergic receptor antagonists.
Croatian: Djelotvornost tazimelteona može biti smanjena u bolesnika koji istodobno uzimaju antagoniste beta adrenergičkih receptora.