natgillin/translations-raw huggingface dataset:
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.
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).
Table 3 Summary of CGI-c in Trial 1
Preglednica 3 Pregled CGI-c pri 1. preskušanju
Patients should be questioned regarding signs of Central Nervous System (CNS) or respiratory depression.
Bolnike je treba vprašati po znakih, povezanih z zaviranjem centralnega živčnega sistema ali dihanja.
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.
Vrh plastenke pokriva pečat iz plastične folije, ki jo morate pred prvo uporabo plastenke odstraniti.
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).
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).
Rebound effects and withdrawal syndrome
Povratno delovanje in odtegnitveni sindrom
If sodium oxybate and valproate are used concomitantly (see section 4.5), a decrease in sodium oxybate dose by 20% is recommended.
Če se natrijev oksibat in valproat uporabljata sočasno (glete poglavje 4.5), je priporočljivo zmanjšanje odmerka natrijevega oksibata za 20 %.
If you have the impression that the effect of Xyrem is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek zdravila Xyrem premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
Sodium oxybate is a hydrophilic compound with an apparent volume of distribution averaging 190384 mL/kg.
Porazdelitev: Natrijev oksibat je hidrofilna spojina s povprečnim navideznim volumnom porazdelitve 190 384 ml/kg.
• 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)
• zdravila, ki jih lahko telo presnavlja podobno kot natrijev oksibat (npr. valproat, fenitoin ali etosuksimid, ki se uporabljajo za zdravljenje krčev)
Treatmentrelated clinical signs were mainly related to sedation, reduced food consumption and secondary changes in body weight, body weight gain and organ weights.
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.
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.
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.
While sitting in bed, drink all of the second dose right before lying down to continue sleeping.
Medtem ko sedite v postelji, popijte drugi odmerek v celoti, se nato takoj ulezite in nadaljujte s spanjem.
Sedative hypnotics
Sedativno delujoči hipnotiki
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).
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).
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).
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).
What Xyrem is and what it is used for What you need to know before you take Xyrem How to take Xyrem
Kaj je zdravilo Xyrem in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Xyrem Kako jemati zdravilo Xyrem Možni neželeni učinki
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.
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.
GHB dehydrogenase inhibitors
Zaviralci dehidrogenaze GHB
In patients with epilepsy, the safety and efficacy of sodium oxybate has not been established, therefore use is not recommended.
Varnost in učinkovitost uporabe natrijevega oksibata pri bolnikih z epilepsijo nista bili ugotovljeni, zato njegova uporaba ni priporočljiva.
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.
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.
During the 8 week double-blind period, patients took modafinil at their established dose or placebo equivalent.
Med 8-tedenskim dvojno slepim preskušanjem so bolniki jemali modafinil ali placebo v ekvivalentnem odmreku.
Limited data from pregnant patients during second and third trimester indicate no malformative or foeto/neonatal toxicity of sodium oxybate.
Omejeni podatki od bolnic v drugem in tretjem trimesečju nosečnosti niso pri uporabi natrijevega oksibata pokazali nobenih malformacij ali toksičnosti za plod/novorojenčka.
The rat and dog exposures at the NOEL were lower (~50%) than that in humans.
Stopnja izpostavljenosti, pri kateri ni bilo opaziti učinka, je bila pri podgani in psu manjša (~50 %) kot pri ljudeh.
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.
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.
NOTE: Medicine will not flow into the syringe unless you keep the bottle in its upright position (See Figure 2).
OPOZORILO: Zdravilo ne bo teklo v injekcijsko brizgo, če ne bo plastenka v pokončnem položaju (glejte sliko 2).
Bradycardia and hypothermia may accompany unconsciousness, as well as muscular hypotonia, but tendon reflexes remain intact.
Nezavest lahko spremljata bradikardija in hipotermija, pa tudi mišična hipotonija z intaktnimi kitnimi refleksi.
The pharmacokinetics of sodium oxybate in paediatric patients under the age of 18 years have not been studied.
Pediatrična populacija: Farmakokinetike natrijevega oksibata pri pediatričnih bolnikih, mlajših od 18 let, niso preučevali.
The association of these developmental effects with maternal toxicity could not be established.
Povezanosti omenjenih učinkov na razvoj s toksičnostjo zdravila za samice niso mogli ugotoviti.
If you are taking valproate together with Xyrem, the dose of Xyrem will be adapted by your doctor.
Če sočasno z zdravilom Xyrem jemljete valproat, vam bo zdravnik prilagodil odmerek zdravila Xyrem.
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.
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.
Drink all of the first dose while sitting in bed, recap the cup, and then lie down right away.
Popijte prvi odmerek medtem ko že sedite v postelji, zaprite merico in se nato takoj uležite.
Trial 2 EDS (MWT)
2. preskušanje EDS (MWT)
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).
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).
Trial 3 enrolled 136 narcoleptic patients with moderate to severe cataplexy (median of 21 cataplexy attacks per week) at baseline.
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).
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.
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).
No effect on the pharmacokinetics of valproate was observed.
Učinka na farmakokinetiko valproata niso opazili.
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine l'Alleud, Belgium Or
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine l'Alleud, Belgija ali
It is eliminated mainly by metabolism with a half-life of 0.5 to 1 hour.
Izloča se v največji meri s pomočjo presnove, biološka razpolovna doba je 0,5 do 1 ure.
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.
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.
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.
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.
Treatment should be initiated by and remain under the guidance of a physician experienced in the treatment of sleep disorders.
Zdravljenje lahko uvede in ga vodi le zdravnik, ki ima izkušnje z zdravljenjem motenj spanja.
If you forget to take Xyrem
Če ste pozabili vzeti zdravilo Xyrem
Succinic acid enters the Krebs cycle where it is metabolised to carbon dioxide and water.
Jantarna kislina vstopa v Krebsov ciklus, kjer se presnavlja do ogljikovega dioksida in vode.
Cases of dependency have occurred after the illicit use of sodium oxybate.
Primeri odvisnosti so se pojavili pri prepovedani uporabi natrijevega oksibata.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Pri vsaki pogostnostni skupini so neželeni učinki navedeni po padajočem vrstnem redu glede na njihovo resnost.
Other neuropsychiatric events include anxiety, psychosis, paranoia, hallucinations, and agitation.
Pojavijo se lahko tudi drugi nevropsihiatrični dogodki, vključno z anksioznostjo, psihozo, paranojo, halucinacijami in agitacijo.
Treatment of narcolepsy with cataplexy in adult patients.
Zdravljenje narkolepsije s katapleksijo pri odraslih bolnikih.
The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials.
Učinki ob prekinitvi zdravljenja z natrijevim oksibatom niso bili sistematično ovrednoteni v nadzorovanih kliničnih preskušanjih.
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.
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.
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
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
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).
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.
Sodium oxybate is absorbed rapidly following oral administration with an absolute bioavailability of about 88 %.
Absorpcija: Po peroralnem jemanju se natrijev oksibat hitro absorbira z absolutno biološko uporabnostjo okoli 88 %.
The resulting pharmacodynamic effects, including increased impairment in cognitive function and sleepiness, were greater with co-administration than those observed with either drug alone.
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.
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.
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.
The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials (see section 4.4).
Učinki ob prekinitvi zdravljenja z natrijevim oksibatom niso bili sistematično ovrednoteni v nadzorovanih kliničnih preskušanjih (glejte poglavje 4.4).
If concomitant use is warranted, dose adjustment is to be considered (see section 4.2).
Če je sočasna uporaba upravičena, je treba prilagoditi odmerek (glejte poglavje 4.2).
Musculoskeletal and connective tissue disorders Common: arthralgia, muscle, spasms, back pain
Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti: artralgija, mišični spazmi, bolečine v hrbtu
- The other ingredients are purified water, malic acid and sodium hydroxyde.
- Pomožne snovi so prečiščena voda, jabolčna kislina in natrijev hidroksid.
No active metabolites have been identified.
Aktivnih presnovkov niso zaznali.
Antidepressants have been used in the treatment of cataplexy.
Za zdravljenje katapleksije se uporabljajo tudi antidepresivi.
A second mitochondrial oxidoreductase enzyme, a transhydrogenase, also catalyses the conversion to succinic semialdehyde in the presence of -ketoglutarate.
Drugi mitohondrijski oksidoreduktazni encim transhidrogenaza prav tako katalizira pretvorbo sukcinat-semialdehida ob prisotnosti -ketoglutarata.
Each measured dose of Xyrem must be dispensed into the dosing cup and diluted with 60 mL of water prior to ingestion.
Vsak odmerjeni odmerek zdravila Xyrem mora biti pred jemanjem odmerjen v merici in razredčen s 60 ml vode.
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.
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.
Next, insert the tip of the measuring syringe into the centre opening of the bottle and press down firmly (See Figure 1).
Nato vstavite konico merilne injekcijske brizge v osrednjo odprtino plastenke in jo močno pritisnite navzdol (glejte sliko 1).
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).
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).
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.
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.
• 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.
• List z bolnikovimi pogosto zastavljenimi vprašanji (prejme bolnik): odgovori na nekatera vprašanja, ki jih bolnik morda ima glede jemanja zdravila Xyrem.
If you stop taking Xyrem
Če ste prenehali jemati zdravilo Xyrem
Marketing Authorisation Holder UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium
Imetnik dovoljenja za promet z zdravilom UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruselj, Belgija
The emergence of depression when patients are treated with sodium oxybate requires careful and immediate evaluation.
Če se pri bolnikih, ki se zdravijo z natrijevim oksibatom, pojavi depresija, je treba njihovo stanje natančno in takoj ovrednotiti.
• How to Take Xyrem brochure (to be given to the patient): to provide patients with information related to the use of Xyrem.
• Brošura kako jemati zdravilo Xyrem (prejme bolnik): bolnikom zagotoviti informacije v zvezi z uporabo zdravila Xyrem
Metabolism and nutrition disorders Common: anorexia, decreased appetite Not known: Dehydration, increased appetite
Presnovne in prehranske motnje pogosti: anoreksija, zmanjšan apetit neznana: dehidracija, povečan apetit
Xyrem has the potential to induce respiratory depression
Zdravilo Xyrem lahko sproži respiratorno depresijo.
Blurred vision has been reported.
Poročali so tudi o zamegljenem vidu.
Patients with succinic semialdehyde dehydrogenase deficiency.
Pri bolnikih z zmanjšano aktivnostjo sukcinat-semialdehid-dehidrogenaze.
Special caution should be observed in patients with an underlying respiratory disorder.
Posebna previdnost je potrebna pri bolnikih z že obstoječimi boleznimi dihal.
There is no clinical data available on the effect of sodium oxybate on fertility.
Kliničnih podatkov o vplivu natrijevega oksibata na plodnost ni.
The clearance of sodium oxybate is almost entirely by biotransformation to carbon dioxide, which is then eliminated by expiration.
Izločanje: Očistek natrijevega oksibata je skoraj v celoti posledica biotransformacije do ogljikovega dioksida, ki se izloča z izdihanih zrakom.
Xyrem will affect you if you drive or operate tools or machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Xyrem bo vplivalo na vas pri vožnji ali upravljanju z orodji ali stroji.
An increasing depth of coma has been observed at higher doses.
Pri večjih odmerkih so opazili poglobljeno komo.
If any of these apply to you, tell your doctor before you take Xyrem.
Če karkoli od zgoraj navedenega velja za vas, o tem pred uporabo zdravila Xyrem obvestite svojega zdravnika.
Table 1 Summary of clinical trials performed using sodium oxybate for the treatment of narcolepsy
Preglednica 1 Pregled izvedenih kliničnih preskušanj z uporabo natrijevega oksibata za zdravljenje narkolepsije
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.
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 .
Infections and infestations Common: nasopharyngitis, sinusitis
Infekcijske in parazitske bolezni pogosti: nazofaringitis, sinusitis
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).
In vitro študije na združenih humanih jetrnih mikrosomih kažejo, da natrijev oksibat ne zavira značilno aktivnosti humanih izoencimov (glejte poglavje 5.2).
Change from Baseline Compared to Placebo (p-value)
sprememba glede na začetno stanje v primerjavi s placebom (vrednost p)
While holding the bottle in its upright position, insert the press-in-bottle-adaptor into the neck of the bottle.
Medtem ko plastenko držite v pokončnem položaju, vstavite adapter, ki se pritisne v plastenko, skozi vrat plastenke.
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.
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.
Sodium intake
Vnos natrija
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.
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.
Animal studies have shown no evidence of teratogenicity but embryolethality was seen in both rat and rabbit studies (see section 5.3).
Študije na živalih niso pokazale teratogenosti, v študijah na podganah in kuncih pa so opazili vpliv na smrtnost zarodkov (glejte poglavje 5.3).
If concomitant use is warranted, patient response and tolerability should be monitored and dose adjustments made if required (see section 4.2).
Če je sočasna uporaba upravičena, je treba spremljati bolnikov odziv in prenašanje ter po potrebi prilagoditi odmerek (glejte poglavje 4.2).
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).
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).
Trial 1 enrolled 246 patients with narcolepsy and incorporated a 1 week up-titration period.
Prvo preskušanje je vključevalo 246 bolnikov z 1-tedenskim titracijskim obdobjem.
Xyrem with food, drink and alcohol You must not drink alcohol while taking Xyrem, as its effects can be increased.
V času jemanja zdravila Xyrem ne smete uživati alkoholnih pijač, ker se lahko povečajo učinki zdravila.
Xyrem is used to treat narcolepsy with cataplexy in adults.
Zdravilo Xyrem se uporablja za zdravljenje narkolepsije s katapleksijo pri odraslih.