FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Hos patienter med LGS og DS var vægttabet tilsyneladende dosisrelateret, og 19 % af de patienter, der fik cannabidiol 20 mg/kg/dag, oplevede et vægttab på ≥ 5 % sammenlignet med 8 % hos patienter, der fik cannabidiol 10 mg/kg/dag.
English: Phenytoin
Danish: Fenytoin
English: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other concurrent therapy (see sections 4.4 under hepatocellular injury and
Danish: Det anbefales normalt at starte i den lave ende af doseringsområdet, hvilket stemmer overens med den større hyppighed af nedsat lever-, nyre- eller hjertefunktion og af anden samtidig sygdom eller anden samtidig behandling (se pkt.
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).
Danish: Adjuverende behandling hos patienter med Lennox-Gastauts syndrom (LGS) Cannabidiols virkning ved adjuverende behandling af anfald forbundet med Lennox-Gastauts syndrom (LGS) blev evalueret i to randomiserede, dobbeltblindede, placebokontrollerede parallelgruppestudier (GWPCARE3 og GWPCARE4).
English: Interaction resulting in an increase in exposure of the active metabolite 7-OH-CBD in HV* studies.
Danish: Interaktion resulterende i en stigning i eksponering for den aktive metabolit 7-OH-CBD i studier med raske frivillige.
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).
Danish: Adjuverende behandling hos patienter med Dravets syndrom Cannabidiols virkning ved adjuverende behandling af anfald forbundet med Dravets syndrom (DS) blev evalueret i to randomiserede, dobbeltblindede, placebokontrollerede parallelgruppestudier (GWPCARE2 og GWPCARE1).
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%.
Danish: I undergruppen af DS-patienter, som fik samtidig behandling med clobazam i 37 til 48 uger (n = 54), var den mediane procent reduktion i hyppigheden af krampeanfald i forhold til baseline 60 % i løbet af uge 1-12, og dette blev opretholdt frem til uge 37-48, med en median procent reduktion i hyppigheden af krampeanfald i forhold til baseline på 45 %.
English: 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.
Danish: d Den samlede p-værdi er baseret på en Cochran-Mantel-Haenszel-test; de nominelle p-værdier for undergruppen med clobazam er baseret på logistisk regressionsanalyse.
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.
Danish: In vitro-data tyder på, at cannabidiol er en hæmmer af CYP1A2-, CYP2B6-, CYP2C8-, CYP2C9-, CYP2C19-, UGT1A9- og UGT2B7-medieret aktivitet ved klinisk relevante koncentrationer.
English: 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.
Danish: d Den samlede p-værdi er baseret på en Cochran-Mantel-Haenszel-test; den nominelle p-værdi for undergruppen med clobazam er baseret på logistisk regressionsanalyse.
English: Concomitant use of cannabidiol and valproate increases the incidence of transaminase enzyme elevations (see section 4.4).
Danish: Samtidig brug af cannabidiol og valproat øger forekomsten af transaminaseenzymforhøjelser (se pkt.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GW Pharma (International) B.V., Databankweg 26
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN GW Pharma (International) B.V., Databankweg 26
English: Hepatocellular injury Cannabidiol causes dose-related elevations of ALT and AST (see section 4.4).
Danish: Hepatocellulær skade Cannabidiol forårsager dosisrelaterede forhøjelser af ALAT og ASAT (se pkt.
English: Do not place the oral syringe in a dishwasher.
Danish: Sprøjten må ikke komme i opvaskemaskinen.
English: 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.
Danish: Det leveres i en flaske med børnesikret låg og sammen med to ens doseringssprøjter på 5 ml og to på 1 ml samt to flaskeadaptere til brug af disse sprøjter.
English: Do not reduce the dose or stop taking Epidyolex without first talking to your doctor.
Danish: Hvis du eller patienten holder op med at tage Epidyolex Du må ikke tage en mindre dosis eller holde op med at tage Epidyolex uden først at tale med lægen.
English: • A plastic bag containing two 1 ml oral syringes and a bottle adaptor
Danish: • En plastpose med to orale sprøjter til 1 ml og en flaskeadapter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 100 mg cannabidiol.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En ml oral opløsning indeholder 100 mg cannabidiol.
English: Signs of taking more Epidyolex than you should include diarrhoea and sleepiness.
Danish: Hvis du har taget for meget Epidyolex, kan det vise sig som diarré og søvnighed.
English: Place the tip of the oral syringe inside the cheek, and gently push the plunger to release the medicine.
Danish: Sæt spidsen af sprøjten i munden og op ad kinden, og tryk forsigtigt på stemplet for at trykke lægemidlet ud.
English: In rats, the EFD study evaluated doses of 75, 150, or 250 mg/kg/day.
Danish: EFD-studiet evaluerede doser til rotter på 75, 150 eller 250 mg/kg/dag.
English: Data for study GWPCARE2 and the with clobazam subgroup are presented as percent reduction from baseline estimated from a negative binomial regression analysis.
Danish: Data for studiet GWPCARE2 og undergruppen med clobazam præsenteres som en procent reduktion i forhold til baseline anslået ud fra en negativ binomial regressionsanalyse.
English: Table 4: Primary and ≥ 50% responder key secondary outcome measures and subgroup analysis in DS studies
Danish: Tabel 4: Primære og vigtige sekundære resultatmål for ≥ 50 % respondere samt undergruppeanalyse i DS-studier
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.
Danish: 5.1) med patienter, som tog cannabidiol 20 mg/kg/dag, var hyppigheden af behandlingsrelaterede forhøjelser af ALAT over 3 gange ULN 31 % (hvoraf 84 % fik valproat) i de tilfælde, hvor ALAT var over ULN ved baseline, sammenlignet med 12 % (hvoraf 89 % fik valproat) i de tilfælde, hvor ALAT var inden for normalområdet ved baseline.
English: Cannabidiol can cause weight loss.
Danish: Cannabidiol kan forårsage vægttab.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
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.
Danish: Vigtige sekundære endepunkter for GWPCARE2 var andelen af patienter med mindst 50 % reduktion i hyppighed af krampeanfald, ændringen i samlet hyppighed af anfald samt omsorgspersonens globale indtryk af ændring (CGIC) ved sidste besøg.
English: Phenytoin has a narrow therapeutic index, so combining cannabidiol with phenytoin should be initiated with caution and if tolerability issues arise, dose reduction of phenytoin should be considered.
Danish: Fenytoin har et smalt terapeutisk indeks, og der skal derfor udvises forsigtighed ved administration af cannabidiol i kombination med fenytoin.
English: p=0.0032c ≥ 50% REDUCTION IN CONVULSIVE SEIZURES (RESPONDER ANALYSIS) Percentage of ≥ 50% Responders, p-valued GWPCARE2
Danish: p < 0,0001c ≥ 50 % REDUKTION I ANFALD, SOM FORÅRSAGER FALD (RESPONDERANALYSE) Procentdel af ≥ 50 % respondere, p-værdid
English: Dose adjustment of any co-administered medicinal product that is known to affect the liver should be considered (e.g., valproate and clobazam) (see section 4.5).
Danish: Det skal overvejes at justere dosis af andre samtidigt administrerede lægemidler, der er kendte for at påvirke leveren (f.eks. valproat og clobazam) (se pkt.
English: Drug interaction studies
Danish: Lægemiddelinteraktionsstudier
English: The metabolite 7-carboxy-cannabidiol (7-COOH-CBD) is also an inhibitor of UGT1A1, UGT1A4 and UGT1A6-mediated activity in vitro.
Danish: Metabolitten 7-carboxy-cannabidiol (7-COOH-CBD) er også en hæmmer af UGT1A1-, UGT1A4- og UGT1A6-medieret aktivitet in vitro.
English: Remove the child-resistant cap on the bottle by pushing the cap down whilst turning the cap anti-clockwise.
Danish: Tag det børnesikrede låg af flasken ved at trykke låget ned, mens du drejer låget mod uret.
English: With Clobazam
Danish: N Undergruppe med clobazam
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).
Danish: Sammenlignet med placebo var cannabidiol forbundet med en stigning i antallet af dage uden krampeanfald i behandlingsperioden i hvert forsøg, hvilket svarer til 2,7 dage pr. 28 dage (10 mg/kg/dag) og 1,3-2,2 dage pr. 28 dage (20 mg/kg/dag).
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.
Danish: b Samlede data præsenteres som en anslået median forskel og p-værdi fra en Wilcoxons nonparametrisk test. Data for undergruppen med clobazam er anslået fra en negativ binomial regressionsanalyse.
English: Table 4 summarises the primary endpoint of percent reduction from baseline in convulsive seizures, and the key secondary measure of proportion of patients with at least a 50% reduction in convulsive seizure frequency, as well as results of the subgroup analysis for these outcome measures in patients treated with concomitant clobazam.
Danish: Tabel 4 opsummerer det primære endepunkt, procent reduktion i hyppighed af krampeanfald i forhold til baseline, og det vigtige sekundære mål, andelen af patienter med mindst 50 % reduktion i hyppigheden af krampeanfald, samt resultaterne af undergruppeanalysen for disse resultatmål hos patienter, som fik samtidig behandling med clobazam.
English: Table 3 summarises the primary endpoint of percent reduction from baseline in drop seizures, and the key secondary measure of proportion of patients with at least a 50% reduction in drop seizure frequency, as well as results of the subgroup analysis for these outcome measures in patients treated with concomitant clobazam.
Danish: Tabel 3 opsummerer det primære endepunkt, procent reduktion i hyppighed af anfald, som forårsager fald, i forhold til baseline, og det vigtige sekundære mål, andelen af patienter med mindst 50 % reduktion i hyppigheden af anfald, som forårsager fald, samt resultaterne af undergruppeanalysen for disse resultatmål hos patienter, som fik samtidig behandling med clobazam.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GW Pharma (International) B.V., Databankweg 26, 3821AL Amersfoort, The Netherlands
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN GW Pharma (International) B.V., Databankweg 26, 3821AL Amersfoort, Holland
English: Risk Factors for Hepatocellular injury Concomitant Valproate and Clobazam, Dose of cannabidiol and Baseline Transaminase Elevations
Danish: Samtidig administration af valproat og clobazam, dosis af cannabidiol og forhøjet transaminase ved baseline
English: • If your dose is 1 ml (100 mg) or less, you should use the smaller 1 ml syringe.
Danish: • Hvis din dosis er 1 ml (100 mg) eller mindre, skal du bruge den lille 1 ml-sprøjte.
English: Epidyolex contains sesame oil, alcohol (ethanol), strawberry flavour components (including benzyl alcohol).
Danish: Epidyolex indeholder sesamolie, alkohol (ethanol) og jordbærsmagskomponenter (herunder benzylalkohol)
English: Open-label data
Danish: Data fra det åbne studie
English: Cannabidiol can cause decreases in haemoglobin and haematocrit.
Danish: Cannabidiol kan forårsage fald i hæmoglobin og hæmatokrit.
English: • If your dose is more than 5 ml (500 mg), you will need to use the larger 5 ml syringe more than once.
Danish: • Hvis din dosis er mere end 5 ml (500 mg), skal du bruge den store 5 ml-sprøjte flere gange.
English: Key secondary endpoints were the proportion of patients with at least a 50% reduction in drop seizure frequency, the percentage change from baseline in total seizure frequency, and Subject/Caregiver Global Impression of Change at the last visit.
Danish: Vigtige sekundære endepunkter var andelen af patienter med mindst 50 % reduktion i hyppighed af anfald, som forårsager fald, den procentvise ændring i forhold til baseline i samlet hyppighed af anfald samt forsøgspersonens/omsorgspersonens globale indtryk af ændring (Global Impression of Change (S/CGIC)) ved sidste besøg.
English: GW Pharma (International) B.V., Databankweg 26, 3821AL Amersfoort, The Netherlands e-mail: info@gwpharm.com
Danish: Indehaver af markedsføringstilladelsen og fremstiller GW Pharma (International) B.V., Databankweg 26, 3821AL Amersfoort, Holland e-mail: info@gwpharm.com
English: The UGT isoforms responsible for the phase II conjugation of cannabidiol are UGT1A7, UGT1A9 and UGT2B7.
Danish: De UGT-isoformer, der er ansvarlige for fase II-konjugationen af cannabidiol, er UGT1A7, UGT1A9 og UGT2B7.
English: The 5 ml syringes are graduated in 0.1 ml increments and the 1 ml syringes are graduated in 0.05 ml increments.
Danish: 5 ml-sprøjterne har inddelinger for hver 0,1 ml, og 1 ml-sprøjterne har inddelinger for hver 0,05 ml.
English: LIST OF EXCIPIENTS Contains refined sesame oil, ethanol and strawberry flavour components (including benzyl alcohol).
Danish: LISTE OVER HJÆLPESTOFFER Indeholder raffineret sesamolie, ethanol og jordbærsmagskomponenter (herunder benzylalkohol).
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
Danish: Hos juvenile rotter medførte administration af cannabidiol i 10 uger (subkutane doser på 0 eller 15 mg/kg på dag 4-6 postnatalt efterfulgt af oral administration af 0, 100, 150 eller 250 mg/kg på dag 7-77 postnatalt) øget legemsvægt, forsinket kønsmodning hos hanner, neuroadfærdsmæssige ændringer, øget knoglemineraltæthed samt leverhepatocytvakuolisering.
English: Each ml of oral solution contains 100 mg of cannabidiol.
Danish: En ml oral opløsning indeholder 100 mg cannabidiol.
English: Package leaflet: Information for the patient Epidyolex 100 mg/ml oral solution cannabidiol
Danish: Indlægsseddel: Information til patienten Epidyolex 100 mg/ml oral opløsning cannabidiol
English: What you or the patient need to know before taking Epidyolex
Danish: Det skal du eller patienten vide, før du begynder at tage Epidyolex
English: Dose response
Danish: Dosisrespons
English: Each Epidyolex carton is supplied with:
Danish: I en æske Epidyolex findes der:
English: Decreased weight
Danish: Nedsat leverfunktion
English: Pneumoniaa, Bronchitis, Nasopharyngitis, Urinary tract infection
Danish: Hyppighed Bivirkninger fra kliniske forsøg Infektioner og parasitære sygdomme Almindelig Pneumonia, bronkitis, nasopharyngitis, urinvejsinfektion
English: When cannabidiol and clobazam are co-administered, bi-directional PK interactions occur.
Danish: Ved samtidig administration af cannabidiol og clobazam forekommer der farmakokinetiske interaktioner begge veje.
English: NAME OF THE MEDICINAL PRODUCT Epidyolex 100 mg/ml oral solution
Danish: LÆGEMIDLETS NAVN Epidyolex 100 mg/ml oral opløsning
English: a Data for the overall population are presented as median percent reduction from baseline.
Danish: CI = 95 % konfidensinterval a Data for den samlede population præsenteres som en median procent reduktion i forhold til baseline.
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).
Danish: Sammenlignet med placebo var cannabidiol forbundet med en stigning i antallet af dage uden anfald, som forårsager fald, i behandlingsperioden i hvert forsøg, svarende til 3,3 dage pr. 28 dage (10 mg/kg/dag) og hhv. 5,5 og 7,6 dage pr. 28 dage for hver af de 2 grupper med 20 mg/kg/dag.
English: a For study GWPCARE1, overall data are presented as median percent reduction from baseline.
Danish: CI = 95 % konfidensinterval a For studiet GWPCARE1 præsenteres samlede data som en median procent reduktion i forhold til baseline.
English: Concomitant AED treatments
Danish: Samtidig behandling med antiepileptika
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)
Danish: - To 1 ml-sprøjter med markeringer for hver 0,05 ml (en markering af 0,05 ml svarer til 5 mg cannabidiol)
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).
Danish: Metabolitten 7-carboxy-cannabidiol (7-COOH-CBD) er en hæmmer af UGT1A1-, UGT1A4- og UGT1A6-medieret aktivitet in vitro ved klinisk relevante koncentrationer.
English: Cannabidiol is a substrate for UGT1A7, UGT1A9 and UGT2B7.
Danish: Cannabidiol er et substrat for UGT1A7, UGT1A9 og UGT2B7.
English: Cannabidiol is a substrate for CYP3A4, CYP2C19, UGT1A7, UGT1A9 and UGT2B7.
Danish: Cannabidiol er et substrat for CYP3A4, CYP2C19, UGT1A7, UGT1A9 og UGT2B7.
English: If the calculated dose is more than 100 mg (1 ml), the larger 5 ml oral syringe should be used.
Danish: Hvis den beregnede dosis er over 100 mg (1 ml), skal den store orale sprøjte med 5 ml bruges.
English: What you or the patient need to know before taking Epidyolex.
Danish: Det skal du eller patienten vide, før du begynder at tage Epidyolex 3.
English: GWPCARE4 Placebo 20 mg/kg/day p=0.0043
Danish: GWPCARE4 Placebo 20 mg/kg/dag p = 0,0043
English: If you forget to take a dose, do not take a double dose to make up for a forgotten dose.
Danish: Hvis du eller patienten har glemt at tage Epidyolex Hvis du har glem at tage en dosis må du ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: • If your dose is more than 1 ml (100 mg), you should use the larger 5 ml syringe.
Danish: • Hvis din dosis er mere end 1 ml (100 mg), skal du bruge den store 5 ml-sprøjte.
English: PHARMACEUTICAL FORM AND CONTENTS Oral solution
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
English: Severe
Danish: Svært
English: NAME OF THE MEDICINAL PRODUCT Epidyolex 100 mg/ml oral solution cannabidiol
Danish: LÆGEMIDLETS NAVN Epidyolex 100 mg/ml oral opløsning cannabidiol
English: GWPCARE3 10 mg/kg/day p=0.0016
Danish: GWPCARE3 10 mg/kg/dag p = 0,0016
English: Patients with sustained transaminase elevations of greater than 5 times the ULN should also have treatment discontinued.
Danish: Behandlingen skal desuden seponeres for patienter, der vedvarende har transaminaseniveauer over 5 gange ULN.
English: Push the bottle adaptor firmly into the neck of the bottle, and make sure it is fully inserted.
Danish: Skub flaskeadapteren ind i flaskehalsen med et fast tryk, og sørg for, at den er trykket helt ind. Adapteren kan løsne sig og være en kvælningsfare, hvis den ikke sidder helt inde.
English: • Epidyolex oral solution bottle
Danish: • En flaske med Epidyolex oral opløsning
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).
Danish: Cannabidiol var forbundet med en stigning i procentdelen af patienter, der oplevede en reduktion større end eller svarende til 75 % i hyppigheden af anfald, som forårsager fald, i behandlingsperioden i hvert forsøg (11 % af dem der fik 10 mg/kg/dag cannabidiol, 31 % til 36 % af dem der fik 20 mg/kg/dag cannabidiol, og 3 % til 7 % af dem der fik placebo).
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).
Danish: I hvert forsøg var medianen for de patienter, som fik cannabidiol, større for procentvis reduktion i samlet antal anfald sammenlignet med placebo (53 % for 10 mg/kg/dag, 64 % til 66 % for 20 mg/kg/dag og 25 % for hver placebogruppe; p = 0,0025 for 10 mg/kg/dag og p < 0,0001 for hver gruppe med 20 mg/kg/dag kontra placebo).
English: Cannabidiol was associated with an increase in the percentage of subjects experiencing a greater than or equal to 75% reduction in convulsive seizure frequency during the treatment period in each trial (36% 10 mg/kg/day cannabidiol, 25% for each 20 mg/kg/day cannabidiol group, 10% to 13% placebo).
Danish: Cannabidiol var forbundet med en stigning i procentdelen af forsøgsdeltagere, der oplevede en reduktion større end eller lig med 75 % i hyppigheden af krampeanfald i behandlingsperioden i hvert forsøg (36 % af dem der fik 10 mg/kg/dag cannabidiol, 25 % for hver gruppe, som fik 20 mg/kg/dag cannabidiol, og 10 % til 13 % af dem der fik placebo).
English: GWPCARE4 20 mg/kg/day p=0.0135
Danish: GWPCARE4 20 mg/kg/dag p = 0,0135
English: Increased seizure frequency
Danish: Øget forekomst af krampeanfald
English: Other medicines and Epidyolex
Danish: Brug af anden medicin sammen med Epidyolex
English: 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.
Danish: Sæt spidsen af den sprøjte, du skal bruge, helt ind i flaskeadapteren, og vend flasken på hovedet med sprøjten isat.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of oral solution contains 100 mg cannabidiol
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En ml oral opløsning indeholder 100 mg cannabidiol
English: If the calculated dose is 100 mg (1 ml) or less, the smaller 1 ml oral syringe should be used.
Danish: Hvis den beregnede dosis er 100 mg (1 ml) eller derunder, skal den lille orale sprøjte med 1 ml bruges.