FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Fenitoin ima uski terapijski indeks, pa bi kombiniranje kanabidiola s fenitoinom trebalo započeti s oprezom te, u slučaju pojave problema s podnošljivošću, razmotriti smanjenje doze fenitoina.
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).
Croatian: S obzirom da nije bilo dosljednog odgovora na doze između 10 mg/kg/dan i 20 mg/kg/dan u ispitivanjima sa stanjima LGS i DS, kanabidiol na početku treba titrirati na preporučenu dozu održavanja od 10 mg/kg/dan (vidjeti dio 4.2).
English: Therefore, dose adjustments of cannabidiol or clobazam may be required.
Croatian: Stoga može biti potrebna prilagodba doze kanabidiola ili klobazama.
English: Steady-state plasma concentrations are attained within 2-4 days of twice daily dosing based on pre-dose (Ctrough) concentrations.
Croatian: Koncentracije u plazmi u stanju dinamičke ravnoteže su dostignute unutar 2-4 dana uz doziranje od dva puta dnevno, na temelju koncentracije (Ctrough) prije doziranja.
English: Animal abuse-related studies show that cannabidiol does not produce cannabinoid-like behavioural responses, including generalisation to delta-9-tetrahydrocannabinol (THC) in a drug discrimination study.
Croatian: Ispitivanja povezana sa zloporabom kod životinja pokazuju kako kanabidiol ne uzrokuje reakcije u ponašanju karakteristične za kanabinoide, uključujući generaliziranje na delta-9-tetrahidrokanabinolu (THC) u ispitivanju s diskriminacijom lijekova.
English: Cannabidiol does not require dose adjustment in patients with mild hepatic impairment (Child-Pugh A).
Croatian: Kanabidiol ne zahtijeva prilagodbe doze u bolesnika s blagim oštećenjem funkcije jetre (Child-Pugh A).
English: Patients should be monitored for signs of suicidal behaviour and ideation and appropriate treatment should be considered.
Croatian: Kod bolesnika treba pratiti znakove suicidalnog ponašanja i suicidalnih primisli, te razmisliti o odgovarajućem liječenju.
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.
Croatian: Nemojte voziti, upravljati strojevima ili sudjelovati u aktivnostima koje od Vas zahtijevaju budnost i finu kontrolu, poput vožnje bicikla, dok ne budete znali kako Epidyolex djeluje na Vas. - naglo prestanete uzimati Epidyolex.
English: The calculated dose should be rounded to the nearest graduated increment.
Croatian: Izračunatu dozu treba zaokružiti na najbližu oznaku na štrcaljki.
English: The occurrence was higher for those patients on concomitant clobazam (see sections 4.5 and 4.8).
Croatian: Incidencija je bila veća u bolesnika koji su istovremeno liječeni klobazamom (vidjeti dijelove 4.5 i 4.8).
English: Clobazam (separate analysis) was a significant covariate which caused the probability of GGT to increase, loss of appetite to decrease, and somnolence to increase.
Croatian: Klobazam (odvojena analiza) predstavljao je značajnu kovarijatu koja je uzrokovala mogućnost povećanja GGT-a, smanjenje gubitka teka i povećanje somnolencije.
English: Given that cannabidiol is highly protein bound and will likely pass freely from plasma into milk, as a precaution, breast-feeding should be discontinued during treatment.
Croatian: Uzevši u obzir da se kanabidiol snažno veže na bjelančevine, vjerojatno će lako prelaziti iz plazme u mlijeko, pa tijekom liječenja kao mjeru opreza treba prekinuti dojenje.
English: Studies in animals have shown toxicological changes in lactating animals, when the mother was treated with cannabidiol (see section 5.3).
Croatian: Ispitivanja na životinjama su pokazala toksikološke promjene u životinja u laktaciji, dok je majka liječena kanabidiolom (vidjeti dio 5.3).
English: Cannabidiol can cause elevations in serum creatinine.
Croatian: Kanabidiol može uzrokovati povišenje serumskog kreatinina.
English: Dose reduction of cannabidiol and/or the inhibitor may be necessary when given in combination.
Croatian: Može biti potrebno smanjenje doze kanabidiola i/ili inhibitora ako se primjenjuju zajedno.
English: Epidyolex contains cannabidiol, a medicine which can be used to treat epilepsy, a condition where someone has seizures or fits.
Croatian: Epidyolex sadrži kanabidiol, lijek koji se može primjenjivati za liječenje epilepsije, stanja u kojem osoba ima napadaje.
English: The alcohol content should be taken into account in pregnant women, children and high-risk groups such as patients with liver disease.
Croatian: Udio alkohola treba uzeti u obzir kod trudnica, djece i skupina visokog rizika, poput bolesnika s bolesti jetre.
English: Epidyolex is an oral solution (a liquid to be swallowed).
Croatian: Epidyolex je oralna otopina (tekućina koju treba progutati).
English: Cannabidiol can cause somnolence and sedation, which occur more commonly early in treatment and may diminish with continued treatment.
Croatian: Kanabidiol može uzrokovati somnolenciju i sedaciju, što se češće događa na početku liječenja i može nestati s njegovim nastavkom.
English: Food may increase cannabidiol levels and therefore it should be taken consistently either with or without food, including the ketogenic diet (see section 5.2).
Croatian: Hrana može povisiti razinu kanabidiola, pa se lijek treba uzimati dosljedno sa ili bez hrane, uključujući ketogenu prehranu (vidjeti dio 5.2).
English: Inhibition of P-gp mediated efflux by cannabidiol in the intestine cannot be ruled out.
Croatian: Inhibicija kanabidiolom izbacivanja posredovanog P-glikoproteinom u crijevima ne može se isključiti.
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.
Croatian: Izloženosti kanabidiolu u plazmi majke pri razini bez uočenih štetnih učinaka (engl. no observed adverse effect level, NOAEL) za embriofetalnu razvojnu toksičnost u zečeva bila je manja od one u ljudi pri 20 mg/kg/dan.
English: The half-life of cannabidiol in plasma was 56-61 hours after twice daily dosing for 7 days in healthy volunteers.
Croatian: U zdravih dobrovoljaca, poluvijek kanabidiola u plazmi je bio 56-61 sati nakon doziranja dvaput dnevno tijekom 7 dana.
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).
Croatian: Svako povećanje doze iznad 10 mg/kg/dan, do maksimalne preporučene doze od 20 mg/kg/dan, trebalo bi se uvesti uzimajući u obzir individualne koristi i rizike i u skladu s punim rasporedom praćenja (vidjeti dio 4.4).
English: In clinical trials, the majority of ALT elevations occurred in patients taking concomitant valproate.
Croatian: U kliničkim se ispitivanjima većina povećanja ALT-a pojavila kod bolesnika koji su istovremeno uzimali valproat.
English: Cannabidiol reduces neuronal hyper-excitability through modulation of intracellular calcium via G protein-coupled receptor 55 (GPR55) and transient receptor potential vanilloid 1 (TRPV-1) channels, as well as modulation of adenosine-mediated signalling through inhibition of adenosine cellular uptake via the equilibrative nucleoside transporter 1 (ENT-1).
Croatian: Kanabidiol smanjuje pretjeranu podražljivost neurona putem modulacije unutarstaničnog kalcija preko receptora 55 vezanog na G-protein (GPR55) i kanala vaniloidnog receptora 1 (TRPV1), kao i modulacije signalizacije adenozinom kroz inhibiciju staničnog preuzimanja adenozina putem ekvilibrativnog nukleozidnog prijenosnog proteina 1 (ENT1).
English: In addition, there was an increased exposure to 7-hydroxy-cannabidiol (7-OH-CBD; an active metabolite of cannabidiol), for which plasma area under the curve (AUC) increased by 47% (see section 5.2).
Croatian: Osim toga, pojavila se i povećana izloženost 7-hidroksi-kanabidiolu (7-OH-CBD; aktivni metabolit kanabidiola), za koju se područje ispod krivulje (AUC) povećalo za 47% (vidjeti dio 5.2).
English: Cannabidiol does not interact with the major renal and hepatic transporters in a way that is likely to result in relevant drug-drug interactions.
Croatian: Kanabidiol nema interakcija s glavnim bubrežnim i jetrenim prijenosnicima na način koji bi vjerojatno doveo do relevantnih interakcija među lijekovima.
English: Potential for cannabidiol to affect other medicinal products
Croatian: Mogućnost utjecaja kanabidiola na druge lijekove:
English: Valproate
Croatian: Valproat
English: Results of the subgroup analysis of patients treated with clobazam compared to patients treated without clobazam, indicated that there is residual statistical uncertainty regarding the treatment effect of cannabidiol in patients not taking clobazam.
Croatian: Rezultati analiza podskupina bolesnika liječenih klobazamom u usporedbi s bolesnicima liječenim bez klobazama pokazali su da postoji preostala statistička nesigurnost u vezi s učinkom liječenja kanabidiolom u bolesnika koji ne uzimaju klobazam.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BOČICA
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.
Croatian: Ovaj lijek sadrži 10% volumena etanola (alkohola), tj. do 700 mg po dozi (za odraslu osobu tjelesne težine 70 kg), što odgovara 14 mililitara (ml) piva ili 6 ml vina po dozi.
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.
Croatian: Snažni induktori CYP3A4, poput karbamazepina, enzalutamida, mitotana, gospine trave, i/ili snažni induktori CYP2C19, poput rifampina, koji se uzimaju zajedno s kanabidiolom, mogu uzrokovati smanjenje plazmatske koncentracije kanabidiola i smanjenje učinkovitosti kanabidiola.
English: 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.
Croatian: Istovremena primjena kanabidiola s obrocima bogatima masnoćom/kalorijama je povećala brzinu i intenzitet apsorpcije (5-struko povećanje Cmax i 4-struko povećanje AUC-a) i smanjila ukupnu varijabilnost izloženosti u usporedbi sa stanjem gladovanja u zdravih dobrovoljaca.
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.
Croatian: Potencijalne interakcije s drugim istovremeno primijenjenim antiepilepticima procijenjene su na zdravim dobrovoljcima i bolesnicima s epilepsijom koji su uzimali klobazam, valproat i stiripentol.
English: Missed doses
Croatian: Preskočene doze
English: Interaction resulting in an approximate 28% increase in Cmax and 55% increase in AUC.
Croatian: Interakcija koja dovodi do povećanja Cmax od 28% i AUC-a od 55%.
English: There is no experience in patients with end-stage renal disease.
Croatian: Nema iskustava u bolesnika u završnoj fazi bolesti bubrega.
English: Remove the plunger from the barrel of the syringe, and rinse both parts under tap water.
Croatian: Izvadite klip iz cilindra štrcaljke, te isperite oba dijela tekućom vodom iz slavine.
English: If clinically significant increases of transaminases occur, cannabidiol and/or concomitant valproate should be reduced or discontinued in all patients until a recovery of transaminase elevations are observed (see section 4.4).
Croatian: Ako dođe do klinički značajnog porasta transaminaza, kanabidiol i/ili valproat koji se uzima istovremeno treba smanjiti ili prekinuti kod svih bolesnika dok se ne primijeti normalizacija povišenih transaminaza (vidjeti dio 4.4).
English: - feeling drowsy or sleepy - decreased appetite - diarrhoea - fever - feeling tired - vomiting
Croatian: - osjećaj mamurluka ili pospanosti - smanjeni apetit - proljev - groznica - osjećaj umora - povraćanje
English: In patients, there is a potential additive anticonvulsant effect from the bi-directional pharmacokinetic interaction between cannabidiol and clobazam, which leads to increases in circulating levels of their respective active metabolites, 7-OH-CBD (approximately 1.5-fold) and N-CLB (approximately 3-fold) (see sections 4.5, 5.1 and 5.2).
Croatian: U bolesnika postoji potencijalno aditivan antikonvulzivni učinak koji potječe iz dvosmjerne farmakokinetičke interakcije između kanabidiola i klobazama, što vodi do povećanja razina njihovih pripadajućih aktivnih metabolita u cirkulaciji. 7-OH-CBD (oko 1,5-struko) i N-CLB (oko 3-struko) (vidjeti dijelove 4.5, 5.1 i 5.2).
English: Management of overdose
Croatian: Upravljanje predoziranjem
English: Table 2: Tabulated list of adverse reactions
Croatian: Tablica 2: Tablični popis nuspojava
English: Interaction resulting in approximately 3-fold increase in N-desmethylclobazam metabolite exposure.
Croatian: Interakcija koja dovodi do približno 3-strukog porasta izloženosti metabolitu
English: 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).
Croatian: Nije primijećen učinak na reproduktivnu sposobnost mužjaka ili ženki štakora pri oralnoj dozi kanabidiola do 150 mg/kg/dan (vidjeti dio 5.3).
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.
Croatian: Ispitivanja na zdravim ispitanicima su pokazala kako nema većih razlika u izloženosti kanabidiolu u plazmi u CYP2C19 srednje brzom i ultra brzom metabolizatoru u usporedbi s brzim metabolizatorima.
English: Each ml of Epidyolex contains 79 mg of ethanol.
Croatian: Jedan ml Epidyolexa sadrži 79 mg etanola.
English: Insufficient data are available to assess the risk of concomitant administration of other hepatotoxic medicinal products and cannabidiol (see section 4.4).
Croatian: Dostupni podaci su nedovoljni za procjenu rizika od istovremene primjene drugih hepatotoksičnih lijekova i kanabidiola (vidjeti dio 4.4).
English: Patients with transaminase elevations greater than 3 times the upper limit of normal (ULN) and bilirubin greater than 2 times the ULN (see section 4.4).
Croatian: Bolesnici s povišenjem transaminaza većim od 3 puta gornje granice normalnih vrijednosti (GGN) i bilirubinom višim od 2 puta GGN (vidjeti dio 4.4).
English: Suicidal behaviour and ideation have been reported in patients treated with AEDs in several indications.
Croatian: Suicidalno ponašanje i suicidalne primisli su prijavljeni u bolesnika liječenih antiepilepticima u nekoliko indikacija.
English: - lack of energy - cold, sore throat - respiratory tract infections (pneumonia, bronchitis) - blood tests showing increases in levels of certain liver enzymes (which may be signs of liver damage) - shaking of the body or parts of it - feeling bad-tempered (irritable, aggressive) - difficulty in sleeping - cough - rash - increased appetite, weight loss - drooling - urinary tract infection - agitation - abnormal behaviour
Croatian: - nedostatak energije - prehlada, bolno grlo - infekcije dišnog sustava (upala pluća, bronhitis) - krvne pretrage koje pokazuju povišenje razina određenih jetrenih enzima (što može biti znak oštećenja jetre) - drhtanje tijela ili dijelova tijela - loše raspoloženje (razdražljivost, agresivnost) - poteškoće spavanja - kašalj - osip - povećan tek, gubitak težine - slinjenje - infekcija mokraćnog sustava - uznemirenost - neuobičajeno ponašanje
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.
Croatian: In vitro podaci su pokazali kako kanabidiol inhibira CYP2C19, što može uzrokovati povišene plazmatske koncentracije lijekova koje ovaj izoenzim metabolizira, poput klobazama i omeprazola.
English: The elevations resolved after discontinuation of cannabidiol.
Croatian: Povećanja su nestala nakon prekida uzimanja kanabidiola.
English: These adverse reactions resolved upon study completion.
Croatian: Ove su nuspojave nestale do završetka ispitivanja.
English: The combination of cannabidiol with clobazam caused an elevation in exposure to the active metabolite N-desmethylclobazam.
Croatian: Kombinacija kanabidiola i klobazama uzrokovala je povišenje izloženosti aktivnom metabolitu N-desmetilklobazamu.
English: No effect on cannabidiol levels.
Croatian: Nema utjecaja na razine kanabidiola.
English: The major CYP450 isoforms responsible for the phase I metabolism of cannabidiol are CYP2C19 and CYP3A4.
Croatian: Glavne izoforme CYP450 odgovorne za metabolizam kanabidiola faze I su CYP2C19 i CYP3A4.
English: 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
Croatian: Općenito, dozu u starijih bolesnika treba birati oprezno, obično s početkom na najnižem kraju raspona doza, pazeći na veću učestalost smanjenja jetrene, bubrežne ili srčane funkcije i pratećih bolesti ili druge istovremene terapije (vidjeti dio 4.4 pod „Hepatocelularna ozljeda“ i dio 5.2).
English: Cannabidiol causes dose-related elevations of liver transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) (see section 4.8).
Croatian: Kanabidiol uzrokuje povišenje jetrenih transaminaza povezano s doziranjem (alanin aminotransferaza [ALT] i/ili aspartat aminotransferaza [AST]) (vidjeti dio 4.8).
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.
Croatian: Čvrsto uvijte zatvarač siguran za djecu natrag na bočicu okretanjem zatvarača u smjeru kretanja kazaljki na satu - ne morate skidati adapter bočice, jer će zatvarač ići preko njega.
English: If you or your patient take more Epidyolex than you should If you may have taken more Epidyolex than you should, tell a doctor or pharmacist immediately, or contact your nearest hospital casualty department, and take the medicine with you.
Croatian: Ako ste uzeli više Epidyolexa nego što biste trebali, odmah recite liječniku ili ljekarniku ili se obratite najbližem odjelu za hitnu pomoć, te ponesite sa sobom lijek.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot
Croatian: 13. BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA Serija
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.
Croatian: Iako primjena klobazama nije značajno utjecala na izloženost kanabidiolu, razine aktivnog metabolita, 7-OH-CBD, su porasle u ovoj kombinaciji.
English: Other medicines and Epidyolex
Croatian: Drugi lijekovi i Epidyolex
English: Cannabidiol and the metabolite 7-OH-CBD do not interact with the major renal or hepatic uptake transporters and therefore are unlikely to result in relevant drug-drug interactions: OAT1, OAT3, OCT1, OCT2, MATE1, MATE2-K, OATP1B1and OATP1B3.
Croatian: Kanabidiol i metabolit 7-OH-CBD nemaju interakcija s glavnim prijenosnicima unosa u bubrege i jetru, pa stoga nije vjerojatno da će doći do relevantne interakcije među lijekovima: OAT1, OAT3, OCT1, OCT2, MATE1, MATE2K, OATP1B1 i OATP1B3.
English: What you or the patient need to know before taking Epidyolex.
Croatian: Što Vi ili bolesnik morate znati prije nego počnete uzimati Epidyolex.
English: Cannabidiol can be administered to patients with mild, moderate, or severe renal impairment without dose adjustment (see section 5.2).
Croatian: Kanabidiol se može primjenjivati u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega bez prilagođavanja doze (vidjeti dio 5.2).
English: Prior to starting treatment with cannabidiol, obtain serum transaminases (ALT and AST) and total bilirubin levels.
Croatian: Prije početka liječenja kanabidiolom provjerite razine serumskih transaminaza (ALT i AST) i ukupnog bilirubina.
English: Concomitant use of cannabidiol and clobazam increases the incidence of somnolence and sedation compared with placebo (see sections 4.4 and 4.8).
Croatian: Istovremena primjena kanabidiola i klobazama povećava incidenciju somnolencije i sedacije u usporedbi s placebom (vidjeti dijelove 4.4 i 4.8).
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).
Croatian: Ispitanici s umjerenim ili teškim oštećenjem funkcije jetre su imali veće koncentracije kanabidiola u plazmi (oko 2,5-5,2-struko viši AUC u usporedbi sa zdravim ispitanicima s normalnom jetrenom funkcijom).
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.
Croatian: Nakon više doza kanabidiola, metabolit 7-OH-CBD (aktivan u pretkliničkom modelu napadaja) cirkulira u ljudskoj plazmi u nižim koncentracijama nego ishodišni lijek kanabidiol (~ 40% izloženosti CBD-u) na temelju AUC-a.
English: 79 mg anhydrous ethanol
Croatian: 79 mg bezvodnog etanola
English: Mean age of the study population was 9 years and 94% were taking 2 or more cAEDs during the trial.
Croatian: Srednja vrijednost dobi populacije u ispitivanju je bila 9 godina, a 94% ispitanika je tijekom ispitivanja uzimalo 2 ili više istovremenih antiepileptika.
English: 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.
Croatian: Prijavljen je blaži do umjeren proljev i somnolencija kod odraslih zdravih ispitanika koji su uzeli jednu dozu od 6000 mg; to odgovara dozi od preko 85 mg/kg za odraslu osobu tjelesne težine 70 kg.
English: Although no formal drug-drug interaction studies have been performed for other AEDs, phenytoin and lamotrigine are addressed based on in vitro data.
Croatian: Iako nisu provedena formalna ispitivanja interakcija s drugim antiepilepticima, fenitoin i lamotrigin opisani su na temelju podataka dobivenih in vitro.
English: 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).
Croatian: U bolesnika koji imaju LGS, populacijsko farmakokinetičko/farmakodinamičko (PK/PD) modeliranje ukazalo je na postojanje odnosa djelotvornosti i izloženosti za vjerojatnost postizanja ≥ 50% smanjenja učestalosti astatskih napadaja unutar testiranog raspona doza kanabidiola (0 [placebo], 10 i 20 mg/kg/dan).