natgillin/translations-raw huggingface dataset:
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.
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.
Cannabidiol is not a substrate for or an inhibitor of the brain uptake transporters OATP1A2 and OATP2B1.
Kanabidiol ni substrat ali zaviralec možganskih privzemnih prenašalcev OATP1A2 in OATP2B1.
CYP3A4 or CYP2C19 inducers
Induktorji CYP3A4 ali CYP2C19
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.
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.
Steady-state plasma concentrations are attained within 2-4 days of twice daily dosing based on pre-dose (Ctrough) concentrations.
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).
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.
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.
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.
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.
In some cases, the decreased weight was reported as an adverse event (see the table above).
Pri nekaterih bolnikih so o zmanjšanju telesne mase poročali kot o neželenem učinku (glejte zgornjo preglednico).
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.
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.
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).
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).
Epidyolex with food
Zdravilo Epidyolex skupaj s hrano
What Epidyolex contains - The active substance is cannabidiol.
Kaj vsebuje zdravilo Epidyolex - Učinkovina je kanabidiol.
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).
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).
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.
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.
Dose reduction should be considered for concomitant medicinal products that are sensitive CYP2C19 substrates or that have a narrow therapeutic index.
Pri sočasno uporabljenih zdravilih, ki so občutljivi substrati za CYP2C19 ali ki imajo ozek terapevtski indeks, je treba razmisliti o zmanjšanju odmerka.
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.
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.
Lamotrigine is a substrate for UGT enzymes including UGT2B7 which is inhibited by cannabidiol in vitro.
Lamotrigin je substrat za encime UGT, vključno z UGT2B7, ki ga in vitro zavira kanabidiol.
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.
Čeprav uporaba klobazama ni opazno vplivala na izpostavljenost kanabidiolu, so bile pri tej kombinaciji koncentracije aktivnega presnovka 7-OH-CBD povečane.
Table 2: Tabulated list of adverse reactions
Preglednica 2: Tabelarni seznam neželenih učinkov Organski sistem
Resolution of transaminase elevations occurred with discontinuation of cannabidiol or reduction of cannabidiol and/or concomitant valproate in about two-thirds of the cases.
Zvišanje transaminaz je po prekinitvi zdravljenja s kanabidiolom ali zmanjšanju odmerka kanabidiola in/ali sočasno uporabljenega valproata izginilo pri približno dveh tretjinah bolnikov.
Overall
Celokupno
Co-administration of cannabidiol is also predicted to cause clinically significant interactions with CYP2C8 (repaglinide) and CYP2C9 (e.g., warfarin) substrates.
Za sočasno dajanjekanabidiola se predvidevajo tudi klinično pomembne interakcije s substrati CYP2C8 (repaglinid) in CYP2C9 (npr. varfarin).
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).
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.