FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary efficacy measure in this trial was the frequency of cataplexy attacks.
Croatian: Primarna mjera djelotvornosti u ovom ispitivanju bila je učestalost napadaja katapleksije.
English: If you are taking valproate together with Xyrem, the dose of Xyrem will be adapted by your doctor.
Croatian: Ako uzimate valproat istodobno sa Xyremom, vaš liječnik će prilagoditi dozu Xyrema.
English: Gamma Butyrolactone (GBL), a pro-drug of GHB tested at exposures similar to the expected in man (1.21-1.64 times) has been classified by NTP as non-carcinogenic in rats and equivocal carcinogen in mice, due to slight increase of pheochromocytomas which was difficult to interpret due to high mortality in the high dose group.
Croatian: Gamabutirolakton (GBL), predlijek GHB-a testiran je pri izloženosti poput one koja se očekuje u ljudi (1,21-1,64 puta) te je prema NTP-u (Nacionalni toksikološki program) klasificiran kao nekarcinogen u štakora te neodređeno karcinogen u miševa zbog blago povećane učestalosti feokromocitoma što je bilo teško za interpretirati zbog visoke smrtnosti u skupini koja je primala visoke doze.
English: GHB had no effect on mating, general fertility or sperm parameters and did not produce embryofoetal toxicity in rats exposed to up 1000 mg/kg/day GHB (1.64 times the human exposure calculated in nonpregnant animals).
Croatian: GHB nije imao učinka na parenje, opću plodnost ili parametre sjemena i nije uzrokovao embriofetalnu toksičnost u štakora izloženih dozama do 1000 mg/kg/dan GHB-a (1,64 puta veća izloženost nego u ljudi, izračunato u odnosu na životinje koje nisu gravidne).
English: Sodium oxybate is a hydrophilic compound with an apparent volume of distribution averaging 190384 mL/kg.
Croatian: Natrijev oksibat je hidrofilna tvar s prosječnim prividnim volumenom distribucije od 190 do 384 mL/kg.
English: If any of these apply to you, tell your doctor before you take Xyrem.
Croatian: Ako se nešto od navedenog odnosi na Vas, obavezno o tome obavijestite svog liječnika prije nego počnete uzimati Xyrem.
English: Talk to your doctor or pharmacist before taking Xyrem: - if you have breathing or lung problems (and especially if you are obese), because Xyrem has the potential to cause difficulty in breathing; - if you have or have previously had depressive illness; - if you have heart failure, hypertension (high blood pressure), liver or kidney problems as your dose may need to be adjusted; - if you have previously abused drugs; - if you suffer from epilepsy as the use of Xyrem is not recommended in this condition; - if you have porphyria (an uncommon metabolic disorder).
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Xyrem: - ako imate problema s disanjem ili plućima (a posebno, ako ste pretili) jer Xyrem može uzrokovati otežano disanje; - ako imate ili ste imali depresiju; - ako imate zatajenje srca, hipertenziju (povišen krvni tlak), probleme s radom jetre ili bubrega jer će Vam možda trebati prilagoditi dozu; - ako ste nekada zlorabili neke lijekove; - ako bolujete od epilepsije jer se onda ne preporučuje primjena Xyrema; - ako imate porfiriju (rijedak metabolički poremećaj).
English: Although gag reflex may be absent in deeply comatose patients, even unconscious patients may become combative to intubation, and rapid sequence induction (without the use of sedative) should be considered.
Croatian: Iako refleks povraćanja može biti odsutan u bolesnika u dubokoj komi, čak i bolesnici bez svijesti mogu postati agresivni kod intubacije te treba razmisliti o brzoj intubaciji u slijedu (bez primjene sedativa).
English: Prior to treatment physicians should evaluate patients for a history of or susceptibility to drug abuse.
Croatian: Prije započinjanja liječenja liječnici moraju procijeniti bolesnike iz perspektive zlouporabe lijekova u anamnezi ili sklonosti da zlorabe lijekove.
English: EDS - Excessive daytime sleepiness; ESS - Epworth Sleepiness Scale; MWT - Maintenance of Wakefulness Test; Naps - Number of inadvertent daytime naps; CGIc - Clinical Global Impression of Change; FOSQ - Functional Outcomes of Sleep Questionnaire
Croatian: EDS - pretjerana dnevna pospanost; ESS - Epworthova skala pospanosti; MWT - test održavanja budnosti; Naps - broj nehotičnih dnevnih epizoda spavanja; CGIc - klinički opći dojam promjene; FOSQ - upitnik o funkcionalnom ishodu spavanja
English: Patients taking Xyrem should not breast feed since it is known that Xyrem passes into breast milk.
Croatian: Bolesnice koje uzimaju Xyrem ne smiju dojiti jer je poznato da se Xyrem izlučuje u majčino mlijeko.
English: Empty the medicine from the syringe into one of the dosing cups provided by pushing on the plunger (See Figure 3).
Croatian: Ispraznite lijek iz štrcaljke u jednu dozirnu čašu pritišćući klip štrcaljke (vidjeti sliku 3).
English: - The other ingredients are purified water, malic acid and sodium hydroxyde.
Croatian: - Pomoćne tvari su pročišćena voda, malatna kiselina i natrijev hidroksid.
English: If you experience any of these, tell your doctor straight away.
Croatian: Ako primijetite bilo koju nuspojavu, odmah se javite svom liječniku.
English: Patients should be routinely monitored and in the case of suspected abuse, treatment with sodium oxybate should be discontinued.
Croatian: Bolesnike treba redovito nadzirati i u slučaju sumnje na zlouporabu, liječenje natrijevim oksibatom treba prekinuti.
English: Sodium oxybate is a central nervous system depressant which reduces excessive daytime sleepiness and cataplexy in patients with narcolepsy and modifies sleep architecture reducing fragmented nighttime sleep.
Croatian: Natrijev oksibat je depresor središnjeg živčanog sustava koji smanjuje pretjeranu dnevnu pospanost i katapleksiju u bolesnika s narkolepsijom te popravlja arhitekturu spavanja tako da smanjuje isprekidanost noćnog spavanja.
English: There are reports of compromise in the rate and depth of respiration and of life-threatening respiratory depression, necessitating intubation and ventilation.
Croatian: Postoje izvješća o smanjenoj frekvenciji i dubini disanja te po život opasnoj respiratornoj depresiji koja je zahtijevala intubaciju i umjetnu ventilaciju.
English: Xyrem contains sodium
Croatian: Xyrem sadrži natrij
English: The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials (see section 4.4).
Croatian: Učinci prekida primjene natrijeva oksibata nisu sustavno procjenjivani u kontroliranim kliničkim ispitivanjima (vidjeti dio 4.4).
English: Place the caps provided on the dosing cups and turn each cap clockwise (to the right) until it clicks and locks into its child-resistant position (See Figure 4).
Croatian: Postavite priložene zatvarače na dozirne čaše i okrenite svaki zatvarač u smjeru kazaljke na satu (udesno) dok se ne čuje klik i dok se ne zaključa u položaj siguran za djecu (vidjeti sliku 4).
English: Xyrem 3 - 9
Croatian: 4 tjedna Xyrem 3 - 9
English: Next, insert the tip of the measuring syringe into the centre opening of the bottle and press down firmly (See Figure 1).
Croatian: Sljedeće, umetnite vrh odmjerne štrcaljke u središte otvora boce i čvrsto pritisnite prema dolje (vidjeti Sliku 1).
English: What Xyrem contains - The active substance is sodium oxybate.
Croatian: Što Xyrem sadrži - Djelatna tvar je natrijev oksibat.
English: Patients with succinic semialdehyde dehydrogenase deficiency.
Croatian: Bolesnici koji imaju deficijenciju sukcinat-semialdehid-dehidrogenaze.
English: The emergence of depression when patients are treated with sodium oxybate requires careful and immediate evaluation.
Croatian: Pojava depresije u bolesnika liječenih natrijevim oksibatom zahtijeva pravovremenu i detaljnu procjenu.
English: Approximately 80% of patients who received sodium oxybate during clinical trials maintained CNS stimulant use.
Croatian: Približno 80% bolesnika koji su uzimali natrijev oksibat tijekom kliničkih ispitivanja, nastavilo je uzimati i stimulanse SŽS-a.
English: The primary measures of efficacy were changes in excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS), and the change in the overall severity of the patient's narcolepsy symptoms as assessed by the investigator using the Clinical Global Impressions of Change (CGI-c) measure.
Croatian: Primarne mjere djelotvornosti bile su promjene u pretjeranoj dnevnoj pospanosti koje su određivane pomoću Epworthove skale pospanosti (ESS) te promjene u ukupnoj težini simptoma bolesnika s narkolepsijom koje je procjenjivao ispitivač na temelju ljestvice za procjenu kliničkog općeg dojma promjene (CGI-c, engl.
English: If you have kidney problems, you should consider a dietary recommendation to reduce sodium intake.
Croatian: Ako imate problema s bubrezima, trebate razmotriti preporuke za dijetalnu prehranu sa smanjenim unosom natrija.
English: Antidepressants have been used in the treatment of cataplexy.
Croatian: Antidepresivi se također primjenjuju u liječenju katapleksije.
English: Repeat administration of sodium oxybate to rats (90 days and 26 weeks) and dogs (52 weeks) did not result in any significant findings in clinical chemistry and micro- and macro pathology.
Croatian: Pri davanju ponavljajućih doza natrijeva oksibata štakorima (90 dana i 26 tjedana) i psima (52 tjedana) nisu zabilježeni nikakvi značajni poremećaji u području biokemije niti mikropatologije, odnosno makropatologije.
English: In addition to the adverse reactions reported during clinical studies, adverse reactions have been reported in post-marketing experience.
Croatian: Pored nuspojava prijavljenih tijekom kliničkih ispitivanja, prijavljene su i nuspojave tijekom razdoblja nakon stavljanja lijeka u promet.
English: Changes in sleep patterns have been observed in breastfed infants from exposed mothers, which may be consistent with the effects of sodium oxybate on the nervous system.
Croatian: Opažena je promjena obrasca spavanja u dojenčadi na majčinom mlijeku liječenih žena, što može biti u skladu s učinkom natrijevog oksibata na živčani sustav.
English: Treatmentrelated clinical signs were mainly related to sedation, reduced food consumption and secondary changes in body weight, body weight gain and organ weights.
Croatian: Klinički znakovi povezani s liječenjem uglavnom su uključivali sedaciju, smanjen unos hrane, odnosno posljedične promjene na tjelesnoj težini, povećanje tjelesne težine ili povećanje mase organa.
English: Respiratory and CNS depression
Croatian: Respiratorna depresija i depresija SŽS-a
English: The sodium oxybate or placebo equivalent dose was 6 g/day for the first 4 weeks and was increased to 9 g/day for the remaining 4 weeks.
Croatian: Tijekom prva 4 tjedna doza natrijeva oksibata ili ekvivalenta placeba bila je 6 g/dan, a zatim je povećana na 9 g/dan tijekom preostala 4 tjedna.
English: Sodium oxybate administered before nocturnal sleep increases Stages 3 and 4 sleep and increases sleep latency, whilst reducing the frequency of sleep onset REM periods (SOREMPs).
Croatian: Natrijev oksibat primijenjen pred noćni počinak pojačava stadije spavanja 3 i 4 te produžuje latenciju spavanja, a smanjuje frekvenciju pojavljivanja REM faza spavanja na početku spavanja (SOREMP, engl. sleep onset REM period).
English: Sedative hypnotics
Croatian: Hipnotici sa sedacijskim djelovanjem
English: Studies in vitro with pooled human liver microsomes indicate that sodium oxybate does not significantly inhibit the activities of the human isoenzymes (see section 5.2).
Croatian: Ispitivanja in vitro na združenim ljudskim jetrenim mikrosomima ukazuju da natrijev oksibat nema značajnog utjecaja na aktivnost ljudskih izoenzima (vidjeti dio 5.2).
English: After a single oral dose of 25 mg/kg, AUC values were double in cirrhotic patients, with apparent oral clearance reduced from 9.1 in healthy adults to 4.5 and 4.1 mL/min/kg in Class A (without ascites) and Class C (with ascites) patients, respectively.
Croatian: Nakon jednokratne oralne doze od 25 mg/kg, AUC vrijednosti su bile udvostručene u bolesnika s cirozom jetre uz značajno smanjenje oralnog klirensa s 9,1 u zdravih ispitanika na 4,5, odnosno 4,1 mL/min/kg u stadiju A (bez ascitesa), odnosno stadiju C (s ascitesom).
English: Special caution should be observed in patients with an underlying respiratory disorder.
Croatian: Poseban oprez je potreban kod bolesnika s postojećim poremećajem dišnog sustava.
English: Sodium oxybate should not be used in combination with sedative hypnotics or other CNS depressants.
Croatian: Natrijev oksibat se ne smije primjenjivati u kombinaciji s hipnoticima sa sedacijskim djelovanjem ili nekim drugim depresorima SŽS-a.
English: Animal studies indicate that metabolism is the major elimination pathway for sodium oxybate, producing carbon dioxide and water via the tricarboxylic acid (Krebs) cycle and secondarily by oxidation.
Croatian: Ispitivanja na životinjama su pokazala da je metabolizam glavni put eliminacije natrijeva oksibata tako što se stvara ugljikov dioksid i voda kroz ciklus trikarboksilnih kiselina (Krebsov ciklus) te dodatno još -oksidacijom.
English: Epileptic patients
Croatian: Bolesnici s epilepsijom
English: Change from Baseline Compared to Placebo (p-value)
Croatian: Promjena od početnog stanja u odnosu na placebo (p-vrijednost)
English: The dose should be titrated to effect based on efficacy and tolerability (see section 4.4) up to a maximum of 9 g/day divided into two equal doses of 4.5 g/dose by adjusting up or down in dose increments of 1.5 g/day (i.e. 0.75 g/dose).
Croatian: Dozu treba titrirati do učinka ovisno o djelotvornosti i podnošljivosti (vidjeti dio 4.4) do najviše 9 g/dan podijeljeno u dvije jednake pojedinačne doze od 4,5 g/dozi, prilagođavajući dozu povećanjem ili smanjenjem za 1,5 g/dan (odnosno 0,75 g/dozi).
English: Trial 3 enrolled 136 narcoleptic patients with moderate to severe cataplexy (median of 21 cataplexy attacks per week) at baseline.
Croatian: U Ispitivanje 3 bilo je uključeno 136 bolesnika s narkolepsijom i umjerenom do teškom katapleksijom (medijan napadaja katapleksije bio je 21 napadaj u tjednu) na početku ispitivanja.
English: Marketing Authorisation Holder UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium
Croatian: Nositelj odobrenja za stavljanje lijeka u promet UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgija
English: Sodium oxybate is not recommended during pregnancy.
Croatian: Primjena natrijeva oksibata tijekom trudnoće se ne preporučuje.
English: Metabolism and nutrition disorders Common: anorexia, decreased appetite Not known: Dehydration, increased appetite
Croatian: Poremećaji metabolizma i prehrane Često: anoreksija, smanjenje apetita Nepoznato: dehidracija, pojačan apetit
English: Sodium oxybate has major influence on the ability to drive and use machines.
Croatian: Natrijev oksibat značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Since sodium oxybate is metabolised by GHB dehydrogenase there is a potential risk of an interaction with medicinal products that stimulate or inhibit this enzyme (e.g. valproate, phenytoin or ethosuximide) (see section 4.4).
Croatian: Budući da se natrijev oksibat metabolizira putem GHB-dehidrogenaze postoji potencijalni rizik interakcije s lijekovima koji stimuliraju ili inhibiraju ovaj enzim (kao što su valproat, fenitoin ili etosuksimid) (vidjeti dio 4.4).
English: If you take two 2.25 g doses of sodium oxybate each night you will take 0.82 g of sodium, or if you take two 4.5 g doses of sodium oxybate each night you will take in 1.6 g sodium.
Croatian: Ako uzmete dvije doze od 2,25 g natrijeva oksibata svaku večer, uzet ćete 0,82 g natrija, ako uzmete dvije doze od 4,5 g natrijeva oksibata svaku večer, unijet ćete 1,6 g natrija.
English: • Gamma hydroxybutyrate (GHB) dehydrogenase inhibitors Caution is required in patients who are treated concomitantly with valproate or other GHB dehydrogenase inhibitors as pharmacokinetic and pharmacodynamic interactions have been observed when sodium oxybate is co-administered with valproate (see section 4.5).
Croatian: • inhibitori gama-hidroksibutirat (GHB) dehidrogenaze Potreban je oprez u bolesnika koji se istodobno liječe valproatom ili drugim inhibitorima GHB-dehidrogenaze budući da su opažene farmakokinetičke i farmakodinamičke interakcije kada se natrijev oksibat istodobno primjenjuje s valproatom (vidjeti dio 4.5).
English: If you take more Xyrem than you were told to take, or take it by accident, get emergency medical help right away.
Croatian: Ako ste slučajno uzeli više Xyrema nego što Vam je liječnik propisao, odmah se javite najbližoj hitnoj pomoći.
English: There have been case reports of dependence after illicit use of GHB at frequent repeated doses (18 to 250 g/day) in excess of the therapeutic dose range.
Croatian: Postoje izvješća o ovisnosti koje se javila nakon nedozvoljene primjene GHB-a u slučajevima učestale ponavljajuće primjene doza (18-250 mg/dan) koje su veće od uobičajenog terapijskog raspona doza.
English: Events associated with withdrawal syndrome have been observed outside the therapeutic range.
Croatian: Događaji povezani sa simptomima ustezanja zabilježeni su pri dozama koje su bile izvan terapijskog raspona.
English: No effect on the pharmacokinetics of valproate was observed.
Croatian: Nije uočen utjecaj na farmakokinetiku valproata.
English: Rebound effects and withdrawal syndrome
Croatian: Povratno djelovanje i simptomi ustezanja
English: Additionally, randomised, double-blind, placebo-controlled, crossover drug-drug interaction studies with ibuprofen, diclofenac and valproate were performed in healthy subjects and are summarised in section 4.5.
Croatian: Osim toga, provedena su randomizirana, dvostruko slijepa, placebom kontrolirana ukrižena ispitivanja interakcija među lijekovima s ibuprofenom, diklofenakom i valproatom u zdravih ispitanika te je sažetak naveden u dijelu 4.5.
English: The clearance of sodium oxybate is almost entirely by biotransformation to carbon dioxide, which is then eliminated by expiration.
Croatian: Klirens natrijeva oksibata je skoro u cijelosti posljedica biotransformacije u ugljikov dioksid koji se zatim odstranjuje disanjem.
English: Additionally, patient response and tolerability should be carefully monitored and dose should be adapted accordingly.
Croatian: Dodatno, treba oprezno pratiti odgovor bolesnika i podnošljivost te sukladno tome prilagoditi dozu.
English: A second mitochondrial oxidoreductase enzyme, a transhydrogenase, also catalyses the conversion to succinic semialdehyde in the presence of -ketoglutarate.
Croatian: Drugi mitohondrijski oksidoredukcijski enzim, transhidrogenaza također katalizira pretvorbu sukcinatsemialdehida u prisutnosti -ketoglutarata.
English: After dilution in the dosing cups, the preparation should be used within 24 hours.
Croatian: Nakon razrjeđivanja u dozirnim čašama, pripravak treba upotrijebiti unutar 24 sata.
English: How to take Xyrem
Croatian: Kako uzimati Xyrem
English: Xyrem should be taken orally upon getting into bed and again between 2.5 to 4 hours later.
Croatian: Xyrem se uzima peroralno neposredno prije odlaska u krevet i zatim ponovno 2,5 do 4 sata kasnije.
English: Blurred vision has been reported.
Croatian: Zabilježen je i zamagljen vid.
English: Xyrem has the potential to induce respiratory depression
Croatian: Xyrem može uzrokovati respiratornu depresiju
English: Each measured dose of Xyrem must be dispensed into the dosing cup and diluted with 60 mL of water prior to ingestion.
Croatian: Svaku izmjerenu dozu Xyrema mora se prenijeti u dozirnu čašu te prije uzimanja razrijediti s 60 mL vode.
English: Xyrem is used to treat narcolepsy with cataplexy in adults.
Croatian: Xyrem se primjenjuje u liječenju narkolepsije s katapleksijom u odraslih.
English: After dilution in the dosing cups the preparation should be used within 24 hours.
Croatian: Nakon razrjeđivanja u dozirnim čašama pripravak treba upotrijebiti unutar 24 sata.
English: The dose of sodium oxybate therefore does not require adjustment when given concomitantly with proton pump inhibitors.
Croatian: Stoga nije potrebno prilagođavati dozu natrijeva oksibata tijekom istodobne primjene s inhibitorima protonske pumpe.
English: • Frequently Asked Questions (FAQ) Patient Information Sheet (to be given to the patient): to provide patients with responses to some questions they might have about taking Xyrem.
Croatian: • list s informacijama za bolesnika s često postavljenim pitanjima (dat će se bolesniku): kako bi se bolesnicima osigurali odgovori na neka pitanja koja mogu imati vezano uz uzimanje Xyrema.
English: The co-administration of sodium oxybate (6 g per day) with valproate (1250 mg per day) resulted in an increase in systemic exposure to sodium oxybate by approximately 25% and no significant change in Cmax.
Croatian: Istodobna primjena natrijeva oksibata (6 g na dan) s valproatom (1250 mg na dan) dovela je do povećanja u sistemskoj izloženosti natrijevu oksibatu za približno 25% i neznatne promjene u Cmax.
English: There is insufficient evidence to recommend the use of naloxone in the treatment of overdose with GHB.
Croatian: Nema dovoljno dokaza za preporuku primjene naloksona u liječenju predoziranja GHB-om.
English: Patients were randomised to continued treatment with sodium oxybate at their stable dose or to placebo.
Croatian: Bolesnici su zatim randomizirani i nastavili s liječenjem natrijevim oksibatom u stabilnoj dozi ili s placebom.
English: Animal studies have shown no evidence of teratogenicity but embryolethality was seen in both rat and rabbit studies (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala teratogenost, ali je zabilježena smrtnost zametaka i u ispitivanjima sa štakorima i u ispitivanjima s kunićima (vidjeti dio 5.3).
English: If you are elderly, your doctor will monitor your condition carefully to check whether Xyrem is having the desired effects.
Croatian: Vaše stanje kako bi bio siguran da Xyrem daje željene učinke.
English: There is no clinical data available on the effect of sodium oxybate on fertility.
Croatian: Nema kliničkih podataka o utjecaju natrijeva oksibata na plodnost.
English: Patients have exhibited varying degrees of depressed consciousness that may fluctuate rapidly between a confusional, agitated combative state with ataxia and coma.
Croatian: Bolesnici su pokazivali različit stupanj suženog stanja svijesti koje može značajno varirati od konfuzije, agitiranog borbenog stanja s ataksijom do kome.
English: The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials.
Croatian: Učinci prekida primjene natrijeva oksibata nisu sustavno ispitivani u kontroliranim kliničkim ispitivanjima.
English: A minimum of one to two weeks is recommended between dose increments.
Croatian: Preporučuje se da se doze povećavaju u vremenskim intervalima od najmanje jednog do dva tjedna.
English: If concomitant use is warranted, dose adjustment is to be considered (see section 4.2).
Croatian: Ako je istodobna primjena opravdana, treba razmotriti prilagodbu doze (vidjeti dio 4.2).
English: Two Phase 3 and one Phase 2 double-blind, parallel-group, placebo-controlled studies were performed to assess the indication of sodium oxybate for fibromyalgia.
Croatian: Provedena su dva dvostruko slijepa, placebom kontrolirana ispitivanja s paralelnim skupinama faze 3 i jedno faze 2 radi ocjene indikacije natrijeva oksibata za fibromijalgiju.
English: When you first start taking Xyrem, until you know whether it makes you sleepy the next day, use extreme care while driving a car, operating heavy machinery or doing anything else that could be dangerous or needs you to be fully mentally alert.
Croatian: Nakon prvog uzimanja Xyrema, dok ne utvrdite jeste li pospani idući dan, budite iznimno oprezni ako upravljate vozilom, teškim strojevima ili obavljate druge aktivnosti koje mogu biti opasne ili zahtijevaju od Vas potpunu budnost.