FrancophonIA/ELRC3.0 huggingface dataset:
English: Events associated with withdrawal syndrome have been observed outside the therapeutic range.
Slovenian: Učinke, povezane z odtegnitvenim sindromom, so opazili pri odmerkih zunaj terapevtskega območja.
English: Take doses within 24 hours after preparation.
Slovenian: Odmerke zaužijte v roku 24 ur od časa priprave.
English: Studies in male and female rats at doses up to 1,000 mg/kg/day GHB have shown no evidence of an adverse effect on fertility.
Slovenian: Študije na samcih in samicah podgan pri odmerkih do 1000 mg/kg/dan GHB niso pokazale neželenih učinkov na plodnost.
English: Because food significantly reduces the bioavailability of sodium oxybate, patients should eat at least several (2-3) hours before taking the first dose of Xyrem at bedtime.
Slovenian: Ker hrana značilno zmanjša biološko uporabnost natrijevega oksibata, morajo bolniki jesti vsaj nekaj ur (2 - 3) preden vzamejo prvi odmerek zdravila Xyrem tik pred spanjem.
English: Trial 1 EDS (ESS); CGIc
Slovenian: 1. preskušanje EDS (ESS); CGIc
English: Xyrem has a well-known abuse potential.
Slovenian: Pri zdravilu Xyrem je dobro znana možnost zlorabe.
English: Epileptic patients
Slovenian: Bolniki z epilepsijo
English: Elimination half-life was significantly longer in Class C and Class A patients than in control subjects (mean t1/2 of 59 and 32 versus 22 minutes).
Slovenian: Biološka razpolovna doba izločanja je bila značilno daljša pri bolnikih iz razreda C in A kot pri preiskovancih iz kontrolne skupine (srednja vrednost t1/2 59 in 32 proti 22 minutam).
English: A possible additive effect of antidepressants and sodium oxybate cannot be excluded.
Slovenian: Možnosti aditivnega učinka antidepresivov in natrijevega oksibata ni mogoče izključiti.
English: Because of the higher risk of sleep apnoea, patients with a BMI ≥40 kg/m should be monitored closely when taking sodium oxybate.
Slovenian: Zaradi povečanega tveganja za apnejo med spanjem se mora bolnike z ITM (BMI) ≥ 40 kg/m2 med jemanjem natrijevega oksibata skrbno spremljati.
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.
Slovenian: O primerih odvisnosti so poročali pri prepovedani uporabi GHB v pogostih, ponavljajočih se odmerkih (18 do 250 g/dan), ki presegajo terapevtsko območje odmerkov.
English: Rinse out the syringe with water.
Slovenian: Injekcijsko brizgo sperite z vodo.
English: Sodium oxybate is the sodium salt of GHB.
Slovenian: Natrijev oksibat je natrijeva sol GHB.
English: Additionally, patient response and tolerability should be carefully monitored and dose should be adapted accordingly.
Slovenian: Dodatno je treba skrbno spremljati bolnikov odziv in prenašanje ter odmerek ustrezno prilagoditi.
English: If you have kidney problems, you should consider a dietary recommendation to reduce sodium intake.
Slovenian: Če imate težave z ledvicami, morate razmisliti o dietnih priporočilih za zmanjšanje vnosa natrija.
English: Myoclonus and tonic-clonic seizures have been reported.
Slovenian: Poročali so tudi o mioklonusu in toničnokloničnih konvulzijah.
English: In a limited number of patients greater than the age of 65 years the pharmacokinetics of sodium oxybate was not different compared to patients younger than 65 years of age.
Slovenian: Starejši: Pri omejenem številu bolnikov, starejših od 65 let, se farmakokinetika natrijevega oksibata v primerjavi s farmakokinetiko pri bolnikih, mlajših od 65 let, ni razlikovala.
English: Cardiac disorders Common: palpitations
Slovenian: Srčne bolezni pogosti: palpitacije
English: Sodium Oxybate should not be used during breastfeeding.
Slovenian: Natrijev oksibat se ne sme uporabljati med dojenjem.
English: Repeat this step for the second dosing cup.
Slovenian: Korak ponovite tudi pri drugi odmerni merici.
English: You should continue to take Xyrem for as long as instructed by your doctor.
Slovenian: Zdravilo Xyrem morate jemati tako dolgo, kot vam je naročil vaš zdravnik.
English: The MAH has established a controlled distribution program that enhances existing controls for Xyrem to allow reaching the intended population of narcolepsy patients while minimizing the risk of Xyrem being diverted by those seeking to misuse it.
Slovenian: Imetnik dovoljenja za promet je vzpostavil nadzorovani program distribucije, ki poveča že obstoječi nadzor zdravila Xyrem ter s tem doseže populacijo bolnikov z narkolepsijo, medtem ko zmanjšuje tveganje, da bi zdravilo Xyrem prišlo do tistih, ki ga želijo zlorabiti.
English: In addition to the adverse reactions reported during clinical studies, adverse reactions have been reported in post-marketing experience.
Slovenian: Poleg neželenih učinkov, o katerih so poročali v kliničnih študijah, obstajajo še neželeni učinki v okviru izkušenj po začetku trženja zdravila.
English: 5 How to store Xyrem Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Xyrem Vsebina pakiranja in dodatne informacije
English: • Healthcare Professional Checklist (i.e. treatment initiation forms): to remind physicians to check the contraindications, warnings, and precautions in the SmPC and specifically highlighting that Xyrem can cause CNS and respiratory depression, that alcohol may result in the potentiation of CNS depression and that Xyrem has an abuse potential.
Slovenian: • Kontrolni seznam za zdravnike (obrazec za začetek zdravljenja): zdravnike opomni, da preverijo kontraindikacije in previdnostne ukrepe v SmPC in še posebej poudari, da lahko zdravilo Xyrem povzroči depresijo CŽS in depresijo dihanja, da lahko alkohol potencira depresijo CŽS in da ima zdravilo Xyrem potencial zlorabe.
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.
Slovenian: Primarno merilo učinkovitosti so bile spremembe v pretirani dnevni zaspanosti, ki so bile izmerjene z Epworthovo lestvico zaspanosti (ESS), in sprememba celotne resnosti bolnikovih simptomov narkolepsije, ki jo je preiskovalec ocenil z uporabo lestvice celostnega kliničnega odziva (CGI-c).
English: Table 3 Summary of CGI-c in Trial 1
Slovenian: Preglednica 3 Pregled CGI-c pri 1. preskušanju
English: None
Slovenian: Nič
English: Patients should be questioned regarding signs of Central Nervous System (CNS) or respiratory depression.
Slovenian: Bolnike je treba vprašati po znakih, povezanih z zaviranjem centralnega živčnega sistema ali dihanja.
English: There is a plastic covered foil seal on the top of the bottle, which must be removed before using the bottle for the first time.
Slovenian: Vrh plastenke pokriva pečat iz plastične folije, ki jo morate pred prvo uporabo plastenke odstraniti.
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).
Slovenian: Natrijev oksibat, apliciran pred nočnim spanjem, podaljša fazi spanja 3 in 4 ter poveča latenco spanja, medtem ko zmanjša pogostnost pojavljanja faze REM ob začetku spanja (SOREMP - sleep onset REM period).
English: Rebound effects and withdrawal syndrome
Slovenian: Povratno delovanje in odtegnitveni sindrom
English: If sodium oxybate and valproate are used concomitantly (see section 4.5), a decrease in sodium oxybate dose by 20% is recommended.
Slovenian: Če se natrijev oksibat in valproat uporabljata sočasno (glete poglavje 4.5), je priporočljivo zmanjšanje odmerka natrijevega oksibata za 20 %.
English: If you have the impression that the effect of Xyrem is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če menite, da je učinek zdravila Xyrem premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
English: Sodium oxybate is a hydrophilic compound with an apparent volume of distribution averaging 190384 mL/kg.
Slovenian: Porazdelitev: Natrijev oksibat je hidrofilna spojina s povprečnim navideznim volumnom porazdelitve 190 384 ml/kg.
English: • medicines that may be processed in a similar way by the body (e.g., valproate, phenytoin or ethosuximide which are used for the treatment of fits)
Slovenian: • zdravila, ki jih lahko telo presnavlja podobno kot natrijev oksibat (npr. valproat, fenitoin ali etosuksimid, ki se uporabljajo za zdravljenje krčev)
English: Treatmentrelated clinical signs were mainly related to sedation, reduced food consumption and secondary changes in body weight, body weight gain and organ weights.
Slovenian: Klinični znaki, povezani z zdravljenjem, so bili povezani predvsem s sedacijo, zmanjšanim uživanjem hrane in sekundarnimi spremembami telesne mase, spremembami pri pridobivanju telesne mase ter s spremembami mase organov.
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.
Slovenian: Natrijev oksibat je zaviralec centralnega živčnega sistema, ki zmanjša prekomerno dnevno zaspanost in katapleksijo pri bolnikih z narkolepsijo ter spremeni arhitekturo spanja tako, da zmanjša prekinitev nočnega spanja.
English: While sitting in bed, drink all of the second dose right before lying down to continue sleeping.
Slovenian: Medtem ko sedite v postelji, popijte drugi odmerek v celoti, se nato takoj ulezite in nadaljujte s spanjem.
English: Sedative hypnotics
Slovenian: Sedativno delujoči hipnotiki
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).
Slovenian: GHB ni imel vpliva na parjenje, splošno plodnost ali parametre semena ter ni povzročal toksičnosti za zarodek in plod pri podganah, izpostavljenih odmerkom do 1000 mg/kg/dan (1, 64-kratnik izpostavljenosti pri človeku, izračunan glede na živali, ki niso breje).
English: In particular Xyrem should not be taken together with sleep inducing medicines and medicines that reduce central nervous system activity (the central nervous system is the part of the body related to the brain and spinal cord).
Slovenian: Zdravila Xyrem ne smete jemati skupaj z zdravili, ki sprožijo spanje in z zdravili, ki zmanjšajo dejavnost centralnega živčnega sistema (centralni živčni sistem vključuje možgane in hrbtenjačo).
English: What Xyrem is and what it is used for What you need to know before you take Xyrem How to take Xyrem
Slovenian: Kaj je zdravilo Xyrem in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Xyrem Kako jemati zdravilo Xyrem Možni neželeni učinki
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.
Slovenian: Dve študiji faze 3 in ena študija faze 2 (dvojno slepe, z vzporednimi skupinami, nadzorovane s placebom) so bile izvedene za oceno indikacije natrijevega oksibata za fibromialgijo.
English: GHB dehydrogenase inhibitors
Slovenian: Zaviralci dehidrogenaze GHB
English: In patients with epilepsy, the safety and efficacy of sodium oxybate has not been established, therefore use is not recommended.
Slovenian: Varnost in učinkovitost uporabe natrijevega oksibata pri bolnikih z epilepsijo nista bili ugotovljeni, zato njegova uporaba ni priporočljiva.
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.
Slovenian: Narkolepsija je motnja spanja, ki lahko vključuje napade spanja v času, ko je človek običajno buden, lahko pa se pojavijo tudi katapleksija, paraliza v spanju, halucinacije in slabo spanje.
English: During the 8 week double-blind period, patients took modafinil at their established dose or placebo equivalent.
Slovenian: Med 8-tedenskim dvojno slepim preskušanjem so bolniki jemali modafinil ali placebo v ekvivalentnem odmreku.
English: Limited data from pregnant patients during second and third trimester indicate no malformative or foeto/neonatal toxicity of sodium oxybate.
Slovenian: Omejeni podatki od bolnic v drugem in tretjem trimesečju nosečnosti niso pri uporabi natrijevega oksibata pokazali nobenih malformacij ali toksičnosti za plod/novorojenčka.
English: The rat and dog exposures at the NOEL were lower (~50%) than that in humans.
Slovenian: Stopnja izpostavljenosti, pri kateri ni bilo opaziti učinka, je bila pri podgani in psu manjša (~50 %) kot pri ljudeh.
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.
Slovenian: Ekvivaletni odmerek natrijevega oksibata ali placeba je bil prve 4 tedne 6 g/dan, nadaljnje 4 tedne pa so ga povečali na 9 g/dan.
English: NOTE: Medicine will not flow into the syringe unless you keep the bottle in its upright position (See Figure 2).
Slovenian: OPOZORILO: Zdravilo ne bo teklo v injekcijsko brizgo, če ne bo plastenka v pokončnem položaju (glejte sliko 2).
English: Bradycardia and hypothermia may accompany unconsciousness, as well as muscular hypotonia, but tendon reflexes remain intact.
Slovenian: Nezavest lahko spremljata bradikardija in hipotermija, pa tudi mišična hipotonija z intaktnimi kitnimi refleksi.
English: The pharmacokinetics of sodium oxybate in paediatric patients under the age of 18 years have not been studied.
Slovenian: Pediatrična populacija: Farmakokinetike natrijevega oksibata pri pediatričnih bolnikih, mlajših od 18 let, niso preučevali.
English: The association of these developmental effects with maternal toxicity could not be established.
Slovenian: Povezanosti omenjenih učinkov na razvoj s toksičnostjo zdravila za samice niso mogli ugotoviti.
English: If you are taking valproate together with Xyrem, the dose of Xyrem will be adapted by your doctor.
Slovenian: Če sočasno z zdravilom Xyrem jemljete valproat, vam bo zdravnik prilagodil odmerek zdravila Xyrem.
English: You need to monitor the amount of salt you take as Xyrem contains sodium (which is found in table salt) which may affect you if you have had high blood pressure, heart or kidney problems in the past.
Slovenian: Ker zdravilo Xyrem vsebuje natrij (ki ga najdete tudi v kuhinjski soli), morate nadzorovati količino zaužite soli, ker lahko to vpliva na vas, če ste v preteklosti imeli težave z visokim krvnim tlakom, srcem ali ledvicami.
English: Drink all of the first dose while sitting in bed, recap the cup, and then lie down right away.
Slovenian: Popijte prvi odmerek medtem ko že sedite v postelji, zaprite merico in se nato takoj uležite.
English: Trial 2 EDS (MWT)
Slovenian: 2. preskušanje EDS (MWT)
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).
Slovenian: Namestite zaporki, ki sta priloženi, na odmerni merici in vsako vrtite v smeri urinega kazalca (v desno), dokler se ne zaskoči in zapre v za otroke varnem položaju (glejte sliko 4).
English: Trial 3 enrolled 136 narcoleptic patients with moderate to severe cataplexy (median of 21 cataplexy attacks per week) at baseline.
Slovenian: V 3. preskušanje je bilo vključenih 136 bolnikov z narkolepsijo, ki so imeli na začetku zmerno do hudo katapleksijo (mediana je bila 21 napadov katapleksije na teden).
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.
Slovenian: Po enkratnem peroralnem odmerku 25 mg/kg so vrednosti AUC pri bolnikih s cirozo dvakrat večje, navidezni peroralni očistek pa se zmanjša z 9,1 pri zdravih preiskovancih na 4,5 ml/min/kg pri razredu A (bolniki brez ascitesa) in na 4,1 ml/min/kg pri razredu C (bolniki z ascitesom).
English: No effect on the pharmacokinetics of valproate was observed.
Slovenian: Učinka na farmakokinetiko valproata niso opazili.
English: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine l'Alleud, Belgium Or
Slovenian: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine l'Alleud, Belgija ali
English: It is eliminated mainly by metabolism with a half-life of 0.5 to 1 hour.
Slovenian: Izloča se v največji meri s pomočjo presnove, biološka razpolovna doba je 0,5 do 1 ure.
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.
Slovenian: Sočasna uporaba natrijevega oksibata (6 g na dan) in valproata (1250 mg na dan) je povzročila povečanje sistemske izpostavljenosti natrijevega oksibata za približno 25 %, brez signifikantne spremembe v Cmax.
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.
Slovenian: Natančen mehanizem, preko katerega natrijev oksibat doseže učinek, ni znan, menijo pa, da natrijev oksibat deluje preko pospeševanja počasnih (delta) valov spanja in ojačenja spanja ponoči.
English: Treatment should be initiated by and remain under the guidance of a physician experienced in the treatment of sleep disorders.
Slovenian: Zdravljenje lahko uvede in ga vodi le zdravnik, ki ima izkušnje z zdravljenjem motenj spanja.
English: If you forget to take Xyrem
Slovenian: Če ste pozabili vzeti zdravilo Xyrem
English: Succinic acid enters the Krebs cycle where it is metabolised to carbon dioxide and water.
Slovenian: Jantarna kislina vstopa v Krebsov ciklus, kjer se presnavlja do ogljikovega dioksida in vode.
English: Cases of dependency have occurred after the illicit use of sodium oxybate.
Slovenian: Primeri odvisnosti so se pojavili pri prepovedani uporabi natrijevega oksibata.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: Pri vsaki pogostnostni skupini so neželeni učinki navedeni po padajočem vrstnem redu glede na njihovo resnost.
English: Other neuropsychiatric events include anxiety, psychosis, paranoia, hallucinations, and agitation.
Slovenian: Pojavijo se lahko tudi drugi nevropsihiatrični dogodki, vključno z anksioznostjo, psihozo, paranojo, halucinacijami in agitacijo.
English: Treatment of narcolepsy with cataplexy in adult patients.
Slovenian: Zdravljenje narkolepsije s katapleksijo pri odraslih bolnikih.
English: The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials.
Slovenian: Učinki ob prekinitvi zdravljenja z natrijevim oksibatom niso bili sistematično ovrednoteni v nadzorovanih kliničnih preskušanjih.
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.
Slovenian: Vaš zdravnik bo lahko postopoma povečal vaš odmerek do največ 9 g/dan, ki ga boste morali vzeti razdeljenega na dva enaka odmerka po 4,5 g/odmerek.
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
Slovenian: EDS - čezmerna dnevna zaspanost; ESS - Epworthova lestvica zaspanosti; MWT - preskus budnosti; dremeži - število nenačrtovanih dremežev čez dan; CGIc - celostni klinični odziv; FOSQreprezentativni rezultati vprašalnika o spanju
English: Studies in vitro with pooled human liver microsomes indicate that sodium oxybate does not significantly inhibit the activities of the human isoenzymes: CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A up to the concentration of 3 mM (378 µg/mL).
Slovenian: In vitro študije z združenimi humanimi jetrnimi mikrosomi kažejo, da natrijev oksibat v koncentracijah do 3 mM (378 g/ml) ne zavira značilno aktivnosti humanih izoencimov CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ali CYP3A.
English: Sodium oxybate is absorbed rapidly following oral administration with an absolute bioavailability of about 88 %.
Slovenian: Absorpcija: Po peroralnem jemanju se natrijev oksibat hitro absorbira z absolutno biološko uporabnostjo okoli 88 %.
English: The resulting pharmacodynamic effects, including increased impairment in cognitive function and sleepiness, were greater with co-administration than those observed with either drug alone.
Slovenian: Farmakodinamični učinki, vključno z motnjami v kognitivni funkciji in zaspanosti, so bili večji pri sočasni uporabi kot pri posamični uporabi katerega koli od obeh zdravila.
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.
Slovenian: Bolnike z depresijo in/ali s poskusom samomora v anamnezi je treba spremljati še posebej natančno zaradi možnosti pojava simptomov depresije v času jemanja natrijevega oksibata.
English: The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials (see section 4.4).
Slovenian: Učinki ob prekinitvi zdravljenja z natrijevim oksibatom niso bili sistematično ovrednoteni v nadzorovanih kliničnih preskušanjih (glejte poglavje 4.4).
English: If concomitant use is warranted, dose adjustment is to be considered (see section 4.2).
Slovenian: Če je sočasna uporaba upravičena, je treba prilagoditi odmerek (glejte poglavje 4.2).
English: Musculoskeletal and connective tissue disorders Common: arthralgia, muscle, spasms, back pain
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti: artralgija, mišični spazmi, bolečine v hrbtu
English: - The other ingredients are purified water, malic acid and sodium hydroxyde.
Slovenian: - Pomožne snovi so prečiščena voda, jabolčna kislina in natrijev hidroksid.
English: No active metabolites have been identified.
Slovenian: Aktivnih presnovkov niso zaznali.
English: Antidepressants have been used in the treatment of cataplexy.
Slovenian: Za zdravljenje katapleksije se uporabljajo tudi antidepresivi.
English: A second mitochondrial oxidoreductase enzyme, a transhydrogenase, also catalyses the conversion to succinic semialdehyde in the presence of -ketoglutarate.
Slovenian: Drugi mitohondrijski oksidoreduktazni encim transhidrogenaza prav tako katalizira pretvorbo sukcinat-semialdehida ob prisotnosti -ketoglutarata.
English: Each measured dose of Xyrem must be dispensed into the dosing cup and diluted with 60 mL of water prior to ingestion.
Slovenian: Vsak odmerjeni odmerek zdravila Xyrem mora biti pred jemanjem odmerjen v merici in razredčen s 60 ml vode.
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.
Slovenian: Alternativna pot biotransformacije vključuje -oksidacijo preko 3,4dihidroksibutirata do acetil-CoA, ki prav tako vstopa v ciklus trikarboksilnih kislin, kjer nastajata ogljikov dioksid in voda.
English: Next, insert the tip of the measuring syringe into the centre opening of the bottle and press down firmly (See Figure 1).
Slovenian: Nato vstavite konico merilne injekcijske brizge v osrednjo odprtino plastenke in jo močno pritisnite navzdol (glejte sliko 1).
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).
Slovenian: Ker se natrijev oksibat presnavlja z dehidrogenazo GHB, obstaja tveganje za medsebojno delovanje z zdravili, ki spodbujajo ali zavirajo ta encim (npr. valproat, fenitoin ali etosuksimid) (glejte poglavje 4.4).