FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetics in special patient groups
Maltese: Il-farmakokinetika fi gruppi ta' pazjenti speċjali
English: DROP SEIZURES PER 28 DAYS Percentage Reduction from Baselinea
Maltese: GĦAL 28 JUM Tnaqqis Perċentwali mil-Linja Bażia
English: 10 mg/kg/day p=0.0095
Maltese: 10 mg/kg/jum p = 0.0095
English: Weight decreased a Grouped Terms: Pneumonia: Pneumonia, Pneumonia RSV, Pneumonia mycoplasmal, Pneumonia adenoviral, Pneumonia viral, Aspiration pneumonia; Somnolence: Somnolence, Sedation.
Maltese: Pnewmonja, Pnewmonja RSV, Pnewmonja mikoplażmali, Pnewmonja adenovirali, Pnewmonja virali, Pnewmonja tal-aspirazzjoni;
English: Somnolence and sedation events have been observed in controlled trials with cannabidiol in LGS and DS.
Maltese: Ġew osservati avvenimenti ta' ngħas u sedazzjoni fi provi kkontrollati b'cannabidiol f'LGS u DS.
English: The half-life of cannabidiol in plasma was 56-61 hours after twice daily dosing for 7 days in healthy volunteers.
Maltese: Il-half-life ta' cannabidiol fil-plażma kienet ta' 56-61 siegħa wara dożaġġ ta' darbtejn kuljum għal 7 ijiem f'voluntiera b'saħħithom.
English: Exposure to phenytoin may be increased when it is co-administered with cannabidiol, as phenytoin is largely metabolised via CYP2C9, which is inhibited by cannabidiol in vitro.
Maltese: L-esponiment għal phenytoin jista' jiżdied meta jingħata flimkien ma' cannabidiol, għax phenytoin jiġi primarjament metabolizzat permezz ta' CYP2C9 li jiġi inibit permezz ta' cannabidiol in vitro.
English: In each trial, patients receiving cannabidiol experienced a greater median percentage reduction in total seizures compared with placebo (53% 10 mg/kg/day, 64% to 66% 20 mg/kg/day, 25% for each placebo group; p=0.0025 for 10 mg/kg/day and p<0.0001 for each 20 mg/kg/day group vs. placebo).
Maltese: F'kull prova, il-pazjenti li rċivew cannabidiol kellhom tnaqqis perċentwali medjan akbar fl-aċċessjonijiet totali meta mqabbel ma' plaċebo (53% 10 mg/kg/jum, 64% sa 66% 20 mg/kg/jum, 25% għal kull grupp tal-plaċebo; p = 0.0025 għal 10 mg/kg/jum u p< 0.0001 għal kull grupp ta'20 mg/kg/jum kontra plaċebo).
English: 5 mg/kg twice daily (10 mg/kg/day)
Maltese: 5 mg/kg darbtejn kuljum (10 mg/kg/jum)
English: 10 mg/kg/day p=0.0030
Maltese: 10 mg/kg/jum p = 0.0030
English: 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.
Maltese: F' pazjenti b'LGS u DS, it-tnaqqis medju fl-emoglobina mil-linja bażi sat-tmiem tat-trattament kien −0.37 g/dL f'pazjenti ttrattati b'cannabidiol.
English: Based on a healthy volunteer study, elevated levels (3- to 4-fold) of N-desmethylclobazam (an active metabolite of clobazam) can occur when combined with cannabidiol, likely mediated by CYP2C19 inhibition.
Maltese: Abbażi ta' studju f'voluntiera b'saħħithom, jistgħu jseħħu livelli elevati (3 sa 4 darbiet aktar) ta' N-desmethylclobazam (metabolit attiv ta' clobazam) meta jingħata flimkien ma' cannabidiol, x'aktarx medjat minn inibizzjoni ta' CYP2C19.
English: The NOAEL was associated with maternal plasma exposures (AUC) approximately 50 times greater than the anticipated exposure in humans at 20 mg/kg/day.
Maltese: In-NOAEL kien assoċjat mal-esponimenti fil-plażma materni (AUC) b'madwar 50 darba aktar mill-esponiment antiċipat fil-bnedmin b'doża ta' 20 mg/kg/jum.
English: The combination of cannabidiol with clobazam caused an elevation in exposure to the active metabolite N-desmethylclobazam.
Maltese: Il-kombinazzjoni ta' cannabidiol ma' clobazam ikkawżat żidiet fil-livell tal-esponiment għall-metabolit attiv N-desmethylclobazam.
English: Adverse reactions reported with cannabidiol in placebo-controlled clinical studies are listed in the table below by System Organ Class and frequency.
Maltese: Ir-reazzjonijiet avversi rrappurtati b'cannabidiol fl-istudji kliniċi kkontrollati bil-plaċebo huma elenkati fit-tabella hawn taħt skont is-Sistema tal-Klassifika tal-Organi u skont il-frekwenza.
English: Each ml of oral solution contains 100 mg of cannabidiol.
Maltese: U KWANTITATTIVA Kull mL ta' soluzzjoni orali fih 100 mg ta' cannabidiol.
English: Across both randomised DS studies, 97.7% of patients who completed the studies were enrolled into GWPCARE5.
Maltese: Fost iż-żewġ studji dwar DS fejn il-pazjenti ntgħażlu b'mod każwali, 97.7% tal-pazjenti li lestew l-istudji ġew irreġistrati fi GWPCARE5.
English: Common side effects (may affect more than 1 in 100 people):
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw aktar minn 1 minn kull 100 persuni):
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.
Maltese: Dejta in vitro wriet li cannabidiol jinibixxi CYP2C19, li jista' jikkawża żieda fil-konċentrazzjonijiet fil-plażma ta' mediċini li jiġu metabolizzati b'din l-isoenzima bħal clobazam, u omeprazole.
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.
Maltese: Il-potenzjal għal interazzjonijiet bejn mediċina u oħra b'AEDs konkomitanti oħra ġie evalwat f'voluntiera b'saħħithom u pazjenti b' epilessija għal clobazam, valproate and stiripentol.
English: In each trial, patients receiving cannabidiol experienced a greater percentage reduction in total seizures compared with placebo (66% 10 mg/kg/day, 54% to 58% 20 mg/kg/day, 27% to 41% placebo; p=0.0003 for 10 mg/kg/day and p=0.0341 and 0.0211 for 20 mg/kg/day vs. placebo).
Maltese: F'kull prova, il-pazjenti li rċivew cannabidiol kellhom tnaqqis perċentwali akbar fl-aċċessjonijiet totali meta mqabbel ma' plaċebo (66% 10 mg/kg/jum, 54% sa 58% 20 mg/kg/jum, 27% sa 41% plaċebo; p = 0.0003 għal 10 mg/kg/jum u p = 0.
English: Table 5: Drug interactions between cannabidiol and concomitant antiepileptic drugs Concomitant AED Influence of AED on cannabidiol Influence of cannabidiol on AED Clobazam
Maltese: AED fl-istess ħin Influwenza ta' AED fuq cannabidiol
English: Cannabidiol does not exert its anticonvulsant effect through interaction with cannabinoid receptors.
Maltese: Cannabidiol ma jeżerċitax l-effett antikonvulżiv tiegħu permezz ta' interazzjoni ma' riċetturi tal-cannabinoid.
English: A pre- and post-natal development study was performed in rats at doses of 75, 150, or 250 mg/kg/day.
Maltese: Twettaq studju dwar l-iżvilupp ta' qabel u wara t-twelid f'firien b'dożi ta' 75, 150, jew 250 mg/kg/jum.
English: Patients with sustained transaminase elevations of greater than 5 times the ULN should also have treatment discontinued.
Maltese: Pazjenti b'żidiet sostnuti fil-livelli ta' transaminases ta' aktar minn 5 darbiet aktar l-ULN għandhom ukoll iwaqqfu it-trattament.
English: Prior to starting treatment with cannabidiol, obtain serum transaminases (ALT and AST) and total bilirubin levels.
Maltese: Qabel ma jinbeda t-trattament b'cannabidiol, għandhom jinkisbu l-livelli ta' transaminases fis-serum (ALT u AST) u l-livelli totali ta' bilirubina.
English: 20 mg/kg/day p=0.0047
Maltese: 20 mg/kg/jum p = 0.0047
English: 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.
Maltese: Iż-żidiet fil-livelli ta' ALT ogħla minn 3 darbiet aktar l-ULN kienu rrappurtati f'16% tal-pazjenti li kienu qed jieħdu cannabidiol 20 mg/kg/jum meta mqabbla ma' 3% f'pazjenti li kienu qed jieħdu cannabidiol 10 mg/kg/jum.
English: 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).
Maltese: Meta mqabbel ma' plaċebo, cannabidiol kien assoċjat ma' żieda fin-numru ta' ġranet mingħajr aċċessjonijiet konvulżivi matul il-perjodu tat-trattament f'kull prova; ekwivalenti għal 2.7 jiem f'kull 28 jum (10 mg/kg/jum) u 1.3 sa 2.2 jiem f'kull 28 jum (20 mg/kg/jum).
English: Data for the with clobazam subgroup are presented as percent reduction from baseline estimated from a negative binomial regression analysis.
Maltese: Id-dejta għas-sottogrupp bi clobazam hija stmata minn analiżi ta' rigressjoni binomjali negattiva.
English: Greater improvements in overall condition, as measured by Global Impression of Change scores at the last visit, were reported by caregivers and patients with both doses of cannabidiol (76% on 10 mg/kg/day, 80% for each group on 20 mg/kg/day, 31% to 46% on placebo; p=0.0005 for 10 mg/kg/day and p<0.0001 and 0.0003 for 20 mg/kg/day vs. placebo).
Maltese: Kien irrappurtat aktar titjib fil-kundizzjoni globali, kif imkejjel mill-punteġġi tal-Impressjoni Globali tal-Bidla (Global Impression of Change) mill-persuni li jieħdu ħsieb il-pazjenti u mill-pazjenti fl-aħħar żjara, biż-żewġ dożi ta' cannabidiol (76% fuq 10 mg/kg/jum, 80% għal kull gruppfuq 20 mg/kg/jum, 31% sa 46% fuq plaċebo; p = 0.0005 għal 10 mg/kg/jum u p< 0.0001 u 0.0003 għal 20 mg/kg/jum kontra plaċebo).
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.
Maltese: Studji f'individwi b'saħħithom urew li ma kien hemm l-ebda differenzi kbar fl-esponimenti fil-plażma għal cannabidiol fil-metabolizzaturi intermedji u ultra-rapidi ta' CYP2C19 meta mqabbel ma' metabolizzaturi estensivi.
English: Cannabidiol can be administered to patients with mild, moderate, or severe renal impairment without dose adjustment (see section 5.2).
Maltese: Cannabidiol jista' jingħata lil pazjenti b'indeboliment renali ħafif, moderat jew sever mingħajr aġġustament fid-doża (ara sezzjoni 5.2).
English: 20 mg/kg/day p=0.0069
Maltese: 20 mg/kg/jum p = 0.0069
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.
Maltese: John's wort, u/jew indutturi qawwija ta' CYP2C19, bħal rifampin, li jingħataw fl-istess ħin ma' cannabidiol, jistgħu jnaqqsu l-konċentrazzjonijiet ta' cannabidiol fil-plażma u jnaqqsu l-effettività ta' cannabidiol.
English: There are only limited data from the use of cannabidiol in pregnant women.
Maltese: Hemm biss dejta limitata dwar l-użu ta' cannabidiol f'nisa tqal.
English: Concomitant use of cannabidiol and clobazam increases the incidence of somnolence and sedation compared with placebo (see sections 4.4 and 4.8).
Maltese: L-użu fl-istess ħin ta' cannabidiol u clobazam iżid l-inċidenza tan-ngħas u sedazzjoni meta mqabbel ma' plaċebo (ara sezzjonijiet 4.4 u 4.8).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GW Pharma (International) B.V., Databankweg 26
Maltese: Isem u indirizz tal-manifattur<i> responsabbli għall-ħruġ tal-lott GW Pharma (International)
English: Cannabidiol can cause decreases in haemoglobin and haematocrit.
Maltese: Cannabidiol jista' jikkawża tnaqqis fl-emoglobina u fl-ematokrit.
English: p<0.0001c ≥ 50% REDUCTION IN DROP SEIZURES (RESPONDER ANALYSIS) Percentage of ≥ 50% Responders, p-valued GWPCARE3 Placebo
Maltese: Perċentwali ta' ≥ 50% Persuni li Wrew Rispons, valur-pd GWPCARE3 Plaċebo
English: In individual patients titration up to a maximum dose of 20 mg/kg/day may be considered, based on the benefit-risk (see Section 4.2).
Maltese: F'pazjenti individwali, it-titrazzjoni sa doża massima ta' 20 mg/kg/jum tista' tiġi kkunsidrata, abbażi tal-benefiċċju-riskju (ara Sezzjoni 4.2).
English: Oral use
Maltese: Soluzzjoni orali
English: Missed doses
Maltese: Twissijiet u prekawzjonijiet
English: • If your dose is more than 1 ml (100 mg), you should use the larger 5 ml syringe.
Maltese: • Jekk id-doża tiegħek hija ta' aktar minn 1 mL (100 mg), għandek tuża s-siringa akbar ta' 5 mL.
English: Twenty-seven percent (27%) of cannabidiol-treated patients developed a new laboratory-defined anaemia during the course of the study (defined as a normal haemoglobin concentration at baseline, with a reported value less than the lower limit of normal at a subsequent time point).
Maltese: Sebgħa u għoxrin fil-mija (27%) ta' pazjenti ttrattati b'cannabidiol żviluppaw anemija ġdida definita mil-laboratorju matul l-istudju (definita bħala konċentrazzjoni tal-emoglobina normali fil-linja bażi) b'valur irrappurtat inqas mil-limitu aktar baxx tan-normal f'punt ta' żmien sussegwenti).
English: 20 mg/kg/day p=0.0006
Maltese: 20 mg/kg/jum p = 0.0006
English: 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.
Maltese: Fi provi kkontrollati (ara sezzjoni 5.1) fuq pazjenti li kienu qed jieħdu cannabidiol 20 mg/kg/jum, il-frekwenza ta' żidiet fil-livelli ta' ALT ogħla minn 3 darbiet aktar l-ULN ikkawżati mit-trattament kienet ta' 31% (84% minn dawn kienu fuq valproate) meta l-ALT kienet ogħla mill-ULN fil-linja bażi, meta mqabbel ma' 12% (89% minn dawn kienu fuq valproate) meta l-ALT kienet fil-medda normali fil-linja bażi.
English: 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.
Maltese: Il-punti ta' tmiem sekondarji ewlenin għal GWPCARE2 kienu l-proporzjon ta' pazjenti li kellhom tnaqqis ta' mill-inqas 50% fil-frekwenza ta' aċċessjonijiet konvulżivi, il-bidla fil-frekwenza totali ta' aċċessjonijiet, u Impressjoni Globali tal-Bidla tal-Individwu/Persuna li Tieħu Ħsieb il-Pazjent fl-aħħar żjara.
English: The maximum recommended single dose of Epidyolex (10 mg/kg) will increase the concentration of ethanol in the body by about 13 mg/l.
Maltese: Id-doża waħda massima rakkomandata ta' cannabidiol (10 mg/kg) se żżid il-konċentrazzjoni ta' ethanol fil-ġisem b'madwar 13 mg/L.
English: Epidyolex with food
Maltese: Epidyolex ma' ikel
English: p<0.0001c
Maltese: 0001c
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.
Maltese: Dijarea ħafifa għal moderata u ngħas kienu rrappurtati f'individwi adulti b'saħħithom li kienu jieħdu doża waħda ta' 6000 mg; din hija ekwivalenti għal doża ta' ogħla minn 85 mg/kg għal adulti ta' 70 kg.
English: When cannabidiol and clobazam are co-administered, bi-directional PK interactions occur.
Maltese: Meta cannabidiol u clobazam jingħataw flimkien, iseħħu interazzjonijiet tal-PK f'żewġ direzzjonijiet.
English: 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.
Maltese: Minħabba l-potenzjal għall-inibizzjoni tal-attività tal-enzimi, għandu jiġu kkunsidrat tnaqqis fid-doża tas-sottostrati ta' UGT1A9, UGT2B7, CYP2C8, u CYP2C9, kif ikun klinikament xieraq, jekk ikun hemm reazzjonijiet avversi meta jingħataw flimkien ma' cannabidiol.
English: The lowest dose causing developmental toxicity in juvenile rats (15 mg/kg subcutaneous/100 mg/kg oral) was associated with Cmax cannabidiol exposures approximately 20 times that in paediatric subjects at 20 mg/kg/day.
Maltese: L-iktar doża baxxa li tikkawża tossiċità tal-iżvilupp fil-firien żgħażagħ (15 mg/kg taħt il-ġilda/100 mg/kg mill-ħalq) kienet assoċjata ma' esponimenti ta' Cmax ta' cannabidiol ta' madwar 20 darba aktar dawk fl-individwi pedjatriċi b'doża ta' 20 mg/kg/jum.
English: The NOAEL was associated with maternal plasma cannabidiol exposures approximately 9 times that in humans at 20 mg/kg/day.
Maltese: In-NOAEL kien assoċjat ma' esponimenti għal cannabidiol fil-plażma tal-omm ta' madwar 9 darbiet aktar milli fil-bniedem b'doża ta' 20 mg/kg/jum.
English: The plasma clearance of cannabidiol following a single 1500 mg dose of cannabidiol is about 1,111 L/h.
Maltese: It-tneħħija ta' cannabidiol mill-plażma wara doża waħda ta' 1500 mg ta' cannabidiol hija ta' madwar 1111 L/siegħa.
English: In cannabidiol-treated patients, the incidence of ALT elevations greater than 3 times the ULN was 23% in patients taking both concomitant valproate and clobazam, 17% in patients taking concomitant valproate (without clobazam), 3% in patients taking concomitant clobazam (without valproate), and 2% in patients taking neither drug.
Maltese: F'pazjenti ttrattati b'cannabidiol, l-inċidenza ta' żidiet fil-livelli ta' ALT ogħla minn 3 darbiet aktar mill-ULN kienet 23% f'pazjenti li kienu qed jieħdu valproate u clobazam it-tnejn li huma fl-istess ħin, 17% f'pazjenti li kienu qed jieħdu valproate fl-istess ħin (mingħajr clobazam), 3% f'pazjenti li kienu qed jieħdu clobazam fl-istess ħin (mingħajr valproate), u 2% f'pazjenti li ma kienu qed jieħdu l-ebda mediċina.
English: It is not known if cannabidiol is dialysable.
Maltese: Mhux magħruf jekk cannabidiol jistax jiġi dijalisizzat.
English: Approximately 65% of the patients were taking concomitant clobazam.
Maltese: Madwar 65% tal-pazjenti kienu qed jieħdu clobazam fl-istess ħin.
English: Interaction resulting in an increase in exposure of the active metabolite 7-OH-CBD in HV* studies.
Maltese: L-interazzjoni rriżultat f'żieda flesponiment tal-metabolit attiv 7-OH-CBD fi studji
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).
Maltese: Peress li ma kien hemm l-ebda rispons għad-doża konsistenti bejn 10 mg/kg/jum u 20 mg/kg/jum fl-istudji ta' LGS u DS, fil-bidu cannabidiol għandu jiġi ttitrat għad-doża ta' manteniment rakkomandata ta' 10 mg/kg/jum (ara Sezzjoni 4.2).
English: The UGT isoforms responsible for the phase II conjugation of cannabidiol are UGT1A7, UGT1A9 and UGT2B7.
Maltese: II ta' cannabidiol huma UGT1A7, UGT1A9 u UGT2B7.
English: Steady-state plasma concentrations are attained within 2-4 days of twice daily dosing based on pre-dose (Ctrough) concentrations.
Maltese: Il-konċentrazzjonijiet fil-plażma fi stat fiss inkisbu fi żmien 2-4 ijiem ta' dożaġġ ta' darbtejn kuljum abbażi tal-konċentrazzjonijiet ta' qabel id-doża (Ctrough).
English: 0.0003 mg benzyl alcohol
Maltese: .8 Effetti mhux mixtieqa
English: Compared with placebo, cannabidiol was associated with an increase in the number of drop seizure-free days during the treatment period in each trial, equivalent to 3.3 days per 28 days (10 mg/kg/day) and 5.5 to 7.6 days per 28 days (20 mg/kg/day).
Maltese: Meta mqabbel mal plaċebo, cannabidiol kien assoċjat ma' żieda fin-numru ta' ġranet mingħajr aċċessjonijiet atoniċi matul il-perjodu tat-trattament f'kull prova; ekwivalenti għal 3.3 jiem f'kull 28 jum (10 mg/kg/jum) u 5.5 sa 7.6 jiem f'kull 28 jum (20 mg/kg/jum).
English: 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.
Maltese: Ħamsa fil-mija (5%) ta' pazjenti (kollha fuq valproate) li kienu qed jieħdu cannabidiol 10 mg/kg/jum kellhom żidiet fil-livelli ta' ALT ogħla minn 3 darbiet aktar l-ULN meta l-ALT kienet ogħla mill-ULN fil-linja bażi, meta mqabbel ma' 3% ta' pazjenti (kollha fuq valproate) meta l-ALT kienet fil-medda normali fil-linja bażi.
English: Very common Somnolencea Common
Maltese: Komuni ħafna Ngħasa Komuni
English: Tel: +34-914197379
Maltese: GW Pharma Spain, S.L. Tel: +34-914197379
English: Mean age of the study population was 15 years and 94% were taking 2 or more concomitant AEDs (cAEDs) during the trial.
Maltese: L-età medja tal-popolazzjoni tal-istudju kienet 15-il sena u 94% kienu qed jieħdu żewġ AEDs jew aktar fl-istess ħin (cAEDs, concomitant AEDs) matul il-prova.
English: 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).
Maltese: Ma kienu osservati l-ebda reazzjonijiet avversi fuq il-fertilità fl-irġiel u fin-nisa jew fuq il-prestazzjoni riproduttiva fil-firien b'dożi li jaslu sa 250 mg/kg/jum (madwar 60 darba aktar mid-doża massima rakkomandata għall-bniedem (MRHD, maximum recommended human dose) b'doża ta' 20 mg/kg/jum).
English: b Overall data are presented as estimated median difference and p-value from a Wilcoxon rank-sum test. Data for the with clobazam subgroup are estimated from a negative binomial regression analysis.
Maltese: b Id-dejta globali hija ppreżentata bħala differenza medjana stmata u valur-p minn test klassifikazzjoni-somma (rank-sum) ta' Wilcoxon.
English: In juvenile rats, administration of cannabidiol for 10 weeks (subcutaneous doses of 0 or 15 mg/kg on postnatal days [PNDs] 4-6 followed by oral administration of 0, 100, 150, or 250 mg/kg on PNDs 7-77
Maltese: F'firien żgħażagħ, l-għoti ta' cannabidiol għal 10 ġimgħat (dożi li jingħataw taħt il-ġilda ta' 0 jew 15 mg/kg fil-jiem ta' wara t-twelid [PNDs, postnatal days] 4-6 segwit mill-għoti mill-ħalq ta' 0, 100, 150, or 250 mg/kg fil-jiem ta' wara t-twelid 7-77) irriżulta f'żieda fil-piż tal-ġisem, dewmien fil-maturazzjoni sesswali tal-irġiel, effetti newrokomportamentali, żieda fid-densità minerali fl-għadam, u vakwolazzjoni fl-epatoċita tal-fwied.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: If the dose is more than 5 ml, repeat Steps 4 to 7 to give the remaining dose using the 5 ml oral syringe.
Maltese: Jekk id-doża tkun aktar minn 5 mL, irrepeti Passi 4 sa 7 biex tagħti d-doża li jmiss billi tuża s-siringa tal-ħalq ta' 5 mL.
English: Reduction in dose of clobazam should be considered if somnolence or sedation are experienced when clobazam is co-administered with cannabidiol.
Maltese: It-tnaqqis fid-doża ta' clobazam għandu jiġi kkunsidrat jekk jiġu esperjenzati n-ngħas u s-sedazzjoni meta clobazam jingħata flimkien ma' cannabidiol.
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).
Maltese: Pazjentili jkollhom żidiet fil-livelli ta' transaminases ogħla minn 3 darbiet aktar mil-limitu massimu tan-normal (ULN, upper limit of normal) u livell ta' bilirubina ogħla minn darbtejn aktar mil-limitu massimu tan-normal (ara sezzjoni 4.4.)
English: PK/PD analysis also demonstrated that systemic exposures to cannabidiol were correlated with some adverse events namely elevated ALT, AST, diarrhoea, fatigue, GGT, loss of appetite, rash, and somnolence (see section 4.8).
Maltese: L-analiżi PK/PD uriet ukoll li l-esponimenti sistemiċi għal cannabidiol kienu wkoll ikkorrelati ma' xi avvenimenti avversi jiġifieri żieda fil-livelli ta' ALT, żieda fil-livelli ta' AST, dijarea, għeja, GGT, telf ta' aptit, raxx, u ngħas (ara sezzjoni 4.8). Clobazam (analiżi separata) kien kovarjant sinifikanti li kkawża l-probabbilità ta' żieda fil-GGT, li jonqos it-telf ta' aptit, u żieda fin-ngħas.
English: It can be used in adults, adolescents and children of at least 2 years of age.
Maltese: Jista' jintuża f'adulti, adolexxenti u tfal li jkollhom mill-inqas sentejn.
English: • If your dose is 1 ml (100 mg) or less, you should use the smaller 1 ml syringe.
Maltese: • Jekk id-doża tiegħek hija ta' 1 mL (100 mg) jew inqas, għandek tuża s-siringa iżgħar ta' 1 mL.