FrancophonIA/ELRC3.0 huggingface dataset:
English: An alternate pathway of biotransformation involves -oxidation via 3,4-dihydroxybutyrate to Acetyl CoA, which also enters the citric acid cycle to result in the formation of carbon dioxide and water.
Croatian: Alternativni put biotransformacije uključuje -oksidaciju preko 3,4-dihidroksibutirata u acetil-koenzimA koji također ulazi u ciklus trikarboksilnih kiselina i na kraju nastaju ugljikov dioksid i voda.
English: The emergence of thought disorders including thoughts of committing violent acts (including harming others) and/or behavioural abnormalities when patients are treated with sodium oxybate requires careful and immediate evaluation.
Croatian: Ako se tijekom liječenja natrijevim oksibatom jave poremećaji razmišljanja uključujući razmišljanja o počinjenju nasilnih djela (uključujući povrede drugih) i/ili abnormalno ponašanje potrebno je napraviti detaljnu i pravovremenu procjenu.
English: Sodium oxybate, which is as the sodium salt of GHB, is a CNS depressant active substance with wellknown abuse potential.
Croatian: Natrijev oksibat, natrijeva sol GHB-a, je djelatna tvar koja uzrokuje depresiju SŽS-a s dobro poznatim potencijalom zlouporabe.
English: Very common: nausea (the frequency of nausea is higher in women than men) Common: vomiting, diarrhoea, abdominal pain upper, Uncommon: faecal incontinence
Croatian: Vrlo često: mučnina (učestalost mučnine je veća u žena nego u muškaraca) Često: povraćanje, proljev, bol u gornjem dijelu abdomena Manje često: inkontinencija stolice
English: The use of haemodialysis and other forms of extracorporeal medicinal product removal have not been studied in sodium oxybate overdose.
Croatian: Primjena hemodijalize i drugih oblika uklanjanja lijekova iz tijela nije ispitivano u slučajevima predoziranja natrijevim oksibatom.
English: Narcolepsy is a sleep disorder that may include attacks of sleep during normal waking hours, as well as cataplexy, sleep paralysis, hallucinations and poor sleep.
Croatian: Narkolepsija je poremećaj spavanja koji uključuje iznenadne epizode spavanja kad je čovjek normalno budan, kao i pojavu katapleksije, paralize sna, halucinacije i lošeg spavanja.
English: Your doctor may gradually increase your dose up to a maximum of 9 g/day given as two equally divided doses of 4.5 g/dose.
Croatian: Liječnik će Vam postupno povećavati dozu do najviše 9 g/dan podijeljeno u dvije jednake doze od po 4,5 g/dozi.
English: • How to Take Xyrem brochure (to be given to the patient): to provide patients with information related to the use of Xyrem.
Croatian: Kako uzimati Xyrem (dat će se bolesniku): kako bi se bolesnicima osigurale informacije vezano uz uzimanje Xyrema.
English: Immune system disorders Uncommon: hypersensitivity
Croatian: Poremećaji imunološkog sustava Manje često: preosjetljivost
English: Eye disorders Common: blurred vision
Croatian: Poremećaji oka Često: zamagljen vid
English: The pharmacokinetics of sodium oxybate in paediatric patients under the age of 18 years have not been studied.
Croatian: Pedijatrijska populacija Farmakokinetika natrijeva oksibata nije ispitivana u pedijatrijskih bolesnika mlađih od 18 godina.
English: The primary pathway involves a cytosolic NADP+-linked enzyme, GHB dehydrogenase, that catalyses the conversion of sodium oxybate to succinic semialdehyde, which is then biotransformed to succinic acid by the enzyme succinic semialdehyde dehydrogenase.
Croatian: Primarni metabolički put uključuje citoplazmatski enzim povezan s NADP+, GHBdehidrogenazu koja katalizira pretvaranje natrijeva oksibata u sukcinat-semialdehid koji se zatim pretvara dalje u sukcinatnu kiselinu enzimom sukcinat-semialdehid-dehidrogenaza.
English: Patients taking sodium oxybate will have an additional daily intake of sodium that ranges from 0.82 g (for a 4.5 g/day Xyrem dose) to 1.6 g (for a 9 g/day Xyrem dose).
Croatian: U bolesnika koji uzimaju natrijev oksibat dodatni dnevni unos natrija varira u rasponu od 0,82 g (za Xyrem u dozi od 4,5 g/dan) do 1,6 g (za Xyrem u dozi od 9 g/dan).
English: Not known: suicidal ideation, homicidal ideation, aggression, euphoric mood, sleep-related eating disorder, panic attack, mania / bipolar disorder, delusion, bruxism, irritability and increased libido
Croatian: Nepoznato: suicidalne ideje, ideje o počinjenju ubojstva, agresija, euforično raspoloženje, poremećaj hranjenja povezan sa spavanjem, napadaj panike, manija/bipolarni poremećaj, deluzija, bruksizam, iritabilnost i povećani libido
English: Succinic acid enters the Krebs cycle where it is metabolised to carbon dioxide and water.
Croatian: Sukcinatna kiselina ulazi u Krebsov ciklus gdje se dalje biotransformira do ugljikovog dioksida i vode.
English: Administration of sodium oxybate immediately after a high fat meal resulted in delayed absorption (average Tmax increased from 0.75 hr to 2.0 hr) and a reduction in peak plasma level (Cmax) by a mean of 58 and of systemic exposure (AUC) by 37.
Croatian: Primjena natrijeva oksibata neposredno nakon obroka s visokim udjelom masti uzrokuje odgođenu apsorpciju (prosječni Tmax se produžuje s 0,75 sata na 2 sata) i smanjenje vršnih koncetracija u plazmi (Cmax) u prosjeku za 58% te sistemske izloženosti (AUC) za 37%.
English: Musculoskeletal and connective tissue disorders Common: arthralgia, muscle, spasms, back pain
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često: artralgija, grčevi u mišićima, bol u leđima
English: A recommendation to reduce sodium intake should be carefully considered in the management of patients with heart failure, hypertension or compromised renal function (see sections 4.2 and 4.9).
Croatian: Preporučuje se pažljivo razmotriti preporuku za smanjenje unosa natrija u bolesnika sa zatajenjem srca, hipertenzijom ili oštećenjem funkcije bubrega (vidjeti dio 4.2 i 4.9).
English: Table 2 Summary of ESS in Trial 1
Croatian: Tablica 2 Pregled ESS-a u Ispitivanju 1
English: The combined use of alcohol, or any CNS -depressant medicinal product, with sodium oxybate may result in potentiation of the CNS-depressant effects of sodium oxybate as well as increased risk of respiratory depression.
Croatian: Istodobna primjena alkohola ili bilo kojeg depresora SŽS-a s natrijevim oksibatom može dovesti do pojačavanja depresornih učinaka natrijeva oksibata na SŽS kao i povećati rizik od respiratorne depresije.
English: Bradycardia and hypothermia may accompany unconsciousness, as well as muscular hypotonia, but tendon reflexes remain intact.
Croatian: Gubitak svijesti može biti praćen bradikardijom i hipotermijom kao i mišićnim hipotonusom, uz očuvane tetivne reflekse.
English: Table 3 Summary of CGI-c in Trial 1
Croatian: Tablica 3 Pregled CGI-c-a u Ispitivanju
English: Changes in sleep patterns have been observed in breastfed infants from exposed mothers.
Croatian: Opažena je promjena obrasca spavanja u dojenčadi na majčinom mlijeku liječenih žena.
English: Primary Efficacy
Croatian: Ispitivanje Primarna mjera djelotvornosti
English: Xyrem is provided for use with a graduated measuring syringe and two 90 mL dosing cups with child resistant caps.
Croatian: Uz Xyrem osigurana je graduirana mjerna štrcaljka i dvije 90 mL dozirne čaše sa sigurnosnim zatvaračima za djecu.
English: Cataplexy Attacks
Croatian: Napadaji katapleksije
English: Therefore, patients should be warned against the use of topiramate in conjunction with sodium oxybate (section 4.5).
Croatian: Stoga bolesnike treba upozoriti da ne uzimaju topiramat zajedno s natrijevim oksibatom (vidjeti dio 4.5).
English: The safety and efficacy of sodium oxybate for the treatment of narcolepsy symptoms was established in four multicentre, randomised, double-blind, placebo-controlled, parallel-group trials in patients with narcolepsy with cataplexy except for one trial where cataplexy was not required for enrolment.
Croatian: Sigurnost i djelotvornost natrijeva oksibata u liječenju simptoma narkolepsije utvrđene su u četiri multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja s paralelnim skupinama u bolesnika s narkolepsijom s katapleksijom, osim jednog ispitivanja u kojem katapleksija nije bila uvjet za uključenje.
English: For storage conditions after first opening of the medicinal product, see section 6.3 For storage conditions after dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon prvog otvaranja lijeka vidjeti u dijelu 6.3.
English: Sodium oxybate also has the potential to induce respiratory depression.
Croatian: Natrijev oksibat ima potencijal da uzrokuje respiratornu depresiju.
English: While sitting in bed, drink all of the second dose right before lying down to continue sleeping.
Croatian: Sjednite u krevetu, popijte sav sadržaj iz druge čaše te ponovno legnite i nastavite spavati.
English: After removing the cap, set the bottle upright on a table-top.
Croatian: Nakon što ste odstranili zatvarač, stavite bocu uspravno na stol.
English: The recommended starting dose for Xyrem, when used together with valproate, is 3.6 g/day, given as two equally divided doses of 1.8 g. Take the first dose upon getting into bed and the second dose 2.5 to 4 hours later.
Croatian: Kada se koristi zajedno s valproatom, preporučena početna doza za Xyrem je 3,6 g/dan podijeljeno u dvije jednake doze od 1,8 g, prvu dozu uzmite prilikom odlaska na spavanje, a drugu dozu 2,5 do 4 sata kasnije.
English: Diclofenac
Croatian: Diklofenak
English: Possible pharmacodynamic and pharmacokinetic interactions when sodium oxybate is used concomitantly with topiramate cannot be excluded as clinical observation(s) of coma, and increased plasma GHB concentration were reported in a patient(s) under concomitant use of sodium oxybate and topiramate (section 4.4).
Croatian: Moguće farmakodinamičke i farmakokinetičke interakcije kod istodobnog uzimanja natrijeva oksibata i topiramata nije moguće isključiti budući da je(su) prijavljeno(a) kliničko(a) opažanje(a) kome i povišene koncentracije GHB-a u plazmi u bolesnika koji su istodobno uzimali natrijev oksibat i topiramat (dio 4.4).
English: Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and ibuprofen.
Croatian: Studije interakcija lijekova u zdravih odraslih ispitanika pokazale su da nema farmakokinetičkih interakcija između natrijeva oksibata i ibuprofena.
English: The starting dose should be halved in all patients with hepatic impairment, and response to dose increments monitored closely (see section 4.4 and 5.2).
Croatian: Početna doza u svih bolesnika s oštećenjem jetre treba biti u pola manja i odgovor na povećanje doze treba pomno nadzirati (vidjeti dio 4.4 i 5.2).
English: Increased sleepiness was observed after concomitant administration of sodium oxybate (2.25 g) and lorazepam (2 mg).
Croatian: Pojačana pospanost zabilježena je nakon istodobne primjene natrijeva oksibata (2,25 g) i lorazepama (2 mg).
English: There is very limited experience with sodium oxybate in the elderly.
Croatian: Iskustva s primjenom natrijevog oksibata u starijih osoba su vrlo ograničena.
English: In some patients, cataplexy may return at a higher frequency on cessation of sodium oxybate therapy, however this may be due to the normal variability of the disease.
Croatian: U nekih se bolesnika ukidanjem terapije natrijeva oksibata može ponovno javiti katapleksija i to s većom učestalošću; međutim to može biti posljedica normalne varijabilnosti osnovne bolesti.
English: While holding the bottle in its upright position, insert the press-in-bottle-adaptor into the neck of the bottle.
Croatian: Dok držite bocu u uspravnom položaju, utisnite nastavak u grlo boce.
English: Epworth Sleepiness Scale (ESS; range 0-24) Dose Group [g/d (n)] Baseline
Croatian: Epworthova skala pospanosti (ESS; raspon 0-24)
English: The precise mechanism by which sodium oxybate produces an effect is unknown, however sodium oxybate is thought to act by promoting slow (delta) wave sleep and consolidating night-time sleep.
Croatian: Točan mehanizam djelovanja natrijeva oksibata nije poznat, međutim pretpostavlja se da natrijev oksibat djeluje tako da potiče nastajanje sporih (delta) valova u spavanju te poboljšava spavanje po noći.
English: All patients with impaired renal function should consider a recommendation to reduce sodium intake (see section 4.4).
Croatian: U svih bolesnika s oštećenom funkcijom bubrega potrebno je preporučiti smanjenje unosa natrija (vidjeti dio 4.4).
English: Elderly patients should be monitored closely for impaired motor and/or cognitive function when taking sodium oxybate (see section 4.4).
Croatian: Starije bolesnike treba pomno nadzirati tijekom primjene natrijeva oksibata zbog mogućnosti oštećenja motoričke i/ili kognitivne funkcije (vidjeti dio 4.4).
English: Because emesis may occur in the presence of impaired consciousness, appropriate posture (left lateral recumbent position) and protection of the airway by intubation may be warranted.
Croatian: Budući da može doći do povraćanja u stanju poremećaja svijesti, bolesnika treba staviti u odgovarajući položaj (lijevi postranični ležeći položaj) i omogućiti prohodnost dišnih puteva intubacijom.
English: Malic acid for pH adjustment Sodium hydroxide for pH adjustment
Croatian: 6.1 Popis pomoćnih tvari voda, pročišćena malatna kiselina za podešavanje pH natrijev hidroksid za podešavanje pH
English: The co-administration of omeprazole has no clinically significant effect on the pharmacokinetics of sodium oxybate.
Croatian: Istodobna primjena omeprazola nema značajnog kliničkog učinka na farmakokinetiku natrijeva oksibata.
English: Sodium Oxybate should not be used during breastfeeding.
Croatian: Natrijev oksibat se ne smije primjenjivati tijekom dojenja.
English: Vascular disorders Common: hypertension
Croatian: Krvožilni poremećaji Često: hipertenzija
English: Table 6 Summary of outcome in Trial 4
Croatian: Tablica 6 Sažetak ishoda u Ispitivanju 4
English: Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and diclofenac.
Croatian: Studije interakcija lijekova u zdravih odraslih ispitanika pokazale su da nema farmakokinetičkih interakcija između natrijeva oksibata i diklofenaka.
English: The recommended starting dose is 4.5 g/day sodium oxybate divided into two equal doses of 2.25 g/dose.
Croatian: Preporučena početna doza je 4,5 g/dan natrijeva oksibatapodijeljeno u dvije jednake doze od 2,25 g/dozi.
English: Each carton contains one bottle, a press-in bottle adaptor, a graduated measuring device (polypropylene syringe), two polypropylene dosing cups and two HDPE child resistant screw closures.
Croatian: Svaka kutija sadrži jednu bocu, nastavak koji se utisne u grlo boce, graduirani dozator (polipropilenska štrcaljka), dvije polipropilenske dozirne čaše i dva HDPE navojna sigurnosna zatvarača za djecu.
English: Skin and subcutaneous tissue disorders Common: hyperhidrosis, rash Not known: urticaria, angioedema, seborrhoea
Croatian: Poremećaji kože i potkožnog tkiva Često: pojačano znojenje, osip Nepoznato: urtikarija, angioedem, seboreja
English: Xyrem is a clear to slightly opalescent solution.
Croatian: Xyrem je bistra do blago opalescentna otopina.
English: Ear and labyrinth disorders Common: vertigo Not known tinnitus
Croatian: Poremećaji uha i labirinta Često: vrtoglavica Nepoznato: tinitus
English: Patients with a previous history of a depressive illness and/or suicide attempt should be monitored especially carefully for the emergence of depressive symptoms while taking sodium oxybate.
Croatian: U bolesnika s depresijom i/ili pokušajem samoubojstva u anamnezi, tijekom uzimanja natrijeva oksibata treba strogo nadzirati zbog mogućnosti pojave simptoma depresije.
English: Doses should be taken within 24 hours after preparation, or else discarded.
Croatian: Nakon pripreme, doze treba upotrijebiti unutar 24 sata ili u suprotnom baciti.
English: Take the first dose upon getting into bed and the second dose 2.5 to 4 hours later.
Croatian: Prvu dozu uzmite neposredno prije odlaska na počinak, a drugu 2,5 do 4 sata kasnije.
English: Symptoms of Xyrem overdose may include agitation, confusion, impaired movement, impaired breathing, blurred vision, profuse sweating, headache, vomiting, decreased consciousness leading to coma and seizures excessive thirst, muscle cramps and weakness.
Croatian: Simptomi predoziranja Xyremom uključuju uznemirenost, smetenost, otežano kretanje, otežano disanje, zamagljen vid, pojačano znojenje, glavobolju, povraćanje, suženje svijesti koje vodi prema komi i napadajima, prekomjernu žeđ, grčeve u mišićima i slabost.
English: Recap the second cup.
Croatian: Prethodno zatvorite i drugu čašu.
English: Table 4 Summary of MWT in Trial 2
Croatian: Tablica 4 Pregled MWT-a u Ispitivanju
English: Because the kidney does not have a significant role in the excretion of sodium oxybate, no pharmacokinetic study in patients with renal dysfunction has been conducted; no effect of renal function on sodium oxybate pharmacokinetics would be expected.
Croatian: Budući da bubrezi nemaju značajnu ulogu u izlučivanju natrijeva oksibata, farmakokinetička ispitivanja nisu provedena u bolesnika s poremećenom funkcijom bubrega.
English: How to store Xyrem
Croatian: Kako čuvati Xyrem
English: If this occurs, they should be evaluated fully, and appropriate intervention considered on an individual basis.
Croatian: U tim slučajevima bolesnike treba ponovno u potpunosti evaluirati i ako je potrebno, provesti odgovarajuću individualno prilagođenu intervenciju.
English: Prepare both doses before bedtime.
Croatian: Prije odlaska na spavanje pripremite odmah obje doze.
English: The starting dose should be halved in all patients with hepatic impairment, and response to dose increments monitored closely (see section 4.2).
Croatian: U svih bolesnika s oštećenjem jetre početnu dozu treba prepoloviti, a odgovor na povećanje doze pažljivo pratiti (vidjeti dio 4.2).
English: In a rat carcinogenicity study with oxybate no compound-related tumours were identified.
Croatian: U ispitivanju karcinogenosti oksibata u štakora nije bilo tumora povezanih s lijekom.
English: To help you, the Xyrem carton contains 1 bottle of medicine, a measuring syringe and two dosing cups with child-resistant caps.
Croatian: Kako bi Vam se olakšala priprema, pakiranje Xyrema sadrži 1 bocu lijeka, odmjernu štrcaljku i dvije dozirne čaše sa sigurnosnim zatvaračem za djecu.
English: Table 5 Summary of outcomes in Trial 3
Croatian: Tablica 5 Sažetak ishoda u Ispitivanju
English: Co-administration of sodium oxybate and diclofenac in healthy volunteers reduced the attention deficit caused by the administration of Xyrem alone as measured by psychometric tests.
Croatian: U skladu s mjerenjima pomoću psihometrijskih testova istodobna primjena natrijeva oksibata i diklofenaka u zdravih dobrovoljaca smanjila je poremećaj pažnje uzrokovan primjenom samoga Xyrema.
English: In rabbits, slight foetotoxicity was observed.
Croatian: U kunića je zabilježena blaga fetotoksičnost.
English: Common: depression, cataplexy, anxiety, abnormal dreams, confusional state, disorientation, nightmares, sleepwalking, sleep disorder, insomnia, middle insomnia, nervousness Uncommon: suicide attempt, psychosis, paranoia, hallucination, abnormal thinking, agitation, initial insomnia
Croatian: Često: depresija, katapleksija, anksioznost, neuobičajeni snovi, stanje smetenosti, dezorijentacija, noćne more, hodanje u snu, poremećaj spavanja, insomnija, srednja insomnija, nervoza Manje često: pokušaj samoubojstva, psihoza, paranoja, halucinacija, neuobičajeno razmišljanje, agitacija, početna insomnija
English: Reporting of suspected adverse reactions after authorisation of the medicinal product is important.
Croatian: Nakon dobivanja odobrenja lijeka važno je prijavljivanje sumnji na njegove nuspojave.
English: Limited data from pregnant patients during second and third trimester indicate no malformative or foeto/neonatal toxicity of sodium oxybate.
Croatian: Primjena natrijeva oksibata u malog broja trudnih bolesnica tijekom drugog i trećeg tromjesečja nije uzrokovalo pojavu malformacija niti toksičnih učinaka na plod/novorođenče.
English: The rate of adverse reactions has increased when sodium oxybate is co-administered with tricyclic antidepressants.
Croatian: Stopa nuspojava se povećala kod istodobne primjene natrijeva oksibata i tricikličkih antidepresiva.
English: If concomitant use is warranted, patient response and tolerability should be monitored and dose adjustments made if required (see section 4.2).
Croatian: Ako je istodobna primjena opravdana, treba pratiti odgovor bolesnika i podnošljivost te sukladno tome ako treba prilagoditi dozu (vidjeti dio 4.2).
English: What Xyrem looks like and contents of the pack Xyrem is supplied in a 240 mL amber plastic bottle containing 180 mL of oral solution and closed with a child-resistant cap.
Croatian: Xyrem dolazi u smeđoj plastičnoj boci od 240 mL koja sadrži 180 ml oralne otopine zatvorenoj sigurnosnim zatvaračem za djecu.
English: When higher doses up to 9 g/d of sodium oxybate are combined with higher doses of hypnotics (within the recommended dose range) pharmacodynamic interactions associated with symptoms of CNS depression and/or respiratory depression cannot be excluded (see section 4.3).
Croatian: Kad se istodobno primjenjuju visoke doze natrijeva oksibata do 9 g/dan s visokim dozama hipnotika (unutar preporučenog terapijskog raspona) ne može se isključiti pojava farmakodinamičkih interakcija povezanih sa simptomima depresije SŽS-a i/ili respiratorne depresije (vidjeti dio 4.3).
English: Patients may become confused while being treated with sodium oxybate.
Croatian: Bolesnici tijekom liječenja natrijevim oksibatom mogu postati konfuzni.
English: When patients first start taking sodium oxybate, until they know whether this medicinal product will still have some carryover effect on them the next day, they should use extreme care while driving a car, operating heavy machines, or performing any other task that could be dangerous or require full mental alertness.
Croatian: Kad bolesnici prvi put počinju uzimati natrijev oksibat moraju biti vrlo oprezni za vrijeme vožnje automobila, upravljanja velikim strojevima ili izvođenja bilo kojeg drugog zadatka koji bi mogao biti opasan ili zahtijeva punu budnost dok ne utvrde kako lijek utječe na njih idući dan.
English: Topiramate
Croatian: Topiramat
English: An increasing depth of coma has been observed at higher doses.
Croatian: Pri većim dozama uočeno je povećanje stupnja kome.
English: The effectiveness of sodium oxybate for the treatment of narcolepsy symptoms was established in four multicentre, randomised, double-blind, placebo-controlled, parallel-group trials (Trial 1, 2, 3 and 4) in patients with narcolepsy with cataplexy except for trial 2 where cataplexy was not required for enrolment Concomitant stimulant use was permitted in all trials (except for the active-treatment phase of Trial 2); antidepressants were withdrawn prior to active treatment in all trials with the exception of Trial 2.
Croatian: Učinkovitost natrijeva oksibata u liječenju simptoma narkolepsije utvrđena je u četiri multicentrična, randomizirana, dvostruko-slijepa, placebom kontrolirana ispitivanja u paralelnim grupama (Ispitivanje 1, 2, 3 i 4) u bolesnika s narkolepsijom i katapleksijom, osim u Ispitivanju 2 u kojem katapleksija nije bila uvjet za uključivanje u ispitivanje.
English: Respiratory, thoracic and mediastinal disorders Common: dyspnoea, snoring, nasal congestion Not known: respiratory depression, sleep apnoea
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Često: dispneja, hrkanje, kongestija nosa Nepoznato: respiratorna depresija, apneja u snu