natgillin/translations-raw huggingface dataset:
Frequency estimate: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Ocena pogostnosti: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Single doses greater than 4.5 g have not been studied.
Enkratnih odmerkov večjih od 4,5 g niso preučevali.
The most commonly reported adverse reactions are dizziness, nausea, and headache, all occurring in 10% to 20% of patients.
Neželeni učinki, o katerih so najpogosteje poročali, so omotičnost, navzea in glavobol, ki se vsi pojavljajo pri 10 % do 20 % bolnikov.
You may need to moderate your intake of salt.
Morda boste morali tudi omejiti vnos soli.
Whilst these effects are uncommon, if they do occur they are usually mild-to-moderate in nature.
Čeprav so ti učinki le občasni, so takrat, ko se pojavijo, običajno blagi do zmerni.
Take Xyrem orally two times each night.
Zdravilo Xyrem morate vzeti peroralno dvakrat vsako noč.
The primary efficacy measure in this trial was the frequency of cataplexy attacks.
Primarno merilo učinkovitosti je bila pri tem preskušanju pogostnost kataplektičnih napadov.
What Xyrem is and what it is used for
Kaj je zdravilo Xyrem in za kaj ga uporabljamo
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVENJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Patients with porphyria
Bolniki s porfirijo
The adaptor can then be left in the bottle for all subsequent uses
Adapter lahko pustite v plastenki za vse nadaljnje uporabe.
Secondary Efficacy Duration Active treatment and Dose (g/d)
Trajanje Aktivno zdravljenje in odmerek (g/dan)
If you forget to take the first dose, take it as soon as you remember and then continue as before.
Če ste pozabili vzeti prvi odmerek, ga vzemite takoj, ko se spomnite, in nato nadaljujte z jemanjem zdravila kot prej.
In each trial, the daily dose was divided into two equal doses.
V vsakem preskušanju je bil dnevni odmerek razdeljen v dva enaka odmerka.
The risk of taking Xyrem during pregnancy is unknown, and, therefore, the use of Xyrem in pregnant women or women trying to become pregnant is not recommended.
Tveganje jemanja zdravila Xyrem med nosečnostjo ni znano, zato njegova uporaba pri nosečnicah in ženskah, ki želijo zanositi ni priporočljiva.
If you are elderly, your doctor will monitor your condition carefully to check whether Xyrem is having the desired effects.
Če ste starejši, bo zdravnik natančno spremljal vaše stanje, da bo ugotovil, ali ima zdravilo Xyrem pri vas želeni učinek.
It is unclear if some or all of these episodes correspond to true somnambulism (a parasomnia occurring during non-REM sleep) or to any other specific medical disorder.
Ni jasno, ali so nekatere ali vse od teh epizod povezane s pravim somnambulizmom (parasomnija, ki se pojavi v času spanja NREM) ali pa z drugo specifično boleznijo.
Xyrem works by consolidating night-time sleep, though its exact mechanism of action is unknown.
Zdravilo Xyrem deluje tako, da okrepi nočni spanec, čeprav natančen mehanizem delovanja ni znan.
Sodium oxybate and/or its metabolites are excreted into breast milk.
Natrijev oksibat in/ali njegovi metaboliti se izločajo v materino mleko.
Whilst there is no clear evidence of emergence of dependence in patients taking sodium oxybate at therapeutic doses, this possibility cannot be excluded.
Čeprav ni jasnih dokazov o pojavu odvisnosti pri bolnikih, ki jemljejo natrijev oksibat v terapevtskih odmerkih, te možnosti ne moremo izključiti.
Cheyne-Stokes respiration and apnoea have been observed.
Opazili so tudi CheyneStokesovo dihanje in apnejo.
The safety and efficacy of sodium oxybate in children and adolescents aged 0-18 years has not been established.
Varnost in učinkovitost natrijevega oksibata pri otrocih in mladostnikih, starih od 0 do18 let, nista bili ugotovljeni.
The following instructions explain how to prepare Xyrem.
Naslednja navodila vam pojasnjujejo, kako morate pripraviti zdravilo Xyrem.
Xyrem 6 - 9 Modafinil 200-600 mg
8 tednov Xyrem 6-9 modafinil 200-600 mg
On average, less than 5% of unchanged medicinal product appears in human urine within 6 to 8 hours after dosing.
V povprečju se manj kot 5 % nespremenjenega zdravila pri ljudeh izloči s sečem v 6 do 8 urah po odmerku.
If you have liver problems, the starting dose should be halved.
Če imate težave z jetri, je treba začetni odmerek razpoloviti.
Single doses of 4.5 g should not be given unless the patient has been titrated previously to that dose level.
Enkratnih odmerkov po 4,5 g ne smemo dati bolniku, razen če je bil bolnikov odmerek že prej titriran do tega odmerka.
A minimum of one to two weeks is recommended between dose increments.
Priporočljivo je, da med posameznimi povečanji odmerka preteče najmanj eden do dva tedna.
There have been very few women who have taken Xyrem sometime during their pregnancy and a few of them had spontaneous abortions.
Manjše število nosečnic je v nekem obdobju nosečnosti jemalo zdravilo Xyrem in nekaj od njih je imelo spontan splav.
• If you are taking valproate, your daily dose of Xyrem will need to be adjusted (see section 3) as it may lead to interactions
• Če jemljete valproat, vam bo moral zdravnik dnevni odmerek zdravila Xyrem prilagoditi (glejte poglavje 3), ker se lahko pojavijo interakcije.
Patients should always observe the same timing of dosing in relation to meals.
Bolniki morajo zdravilo jemati vedno ob enakem času glede na obroke hrane.
Information about signs and symptoms associated with overdose with sodium oxybate is limited.
Informacije o znakih in simptomih, povezanih s prevelikim odmerjanjem natrijevega oksibata, so omejene.
These levels are considerably higher than levels achieved with therapeutic doses.
Te koncentracije so bistveno večje kot koncentracije, dosežene pri terapevtskih odmerkih.
Then add about 60 ml of water to each dosing cup (60 mL is about 4 tablespoons).
Nato dodajte okoli 60 ml vode v vsako od odmernih meric (60 mililitrov je približno 4 velike žlice).
If the patient stops taking the medicinal product for more than 14 consecutive days, titration should be restarted from the lowest dose.
Če bolnik prekine zdravljenje z zdravilom za več kot 14 zaporednih dni, je treba odmerek ponovno titrirati od najmanjšega odmerka.
If you take more Xyrem than you were told to take, or take it by accident, get emergency medical help right away.
Če ste vzeli večji odmerek zdravila Xyrem, kot so vam naročili, ali če ste ga vzeli po nesreči, takoj poiščite nujno medicinsko pomoč.
Patients have exhibited varying degrees of depressed consciousness that may fluctuate rapidly between a confusional, agitated combative state with ataxia and coma.
Pri bolnikih se pokažejo različne stopnje zožene zavesti, ki lahko hitro prehajajo med zmedenim, agitiranim bojevitim stanjem z ataksijo in komo.
Just before going to sleep, place your second dose near your bed.
Tik pred spanjem postavite drugi odmerek poleg svoje postelje.
You should have received a Xyrem Information Pack from your physician, which includes a booklet on how to take the medicine, a Frequently Asked Questions patient information sheet and a patient alert card.
Od zdravnika morate prejeti tudi Zavitek z informacijami o zdravilu Xyrem, ki vsebuje brošuro o tem, kako jemati zdravilo, list z bolnikovimi pogosto zastavljenimi vprašanji in opozorilno kartico za bolnike.
You may need to set an alarm clock to make sure you wake up to take the second dose.
Morda si boste morali nastaviti budilko, da se boste zagotovo zbudili za drugi odmerek zdravila.
When you wake up 2.5 to 4 hours later, remove the cap from the second dosing cup.
Ko se boste čez 2,5 do 4 ure kasneje zbudili, odstranite zaporko iz druge odmerne merice.
Injury, poisoning and procedural complications Common: fall
Poškodbe, zastrupitve in zapleti pri posegih pogosti: padec
Date for first authorisation: 13 October 2005 Date of latest renewal: 08 September 2015
Datum zadnjega podaljšanja: 08. september 2015
For at least 6 hours after taking sodium oxybate, patients must not undertake activities requiring complete mental alertness or motor co-ordination, such as operating machinery or driving.
Vsaj 6 ur po aplikaciji natrijevega oksibata bolniki ne smejo izvajati aktivnosti, ki zahtevajo popolno mentalno budnost ali motorično koordinacijo, kot je upravljanje s stroji ali vožnja.
Investigations Common: blood pressure increased, weight decreased
Preiskave pogosti: povišan krvni tlak, zmanjšanje telesne mase
There are reports of compromise in the rate and depth of respiration and of life-threatening respiratory depression, necessitating intubation and ventilation.
Na voljo so tudi poročila o kompromisu med hitrostjo in globino dihanja ter o življenje ogrožajoči depresiji dihanja, ki zahteva intubacijo in ventilacijo.
It is recommended that both doses of Xyrem should be made up at the same time upon retiring to bed.
Priporočljivo je, da sta oba odmerka zdravila Xyrem pripravljena istočasno, pred odhodom v posteljo.
This needs only to be done the first time that the bottle is opened.
To boste morali storiti le ob prvem odprtju plastenke.
Data from a limited number of pregnant women exposed in the first trimester indicate a possible increased risk of spontaneous abortions.
Podatki dobljeni iz omejenega števila nosečnic, ki so bile izpostavljene natrijevemu oksibatu v prvem trimesečju nosečnosti nakazujejo na možnost povečanega tveganja spontanih splavov.
The primary measure of efficacy was excessive daytime sleepiness as measured by objective response in MWT.
Primarno merilo učinkovitosti je bila čezmerna dnevna zaspanost, ki je bila izmerjena z objektivnim odzivom pri preskusu budnosti (MWT).
Drug discrimination studies show that GHB produces a unique discriminative stimulus that in some respects is similar to that of alcohol, morphine and certain GABA-mimetic medicinal products.
Študije razlikovanja zdravil so pokazale, da GHB povzroči edinstven stimulus, ki je različen od drugih, čeprav je v nekaterih pogledih podoben tistim, ki jih povzročajo alkohol, morfin in določena gabamimetično delujoča zdravila.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Do not use this medicine after the expiry date stated on the bottle after (EXP).
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki (EXP).
Also tell your doctor or pharmacist if your are taking any of the following types of medicines:
Prav tako obvestite zdravnika ali farmacevta, če jemljete naslednja zdravila:
Placebo 3.0 g/day 6.0 g/day 9.0 g/day
mediana napadi/teden placebo 3,0 g/dan 6,0 g/dan 9,0 g/dan
Remove the syringe from the centre opening of the bottle.
Odstranite injekcijsko brizgo iz osrednje odprtine plastenke.
Selfadministration studies in rats, mice and monkeys have produced conflicting results, whereas tolerance to GHB as well as cross-tolerance to alcohol and baclofen has been clearly demonstrated in rodents.
Študije samoaplikacije pri podganah, miših in opicah so dale nasprotujoče si rezultate, medtem ko so lahko toleranco na GHB in navzkrižno toleranco z alkoholom in baklofenom pri glodalcih jasno pokazali.
At sodium oxybate concentrations ranging from 3 to 300 µg/mL, less than 1% is bound to plasma proteins.
V območju koncentracij natrijevega oksibata med 3 in 300 g/ml ga je manj kot 1 % vezanega na plazemske beljakovine.
Trial 4 was designed specifically to evaluate the continued efficacy of sodium oxybate after long-term use.
Četrto preskušanje je bilo specifično namenjeno oceni nadaljnje učinkovitosti natrijevega oksibata pri dolgotrajnem zdravljenju.
Other medicines and Xyrem
Druga zdravila in zdravilo Xyrem
Pharmacotherapeutic group: Other nervous system drugs, ATC code: N07XX04.
Farmakoterapevtska skupina: Druga zdravila z delovanjem na živčevje Oznaka ATC: N07XX04
• Patient Alert Card (to be given to the patient): to remind patients, physicians and/or pharmacists of the important safety information related to the use of Xyrem.
• Opozorilna kartica za bolnike (prejme bolnik): bolnike, zdravnike in/ali farmacevte opomni glede pomembnih varnostnih informacij v povezavi z uporabo zdravila Xyrem.
You may need to set an alarm so you wake up to take your second dose no earlier than 2.5 hours and no later than 4 hours after your first dose.
Morda boste morali nastaviti budilko, da se boste zbudili za drugi odmerek, ki ga ne smete vzeti prej kot po 2,5 urah in ne kasneje kot po 4 urah po prvem odmerku.
Bradycardia has been responsive to atropine intravenous administration.
Bradikardija se odziva na intravensko aplikacijo atropina.
EU/1/05/312/001
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/05/312/001
Apnoea and respiratory depression have been observed in a fasting healthy subject after a single intake of 4.5 g (twice the recommended starting dose).
Apnejo in respiratorno depresijo so opazili pri teščih, zdravih osebah po enkratnem vnosu 4,5 g (dvakratni priporočeni začetni odmerek).
Once you open a bottle of Xyrem, any contents that you have not used with 40 days of opening should be disposed of.
Po odprtju plastenke zdravila Xyrem morate vsebino, ki je ne boste porabili v 40 dneh po odprtju, zavreči.
What you need to know before you take Xyrem
Kaj morate vedeti, preden boste vzeli zdravilo Xyrem
Patients taking Xyrem should not breast feed since it is known that Xyrem passes into breast milk.
Bolnice, ki jemljejo zdravilo Xyrem, ne smejo dojiti, ker je znano, da Xyrem prehaja v materino mleko.
If you stop taking Xyrem for more than 14 consecutive days you should consult your doctor as you should restart taking Xyrem at a reduced dose.
Če boste za več kot 14 zaporednih dni prekinili jemanje zdravila Xyrem, se morate posvetovati s svojim zdravnikom, saj boste ponovno jemanje zdravila Xyrem začeli z zmanjšanim odmerkom.
The pharmacodynamic interaction with zolpidem has not been assessed.
Farmakodinamične interakcije z zolpidemom niso ocenili.
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.
Pri dajanju ponavljajočih se odmerkov natrijevega oksibata podganam (90 dni in 26 tednov) in psom (52 tednov) niso odkrili nobenih pomembnih dejstev na področju klinične kemije ter mikro- in makropatologije.
The dose of 9 g/day should not be exceeded due to the possible occurrence of severe symptoms at doses of 18 g/day or above (see section 4.4).
Odmerka 9 g/dan ne smemo prekoračiti zaradi možnega pojava hudih simptomov pri odmerkih 18 g/dan ali več (glejte poglavje 4.4).
Sodium oxybate has major influence on the ability to drive and use machines.
Natrijev oksibat ima pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
Sodium oxybate is rapidly and almost completely absorbed after oral administration; absorption is delayed and decreased by a high fat meal.
Natrijev oksibat se po peroralnem jemanju hitro in skoraj popolnoma absorbira; absorpcija je po obroku z veliko vsebnostjo maščob zakasnjena in zmanjšana.
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.
Čeprav je lahko refleks bruhanja pri bolnikih v globoki komi odsoten, pa lahko tudi nezavestni bolniki postanejo agresivni pri intubaciji in je treba razmisliti o hitri zaporedni indukciji (brez uporabe sedativa).
The most serious adverse reactions are suicidal attempt, psychosis, respiratory depression and convulsion.
Najresnejši neželeni učinki so poskus samomora, psihoza, depresija dihanja in konvulzija.
• Benzodiazepines
• Benzodiazepini
In Trial 4, the response was numerically similar for patients treated with doses of 6 to 9 g/day, but there was no effect seen in patients treated with doses less than 6 g/day.
V 4. preskušanju je bil odgovor številčno podoben pri bolnikih, ki so jemali odmerke 6 do 9 g/dan, pri odmerkih, manjših od 6 g/dan, pa pri bolnikih niso opazili učinka.
If you miss the second dose, skip that dose and do not take Xyrem again until the next night.
Če ste pozabili vzeti drugi odmerek, preskočite ta odmerek in zdravilo Xyrem ponovno vzemite šele naslednjo noč.
Trial 4 enrolled 55 narcoleptic patients who had been taking open-label sodium oxybate for 7 to 44 months.
V 4. preskušanje je bilo vključenih 55 bolnikov z narkolepsijo, ki so v odprti študiji že prej 7 do 44 mesecev prejemali natrijev oksibat.
Whether this affected respiration during the night is unknown.
Ni znano, ali je to ponoči vplivalo na dihanje.
Faecal excretion is negligible.
Izločanje z blatom je zanemarljivo.
Given the possibility of increasing the risk of respiratory depression, the concomitant use of benzodiazepines and sodium oxybate should be avoided.
Zaradi možnosti povečanja tveganja za nastanek respiratorne depresije se je treba izogibati sočasni uporabi benzodiazepinov in natrijevega oksibata.
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom.
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, Velika Britanija
In the clinical trial database, greater than 80 % of patients maintained concomitant stimulant use.
Na podlagi baze podatkov iz kliničnih preskušanj je več kot 80 % bolnikov sočasno jemalo stimulanse.
Before increasing the sodium oxybate dose (see section 4.2), prescribers should be aware that sleep apnoea occurs in up to 50% of patients with narcolepsy.
Pred povečanjem odmerka natrijevega oksibata (glejte poglavje 4.2) se morajo zdravniki, ki predpisujejo zdravilo, zavedati, da se sindrom apneje v spanju pojavi pri do 50 % bolnikov z narkolepsijo.
Patients being treated with opioids or barbiturates.
Pri bolnikih, ki se zdravijo z opiodi ali barbiturati.
Very common (may affect more than 1 in 10 people): Nausea, dizziness, headache
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): siljenje na bruhanje, omotičnost, glavobol
Events associated with withdrawal syndrome have been observed outside the therapeutic range.
Učinke, povezane z odtegnitvenim sindromom, so opazili pri odmerkih zunaj terapevtskega območja.
Take doses within 24 hours after preparation.
Odmerke zaužijte v roku 24 ur od časa priprave.
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.
Študije na samcih in samicah podgan pri odmerkih do 1000 mg/kg/dan GHB niso pokazale neželenih učinkov na plodnost.
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.
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.
Trial 1 EDS (ESS); CGIc
1. preskušanje EDS (ESS); CGIc
Xyrem has a well-known abuse potential.
Pri zdravilu Xyrem je dobro znana možnost zlorabe.
Epileptic patients
Bolniki z epilepsijo
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).
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).
A possible additive effect of antidepressants and sodium oxybate cannot be excluded.
Možnosti aditivnega učinka antidepresivov in natrijevega oksibata ni mogoče izključiti.
Because of the higher risk of sleep apnoea, patients with a BMI ≥40 kg/m should be monitored closely when taking sodium oxybate.
Zaradi povečanega tveganja za apnejo med spanjem se mora bolnike z ITM (BMI) ≥ 40 kg/m2 med jemanjem natrijevega oksibata skrbno spremljati.
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.
O primerih odvisnosti so poročali pri prepovedani uporabi GHB v pogostih, ponavljajočih se odmerkih (18 do 250 g/dan), ki presegajo terapevtsko območje odmerkov.
Rinse out the syringe with water.
Injekcijsko brizgo sperite z vodo.
Sodium oxybate is the sodium salt of GHB.
Natrijev oksibat je natrijeva sol GHB.
Additionally, patient response and tolerability should be carefully monitored and dose should be adapted accordingly.
Dodatno je treba skrbno spremljati bolnikov odziv in prenašanje ter odmerek ustrezno prilagoditi.
If you have kidney problems, you should consider a dietary recommendation to reduce sodium intake.
Če imate težave z ledvicami, morate razmisliti o dietnih priporočilih za zmanjšanje vnosa natrija.
Myoclonus and tonic-clonic seizures have been reported.
Poročali so tudi o mioklonusu in toničnokloničnih konvulzijah.
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.
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.
Cardiac disorders Common: palpitations
Srčne bolezni pogosti: palpitacije
Sodium Oxybate should not be used during breastfeeding.
Natrijev oksibat se ne sme uporabljati med dojenjem.
Repeat this step for the second dosing cup.
Korak ponovite tudi pri drugi odmerni merici.
You should continue to take Xyrem for as long as instructed by your doctor.
Zdravilo Xyrem morate jemati tako dolgo, kot vam je naročil vaš zdravnik.
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.
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.
In addition to the adverse reactions reported during clinical studies, adverse reactions have been reported in post-marketing experience.
Poleg neželenih učinkov, o katerih so poročali v kliničnih študijah, obstajajo še neželeni učinki v okviru izkušenj po začetku trženja zdravila.
5 How to store Xyrem Contents of the pack and other information
5 Shranjevanje zdravila Xyrem Vsebina pakiranja in dodatne informacije
• 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.
• 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.