natgillin/translations-raw huggingface dataset:
In some patients, a synergistic effect of concomitant treatment with valproate upon baseline elevated transaminases resulted in a higher risk of transaminase elevations. 
Pri nekaterih bolnikih se je zaradi sinergijskega učinka sočasnega zdravljenja z valproatom ob povišanih izhodiščnih vrednostih transaminaz povečalo tveganje za zvišanje transaminaz.
Epidyolex is used in combination with clobazam or with clobazam and other antiepileptic medicines to treat seizures that occur with two rare conditions, called Dravet syndrome and Lennox-Gastaut syndrome. 
Zdravilo Epidyolex se v kombinaciji s klobazamom ali s klobazamom in drugimi antiepileptiki uporablja za zdravljenje epileptičnih napadov, ki se pojavljajo pri dveh redkih boleznih, imenovanih Dravetov sindrom in Lennox-Gastautov sindrom.
Exposure to phenytoin may be increased when it is co-administered with cannabidiol, as phenytoin is largely metabolised via CYP2C9, which is inhibited by cannabidiol in vitro. 
Izpostavljenost fenitoinu se lahko poveča, če se jemlje sočasno s kanabidiolom, saj se fenitoin v veliki meri presnavlja prek CYP2C9, ki ga in vitro zavira kanabidiol.
In the phase 3 clinical trials, the observed frequency of status epilepticus was similar between the cannabidiol and placebo groups. 
V kliničnih preskušanjih tretje faze je bila opažena podobna pogostnost pojavnosti epileptičnih stanj med skupinami bolnikov, ki so jemali kanabidiol in bolnikov, ki so jemali placebo.
Interaction resulting in approximately 3-fold increase in N-desmethylclobazam metabolite exposure. 
Interakcija je povzročila približno 3-kratno povečanje izpostavljenosti presnovku N-desmetil-klobazamu.
In another study, cannabidiol was dosed to juvenile rats from PND 4-21 (as a subcutaneous injection) and from PND 22-50 (as an intravenous injection). 
V drugi študiji so pri mladih podganah kanabidiol odmerjali od 4. do 21. dne postnatalno (v obliki subkutane injekcije) in od 22. do 50. dne postnatalno (v obliki intravenske injekcije).
Monitoring 
Spremljanje
Psychiatric disorders 
Psihiatrične motnje
Patients with end-stage renal disease were not studied. 
Bolnikov s končno odpovedjo ledvic niso proučevali.
The half-life of cannabidiol in plasma was 56-61 hours after twice daily dosing for 7 days in healthy volunteers. 
Pri zdravih prostovoljcih je bila po 7-dnevnem odmerjanju dvakrat dnevno razpolovna doba kanabidiola v plazmi 56-61 ur.
The major CYP450 isoforms responsible for the phase I metabolism of cannabidiol are CYP2C19 and CYP3A4. 
Glavni izoobliki CYP450, odgovorni za presnavljanje (faza I) kanabidiola, sta CYP2C19 in CYP3A4.
- Two 1 ml syringes graduated in 0.05 ml increments (each 0.05 ml increment corresponds to 5 mg cannabidiol) - Two 5 ml syringes graduated in 0.1 ml increments (each 0.1 ml increment corresponds to 10 mg cannabidiol) 
- dve 1-mililitrski brizgi, graduirani v korakih po 0,05 ml (vsak korak po 0,05 ml ustreza 5 mg kanabidiola); - dve 5-mililitrski brizgi, graduirani v korakih po 0,1 ml (vsak korak po 0,1 ml ustreza 10 mg kanabidiola).
The embryo-foetal development (EFD) study performed in rabbits evaluated doses of 50, 80, or 125 mg/kg/day. 
Študija embrio-fetalnega razvoja (EFD - embryo-foetal development), izvedena pri kuncih, je ocenjevala odmerke 50, 80 ali 125 mg/kg/dan.
In individual patients titration up to a maximum dose of 20 mg/kg/day may be considered, based on the benefit-risk (see Section 4.2). 
Pri posameznih bolnikih se lahko na podlagi koristi in tveganja pretehta titracija do največjega odmerka 20 mg/kg/dan (glejte poglavje 4.2).
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. 
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
The primary endpoint was the change in convulsive seizure frequency during the treatment period (Day 1 to the end of the evaluable period) compared to baseline (GWPCARE2), and the percentage change from baseline in convulsive seizures per 28 days over the treatment period (GWPCARE1) for the cannabidiol groups compared to placebo. 
Primarni merili sta bili sprememba pogostnosti konvulzivnih napadov v obdobju zdravljenja (od 1. dne do konca obdobja, primernega za vrednotenje) v primerjavi z izhodiščem (GWPCARE2) in odstotna sprememba pogostnosti konvulzivnih napadov v 28 dneh med obdobjem zdravljenja glede na izhodišče (GWPCARE1) v skupinah, ki so prejemale kanabidiol, v primerjavi s skupino, ki je prejemala placebo.
Reversibility was not assessed in studies in LGS and DS. 
V študijah pri bolnikih z LGS in DS reverzibilnost ni bila ocenjena.
Do not drive, operate machinery, or take part in activities that require you to be alert and have fine control, such as cycling, until you know how Epidyolex affects you. 
Ne vozite, ne upravljajte strojev in ne opravljajte dejavnosti, ki zahtevajo vašo pozornost in dober nadzor, na primer kolesarjenje, dokler ne veste, kako zdravilo Epidyolex vpliva na vas; - ste nenadoma prenehali jemati zdravilo Epidyolex;
Approximately 50% of the patients were taking concomitant clobazam. 
Približno 50 % bolnikov se je sočasno zdravilo s klobazamom.
The frequency in patients receiving 10 mg/kg/day cannabidiol and taking clobazam was 36%. 
Pogostnost pri bolnikih, ki so prejemali 10 mg/kg/dan kanabidiola in jemali klobazam, je bila 36 %.
Based on a healthy volunteer study, elevated levels (3- to 4-fold) of N-desmethylclobazam (an active metabolite of clobazam) can occur when combined with cannabidiol, likely mediated by CYP2C19 inhibition. 
Glede na študijo z zdravimi prostovoljci se lahko pri sočasni uporabi s kanabidiolom pojavijo zvišane vrednosti (tri- do štirikratno) N-desmetilklobazama (aktivni presnovek klobazama), ki jih verjetno povzroči zaviranje CYP2C19.
Patients with identified baseline elevations of ALT or AST and patients who are taking valproate should have serum transaminases and total bilirubin levels obtained at 2 weeks, 1 month, 2 months, 3 months, and 6 months after initiation of treatment with cannabidiol, and periodically thereafter or as clinically indicated. 
Pri bolnikih z ugotovljenim izhodiščnim zvišanjem ALT ali AST in bolnikih, ki jemljejo valproat, je treba vrednosti serumskih transaminaz in skupnega bilirubina določiti 2 tedna, 1 mesec, 2 meseca, 3 mesece in 6 mesecev po uvedbi zdravljenja s kanabidiolom, nato pa periodično oziroma kot je to klinično indicirano.
UGT inhibitors 
Zaviralci UGT
After one week, the dose should be increased to a maintenance dose of 5 mg/kg twice daily (10 mg/kg/day). 
Po enem tednu je treba odmerek povečati do vzdrževalnega odmerka 5 mg/kg dvakrat dnevno (10 mg/kg/dan).
Weight decreased a Grouped Terms: Pneumonia: Pneumonia, Pneumonia RSV, Pneumonia mycoplasmal, Pneumonia adenoviral, Pneumonia viral, Aspiration pneumonia; Somnolence: Somnolence, Sedation. 
Zmanjšanje telesne mase a Skupni izrazi: pljučnica: pljučnica, pljučnica RSV, mikoplazmatska pljučnica, adenovirusna pljučnica, virusna pljučnica, aspiracijska pljučnica; somnolenca: somnolenca, sedacija
If a patient develops clinical signs or symptoms suggestive of hepatic dysfunction, serum transaminases and total bilirubin should be promptly measured and treatment with cannabidiol should be interrupted or discontinued, as appropriate. 
Če se pri bolniku pojavijo klinični znaki ali simptomi, ki kažejo na moteno delovanje jeter, je treba takoj izmeriti koncentracije serumskih transaminaz in skupnega bilirubina, zdravljenje s kanabidiolom pa začasno oziroma trajno prekiniti.
Mild to moderate diarrhoea and somnolence have been reported in healthy adult subjects taking a single dose of 6000 mg; this equates to a dose of over 85 mg/kg for a 70 kg adult. 
Pri zdravih odraslih preiskovancih, ki so prejeli enkratni odmerek 6000 mg, so poročali o blagi do zmerni diareji in somnolenci; to ustreza odmerku več kot 85 mg/kg za odraslo osebo, ki tehta 70 kg.
The bottle is packaged in a carton with two 5 ml and two 1 ml calibrated oral dosing syringes (plunger HDPE and barrel polypropylene) and two bottle adapters (LDPE). 
Steklenica je pakirana v škatlo skupaj z dvema 5-mililitrskima in dvema 1-mililitrskima brizgama za peroralno dajanje (bat iz HDPE in telo iz polipropilena) ter dvema nastavkoma za steklenico (iz LDPE).
The most commonly used cAEDs (> 25% of patients) in both trials were valproate, clobazam, stiripentol, and levetiracetam. 
Najpogosteje uporabljana cAED (> 25 %) pri obeh preskušanjih so bila valproat, klobazam, stiripentol in levetiracetam.
In rats, the EFD study evaluated doses of 75, 150, or 250 mg/kg/day. 
Pri podganah so s študijo EFD ocenili odmerke 75, 150 ali 250 mg/kg/dan.
The frequency in patients receiving 20 mg/kg/day cannabidiol and taking clobazam was 41%. 
Pogostnost pri bolnikih, ki so prejemali 20 mg/kg/dan kanabidiola in jemali klobazam, pa je bila 41 %.
Fill a cup with warm soapy water and clean the oral syringe by drawing water in and out using the plunger. 
Kozarec napolnite s toplo milnico in očistite brizgo za peroralno dajanje tako, da z batom milnico potegnete v brizgo in potisnete iz nje.
In controlled studies for LGS and DS, the incidence of ALT elevations above 3 times the ULN was 13% in cannabidiol-treated patients compared with 1% in patients on placebo. 
V kontroliranih študijah sindromov LGS in DS je bila pri bolnikih, zdravljenih s kanabidiolom, incidenca vrednosti ALT, zvišanih nad 3-kratno ZMN, 13 % v primerjavi z 1 % pri bolnikih, ki so dobivali placebo.
In patients with LGS, population pharmacokinetic pharmacodynamic (PK/PD) modelling indicated the presence of an exposure efficacy relationship for the likelihood of achieving a ≥ 50% reduction in drop seizure frequency across the cannabidiol dose range tested (0 [placebo], 10 and 20 mg/kg/day). 
Pri bolnikih z LGS se je modeliranjem populacijske farmakokinetike in farmakodinamike (FK/FD) pokazala povezava med izpostavljenostjo in učinkovitostjo pri verjetnosti doseganja ≥ 50-odstotnega zmanjšanja pogostnosti akinetičnih napadov v celotnem razponu preizkušenih odmerkov kanabidiola (0 [placebo], 10 mg/kg/dan in 20 mg/kg/dan).
Cannabidiol can be administered to patients with mild, moderate, or severe renal impairment without dose adjustment (see section 5.2). 
Pri bolnikih z blago, zmerno ali hudo okvaro ledvic se kanabidiol lahko uporablja brez prilagoditve odmerka (glejte poglavje 5.2).
Taking Epidyolex with food can increase the amount of medicine your body takes in. You should try, as far as possible, to take Epidyolex consistently either with or without food, and according to your daily routine, so you get the same effect each time. 
Zdravilo Epidyolex poskušajte jemati čim bolj dosledno s hrano ali brez nje, in v skladu s svojo vsakdanjo rutino, tako da bo učinek zdravila vedno isti.
Serum transaminases and total bilirubin levels should be obtained at 1 month, 3 months, and 6 months after initiation of treatment with cannabidiol, and periodically thereafter or as clinically indicated. 
Vrednosti serumskih transaminaz in skupnega bilirubina je treba določiti 1 mesec, 3 mesece in 6 mesecev po uvedbi zdravljenja s kanabidiolom, nato pa v rednih intervalih ali če je klinično indicirano.
The pharmacokinetics of cannabidiol are complex and may cause interactions with the patient's concomitant AED treatments. 
Farmakokinetika kanabidiola je kompleksna in lahko povzroči medsebojno delovanje z AED, ki se jemljejo sočasno.
Cannabidiol does not interact with the major renal and hepatic transporters in a way that is likely to result in relevant drug-drug interactions. 
Kanabidiol na ledvične in jetrne prenašalce ne vpliva na način, ki bi lahko povzročil pomembne interakcije z drugimi zdravili.
In controlled trials (see section 5.1) in patients taking cannabidiol 20 mg/kg/day, the frequency of treatment-emergent ALT elevations greater than 3 times the ULN was 31% (84% of these were on valproate) when ALT was above the ULN at baseline, compared to 12% (89% of these were on valproate) when ALT was within the normal range at baseline. 
V kontroliranih preskušanjih (glejte poglavje 5.1) pri bolnikih, ki so jemali kanabidiol v odmerku 20 mg/kg/dan, je bila pogostnost zvišanih vrednosti ALT, ki so se pojavile zaradi zdravljenja in ki so presegale 3-kratno ZMN, 31 % (84 % od teh je prejemalo valproat), če je bila izhodiščna vrednost ALT nad ZMN, v primerjavi z 12 % (89 % od teh je prejemalo valproat), če je bila izhodiščna vrednost ALT znotraj normalnega območja.
Dose adjustment of any co-administered medicinal product that is known to affect the liver should be considered (e.g., valproate and clobazam) (see section 4.5). 
Razmisliti je treba o prilagoditvi odmerkov vseh sočasno uporabljenih zdravil, za katera je znano, da vplivajo na jetra (npr. valproat in klobazam (glejte poglavje 4.5).
There are only limited data from the use of cannabidiol in pregnant women. 
Podatkov o uporabi kanabidiola pri nosečnicah ni oziroma so omejeni.
Phenytoin has a narrow therapeutic index, so combining cannabidiol with phenytoin should be initiated with caution and if tolerability issues arise, dose reduction of phenytoin should be considered. 
Fenitoin ima ozek terapevtski indeks, zato je treba jemanje kombinacije kanabidiola in fenitoina začeti previdno.
The recommended starting dose of cannabidiol is 2.5 mg/kg taken twice daily (5 mg/kg/day) for one week. 
Priporočeni začetni odmerek kanabidiola je 2,5 mg/kg dvakrat dnevno (5 mg/kg/dan) v trajanju enega tedna.
Cannabidiol is predominantly cleared by metabolism in the liver and gut and excreted in faeces, with renal clearance of parent drug being a minor pathway. 
Kanabidiol se očisti predvsem s presnavljanjem v jetrih in črevesju, nato pa se izloči z blaomu, ledvični očistek matične učinkovine pa je manj pomembna pot izločanja.
Very common Pyrexia, Fatigue 
Pireksija, utrujenost
Based on individual clinical response and tolerability, each dose can be further increased in weekly increments of 2.5 mg/kg administered twice daily (5 mg/kg/day) up to a maximum recommended dose of 10 mg/kg twice daily (20 mg/kg/day). 
Glede na klinični odziv posameznega bolnika in njegovo prenašanje zdravila lahko odmerek povečujemo v tedenskih korakih po 2,5 mg/kg dvakrat na dan (5 mg/kg/dan) do največjega priporočenega dnevnega odmerka 10 mg/kg dvakrat na dan (20 mg/kg/dan).
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other concurrent therapy (see sections 4.4 under hepatocellular injury and 
Na splošno je treba biti pri določitvi odmerka pri starejših bolnikih previden (običajno začnemo z manjšimi odmerki), ker je pri njih pogosteje oslabljeno delovanje jeter, ledvic ali srca ali imajo sočasne bolezni oziroma sočasno prejemajo druga zdravila (glejte poglavje 4.4 pod naslovom »Okvara jetrnih celic« in poglavje 5.2).
In general, transaminase elevations of greater than 3 times the ULN in the presence of elevated bilirubin without an alternative explanation are an important predictor of severe liver injury. 
Navadno je zvišanje transaminaz, ki presega 3-kratno ZMN, in hkratno zvišanje vrednosti bilirubina, ki ju ni mogoče drugače pojasniti, pomemben napovednik hude okvare jeter.
The Cmax and AUC of cannabidiol are close to dose-proportional over the therapeutic dose range. 
V območju terapevtskih odmerkov sta vrednosti Cmax in AUC za kanabidiol približno sorazmerni odmerku.
Decreased growth, delayed sexual maturation, behavioural changes (decreased activity), and adverse effects on male reproductive organ development (small testes in adult offspring) and fertility were observed in the offspring at doses ≥ 150 mg/kg/day. 
Pri mladičih so pri odmerkih ≥ 150 mg/kg/dan opazili upočasnjeno rast, upočasnjeno spolno dozorevanje, vedenjske spremembe (zmanjšana aktivnost) in neželene učinke na razvoj moških reproduktivnih organov (majhni testisi pri odraslih potomcih) in plodnost.
The NOAEL was associated with maternal plasma exposures (AUC) approximately 50 times greater than the anticipated exposure in humans at 20 mg/kg/day. 
Raven NOAEL je bila povezana z maternalno plazemsko izpostavljenostjo (AUC), ki je bila približno 50-krat večja od predvidene izpostavljenosti pri ljudeh pri odmerku 20 mg/kg/dan.
Adjunctive Therapy in Patients with Dravet Syndrome The efficacy of cannabidiol for the adjunctive therapy of seizures associated with Dravet syndrome (DS) was evaluated in two randomised, double-blind, placebo-controlled, parallel-group studies (GWPCARE2 and GWPCARE1). 
Dopolnilno zdravljenje bolnikov z Dravetovim sindromom Učinkovitost kanabidiola za dopolnilno zdravljenje epileptičnih napadov, povezanih z Dravetovim sindromom (DS), je bila ocenjena v dveh randomiziranih, dvojno slepih, s placebom kontroliranih študijah z vzporednimi skupinami (GWPCARE2 in GWPCARE1).
A pre- and post-natal development study was performed in rats at doses of 75, 150, or 250 mg/kg/day. 
Pri podganah je bila izvedena študija pre- in postnatalnega razvoja pri odmerkih 75, 150 ali 250 mg/kg/dan.
Concomitant use of cannabidiol and valproate increases the incidence of transaminase enzyme elevations (see section 4.4). 
Sočasna uporaba kanabidiola in valproata poveča incidenco zvišanja transaminaz (glejte poglavje 4.4).
Turn the bottle the right side up, and carefully remove the oral syringe from the adaptor. 
Steklenico obrnite pokončno navzgor in iz nastavka previdno izvlecite brizgo za peroralno dajanje.
Cannabidiol should be discontinued in any patients with elevations of transaminase levels greater than 3 times the ULN and bilirubin levels greater than 2 times the ULN. 
Zdravljenje s kanabidiolom je treba trajno prekiniti pri vseh bolnikih z zvišanimi vrednostmi transaminaz, ki presegajo 3-kratno ZMN, in hkratnimi zvišanimi vrednostmi bilirubina, ki presegajo 2- kratno ZMN.
ALT elevations greater than 3 times the ULN were reported in 16% of patients taking cannabidiol 20 mg/kg/day compared with 3% in patients taking cannabidiol 10 mg/kg/day. 
O zvišanih vrednostih ALT, ki so presegale 3-kratno ZMN, so poročali pri 16 % bolnikov, ki so kanabidiol prejemali v odmerku 20 mg/kg/dan, v primerjavi s 3 % bolnikov, ki so kanabidiol prejemali v odmerku 10 mg/kg/dan.
GWPCARE1 
GWPCARE1 Placebo
What Epidyolex is and what it is used for 
Kaj je zdravilo Epidyolex in za kaj ga uporabljamo
AST increased, ALT increased, GGT increased, Liver function test abnormal 
Zvišana AST, zvišana ALT, zvišana GGT, nenormalni izvidi preiskav delovanja jeter
Key secondary endpoints for GWPCARE2 were the proportion of patients with at least a 50% reduction in convulsive seizure frequency, the change in total seizure frequency, and Caregiver Global Impression of Change at the last visit. 
Ključna sekundarna merila v okviru študije GWPCARE2 so bile delež bolnikov z vsaj 50-odstotnim zmanjšanjem pogostnosti konvulzivnih napadov, sprememba pogostnosti vseh epileptičnih napadov in negovalčev globalni vtis o spremembi ob zadnjem obisku.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GW Pharma (International) B.V., Databankweg 26, 3821AL Amersfoort, The Netherlands 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GW Pharma (International) B.V., Databankweg 26, 3821AL Amersfoort, Nizozemska
Ethanol in the formulation 
Etanol v zdravilu
Place the tip of the oral syringe inside the cheek, and gently push the plunger to release the medicine. 
Konico brizge za peroralno dajanje namestite na notranjo stran ličnice in previdno pritiskajte bat, da iztisnete zdravilo.
Elderly patients Pharmacokinetics of cannabidiol have not been studied in patients > 55 years of age. 
Starejši bolniki Pri bolnikih, starih > 55 let, farmakokinetike kanabidiola niso proučevali.
Patients and caregivers of patients should be advised to seek medical advice should any signs of suicidal behaviour and ideation emerge. 
Bolnike in skrbnike bolnikov je treba opozoriti, da morajo v primeru, če se pri bolniku pojavijo kakršni koli znaki samomorilnega vedenja in razmišljanja, takoj poiskati zdravniško pomoč.
p=0.0032c ≥ 50% REDUCTION IN CONVULSIVE SEIZURES (RESPONDER ANALYSIS) Percentage of ≥ 50% Responders, p-valued GWPCARE2 
p = 0,0032c ≥ 50 % ZMANŠANJE POJAVA KONVULZNIH NAPADOV (ANALIZA DELEŽA ODZIVNIH BOLNIKOV)
• If your dose is more than 5 ml (500 mg), you will need to use the larger 5 ml syringe more than once. 
• Če vaš odmerek znaša več kot 5 ml (500 mg), boste morali večjo, 5-mililitrsko brizgo uporabiti večkrat.
No effect on reproductive ability of male or female rats was noted with an oral dose of up to 150 mg/kg/day cannabidiol (see section 5.3). 
Pri peroralnih odmerkih kanabidiola do 150 mg/kg/dan niso opazili učinkov na reproduktivno sposobnost samcev in samic podgane (glejte poglavje 5.3).
Table 5: Drug interactions between cannabidiol and concomitant antiepileptic drugs Concomitant AED Influence of AED on cannabidiol Influence of cannabidiol on AED Clobazam 
Preglednica 5: Interakcije med kanabidiolom in sočasno uporabljenimi antiepileptiki Sočasno uporabljen AED
In vitro assessment of interaction with UGT enzymes In vitro data suggest that cannabidiol is a reversible inhibitor of UGT1A9 and UGT2B7-mediated activity at clinically relevant concentrations. 
In vitro ocena medsebojnega delovanja z encimi UGT Podatki, pridobljeni in vitro, kažejo, da je kanabidiol pri klinično pomembnih koncentracijah reverzibilni zaviralec aktivnosti, posredovane z UGT1A9 in UGT2B7.
Baseline transaminase elevations 
Izhodiščno zvišane vrednosti transaminaz
Other medicines and Epidyolex 
Druga zdravila in zdravilo Epidyolex
Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older. 
Zdravilo Epidyolex je v povezavi s klobazamom indicirano za uporabo kot dopolnilno zdravljenje epileptičnih napadov, povezanih z Lennox-Gastautovim sindromom (LGS) ali Dravetovim sindromom (DS), pri bolnikih, starih 2 leti ali več.
PHARMACEUTICAL FORM AND CONTENTS Oral solution 
FARMACEVTSKA OBLIKA IN VSEBINA
There are no human studies on excretion of cannabidiol in breast milk. 
Študije o izločanju kanabidiola v materino mleko pri ljudeh niso bile opravljene.
Drug interaction studies 
Študije medsebojnega delovanja AED
If you miss many doses, please talk to your doctor about the correct dose to take. 
Če izpustite večje število odmerkov, se o naslednjem ustreznem odmerku posvetujte z zdravnikom.
The NOAEL was associated with maternal plasma cannabidiol exposures approximately 9 times that in humans at 20 mg/kg/day. 
Raven NOAEL je bila povezana z maternalno plazemsko izpostavljenostjo kanabidiolu, ki je bila približno 9-krat večja od izpostavljenosti pri človeku pri odmerku 20 mg/kg/dan.
What you or the patient need to know before taking Epidyolex. 
Kaj morate vi ali vaš bolnik vedeti, preden boste vzeli zdravilo Epidyolex
It comes in a bottle which has a child-resistant cap, together with two identical 5 ml or 1 ml oral dosing syringes and two bottle adaptors for using these syringes. 
Na voljo je v steklenici, ki je zaprta z za otroke varno zaporko, skupaj s po dvema enakima 5- in 1-mililitrskima brizgama za peroralno dajanje in dvema nastavkoma za steklenico, ki se uporabljata s temi brizgami.
Cannabidiol can cause weight loss. 
Kanabidiol lahko povzroči izgubo telesne mase.
Patients with baseline transaminase levels above the ULN had higher rates of transaminase elevations when taking cannabidiol. 
Pri bolnikih, ki so imeli izhodiščne vrednosti transaminaz nad ZMN, so se pri uporabi kanabidiola pogosteje pojavljala zvišanja transaminaz.
Remove the plunger from the barrel of the syringe, and rinse both parts under tap water. 
Bat izvlecite iz telesa brizge in oba sestavna dela sperite s tekočo vodo iz pipe.
Because of potential for both induction and inhibition of enzyme activity, dose adjustment of substrates of CYP1A2 and CYP2B6 should be considered, as clinically appropriate. 
Zaradi možne indukcije in inhibicije encimskega delovanja je treba glede na klinično stanje bolnika razmisliti o prilagoditvi odmerka substratov CYP1A2 in CYP2B6.