FrancophonIA/ELRC3.0 huggingface dataset:
English: The metabolite 7-carboxy-cannabidiol (7-COOH-CBD) is an inhibitor of UGT1A1, UGT1A4 and UGT1A6-mediated activity, in vitro at clinically relevant concentrations (see also section 4.5).
Maltese: Il-metabolit 7-carboxy-cannabidiol (7-COOH-CBD) huwa inibitur tal-attività in vitro medjata minn UGT1A1, UGT1A4 u UGT1A6, in vitro f'konċentrazzjonijiet klinikament rilevanti (ara wkoll sezzjoni 4.5).
English: When cannabidiol was combined with stiripentol there was a minor increase in stiripentol levels of 28% for Cmax and 55% for AUC.
Maltese: Meta cannabidiol jingħata flimkien ma' stiripentol ikun hemm żieda żgħira fil-livelli ta' stiripentol ta' 28% għal Cmax u żieda ta' 55% għal AUC.
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)
Maltese: - Żewġ siringi ta' 1 mL iggradwati f'inkrementi ta' 0.05 mL (kull inkrement ta' 0.05 mL jikkorrispondi għal 5 mg ta' cannabidiol) - Żewġ siringi ta' 5 mL iggradwati f'inkrementi ta' 0.1 mL (kull inkrement ta' 0.1 mL jikkorrispondi għal 10 mg ta' cannabidiol)
English: - Epidyolex makes you feel sleepy.
Maltese: - Epidyolex jista' jqabbdek in-ngħas.
English: Epidyolex contains sesame oil, alcohol (ethanol), strawberry flavour components (including benzyl alcohol).
Maltese: Epidyolex fih żejt tal-ġulġlien raffinat, alkoħol (ethanol), komponenti tat-togħma tal-frawli (inkluż benzyl alcohol).
English: Interaction resulting in a decrease (approximately 30%) in Cmax and AUC of the active metabolite 7-OH-CBD in HV* trials.
Maltese: L-interazzjoni rriżultat fi tnaqqis (madwar 30%) fis-Cmax u fl-AUC tal-metabolit attiv 7-OH-CBD fi provi HV*.
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).
Maltese: Fil-pazjenti, hemm effett antikonvulsanti addittiv potenzjali mill-interazzjoni farmakokinetika bi-direzzjonali bejn cannabidiol u clobazam, li jwassal għal żidiet fil-livelli li jiċċirkolaw tal-metaboliti attivi rispettivi tagħhom, 7-OH-CBD (bejn wieħed u ieħor 1.5 darbiet aktar) u N-CLB (bejn wieħed u ieħor 3 darbiet aktar) (ara sezzjonijiet 4.5, 5.1 u 5.2).
English: A NOAEL of 15 mg/kg/day was established.
Maltese: Kien stabbilit NOAEL ta' 15 mg/kg/jum.
English: Cannabidiol can cause elevations in serum creatinine.
Maltese: Cannabidiol jista' jikkawża żidiet fil-livelli tal-kreatinina fis-serum.
English: The most commonly used cAEDs (> 25% of patients) in both trials were valproate, clobazam, stiripentol, and levetiracetam.
Maltese: Il-cAEDs użati bl-aktar mod komuni (> 25% tal-pazjenti) fiż-żewġ provi kienu valproate, clobazam, stiripentol, u levetiracetam.
English: Drug interaction studies with AEDs
Maltese: Studji dwar l-interazzjoni mediċinali b'AEDs
English: Reversibility was not assessed in studies in LGS and DS.
Maltese: Ir-riversibilità ma ġietx evalwata fi studji dwar l-LGS u DS.
English: NAME OF THE MEDICINAL PRODUCT Epidyolex 100 mg/ml oral solution cannabidiol
Maltese: IL-PRODOTT MEDIĊINALI Epidyolex 100 mg/mL soluzzjoni orali cannabidiol
English: Frequency Adverse reactions from clinical trials
Maltese: Kategorija Reazzjonijiet avversi mill-provi kliniċi
English: NAME OF THE MEDICINAL PRODUCT Epidyolex 100 mg/ml oral solution
Maltese: IL-PRODOTT MEDIĊINALI Epidyolex 100 mg/mL soluzzjoni orali
English: Maintenance Dose Maximum Recommended Dose
Maltese: Doża Massima Rakkomandata
English: In vitro data suggest that cannabidiol is an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, UGT1A9 and UGT2B7-mediated activity at clinically relevant concentrations.
Maltese: Dejta in vitro tissuġġerixxi li cannabidiol huwa inibitur ta' attività medjata minn CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, UGT1A9 u UGT2B7 f'konċentrazzjonijiet klinikament rilevanti.
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).
Maltese: Barra minn hekk, kien hemm żieda fl-esponiment għal 7-hydroxy-cannabidiol (7-OH-CBD; metabolit attiv ta' cannabidiol), u l-erja taħt il-kurva (AUC, area under the curve) tal-plażma tiegħu żdiedet b'47% (ara sezzjoni 5.2).
English: CONVULSIVE SEIZURES PER 28 DAYS Percentage Reduction from Baselinea GWPCARE2
Maltese: AĊĊESSJONIJIET KONVULŻIVI GĦAL 28 JUM Tnaqqis Perċentwali mil-Linja Bażia GWPCARE2
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
Maltese: bħal omeprazole - mitotane (mediċina li tintuża biex tittratta tumuri fil-glandoli adrenali) - morfina jew diflunisal (mediċini li jintużaw biex jittrattaw l-uġigħ) - efavirenz (mediċina li tintuża biex tittratta l-HIV/AIDS) - theophylline (mediċina li tintuża biex tittratta l-ażżma) - kaffeina (mediċina għat-trabi li jkollhom bżonn għajnuna biex jieħdu n-nifs) - propofol (anestetiku li jintuża għal nies li jkunu qed jagħmlu operazzjoni) - simvastatin, fenofibrate, gemfibrozil, (mediċini li jintużaw biex inaqqsu l-kolesterol/lipidi) - enzalutamide (mediċina li tittratta l-kanċer tal-prostata) - bupropion (mediċina li tgħin biex twaqqaf it-tipjip jew biex tittratta l-obeżità) - St.
English: Placebo 20 mg/kg/day p=0.0784
Maltese: Plaċebo 20 mg/kg/jum p = 0.0784
English: (See also section 3, How to take Epidyolex).
Maltese: (Ara wkoll Sezzjoni 3, Kif għandek tieħu Epidyolex).
English: Cannabidiol is a substrate for CYP3A4, CYP2C19, UGT1A7, UGT1A9 and UGT2B7.
Maltese: Cannabidiol huwa sottostrat għal CYP3A4, CYP2C19, UGT1A7, UGT1A9 u UGT2B7.
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.
Maltese: Dan il-prodott mediċinali fih 10% skont il-volum ta' ethanol (alkoħol), jiġifieri sa 700 mg għal kull doża (għal adult li jiżen 70 kg), ekwivalenti għal 14-il millimetru (mL) ta' birra, jew 6 mL ta' inbid kull doża.
English: listed in Appendix V.
Maltese: Tabella 5:
English: 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.
Maltese: Fi studju kkontrollati għal LGS u DS, l-inċidenza ta' żidiet fil-livelli ta' ALT ogħla minn 3 darbiet aktar mill-ULN kienet 13% f'pazjenti ttrattati b'cannabidiol meta mqabbla ma' 1% f'pazjenti fuq il-plaċebo.
English: Each ml of Epidyolex contains 79 mg of ethanol.
Maltese: Kull mL ta' cannabidiol fih 79 mg ta' ethanol.
English: The metabolite 7-carboxy-cannabidiol (7-COOH-CBD) is also an inhibitor of UGT1A1, UGT1A4 and UGT1A6-mediated activity in vitro.
Maltese: Il-metabolit 7-carboxy-cannabidiol (7-COOH-CBD) huwa wkoll inibitur tal-attività in vitro medjata minn UGT1A1, UGT1A4 u UGT1A6.
English: 2 mg/kg twice daily (4 mg/kg/day)* *Higher doses of cannabidiol may be considered in patients with severe hepatic impairment where the potential benefits outweigh the risks.
Maltese: 2 mg/kg darbtejn kuljum (4 mg/kg/jum)* *Dożi ogħla ta' cannabidiol jistgħu jiġu kkunsidrati f'pazjenti b'indeboliment epatiku sever fejn il-benefiċċji potenzjali jegħlbu r-riskji.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GW Pharma (International) B.V., Databankweg 26, 3821AL Amersfoort, The Netherlands
Maltese: GW Pharma (International) B.V., Amersfoort A1, Databankweg 26 3821AL Amersfoort, L-Olanda
English: Concomitant Valproate and Clobazam
Maltese: Sottogrupp Bi Clobazam
English: - If your seizures happen more often, or if you experience a severe seizure while taking Epidyolex.
Maltese: - Jekk ikollok aċċessjonijiet aktar frekwenti, jew jekk tesperjenza aċċessjoni serja waqt li qed tieħu Epidyolex.
English: Interaction resulting in an approximate 28% increase in Cmax and 55% increase in AUC.
Maltese: L-interazzjoni rriżultat f'żieda ta' madwar 28% fis-Cmax u żieda ta' 55% flAUC.
English: Table 3: Primary and ≥ 50% responder key secondary outcome measures and subgroup analysis in LGS studies
Maltese: Tabella 3: Kejl tar-riżultati primarji u sekondarji ewlenin ta' ≥ 50% persuni li wrew rispons u analiżi tas-sottogruppi fi studji ta' LGS
English: Caution should be used in patients with moderate (Child-Pugh B) or severe hepatic impairment (Child-Pugh C).
Maltese: Għandha tintuża l-kawtela f'pazjenti b'indeboliment epatiku moderat (Child-Pugh B) jew sever (Child-Pugh C).
English: b For study GWPCARE1, overall data are presented as estimated median difference and p-value from a Wilcoxon rank-sum test. Data for study GWPCARE2 and the with clobazam subgroup are estimated from a negative binomial regression analysis.
Maltese: b Għall-istudju GWPCARE1, id-dejta globali hija ppreżentata bħala differenza medjana stmata u valur-p minn test klassifikazzjoni-somma (rank-sum) ta' Wilcoxon.
English: Cannabidiol is a substrate for UGT1A7, UGT1A9 and UGT2B7.
Maltese: Cannabidiol huwa sottostrat għal UGT1A7, UGT1A9 u UGT2B7.
English: - The other ingredients are refined sesame oil, anhydrous ethanol, sucralose and strawberry flavour (including benzyl alcohol)
Maltese: - Is-sustanzi mhux attivi l-oħra huma żejt tal-ġulġlien raffinat, anhydrous ethanol, sucralose u togħma tal-frawli (inkluż benzyl alcohol)
English: AST increased, ALT increased, GGT increased, Liver function test abnormal
Maltese: Żieda fl-AST, Żieda fl-ALT, Żieda filGGT, Test tal-funzjoni tal-fwied anormali
English: CLINICAL PARTICULARS
Maltese: Effikaċja klinika
English: Epidyolex contains refined sesame oil which may rarely cause severe allergic reactions.
Maltese: Epidyolex fih żejt tal-ġulġlien raffinat li rarament jista' jikkawża reazzjonijiet allerġiċi severi.
English: 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.
Maltese: Kienu osservati tnaqqis fit-tkabbir, dewmien fil-maturazzjoni sesswali, bidliet fl-imġiba (tnaqqis fl-attività), u effetti avversi fuq l-iżvilupp tal-organu riproduttiv tar-raġel (testikoli żgħar fil-wild adult) u l-fertilità fil-wild b'dożi ta' ≥ 150 mg/kg/jum.
English: Package leaflet: Information for the patient Epidyolex 100 mg/ml oral solution cannabidiol
Maltese: Informazzjoni għall-pazjent Epidyolex 100 mg/mL soluzzjoni orali cannabidiol
English: Strawberry flavour (including benzyl alcohol)
Maltese: Togħma tal-frawli (inkluż benzyl alcohol) 6.2 Inkompatibbiltajiet
English: 10 mg/kg/day, 62% to 77% on 20 mg/kg/day, 30% to 41% on placebo; p=0.0009 for 10 mg/kg/day and p=0.0018 and 0.0136 for 20 mg/kg/day vs. placebo).
Maltese: 41% fuq plaċebo; p = 0.0009 għal 10 mg/kg/jum u p = 0.0018 u 0.0136 għal 20 mg/kg/jum kontra plaċebo).
English: In clinical trials, cannabidiol discontinuation was achieved by reducing the dose by approximately 10% per day for 10 days (see section 4.4).
Maltese: Fil-provi kliniċi, it-twaqqif ta' cannabidiol inkiseb billi tnaqqset id-doża b'madwar 10% kuljum għal 10 ijiem (ara sezzjoni 4.4).
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.
Maltese: Cannabidiol ma jinteraġġix mat-trasportaturi maġġuri renali u tal-fwied b'mod li x'aktarx iwassal għal interazzjonijiet rilevanti bejn mediċina u oħra.
English: 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%.
Maltese: Fis-sottogrupp ta' pazjenti b'DS ittrattati bi clobazam konkomitanti għal 37 sa 48 ġimgħa (N = 54), it-tnaqqis perċentwali medjan mil-linja bażi fil-frekwenza tal-aċċessjonijiet konvulżivi kien ta' 60% matul Ġimgħa 1-12, li nżamm sa Ġimgħa 37-48 bi tnaqqis perċentwali medjan mil-linja bażi fil-frekwenza ta' aċċessjonijiet konvulżivi ta' 45%.
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).
Maltese: F'pazjenti b'LGS, l-immudellar farmakokinetiku farmakodinamiku (PK/PD - pharmacokinetic pharmacodynamic) tal-popolazzjoni indikat il-preżenza ta' relazzjoni bejn l-esponiment u l-effikaċja għall-probabbilità li jinkiseb tnaqqis ta' ≥ 50% fil-frekwenza ta' aċċessjonijiet atoniċi fil-medda tad-doża ttestjata ta' cannabidiol (0 [plaċebo], 10 u 20 mg/kg/jum).
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).
Maltese: L-individwi b'indeboliment epatiku moderat jew sever urew konċentrazzjonijiet ta' cannabidiol fil-plażma ogħla (madwar 2.5-5.2 darbiet aktar mill-AUC meta mqabbla ma' individwi b'saħħithom b'funzjoni epatika normali).
English: Interaction resulting in approximately 3-fold increase in N-desmethylclobazam metabolite exposure.
Maltese: L-interazzjoni rriżultat f'żieda ta' madwar 3 darbiet aktar fl-esponiment tal-metabolit N-desmethylclobazam.
English: Contains refined sesame oil, ethanol and strawberry flavour components (including benzyl alcohol).
Maltese: TA' EĊĊIPJENTI Fih żejt tal-ġulġlien raffinat, ethanol u komponenti tat-togħma tal-frawli (inkluż benzyl alcohol).
English: For an adult weighing 70 kg, this is equivalent to 14 millilitres (ml) of beer, or 6 ml of wine per dose.
Maltese: Għal adult li jkun jiżen 70 kg, dan huwa ekwivalenti għal 14-il millilitru (mL) ta' birra, jew 6 mL ta' nbid kull doża.
English: 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%.
Maltese: Fis-sottogrupp ta' pazjenti b'LGS ittrattati bi clobazam konkomitanti għal 37 sa 48 ġimgħa (N = 161), it-tnaqqis perċentwali medjan mil-linja bażi fil-frekwenza tal-aċċessjonijiet atoniċi kien ta' 71% matul Ġimgħa 1-12, li nżamm sa Ġimgħa 37-48 bi tnaqqis perċentwali medjan mil-linja bażi fil-frekwenza ta' aċċessjonijiet atoniċi ta' 63%.
English: The DS population in studies GWPCARE2 and GWPCARE1 was predominantly paediatric patients, with only 5 adult patients who were 18 years old (1.6%), and therefore limited efficacy and safety data were obtained in the adult DS population.
Maltese: Il-popolazzjoni DS fl-istudji GWPCARE2 u GWPCARE1 kienen fil-maġġoranza tagħha pazjenti pedjatriċi b'5 pazjenti adulti bis li kellhom 18-il sena (1.6%), u għalhekk inkisbet dejta limitata dwar l-effikaċja u s-sigurtà għall-popolazzjoni adulta
English: 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).
Maltese: Terapija Aġġuntiva f'Pazjenti bis-Sindrome ta' Dravet L-effikaċja ta' cannabidiol għat-terapija aġġuntiva tal-aċċessjonijiet assoċjati mas-sindrome ta' Dravet kienet evalwata f'żewġ studji paralleli, fejn il-pazjenti ntgħażlu b'mod każwali, double-blind, ikkontrollati bil-plaċebo (GWPCARE2 u GWPCARE1).
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).
Maltese: Ma kien innutat l-ebda effett fuq l-abilità riproduttiva tal-firien irġiel u nisa b'doża orali li tasal sa 150 mg/kg/jum ta' cannabidiol (ara sezzjoni 5.3).
English: 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).
Maltese: Terapija aġġuntiva f'pazjenti bis-sindrome ta' Lennox-Gastaut (LGS, Lennox-Gastaut syndrome) L-effikaċja ta' cannabidiol għat-terapija aġġuntiva tal-aċċessjonijiet assoċjati mas-sindrome ta' Lennox-Gastaut (LGS) kienet evalwata f'żewġ studji paralleli, fejn il-pazjenti ntgħażlu b'mod każwali, double-blind, ikkontrollati bil-plaċebo (GWPCARE3 u GWPCARE4).
English: Excretion
Maltese: Eliminazzjoni
English: 1 mg/kg twice daily (2 mg/kg/day)
Maltese: 1 mg/kg darbtejn kuljum (2 mg/kg/jum)
English: Lamotrigine levels may be elevated when it is co-administered with cannabidiol.
Maltese: Il-livelli ta' lamotrigine jistgħu jiżdiedu meta jingħata flimkien ma' cannabidiol.
English: Cannabidiol was associated with an increase in the percentage of subjects experiencing a greater than or equal to 75% reduction in drop seizure frequency during the treatment period in each trial (11% 10 mg/kg/day cannabidiol, 31% to 36% 20 mg/kg/day cannabidiol, 3% to 7% placebo).
Maltese: Kejl tar-riżultati sekondarji addizzjonali fis-sottogrupp ta' pazjenti ttrattati bi clobazam konkomitanti Cannabidiol kien assoċjat ma' żieda fil-perċentwali ta' individwi li kellhom tnaqqis ta' 75% jew aktar fil-frekwenza ta' aċċessjonijiet atoniċi matul il-perjodu ta' trattament f'kull prova (11% 10 mg/kg/jum cannabidiol, 31% sa 36% 20 mg/kg/jum cannabidiol, 3% sa 7% plaċebo).
English: Table 4: Primary and ≥ 50% responder key secondary outcome measures and subgroup analysis in DS studies
Maltese: Tabella 4: Kejl tar-riżultati primarji u sekondarji ewlenin ta' ≥ 50% persuni li wrew rispons u analiżi tas-sottogruppi fi studji ta' DS
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.
Maltese: Studji fl-annimali relatati mal-abbuż juru li cannabidiol ma jipproduċix risponsi ta' mġiba simili għal cannabinoid, li jinkludu ġeneralizzazzjoni għal delta-9-tetrahydrocannabinol (THC, tetrahydrocannabinol) fi studju ta' diskriminazzjoni tal-mediċina.
English: (See section 4.2 for information on paediatric use).
Maltese: (Ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku). 5.2 Tagħrif farmakokinetiku
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
Maltese: - nuqqas ta' enerġija - sogħla, uġigħ fil-griżmejn - infezzjonijiet tal-apparat respiratorju (pnewmonja, bronkite) - testijiet tad-demm li juru żidiet fil-livelli ta' ċerti enzimi tal-fwied (li jistgħu jkunu sinjali ta'
English: The mechanism of this risk is not known, and the available data do not exclude the possibility of an increased risk for cannabidiol.
Maltese: Il-mekkaniżmu ta' dan riskju mhuwiex magħruf u d-dejta disponibbli ma teskludix il-possibbiltà ta' żieda fir-riskju għal cannabidiol.
English: The key secondary endpoint for GWPCARE1 was the proportion of patients with at least a 50% reduction in convulsive seizure frequency.
Maltese: Il-punt ta' tmiem sekondarju ewlieni għal GWPCARE1 kien il-proporzjon ta' pazjenti bi tnaqqis ta' mill-inqas 50% fil-frekwenza ta' aċċessjonijiet konvulżivi.
English: 20 mg/kg/day p=0.0299
Maltese: 20 mg/kg/jum p = 0.0299
English: Table 1: Dose adjustments in patients with moderate or severe hepatic impairment
Maltese: Tabella 1: Aġġustamenti fid-doża għal pazjenti b'indeboliment epatiku moderat jew sever Indeboliment
English: In vitro assessment of interaction with UGT enzymes In vitro data suggest that cannabidiol is a reversible inhibitor of UGT1A9 and UGT2B7-mediated activity at clinically relevant concentrations.
Maltese: Evalwazzjoni in vitro tal-interazzjoni ma' enzimi UGT Dejta in vitro tissuġġerixxi li cannabidiol huwa inibitur riversibbli ta' attività medjata minn UGT1A9 u UGT2B7 f'konċentrazzjonijiet klinikament rilevanti.
English: B. PACKAGE LEAFLET
Maltese: Korriment epatoċellulari
English: • A plastic bag containing two 1 ml oral syringes and a bottle adaptor
Maltese: • Borża tal-plastik li fiha żewġ siringi tal-ħalq ta' 1 mL u adapter tal-flixkun
English: 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.
Maltese: Il-livelli ta' transaminases fis-serum u l-livelli totali ta' bilirubina għandhom jinkisbu wara xahar wieħed, 3 xhur, u 6 xhur wara l-bidu tat-trattament b'cannabidiol, u regolarment wara jew kif klinikament indikat.
English: 0.5 mg/kg twice daily (1 mg/kg/day)
Maltese: 0.5 mg/kg darbtejn kuljum (1 mg/kg/jum)
English: How to store Epidyolex
Maltese: Mediċini oħra u Epidyolex
English: 20 mg/kg/day p=0.0123
Maltese: 20 mg/kg/jum p = 0.0123
English: There have not been any clinical studies formally investigating this interaction.
Maltese: Ma saru l-ebda studji kliniċi li investigaw din l-interazzjoni formalment.
English: Moderate 1.25 mg/kg twice daily (2.5 mg/kg/day)
Maltese: 1.25 mg/kg darbtejn kuljum (2.5 mg/kg/jum)
English: The 5 ml syringes are graduated in 0.1 ml and the 1 ml in 0.05 ml increments.
Maltese: Is-siringi ta' 5 mL huma gradwati f'inkrementi ta' 0.1 mL u s-siringi ta' 1 mL huma gradwati f'inkrementi ta' 0.05 mL.
English: a For study GWPCARE1, overall data are presented as median percent reduction from baseline.
Maltese: aGħall-istudju GWPCARE1, id-dejta globali hija ppreżentata bħala tnaqqis perċentwali medjan mil-linja bażi.
English: Across both randomised LGS studies, 99.5% of patients who completed the studies were enrolled into the long-term open-label extension study (GWPCARE5).
Maltese: Fost iż-żewġ studji dwar LGS fejn il-pazjenti ntgħażlu b'mod każwali, 99.5% tal-pazjenti li lestew l-istudji ġew irreġistrati fl-istudju ta' estensjoni open-label li jdum fit-tul (GWPCARE5).
English: 2.5 mg/kg twice daily (5 mg/kg/day)
Maltese: 2.5 mg/kg darbtejn kuljum (5 mg/kg/jum)
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.
Maltese: Epidyolex jintuża flimkien ma' clobazam jew ma' clobazam u mediċini oħra kontra l-epilessija biex jiġu ttrattati aċċessjonijiet li jseħħu b'żewġ kundizzjonijiet rari, imsejħa sindrome ta' Dravet u sindrome ta' Lennox-Gastaut.
English: Hepatocellular injury Cannabidiol causes dose-related elevations of ALT and AST (see section 4.4).
Maltese: Korriment epatoċellulari Cannabidiol jikkawża żidiet fil-livelli ta' ALT u AST relatati mad-doża (ara sezzjoni 4.4).