natgillin/translations-raw huggingface dataset:
The average peak plasma concentrations (1st and 2nd peak) following administration of a 9 g daily dose divided into two equivalent doses given four hours apart were 78 and 142 μ g/ ml, respectively.
Po peroralni aplikaciji odmerka 9 g, razdeljenega na dva enaka odmerka, ki ju bolnik prejme v razmiku 4 ur, je bila povprečna največja plazemska koncentracija pri prvem maksimumu 78 μg/ ml, pri drugem pa 142 μg/ ml.
The average time to peak plasma concentration (Tmax) ranged from 0.5 to 2 hours in eight pharmacokinetic studies.
V osmih farmakokinetičnih študijah je bil povprečni čas za dosego največje plazemske koncentracije (Tmax) med 0, 5 ure in 2 urama.
Following oral administration, the plasma levels of sodium oxybate increase more than proportionally with increasing dose.
Po peroralni aplikaciji se plazemske koncentracije natrijevega oksibata povečajo več kot le sorazmerno glede na odmerek.
Single doses greater than 4.5 g have not been studied.
Enkratnih odmerkov večjih od 4, 5 g niso preučevali.
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%.
10 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%.
Sodium oxybate is a hydrophilic compound with an apparent volume of distribution averaging 190-384 ml/ kg.
Natrijev oksibat je hidrofilna spojina s povprečnim navideznim volumnom porazdelitve 190−384 ml/ kg.
At sodium oxybate concentrations ranging from 3 to 300 μ g/ ml, less than 1% is bound to plasma proteins.
V območju koncentracij natrijevega oksibata med 3 do 300 μg/ ml ga je manj kot 1% vezanega na plazemske beljakovine.
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 β -oxidation.
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 β- oksidacijo.
The primary pathway involves a cytosolic NADP+-linked enzyme, GHB dehydrogenase, that catalyses the conversion of sodium oxybate to succinic semialdehyde, which is then biotransformed to succinic acid by the enzyme succinic semialdehyde dehydrogenase.
Primarna pot vključuje citosolni z NADP+ povezan encim, dehidrogenazo GHB, ki katalizira pretvorbo natrijevega oksibata v sukcinat- semialdehid, ki se nato biotransformira v jantarno kislino z encimom sukcinat- semialdehid- dehidrogenaza.
A second mitochondrial oxidoreductase enzyme, a transhydrogenase, also catalyses the conversion to succinic semialdehyde in the presence of α -ketoglutarate.
Drugi mitohondrijski oksidoreduktazni encim transhidrogenaza prav tako katalizira pretvorbo sukcinat- semialdehida ob prisotnosti α- ketoglutarata.
An alternate pathway of biotransformation involves β -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 β- oksidacijo preko 3, 4 - dihidroksibutirata do acetil- CoA, ki prav tako vstopa v ciklus trikarboksilnih kislin, kjer nastajata ogljikov dioksid in voda.
CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A up to the concentration of 3 mM (378 μ g/ ml).
In vitro študije z združenimi humanimi jetrnimi mikrosomi kažejo, da natrijev oksibat v koncentracijah do 3 mM (378 μg/ ml) ne zavira značilno aktivnosti humanih izoencimov CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ali CYP3A.
The clearance of sodium oxybate is almost entirely by biotransformation to carbon dioxide, which is then eliminated by expiration.
Očistek natrijevega oksibata je skoraj v celoti posledica biotransformacije do ogljikovega dioksida, ki se izloča z izdihanih zrakom.
On average, less than 5% of unchanged drug 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.
The pharmacokinetics of sodium oxybate in patients greater than the age of 65 years have not been studied.
Farmakokinetike natrijevega oksibata pri bolnikih, starejših od 65 let, niso preučevali.
The pharmacokinetics of sodium oxybate in paediatric patients under the age of 18 years have not been studied.
Farmakokinetike natrijevega oksibata pri pediatričnih bolnikih, mlajših od 18 let, niso preučevali.
Because the kidney does not have a significant role in the excretion of sodium oxybate, no pharmacokinetic study in patients with renal dysfunction has been conducted; no effect of renal function on sodium oxybate pharmacokinetics would be expected.
Ni pričakovati, da bi imelo delovanje ledvic vpliv na farmakokinetiko natrijevega oksibata.
Sodium oxybate undergoes significant presystemic (hepatic first-pass) metabolism.
Natrijev oksibat je podvržen izraziti predsistemskemi (prvi prehod preko jeter) presnovi.
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 iz 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).
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).
It is prudent to reduce the starting dose of sodium oxybate by one-half in patients with liver dysfunction (see Section 4.2).
Pri bolnikih z jetrno disfunkcijo je smiselno zmanjšati začetni odmerek natrijevega oksibata za polovico (glejte poglavje 4. 2).
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.
Treatment- related 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,
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.
11 Gamma Butyrolactone (GBL), a pro-drug of GHB tested at exposures similar to the expected in man (1.21-1.64 times) has been classified by NTP as non-carcinogenic in rats and equivocal carcinogen in mice, due to slight increase of pheochromocytomas which was difficult to interpret due to high mortality in the high dose group.
V nacionalnem programu toksičnosti (NTP - National Toxicology Program) so ga klasificirali kot nekancerogenega pri podganah ter kot nezanesljivo kancerogenega pri miših, kjer je prišlo do rahlega povečanja pogostnosti feokromocitoma, kar pa je bilo zaradi velike smrtnosti v skupini z velikimi odmerki težko interpretirati.
GHB had no effect on mating, general fertility or sperm parameters and did not produce embryo-foetal 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).
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 drugs.
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.
Self-administration studies in rats, mice and monkeys have produced conflicting results, whereas tolerance to GHB as well as cross-tolerance to alcohol have 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 pri glodalcih jasno pokazali.
Purified water Malic acid for pH adjustment Sodium Hydroxide for pH adjustment
prečiščena voda jabolčna kislina za uravnavanje pH natrijev hidroksid za uravnavanje pH
6.3 Shelf life 5 years
5 let.
After First opening:
Po prvem odpiranju zdravila:
40 days
40 dni.
After dilution in the dosing cups (see Section 4.2), the preparation should be used within 24 hours.
Po redčenju v odmernih mericah (glejte poglavje 4. 2) je potrebno zdravilo porabiti v 24 urah.
This medicinal product does not require any special storage conditions.
Za zdravilo niso potrebni posebni pogoji shranjevanja.
Amber oval PET bottle with a child resistant closure composed of HDPE/ polypropylene with a LDPE liner fitted with a PVC tamper evident seal.
Rjava, ovalna PET plastenka z za otroke varno zaporko iz HDPE/ polipropilena z LDPE vložkom, pritrjenim s PVC membrano, zaščiteno pred nedovoljenim odpiranjem.
Each carton contains one bottle of 180ml Xyrem, a press-in bottle adaptor consisting of an LDPE bottle-well housing, a Silastic Biomedical ETR Elastomer valve, an acrylonitrile butadiene styrene terpolymer valve retainer and LDPE tubing, a graduated 10ml measuring device (polypropylene syringe), two polypropylene dosing cups and two HDPE child resistant screw closures.
12 Vsaka škatla vsebuje eno plastenko po 180 ml zdravila Xyrem, adapter, ki se pritisne v plastenko in je sestavljen iz ogrodja iz LDPE, kjer iz plastenke izhaja zdravilo, gumijstega EPDM biomedicinskega ETR elastomernega (Silastic) ventila, držala za ventil iz acrilonitril/ butadien/ stiren terpolimera in cevk iz LDPE, graduiran 10- mililitrski merilni pripomoček (polipropilenska injekcijska brizga), dve polipropilenski odmerni merici in dve HDPE za otroke varni navojni zaporki.
UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE UK
UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE Velika Britanija
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strain Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /
Recipharm Limited Vale of Bardsley, Ashton under Lyne Lancashire OL7 9RR United Kingdom
Recipharm Limited Vale of Bardsley, Ashton under Lyne Lancashire OL7 9RR Velika Britanija
UCB Pharma Ltd Unit 11 - 14 Foster Avenue Woodside Park Dunstable Bedfordshire LU5 5TA United Kingdom
UCB Pharma Ltd Unit 11 - 14 Foster Avenue Woodside Park Dunstable Bedfordshire LU5 5TA Velika Britanija
UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE United Kingdom
UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE Velika Britanija
Medicinal product subject to special and restricted medical prescription (See Annex I:
Izdaja zdravila je le pod omejenimi pogoji in na recept (Glej Dodatek I:
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
17 PODATKI NA ZUNANJI OVOJNINI Škatla
Xyrem 500 mg/ ml oral Solution sodium oxybate
Xyrem 500 mg/ ml peroralna raztopina natrijev oksibat
500 mg/ ml sodium oxybate
500 mg/ ml natrijevega oksibata
Purified water Malic acid Sodium Hydroxide
prečiščena voda jabolčna kislina natrijev hidroksid
One 180 ml bottle
1 plastenka po 180 ml
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
POSEBNO OPOZORILO O SHRANJEVENJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
UK.
UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE Velika Britanija
< Batch >
< Serija >
Medicinal product subject to medical prescription.
Zdravilo se izdaja le na recept.
19 MINIMUM PARTICULARS TO APPEAR BOTTLE
19 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PLASTENKI
Xyrem 500 mg/ ml oral solution Oral use
Xyrem 500 mg/ ml peroralna raztopina peroralna uporaba
< EXP {MM/YYYY} >
< EXP {MM/ LLLL} >
180 ml of a 500mg / ml sodium oxybate solution
180 ml raztopine s 500 mg/ ml natrijevega oksibata
Xyrem 500 mg/ ml oral solution Sodium oxybate
Xyrem 500 mg/ ml peroralna raztopina natrijev oksibat
What Xyrem is and what it is used for 2.
Kaj je zdravilo Xyrem in za kaj ga uporabljamo 2.
Before you take Xyrem 3.
Kaj morate vedeti, preden boste vzeli zdravilo Xyrem 3.
How to take Xyrem 4.
Kako jemati zdravilo Xyrem 4.
Possible side effects 5 How to store Xyrem 6.
Možni neželeni učinki 5 Shranjevanje zdravila Xyrem 6.
WHAT XYREM IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO XYREM IN ZA KAJ GA UPORABLJAMO
Xyrem is used to treat narcolepsy with cataplexy in adult patients.
Zdravilo Xyrem se uporablja za zdravljenje narkolepsije s katapleksijo pri odraslih bolnikih.
BEFORE YOU TAKE XYREM
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO XYREM
Do not take Xyrem
Ne jemljite zdravila Xyrem
- if you are allergic (hypersensitive) to sodium oxybate or any of the other ingredients of Xyrem
- če ste alergični na (preobčutljivi za) natrijev oksibat ali katerokoli sestavino zdravila Xyrem
- if you have succinic semialdehyde dehydrogenase deficiency (a rare metabolic disorder)
- če imate zmanjšano delovanje encima sukcinat- semialdehid- dehidrogenaze (redka presnovna
- if you are being treated with opoids or barbiturate agents
- če se zdravite z opioidi ali barbiturati
Take special care with Xyrem
Bodite posebno pozorni pri jemanju zdravila Xyrem
- if you have breathing or lung problems
- če imate težave z dihanjem ali s pljuči
- if you have or have previously had depressive illness
- če imate ali ste imeli depresijo
- if you have heart failure, hypertension (high blood pressure), liver or kidney problems as your
- če imate srčno popuščanje, hipertenzijo (visok krvni tlak), težave z jetri ali ledvicami, ker bo
dose may need to be adjusted
morda potrebno prilagoditi odmerek
- if you are taking other CNS depressants or alcohol
- če jemljete druge zaviralce centralnega živčnega sistema ali uživate alkohol
- if you have previously had experience with drug abuse
- če ste že kdaj zlorabljali zdravila
- if you suffer from epilepsy the use of Xyrem is not recommended
- če imate epilepsijo, saj v tem primeru uporaba zdravila Xyrem ni priporočljiva
- if you have porphyria (an uncommon metabolic disorder)
- če imate porfirijo (redka presnovna bolezen)
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.
22 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.
22 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.
Xyrem should not be taken by children.
Zdravila Xyrem ne smejo jemati otroci.
When you discontinue taking Xyrem you need to follow your doctor’ s instructions as it may result in side effects e. g. headache, lack of sleep, mood changes and hallucinations.
Ko boste prenehali jemati zdravilo Xyrem, morate upoštevati zdravnikova navodila, ker se lahko pojavijo neželeni učinki npr. glavobol, pomanjkanje spanja, spremembe razpoloženja in halucinacije.
Taking Xyrem with food and drink You must not drink alcohol while taking Xyrem, as its effects can be increased.
V času jemanja zdravila Xyrem ne smete uživati alkohola, ker se lahko povečajo učinki zdravila.
Xyrem is to be taken at a set time well after a meal (two - three hours) as food decreases the amount of Xyrem that is absorbed by your body.
Zdravilo Xyrem morate jemati vedno ob enakem času po obroku (dve - tri ure), ker lahko hrana zmanjša količino zdravila Xyrem, ki jo absorbira vaše telo.
Xyrem should be diluted only with water.
Zdravilo Xyrem lahko redčite samo z vodo.
You need to monitor the amount of salt you take as Xyrem contains sodium (which is found in table salt) which may effect you if you have had 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 s krvnim tlakom, srcem ali z ledvicami.
If you take two 2.25 g doses of sodium oxybate each night you will take 0.82g of sodium, or if you take two 4.5 g doses of sodium oxybate each night you will take in 1.6g sodium.
Če vsako noč vzamete dva odmerka po 2. 25 g zdravila natrijev oksibat, boste ob tem zaužili 0, 82 g natrija, če pa vsako noč vzamete dva odmerka po 4. 5 g zdravila natrijev oksibat, boste ob tem zaužili 1, 6 g natrija.
Pregnancy and breast-feeding The effects of Xyrem in pregnant women are not known, and so the use of Xyrem in pregnant women is not recommended.
Nosečnost in dojenje Učinki zdravila Xyrem pri nosečnicah niso znani, zato njegova uporaba pri nosečnicah ni priporočljiva.
Tell your doctor if you are pregnant or are planning to become pregnant.
Povejte svojemu zdravniku, če ste noseči ali želite zanositi.
Xyrem is not recommended during pregnancy unless on the advice of your doctor
Uporaba zdravila Xyrem v času nosečnosti ni priporočljiva, razen če vam je tako svetoval zdravnik.
Driving and using machines 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.
HOW TO TAKE XYREM
KAKO JEMATI ZDRAVILO XYREM
Always take Xyrem exactly as your doctor has instructed you.
Natančno upoštevajte zdravnikova navodila.
The usual starting dose is 4.5 g/ day, given as two equally divided doses of 2.25 g/ dose.
23 Običajni začetni odmerek je 4, 5 g/ dan, ki ga morate vzeti razdeljenega na dva enaka odmerka po 2, 25 g/ odmerek.
Your doctor may gradually increase your dose up to a maximum of 9 g/ day given as two equally divided doses of 4.5g/ 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.
Take the first dose upon getting into bed and the second dose 2.5 to 4 hours later.
Prvi odmerek vzemite tik preden greste v posteljo, drugega pa 2, 5 do 4 ure kasneje.
You may need to set an alarm clock to make sure you wake up to take the second dose.
Morda si boste morali naviti budilko, da se boste zagotovo zbudili za drugi odmerek zdravila.
Therefore, it is best to take Xyrem at set times well after a meal (two-three hours).
Hrana zmanjša količino zdravila Xyrem, ki ga vaše telo absorbira, zato je najbolje, da jemljete zdravilo Xyrem vedno ob enakem času po obroku (dve - tri ure).
23 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.
To help you, the Xyrem carton contains 1 bottle of medicine, a measuring syringe and two dosing cups with child-resistant caps.
V pomoč vam bo podatek, da je v škatlici zdravila Xyrem 1 plastenka zdravila, merilna injekcijska brizga in dve odmerni merici z za otroke varno zaporko.
The bottle will contain a tamper-evident seal that will need to be removed before using the bottle for the first time.
Plastenka ima membrano za zaščito zdravila pred nedovoljenim odpiranjem, ki jo boste morali 1. odstraniti pred prvo uporabo zdravila.
Remove the bottle cap by pushing down while turning the cap anticlockwise (to the left).
Odstranite zaporko plastenke tako, da jo med vrtenjem v smeri proti urinemu kazalcu (v levo) pritisnete navzdol.
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 2. pritisnite navzdol (glejte Sliko 1).
While holding the bottle and syringe with one hand, draw up the prescribed dose with the other hand by pulling on the plunger.
Medtem ko z eno roko držite plastenko in injekcijsko brizgo, z drugo s pomočjo bata potegnite 3. v injekcijsko brizgo predpisan odmerek.
Medicine will not flow into the syringe unless you keep the bottle in its upright position (See Figure 2).
Zdravilo ne bo teklo v injekcijsko brizgo, če ne bo plastenka v pokončnem položaju (glejte Sliko 2).
Empty the medicine from the syringe into one of the dosing cups provided by pushing on the plunger (See Figure 3).
Zdravilo, ki je v injekcijski brizgi, s pritiskom na bat prenesite v eno od priloženih odmernih meric (glejte Sliko 3).
Then add about 60 ml of water to each dosing cup (60 mls is about 4 tablespoons)
Nato dodajte okoli 60 ml vode v vsako od odmernih meric (60
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).
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 naviti 6. 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.
Remove the cap from the first dosing cup by pressing down on the child- resistant locking tab and turning the cap anticlockwise (to the left).
Odstranite zaporko iz prve odmerne merice, tako da pritisnete na za otroke varno zaporno zanko in zavrtite zaporko v smeri nasproti urinemu kazalcu (v levo).
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.
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.
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 in se nato takoj ulezite in nadaljujte s spanjem.
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 s farmacevtom.
If you take more Xyrem than you should Symptoms of Xyrem overdose may include agitation, confusion, impaired movement, impaired breathing, blurred vision, profuse sweating, headache, vomiting, decreased consciousness leading to coma and seizures.
Če ste vzeli večji odmerek zdravila Xyrem, kot bi smeli Simptomi prevelikega odmerjanja zdravila Xyrem lahko vključujejo agitacijo, zmedenost, težave pri gibanju, težave pri dihanju, zamegljen vid, obilno znojenje, glavobol, bruhanje, zmanjšano zavest, ki vodi v komo in epileptični napad.