FrancophonIA/ELRC3.0 huggingface dataset:
English: Cannabidiol is extensively metabolised by the liver via CYP450 enzymes and the UGT enzymes.
Slovenian: Kanabidiol se v veliki meri presnavlja v jetrih s pomočjo encimov CYP450 in UGT.
English: Prior to starting treatment with cannabidiol, obtain serum transaminases (ALT and AST) and total bilirubin levels.
Slovenian: Pred začetkom zdravljenja s kanabidiolom izmerite vrednosti serumskih transaminaz (ALT in AST) in skupnega bilirubina.
English: It is important that you use the correct oral syringe to measure your dose.
Slovenian: Pomembno je, da za odmerjanje odmerka uporabite ustrezno brizgo za peroralno dajanje.
English: Studies in animals have shown toxicological changes in lactating animals, when the mother was treated with cannabidiol (see section 5.3).
Slovenian: Študije na živalih so pokazale toksikološke spremembe pri doječih živalih, če je samica prejemala kanabidiol (glejte poglavje 5.3).
English: This medicinal product contains 10% by volume ethanol (alcohol), i.e. up to 700 mg per dose (for an adult weighing 70 kg), equivalent to 14 millilitres (ml) of beer, or 6 ml of wine per dose.
Slovenian: To zdravilo vsebuje 10 % volumskega deleža etanola (alkohola), tj. največ 700 mg na odmerek (za odraslega s telesno maso 70 kg), kar ustreza 14 mililitrom (ml) piva ali 6 ml vina na odmerek.
English: 4.7 Effects on ability to drive and use machines Cannabidiol has major influence on the ability to drive and operate machines because it may cause somnolence and sedation (see section 4.4).
Slovenian: Kanabidiol ima pomemben vpliv na sposobnost vožnje in upravljanja strojev, ker lahko povzroči somnolenco in sedacijo (glejte poglavje 4.4).
English: Approximately 65% of the patients were taking concomitant clobazam.
Slovenian: Približno 65 % bolnikov je sočasno jemalo klobazam.
English: Ask your pharmacist about how to throw away any medicine that you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: Concomitant use of cannabidiol and clobazam increases the incidence of somnolence and sedation compared with placebo (see sections 4.4 and 4.8).
Slovenian: Sočasna uporaba kanabidiola in klobazama poveča incidenco somnolence in sedacije v primerjavi s placebom (glejte poglavji 4.4 in 4.8).
English: The potential for drug-drug interactions with other concomitant AEDs has been assessed in healthy volunteers and patients with epilepsy for clobazam, valproate and stiripentol.
Slovenian: Možnost medsebojnega delovanja z drugimi zdravili so pri zdravih prostovoljcih in bolnikih z epilepsijo ocenili za klobazam, valproat in stiripentol.
English: Embryofoetal mortality was observed at the high dose, with no treatment-related effects on implantation loss at the low or mid doses.
Slovenian: Pri velikem odmerku je bila zabeležena embrio-fetalna umrljivost, pri majhnem oz. srednjem odmerku pa niso opazili nobenih z zdravilom povezanih učinkov na implantacijsko izgubo.
English: midazolam, phenytoin, stiripentol and valproate that are used to treat seizures - medicines used to treat acid reflux (heartburn or acid regurgitation) such as omeprazole - mitotane (a medicine used to treat tumours in the adrenal gland) - morphine or diflunisal (medicines used to treat pain) - efavirenz (a medicine used to treat HIV/AIDS) - theophylline (a medicine used to treat asthma) - caffeine (a medicine for babies who need help breathing) - propofol (an anaesthetic used for people undergoing surgery) - simvastatin, fenofibrate, gemfibrozil, (medicines used to reduce cholesterol/lipids) - enzalutamide (a medicine to treat prostate cancer) - bupropion (a medicine to help stop smoking or for treating obesity) - St. John's wort (Hypericum perforatum) (a herbal medicine used to treat mild anxiety) - medicines to treat bacterial infections, such as rifampin, clarithromycin and erythromycin
Slovenian: midazolam, fenitoin, stiripentol in valproat, k se uporabljajo za zdravljenje epileptičnih napadov; - zdravila, ki se uporabljajo za zdravljenje refluksa želodčne kisline (zgaga ali regurgitacija), kot je omeprazol; - mitotan (zdravilo, ki se uporablja za zdravljenje tumorjev nadledvične žleze); - morfin ali diflunizal (zdravili, ki se uporabljata za lajšanje bolečin); - efavirenz (zdravilo, ki se uporablja za zdravljenje okužbe s HIV/AIDS-a); - teofilin (zdravilo, ki se uporablja za zdravljenje astme); - kofein (zdravilo za dojenčke, ki potrebujejo pomoč pri dihanju); - propofol (anestetik, ki se uporablja za bolnike pri operaciji); - simvastatin, fenofibrat, gemfibrozil (zdravila, ki se uporabljajo za zniževanje holesterola/lipidov); - enzalutamid (zdravilo, ki se uporablja za zdravljenje raka prostate); - bupropion (zdravilo, ki se uporablja kot pomoč pri opustitvi kajenja ali za zdravljenje debelosti); - šentjanževka (Hypericum perforatum) (zdravilo rastlinskega izvora, ki se uporablja za zdravljenje blage tesnobnosti); - zdravila za zdravljenje bakterijskih okužb, na primer rifampin, klaritromicin in eritromicin.
English: Given that there was no consistent dose response between 10 mg/kg/day and 20 mg/kg/day in the LGS and DS studies, cannabidiol should be titrated initially to the recommended maintenance dose of 10 mg/kg/day (see Section 4.2).
Slovenian: Glede na to, da v študijah LGS in DS ni bilo dosledne razlike v odzivu na odmerka 10 mg/kg/dan in 20 mg/kg/dan, je treba kanabidiol na začetku titrirati do priporočenega vzdrževalnega odmerka 10 mg/kg/dan (glejte poglavje 4.2).
English: Dose reduction of cannabidiol and/or the inhibitor may be necessary when given in combination.
Slovenian: Morda bo potrebno zmanjšati odmerek kanabidiola in/ali zaviralca, ko se dajeta v kombinaciji.
English: The dose titration should be performed as detailed in the table below.
Slovenian: Titriranje odmerka je treba izvesti, kakor je podrobneje opisano v spodnji preglednici.
English: The most commonly used cAEDs (> 25% of patients) in both trials were valproate, clobazam, lamotrigine, levetiracetam, and rufinamide.
Slovenian: Najpogosteje uporabljana cAED (> 25 %) pri obeh preskušanjih so bila valproat, klobazam, lamotrigin, levetiracetam in rufinamid.
English: Read all of this leaflet carefully before you or the patient start taking this medicine because it contains important information for you or the patient
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: The combination of cannabidiol with clobazam caused an elevation in exposure to the active metabolite N-desmethylclobazam.
Slovenian: Kombinacija kanabidiola in klobazama je povzročila povečano izpostavljenost aktivnemu presnovku N- desmetilklobazamu.
English: - feeling drowsy or sleepy - decreased appetite - diarrhoea - fever - feeling tired - vomiting
Slovenian: - občutek dremavosti ali zaspanosti - zmanjšan apetit - driska - povišana telesna temperatura - občutek utrujenosti - bruhanje
English: Subjects with moderate and severe hepatic impairment showed higher plasma concentrations of cannabidiol (approximately 2.5-5.2-fold higher AUC compared to healthy subjects with normal hepatic function).
Slovenian: Preiskovanci z zmerno in hudo okvaro jeter so imeli višje plazemske koncentracije kanabidiola (približno 2,5-5,2-krat večja vrednost AUC v primerjavi z zdravimi preiskovanci z normalnim delovanjem jeter).
English: In vitro data have demonstrated that cannabidiol inhibits CYP2C19, which may cause increased plasma concentrations of medicines that are metabolised by this isoenzyme such as clobazam and omeprazole.
Slovenian: Podatki, pridobljeni in vitro, so pokazali, da kanabidiol zavira CYP2C19, kar lahko povzroči povečane plazemske koncentracije zdravil, ki jih ta izoencim presnavlja, npr. klobazama in omeprazola.
English: In vivo assessment of drug interactions
Slovenian: In vivo ocena medsebojnega delovanja zdravil
English: Lamotrigine
Slovenian: Lamotrigin
English: The plasma clearance of cannabidiol following a single 1500 mg dose of cannabidiol is about 1,111 L/h.
Slovenian: Po enkratnem 1.500-miligramskem odmerku kanabidiola je očistek kanabidiola v plazmi približno 1.111 l/h.
English: In a human abuse potential study, acute administration of cannabidiol to non-dependent adult recreational drug users at therapeutic and supratherapeutic doses produced small responses on positive subjective measures such as Drug Liking and Take Drug Again.
Slovenian: V študiji potenciala za zlorabo pri ljudeh je akutna uporaba kanabidiola v terapevtskih in supraterapevtskih odmerkih povzročila majhne odzive v okviru pozitivnih subjektivnih meril, npr. »ugajanje zdravila« in »pripravljenost za ponovno uporabo zdravila.
English: Caution should be used in patients with moderate (Child-Pugh B) or severe hepatic impairment (Child-Pugh C).
Slovenian: Pri bolnikih z zmerno (ChildPugh B) ali hudo okvaro jeter (ChildPugh C) je potrebna previdnost.
English: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, UGT1A9, and UGT2B7 Substrates In vitro data predict drug-drug interactions with CYP1A2 substrates (e.g., theophylline, caffeine), CYP2B6 substrates (e.g., bupropion, efavirenz), uridine 5' diphospho-glucuronosyltransferase 1A9 (UGT1A9) (e.g., diflunisal, propofol, fenofibrate), and UGT2B7 (e.g., gemfibrozil, morphine, lorazepam) when co-administered with cannabidiol.
Slovenian: Substrati CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, UGT1A9 in UGT2B7 Podatki, pridobljeni in vitro, nakazujejo interakcije med zdravili pri sočasnem dajanju substratov CYP1A2 (npr. teofilin, kofein), substratov CYP2B6 (npr. bupropion, efavirenz), uridin-5'-difosfat-glukuronoziltransferaze 1A9 (UGT1A9) (npr. diflunizal, propofol, fenofibrat) in UGT2B7 (npr. gemfibrozil, morfin, lorazepam) in kanabidiola.
English: The metabolite 7-COOH-CBD is a P-gp/MDR1 substrate and has the potential to inhibit BCRP, OATP1B3, and OAT3.
Slovenian: Presnovek 7-COOH-CBD je substrat P-gp/MDR1 in ima potencial za zaviranje BCRP, OATP1B3 in OAT3.
English: In cannabidiol-treated patients, the incidence of ALT elevations greater than 3 times the ULN was 23% in patients taking both concomitant valproate and clobazam, 17% in patients taking concomitant valproate (without clobazam), 3% in patients taking concomitant clobazam (without valproate), and 2% in patients taking neither drug.
Slovenian: Pri bolnikih, zdravljenih s kanabidiolom, je bila incidenca zvišanih vrednosti ALT, ki so presegale 3-kratno ZMN, 23 % pri bolnikih, ki so sočasno jemali tako valproat kot klobazam, 17 % pri bolnikih, ki so sočasno jemali valproat (brez klobazama), 3 % pri bolnikih, ki so sočasno jemali klobazam (brez valproata) in 2 % pri bolnikih, ki niso jemali nobenega od teh dveh zdravil.
English: Cannabidiol is not a substrate for or an inhibitor of the brain uptake transporters OATP1A2 and OATP2B1.
Slovenian: Kanabidiol ni substrat ali zaviralec možganskih privzemnih prenašalcev OATP1A2 in OATP2B1.
English: GW Pharma (International) B.V., Databankweg 26, 3821AL Amersfoort, The Netherlands e-mail: info@gwpharm.com
Slovenian: GW Pharma (International) B.V., Databankweg 26, 3821AL Amersfoort, Nizozemska e-pošta: info@gwpharm.com
English: CYP3A4 or CYP2C19 inducers
Slovenian: Induktorji CYP3A4 ali CYP2C19
English: After multiple dosing with cannabidiol, the 7-OH-CBD metabolite (active in a preclinical model of seizure) circulates in human plasma at lower concentrations than the parent drug cannabidiol (~ 40% of CBD exposure) based on AUC.
Slovenian: Po večkratnih odmerkih kanabidiola presnovek 7-OH-CBD (aktiven v predkliničnih modelih epileptičnih napadov) kroži v človeški plazmi pri nižjih koncentracijah kot matična učinkovina kanabidiol (~ 40 % izpostavljenosti CBD) glede na AUC.
English: Steady-state plasma concentrations are attained within 2-4 days of twice daily dosing based on pre-dose (Ctrough) concentrations.
Slovenian: Plazemske koncentracije v stanju dinamičnega ravnovesja so dosežene po 2-4 dneh odmerjanja dvakrat na dan, glede na izmerjene najnižje koncentracije pred dajanjem naslednjega odmerka (Ctrough).
English: Screw the child resistant cap back on the bottle tightly, by turning the cap clockwise - you do not need to remove the bottle adaptor, as the cap will fit over it.
Slovenian: Za otroke varno zaporko trdno privijte nazaj na steklenico tako, da jo vrtite v smeri urinega kazalca - nastavka za steklenico ni treba odstraniti, saj se mu zaporka prilega.
English: Studies in healthy subjects showed there were no major differences in the plasma exposure to cannabidiol in CYP2C19 intermediate and ultra-rapid metabolisers when compared to extensive metabolisers.
Slovenian: Študije pri zdravih preiskovancih niso pokazale pomembnejših razlik v plazemski izpostavljenosti kanabidiolu pri osebah s srednje hitro in ultrahitro presnovo z CYP2C19 v primerjavi z osebami z obsežno presnovo.
English: In some cases, the decreased weight was reported as an adverse event (see the table above).
Slovenian: Pri nekaterih bolnikih so o zmanjšanju telesne mase poročali kot o neželenem učinku (glejte zgornjo preglednico).
English: Patients with elevated baseline transaminase levels above 3 times the ULN, or elevations in bilirubin above 2 times the ULN, should be evaluated prior to initiation of cannabidiol treatment.
Slovenian: Bolnike z zvišanimi izhodiščnimi vrednostmi transaminaz nad 3-kratno ZMN ali zvišanjem bilirubina nad 2-kratno ZMN je treba pred uvedbo zdravljenja s kanabidiolom oceniti.
English: The phase I metabolites identified in standard in vitro assays were 7-COOH-CBD, 7-OH-CBD, and 6-OH-CBD (a minor circulating metabolite).
Slovenian: Presnovki faze I, ki so jih opredelili s standardnimi testi in vitro, so bili 7-COOH-CBD, 7-OH-CBD in 6-OH-CBD (manj pomemben presnovek v obtoku).
English: Epidyolex with food
Slovenian: Zdravilo Epidyolex skupaj s hrano
English: What Epidyolex contains - The active substance is cannabidiol.
Slovenian: Kaj vsebuje zdravilo Epidyolex - Učinkovina je kanabidiol.
English: Any dose increases above 10 mg/kg/day, up to the maximum recommended dose of 20 mg/kg/day, should be made considering individual benefit and risk and with adherence to the full monitoring schedule (see section 4.4).
Slovenian: Pri vsakem povečanju odmerka nad 10 mg/kg/dan do največjega priporočenega dnevnega odmerka 20 mg/kg/dan je treba pretehtati koristi in tveganja za posameznega bolnika ter izvesti celotno shemo spremljanja (glejte poglavje 4.4).
English: Strong inducers of CYP3A4, such as carbamazepine, enzalutamide, mitotane, St. John's wort, and/or strong inducers of CYP2C19, such as rifampin, administered concomitantly with cannabidiol may decrease the plasma concentrations of cannabidiol and decrease the effectiveness of cannabidiol.
Slovenian: Pri sočasni uporabi kanabidiola in močnih induktorjev CYP3A4, kot so karbamazepin, enzalutamid, mitotan in šentjanževka, in/ali močnih induktorjev CYP2C19, kot je rifampin, se lahko zmanjšajo plazemske koncentracije kanabidiola, kar zmanjša učinkovitost kanabidiola.
English: Dose reduction should be considered for concomitant medicinal products that are sensitive CYP2C19 substrates or that have a narrow therapeutic index.
Slovenian: Pri sočasno uporabljenih zdravilih, ki so občutljivi substrati za CYP2C19 ali ki imajo ozek terapevtski indeks, je treba razmisliti o zmanjšanju odmerka.
English: As with other AEDs, a clinically relevant increase in seizure frequency may occur during treatment with cannabidiol, which may require adjustment in dose of cannabidiol and/or concomitant AEDs, or discontinuation of cannabidiol, should the benefit-risk be negative.
Slovenian: Kot pri vseh AED lahko med zdravljenjem s kanabidiolom pride do klinično pomembnega povečanja pogostnosti epileptičnih napadov, zaradi česar bo morda potrebna prilagoditev odmerka kanabidiola in/ali sočasno uporabljanih AED ali prekinitev zdravljenja s kanabidiolom, če je razmerje med koristmi in tveganji negativno.
English: Lamotrigine is a substrate for UGT enzymes including UGT2B7 which is inhibited by cannabidiol in vitro.
Slovenian: Lamotrigin je substrat za encime UGT, vključno z UGT2B7, ki ga in vitro zavira kanabidiol.
English: Although exposure to cannabidiol was not notably affected by clobazam use, the levels of an active metabolite, 7-OH-CBD, were elevated by this combination.
Slovenian: Čeprav uporaba klobazama ni opazno vplivala na izpostavljenost kanabidiolu, so bile pri tej kombinaciji koncentracije aktivnega presnovka 7-OH-CBD povečane.
English: Table 2: Tabulated list of adverse reactions
Slovenian: Preglednica 2: Tabelarni seznam neželenih učinkov Organski sistem
English: Resolution of transaminase elevations occurred with discontinuation of cannabidiol or reduction of cannabidiol and/or concomitant valproate in about two-thirds of the cases.
Slovenian: Zvišanje transaminaz je po prekinitvi zdravljenja s kanabidiolom ali zmanjšanju odmerka kanabidiola in/ali sočasno uporabljenega valproata izginilo pri približno dveh tretjinah bolnikov.
English: Overall
Slovenian: Celokupno
English: Co-administration of cannabidiol is also predicted to cause clinically significant interactions with CYP2C8 (repaglinide) and CYP2C9 (e.g., warfarin) substrates.
Slovenian: Za sočasno dajanjekanabidiola se predvidevajo tudi klinično pomembne interakcije s substrati CYP2C8 (repaglinid) in CYP2C9 (npr. varfarin).
English: In some patients, a synergistic effect of concomitant treatment with valproate upon baseline elevated transaminases resulted in a higher risk of transaminase elevations.
Slovenian: Pri nekaterih bolnikih se je zaradi sinergijskega učinka sočasnega zdravljenja z valproatom ob povišanih izhodiščnih vrednostih transaminaz povečalo tveganje za zvišanje transaminaz.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: In the phase 3 clinical trials, the observed frequency of status epilepticus was similar between the cannabidiol and placebo groups.
Slovenian: 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.
English: Interaction resulting in approximately 3-fold increase in N-desmethylclobazam metabolite exposure.
Slovenian: Interakcija je povzročila približno 3-kratno povečanje izpostavljenosti presnovku N-desmetil-klobazamu.
English: 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).
Slovenian: 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).
English: Monitoring
Slovenian: Spremljanje
English: Psychiatric disorders
Slovenian: Psihiatrične motnje
English: Patients with end-stage renal disease were not studied.
Slovenian: Bolnikov s končno odpovedjo ledvic niso proučevali.
English: The half-life of cannabidiol in plasma was 56-61 hours after twice daily dosing for 7 days in healthy volunteers.
Slovenian: Pri zdravih prostovoljcih je bila po 7-dnevnem odmerjanju dvakrat dnevno razpolovna doba kanabidiola v plazmi 56-61 ur.
English: The major CYP450 isoforms responsible for the phase I metabolism of cannabidiol are CYP2C19 and CYP3A4.
Slovenian: Glavni izoobliki CYP450, odgovorni za presnavljanje (faza I) kanabidiola, sta CYP2C19 in CYP3A4.
English: - 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)
Slovenian: - 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).
English: The embryo-foetal development (EFD) study performed in rabbits evaluated doses of 50, 80, or 125 mg/kg/day.
Slovenian: Študija embrio-fetalnega razvoja (EFD - embryo-foetal development), izvedena pri kuncih, je ocenjevala odmerke 50, 80 ali 125 mg/kg/dan.
English: 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).
Slovenian: Pri posameznih bolnikih se lahko na podlagi koristi in tveganja pretehta titracija do največjega odmerka 20 mg/kg/dan (glejte poglavje 4.2).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Reversibility was not assessed in studies in LGS and DS.
Slovenian: V študijah pri bolnikih z LGS in DS reverzibilnost ni bila ocenjena.
English: 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.
Slovenian: 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;
English: Approximately 50% of the patients were taking concomitant clobazam.
Slovenian: Približno 50 % bolnikov se je sočasno zdravilo s klobazamom.
English: The frequency in patients receiving 10 mg/kg/day cannabidiol and taking clobazam was 36%.
Slovenian: Pogostnost pri bolnikih, ki so prejemali 10 mg/kg/dan kanabidiola in jemali klobazam, je bila 36 %.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: UGT inhibitors
Slovenian: Zaviralci UGT