FrancophonIA/ELRC3.0 huggingface dataset:
English: The hyponatraemic effect of diuretics may be intensified by concomitant administration of medicinal products such as antidepressants, antipsychotics, antiepileptics, etc.
Maltese: L-effett iponatremiku tad-dijuretiċi jista' jitqawwa blgħoti flimkien ta' prodotti mediċinali bħal antidipressanti, antipsikotiċi, antiepliettiċi, u l-bqija.
English: EU/1/09/570/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/570/012 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/570/011 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża
English: Hepatobiliary disorders
Maltese: Sindromu ekstrapiramidali
English: • breath odour
Maltese: • dardir u rimettar
English: • increase of urea nitrogen, creatinine and uric acid in the blood
Maltese: • żieda fin-nitroġenu tal-urea, fil-kreatinina u fl-aċidu uriku fid-demm
English: Distribution: The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.
Maltese: Il-volum ta' distribuzzjoni ta' valsartan fi stat fiss wara li jingħata ġol-vina huwa ta' madwar 17-il litru, li jindika li valsartan ma jinfirixx b'mod estensiv fit-tessuti.
English: EU/1/09/570/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/570/024 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/570/023 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża
English: Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers.
Maltese: Bidliet bijokimiċi riversibbli fir-ras tal-ispermatozoa ġew irrappurtati f'xi pazjenti trattati blimblokkaturi tal-kanali tal-kalċju.
English: Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Maltese: Imprida HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: Dyspepsia
Maltese: Dijarea
English: Brown-yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VHL” on the other side.
Maltese: Pilloli sofor ċari, b'forma ovali, konvessi fuq iż-żewġ naħat, bix-xifer tasturat, imnaqqxin b'“NVR” fuq naħa waħda u b'“VDL” fuq in-naħa l-oħra.
English: Hepatic impairment
Maltese: Glikosidi diġitali
English: Multipack comprising 4 cartons, each containing 70 tablets.
Maltese: Pakkett b'ħafna magħmul minn 4 kartuniet, li kull waħda minnhom fiha 70 pillola.
English: Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Imprida HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorthiazide
English: Thiazides, including hydrochlorothiazide, may reduce the renal excretion of cytotoxic agents (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
Maltese: It-thiazides, inkluż hydrochlorthiazide, jistgħu jnaqqsu ttneħħija renali ta' sustanzi ċitotossiċi (eż. ċiklofosfamid, methotrexate) u jsaħħu l-effetti majelosoppressivi tagħhom.
English: Acute angle-closure glaucoma
Maltese: Glawkoma gravi fl-angolu tal-għeluq
English: • difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress,
Maltese: • diffikultà biex tieħu n-nifs flimkien ma' deni, sogħla, tisfir, qtugħ ta' nifs (mard respiratorju,
English: Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg/kg/day showed no evidence of carcinogenicity.
Maltese: Il-firien u l-ġrieden ikkurati b'amlodipine fid-dieta għal sentejn, f'konċentrazzjonijiet ikkalkulati biex jagħtu livelli ta' dożaġġ kuljum ta' 0.5, 1.25, u 2.5 mg/kg/ġurnata ma wrew l-ebda evidenza ta' karċinoġeniċità.
English: Imprida HCT 5 mg/160 mg/25 mg film-coated tablets
Maltese: Imprida HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita
English: • breast enlargement in men
Maltese: • għamil tal-awrina mnaqqas ħafna
English: More than 95% of the absorbed dose is being excreted as unchanged compound in the urine.
Maltese: Aktar minn 95% tad-doża assorbita tiġi mneħħija bħala sustanza mhux mibdula fl-awrina.
English: Imprida HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Imprida HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorthiazide
English: Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Imprida HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorthiazide
English: Iodine contrasting agents
Maltese: Ir-Renju Unit
English: There was no effect on the fertility of rats treated with amlodipine (males for 64 days and females 14 days prior to mating) at doses up to 10 mg/kg/day (8 times* the maximum recommended human dose of 10 mg on a mg/m basis).
Maltese: Ma kien hemm ebda effett fuq il-fertilità tal-firien ikkurati b'amlodipine (irġiel għal 64 ġurnata u nnisa 14-il ġurnata qabel it-tgħammir) b'dożi sa 10 mg/kg/ġurnata (8 darbiet*id-doża massima rakkomandata għall-bniedem ta' 10 mg fuq bażi ta' mg/m2).
English: Absolute bioavailability of hydrochlorothiazide is 70% after oral administration.
Maltese: Il-bijodisponibbiltà assoluta ta' hydrochlorthiazide hija ta' bejn 70% wara l-għoti mill-ħalq.
English: Multipack comprising 20 cartons each containing 14 tablets.
Maltese: Pakkett b'ħafna magħmul minn 20 kartuna, li kull waħda minnhom fiha 14-il pillola.
English: Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Imprida HCT, 10 mg/320 mg/25 mg.
Maltese: Hija rrakkomandata kawtela f'pazjenti b'insuffiċjenza tal-qalb u b'mard tal-arterji koronarji, b'mod partikulari meta tingħata logħla doża ta' Imprida HCT, 10 mg/320 mg/25 mg.
English: Agranulocytosis, bone marrow depression
Maltese: Kolestażi ġol-fwied, suffejra
English: Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide.
Maltese: Metformin għandu jintuża b'kawtela minħabba r-riskju ta' aċidożi lattika kkaġunata minn insuffiċjenza funzjonali renali li jista' jkun hemm u li hija marbuta ma' hydrochlorthiazide.
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Maltese: Sakemm kura b'AIIRA kontinwata hija kkunsidrata essenzjali, pazjenti li qed jippjanaw għal tqala għandhom jinqalbu għal kura alternattiva kontra l-pressjoni għolja li għandha profil ta' sigurtà stabbilit gћall-użu fit-tqala.
English: Imprida HCT 10 mg/160 mg/25 mg film-coated tablets
Maltese: Imprida HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita
English: Following oral administration of Imprida HCT in normal healthy adults, peak plasma concentrations of amlodipine, valsartan and hydrochlorothiazide are reached in 6-8 hours, 3 hours, and 2 hours, respectively.
Maltese: Wara l-għoti mill-ħalq ta' Imprida HCT lil adulti normali u b'saħħithom, l-ogħla konċentrazzjonijiet ta' amlodipine, valsartan u hydrochlorthiazide fil-plażma jintlaħqu f'6-8 sigħat, fi 3 sigħat, u f'sagħtejn, rispettivament.
English: Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets
Maltese: Imprida HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita
English: EU/1/09/570/006 98 film-coated tablets
Maltese: EU/1/09/570/009 98 x pillola 1 miksija b'rita (doża waħda)
English: Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Maltese: Glukonat tal-kalċju mogħti minn ġol-vina jista' jgħin biex ireġġa' lura l-effetti tal-imblukkar tal-kanali tal-kalċju.
English: • severe upper stomach ache (inflammation of the pancreas)
Maltese: • l-istat metaboliku tad-dijabete jmur għall-agħar
English: Imprida HCT 10 mg/160 mg/25 mg film-coated tablets: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan, and 25 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 10 mg ta' amlodipine (bħala amlodipine besylate), 160 mg ta' valsartan, u 25 mg ta' hydrochlorthiazide.
English: Imprida HCT 5 mg/160 mg/25 mg film-coated tablets: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 5 mg ta' amlodipine (bħala amlodipine besylate), 160 mg ta' valsartan, u 25 mg ta' hydrochlorthiazide.
English: Neutropenia
Maltese: Disgewżja
English: Insomnia/sleep disturbances Uncommon Uncommon
Maltese: Insomnja/disturbi fl-irqad
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Maltese: Trabi li ommhom ħadet AIIRAs għandhom ikunu taħt osservazzjoni mill-qrib għall-pressjoni baxxa (ara wkoll sezzjonijiet 4.3 u 4.4).
English: • iodine contrast media (agents used for imaging examinations); medicines for the treatment of diabetes (oral agents such as metformin or insulins); medicines for the treatment of gout, such as allopurinol; medicines that may increase blood sugar levels (beta blockers, diazoxide);
Maltese: • mediċini għall-kura tad-dijabete (sustanzi mill-ħalq bħal metformin jew insulini); mediċini użati għat-trattament tal-gotta, bħal allopurinol;
English: Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate),160 mg valsartan, and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 10 mg ta' amlodipine (bħala amlodipine besylate), 160 mg ta' valsartan, u 12.5 mg ta' hydrochlorthiazide.
English: Digitalis glycosides
Maltese: TWISSIJA(IET) SPEĊJALI
English: In patients with severe renal impairment an 8-fold increase in AUC has been observed.
Maltese: F'pazjenti b'indeboliment renali qawwi dehret żieda ta' 8 darbiet fl-AUC.
English: Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets
Maltese: Imprida HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita
English: Breath odour
Maltese: TAGĦRIF
English: • medicines that may induce “torsades de pointes” (irregular heart beat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics;
Maltese: • mediċini li jistgħu jwasslu għal “torsades de pointes” (taħbit tal-qalb irregolari), bħallantiirritmiċi (mediċini użati biex jittrattaw problemi tal-qalb) u xi antipsikotiċi;
English: This metabolite is pharmacologically inactive.
Maltese: Dan il-metabolit m'għandux attività farmakoloġika.
English: EU/1/09/570/044 56 x 1 film-coated tablet (unit dose) EU/1/09/570/045 98 x 1 film-coated tablet (unit dose) EU/1/09/570/046 280 x 1 film-coated tablet (unit dose)
Maltese: EU/1/09/570/037 14-il pillola miksija b'rita EU/1/09/570/038 28 pillola miksija b'rita EU/1/09/570/039 30 pillola miksija b'rita EU/1/09/570/040 56 pillola miksija b'rita EU/1/09/570/041 90 pillola miksija b'rita EU/1/09/570/042 98 pillola miksija b'rita EU/1/09/570/043 280 pillola miksija b'rita EU/1/09/570/044 56 x pillola 1 miksija b'rita (doża waħda)
English: * HV=Healthy Volunteer
Maltese: *HV = Healthy Volunteers (Voluntiera b'Saħħithom)
English: CI=95% confidence interval.
Maltese: CI = 95% intervall tal-kunfidenza.
English: The Netherlands E-mail: info@gwpharm.com
Maltese: E-mail: info@gwpharm.com
English: Open-label data
Maltese: Dejta open-label
English: c Nominal p-value.
Maltese: c Valur-p nominali.
English: Subgroup analyses were conducted on multiple factors, including cAEDs.
Maltese: Kien mwettqa analiżijiet tas-sottogruppi fuq fatturi multipli, inkluż cAEDs.
English: Intensified Monitoring:
Maltese: Monitoraġġ Intensifikat:
English: Adult population
Maltese: Popolazzjoni adulta
English: Possible side effects.
Maltese: Effetti sekondarji possibbli.
English: Irritability, Insomnia, Aggression, Abnormal behaviour, Agitation
Maltese: Irritabilità, Insomnja, Aggressjoni, Imġiba anomali, Aġitazzjoni
English: 79 mg anhydrous ethanol
Maltese: 79 mg ta' anhydrous ethanol
English: Table 2: Tabulated list of adverse reactions
Maltese: Tabella 2: Lista tabulata tar-reazzjonijiet avversi
English: In vitro assessment of drug interactions
Maltese: Evalwazzjoni in vitro ta' interazzjoni mediċinali
English: What Epidyolex contains - The active substance is cannabidiol.
Maltese: X'fih Epidyolex - Is-sustanza attiva hi cannabidiol.
English: 3821AL Amersfoort, The Netherlands
Maltese: 3821AL Amersfoort, L-Olanda
English: Linearity
Maltese: Linearità
English: Cannabidiol causes dose-related elevations of liver transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) (see section 4.8).
Maltese: Cannabidiol jikkawża żidiet fil-livelli ta' transaminases tal-fwied (alanine aminotransferase [ALT] u/jew aspartate aminotransferase [AST])marbuta mad-doża (ara sezzjoni 4.8).
English: Ethanol in the formulation
Maltese: Ethanol fil-formulazzjoni
English: The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100).
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.
Maltese: Cannabidiol u l-metabolit 7-OH-CBD ma jinteraġixxux mat-trasportaturi tal-assorbiment renali jew epatiċi maġġuri, u għalhekk mhux probabbli li jwasslu għal interazzjonijiet bejn mediċina u oħra: OAT1, OAT3, OCT1, OCT2, MATE1, MATE2-K, OATP1B1u OATP1B3.
English: In vivo assessment of drug interactions
Maltese: Evalwazzjoni in vivo ta' interazzjoni mediċinali
English: Epidyolex is an oral solution (a liquid to be swallowed).
Maltese: Epidyolex huwa soluzzjoni orali (likwidu li għandu jinbela').
English: The apparent volume of distribution was high in healthy volunteers at 20,963 L to 42,849 L and greater than total body water, suggesting a wide distribution of cannabidiol.
Maltese: Il-volum ta' distribuzzjoni apparenti kien għoli f'voluntiera b'saħħithom b'valuri ta' 20,963 L sa 42,849 L u akbar mill-ilma totali tal-ġisem, li jindika distribuzzjoni b'mod mifrux ta' cannabidiol.
English: a average increases of 47% in AUC and 73% in Cmax b based on Cmax and AUC
Maltese: a żidiet medji ta' 47% fl-AUC u ta' 73% fis-Cmax b ibbażati fuq is-Cmax u l-AUC
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics; ATC code: N03AX24
Maltese: Kategorija farmakoterapewtika: antiepilettiċi, antiepilettiċi oħra; Kodiċi ATC:
English: CYP3A4 or CYP2C19 inducers
Maltese: Indutturi ta' CYP3A4 u CYP2C19
English: The phase I metabolites identified in standard in vitro assays were 7-COOH-CBD, 7-OH-CBD, and 6-OH-CBD (a minor circulating metabolite).
Maltese: Il-metabolizzaturi ta' fażi I identifikati fl-assaġġi in vitro standard kienu 7-COOH-CBD, 7-OH-CBD, u 6-OH-CBD (metabolit minuri li jiċċirkola).
English: INFORMATION IN BRAILLE epidyolex
Maltese: INFORMAZZJONI BIL-BRAILLE epidyolex
English: Pneumoniaa, Bronchitis, Nasopharyngitis, Urinary tract infection
Maltese: Pnewmonjaa, Bronkite, Nasofarinġite, Infezzjoni fl-apparat tal-awrina
English: 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
Maltese: GWPCARE3 Plaċebo 10 mg/kg/jum 20 mg/kg/jum GWPCARE4 Plaċebo 20 mg/kg/jum Differenza jew Tnaqqis Perċentwali Meta Mqabbel mal-Plaċebo (95% CI), valur-pb
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).
Maltese: Cannabidiol inaqqas l-iper-eċċitabbiltà newronali permezz tal-modulazzjoni tal-kalċju intraċellulari minn ġol-kanali tar-riċettur 55 imwaħħal mal-proteina G (GPR55, G protein-coupled receptor 55) u r-riċettur transitorju potenzjali vanilloid 1 (TRPV-1, transient receptor potential vanilloid 1), kif ukoll il-modulazzjoni tas-sinjalar medjat mill-adenosine permezz ta' inibizzjoni tat-tlugħ ta adenosine cellulari permezz tat-trasportatur 1 nukleosid ekwilibrattiv (ENT-1, equilibrative nucleoside transporter 1).
English: Routine Monitoring:
Maltese: Monitoraġġ ta' Rutina:
English: GW Pharma (International) B.V., Databankweg 26, 3821AL Amersfoort, The Netherlands e-mail: info@gwpharm.com
Maltese: B.V., Databankweg 26, 3821AL Amersfoort, L-Olanda e-mail: info@gwpharm.com
English: Each ml of solution contains:
Maltese: Kull mL ta' soluzzjoni fih:
English: Haematologic abnormalities
Maltese: Anormalitajiet ematoloġiċi
English: Placebo 10 mg/kg/day 20 mg/kg/day
Maltese: Plaċebo 10 mg/kg/jum 20 mg/kg/jum
English: Contents of the pack and other information.
Maltese: Kontenut tal-pakkett u informazzjoni oħra.
English: 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.
Maltese: Dejta in vitro tbassar interazzjonijiet bejn mediċina u oħra bis-sottostrati ta' CYP1A2 (eż., theophylline, kaffeina), sottostrati ta' CYP2B6 (eż., bupropion, efavirenz), uridine 5' diphospho-glucuronosyltransferase 1A9 (UGT1A9) (eż., diflunisal, propofol, fenofibrate), u UGT2B7 (eż., gemfibrozil, morphine, lorazepam) meta jingħataw flimkien ma' cannabidiol.
English: In the phase 3 clinical trials, the observed frequency of status epilepticus was similar between the cannabidiol and placebo groups.
Maltese: Fil-provi kliniċi ta' fażi 3, il-frekwenza osservata ta' status epilepticus kienet simili bejn il-gruppi ta' cannabidiol u l-plaċebo.
English: p=0.0032c ≥ 50% REDUCTION IN CONVULSIVE SEIZURES (RESPONDER ANALYSIS) Percentage of ≥ 50% Responders, p-valued GWPCARE2
Maltese: p=0.0032c ≥ 50% TNAQQIS FL-AĊĊESSJONIJIET KONVULŻIVI (ANALIŻI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1389/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1389/001
English: Co-administration of cannabidiol is also predicted to cause clinically significant interactions with CYP2C8 (repaglinide) and CYP2C9 (e.g., warfarin) substrates.
Maltese: cannabidiol huwa wkoll imbassar li jikkawża interazzjonijiet klinikament sinifikanti ma' sottostrati ta' CYP2C8 (repaglinide) u CYP2C9 (eż., warfarin).
English: There was a significant positive correlation between the derived AUC of cannabidiol and the probability of a ≥ 50% response.
Maltese: Kien hemm korrelazzjoni pożittiva sinifikanti bejn l-AUC derivata ta' cannabidiol u l-probabbilità ta' rispons ta' ≥ 50%.
English: Overall
Maltese: Globali
English: The major CYP450 isoforms responsible for the phase I metabolism of cannabidiol are CYP2C19 and CYP3A4.
Maltese: L-iżoformi ta' CYP450 maġġuri responsabbli għall-metaboliżmu ta' fażi I ta' cannabidiol huma CYP2C19 u CYP3A4.
English: Cannabidiol does not require dose adjustment in patients with mild hepatic impairment (Child-Pugh A).
Maltese: Cannabidiol ma jeħtieġx aġġustament fid-doża f'pazjenti b'indeboliment epatiku ħafif (Child-Pugh A).
English: Lamotrigine is a substrate for UGT enzymes including UGT2B7 which is inhibited by cannabidiol in vitro.
Maltese: Lamotrigine huwa sottostrat għall-enzimi ta' UGT inkluż UGT2B7 li tiġi inibita permezz ta' cannabidiol in vitro.
English: The most commonly used cAEDs (> 25% of patients) in both trials were valproate, clobazam, lamotrigine, levetiracetam, and rufinamide.
Maltese: Il-cAEDs użati bl-aktar mod komuni (> 25% tal-pazjenti) fiż-żewġ provi kienu valproate, clobazam, lamotrigine, levetiracetam, u rufinamide.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot
Maltese: NUMRU TAL-LOTT, DONAZZJONI U KOWD TAL-PRODOTT Lot
English: Cannabidiol is extensively metabolised by the liver via CYP450 enzymes and the UGT enzymes.
Maltese: Cannabidiol jiġi metabolizzat b'mod estensiv mill-fwied permezz tal-enzimi ta' CYP450 u l-enzimi ta' UGT.
English: Placebo 20 mg/kg/day Difference or Percent Reduction Compared with Placebo (95% CI), p-valueb GWPCARE2
Maltese: Plaċebo 20 mg/kg/jum Differenza jew Tnaqqis Perċentwali Meta Mqabbel mal-Plaċebo (95% CI), valur-pb GWPCARE2
English: Cannabidiol induces CYP1A2 and CYP2B6 mRNA expression at clinically relevant concentrations.
Maltese: Cannabidiol jinduċi l-espressjoni mRNA ta' CYP1A2 u CYP2B6 f'konċentrazzjonijiet klinikament rilevanti.
English: Tabulated list of adverse reactions
Maltese: Lista tabulata tar-reazzjonijiet avversi
English: In vitro, > 94% of cannabidiol and its phase I metabolites were bound to plasma proteins, with preferential binding to human serum albumin.
Maltese: In vitro, > 94% ta' cannabidiol u tal-metaboliti tiegħu ta' fażi 1 kienu marbuta mal-proteina tal-plażma b'irbit preferenzjali mal-albumina fis-serum tal-bniedem.
English: Biotransformation and elimination
Maltese: Bijotrasformazzjoni u eliminazzjoni
English: GWPCARE3 10 mg/kg/day p=0.0016
Maltese: GWPCARE3 10 mg/kg/jum p = 0.0016
English: Potential interactions between cannabidiol (750 mg twice daily in healthy volunteers and 20 mg/kg/day in patients) and other AEDs were investigated in drug-drug interaction studies in healthy volunteers and in patients and in a population pharmacokinetic analysis of plasma drug concentrations from placebo-controlled studies in the treatment of patients with LGS.
Maltese: L-interazzjonijiet potenzjali bejn cannabidiol (750 mg darbtejn kuljum f'voluntiera b'saħħithom u 20 mg/kg/jum fil-pazjenti) u AEDs oħra kienu investigati fi studji dwar l-interazzjoni mediċinali f'voluntiera b'saħħithom u fil-pazjenti, u f'analiżi farmakokinetika tal-popolazzjoni tal-konċentrazzjonijiet tal-mediċina fil-plażma minn studji kkontrollati bil-pazjent fit-trattament ta' pazjenti b'LGS.
English: In rats, the EFD study evaluated doses of 75, 150, or 250 mg/kg/day.
Maltese: Fil-firien, l-istudju EFD evalwa dożi ta' 75, 150, jew 250 mg/kg/jum.
English: Pharmacokinetic/pharmacodynamic relationship(s)
Maltese: Relazzjoni(-jiet) farmakokinetika(ċi)/farmakodinamika(ċi)
English: Mean age of the study population was 9 years and 94% were taking 2 or more cAEDs during the trial.
Maltese: L-età medja tal-popolazzjoni tal-istudju kienet 9 snin u 94% kienu qed jieħdu żewġ cAEDs jew aktar matul il-prova.
English: Convulsive seizures were defined as atonic, tonic, clonic, and tonic-clonic seizures.
Maltese: L-aċċessjonijiet konvulżivi kienu definiti bħala aċċessjonijiet atoniċi, toniċi, klonici u toniċi-kloniċi.
English: No effect on clobazam levels.
Maltese: L-ebda effett fuq il-livelli ta' clobazam.
English: A corresponding decrease in haematocrit was also observed, with a mean change of −1.4% in cannabidiol-treated patients.
Maltese: Kien ukoll osservat tnaqqis korrispondenti fl-ematokrit, b'bidla medja ta' −1.4% f'pazjenti ttrattati b'cannabidiol.
English: Elderly patients Pharmacokinetics of cannabidiol have not been studied in patients > 55 years of age.
Maltese: Pazjenti anzjani Il-farmakokinetika ta' cannabidiol ma ġietx studjata f'pazjenti li kellhom > 55 sena.
English: GWPCARE4 20 mg/kg/day p=0.0135
Maltese: GWPCARE4 20 mg/kg/jum p = 0.0135
English: The metabolite 7-COOH-CBD is a P-gp/MDR1 substrate and has the potential to inhibit BCRP, OATP1B3, and OAT3.
Maltese: Il-metabolit 7-COOH-CBD huwa sottostrat ta' P-gp/MDR1 u għandu l-potenzjal li jinibixxi BCRP, OATP1B3, u OAT3.