natgillin/translations-raw huggingface dataset:
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
In clinical trials, cannabidiol discontinuation was achieved by reducing the dose by approximately 10% per day for 10 days (see section 4.4).
V kliničnih preskušanjih so prekinitev zdravljenja s kanabidiolom dosegli tako, da so odmerek 10 dni zmanjševali za približno 10 % na dan (glejte poglavje 4.4).
Epidyolex must not be given to children under the age of 2 years, since there is no information on use in children below this age.
Zdravila Epidyolex ne smete dajati otrokom, mlajšim od 2 let, saj za to starostno skupino ni na voljo informacij o uporabi.
For any information about this medicine, please contact the medical information representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Do not reduce the dose or stop this medicine unless the doctor tells you to.
Ne zmanjšajte odmerka oziroma ne prenehajte jemati tega zdravila, razen če vam to naroči zdravnik.
a average increases of 47% in AUC and 73% in Cmax b based on Cmax and AUC
a AUC se je v povprečju povečala za 47 %, Cmax pa za 73 % b glede na Cmax in AUC
In vitro, > 94% of cannabidiol and its phase I metabolites were bound to plasma proteins, with preferential binding to human serum albumin.
In vitro se > 94 % kanabidiola in njegovih presnovkov faze I veže na beljakovine v plazmi s preferenčno vezavo na humani serumski albumin.
The mechanism has not been determined.
Mehanizma še niso ugotovili.
Push the bottle adaptor firmly into the neck of the bottle, and make sure it is fully inserted.
Nastavek za steklenico močno potisnite v vrat steklenice in se prepričajte, da je popolnoma vstavljen.
Upon changes in cannabidiol dose above 10 mg/kg/day or changes in medicinal products (dose change or additions) that are known to impact the liver, this monitoring schedule should be restarted.
Po spremembah odmerka kanabidiola nad 10 mg/kg/dan ali spremembah zdravil (sprememba ali dodajanje odmerkov), za katera je znano, da vplivajo na jetra, je treba ponovno izvesti to shemo spremljanja.
The mechanism of this interaction is unknown.
Mehanizem te interakcije ni znan.
Tell your doctor if you have liver problems because the doctor may need to adjust the dose.
Obvestite zdravnika, če imate težave z jetri, ker vam bo morda moral prilagoditi odmerek.
Results of the subgroup analysis of patients treated with clobazam compared to patients treated without clobazam, indicated that there is residual statistical uncertainty regarding the treatment effect of cannabidiol in patients not taking clobazam.
Rezultati analize podskupin pri bolnikih, zdravljenih s klobazamom, v primerjavi z bolniki, ki so se zdravili brez klobazama, so pokazali, da obstaja statistična negotovost glede učinka zdravljenja s kanabidiolom pri bolnikih, ki ne jemljejo klobazama.
The safety and efficacy of cannabidiol in children aged 6 months to 2 years have not yet been established.
Varnost in učinkovitost kanabidiola pri bolnikih, starih od 6 mesecev do 2 let, še nista bili dokazani.
A no-effect dose was not established.
Odmerka brez učinka niso ugotovili.
Interaction resulting in an approximate 28% increase in Cmax and 55% increase in AUC.
Interakcija je povzročila približno 28odstotno povečanje Cmax in 55-odstotno povečanje AUC.
Patients should be advised not to drive or operate machinery until they have gained sufficient experience to gauge whether it adversely affects their abilities (see section 4.8).
Bolnikom je treba odsvetovati vožnjo ali upravljanje strojev, dokler z zdravilom ne pridobijo zadostnih izkušenj, da znajo presoditi, ali negativno vpliva na njihove sposobnosti (glejte poglavje 4.8).
The doctor will explain how to gradually stop taking Epidyolex.
Zdravnik vam bo razložil, kako postopoma prenehati z jemanjem zdravila Epidyolex.
If there is an air bubble in the syringe, push the liquid back into the bottle whilst keeping the bottle upside down, and repeat Step 5 until the bubble has gone.
Če je v brizgi zračni mehurček, potisnite tekočino nazaj v steklenico, ki jo držite obrnjeno navzdol, nato pa ponovite korak 5, da mehurček izgine.
The dose titration should be performed as detailed in section 4.2.
Titriranje odmerka je treba izvesti, kakor je podrobneje opisano v poglavju 4.2.
A corresponding decrease in haematocrit was also observed, with a mean change of −1.4% in cannabidiol-treated patients.
Primerljivo znižanje so opazili tudi pri vrednostih hematokrita, in sicer s povprečno spremembo −1,4 % pri bolnikih, zdravljenih s kanabidiolom.
Although no formal drug-drug interaction studies have been performed for other AEDs, phenytoin and lamotrigine are addressed based on in vitro data.
Čeprav niso bile izvedene nobene formalne študije medsebojnega delovanja zdravil za druge AED, sta fenitoin in lamotrigin obravnavana na podlagi podatkov in vitro.
Elderly (65 years of age and above) The safety and efficacy of cannabidiol in patients ≥ 65 years of age have not been established.
Starejši bolniki (stari 65 let in več) Varnost in učinkovitost kanabidiola pri bolnikih, starih ≥ 65 let, nista bili dokazani.
Your doctor will calculate the dose according to your body weight.
Zdravnik vam bo izračunal ustrezen odmerek na osnovi vaše telesne mase.
The maximum recommended single dose of Epidyolex (10 mg/kg) will increase the concentration of ethanol in the body by about 13 mg/l.
Največji priporočeni enkratni odmerek zdravila Epidyolex (10 mg/kg) poveča koncentracijo etanola v telesu za približno 13 mg/l.
Clear, colourless to yellow solution
Bistra, brezbarvna do rumena raztopina
Detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila, http://www.ema.europa.eu.
To minimise the variability in the bioavailability of cannabidiol in the individual patient, administration of cannabidiol should be standardised in relation to food intake including a ketogenic diet (high-fat meal).
Za zmanjšanje variabilnosti v biološki uporabnosti kanabidiola pri posameznem bolniku je treba dajanje kanabidiola standardizirati glede na vnos hrane, vključno s ketogeno dieto (obroki z veliko maščobe).
Decreased appetite and weight loss may result in slightly reduced height gain.
Zmanjšan apetit in izguba telesne mase lahko povzročita nekoliko zmanjšano pridobivanje telesne višine.
The alcohol content should be taken into account in pregnancy and high-risk groups such as patients with liver disease.
Vsebnost alkohola je treba upoštevati pri nosečnicah in skupinah z visokim tveganjem, kot so bolniki z jetrnimi obolenji.
Other CNS depressants, including alcohol, can potentiate the somnolence and sedation effect.
Drugi zaviralci centralnega živčnega sistema, vključno z alkoholom, lahko ojačajo učinek somnolence in sedacije.
The clinical relevance of this is unknown, but the patient should be closely monitored for adverse drug reactions.
Klinična pomembnost tega ni znana, bolnika pa je treba skrbno spremljati glede pojava neželenih učinkov zdravila.
The DS population in studies GWPCARE2 and GWPCARE1 was predominantly paediatric patients, with only 5 adult patients who were 18 years old (1.6%), and therefore limited efficacy and safety data were obtained in the adult DS population.
Populacijo bolnikov z DS v študijah GWPCARE2 in GWPCARE1 so sestavljali pretežno pediatrični bolniki in samo 5 odraslih bolnikov, starih 18 let (1,6 %), zato je bilo v odrasli populaciji bolnikov z DS pridobljenih le malo podatkov o učinkovitosti in varnosti zdravila.
The dose level of 125 mg/kg/day induced decreased foetal body weights and increased foetal structural variations associated with maternal toxicity.
Odmerek 125 mg/kg/dan je povzročil zmanjšanje telesne mase ploda in povečane strukturne spremembe ploda, povezane s toksičnostjo pri materi.
Therefore, dose adjustments of cannabidiol or clobazam may be required.
Zato so lahko potrebne prilagoditve odmerka kanabidiola ali klobazama.
Hypersensitivity to the active substance, to sesame oil, or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino, sezamovo olje ali katero koli pomožno snov, navedeno v poglavju 6.1.
Of the patients that were not taking clobazam, the majority had previously taken and subsequently discontinued clobazam treatment.
Od bolnikov, ki niso jemali klobazama, se je večina bolnikov predhodno zdravila s klobazamom in je zdravljenje s klobazamom kasneje prekinila.
The European Medicines Agency has deferred the obligation to submit the results of studies with cannabidiol in one or more subsets of the paediatric population in treatment of seizures associated with DS and LGS.
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s kanabidiolom za eno ali več podskupin pediatrične populacije pri zdravljenju epileptičnih napadov, povezanih z DS in LGS.
Animal abuse-related studies show that cannabidiol does not produce cannabinoid-like behavioural responses, including generalisation to delta-9-tetrahydrocannabinol (THC) in a drug discrimination study.
Študije na živalih, povezane z zlorabo, kažejo, da kanabidiol ne povzroča kanabinoidnih vedenjskih odzivov, kar vključuje generalizacijo na delta-9-tetrahidrokanabinol (THC) v študiji razlikovanja zdravil.
Open the bag containing the correct oral syringe to measure your dose.
Odprite vrečko, ki vsebuje ustrezno brizgo za peroralno dajanje, da boste lahko odmerili odmerek.
Cannabidiol can cause somnolence and sedation, which occur more commonly early in treatment and may diminish with continued treatment.
Kanabidiol lahko povzroči somnolenco in sedacijo, ki se pogosteje pojavita v zgodnjem obdobju zdravljenja in se lahko med nadaljevanjem zdravljenja zmanjšata.
Concomitant use of clobazam also increased the incidence of transaminase elevations, although to a lesser extent than valproate.
Tudi sočasna uporaba klobazama je povečala incidenco zvišanja transaminaz, vendar v manjši meri kot valproat.
There are no clinical data on the presence of cannabidiol or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
Klinični podatki o prisotnosti kanabidiola ali njegovih presnovkov v materinem mleku, učinkih na dojenega dojenčka ali učinkih na nastajanje mleka niso na voljo.
Given that cannabidiol is highly protein bound and will likely pass freely from plasma into milk, as a precaution, breast-feeding should be discontinued during treatment.
Glede na to, da se kanabidiol močno veže na beljakovine in prosto prehaja iz plazme v mleko, je treba med zdravljenjem prenehati z dojenjem.
Drop seizures were defined as atonic, tonic, or tonic-clonic seizures that led or could have led to a fall or injury.
Akinetični napadi so bili opredeljeni kot atonični, tonični ali tonično-klonični epileptični napadi, ki so povzročili ali bi lahko povzročili padec ali poškodbo.
Effects of alcohol in children under the age of 6 years old may include sleepiness, behavioural changes, and problems with concentration and taking part in school activities.
Učinki alkohola pri otrocih, mlajših od 6 let, lahko vključujejo zaspanost, vedenjske spremembe in težave s koncentracijo ter sodelovanjem pri šolskih dejavnostih.
If cannabidiol has to be discontinued, the dose should be decreased gradually.
Če je treba zdravljenje s kanabidiolom prekiniti, je odmerek priporočljivo zmanjševati postopoma.
Taking Epidyolex with certain other medicines may cause side effects, affect how the other medicines work, or affect how Epidyolex works.
Jemanje zdravila Epidyolex z nekaterimi drugimi zdravili lahko povzroči neželene učinke, vpliva na delovanje teh drugih zdravil ali vpliva na delovanje zdravila Epidyolex.
Warnings and precautions Talk to your doctor or pharmacist before taking Epidyolex or during treatment if: - you have or have had liver problems, as your doctor may need to change the dose of Epidyolex or may decide that Epidyolex is not appropriate for you.
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Epidyolex ali med zdravljenjem se posvetujte z zdravnikom ali farmacevtom, če: - imate ali ste kdaj imeli težave z jetri, saj bo zdravnik morda moral spremeniti odmerek zdravila Epidyolex oziroma lahko presodi, da zdravilo Epidyolex za vas ni primerno.
This leaflet was last revised in .
Navodilo je bilo nazadnje revidirano dne
Effects of alcohol in children less than 6 years old may include sleepiness, behavioural changes, and impaired ability to concentrate and participate in school activities.
Učinki alkohola pri otrocih, starih manj kot 6 let, lahko vključujejo zaspanost, vedenjske spremembe ter zmanjšano sposobnost koncentracije in sodelovanja pri šolskih dejavnostih.
In the case of more than 7 days' missed doses, re-titration to the therapeutic dose should be made.
Če so bili odmerki izpuščeni v obdobju več kot 7 dni, je potrebno ponovno titriranje odmerka nazaj na terapevtski odmerek.
The alcohol content should be taken into account in pregnant women, children and high-risk groups such as patients with liver disease.
Vsebnost alkohola je treba upoštevati pri nosečnicah, otrocih in skupinah z visokim tveganjem, kot so bolniki z jetrnimi obolenji.
Epidyolex should be initiated and supervised by physicians with experience in the treatment of epilepsy.
Zdravilo Epidyolex mora uvesti in nadzorovati zdravnik z izkušnjami z zdravljenjem epilepsije.
Insufficient data are available to assess the risk of concomitant administration of other hepatotoxic medicinal products and cannabidiol (see section 4.4).
Na voljo ni dovolj podatkov, da bi lahko ocenili tveganje sočasnega dajanja drugih hepatotoksičnih zdravil in kanabidiola (glejte poglavje 4.4).
Signs of taking more Epidyolex than you should include diarrhoea and sleepiness.
Znaki, da ste vzeli večji odmerek zdravila Epidyolex, kot bi smeli, vključujejo drisko in zaspanost.
Concomitant AED treatments
Sočasno zdravljenje z AED
Potential interactions between cannabidiol (750 mg twice daily in healthy volunteers and 20 mg/kg/day in patients) and other AEDs were investigated in drug-drug interaction studies in healthy volunteers and in patients and in a population pharmacokinetic analysis of plasma drug concentrations from placebo-controlled studies in the treatment of patients with LGS.
Možne interakcije med kanabidiolom (v odmerku 750 mg dvakrat na dan pri zdravih prostovoljcih in 20 mg/kg/dan pri bolnikih) in drugimi AED so proučevali v študijah medsebojnega delovanja zdravil pri zdravih prostovoljcih in bolnikih ter v okviru analiz populacijske farmakokinetike koncentracij zdravila v plazmi iz študij, kontroliranih s placebom, pri zdravljenju bolnikov z LGS.
Do not place the oral syringe in a dishwasher.
Brizge za peroralno dajanje ne perite v pomivalnem stroju.
Dose adjustment may be necessary.
Morda bo potrebno prilagoditi odmerek.
Patients should be monitored for signs of suicidal behaviour and ideation and appropriate treatment should be considered.
Zato je treba bolnike spremljati glede znakov samomorilnega vedenja in razmišljanja ter razmisliti o ustreznem zdravljenju.
cannabidiol and/or concomitant AED treatment should therefore be adjusted during regular medical supervision and the patient should be closely monitored for adverse drug reactions.
Zdravljenje s kanabidiolom in/ali sočasnim(i) AED je zato treba med rednim zdravniškim nadzorom prilagoditi, bolnika pa je treba skrbno spremljati glede pojava neželenih učinkov zdravila.
Cannabidiol appears rapidly in plasma with a time to maximum plasma concentration of 2.5-5 hours at steady state.
Kanabidiol se hitro pojavi v plazmi, pri čemer je čas do največje plazemske koncentracije v stanju dinamičnega ravnovesja 2,5-5 ur.
- If your seizures happen more often, or if you experience a severe seizure while taking Epidyolex.
- če imate pogostejše epileptične napade ali če doživite hud epileptični napad med jemanjem zdravila Epidyolex.
Intensified Monitoring:
Intenzivno spremljanje
If you or your patient take more Epidyolex than you should If you may have taken more Epidyolex than you should, tell a doctor or pharmacist immediately, or contact your nearest hospital casualty department, and take the medicine with you.
Če ste vi ali vaš bolnik vzeli večji odmerek zdravila Epidyolex, kot bi smeli Če ste vzeli večji odmerek zdravila Epidyolex, kot bi smeli, o tem takoj obvestite svojega zdravnika ali farmacevta, ali pa pojdite na urgentni oddelek najbližje bolnišnice in s seboj prinesite zdravilo.
The interactions are summarised in the table below.
Interakcije so povzete v spodnji preglednici.
As a precautionary measure, cannabidiol should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the foetus.
Iz previdnostnih razlogov se med nosečnostjo kanabidiol ne sme uporabljati, razen če pričakovana korist za mater nedvomno odtehta morebitno tveganje za plod.
The most frequent cause of discontinuations was transaminase elevation.
Najpogostejši vzrok prekinitve zdravljenja je bil zvišanje transaminaz.
Your doctor may do blood tests to check your liver before you start taking this medicine and during treatment, as Epidyolex can cause liver problems.
Zdravnik bo morda opravil krvne preiskave, da preveri delovanje jeter, preden začnete jemati to zdravilo ali med samim zdravljenjem, saj lahko zdravilo Epidyolex povzroči težave z jetri.
The following side effects could be very serious:
Spodaj navedeni neželeni učinki so lahko zelo resni.
Cannabidiol does not exert its anticonvulsant effect through interaction with cannabinoid receptors.
Kanabidiol svojega antikonvulzivnega učinka ne doseže na podlagi medsebojnega delovanja s kanabinoidnimi receptorji.
Juvenile toxicity
Toksičnost za mladiče
Table 1: Dose adjustments in patients with moderate or severe hepatic impairment
Preglednica 1: Prilagoditve odmerka pri bolnikih z zmerno ali hudo okvaro jeter
Increases in creatinine
Zvišanje kreatinina
Continuous weight loss/absence of weight gain should be periodically checked to evaluate if cannabidiol treatment should be continued.
Kontinuirano izgubo telesne mase/nepridobivanje telesne mase je treba redno preverjati in oceniti, ali lahko zdravljenje s kanabidiolom nadaljujemo.
Across both randomised LGS studies, 99.5% of patients who completed the studies were enrolled into the long-term open-label extension study (GWPCARE5).
V obeh randomiziranih študijah LGS je bilo 99,5 % bolnikov, ki so zaključili študijo, vključenih v dolgoročno odprto podaljšano študijo (GWPCARE5).
Clobazam (separate analysis) was a significant covariate which caused the probability of GGT to increase, loss of appetite to decrease, and somnolence to increase.
Klobazam (ločena analiza) je bil pomembna sospremenljivka, ki je povzročila večjo verjetnost povečanja GGT, zmanjšanja apetita in povečanja zaspanosti.
PK/PD analysis also demonstrated that systemic exposures to cannabidiol were correlated with some adverse events namely elevated ALT, AST, diarrhoea, fatigue, GGT, loss of appetite, rash, and somnolence (see section 4.8).
Analiza FK/FD je pokazala tudi, da so bile sistemske izpostavljenosti kanabidiolu povezane z nekaterimi neželenimi učinki, in sicer zvišanima ALT in AST, drisko, utrujenostjo, GGT, izgubo apetita, izpuščajem in zaspanostjo (glejte poglavje 4.8).
Slowly pull back the plunger of the syringe, so the volume (number of ml) of solution needed is drawn into the syringe.
Bat brizge počasi povlecite nazaj, tako da v brizgo potegnete potrebno količino (število mililitrov) raztopine.
Across both randomised DS studies, 97.7% of patients who completed the studies were enrolled into GWPCARE5.
V obeh randomiziranih študijah LGS je bilo 97,7 % bolnikov, ki so zaključili študijo, vključenih v študijo GWPCARE5.
Concomitant use of cannabidiol and valproate increases the incidence of diarrhoea and events of decreased appetite.
Sočasna uporaba kanabidiola in valproata poveča incidenco diareje in zmanjšanja apetita.
Mean age of the study population was 9 years and 94% were taking 2 or more cAEDs during the trial.
Starost študijske populacije je bila v povprečju 9 let, 94 % bolnikov pa je med preskušanjem sočasno jemalo 2 ali več vrst cAED.
You should not drive, use machines or take part in activities that require you to be alert and have fine control, until it is established that your ability to perform such activities is not affected.
Ne vozite, ne upravljajte strojev in ne opravljajte dejavnosti, ki zahtevajo vašo pozornost in dober nadzor, dokler ni potrjeno, da zdravilo ne vpliva na vašo sposobnost izvajanja teh dejavnosti.
Less than 1% of cannabidiol-treated patients had ALT or AST levels greater than 20 times the ULN.
Manj kot 1 % bolnikov, zdravljenih s kanabidiolom, je imelo vrednosti ALT ali AST zvišane nad 20-kratno ZMN.
In an uncontrolled study in patients in a different non-epilepsy indication, 2 elderly patients experienced elevations of alkaline phosphatase levels above 2 times the ULN in combination with transaminase elevations.
V nekontrolirani študiji, opravljeni pri bolnikih z drugačno indikacijo, ki ni povezana z epilepsijo, sta imela 2 starejša bolnika zvišane vrednosti alkalne fosfataze nad 2-kratno ZMN in hkrati zvišane vrednosti transaminaz.
Line up the end of the plunger with the volume marking required, as shown opposite.
Konec bata poravnajte z ustrezno oznako za količino, kot je prikazano na sliki na nasprotni strani.
Always take Epidyolex according to your doctor's instructions and consistently either with or without food including high-fat meals (such as ketogenic diet).
Zdravilo Epidyolex vedno jemljite v skladu z zdravnikovimi navodili in dosledno bodisi s hrano ali brez nje, vključno z obroki z veliko maščobe (npr. pri ketogeni dieti).
Your doctor or pharmacist will let you know which syringe to use depending on the dose that has been prescribed.
Zdravnik ali farmacevt vam bo glede na odmerek, ki vam je bil predpisan, povedal, katero brizgo morate uporabiti.
If the dose is more than 5 ml, repeat Steps 4 to 7 to give the remaining dose using the 5 ml oral syringe.
Če odmerek znaša več kot 5 ml, s pomočjo 5-mililitrske brizge ponovite korake od 4 do 7, da aplicirate preostalo količino odmerka.
Common side effects (may affect more than 1 in 100 people):
Pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 100 bolnikov):
Concomitant Valproate and Clobazam
Sočasna uporaba valproata in klobazama
A meta-analysis of randomised placebo-controlled trials with AEDs has shown a small increased risk of suicidal behaviour and ideation.
Metaanaliza randomiziranih, s placebom kontroliranih kliničnih preskušanj AED je pokazala majhno povečanje tveganja za pojav samomorilnega vedenja in razmišljanja.
Effect of age, weight, sex, race
Vpliv starosti, telesne mase, spola in rase
If you have these thoughts at any time, contact your doctor
Če imate kadar koli takšne misli, se posvetujte z zdravnikom.
Population pharmacokinetic analyses demonstrated that there were no clinically relevant effects of age, body weight, sex, or race on exposure to cannabidiol.
Analize populacijske farmakokinetike so pokazale, da starost, telesna masa, spol ali rasa nimajo klinično pomembnega vpliva na izpostavljenost kanabidiolu.
Convulsive seizures were defined as atonic, tonic, clonic, and tonic-clonic seizures.
Konvulzivni napadi so bili opredeljeni kot atonični, tonični, klonični in tonično-klonični epileptični napadi.
When cannabidiol was combined with stiripentol there was a minor increase in stiripentol levels of 28% for Cmax and 55% for AUC.
Pri uporabi kanabidiola v kombinaciji s stiripentolom je prišlo do majhnega povečanja Cmax koncentracije stiripentola za 28 % in AUC za 55 %.
You should not take Epidyolex while you are pregnant unless the doctor decides the benefits outweigh the potential risks.
Med nosečnostjo zdravila Epidyolex ne bi smeli jemati, razen če je zdravnik odločil, da prednosti zdravljenja pretehtajo potencialne nevarnosti.