natgillin/translations-raw huggingface dataset:
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.
Za bolesnike s identificiranim povišenjem početne razine ALT-a ili AST-a i bolesnike koji uzimaju valproat bi trebalo dobiti razine serumskih transaminaza i ukupnog bilirubina 2 tjedna, 1 mjesec, 2 mjeseca, 3 mjeseca i 6 mjeseci nakon početka liječenja kanabidiolom, te kasnije povremeno ili prema kliničkoj indikaciji.
The dose titration should be performed as detailed in the table below.
Titraciju doze treba obaviti u skladu s podacima u tablici u nastavku.
Phenytoin
Fenitoin
Interaction resulting in a decrease (approximately 30%) in Cmax and AUC of the active metabolite 7-OH-CBD in HV* trials.
Interakcija koja dovodi do pada (oko 30%) Cmax i AUC aktivnog metabolita 7-OH-CBD u ispitivanjima na zdravim dobrovoljcima.
Cannabidiol induces CYP1A2 and CYP2B6 mRNA expression at clinically relevant concentrations.
Kanabidiol inducira ekspresiju CYP1A2 i CYP2B6 mRNA u klinički značajnim koncentracijama.
Insert the tip of the correct oral syringe fully into the bottle adaptor, and with the oral syringe in place, turn the bottle upside down.
Umetnite vrh štrcaljke za usta do kraja u adapter, pa kad štrcaljka za usta bude na svom mjestu, okrenite bočicu naopako.
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.
Pet posto (5%) bolesnika (svi na valproatu) koji su uzimali kanabidiol u dozi od 10 mg/kg/dan je imalo povišenje razine ALT-a veće od 3 puta GGN kad je ALT bio iznad vrijednosti GGN na početku, u odnosu na 3% bolesnika (svi na valproatu) kad je ALT bio unutar normalnih granica na početku.
Cannabidiol should be used with caution in patients with moderate or severe hepatic impairment.
Kanabidiol treba primjenjivati s oprezom u bolesnika s umjerenim ili teškim oštećenjem funkcije jetre.
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.
Trebali biste, koliko god je to moguće, uzimati Epidyolex dosljedno s hranom ili bez nje, i u skladu sa svojom dnevnom rutinom, kako biste uvijek imali isti učinak.
GWPCARE3 Placebo 10 mg/kg/day 20 mg/kg/day GWPCARE4 Placebo 20 mg/kg/day Difference or Percent Reduction Compared with Placebo (95% CI), p-valueb
GWPCARE3 Placebo 10 mg/kg/dan 20 mg/kg/dan GWPCARE4 Placebo 20 mg/kg/dan Razlika ili postotno smanjenje u usporedbi s placebom (95% CI), p-vrijednostb
Cannabidiol and 7-OH-CBD are not substrates for or inhibitors of efflux transports P-gp/MDR1, BCRP or BSEP at clinically relevant plasma concentrations.
Kanabidiol i 7-OH-CBD nisu supstrati niti inhibitori prijenosnika izbacivanja P-glikoproteina/MDR1, BCRP ili BSEP pri klinički značajnim koncentracijama u plazmi.
Because of potential for both induction and inhibition of enzyme activity, dose adjustment of substrates of CYP1A2 and CYP2B6 should be considered, as clinically appropriate.
Zbog postojanja mogućnosti indukcije i inhibicije aktivnosti enzima treba razmotriti i prilagođavanje doze supstrata CYP1A2 i CYP2B6 prema kliničkoj situaciji.
The interactions are summarised in the table below.
Interakcije su sažete u tablici u nastavku.
Lamotrigine is a substrate for UGT enzymes including UGT2B7 which is inhibited by cannabidiol in vitro.
Lamotrigin je supstrat enzima UGT, uključujući UGT2B7, kojeg kanabidiol inhibira in vitro.
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.
Primarna mjera ishoda bila je promjena učestalosti konvulzivnih napadaja tijekom razdoblja liječenja (Dan 1 do kraja razdoblja koje se može procijeniti) u usporedbi s početkom (GWPCARE2), te postotna promjena konvulzivnih napadaja od početka na 28 dana tijekom razdoblja liječenja (GWPCARE1) za skupine liječene kanabidiolom u usporedbi s placebom.
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.
Izloženost fenitoinu može se povećati kad se primjenjuje zajedno s kanabidiolom jer se fenitoin značajno metabolizira putem CYP2C9, kojeg kanabidiol inhibira in vitro.
The NOAEL was associated with maternal plasma cannabidiol exposures approximately 9 times that in humans at 20 mg/kg/day.
NOAEL je povezan s izloženostima kanabidiolu u plazmi majke oko 9 puta većima od one u ljudi pri 20 mg/kg/dan.
The embryo-foetal development (EFD) study performed in rabbits evaluated doses of 50, 80, or 125 mg/kg/day.
Ispitivanje embriofetalnog razvoja provedeno na zečevima procjenjivalo je doze od 50, 80 ili 125 mg/kg/dan.
It comes in a bottle which has a child-resistant cap, together with two identical 5 ml or 1 ml oral dosing syringes and two bottle adaptors for using these syringes.
Dolazi u bočici koja ima zatvarač siguran za djecu, zajedno s dvjema jednakim dozirnim štrcaljkama za usta od 5 ml ili 1 ml i dvama adapterima koji se upotrebljavaju s ovim štrcaljkama.
Paediatric patients Pharmacokinetics of cannabidiol has not been studied in paediatric patients < 2 years of age.
Pedijatrijski bolesnici Farmakokinetika kanabidiola nije proučavana u pedijatrijskih bolesnika mlađih od 2 godine.
A lower starting dose is recommended in patients with moderate or severe hepatic impairment.
Niža početna doza se preporuča bolesnicima s umjerenim ili teškim oštećenjem funkcije jetre.
In LGS and DS patients, the mean decrease in haemoglobin from baseline to end of treatment was −0.37 g/dL in cannabidiol-treated patients.
U bolesnika koji imaju LGS i DS, srednja vrijednost smanjenja hemoglobina od početka do završetka liječenja je bila −0,37 g/dl u bolesnika koji su uzimali kanabidiol.
If you forget to take a dose, do not take a double dose to make up for a forgotten dose.
Ako ste Vi ili bolesnik zaboravili uzeti Epidyolex Ako ste zaboravili uzeti dozu, nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
The recommended starting dose of cannabidiol is 2.5 mg/kg taken twice daily (5 mg/kg/day) for one week.
Preporučena početna doza kanabidiola je 2,5 mg/kg dvaput dnevno (5 mg/kg/dan) tijekom jednog tjedna.
The primary endpoint was the percentage change from baseline in drop seizures per 28 days over the treatment period for the cannabidiol group compared to placebo.
Primarna mjera ishoda je bila postotna promjena u odnosu na početnu vrijednost astatskih napadaja u 28 dana tijekom razdoblja liječenja za skupinu na kanabidiolu u odnosu na placebo.
Adjunctive therapy in patients with Lennox-Gastaut syndrome (LGS) The efficacy of cannabidiol for the adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) was evaluated in two randomised, double-blind, placebo-controlled, parallel-group studies (GWPCARE3 and GWPCARE4).
Dodatna terapija u bolesnika sa Lennox-Gastautovim sindromom (LGS) Učinkovitost kanabidiola za dodatnu terapiju napadaja povezanih sa Lennox-Gastautovim sindromom (LGS) je procijenjena u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja s paralelnim skupinama (GWPCARE3 i GWPCARE4).
d The Overall p-value is based on a Cochran-Mantel-Haenszel test; the nominal p-value for the with clobazam subgroup is based on logistic regression analysis.
d Ukupna p-vrijednost temelji se na testu Cochran-Mantel-Haenszel; nominalna p-vrijednost za podskupine s klobazamom temelji se na analizi logističke regresije.
In vivo assessment of drug interactions
In vivo procjena interakcija lijekova
Approximately 50% of the patients were taking concomitant clobazam.
Oko 50% bolesnika istovremeno je uzimalo klobazam.
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).
Nisu uočene nuspojave vezane uz plodnost muških ili ženskih štakora, kao ni na reproduktivnu sposobnost pri dozama do 250 mg/kg/dan (oko 60 puta više nego u ljudi pri maksimalnoj preporučenoj dozi za ljude (engl. maximum recommended human dose, MRHD) od 20 mg/kg/dan).
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.
U kontroliranim ispitivanjima (vidjeti dio 5.1) u bolesnika koji uzimaju kanabidiol u dozi od 20 mg/kg/dan, učestalost povišenja ALT-a povezanih s liječenjem većih od 3 puta GGN bila je 31% (84% njih je bilo na valproatu) kad je ALT bio iznad gornje granice normalnih vrijednosti (GGN) na početku, u odnosu na 12% (89% njih je bilo na valproatu) kad je ALT bio unutar normalnih granica na početku.
Placebo 10 mg/kg/day 20 mg/kg/day
Placebo 10 mg/kg/dan 20 mg/kg/dan
d The Overall p-value is based on a Cochran-Mantel-Haenszel test; the nominal p-values for the with clobazam subgroup are based on logistic regression analysis.
d Ukupna p-vrijednost se temelji se na testu Cochran-Mantel-Haenszel; nominalne p-vrijednosti za podskupine s klobazamom temelje se na analizi logističke regresije.
No effects on cannabidiol or metabolite exposures were observed following administration of a single dose of cannabidiol 200 mg in subjects with mild hepatic impairment.
Nisu uočeni učinci na izloženost kanabidiolu ili metabolitima nakon primjene jedne doze kanabidiola od 200 mg u ispitanika s blagim oštećenjem funkcije jetre.
Signs of taking more Epidyolex than you should include diarrhoea and sleepiness.
Znakovi predoziranja Epidyolexom uključuju proljev i pospanost.
The frequency in patients receiving 10 mg/kg/day cannabidiol and taking clobazam was 36%.
Učestalost u bolesnika koji su primali 10 mg/kg/dan kanabidiola i uzimali klobazam bila je 36%.
Frequency Adverse reactions from clinical trials
Nuspojave iz kliničkih ispitivanja
Concomitant use of cannabidiol and valproate increases the incidence of transaminase enzyme elevations (see section 4.4).
Istovremena primjena kanabidiola i valproata povećava incidenciju povišenja enzima transaminaza (vidjeti dio 4.4).
The frequency in patients receiving 20 mg/kg/day cannabidiol and taking clobazam was 41%.
Učestalost u bolesnika koji su primali 20 mg/kg/dan kanabidiola i uzimali klobazam bila je 41%.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 100 mg cannabidiol.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml oralne otopine sadrži 100 mg kanabidiola.
The European Medicines Agency has deferred the obligation to submit the results of studies with cannabidiol in one or more subsets of the paediatric population in treatment of seizures associated with DS and LGS.
Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja s kanabidiolom na jednoj ili više podskupina pedijatrijske populacije u liječenju napadaja povezanih sa stanjima DS i LGS (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Epidyolex contains sesame oil, alcohol (ethanol), strawberry flavour components (including benzyl alcohol).
Epidyolex sadrži sezamovo ulje, alkohol (etanol), komponente za okus jagode (uključujući benzilni alkohol).
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).
Dodatna terapija u bolesnika sa Dravetovim sindromom Djelotvornost kanabidiola za dodatnu terapiju napadaja povezanih sa Dravetovim sindromom (DS) je procijenjena u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja s paralelnim skupinama (GWPCARE2 i GWPCARE1).
The most commonly used cAEDs (> 25% of patients) in both trials were valproate, clobazam, stiripentol, and levetiracetam.
Najčešće istovremeno primjenjivani antiepileptici (> 25% bolesnika) u oba ispitivanja su bili valproat, klobazam, stiripentol i levetiracetam.
Cannabidiol should be discontinued in any patients with elevations of transaminase levels greater than 3 times the ULN and bilirubin levels greater than 2 times the ULN.
Primjenu kanabidiola bi trebalo prekinuti kod bolesnika s povišenjem razina transaminaza većim od 3 puta GGN i razinom bilirubina većom od 2 puta GGN.
Patients with baseline transaminase levels above the ULN had higher rates of transaminase elevations when taking cannabidiol.
Bolesnici čije su početne vrijednosti razine transaminaza bile iznad GGN imali su više stope povišenja razina transaminaza dok su uzimali kanabidiol.
cannabidiol and/or concomitant AED treatment should therefore be adjusted during regular medical supervision and the patient should be closely monitored for adverse drug reactions.
Zato se za vrijeme redovitog medicinskog nadzora mora prilagoditi doza kanabidiola i/ili istovremeno korištenog antiepileptika, a bolesnici se moraju pomno pratiti zbog nuspojava lijeka.
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.
Bolesnike čije su početne vrijednosti razine transaminaza bile više od 3 puta GGN ili sa povišenjem bilirubina višim od 2 puta GGN treba procijeniti prije početka liječenja kanabidiolom.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GW Pharma (International) B.V., Databankweg 26, 3821AL Amersfoort, The Netherlands
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GW Pharma (International) B.V., Databankweg 26, 3821AL Amersfoort, Nizozemska
Concomitant use of cannabidiol and valproate increases the incidence of diarrhoea and events of decreased appetite.
Istovremena primjena kanabidiola i valproata povećava incidenciju proljeva i smanjenog teka.
Resolution of transaminase elevations occurred with discontinuation of cannabidiol or reduction of cannabidiol and/or concomitant valproate in about two-thirds of the cases.
S prekidom uzimanja kanabidiola ili smanjenjem doze kanabidiola i/ili istovremenog valproata riješen je problem povišenih transaminaza u otprilike dvije trećine slučajeva.
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).
Metabolit 7-karboksikanabidiol (7-COOH-CBD) je inhibitor aktivnosti posredovane putem UGT1A1, UGT1A4 i UGT1A6, in vitro u klinički značajnim koncentracijama (vidjeti i dio 4.5).
Mean age of the study population was 15 years and 94% were taking 2 or more concomitant AEDs (cAEDs) during the trial.
Srednja vrijednost dobi populacije u ispitivanju je bila 15 godina, a 94% ispitanika je tijekom ispitivanja uzimalo 2 ili više istovremenih antiepileptika.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Nuspojave su unutar pojedinih skupina učestalosti navedene u padajućem nizu prema ozbiljnosti.
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).
Bočica je zapakirana u kartonsku ambalažu u kojoj se nalaze dvije dozirne štrcaljke za usta kalibrirane na 5 ml i dvije dozirne štrcaljke za usta kalibrirane na 1 ml (klip štrcaljke od polietilena visoke gustoće (HDPE) i cilindar štrcaljke od polipropilena), te dva adaptera za bočicu (LDPE).
• Epidyolex oral solution bottle
• Bočica Epidyolex oralne otopine
Place the tip of the oral syringe inside the cheek, and gently push the plunger to release the medicine.
Postavite vrh štrcaljke u usta, te nježno pritisnite klip kako biste ispustili lijek.
Amber glass bottle (type III) with a child-resistant and tamper-evident screw cap (polypropylene).
Smeđa staklena bočica (tip III) sa zaštitnim zatvaračem s navojem sigurnim za djecu (polipropilen).
In vitro assessment of drug interactions
In vitro procjena interakcija lijekova
Do not reduce the dose or stop taking Epidyolex without first talking to your doctor.
Ako Vi ili bolesnik prestanete uzimati Epidyolex Nemojte smanjivati dozu ili prestati s uzimanjem Epidyolexa bez prethodnog razgovora sa svojim liječnikom.
• A plastic bag containing two 1 ml oral syringes and a bottle adaptor
• Plastična vrećica s dvjema štrcaljkama za usta od 1 ml i adapterom za bočicu
Hepatocellular injury Cannabidiol causes dose-related elevations of ALT and AST (see section 4.4).
Hepatocelularna ozljeda Kanabidiol uzrokuje povišenje ALT-a i AST-a povezano s dozom (vidjeti dio 4.4).
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 uglavnom uklanja kroz metabolizam u jetri i crijevima, te izlučuje u stolici, uz manje izlučivanje ishodišnog lijeka putem bubrega.
Cannabidiol can cause decreases in haemoglobin and haematocrit.
Kanabidiol može uzrokovati pad hemoglobina i hematokrita.
Lamotrigine levels may be elevated when it is co-administered with cannabidiol.
Razine lamotrigina mogu porasti ako se primjenjuje zajedno s kanabidiolom.
Key secondary endpoints for GWPCARE2 were the proportion of patients with at least a 50% reduction in convulsive seizure frequency, the change in total seizure frequency, and Caregiver Global Impression of Change at the last visit.
Ključne sekundarne mjere ishoda za GWPCARE2 su bile udio bolesnika s barem 50%-tnim smanjenjem učestalosti konvulzivnih napadaja, promjena u ukupnoj učestalosti napadaja, te globalni dojam promjene njegovatelja na zadnjem posjetu.
Subgroup analyses were conducted on multiple factors, including cAEDs.
Analize podskupina provedene su s više faktora, uključujući istovremene antiepileptike.
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.
U bolesnika koji imaju LGS i DS čini se kako je smanjenje tjelesne težine povezano s dozom, s 19% bolesnika koji su uzimali kanabidiol u dozi od 20 mg/kg/dan koji su izgubili ≥ 5% tjelesne težine, u usporedbi sa 8% bolesnika koji su uzimali kanabidiol u dozi od 10 mg/kg/dan.
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.
In vitro podaci predviđaju interakcije sa supstratima CYP1A2 (npr. teofilin, kofein), supstratima CYP2B6 (npr. bupropion, efavirenz), uridin-5'-difosfoglukuronoziltransferaza 1A9 (UGT1A9) (npr. diflunisal, propofol, fenofibrat) i UGT2B7 (npr. gemfibrozil, morfin, lorazepam) kad se primjenjuju zajedno s kanabidiolom.
Compared with placebo, cannabidiol was associated with an increase in the number of convulsive seizure-free days during the treatment period in each trial, equivalent to 2.7 days per 28 days (10 mg/kg/day) and 1.3 to 2.2 days per 28 days (20 mg/kg/day).
U usporedbi s placebom, kanabidiol je povezan s povećanjem broja dana bez konvulzivnih napadaja tijekom razdoblja liječenja u svakom od ispitivanja; ekvivalentno 2,7 dana na 28 dana (10 mg/kg/dan) odnosno 1,3 do 2,2 dana na 28 dana (20 mg/kg/dan).
Package leaflet: Information for the patient Epidyolex 100 mg/ml oral solution cannabidiol
Uputa o lijeku: Informacije za bolesnika Epidyolex 100 mg/ml oralna otopina kanabidiol
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.
Zbog moguće inhibicije aktivnosti enzima, treba razmotriti i smanjenje doze supstrata UGT1A9, UGT2B7, CYP2C8 i CYP2C9 prema kliničkoj situaciji, u slučaju nuspojava kod istovremene primjene s kanabidiolom.
Population pharmacokinetic analyses demonstrated that there were no clinically relevant effects of age, body weight, sex, or race on exposure to cannabidiol.
Učinak dobi, tjelesne težine, spola, etničke pripadnosti Analiza populacijske farmakokinetike je pokazala kako nema klinički značajnih učinaka dobi, tjelesne težine, spola i etničke pripadnosti na izloženost kanabidiolu.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GW Pharma (International) B.V., Databankweg 26
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GW Pharma (International) B.V., Databankweg 26
A pre- and post-natal development study was performed in rats at doses of 75, 150, or 250 mg/kg/day.
Ispitivanje prenatalne i postnatalne razvojne toksičnosti u štakora provedeno je pri dozama od 75, 150 ili 250 mg/kg/dan.
In the subgroup of DS patients treated with concomitant clobazam for 37 to 48 weeks (N=54), the median percentage reduction from baseline in convulsive seizure frequency was 60% during Week 1-12, which was maintained through to Week 37-48, with a median percentage reduction from baseline in convulsive seizure frequency of 45%.
U podskupini bolesnika koji imaju DS istovremeno liječenih klobazamom tijekom 37 do 48 tjedana (N = 54), medijan postotnog smanjenja učestalosti konvulzivnih napadaja u odnosu na početnu vrijednost bio je 60% tijekom 1. do 12. tjedna, što se održalo do 37. do 48. tjedna uz medijan postotnog smanjenja učestalosti konvulzivnih napadaja od 45%.
ALT elevations greater than 3 times the ULN were reported in 16% of patients taking cannabidiol 20 mg/kg/day compared with 3% in patients taking cannabidiol 10 mg/kg/day.
Povišenja ALT-a veća od 3 puta GGN su prijavljena u 16% bolesnika koji uzimaju kanabidiol u dozi od 20 mg/kg/dan u usporedbi s 3% u bolesnika koji uzimaju kanabidiol u dozi od 10 mg/kg/dan.
In the subgroup of LGS patients treated with concomitant clobazam for 37 to 48 weeks (N=161), the median percentage reduction from baseline in drop seizure frequency was 71% during Week 1-12, which was maintained through to Week 37-48, with a median percentage reduction from baseline in drop seizure frequency of 63%.
U podskupini bolesnika s LGS-om istovremeno liječenih klobazamom tijekom 37 do 48 tjedana (N = 161), medijan postotnog smanjenja učestalosti astatskih napadaja u odnosu na početnu vrijednost bio je 71% tijekom 1. do 12. tjedna, što se održalo do 37. do 48. tjedna uz medijan postotnog smanjenja učestalosti astatskih napadaja od 63% u odnosu na početnu vrijednost.
• If your dose is more than 5 ml (500 mg), you will need to use the larger 5 ml syringe more than once.
• Ako je Vaša doza veća od 5 ml (500 mg), trebali biste upotrebljavati veću štrcaljku od 5 ml više od jedanput.
NAME OF THE MEDICINAL PRODUCT Epidyolex 100 mg/ml oral solution
NAZIV LIJEKA Epidyolex 100 mg/ml oralna otopina
The 5 ml syringes are graduated in 0.1 ml and the 1 ml in 0.05 ml increments.
Štrcaljke od 5 ml imaju oznake na svakih 0,1 ml, a štrcaljke od 1 ml na svakih 0,05 ml.
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane Vrlo često