FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric patients Pharmacokinetics of cannabidiol has not been studied in paediatric patients < 2 years of age.
Slovenian: Pri pediatričnih bolnikih, starih < 2 leti, farmakokinetike kanabidiola niso proučevali.
English: Very common Decreased appetite Common
Slovenian: Zmanjšan apetit
English: Cannabidiol does not require dose adjustment in patients with mild hepatic impairment (Child-Pugh A).
Slovenian: Okvara jeter Pri bolnikih z blago okvaro jeter prilagoditev odmerka zdravila Epidyolex ni potrebna (ChildPugh A).
English: If you forget to take a dose, do not take a double dose to make up for a forgotten dose.
Slovenian: Če ste vi ali vaš bolnik pozabili vzeti zdravilo Epidyolex Če ste pozabili vzeti odmerek zdravila, ne vzemite dvojnega odmerka, da bi nadomestili pozabljenega.
English: Data for the with clobazam subgroup are presented as percent reduction from baseline estimated from a negative binomial regression analysis.
Slovenian: Podatki za podskupine s klobazamom so predstavljeni kot odstotek zmanjšanja glede na izhodiščno vrednost, ocenjen z negativno binomsko regresijsko analizo.
English: 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.
Slovenian: (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.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 100 mg cannabidiol.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml peroralne raztopine vsebuje 100 mg kanabidiola.
English: A lower starting dose is recommended in patients with moderate or severe hepatic impairment.
Slovenian: Pri bolnikih z zmerno ali hudo okvaro jeter je priporočljiv manjši začetni odmerek.
English: Cannabidiol should be used with caution in patients with moderate or severe hepatic impairment.
Slovenian: Pri bolnikih z zmerno ali hudo okvaro jeter je treba kanabidiol uporabljati previdno.
English: 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.
Slovenian: 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.
English: Do not reduce the dose or stop taking Epidyolex without first talking to your doctor.
Slovenian: 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.
English: What Epidyolex is and what it is used for.
Slovenian: Kaj je zdravilo Epidyolex in za kaj ga uporabljamo 2.
English: Cannabidiol can cause decreases in haemoglobin and haematocrit.
Slovenian: Kanabidiol lahko povzroči znižanje vrednosti hemoglobina in hematokrita.
English: 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.
Slovenian: 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.
English: Data for study GWPCARE2 and the with clobazam subgroup are presented as percent reduction from baseline estimated from a negative binomial regression analysis.
Slovenian: Podatki pri študiji GWPCARE2 in za podskupine s klobazamom so predstavljeni kot odstotek zmanjšanja glede na izhodiščno vrednost, ocenjen z negativno binomsko regresijsko analizo.
English: (See section 4.2 for information on paediatric use).
Slovenian: Za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
English: • If your dose is 1 ml (100 mg) or less, you should use the smaller 1 ml syringe.
Slovenian: • Če vaš odmerek znaša 1 ml (100 mg) ali manj, uporabite manjšo, 1-mililitrsko brizgo.
English: Remove the child-resistant cap on the bottle by pushing the cap down whilst turning the cap anti-clockwise.
Slovenian: Za otroke varno zaporko s steklenice odstranite tako, da jo pritiskate navzdol, obenem pa jo vrtite v nasprotni smeri urinega kazalca.
English: 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.
Slovenian: 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 %
English: The 5 ml syringes are graduated in 0.1 ml and the 1 ml in 0.05 ml increments.
Slovenian: 5-mililitrski brizgi sta graduirani v korakih po 0,1 ml, 1-mililitrski brizgi pa v korakih po 0,05 ml.
English: What Epidyolex looks like and contents of the pack Epidyolex is a clear, colourless to yellow oral solution.
Slovenian: Epidyolex je bistra, brezbarvna do rumena raztopina.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: • A plastic bag containing two 1 ml oral syringes and a bottle adaptor
Slovenian: • plastično vrečko z dvema 1-mililitrskima brizgama za peroralno dajanje in nastavkom za steklenico,
English: Dose
Slovenian: Izpuščaj
English: If the calculated dose is 100 mg (1 ml) or less, the smaller 1 ml oral syringe should be used.
Slovenian: Če izračunani odmerek znaša 100 mg (1 ml) ali manj, je treba uporabiti manjšo, 1-mililitrsko brizgo za peroralno dajanje.
English: Risk Factors for Hepatocellular injury Concomitant Valproate and Clobazam, Dose of cannabidiol and Baseline Transaminase Elevations
Slovenian: Sočasna uporaba valproata in klobazama, odmerek kanabidiol in izhodiščno zvišane vrednosti transaminaz
English: 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
Slovenian: Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij GW Pharma (International) B.V., Databankweg 26
English: Increased seizure frequency
Slovenian: Povečana pogostnost epileptičnih napadov
English: Cannabidiol is a substrate for CYP3A4, CYP2C19, UGT1A7, UGT1A9 and UGT2B7.
Slovenian: Kanabidiol je substrat za CYP3A4, CYP2C19, UGT1A7, UGT1A9 in UGT2B7.
English: NAME OF THE MEDICINAL PRODUCT Epidyolex 100 mg/ml oral solution
Slovenian: IME ZDRAVILA Epidyolex 100 mg/ml peroralna raztopina
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: No effect on cannabidiol levels.
Slovenian: Ne vpliva na koncentracije kanabidiola.
English: Table 3: Primary and ≥ 50% responder key secondary outcome measures and subgroup analysis in LGS studies
Slovenian: Preglednica 3: Primarna merila izida in ključno sekundarno merilo, delež odzivnih bolnikov z ≥ 50-% zmanjšanjem, ter analiza podskupin v študijah LGS
English: These adverse reactions resolved upon study completion.
Slovenian: Po zaključku študije so ti neželeni učinki izzveneli.
English: Cannabidiol is a substrate for UGT1A7, UGT1A9 and UGT2B7.
Slovenian: Kanabidiol je substrat za UGT1A7, UGT1A9 in UGT2B7.
English: a For study GWPCARE1, overall data are presented as median percent reduction from baseline.
Slovenian: IZ = 95-odstotni interval zaupanja a Pri študiji GWPCARE1 so celokupni podatki predstavljeni kot mediana vrednost odstotka zmanjšanja glede na izhodišče.
English: If the calculated dose is more than 100 mg (1 ml), the larger 5 ml oral syringe should be used.
Slovenian: Če izračunani odmerek znaša več kot 100 mg (1 ml), je treba uporabiti večjo, 5-mililitrsko brizgo za peroralno dajanje.
English: In vitro data suggest that cannabidiol is an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, UGT1A9 and UGT2B7-mediated activity at clinically relevant concentrations.
Slovenian: Podatki, pridobljeni in vitro, kažejo, da kanabidiol pri klinično pomembnih koncentracijah zavira delovanje, posredovano z CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, UGT1A9 in UGT2B7.
English: The UGT isoforms responsible for the phase II conjugation of cannabidiol are UGT1A7, UGT1A9 and UGT2B7.
Slovenian: Izooblike UGT, odgovorne za konjugacijo (faza II) kanabidiola, so UGT1A7, UGT1A9 in UGT2B7.
English: The metabolite 7-carboxy-cannabidiol (7-COOH-CBD) is also an inhibitor of UGT1A1, UGT1A4 and UGT1A6-mediated activity in vitro.
Slovenian: Presnovek 7-karboksikanabidiol (7-COOH-CBD) je in vitro tudi zaviralec aktivnosti, posredovane z UGT1A1, UGT1A4 in UGT1A6.
English: 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).
Slovenian: 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).
English: Somnolence and sedation events have been observed in controlled trials with cannabidiol in LGS and DS.
Slovenian: Pri nadzorovanih preskušanjih kanabidiola pri LGS in DS so opazili somnolenco in sedacijo.
English: Interaction resulting in a decrease (approximately 30%) in Cmax and AUC of the active metabolite 7-OH-CBD in HV* trials.
Slovenian: V preskušanjih pri zdravih prostovoljcih je interakcija povzročila zmanjšanje (za približno 30 %) Cmax in AUC aktivnega presnovka 7-OH-CBD.
English: Suicidal behaviour and ideation have been reported in patients treated with AEDs in several indications.
Slovenian: Pri bolnikih, ki so se zaradi različnih indikacij zdravili z AED, so poročali o samomorilnem vedenju in razmišljanju.
English: Epidyolex contains sesame oil, alcohol (ethanol), strawberry flavour components (including benzyl alcohol).
Slovenian: Epidyolex vsebuje sezamovo olje, alkohol (etanol) in sestavine arome jagode (vključno z benzil alkoholom).
English: Skin and subcutaneous tissue disorders Common
Slovenian: Bolezni kože in podkožja
English: How to take Epidyolex.
Slovenian: Kako jemati zdravilo Epidyolex
English: • 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.
Slovenian: V škatli je po ena rezervna brizga v vsaki velikosti za primer, da se prva poškoduje ali izgubi.
English: • If your dose is more than 1 ml (100 mg), you should use the larger 5 ml syringe.
Slovenian: • Če vaš odmerek znaša več kot 1 ml (100 mg), uporabite večjo, 5-mililitrsko brizgo.
English: There were cases of transaminase elevations associated with hospitalisation in patients taking cannabidiol.
Slovenian: Pri bolnikih, ki so jemali kanabidiol, so bili zabeleženi primeri zvišanja transaminaz, zaradi katerih so bili sprejeti v bolnišnico.
English: In juvenile rats, administration of cannabidiol for 10 weeks (subcutaneous doses of 0 or 15 mg/kg on postnatal days [PNDs] 4-6 followed by oral administration of 0, 100, 150, or 250 mg/kg on PNDs 7-77
Slovenian: Dajanje kanabidiola mladim podganam v obdobju 10 tednov (subkutani odmerki 0 mg/kg ali 15 mg/kg od 4. do 6. dne postnatalno, ki jim je sledilo peroralno dajanje odmerka 0 mg/kg/dan, 100 mg/kg/dan, 150 mg/kg/dan ali 250 mg/kg/dan od 7. do 77. dne postnatalno) je povzročilo povečanje telesne mase, upočasnjeno spolno dozorevanje samčkov, nevro-vedenjske učinke, povečano mineralno gostoto kosti in vakuolizacijo hepatocitov.
English: In each trial, patients receiving cannabidiol experienced a greater median percentage reduction in total seizures compared with placebo (53% 10 mg/kg/day, 64% to 66% 20 mg/kg/day, 25% for each placebo group; p=0.0025 for 10 mg/kg/day and p<0.0001 for each 20 mg/kg/day group vs. placebo).
Slovenian: V vsakem preskušanju so imeli bolniki, ki so prejemali kanabidiol, večji mediani odstotek zmanjšanja vseh epileptičnih napadov v primerjavi s placebom (53 % 10 mg/kg/dan, 64 % do 66 % 20 mg/kg/dan, 25 % v vsaki skupini s placebom; p = 0,0025 za 10 mg/kg/dan in p < 0,0001 za 20 mg/kg/dan v vsaki skupini v primerjavi s placebom).
English: NAME OF THE MEDICINAL PRODUCT Epidyolex 100 mg/ml oral solution cannabidiol
Slovenian: Navodilo za uporabo Epidyolex 100 mg/ml peroralna raztopina kanabidiol
English: Each ml of oral solution contains 100 mg of cannabidiol.
Slovenian: En ml peroralne raztopine vsebuje 100 mg kanabidiola.
English: GWPCARE4 Placebo 20 mg/kg/day p=0.0043
Slovenian: GWPCARE4 Placebo 20 mg/kg/dan p = 0,0043
English: Contact your doctor if you are unsure of your dose or if you think your dose may need to be changed.
Slovenian: Če niste prepričani o pravem odmerku ali če menite, da je treba odmerek spremeniti, se obrnite na zdravnika.
English: GWPCARE4 20 mg/kg/day p=0.0135
Slovenian: GWPCARE4 20 mg/kg/dan p = 0,0135
English: 736 mg refined sesame oil
Slovenian: 79 mg brezvodnega etanola 736 mg rafiniranega sezamovega olja 0,0003 mg benzilalkohola
English: b For study GWPCARE1, overall data are presented as estimated median difference and p-value from a Wilcoxon rank-sum test. Data for study GWPCARE2 and the with clobazam subgroup are estimated from a negative binomial regression analysis.
Slovenian: b Pri študiji GWPCARE1 so celokupni podatki predstavljeni kot ocenjena mediana razlika in vrednost p iz Wilcoxonovega testa vsote rangov.
English: Hepatocellular injury Cannabidiol causes dose-related elevations of ALT and AST (see section 4.4).
Slovenian: Okvara jetrnih celic Kanabidiol povzroča od odmerka odvisno zvišanje vrednosti ALT in AST (glejte poglavje 4.4).
English: A NOAEL of 15 mg/kg/day was established.
Slovenian: Raven NOAEL je bila pri 15 mg/kg/dan.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: Table 4: Primary and ≥ 50% responder key secondary outcome measures and subgroup analysis in DS studies
Slovenian: Preglednica 4: Primarno merila izida in ključno sekundarno merilo, delež odzivnih bolnikov z ≥ 50-% zmanjšanjem, ter analiza podskupin v študijah DS
English: - The other ingredients are refined sesame oil, anhydrous ethanol, sucralose and strawberry flavour (including benzyl alcohol)
Slovenian: - Druge sestavine zdravila so rafinirano sezamovo olje, brezvodni etanol, sukraloza in aroma jagode (vključno z benzil alkoholom).
English: When cannabidiol and clobazam are co-administered, bi-directional PK interactions occur.
Slovenian: Pri sočasnem dajanju kanabidiola in klobazama se pojavijo dvosmerne farmakokinetične interakcije.
English: Greater improvements in overall condition, as measured by Global Impression of Change scores at the last visit, were reported by caregivers and patients with both doses of cannabidiol (76% on 10 mg/kg/day, 80% for each group on 20 mg/kg/day, 31% to 46% on placebo; p=0.0005 for 10 mg/kg/day and p<0.0001 and 0.0003 for 20 mg/kg/day vs. placebo).
Slovenian: Z obema odmerkoma kanabidiola so negovalci in bolniki poročali o večjih izboljšavah splošnega stanja, ki so jih izmerili z vprašalnikom o globalnem vtisu o spremembah (Global Impression of Change) pri zadnjem obisku (76 % pri 10 mg/kg/dan, 80 % v obeh skupinah, ki sta prejemali odmerek 20 mg/kg/dan, 31 % do 46 % pri placebu; p = 0,0005 za 10 mg/kg/dan in p < 0,0001 in 0,0003 za 20 mg/kg/dan v primerjavi s placebom).
English: Because of potential inhibition of enzyme activity, dose reduction of substrates of UGT1A9, UGT2B7, CYP2C8, and CYP2C9 should be considered, as clinically appropriate, if adverse reactions are experienced when administered concomitantly with cannabidiol.
Slovenian: Če se pri sočasni uporabi s kanabidiolom pojavijo neželeni učinki, je treba zaradi možnega zaviranja encimskega delovanja razmisliti o zmanjšanju odmerka substratov UGT1A9, UGT2B7, CYP2C8 in CYP2C9, glede na klinično stanje bolnika.
English: - High liver enzymes (transaminases elevations) seen in blood tests, which can be a sign of liver injury, have been reported in patients receiving Epidyolex - People taking this medicine can have thoughts of harming or killing themselves.
Slovenian: - Pri bolnikih, ki so prejemali zdravilo Epidyolex, so poročali o zvišanih jetrnih encimih (zvišanje transaminaz), ugotovljenih s krvnimi preiskavami, ki so lahko znak okvare jeter.
English: Missed doses
Slovenian: Izpuščeni odmerki
English: Lamotrigine levels may be elevated when it is co-administered with cannabidiol.
Slovenian: Pri sočasni uporabi s kanabidiolom je lahko raven lamotrigina povišana.
English: DROP SEIZURES PER 28 DAYS Percentage Reduction from Baselinea
Slovenian: KONVULZNI NAPADI V 28 DNEH
English: Amber glass bottle (type III) with a child-resistant and tamper-evident screw cap (polypropylene).
Slovenian: Steklenica jantarne barve (tipa III) z za otroke varno navojno zaporko (polipropilensko) z zaščito pred poseganjem v zdravilo.
English: Inhibition of P-gp mediated efflux by cannabidiol in the intestine cannot be ruled out.
Slovenian: Ni mogoče izključiti možnosti, da kanabidiol v črevesju zavira izločanje, ki ga povzroča P-gp.
English: p<0.0001c ≥ 50% REDUCTION IN DROP SEIZURES (RESPONDER ANALYSIS) Percentage of ≥ 50% Responders, p-valued GWPCARE3 Placebo
Slovenian: Odstotek ≥ 50 % odzivnih bolnikov, p-vrednostd GWPCARE2 Placebo
English: The adaptor could come off and cause choking if it is not fully inserted.
Slovenian: Če nastavek ni popolnoma vstavljen, se lahko sname in povzroči zadušitev.
English: Patients with sustained transaminase elevations of greater than 5 times the ULN should also have treatment discontinued.
Slovenian: Zdravljenje je treba prekiniti tudi pri bolnikih, ki imajo vrednosti transaminaz dolgotrajno zvišane nad 5-kratno ZMN.
English: You may get the following side effects with this medicine.
Slovenian: Pri jemanju tega zdravila se lahko pojavijo spodaj navedeni neželeni učinki.
English: Dose adjustment or discontinuation of valproate or dose adjustment of clobazam should be considered if transaminase elevations occur.
Slovenian: Če se pojavi zvišanje transaminaz, je treba razmisliti o prilagoditvi odmerka valproata ali o prekinitvi zdravljenja z njim, oziroma o prilagoditvi odmerka klobazama.
English: Cannabidiol was associated with an increase in the percentage of subjects experiencing a greater than or equal to 75% reduction in convulsive seizure frequency during the treatment period in each trial (36% 10 mg/kg/day cannabidiol, 25% for each 20 mg/kg/day cannabidiol group, 10% to 13% placebo).
Slovenian: Dodatna sekundarna merila izidov v podskupini bolnikov, ki so se sočasno zdravili s klobazamom Kanabidiol je bil povezan s povečanjem odstotka oseb, ki so imele v vsakem od preskušanj v obdobju zdravljenja 75-odstotno ali večje zmanjšanje pogostnosti konvulznih napadov (36 % bolnikov, ki so prejemali 10 mg/kg kanabidiola na dan, 25 % bolnikov za vsako skupino z odmerkom 20 mg/kg kanabidiola na dan, 10 % do 13 % prejemnikov placeba).
English: 1 mg/kg twice daily (2 mg/kg/day)
Slovenian: 1 mg/kg dvakrat na dan (2 mg/kg/dan)
English: Cannabidiol induces CYP1A2 and CYP2B6 mRNA expression at clinically relevant concentrations.
Slovenian: Kanabidiol pri klinično pomembnih koncentracijah izzove ekspresijo mRNA za encima CYP1A2 in CYP2B6.
English: Cannabidiol was associated with an increase in the percentage of subjects experiencing a greater than or equal to 75% reduction in drop seizure frequency during the treatment period in each trial (11% 10 mg/kg/day cannabidiol, 31% to 36% 20 mg/kg/day cannabidiol, 3% to 7% placebo).
Slovenian: Dodatna sekundarna merila izidov v podskupini bolnikov, ki so se sočasno zdravili s klobazamom Kanabidiol je bil povezan s povečanjem odstotka oseb, ki so imele v vsakem od preskušanj med zdravljenjem vsaj 75-odstotno zmanjšanje pogostnosti epileptičnih napadov (11 % bolnikov, ki so prejemali 10 mg/kg kanabidiola na dan, 31 % do 36 % bolnikov, ki so prejemali 20 mg/ kg kanabidiola na dan, 3 % do 7 % prejemnikov placeba).
English: Contains refined sesame oil, ethanol and strawberry flavour components (including benzyl alcohol).
Slovenian: Vsebuje rafinirano sezamovo olje, etanol in sestavine arome jagode (vključno z benzil alkoholom).
English: 20 mg/kg/day p=0.0299
Slovenian: 20 mg/kg/dan p = 0,0299
English: b Overall data are presented as estimated median difference and p-value from a Wilcoxon rank-sum test. Data for the with clobazam subgroup are estimated from a negative binomial regression analysis.
Slovenian: b Celokupni podatki so predstavljeni kot ocenjena mediana razlika in vrednost p iz Wilcoxonovega testa vsote rangov.
English: Hepatobiliary disorders
Slovenian: Hematološke nepravilnosti