natgillin/translations-raw huggingface dataset:
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.
d The Overall p-value is based on a Cochran-Mantel-Haenszel test; the nominal p-value for the with clobazam subgroup is based on logistic regression analysis.
c Nazivna p-vrednost d Celokupna p-vrednost temelji na testu Cochran-Mantel-Haenszel; nazivne p-vrednosti za podskupine s klobazamom, temelji na logistični regresijski analizi.
No effect on clobazam levels.
Ne vpliva na koncentracije klobazama.
Insert the tip of the correct oral syringe fully into the bottle adaptor, and with the oral syringe in place, turn the bottle upside down.
Konico ustrezne brizge za peroralno dajanje v celoti vstavite v nastavek za steklenico, nato pa steklenico skupaj z nameščeno brizgo za peroralno dajanje obrnite navpično navzdol.
INFORMATION IN BRAILLE epidyolex
PODATKI V BRAILLOVI PISAVI epidyolex
Co-administration of cannabidiol with a high-fat/high calorie meal increased the rate and extent of absorption (5-fold increase in Cmax and 4-fold increase in AUC) and reduced the total variability of exposure compared with the fasted state in healthy volunteers.
V primerjavi z zaužitjem kanabidiola na tešče je zaužitje zdravila skupaj z obrokom hrane z veliko maščob/kalorij pri zdravih prostovoljcih povzročilo povečanje hitrosti in obsega absorpcije (5-kratno zvišanje Cmax in 4-kratno povečanje AUC) in zmanjšanje celokupne variabilnosti pri izpostavljenosti zdravilu.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GW Pharma (International) B.V., Databankweg 26
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GW Pharma (International) B.V., Databankweg 26
The primary endpoint was the percentage change from baseline in drop seizures per 28 days over the treatment period for the cannabidiol group compared to placebo.
Primarno merilo je bila odstotna sprememba pogostnosti akinetičnih napadov v 28 dneh v obdobju zdravljenja glede na izhodiščno vrednost v skupini, ki je prejemala kanabidiol, v primerjavi s skupino, ki je prejemala placebo.
In the subgroup of DS patients treated with concomitant clobazam for 37 to 48 weeks (N=54), the median percentage reduction from baseline in convulsive seizure frequency was 60% during Week 1-12, which was maintained through to Week 37-48, with a median percentage reduction from baseline in convulsive seizure frequency of 45%.
V podskupini bolnikov z DS, ki so se sočasno zdravili s klobazamom 37 do 48 tednov (N = 54), je mediana odstotnega zmanjšanja pogostnosti konvulznih napadov glede na izhodišče znašala 60 % v času od 1. do 12. tedna, odziv pa se je ohranil tudi do 37.-48. tedna, z mediano zmanjšanja pogostnosti konvulznih napadov glede na izhodišče za 45 %.
Open-label data
Podatki iz odprte študije
2 years.
6.3 Rok uporabnosti 2 leti
Cannabidiol and 7-OH-CBD are not substrates for or inhibitors of efflux transports P-gp/MDR1, BCRP or BSEP at clinically relevant plasma concentrations.
Kanabidiol in 7-OH-CBD pri klinično pomembnih plazemskih koncentracijah nista substrata ali zaviralca izločevalnih prenašalcev P-gp/MDR1, BCRP ali BSEP.
Adjunctive therapy in patients with Lennox-Gastaut syndrome (LGS) The efficacy of cannabidiol for the adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) was evaluated in two randomised, double-blind, placebo-controlled, parallel-group studies (GWPCARE3 and GWPCARE4).
Dopolnilno zdravljenje bolnikov z Lennox-Gastautovim sindromom Učinkovitostkanabidiola za dopolnilno zdravljenje epileptičnih napadov, povezanih z Lennox-Gastautovim sindromom (LGS), je bila ocenjena v dveh randomiziranih, dvojno slepih, s placebom kontroliranih študijah z vzporednimi skupinami (GWPCARE3 in GWPCARE4).
Compared with placebo, cannabidiol was associated with an increase in the number of convulsive seizure-free days during the treatment period in each trial, equivalent to 2.7 days per 28 days (10 mg/kg/day) and 1.3 to 2.2 days per 28 days (20 mg/kg/day).
Kanabidiol je bil v primerjavi s placebom povezan s povečanjem števila dni brez konvulznih napadov med obdobjem zdravljenja v posameznem preskušanju, to pomeni 2,7 dneva v 28 dneh (10 mg/kg/dan) in 1,3 do 2,2 dneva v 28 dneh (20 mg/kg/dan).
In the subgroup of LGS patients treated with concomitant clobazam for 37 to 48 weeks (N=161), the median percentage reduction from baseline in drop seizure frequency was 71% during Week 1-12, which was maintained through to Week 37-48, with a median percentage reduction from baseline in drop seizure frequency of 63%.
V podskupini bolnikov z LGS, ki so se sočasno zdravili s klobazamom 37 do 48 tednov (N = 161), je mediana odstotnega zmanjšanja pogostnosti akinetičnih napadov glede na izhodišče v času od 1. do 12. tedna znašala 71 %, odziv pa se je ohranil tudi do 37.-48. tedna, z mediano zmanjšanja pogostnosti akinetičnih napadov glede na izhodišče za
Instructions for the oral use of Epidyolex
Navodila za peroralno uporabo zdravila Epidyolex
Paediatric patients Pharmacokinetics of cannabidiol has not been studied in paediatric patients < 2 years of age.
Pri pediatričnih bolnikih, starih < 2 leti, farmakokinetike kanabidiola niso proučevali.
Very common Decreased appetite Common
Zmanjšan apetit
Cannabidiol does not require dose adjustment in patients with mild hepatic impairment (Child-Pugh A).
Okvara jeter Pri bolnikih z blago okvaro jeter prilagoditev odmerka zdravila Epidyolex ni potrebna (ChildPugh A).
If you forget to take a dose, do not take a double dose to make up for a forgotten dose.
Če ste vi ali vaš bolnik pozabili vzeti zdravilo Epidyolex Če ste pozabili vzeti odmerek zdravila, ne vzemite dvojnega odmerka, da bi nadomestili pozabljenega.
Data for the with clobazam subgroup are presented as percent reduction from baseline estimated from a negative binomial regression analysis.
Podatki za podskupine s klobazamom so predstavljeni kot odstotek zmanjšanja glede na izhodiščno vrednost, ocenjen z negativno binomsko regresijsko analizo.
Maternal plasma cannabidiol exposures at the no observed-adverse-effect-level (NOAEL) for embryofoetal developmental toxicity in rabbits were less than that in humans at 20 mg/kg/day.
(NOAEL - No Observed Adverse Effect Level) za embrio-fetalno razvojno toksičnost pri kuncih so bile manjše kot izpostavljenosti pri človeku pri odmerku 20 mg/kg/dan.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 100 mg cannabidiol.
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml peroralne raztopine vsebuje 100 mg kanabidiola.
A lower starting dose is recommended in patients with moderate or severe hepatic impairment.
Pri bolnikih z zmerno ali hudo okvaro jeter je priporočljiv manjši začetni odmerek.
Cannabidiol should be used with caution in patients with moderate or severe hepatic impairment.
Pri bolnikih z zmerno ali hudo okvaro jeter je treba kanabidiol uporabljati previdno.
Key secondary endpoints were the proportion of patients with at least a 50% reduction in drop seizure frequency, the percentage change from baseline in total seizure frequency, and Subject/Caregiver Global Impression of Change at the last visit.
Ključna sekundarna merila so bila delež bolnikov z vsaj 50-odstotnim zmanjšanjem pogostnosti akinetičnih napadov, odstotna sprememba pogostnosti vseh epileptičnih napadov glede na izhodišče in preiskovančev/negovalčev globalni vtis o spremembi.
Do not reduce the dose or stop taking Epidyolex without first talking to your doctor.
Če ste vi ali vaš bolnik prenehali jemati zdravilo Epidyolex Ne zmanjšajte odmerka oziroma ne prenehajte jemati zdravila Epidyolex, ne da bi se o tem najprej posvetovali z zdravnikom.
What Epidyolex is and what it is used for.
Kaj je zdravilo Epidyolex in za kaj ga uporabljamo 2.
Cannabidiol can cause decreases in haemoglobin and haematocrit.
Kanabidiol lahko povzroči znižanje vrednosti hemoglobina in hematokrita.
No effects on the Cmax or AUC of cannabidiol were observed following administration of a single dose of cannabidiol 200 mg in subjects with mild, moderate, or severe renal impairment when compared to patients with normal renal function.
Po enkratnem 200-miligramskem odmerku kanabidiola pri preiskovancih z blago, zmerno ali hudo okvaro ledvic niso opazili učinkov na Cmax ali AUC kanabidiola v primerjavi z bolniki z normalnim delovanjem ledvic.
Data for study GWPCARE2 and the with clobazam subgroup are presented as percent reduction from baseline estimated from a negative binomial regression analysis.
Podatki pri študiji GWPCARE2 in za podskupine s klobazamom so predstavljeni kot odstotek zmanjšanja glede na izhodiščno vrednost, ocenjen z negativno binomsko regresijsko analizo.
(See section 4.2 for information on paediatric use).
Za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
• If your dose is 1 ml (100 mg) or less, you should use the smaller 1 ml syringe.
• Če vaš odmerek znaša 1 ml (100 mg) ali manj, uporabite manjšo, 1-mililitrsko brizgo.
Remove the child-resistant cap on the bottle by pushing the cap down whilst turning the cap anti-clockwise.
Za otroke varno zaporko s steklenice odstranite tako, da jo pritiskate navzdol, obenem pa jo vrtite v nasprotni smeri urinega kazalca.
Five percent (5%) of patients (all on valproate) taking cannabidiol 10 mg/kg/day experienced ALT elevations greater than 3 times the ULN when ALT was above the ULN at baseline, compared with 3% of patients (all on valproate) in whom ALT was within the normal range at baseline.
Pri petih odstotkih (5 %) bolnikov (vsi so prejemali valproat), ki so jemali kanabidiol v odmerku 10 mg/kg/dan, so se pojavile zvišane vrednosti ALT, ki so presegale 3-kratno ZMN, če je bila izhodiščna vrednost ALT nad ZMN, v primerjavi s 3 %
The 5 ml syringes are graduated in 0.1 ml and the 1 ml in 0.05 ml increments.
5-mililitrski brizgi sta graduirani v korakih po 0,1 ml, 1-mililitrski brizgi pa v korakih po 0,05 ml.
What Epidyolex looks like and contents of the pack Epidyolex is a clear, colourless to yellow oral solution.
Epidyolex je bistra, brezbarvna do rumena raztopina.
In LGS and DS patients, the decrease in weight appeared to be dose-related, with 19% of patients on cannabidiol 20 mg/kg/day experiencing a decrease in weight ≥ 5%, compared to 8% in patients on cannabidiol 10 mg/kg/day.
Pri bolnikih z LGS ali DS se je izkazalo, da je bilo zmanjšanje telesne mase povezano z odmerkom, saj je do zmanjšanja telesne mase za ≥ 5 % prišlo pri 19 % bolnikov, ki so kanabidiol dobivali v odmerku 20 mg/kg/dan, v primerjavi z 8 % pri bolnikih, ki so kanabidiol dobivali v odmerku 10 mg/kg/dan.
Compared with placebo, cannabidiol was associated with an increase in the number of drop seizure-free days during the treatment period in each trial, equivalent to 3.3 days per 28 days (10 mg/kg/day) and 5.5 to 7.6 days per 28 days (20 mg/kg/day).
Kanabidiol je bil v primerjavi s placebom povezan s povečanjem števila dni brez akinetičnih napadov med obdobjem zdravljenja v posameznem preskušanju, to pomeni 3,3 dneva v 28 dneh (10 mg/kg/dan) in 5,5 do 7,6 dneva v 28 dneh (20 mg/kg/dan).
Table 4 summarises the primary endpoint of percent reduction from baseline in convulsive seizures, and the key secondary measure of proportion of patients with at least a 50% reduction in convulsive seizure frequency, as well as results of the subgroup analysis for these outcome measures in patients treated with concomitant clobazam.
Preglednica 4 povzema primarno merilo, odstotek zmanjšanja od izhodišča pri pojavnosti konvulzivnih napadov, in ključno sekundarno merilo, delež bolnikov z vsaj 50-% zmanjšanjem pogostnosti konvulzivnih napadov, kot tudi rezultate analize podskupin za ti dve merili izida pri bolnikih, ki so se sočasno zdravili s klobazamom.
No adverse reactions were observed on male or female fertility or reproduction performance in rats at doses up to 250 mg/kg/day (approximately 60-fold greater than the maximum recommended human dose (MRHD) at 20 mg/kg/day).
Pri podganah pri odmerkih do 250 mg/kg/dan niso opazili neželenih učinkov na plodnost samcev ali samic (približno 60-krat večja izpostavljenost kot pri največjem priporočenem odmerku za človeka 20 mg/kg/dan).
• A plastic bag containing two 1 ml oral syringes and a bottle adaptor
• plastično vrečko z dvema 1-mililitrskima brizgama za peroralno dajanje in nastavkom za steklenico,
Dose
Izpuščaj
If the calculated dose is 100 mg (1 ml) or less, the smaller 1 ml oral syringe should be used.
Če izračunani odmerek znaša 100 mg (1 ml) ali manj, je treba uporabiti manjšo, 1-mililitrsko brizgo za peroralno dajanje.
Risk Factors for Hepatocellular injury Concomitant Valproate and Clobazam, Dose of cannabidiol and Baseline Transaminase Elevations
Sočasna uporaba valproata in klobazama, odmerek kanabidiol in izhodiščno zvišane vrednosti transaminaz
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release GW Pharma (International) B.V., Databankweg 26
Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij GW Pharma (International) B.V., Databankweg 26
Increased seizure frequency
Povečana pogostnost epileptičnih napadov
Cannabidiol is a substrate for CYP3A4, CYP2C19, UGT1A7, UGT1A9 and UGT2B7.
Kanabidiol je substrat za CYP3A4, CYP2C19, UGT1A7, UGT1A9 in UGT2B7.
NAME OF THE MEDICINAL PRODUCT Epidyolex 100 mg/ml oral solution
IME ZDRAVILA Epidyolex 100 mg/ml peroralna raztopina
The metabolite 7-carboxy-cannabidiol (7-COOH-CBD) is an inhibitor of UGT1A1, UGT1A4 and UGT1A6-mediated activity, in vitro at clinically relevant concentrations (see also section 4.5).
Presnovek 7-karboksikanabidiol (7-COOH-CBD) in vitro pri klinično pomembnih koncentracijah zavira delovanje, posredovano z UGT1A1, UGT1A4 in UGT1A6 (glejte tudi poglavje 4.5).
Table 3 summarises the primary endpoint of percent reduction from baseline in drop seizures, and the key secondary measure of proportion of patients with at least a 50% reduction in drop seizure frequency, as well as results of the subgroup analysis for these outcome measures in patients treated with concomitant clobazam.
Preglednica 3 povzema primarno merilo, odstotek zmanjšanja od izhodišča pri pojavnosti akinetičnih napadov, ter ključno sekundarno merilo, delež bolnikov z vsaj 50-% zmanjšanjem pogostnosti akinetičnih napadov, kot tudi rezultate analize podskupin za ti dve merili izida pri bolnikih, ki so se sočasno zdravili s klobazamom.
No effect on cannabidiol levels.
Ne vpliva na koncentracije kanabidiola.
Table 3: Primary and ≥ 50% responder key secondary outcome measures and subgroup analysis in LGS studies
Preglednica 3: Primarna merila izida in ključno sekundarno merilo, delež odzivnih bolnikov z ≥ 50-% zmanjšanjem, ter analiza podskupin v študijah LGS
These adverse reactions resolved upon study completion.
Po zaključku študije so ti neželeni učinki izzveneli.
Cannabidiol is a substrate for UGT1A7, UGT1A9 and UGT2B7.
Kanabidiol je substrat za UGT1A7, UGT1A9 in UGT2B7.
a For study GWPCARE1, overall data are presented as median percent reduction from baseline.
IZ = 95-odstotni interval zaupanja a Pri študiji GWPCARE1 so celokupni podatki predstavljeni kot mediana vrednost odstotka zmanjšanja glede na izhodišče.
If the calculated dose is more than 100 mg (1 ml), the larger 5 ml oral syringe should be used.
Če izračunani odmerek znaša več kot 100 mg (1 ml), je treba uporabiti večjo, 5-mililitrsko brizgo za peroralno dajanje.
In vitro data suggest that cannabidiol is an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, UGT1A9 and UGT2B7-mediated activity at clinically relevant concentrations.
Podatki, pridobljeni in vitro, kažejo, da kanabidiol pri klinično pomembnih koncentracijah zavira delovanje, posredovano z CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, UGT1A9 in UGT2B7.
The UGT isoforms responsible for the phase II conjugation of cannabidiol are UGT1A7, UGT1A9 and UGT2B7.
Izooblike UGT, odgovorne za konjugacijo (faza II) kanabidiola, so UGT1A7, UGT1A9 in UGT2B7.
The metabolite 7-carboxy-cannabidiol (7-COOH-CBD) is also an inhibitor of UGT1A1, UGT1A4 and UGT1A6-mediated activity in vitro.
Presnovek 7-karboksikanabidiol (7-COOH-CBD) je in vitro tudi zaviralec aktivnosti, posredovane z UGT1A1, UGT1A4 in UGT1A6.
10 mg/kg/day, 62% to 77% on 20 mg/kg/day, 30% to 41% on placebo; p=0.0009 for 10 mg/kg/day and p=0.0018 and 0.0136 for 20 mg/kg/day vs. placebo).
20 mg/kg/dan, 27 % do 41 % pri placebu; p = 0,0003 za 10 mg/kg/dan in p = 0,0341 in 0,0211 za 20 mg/kg/dan v primerjavi s placebom).
Somnolence and sedation events have been observed in controlled trials with cannabidiol in LGS and DS.
Pri nadzorovanih preskušanjih kanabidiola pri LGS in DS so opazili somnolenco in sedacijo.
Interaction resulting in a decrease (approximately 30%) in Cmax and AUC of the active metabolite 7-OH-CBD in HV* trials.
V preskušanjih pri zdravih prostovoljcih je interakcija povzročila zmanjšanje (za približno 30 %) Cmax in AUC aktivnega presnovka 7-OH-CBD.
Suicidal behaviour and ideation have been reported in patients treated with AEDs in several indications.
Pri bolnikih, ki so se zaradi različnih indikacij zdravili z AED, so poročali o samomorilnem vedenju in razmišljanju.
Epidyolex contains sesame oil, alcohol (ethanol), strawberry flavour components (including benzyl alcohol).
Epidyolex vsebuje sezamovo olje, alkohol (etanol) in sestavine arome jagode (vključno z benzil alkoholom).
Skin and subcutaneous tissue disorders Common
Bolezni kože in podkožja
How to take Epidyolex.
Kako jemati zdravilo Epidyolex
• A plastic bag containing two 5 ml oral syringes and a bottle adaptor A spare syringe of each size is provided in the pack in case the first one is damaged or lost.
V škatli je po ena rezervna brizga v vsaki velikosti za primer, da se prva poškoduje ali izgubi.