FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Ena škatla vsebuje eno plastenko, adapter, ki se pritisne v plastenko, graduiran merilni pripomoček (polipropilenska injekcijska brizga), dve polipropilenski odmerni merici in dve HDPE navojni zaporki, varni za otroke.
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).
Slovenian: Kadar se višje odmerke, do 9 g/dan natrijevega oksibata, kombinira z višjimi odmerki hipnotikov (znotraj razpona priporočenih odmerkov) se farmakodinamičnih interakcij povezanih s simptomi depresije centralnega živčnega sistema in/ali respiratorne depresije ne more izključiti (glejte poglavje 4.3).
English: If a patient experiences urinary or faecal incontinence during sodium oxybate therapy, the prescriber should consider pursuing investigations to rule out underlying aetiologies.
Slovenian: Če se med zdravljenjem z natrijevim oksibatom pojavi inkontinenca seča ali blata, mora zdravnik, ki je predpisal zdravilo, razmisliti o dodatnih preiskavah, s katerimi bo izključil drugo etiologijo stanja.
English: General disorders and administration site conditions Common: asthenia, fatigue, feeling drunk, oedema peripheral
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti: astenija, utrujenost, občutek opitosti, periferni edem
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.
Slovenian: dehidrogenazo GHB, ki katalizira pretvorbo natrijevega oksibata v sukcinat-semialdehid, ki se nato biotransformira v jantarno kislino z encimom sukcinat-semialdehid-dehidrogenaza.
English: After removing the cap, set the bottle upright on a table-top.
Slovenian: Ko ste odstranili zaporko, postavite plastenko v pokončnem položaju na mizo.
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.
Slovenian: Psihometrični testi so pokazali, da je sočasna uporaba natrijevega oksibata in diklofenaka pri zdravih prostovoljcih poslabšala pomanjkanje pozornosti, ki ga povzroči uporaba samo zdravila Xyrem.
English: Perinatal mortality was increased and mean pup weight was decreased during the lactation period in high-dose F1 animals.
Slovenian: V času laktacije je bila pri živalih F1, ki so prejemale velike odmerke, povečana perinatalna smrtnost, srednja vrednost mase mladičev pa zmanjšana.
English: Sodium oxybate undergoes significant presystemic (hepatic first-pass) metabolism.
Slovenian: Jetrna okvara: Natrijev oksibat je podvržen izraziti predsistemski (prvi prehod preko jeter) presnovi.
English: Remove the cap from the first dosing cup by pressing down on the childresistant locking tab and turning the cap anticlockwise (to the left).
Slovenian: Odstranite zaporko iz prve odmerne merice, tako da pritisnete na za otroke varno zaporno zanko in zavrtite zaporko v nasprotni smeri urinega kazalca (v levo).
English: The recommended starting dose is 4.5 g/day, given as two equally divided doses of 2.25 g/dose.
Slovenian: Priporočeni začetni odmerek je 4,5 g/dan, ki ga morate vzeti razdeljenega na dva enaka odmerka po 2,25 g/odmerek.
English: Malic acid for pH adjustment Sodium hydroxide for pH adjustment
Slovenian: 6.1 Seznam pomožnih snovi prečiščena voda jabolčna kislina za uravnavanje pH natrijev hidroksid za uravnavanje pH
English: The first dose each night was taken at bedtime and the second dose was taken 2.5 to 4 hours later.
Slovenian: Prvi odmerek so bolniki vsako noč vzeli tik pred spanjem, drugega pa 2,5 do 4 ure kasneje.
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.
Slovenian: Učinkovitost natrijevega oksibata za zdravljenje simptomov narkolepsije je bila dokazana v štirih multicentričnih, randomiziranih, dvojno slepih, s placebom nadzorovanih preskušanjih v vzporednih skupinah (1., 2., 3. in 4. preskušanje) pri bolnikih z narkolepsijo s katapleksijo, razen pri 2. preskušanju, kjer katapleksija ni bila pogoj za vključitev v študijo.
English: Sodium oxybate p <0.001
Slovenian: mediana napadi/dva tedna placebo natrijev oksibat p <0,001
English: Sleep Architecture/ ESS/CGIc/Naps
Slovenian: Arhitektura spanja/ ESS/CGIc/dremeži
English: After dilution in the dosing cups the preparation should be used within 24 hours.
Slovenian: Po razredčenju v odmernih mericah morate pripravek porabiti v 24 urah.
English: The oral solution is clear to slightly opalescent.
Slovenian: Peroralna raztopina je bistra do rahlo opalescentna.
English: Each mL contains 500 mg of sodium oxybate.
Slovenian: En ml vsebuje 500 mg natrijevega oksibata.
English: The recommended starting dose is 4.5 g/day sodium oxybate divided into two equal doses of 2.25 g/dose.
Slovenian: Priporočeni začetni odmerek natrijevega oksibata je 4,5 g/dan, razdeljen na dva enaka odmerka po 2,25 g/odmerek.
English: Empty the medicine from the syringe into one of the dosing cups provided by pushing on the plunger (See Figure 3).
Slovenian: Zdravilo, ki je v injekcijski brizgi, s pritiskom na bat prenesite v eno od priloženih odmernih meric (glejte sliko 3).
English: Number of Subjects
Slovenian: Število preiskovancev
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).
Slovenian: Pri sočasni uporabi natrijevega oksibata s topiramatom ne smemo izključiti možnih farmakodinamičnih in farmakokinetičnih interakcij, saj so poročali o kliničnih opažanjih kome in povečanju plazemske koncentracije GHB pri bolnikih, ki so jemali natrijev oksibat skupaj s topiramatom (poglavje 4.4).
English: Therefore, episodes of sleepwalking should be fully evaluated and appropriate interventions considered.
Slovenian: je treba upoštevati tveganje za poškodbo ali samopoškodbo ter epizode hoje v spanju v celoti ovrednotiti in razmisliti o sprejetju ustreznih ukrepov.
English: Patients should be warned against the use of any alcoholic beverages in conjunction with sodium oxybate.
Slovenian: Bolnike je zato treba opozoriti na nevarnost uporabe alkoholnih pijač skupaj z natrijevim oksibatom.
English: You may find that your cataplexy attacks return if your medicine is stopped and you may experience insomnia, headache, anxiety, dizziness, sleeping problems, sleepiness, hallucination and abnormal thinking.
Slovenian: Če boste prenehali jemati zdravilo, se vam lahko zopet pojavijo kataplektični napadi ter tudi nespečnost, glavobol, občutek tesnobe, omotičnost, težave s spanjem, zaspanost, halucinacije in motnje mišljenja.
English: Xyrem should be taken orally upon getting into bed and again between 2.5 to 4 hours later.
Slovenian: Zdravilo Xyrem mora bolnik vzeti peroralno tik pred spanjem in nato spet 2,5 ure do 4 ure kasneje.
English: Tabulated summary of adverse reactions Undesirable effects are listed according to MedDRA System Organ Class.
Slovenian: Neželeni učinki so navedeni po MedDRA podatkovni bazi glede na organske sisteme.
English: Emesis (even with impaired consciousness), diaphoresis, headache, and impaired psychomotor skills may be observed.
Slovenian: Opazimo lahko tudi bruhanje (tudi ob zmanjšani zavesti), diaforezo, glavobol in motnje v psihomotoričnih spretnostih.
English: 180 mL solution in an amber oval 240 mL PET bottle which is delivered with a plastic/foil seal and closed with a child resistant closure composed of HDPE/polypropylene with a pulpboard inner liner.
Slovenian: 6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo 180 ml raztopine v rjavi, ovalni 240 ml PET plastenki, zapečateni s plastično folijo in zaprti z zaporko, varno za otroke iz HDPE/polipropilena z notranjim vložkom iz stisnjene lepenke.
English: • Topiramate
Slovenian: • Topiramat
English: Xyrem 500 mg/mL oral solution Sodium oxybate
Slovenian: Xyrem 500 mg/ml peroralna raztopina natrijev oksibat
English: Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na poseben recept in le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
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).
Slovenian: Odmerek je treba titrirati s povečevanjem ali zmanjševanjem v korakih po 1,5 g/dan (t. j. 0.75 g/odmerek) do ustreznega učinka, ki temelji na učinkovitosti in bolnikovem prenašanju zdravila (glejte poglavje 4.4), in sicer do največjega odmerka 9 g/dan, razdeljenega na dva enaka odmerka po 4,5 g/odmerek.
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).
Slovenian: Pri vseh bolnikih z jetrno okvaro mora biti začetni odmerek za polovico manjši, odgovor na postopno povečanje odmerka pa je treba skrbno spremljati (glejte poglavji 4.4 in 5.2).
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.
Slovenian: Ledvična okvara: Ker ledvice nimajo pomembne vloge pri izločanju natrijevega oksibata, farmakokinetična študija pri bolnikih z ledvično disfunkcijo ni bila izvedena.
English: The average time to peak plasma concentration (Tmax) ranged from 0.5 to 2 hours in eight pharmacokinetic studies.
Slovenian: V osmih farmakokinetičnih študijah je bil povprečni čas za dosego največje plazemske koncentracije (Tmax) med 0,5 ure in 2 urama.
English: Elderly patients should be monitored closely for impaired motor and/or cognitive function when taking sodium oxybate (see section 4.4).
Slovenian: V času jemanja natrijevega oksibata je treba starejše bolnike skrbno spremljati zaradi možnih motenj v motoričnih in/ali kognitivnih funkcijah (glejte poglavje 4.4).
English: Immune system disorders Uncommon: hypersensitivity
Slovenian: Bolezni imunskega sistema občasni: preobčutljivost
English: Although the clinical trial experience with sodium oxybate in narcolepsy/cataplexy patients at therapeutic doses does not show clear evidence of a withdrawal syndrome, in rare cases, events such as insomnia, headache, anxiety, dizziness, sleep disorder, somnolence, hallucination, and psychotic disorders were observed after GHB discontinuation.
Slovenian: Čeprav izkušnje iz kliničnih preskušanj z uporabo natrijevega oksibata v terapevtskih odmerkih pri bolnikih z narkolepsijo/katapleksijo niso dale jasnih dokazov o odtegnitvenem sindromu, so v redkih primerih po prekinitvi zdravljenja z GHB poročali o pojavu nespečnosti, glavobola, občutka tesnobe, omotičnosti, motenj spanja, zaspanosti, halucinacijah in psihotičnih motnjah.
English: Sodium oxybate was non-mutagenic and non-clastogenic in in vitro and in vivo assays.
Slovenian: V in vitro in in vivo analizah natrijev oksibat ni bil mutagen in klastogen.
English: Sodium oxybate, which is as the sodium salt of GHB, is a CNS depressant active substance with wellknown abuse potential.
Slovenian: Natrijev oksibat, ki je natrijeva sol GHB, je zdravilna učinkovina, ki zavira centralni živčni sistem in za katero je dobro znana možnost zlorabe.
English: Remove the bottle cap by pushing down while turning the cap anticlockwise (to the left).
Slovenian: Odstranite zaporko plastenke tako, da jo med vrtenjem v nasprotni smeri urinega kazalca (v levo) pritisnete navzdol.
English: Seizures have been observed in patients treated with sodium oxybate.
Slovenian: Pri bolnikih, ki so se zdravili z natrijevim oksibatom, so opazili epileptične napade.
English: After dilution in the dosing cups, the preparation should be used within 24 hours.
Slovenian: Po redčenju v odmernih mericah je treba zdravilo porabiti v 24 urah.
English: Respiratory, thoracic and mediastinal disorders Common: dyspnoea, snoring, nasal congestion Not known: respiratory depression, sleep apnoea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti: dispneja, smrčanje, zamašitev nosu neznana: depresija dihanja, apneja med spanjem
English: Do not take Xyrem - if you are allergic to sodium oxybate or any of the other ingredients of this medicine (listed in section 6); - if you have succinic semialdehyde dehydrogenase deficiency (a rare metabolic disorder); - if you suffer from major depression; - if you are being treated with opioid or barbiturate medicines.
Slovenian: - če imate zmanjšano delovanje encima sukcinat-semialdehid-dehidrogenaze (redka presnovna bolezen): - če imate hudo depresijo; - če se zdravite z opioidi ali barbiturati.
English: Sleeping problems including insomnia, blurred vision, feeling the heartbeat, vomiting, stomach pains, diarrhoea, anorexia, decreased appetite, weight loss, weakness, abnormal dreams, tiredness, feeling drunk, sleep paralysis, sleepiness, trembling, confusion/ disorientation, nightmares, sleep walking, bed wetting, sweating, depression, muscle cramps, swelling, fall, joint pain, back pain, excessive daytime sleepiness, balance disorder, disturbance in attention, decreased sensitivity particularly to touch, abnormal touch sensation, feeling of “pins and needles” (part of the body (typically a foot or hand) begins to tingle and becomes numb, or"falls asleep" sedation, abnormal taste, anxiety, difficulty in falling asleep in the middle of the night, nervousness, feeling of “spinning” (vertigo), urinary incontinence, shortness of breath, snoring, congestion of the nose, rash, inflammation of the sinuses, inflammation of nose and throat, increased blood pressure
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): težave pri spanju vključno z nespečnostjo, zamegljen vid, občutek utripanja srca, bruhanje, bolečine v želodcu, driska, anoreksija, zmanjšan apetit, izguba telesne mase, šibkost, neobičajne sanje, utrujenost, občutek pijanosti, paraliza v spanju, zaspanost, drgetanje, zmedenost/motnje orientacije, nočne more, hoja v spanju, močenje postelje, potenje, depresija, mišični krči, otekline, padec, bolečine v sklepih, bolečine v hrbtu, pretirana zaspanost čez dan, motnje ravnotežja, motnje pozornosti, zmanjšana občutljivost, še posebej na dotik, nenormalen občutek na dotik, občutek mravljinčenja (v delu telesa (običajno stopalo ali dlan) se pojavi občutek zbadanja in otrplost ali pa »zaspi«), sedacija, nenavaden okus, tesnoba, težave zaspati sredi noči, živčnost, občutek “vrtenja” (vrtoglavica), nezmožnost zadrževanja urina, oteženo dihanje, smrčanje, zamašen nos, izpuščaj, vnetje sinusov, vnetje nosu in žrela, povišan krvni tlak
English: Although the clinical trial experience with sodium oxybate in narcolepsy/cataplexy patients at therapeutic doses does not show clear evidence of a withdrawal syndrome, in rare cases, adverse reactions such as insomnia, headache, anxiety, dizziness, sleep disorder, somnolence, hallucination, and psychotic disorders were observed after GHB discontinuation.
Slovenian: Čeprav izkušnje iz kliničnih preskušanj z uporabo natrijevega oksibata v terapevtskih odmerkih pri bolnikih z narkolepsijo/katapleksijo niso dale jasnih dokazov o odtegnitvenem sindromu, so v redkih primerih po prekinitvi zdravljenja z GHB poročali o pojavu neželenih učinkov, kot so nespečnost, glavobol, občutek tesnobe, omotičnost, motnje spanja, somnolenca, halucinacije in psihotične motnje.
English: Your doctor will ask if you have ever abused any drugs before you start taking Xyrem and whilst you are using the medicine
Slovenian: Preden boste začeli z jemanjem zdravila Xyrem in medtem, ko ga boste jemali, vas bo zdravnik vprašal, če ste že kdaj zlorabili katerokoli zdravilo.
English: Clinical Global Impressions of Change (CGI-c) Dose Group [g/d (n)]
Slovenian: Celostni klinični odziv (CGI-c)
English: The average peak plasma concentrations (1st and 2nd peak) following administration of a 9 g daily dose divided into two equivalent doses given four hours apart were 78 and 142 µg/mL, respectively.
Slovenian: Po peroralni aplikaciji odmerka 9 g, razdeljenega na dva enaka odmerka, ki ju bolnik prejme v razmiku 4 ur, je bila povprečna največja plazemska koncentracija pri prvem maksimumu 78 g/ml, pri drugem pa 142 g/ml.
English: Common: sleep paralysis, somnolence, tremor, balance disorder, disturbance in attention, hypoesthesia, paraesthesia, sedation, dysgeusia Uncommon: myoclonus, amnesia, restless legs syndrome Not known: convulsion, loss of consciousness, dyskinesia
Slovenian: Bolezni živčevja zelo pogosti: omotičnost, glavobol pogosti: paraliza v spanju, somnolenca, tremor, motnje ravnotežja, motnje pozornosti, hipoestezija, parestezija, sedacija, disgevzija občasni: mioklonus, amnezija, sindrom nemirnih nog neznana: konvulzija, izguba zavesti, diskinezija
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.
Slovenian: Kadar bolniki prvič začnejo z jemanjem natrijevega oksibata, morajo biti izjemno previdni pri vožnji avtomobila, upravljanju s težkimi stroji ali izvajanju drugih aktivnosti, ki bi lahko bile nevarne ali zahtevajo popolno mentalno budnost, dokler ne vedo, ali ima zdravilo nekaj vpliva na njih tudi naslednji dan.
English: Xyrem 500 mg/mL oral solution
Slovenian: Xyrem 500 mg/ml peroralna raztopina
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.
Slovenian: Če ste vzeli večji odmerek zdravila Xyrem, kot bi smeli Simptomi prevelikega odmerjanja zdravila Xyrem lahko vključujejo agitacijo, zmedenost, težave pri gibanju, težave pri dihanju, zamegljen vid, obilno znojenje, glavobol, bruhanje, zmanjšano zavest, ki vodi v komo in epileptični napad, prekomerno žejo, mišične krče in oslabelost.
English: The combined use of alcohol with sodium oxybate may result in potentiation of the central nervous system-depressant effects of sodium oxybate.
Slovenian: Pri sočasni uporabi alkohola z natrijevim oksibatom se lahko okrepijo zaviralni učinki natrijevega oksibata na centralni živčni sistem.
English: Convulsion, decreased breathing depth or rate, hives, suicidal thoughts, short cessation of breathing during sleep, euphoric mood, dry mouth, swelling face (angioedema), dehydration, panic attack, mania / bipolar disorder, delusion, bruxism (teeth grinding and jaw clenching), pollakiuria / micturition urgency (increase need to urinate), nocturia (excessive urination at night), tinnitus (noise in the ears such as ringing or buzzing) sleep-related eating disorder, loss of consciousness, increased appetite, irritability, aggression, dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) and thoughts of committing violent acts (including harming others), dandruff and increased sexual desire
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov): konvulzija (napad krčev), zmanjšana globina ali hitrost dihanja, koprivnica, misli o samomoru, kratka prekinitev dihanja med spanjem, evforično razpoloženje, suha usta, otekanje obraza (angioedem), dehidracija, panični napad, manija/bipolarna motnja, blodnje, bruksizem (škripanje z zobmi in stiskanje čeljusti), polakisurija/nujna potreba po uriniranju (povečana potreba po uriniranju), nokturija (prekomerno uriniranje ponoči), tinitus (zvok v ušesih kot zvonjenje ali šumenje), s spanjem povezana motnja hranjenja, izguba zavesti, povečan apetit, razdražljivost, agresivnost, diskinezija (nenormalni, nenadzorovani gibi udov) in misli, da bi storili nasilna dejanja (vključno škodovati drugim), prhljaj in povečano spolno poželenje.
English: To help you, the Xyrem carton contains 1 bottle of medicine, a measuring syringe and two dosing cups with child-resistant caps.
Slovenian: V pomoč vam bo podatek, da je v škatlici zdravila Xyrem 1 plastenka zdravila, merilna injekcijska brizga in dve odmerni merici z zaporkama, varnima za otroke .
English: Events of hypernatremia with metabolic alkalosis have been reported in the context of concomitant use of NaCl infusion.
Slovenian: Pri sočasni uporabi infuzije NaCl so poročali o primerih hipernatriemije z metabolično alkalozo.
English: Table 6 Summary of outcome in Trial 4
Slovenian: Preglednica 6 Pregled rezultatov pri 4. preskušanju obravnavana skupina število preiskovancev kataplektični napadi preskušanje 4
English: UCB Pharma Ltd.
Slovenian: United Kingdom UCB Pharma Ltd.
English: Cataplexy is the onset of sudden muscle weakness or paralysis without losing consciousness, in response to a sudden emotional reaction such as anger, fear, joy, laughter or surprise.
Slovenian: Pojavi se kot odgovor na nenadno čustveno reakcijo, kot so jeza, strah, veselje, smeh ali presenečenje.
English: Psychosis (a mental disorder that may involve hallucinations, incoherent speech, or disorganized and agitated behaviour), paranoia, abnormal thinking, hallucination, agitation, suicide attempt, difficulty in falling asleep, restless legs, forgetfulness, myoclonus (involuntary contractions of muscles), involuntary passage of faeces, hypersensitivity
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): psihoza (duševna motnja, ki lahko vključuje halucinacije, nepovezan govor ali neorganizirano in razburjeno vedenje), paranoja, motnje mišljenja, halucinacije, agitacija (vznemirjenost), poskus samomora, s težavo zaspati, nemirne noge, pozabljivost, mioklonus (nehoteno krčenje mišic), nehoteno uhajanje blata, preobčutljivost
English: Ear and labyrinth disorders Common: vertigo Not known tinnitus
Slovenian: Ušesne bolezni, vključno z motnjami labirinta pogosti: vrtoglavica neznana: tinitus
English: Xyrem contains the active substance sodium oxybate.
Slovenian: Zdravilo Xyrem vsebuje zdravilno učinkovino natrijev oksibat.
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.
Slovenian: V nacionalnem programu toksičnosti (NTP - National Toxicology Program) so ga klasificirali kot nekancerogenega pri podganah ter kot nezanesljivo kancerogenega pri miših, kjer se je rahlo povečala pogostnost feokromocitoma, kar pa je bilo zaradi velike smrtnosti v skupini z velikimi odmerki težko interpretirati.
English: Table 5 Summary of outcomes in Trial 3
Slovenian: Preglednica 5 Pregled rezultatov pri 3. preskušanju odmerek število preiskovancev kataplektični napadi