natgillin/translations-raw huggingface dataset:
Not known • Development of any combination of the following symptoms: pain, numbness, tingling in the arms and legs, lumps or raised patches in the skin, worsening problems with breathing, nasal congestion (signs of so-called “ Churg-Strauss syndrome”). • Low blood platelet count with symptoms such as bleeding or bruising more easily than normal. • Development of any of the following symptoms, especially if in combination: joint pain with or without swelling, rash, fever, swollen lymph nodes, muscle pain, (signs of serum sickness).
Pogostnost neznana • razvijanje kakršnekoli kombinacije naslednjih simptomov: bolečina, odrevenelost, mravljinčenje v rokah in nogah, mehurji ali lise nad ravnijo kože, poslabševanje težav z dihanjem, kongestija nosne sluznice, (znaki takoimenovanega “ Churg- Straussovega sindroma ”); • nizko število trombocitov z znaki, kot so krvavitev ali pojavljanje modric v večji meri kot normalno; • razvoj katerega od naslednjih znakov ali simptomov, posebno v kombinaciji: bolečine v sklepih z otekanjem ali brez njega, izpuščaj, zvišana telesna temperatura, povečane bezgavke, bolečine v mišicah (znaki serumske bolezni).
If you experience any of these, tell a doctor or nurse straight away.
Če pri vas pride do katerega od navedenih učinkov, takoj obvestite zdravnika ali medicinsko sestro.
Common side effects • headache • reactions at the injection site including pain, swelling, itching and redness.
Pogosti neželeni učinki • glavobol, • reakcije na mestu injiciranja, ki obsegajo bolečino, oteklino, srbenje in rdečino.
Uncommon side effects • feeling dizzy, sleepy or tired • tingling or numbness of the hands or feet • fainting, low blood pressure while sitting or standing (postural hypotension), flushing • sore throat, coughing, acute breathing problems • feeling sick (nausea), diarrhoea, indigestion • itching, hives, rash, increased sensitivity of the skin to sun • weight increase • flu-like symptoms, joint pain, muscle pain and joint swelling • hair loss
Občasni neželeni učinki • občutek vrtoglavosti, zaspanosti ali utrujenosti, • mravljinčenje ali odrevenelost dlani ali stopal, • omedlevica, nizek krvni tlak sede ali stoje (posturalna hipotenzija), rdečica, • vneto žrelo, kašelj, akutne težave z dihanjem, • slabost s siljenjem na bruhanje (navzea), driska, prebavne motnje, • srbenje, koprivnica, izpuščaj, povečana občutljivost kože za sončne žarke, • povečanje telesne mase, • gripi podobni simptomi, bolečine v sklepih in mišicah ter otekanje sklepov, • izpadanje las.
Rare side effects • parasitic infection
Redki neželeni učinki • okužba s paraziti
- Store in the original package in order to protect from light.
- Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo
- Store in a refrigerator (2°C – 8°C).
Shranjujte v hladilniku (2 °C – 8 °C).
One syringe of 0.5 ml solution contains 75 mg
Ena injekcijska brizga z 0, 5 ml raztopine vsebuje 75 mg
omalizumab.
omalizumaba.
Polysorbate 20 and water for injections.
- Pomožne snovi so L- arginin hidroklorid, L- histidin hidroklorid, L- histidin, polisorbat 20, voda
What Xolair looks like and contents of the pack Xolair solution for injection is supplied as a clear to opalescent, slightly yellow to brown solution in a pre-filled syringe, and is available as 75 mg and 150 mg solution for injection.
75 mg in 150 mg raztopine za injiciranje.
Not all pack sizes may be marketed in your country.
V vaši državi morda ni na voljo vseh pakiranj.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
103 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Κύπρος Δημητριάδης και Παπαέλληνας Λτδ Τηλ: +357 22 690 690
104 Κύπρος Δημητριάδης και Παπαέλληνας Λτδ Τηλ: +357 22 690 690
104 INFORMATION FOR THE HEALTHCARE PROFESSIONAL
105 INFORMACIJE ZA ZDRAVSTVENO OSEBJE
Before using the syringe, please read the following information carefully.
Pred uporabo injekcijske brizge natančno preberite naslednje informacije.
Parts of the pre-filled syringe Needle cap
Sestavni deli napolnjene injekcijske brizge pokrovček igle zapiralo igle
Needle guard Viewing window
sponke za aktivacijo
Finger flange
ročaj bata
Activation clips
pregledno okence
Plunger rod
mehanizma
Preparing the syringe for use Warning:
Pripravljanje injekcijske brizge za uporabo Opozorilo:
Take the box containing the syringe out of the refrigerator and leave it unopened for about 20 minutes so that it reaches room temperature.
Škatlo z injekcijsko brizgo vzemite iz hladilnika in pustite zaprto približno 20 minut, da doseže sobno temperaturo.
Holding the syringe horizontally (as shown below), look into the viewing window to check the dose (75 mg or 150 mg) of medicine and the expiry date printed on the label.
Injekcijsko brizgo držite vodoravno in v preglednem okencu preverite odmerek zdravila (75 mg ali 150 mg) ter preglejte datum izteka roka uporabnosti, ki je natisnjen na nalepki.
Rotate the inner part of the syringe assembly as shown below so that the label can be read in the viewing window.
Pozor: zavrtite notranji del sestave, kot prikazuje spodnja slika, tako da lahko v preglednem okencu odčitate nalepko.
DO NOT USE if the product has expired or if the dose is incorrect.
pregledno okence IZDELKA NE UPORABITE, če mu je potekel rok uporabe ali če odmerek ni pravi.
Having an air bubble is acceptable.
Nič ni narobe, če je v injekcijski brizgi zračni mehurček.
You do not have to expel any air before use.
Pred uporabo vam ni treba iztiskati zraka.
Carefully pull off the needle cap from the syringe and discard it.
Previdno potegnite pokrovček igle z injekcijske brizge in ga zavrzite.
107
107 Počasi sprostite bat in pustite, da zapiralo igle samodejno pokrije odkrito iglo.
Xyrem is an oral solution, which contains the active substance sodium oxybate (500 mg/ ml).
Zdravilo Xyrem je peroralna raztopina, ki vsebuje zdravilno učinkovino natrijev oksibat (500 mg/ ml).
Cataplexy is a symptom of narcolepsy involving sudden muscle weakness in response to an emotional reaction such as anger, fear, joy, laughter or surprise.
Katapleksija je simptom narkolepsije, ki se kaže kot nenada izguba mišičnega tonusa kot odgovor na čustveno reakcijo, kot je na primer jeza, strah, veselje, smeh ali presenečenje.
Because the number of patients with narcolepsy is low, the disease is considered ‘ rare’, and Xyrem was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 3 February 2003.
Bolnikov z nakrolepsijo je malo, zato velja ta bolezen za redko, zdravilo Xyrem pa je bilo 3. februarja 2003 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
The medicine can only be obtained with a special prescription.
Zdravilo se dobi samo na poseben recept.
Xyrem treatment should be initiated and given under the guidance of a doctor who has experience in the treatment of sleep disorders.
Zdravljenje z zdravilom Xyrem je treba uvesti in ga izvajati pod vodstvom zdravnika, ki ima izkušnje z zdravljenjem motenj spanja.
Because sodium oxybate can be abused, doctors should check for a history of drug abuse.
Ker je natrijev oksibat mogoče zlorabljati, morajo zdravniki preveriti morebitne zlorabe zdravil v preteklosti.
Xyrem is given at a dose of 4.5 to 9 g per day in two equally divided doses.
Zdravilo Xyrem se daje v odmerku od 4, 5 do 9 g dnevno v dveh enakih odmerkih.
Patients should usually start with two doses of 2.25 g (4.5 ml) per day.
Bolniki običajno začnejo z dvema odmerkoma po 2, 25 g (4, 5 ml) dnevno.
The dose is then adjusted at one- to two-week intervals depending on the patient’ s response.
Odmerek se nato prilagaja v eno - do dvo- tedenskih intervalih, odvisno od bolnikovega odziva.
Patients who have problems with their kidneys should consider a low sodium diet.
Za bolnike, ki imajo težave z ledvicami, se priporoča dieta z malo natrija.
Patients taking Xyrem should avoid alcohol, as it can increase Xyrem’ s effects.
Bolniki, ki jemljejo zdravilo Xyrem, se morajo izogibati alkoholu, saj lahko ta poveča učinke zdravila Xyrem.
Xyrem is supplied with a measuring device and a cup.
Zdravilo Xyrem se dobavlja z merilno napravo in merico.
The first dose of the day is taken at bedtime, at least 2 to 3 hours after food.
Prvi dnevni odmerek se vzame pred spanjem, najmanj 2 do 3 ure po obroku.
The second dose is taken 2.5 to 4 hours later.
Drugi odmerek se vzame 2, 5 do 4 ure pozneje.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Zdravilo Xyrem, če ga vzamete pred 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The active substance in Xyrem, sodium oxybate, is a central nervous system depressant.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged spanjem, poveča globoko spanje in količino nočnega spanca, pri tem pa zmanjša pogostost spanja podnevi.
The effects of Xyrem in narcolepsy and cataplexy have been studied in 707 patients in four studies.
Učinke zdravila Xyrem pri narkolepsiji in katapleksiji so preučevali v štirih študijah s 707 bolniki.
In all studies, Xyrem was given at a daily dose between 3 and 9 g, and it was compared with placebo (a dummy treatment).
V vseh študijah so bolniki zdravilo Xyrem prejemali v dnevnem odmerku med 3 in 9 g, pri čemer so njegov učinek primerjali s placebom 8zdravilom brez zdravilne učinkovine).
The first study (136 patients) examined the effects of Xyrem on the number of cataplexy attacks over 4 weeks of treatment.
V prvi študiji (136 bolnikov) so preučevali učinke zdravila Xyrem na število kataplektičnih napadov v 4 tednih zdravljenja.
The second study, including 56 patients who had taken Xyrem for at least 6 months, compared the effects of continuing to take Xyrem at the same dose as before, with switching to placebo.
V drugi študiji s 56 bolniki, ki so jemali zdravilo Xyrem najmanj 6 mesecev, so primerjali učinke nadaljnjega jemanja zdravila Xyrem pri enakem odmerku kot doslej z učinki pri prehodu na placebo.
The study measured the number of cataplexy attacks over 2 weeks.
V raziskavi so merili število kataplektičnih napadov v obdobju 2 tednov.
The other two studies (516 patients) examined the effects of Xyrem on excessive daytime sleepiness and other symptoms of narcolepsy, either taken alone or as an add-on to the patient ’ s existing dose of modafinil (a stimulant medicine used to treat narcolepsy).
Zdravilo je bilo dajano samostojno ali kot dodatek bolnikovemu obstoječemu odmerku modafinila (stimulansa, ki se uporablja za zdravljenje narkolepsije).
What benefit has Xyrem shown during the studies?
Kakšne koristi je zdravilo Xyrem izkazalo med raziskavami?
In the first study, a daily dose of 9 g reduced the number of cataplexy attacks by 16.1 (from 23.5 to 8.7) per week, compared to a fall of 4.3 per week in the patients taking placebo.
V prvi študiji je dnevni 9- gramski odmerek zmanjšal število kataplektičnih napadov za 16, 1 (iz 23, 5 na 8, 7) tedensko, medtem ko je bilo tedensko zmanjšanje pri bolnikih, ki so jemali placebo, za 4, 3.
The second study showed that Xyrem continued to prevent cataplexy attacks after long-term treatment: there was no change over 2 weeks in the number of attacks in the patients continuing to take Xyrem, compared to an increase of 21.0 in those switching to placebo.
Druga študija je pokazala, da je zdravilo Xyrem po dolgoročnem zdravljenju še naprej preprečevalo kataplektične napade: pri bolnikih, ki so nadaljevali z jemanjem zdravila Xyrem, v 2 tednih ni bilo spremembe v številu napadov, medtem ko se je pri bolnikih, ki so prešli na placebo, število napadov povečalo za 21, 0.
Xyrem also reduced excessive daytime sleepiness, in patients who continued to take modafinil, as well as in those who took Xyrem alone.
Zdravilo Xyrem je tudi zmanjšalo prekomerno dnevno zaspanost pri bolnikih, ki so nadaljevali z jemanjem modafinila, kot tudi pri bolnikih, ki so jemali samo zdravilo Xyrem.
The most common side effects when taking Xyrem (seen in more than 1 patient in 10) are dizziness, headache and nausea (feeling sick).
Najpogostejši neželeni učinki pri jemanju zdravila Xyrem (opaženi pri več kot 1 izmed 10 bolnikov) so omotica, glavobol in navzeja (občutek slabostti).
Xyrem can also cause respiratory depression (inhibition of breathing).
Zdravilo Xyrem lahko povzroči tudi respiratorno depresijo (zmanjšanje dihanja).
For the full list of all side effects reported with Xyrem, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Xyrem, glejte Navodilo za uporabo.
Xyrem should not be used in people who may be hypersensitive (allergic) to sodium oxybate or any of the other ingredients.
Zdravila Xyrem ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) natrijev oksibat ali na katero drugo sestavino.
It should not be used in patients with ‘ succinic semialdehyde dehydrogenase deficiency’ (a rare metabolic disease), or in patients being treated with opioids (such as some painkillers) or barbiturates (such as some anaesthetics and medicines used to prevent seizures [fits]).
Ne smejo ga uporabljati bolniki z „ zmanjšanim delovanjem encima sukcinat- semialdehid- dehidrogenaze “ (redka presnovna bolezen) ali bolniki, ki se zdravijo z opioidi (sem sodijo na primer nekatera zdravila za lajšanje bolečine) ali barbiturati (sem sodijo na primer nekateri anestetiki in zdravila, ki se uporabljajo za preprečevanje napadov [krčev]).
The Committee for Medicinal products for Human Use (CHMP) decided that Xyrem’ s benefits are greater than its risks for the treatment of narcolepsy with cataplexy in adult patients.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Xyrem pri zdravljenju odraslih bolnikov, ki imajo narkolepsijo s katapleksijo, večje od z njim povezanih tveganj.
Although the 9 g dose was the most effective, it was linked to high levels of side effects, so the committee recommended a starting dose of 4.5 g per day.
Čeprav je bil 9- gramski odmerek najbolj učinkovit, je bil povezan z mnogimi stranskimi učinki, zato je Odbor priporočil začetni odmerek 4, 5 g dnevno.
Since the effective dose is close to the dose at which side effects become serious, increases in dose must be carried out strictly and under the supervision of a doctor specialised in the treatment of sleep disorders.
Ker je učinkovit odmerek blizu odmerka, pri katerem postanejo stranski učinki resni, je treba povečanja odmerka izvajati strogo in pod nadzorom zdravnika, ki je posebej usposobljen za zdravljenje motenj spanja.
The committee recommended that Xyrem be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Xyrem odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Xyrem?
Kateri ukrepi so sprejeti za zagotavljanje varne uporabe zdravila Xyrem?
The company that makes Xyrem will minimise the risk of abuse of Xyrem by providing educational materials to healthcare workers and patients, strictly controlling the distribution of the medicine, and monitoring its use.
Podjetje, ki izdeluje zdravilo Xyrem, bo na najmanjšo možno mero zmanjšalo tveganje za zlorabo zdravila Xyrem tako, da bo priskrbelo izobraževalno gradivo zdravstvenim delavcem in bolnikom, strogo nadzorovalo distribucijo zdravila in spremljalo njegovo uporabo.
The summary of opinion of the Committee for Orphan Medicinal Products for Xyrem is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Xyrem je na voljo tukaj.
The full EPAR for Xyrem can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Xyrem je na voljo tukaj.
Route of Administration
Na in uporabe zdravila
bottle (PET)
Stekleni ka (PET)
1 bottle + 1 graduated 10 ml measuring device
1 stekleni ka 1 graduirana 10 ml merilna priprava
Xyrem 500 mg/ ml oral solution.
Xyrem 500 mg/ ml peroralna raztopina
One ml Xyrem contains 500 mg of sodium oxybate.
En mililiter zdravila Xyrem vsebuje 500 mg natrijevega oksibata.
The oral solution is clear to slightly opalescent.
Peroralna raztopina je bistra do rahlo opalescenčna.
Due to the well known potential of abuse of sodium oxybate, physicians should evaluate patients for a history of drug abuse (see section 4.4).
Zaradi dobro poznane možnosti zlorabe natrijevega oksibata morajo zdravniki ovrednotiti bolnike z vidika zlorabe zdravil v anamnezi (glejte poglavje 4. 4).
The recommended starting dose is 4.5 g/ day sodium oxybate divided into two equal doses of 2.25 g/ dose.
Priporočeni začetni odmerek natrijevega oksibata je 4, 5 g/ dan, razdeljen na dva enaka odmerka po 2, 25 g/ odmerek.
The dose should be titrated to effect based on efficacy and tolerability (see Section 4.4) up to a maximum of 9 g/ day divided into two equal doses of 4.5g/ dose by adjusting up or down in dose increments of 1.5 g/ day (i. e.
0. 75 g/ odmerek) do ustreznega učinka, ki temelji na učinkovitosti in bolnikovem prenašanju zdravila (glejte poglavje 4. 4), in sicer do največjega odmerka 9 g/ dan, razdeljenega na dva enaka odmerka po 4, 5 g/ odmerek.
A minimum of one to two weeks is recommended between dosage increments.
Priporočljivo je, da med posameznimi povečanji odmerka preteče najmanj eden do dva tedna.
The dose of 9g/ 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).
A 10ml measuring syringe and two 90 ml dosing cups are provided with Xyrem.
K zdravilu Xyrem je priložena merilna injekcijska brizga po 10 ml in dve odmerni merici po 90 ml.
Each dose of Xyrem must be diluted with 60 ml of water in the dosing cup prior to ingestion.
Vsak odmerek zdravila Xyrem moramo pred jemanjem razredčiti v odmerni merici s 60 ml vode.
Single doses of 4.5g 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.
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 (2 - 3) ur preden vzamejo prvi odmerek zdravila Xyrem tik pred spanjem.
Using Xyrem
Uporaba zdravila Xyrem
Xyrem should be taken orally upon getting into bed and again between 2.5 to 4 hours later.
Zdravilo Xyrem mora bolnik vzeti peroralno tik pred spanjem in nato spet 2, 5 ure do 4 ure kasneje.
Xyrem is provided for use with a graduated measuring syringe and dosing cup with child resistant cap.
Zdravilo Xyrem je namenjeno uporabi z graduirano merilno injekcijsko brizgo in odmerno merico z za otroke varno zaporko.
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.
2 Discontinuation of Xyrem
2 Prekinitev zdravljenja z zdravilom Xyrem
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 the patient stops medication for more than 14 consecutive days, titration should be restarted from the lowest dose Patients with hepatic impairment
Če bolnik prekine zdravljenje za več kot 14 zaporednih dni, je treba odmerek ponovno titrirati od najmanjšega odmerka.
The starting dose should be halved in patients with hepatic impairment, and response to dose increments monitored closely (see section 4.4).
Pri bolnikih z jetrno okvaro mora biti začetni odmerek za polovico manjši, odgovor na postopno povečanje odmerka pa je potrebno skrbno spremljati (glejte poglavje 4. 4).
Patients with impaired renal function should consider a dietary recommendation to reduce sodium intake (see section 4.4).
Pri bolnikih z ledvično okvaro je treba upoštevati priporočilo za zmanjšanje vnosa natrija s hrano (glejte poglavje 4. 4).
Elderly patients should be monitored closely for impaired motor and/ or cognitive function when taking Sodium oxybate (see section 4.4).
V času jemanja natrijevega oksibata je treba starejše bolnike skrbno spremljati zaradi možnih motenj v motoričnih in/ ali kognitivnih funkcijah (glejte poglavje 4. 4).
Safety and effectiveness in children and adolescents has not been established, therefore use in patients under 18 years of age is not recommended.
Varnost in učinkovitost zdravila pri otrocih in mladostnikih ni bila ugotovljena, zato ni priporočljiva uporaba zdravila pri bolnikih, mlajših od 18 let.
Hypersensitivity to sodium oxybate or to any of the excipients.
Preobčutljivost za natrijev oksibat ali katerokoli pomožno snov.
Sodium oxybate is contraindicated in patients with succinic semialdehyde dehydrogenase deficiency.
Natrijev oksibat je kontraindiciran pri bolnikih z zmanjšano aktivnostjo sukcinat- semialdehid - dehidrogenaze.
Sodium oxybate is contraindicated in patients being treated with opoids or barbiturates.
Natrijev oksibat je kontraindiciran pri bolnikih, ki se zdravijo z opoidi ali barbiturati.
Xyrem has the potential to induce respiratory depression
Zdravilo Xyrem lahko inducira respiratorno depresijo.
Abuse potential and dependance The active substance in Xyrem is sodium oxybate, which is as the sodium salt of gamma hydroxybutyrate (GHB), a CNS depressant active substance with well known abuse potential.
Možnost zlorabe in odvisnost Zdravilna učinkovina zdravila Xyrem je natrijev oksibat, ki je natrijeva sol gamahidroksibutirata (GHB), zdravilne učinkovine, ki zavira centralni živčni sistem in za katero je dobro znana možnost zlorabe.
Physicians should evaluate patients for a history of drug abuse and follow such patients closely.
Zdravnik mora ovrednotiti bolnikovo anamnezo z vidika zlorabe zdravil in take bolnike 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.
CNS depression The combined use of alcohol or any CNS depressant drug with sodium oxybate may result in potentiation of the CNS-depressant effects of sodium oxybate.
3 Depresija centralnega živčnega sistema Pri sočasni uporabi alkohola ali kateregakoli zaviralca centralnega živčnega sistema z natrijevim oksibatom lahko pride do potenciranja zaviralnih učinkov natrijevega oksibata na centralni živčni sistem.
Patients with porphyria 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.
Bolniki s porfirijo Uporaba natrijevega oksibata ni varna pri bolnikih s porfirijo, saj so študije na živalih ali v in vitro sistemih pokazale porfirogeni učinek zdravila.
3 Respiratory depression Sodium oxybate also has the potential to induce respiratory depression.
Respiratorna depresija Natrijev oksibat lahko inducira tudi depresijo dihanja.
Apnoea and respiratory depression have been observed in a fasting healthy subject after a single intake of 4.5g (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).
Patients should be questioned regarding signs of CNS or respiratory depression.
Bolnike je treba vprašati po znakih, povezanih z zaviranjem centralnega živčnega sistema ali dihanja.
Special caution should be observed in patients with an underlying respiratory disorder.
Posebna previdnost je potrebna pri bolnikih z že obstoječimi obolenji dihal.