FrancophonIA/ELRC3.0 huggingface dataset:
English: Additionally, randomised, double-blind, placebo-controlled, crossover drug-drug interaction studies with ibuprofen, diclofenac and valproate were performed in healthy subjects and are summarised in section 4.5.
Slovenian: Poleg tega so izvedli randomizirane, dvojno slepe, s placebom nadzorovane, navzkrižne študije o medsebojnem delovanju zdravil z ibuprofenom, diklofenakom in valproatom pri zdravih osebah in so povzete v poglavju 4.5.
English: • Frequently Asked Questions (FAQ) Patient Information Sheet (to be given to the patient): to provide patients with responses to some questions they might have about taking Xyrem.
Slovenian: • List z bolnikovimi pogosto zastavljenimi vprašanji (prejme bolnik): odgovori na nekatera vprašanja, ki jih bolnik morda ima glede jemanja zdravila Xyrem.
English: If you stop taking Xyrem
Slovenian: Če ste prenehali jemati zdravilo Xyrem
English: Marketing Authorisation Holder UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium
Slovenian: Imetnik dovoljenja za promet z zdravilom UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruselj, Belgija
English: The emergence of depression when patients are treated with sodium oxybate requires careful and immediate evaluation.
Slovenian: Če se pri bolnikih, ki se zdravijo z natrijevim oksibatom, pojavi depresija, je treba njihovo stanje natančno in takoj ovrednotiti.
English: • How to Take Xyrem brochure (to be given to the patient): to provide patients with information related to the use of Xyrem.
Slovenian: • Brošura kako jemati zdravilo Xyrem (prejme bolnik): bolnikom zagotoviti informacije v zvezi z uporabo zdravila Xyrem
English: Metabolism and nutrition disorders Common: anorexia, decreased appetite Not known: Dehydration, increased appetite
Slovenian: Presnovne in prehranske motnje pogosti: anoreksija, zmanjšan apetit neznana: dehidracija, povečan apetit
English: Xyrem has the potential to induce respiratory depression
Slovenian: Zdravilo Xyrem lahko sproži respiratorno depresijo.
English: Blurred vision has been reported.
Slovenian: Poročali so tudi o zamegljenem vidu.
English: Patients with succinic semialdehyde dehydrogenase deficiency.
Slovenian: Pri bolnikih z zmanjšano aktivnostjo sukcinat-semialdehid-dehidrogenaze.
English: Special caution should be observed in patients with an underlying respiratory disorder.
Slovenian: Posebna previdnost je potrebna pri bolnikih z že obstoječimi boleznimi dihal.
English: There is no clinical data available on the effect of sodium oxybate on fertility.
Slovenian: Kliničnih podatkov o vplivu natrijevega oksibata na plodnost ni.
English: The clearance of sodium oxybate is almost entirely by biotransformation to carbon dioxide, which is then eliminated by expiration.
Slovenian: Izločanje: Očistek natrijevega oksibata je skoraj v celoti posledica biotransformacije do ogljikovega dioksida, ki se izloča z izdihanih zrakom.
English: Xyrem will affect you if you drive or operate tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Xyrem bo vplivalo na vas pri vožnji ali upravljanju z orodji ali stroji.
English: An increasing depth of coma has been observed at higher doses.
Slovenian: Pri večjih odmerkih so opazili poglobljeno komo.
English: If any of these apply to you, tell your doctor before you take Xyrem.
Slovenian: Če karkoli od zgoraj navedenega velja za vas, o tem pred uporabo zdravila Xyrem obvestite svojega zdravnika.
English: Table 1 Summary of clinical trials performed using sodium oxybate for the treatment of narcolepsy
Slovenian: Preglednica 1 Pregled izvedenih kliničnih preskušanj z uporabo natrijevega oksibata za zdravljenje narkolepsije
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.
Slovenian: Pri dajanju natrijevega oksibata takoj po obroku z veliko vsebnostjo maščob je prišlo do zakasnjene absorpcije (povprečen Tmax se je podaljšal iz 0,75 ure na 2,0 uri) ter do zmanjšanja največje plazemske koncentracije (Cmax) za 58  (povprečna vrednost) in sistemske izpostavljenosti zdravila (AUC) za 37 .
English: Infections and infestations Common: nasopharyngitis, sinusitis
Slovenian: Infekcijske in parazitske bolezni pogosti: nazofaringitis, sinusitis
English: Studies in vitro with pooled human liver microsomes indicate that sodium oxybate does not significantly inhibit the activities of the human isoenzymes (see section 5.2).
Slovenian: In vitro študije na združenih humanih jetrnih mikrosomih kažejo, da natrijev oksibat ne zavira značilno aktivnosti humanih izoencimov (glejte poglavje 5.2).
English: Change from Baseline Compared to Placebo (p-value)
Slovenian: sprememba glede na začetno stanje v primerjavi s placebom (vrednost p)
English: While holding the bottle in its upright position, insert the press-in-bottle-adaptor into the neck of the bottle.
Slovenian: Medtem ko plastenko držite v pokončnem položaju, vstavite adapter, ki se pritisne v plastenko, skozi vrat plastenke.
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.
Slovenian: Če se pri bolnikih, ki se zdravijo z natrijevim oksibatom, pojavijo motnje mišljenja, vključno z mislimi, da bi storili nasilna dejanja (vključno škodovati drugim) in/ali nenormalno vedenje, je treba njihovo stanje natančno in takoj ovrednotiti.
English: Sodium intake
Slovenian: Vnos natrija
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.
Slovenian: Zaradi bruhanja, ki se lahko pojavi v stanju motene zavesti, je potreben ustrezen položaj bolnika (levi lateralni ležeči položaj) in zaščita prehodnosti dihalnih poti z intubacijo.
English: Animal studies have shown no evidence of teratogenicity but embryolethality was seen in both rat and rabbit studies (see section 5.3).
Slovenian: Študije na živalih niso pokazale teratogenosti, v študijah na podganah in kuncih pa so opazili vpliv na smrtnost zarodkov (glejte poglavje 5.3).
English: If concomitant use is warranted, patient response and tolerability should be monitored and dose adjustments made if required (see section 4.2).
Slovenian: Če je sočasna uporaba upravičena, je treba spremljati bolnikov odziv in prenašanje ter po potrebi prilagoditi odmerek (glejte poglavje 4.2).
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).
Slovenian: Priporočilo o zmanjšanju vnosa natrija je treba še posebej upoštevati pri zdravljenju bolnikov s srčnim popuščanjem, hipertenzijo ali z zmanjšanim delovanjem ledvic (glejte poglavji 4.2 in 4.9).
English: Trial 1 enrolled 246 patients with narcolepsy and incorporated a 1 week up-titration period.
Slovenian: Prvo preskušanje je vključevalo 246 bolnikov z 1-tedenskim titracijskim obdobjem.
English: Xyrem with food, drink and alcohol You must not drink alcohol while taking Xyrem, as its effects can be increased.
Slovenian: V času jemanja zdravila Xyrem ne smete uživati alkoholnih pijač, ker se lahko povečajo učinki zdravila.
English: Xyrem is used to treat narcolepsy with cataplexy in adults.
Slovenian: Zdravilo Xyrem se uporablja za zdravljenje narkolepsije s katapleksijo pri odraslih.
English: • Gamma hydroxybutyrate (GHB) dehydrogenase inhibitors Caution is required in patients who are treated concomitantly with valproate or other GHB dehydrogenase inhibitors as pharmacokinetic and pharmacodynamic interactions have been observed when sodium oxybate is co-administered with valproate (see section 4.5).
Slovenian: • Zaviralci gama-hidroksibutirat (GHB) dehidrogenaze Pri bolnikih, ki se sočasno zdravijo z valproatom ali drugimi zaviralci GHB dehidrogenaze je potrebna previdnost, saj so opazili farmakokinetične in farmakodinamične interakcije pri sočasni uporabi natrijevega oksibata in valproata (glejte poglavje 4.5).
English: If you take two 2.25 g doses of sodium oxybate each night you will take 0.82 g of sodium, or if you take two 4.5 g doses of sodium oxybate each night you will take in 1.6 g sodium.
Slovenian: Če vsako noč vzamete dva odmerka po 2,25 g natrijevega oksibata, boste ob tem zaužili 0,82 g natrija, če pa vsako noč vzamete dva odmerka po 4,5 g natrijevega oksibata, boste ob tem zaužili 1,6 g natrija.
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).
Slovenian: Bolniki, ki jemljejo natrijev oksibat, bodo dnevno dodatno vnašali natrij, in sicer od 0,82 g (pri odmerku zdravila Xyrem 4,5 g/dan) do 1,6 g (pri odmerku zdravila Xyrem 9 g/dan).
English: Following oral administration, the plasma levels of sodium oxybate increase more than proportionally with increasing dose.
Slovenian: Po peroralnem jemanju se plazemske koncentracije natrijevega oksibata povečajo več kot le sorazmerno glede na odmerek.
English: Prepare both doses before bedtime.
Slovenian: Oba odmerka zdravila si pripravite pred odhodom v posteljo.
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.
Slovenian: Varnost in učinkovitost natrijevega oksibata za zdravljenje simptomov narkolepsije je bila ugotovljena v štirih multicentričnih, randomiziranih, dvojno slepih, s placebom nadzorovanih preskušanjih z vzporednimi skupinami pri bolnikih z narkolepsijo s katapleksijo, razen v enem preskušanju, kjer katapleksija ni bila pogoj za vključitev v študijo.
English: When you first start taking Xyrem, until you know whether it makes you sleepy the next day, use extreme care while driving a car, operating heavy machinery or doing anything else that could be dangerous or needs you to be fully mentally alert.
Slovenian: Od takrat, ko boste prvič začeli jemati zdravilo Xyrem, pa dokler ne boste ugotovili, ali zdravilo pri vas naslednji dan povzroči zaspanost, bodite izredno previdni pri vožnji avtomobila, upravljanju s težkimi stroji in pri izvajanju drugih dejavnosti, ki bi lahko bile nevarne ali zahtevajo vašo popolno mentalno budnost.
English: There is insufficient evidence to recommend the use of naloxone in the treatment of overdose with GHB.
Slovenian: Dokazi za priporočilo uporabe naloksona pri zdravljenju prevelikega odmerjanja GHB niso zadostni.
English: While you are taking Xyrem, if you experience bed wetting and incontinence (both urine and faeces), confusion, hallucinations, episodes of sleepwalking or abnormal thinking you should tell your doctor straight away.
Slovenian: Če v času jemanja zdravila Xyrem začnete močiti posteljo in imate inkontinenco (tako seča kot tudi blata), ste zmedeni, imate halucinacije, epizode hoje v spanju ali motnje mišljenja, morate o tem takoj obvestiti zdravnika.
English: Xyrem contains sodium
Slovenian: Zdravilo Xyrem vsebuje natrij
English: The recommended starting dose for sodium oxybate, when used concomitantly with valproate, is 3.6 g/day administered orally in two equal divided doses of approximately 1.8 g. If concomitant use is warranted, patient response and tolerability should be monitored and dose should be adapted accordingly (see section 4.4)
Slovenian: Priporočljivi začetni odmerek natrijevega oksibata, če se ga uporablja sočasno z valproatom, je 3,6 g/dan, ki se ga vzame peroralno, razdeljenega na dva enaka odmerka, približno 1,8 g. Če je sočasna uporaba upravičena, je treba spremljati bolnikov odziv in prenašanje ter odmerek ustrezno prilagoditi (glejte poglavje 4.4).
English: Table 2 Summary of ESS in Trial 1
Slovenian: Preglednica 2 Pregled ESS pri 1. preskušanju
English: Trial 2 compared the effects of orally administered sodium oxybate, modafinil and sodium oxybate + modafinil, with placebo in the treatment of daytime sleepiness in narcolepsy.
Slovenian: V 2. preskušanju so primerjali učinke peroralne uporabe natrijevega oksibata, modafinila in natrijevega oksibata + modafinila s placebom pri zdravljenju dnevne zaspanosti zaradi narkolepsije.
English: Vascular disorders Common: hypertension
Slovenian: Žilne bolezni pogosti: hipertenzija
English: All patients with impaired renal function should consider a recommendation to reduce sodium intake (see section 4.4).
Slovenian: Pri vseh bolnikih z ledvično okvaro je treba upoštevati priporočilo za zmanjšanje vnosa natrija (glejte poglavje 4.4).
English: Take the first dose upon getting into bed and the second dose 2.5 to 4 hours later.
Slovenian: Prvi odmerek vzemite tik preden greste v posteljo, drugega pa 2,5 do 4 ure kasneje.
English: Approximately 80% of patients who received sodium oxybate during clinical trials maintained CNS stimulant use.
Slovenian: Približno 80 % bolnikov, ki so med kliničnimi preskušanji prejemali natrijev oksibat, je jemalo tudi stimulanse centralnega živčnega sistema.
English: The medicinal product should be used within 40 days after the first opening.
Slovenian: Po prvem odprtju je treba zdravilo porabiti v 40 dneh.
English: Changes in sleep patterns have been observed in breastfed infants from exposed mothers, which may be consistent with the effects of sodium oxybate on the nervous system.
Slovenian: Pri dojenčkih, katerih matere so bile izpostavljene natrijevemu oksibatu, so opazili spremembe vzorca spanja, ki so lahko skladne z učinki natrijevega oksibata na živčni sistem.
English: If you experience any of these, tell your doctor straight away.
Slovenian: Če se pri vas pojavi kateri od neželenih učinkov, takoj obvestite svojega zdravnika.
English: • Additional risk minimisation measures The Marketing Authorisation Holder (MAH) shall develop an educational programme for Xyrem to ensure that physicians who intend to prescribe Xyrem are aware about the posology of Xyrem and about the important risks.
Slovenian: Imetnik dovoljenja za promet bo razvil izobraževalni program za zdravilo Xyrem in s tem zagotovil, da bodo zdravniki, ki nameravajo predpisovati zdravilo Xyrem, poznali odmerjanje zdravila Xyrem in pomembna tveganja.
English: Doses should be taken within 24 hours after preparation, or else discarded.
Slovenian: Odmerek naj bolnik zaužije v roku 24 ur od časa priprave, v nasprotnem primeru naj odmerek zavrže.
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.
Slovenian: Za shranjevanje zdravila po prvem odprtju glejte poglavje 6.3
English: Patients were randomised to continued treatment with sodium oxybate at their stable dose or to placebo.
Slovenian: Bolniki so randomizirano nadaljevali zdravljenje z natrijevim oksibatom v enakem odmerku ali s placebom.
English: Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and ibuprofen.
Slovenian: Študije medsebojnega delovanja zdravil pri zdravih odraslih niso pokazale farmakokinetičnih interakcij med natrijevim oksibatom in ibuprofenom.
English: Race The effect of race on metabolism of sodium oxybate has not been evaluated.
Slovenian: Rasa Vpliva rase na presnovo natrijevega oksibata niso ovrednotili.
English: Sodium oxybate should not be used in combination with sedative hypnotics or other CNS depressants.
Slovenian: Natrijevega oksibata se ne sme uporabljati skupaj s sedativno delujočimi hipnotiki ali drugimi zaviralci centralnega živčnega sistema.
English: How to take Xyrem
Slovenian: Kako jemati zdravilo Xyrem
English: Skin and subcutaneous tissue disorders Common: hyperhidrosis, rash Not known: urticaria, angioedema, seborrhoea
Slovenian: Bolezni kože in podkožja pogosti: hiperhidroza, izpuščaj neznana: urtikarija, angioedem, seboreja
English: Eye disorders Common: blurred vision
Slovenian: Očesne bolezni pogosti: zamegljen vid
English: Sodium oxybate is not recommended during pregnancy.
Slovenian: Uporaba natrijevega oksibata v času nosečnosti ni priporočljiva.
English: The starting dose should be halved in all patients with hepatic impairment, and response to dose increments monitored closely (see section 4.2).
Slovenian: Začetni odmerek je potrebno prepoloviti pri vseh bolnikih z jetrno okvaro, odziv pri povečanju odmerka pa skrbno spremljati (glejte poglavje 4.2).
English: Talk to your doctor or pharmacist before taking Xyrem: - if you have breathing or lung problems (and especially if you are obese), because Xyrem has the potential to cause difficulty in breathing; - if you have or have previously had depressive illness; - if you have heart failure, hypertension (high blood pressure), liver or kidney problems as your dose may need to be adjusted; - if you have previously abused drugs; - if you suffer from epilepsy as the use of Xyrem is not recommended in this condition; - if you have porphyria (an uncommon metabolic disorder).
Slovenian: Xyrem sproži težave z dihanjem; - če imate ali ste imeli depresijo; - če imate srčno popuščanje, hipertenzijo (visok krvni tlak), težave z jetri ali ledvicami, ker bo morda treba prilagoditi odmerek; - če ste že kdaj zlorabljali zdravila; - če imate epilepsijo, saj v tem primeru uporaba zdravila Xyrem ni priporočljiva;
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.
Slovenian: Priporočeni začetni odmerek zdravila Xyrem, če ga jemljete sočasno z valproatom, je 3,6 g/dan, razdeljen na dva enaka odmerka po 1,8 g. Prvi odmerek vzemite, ko ste že v postelji, drugi odmerek pa 2,5 ure do 4 ure kasneje.
English: Diclofenac
Slovenian: Diklofenak
English: While holding the bottle and syringe with one hand, draw up the prescribed dose with the other hand by pulling on the plunger.
Slovenian: Medtem ko z eno roko držite plastenko in injekcijsko brizgo, z drugo s pomočjo bata potegnite v injekcijsko brizgo predpisan odmerek.
English: Table 4 Summary of MWT in Trial 2
Slovenian: Preglednica 4 Pregled MWT pri 2. preskušanju
English: Sodium oxybate is considered to be unsafe in patients with porphyria because it has been shown to be porphyrogenic in animals or in vitro systems.
Slovenian: Uporaba natrijevega oksibata ni varna pri bolnikih s porfirijo, saj so študije na živalih ali v in vitro sistemih pokazale porfirogeni učinek zdravila.
English: Placebo (56) Sodium Oxybate (55) Modafinil (63) Sodium Oxybate + Modafinil (57)
Slovenian: odmerek začetno stanje končno stanje mediana spremembe glede na začetno stanje končno stanje v primerjavi s placebom placebo (56) natrijev oksibat (55) modafinil (63) natrijev oksibat + modafinil (57)
English: 246 MWT/Sleep Architecture/ Cataplexy/Naps/FOSQ
Slovenian: MWT/arhitektura spanja/ katapleksija/dremeži/FO SQ
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 13. oktober 2005
English: Xyrem is a clear to slightly opalescent solution.
Slovenian: Zdravilo Xyrem je bistra do rahlo opalescentna raztopina.
English: What Xyrem contains - The active substance is sodium oxybate.
Slovenian: Kaj vsebuje zdravilo Xyrem - Zdravilna učinkovina je natrijev oksibat.
English: EDS (ESS)/CGIc/Naps
Slovenian: EDS (ESS)/CGIc/dremeži
English: Increased sleepiness was observed after concomitant administration of sodium oxybate (2.25 g) and lorazepam (2 mg).
Slovenian: Povečano zaspanost so opazili po sočasni uporabi natrijevega oksibata (2,25 g) in lorazepama (2 mg).
English: Major depression is contraindicated for use with Xyrem (section 4.3).
Slovenian: Pri hudi depresiji je zdravilo Xyrem kontraindicirano (glejte poglavje 4.3).
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.
Slovenian: Pri nekaterih bolnikih se ob prekinitvi zdravljenja z natrijevim oksibatom lahko katapleksija začne pojavljati z večjo pogostnostjo, kar pa je lahko tudi posledica običajne spremenljivosti bolezni.
English: Animal studies indicate that metabolism is the major elimination pathway for sodium oxybate, producing carbon dioxide and water via the tricarboxylic acid (Krebs) cycle and secondarily by oxidation.
Slovenian: Biotransformacija: Študije na živalih so pokazale, da je presnova glavna pot izločanja natrijevega oksibata, kjer v ciklusu trikarboksilnih kislin (Krebsov ciklus) nastajata ogljikov dioksid in voda, ki sekundarno nastajata tudi z -oksidacijo.
English: Xyrem 500 mg/mL (applies to carton only)
Slovenian: PODATKI V BRAILLOVI PISAVI Xyrem 500 mg/ml (samo za škatlo)
English: Epworth Sleepiness Scale (ESS; range 0-24) Dose Group [g/d (n)] Baseline
Slovenian: Epworthova lestvica zaspanosti (ESS; območje 0-24)
English: Xyrem is provided for use with a graduated measuring syringe and two 90 mL dosing cups with child resistant caps.
Slovenian: Zdravilo Xyrem je namenjeno uporabi z graduirano merilno injekcijsko brizgo in z dvema 90 ml odmernima mericama z zaporkama, varnima za otroke.
English: In a rat carcinogenicity study with oxybate no compound-related tumours were identified.
Slovenian: Pri študijah kancerogenosti pri podganah niso ob uporabi oksibata našli nobenih z zdravilom povezanih tumorjev.
English: Responders* N (%)
Slovenian: odmerek [g/dan (št)] Bolniki z odzivom* število (%)
English: Pharmacokinetics is nonlinear with the area under the plasma concentration curve (AUC) versus time curve increasing 3.8-fold as dose is doubled from 4.5 g to 9 g. The pharmacokinetics is not altered with repeat dosing.
Slovenian: Farmakokinetika je nelinearna; površina pod krivuljo plazemske koncentracije (AUC) v odvisnosti od časa se po podvojitvi odmerka iz 4,5 g na 9 g poveča za 3,8-krat.
English: Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and diclofenac.
Slovenian: Študije medsebojnega delovanja zdravil pri zdravih odraslih niso pokazale farmakokinetičnih interakcij med natrijevim oksibatom in diklofenakom.
English: Therefore, patients should be warned against the use of alcohol in conjunction with sodium oxybate.
Slovenian: Bolnike je zato treba opozoriti na nevarnost uporabe alkohola skupaj z natrijevim oksibatom.
English: Very common: nausea (the frequency of nausea is higher in women than men) Common: vomiting, diarrhoea, abdominal pain upper, Uncommon: faecal incontinence
Slovenian: Bolezni prebavil zelo pogosti: navzea (pogostnost navzee je večja pri ženskah kot pri moških) pogosti: bruhanje, diareja, bolečina v zgornjem delu trebuha občasni: inkontinenca blata neznana: suha usta
English: Therefore, patients should be warned against the use of topiramate in conjunction with sodium oxybate (section 4.5).
Slovenian: Bolnike je treba opozoriti na nevarnost uporabe topiramata skupaj z natrijevim oksibatom (glejte poglavje 4.5).
English: When higher doses up to 9 g/day of sodium oxybate are combined with higher doses of opioids (within the recommended dose range) pharmacodynamic interactions associated with symptoms of CNS depression and/or respiratory depression cannot be excluded (see sections 4.3).
Slovenian: Kadar se višje odmerke, do 9 g/dan natrijevega oksibata, kombinira z višjimi odmerki opioidov (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).