FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism of this risk is not known, and the available data do not exclude the possibility of an increased risk for cannabidiol.
Danish: Mekanismen bag denne risiko kendes ikke, og de foreliggende data udelukker ikke muligheden for en øget risiko for cannabidiol.
English: Effect of age, weight, sex, race
Danish: Virkning af alder, vægt, køn, race
English: There have not been any clinical studies formally investigating this interaction.
Danish: Der er ikke udført kliniske studier, som formelt har undersøgt denne interaktion.
English: Biotransformation and elimination
Danish: Biotransformation og elimination
English: Each study consisted of a 4-week baseline period, a 2-week titration period and a 12-week maintenance period.
Danish: Hvert studie bestod af en 4-ugers baseline-periode, en 2-ugers titreringsperiode og en 12-ugers vedligeholdelsesperiode.
English: (See section 4.2 for information on paediatric use).
Danish: 4.2 for oplysninger om pædiatrisk anvendelse).
English: The mechanism has not been determined.
Danish: Mekanismen er ikke blevet fastlagt.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot
Danish: BATCHNUMMER, DONATIONS- OG PRODUKTKODER Lot
English: The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Danish: Hyppighederne defineres som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1.000 til < 1/100).
English: The medicine may be harmful for those suffering from alcoholism.
Danish: Dette lægemiddel kan være skadeligt for alkoholikere.
English: Reversibility was not assessed in studies in LGS and DS.
Danish: Reversibilitet blev ikke vurderet i studierne med LGS og DS.
English: Contact your doctor or go to a hospital straight away.
Danish: Kontakt lægen eller tag på hospitalet med det samme.
English: The Netherlands E-mail: info@gwpharm.com
Danish: E-mail: info@gwpharm.com
English: Increased systemic levels of these active substances may lead to enhanced pharmacological effects and to an increase in adverse drug reactions.
Danish: Øgede systemiske niveauer af disse aktive stoffer kan føre til forstærkede farmakologiske virkninger og til en stigning i lægemiddelbivirkninger.
English: Your doctor will calculate the dose according to your body weight.
Danish: Lægen vil beregne din dosis efter din legemsvægt.
English: Epidyolex must not be given to children under the age of 2 years, since there is no information on use in children below this age.
Danish: Epidyolex må ikke gives til børn under 2 år, da der ikke er nogen oplysninger om brugen af dette lægemiddel til børn under denne alder.
English: In some cases, the decreased weight was reported as an adverse event (see the table above).
Danish: I nogle tilfælde blev vægttabet indberettet som en bivirkning (se tabellen ovenfor).
English: Read all of this leaflet carefully before you or the patient start taking this medicine because it contains important information for you or the patient
Danish: Læs denne indlægsseddel grundigt, inden du eller patienten begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger til dig eller patienten.
English: You may start on a low dose that your doctor gradually increases over time.
Danish: Det kan være, du i starten skal tage en lav dosis, som lægen så øger med tiden.
English: Contact your doctor or go to a hospital straight away (See section 4).
Danish: Tal med lægen, eller tag straks på hospitalet (se afsnit 4).
English: Dosing should be resumed at the existing treatment schedule.
Danish: Administrationen skal genoptages i henhold til det eksisterende behandlingsskema.
English: The rapid achievement of steady state is related to the multiphasic elimination profile of the drug in which the terminal elimination represents only a small fraction of the drug's clearance.
Danish: Den hurtige opnåelse af steady state er relateret til stoffets flerfasede eliminationsprofil, hvor den terminale elimination kun repræsenterer en lille del af stoffets clearance.
English: a average increases of 47% in AUC and 73% in Cmax b based on Cmax and AUC
Danish: a gennemsnitlige stigninger på 47 % i AUC og 73 % i Cmax b baseret på Cmax og AUC
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1389/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1389/001
English: A no-effect dose was not established.
Danish: Der blev ikke fastlagt en nuleffektsdosis.
English: It is not known if cannabidiol is dialysable.
Danish: Det vides ikke, om cannabidiol er dialyserbart.
English: There was a significant positive correlation between the derived AUC of cannabidiol and the probability of a ≥ 50% response.
Danish: Der var en signifikant positiv korrelation mellem det afledte AUC for cannabidiol og sandsynligheden for et ≥ 50 % respons.
English: Your doctor and pharmacist will tell you how much (number of ml) Epidyolex to take each day, how many times a day you should take it and which syringe you should use for your dose (1 ml or 5 ml).
Danish: Lægen og apotekspersonalet vil fortælle dig, hvor meget (hvor mange ml) Epidyolex du skal tage hver dag, hvor mange gange om dagen du skal tage det, og hvilken sprøjte du skal bruge til din dosis (1 ml eller 5 ml).
English: Juvenile toxicity
Danish: Juvenil toksicitet
English: Embryofoetal mortality was observed at the high dose, with no treatment-related effects on implantation loss at the low or mid doses.
Danish: Embryoføtal mortalitet blev observeret ved den høje dosis, og der var ingen behandlingsrelaterede virkninger på implantationstab ved de lave eller mellemhøje doser.
English: If the solution in the bottle has turned cloudy, this doesn't change how well it works.
Danish: Hvis væsken i flasken bliver uklar, har det ingen indvirkning på, hvor godt den virker.
English: The elevations typically occur in the first two months of treatment initiation; however, there were cases observed up to 18 months after initiation of treatment, particularly in patients taking concomitant valproate.
Danish: Forhøjelserne forekom typisk inden for de første to måneder efter påbegyndelse af behandlingen, men der blev observeret tilfælde op til 18 måneder efter påbegyndelse af behandlingen, især hos patienter, der samtidig tog valproat.
English: Early identification of elevated transaminase may decrease the risk of a serious outcome.
Danish: Tidlig påvisning af forhøjet transaminase kan nedsætte risikoen for et alvorligt udfald.
English: One 100 ml bottle
Danish: En 100 ml flaske
English: Epidyolex should be initiated and supervised by physicians with experience in the treatment of epilepsy.
Danish: Epidyolex skal initieres og overvåges af læger med erfaring i behandling af epilepsi.
English: Experience with doses higher than the recommended therapeutic dose is limited.
Danish: Der er begrænsede erfaringer med doser, der er højere end den anbefalede terapeutiske dosis.
English: - if your doctor determines that you have certain abnormal liver blood tests.
Danish: - hvis din læge finder ud af, at dine resultater af visse leverblodprøver er unormale.
English: Use within 8 weeks after first opening the bottle.
Danish: Anvendes inden for 8 uger efter første åbning af flasken.
English: The clinical relevance of this is unknown, but the patient should be closely monitored for adverse drug reactions.
Danish: Den kliniske relevans af dette kendes ikke, men patienten skal monitoreres nøje for lægemiddelbivirkninger.
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.
Danish: Det tilsyneladende fordelingsvolumen var stort hos raske frivillige - 20.963 l til 42.849 l - og større end den samlede mængde vand i legemet, hvilket tyder på en udbredt fordeling af cannabidiol.
English: A small number of patients < 2 years with treatment-resistant epilepsy have been exposed to cannabidiol in an expanded access programme.
Danish: Et lille antal patienter < 2 år med behandlingsresistent epilepsi er blevet eksponeret for cannabidiol i et program med udvidet adgang.
English: - Epidyolex makes you feel sleepy.
Danish: - Epidyolex gør dig søvnig.
English: Compared to dronabinol (synthetic THC) and alprazolam, cannabidiol has low abuse potential.
Danish: Sammenlignet med dronabinol (syntetisk THC) samt alprazolam har cannabidiol et lavt misbrugspotentiale.
English: Potential for cannabidiol to affect other medicinal products
Danish: Cannabidiols potentiale for at påvirke andre lægemidler
English: The precise mechanisms by which cannabidiol exerts its anticonvulsant effects in humans are unknown.
Danish: De præcise mekanismer, hvormed cannabidiol udøver sine antikonvulsive virkninger hos mennesker, er ukendte.
English: Somnolence and sedation
Danish: Døsighed og sedation
English: Clear, colourless to yellow solution
Danish: Klar, farveløs til gul opløsning
English: If cannabidiol has to be discontinued, the dose should be decreased gradually.
Danish: Hvis cannabidiol skal seponeres, skal dosis reduceres gradvist.
English: Irritability, Insomnia, Aggression, Abnormal behaviour, Agitation
Danish: Almindelig Irritabilitet, insomni, aggression, unormal adfærd, agitation
English: These adverse reactions resolved upon study completion.
Danish: Disse bivirkninger forsvandt, da studiet blev afsluttet.
English: If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Cannabidiol does not exert its anticonvulsant effect through interaction with cannabinoid receptors.
Danish: Cannabidiol udøver ikke sin antikonvulsive virkning gennem interaktion med cannabinoid-receptorer.
English: Pharmacokinetics in special patient groups
Danish: Farmakokinetik hos særlige patientgrupper
English: 0.0003 mg benzyl alcohol
Danish: 0,0003 mg benzylalkohol
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.
Danish: Cannabidiol interagerer ikke med de vigtigste renale og hepatiske transportører på en måde, der sandsynligvis ville føre til relevante lægemiddelinteraktioner.
English: In the event of overdose the patient should be observed and appropriate symptomatic treatment given, including monitoring of vital signs.
Danish: I tilfælde af overdosering skal patienten observeres, og der skal indledes passende behandling, herunder monitorering af vitale tegn.
English: If there is an air bubble in the syringe, push the liquid back into the bottle whilst keeping the bottle upside down, and repeat Step 5 until the bubble has gone.
Danish: Hvis der er en luftboble i sprøjten, skal du trykke væsken tilbage i flasken, mens du holder flasken på hovedet, og gentage trin 5, indtil boblen er forsvundet.
English: Other CNS depressants, including alcohol, can potentiate the somnolence and sedation effect.
Danish: Andre CNS-deprimerende midler, herunder alkohol, kan potensere døsigheds- og sedationsvirkningen.
English: A NOAEL of 15 mg/kg/day was established.
Danish: Der blev fastlagt et NOAEL på 15 mg/kg/dag.
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer):
English: Monitoring
Danish: Monitorering
English: Steady-state plasma concentrations are attained within 2-4 days of twice daily dosing based on pre-dose (Ctrough) concentrations.
Danish: Steady-state plasmakoncentrationerne opnås inden for 2-4 dage efter dosering to gange dagligt baseret på præ-dosis-koncentrationer (Ctrough).
English: Epidyolex contains refined sesame oil which may rarely cause severe allergic reactions.
Danish: Epidyolex indeholder raffineret sesamolie, som i sjældne tilfælde kan medføre svære allergiske reaktioner.
English: In this case, keep careful track of how many times you have filled the syringe (e.g., by marking off each 5 ml dose, respectively) so that you take the right dose.
Danish: I dette tilfælde skal du omhyggeligt holde styr på, hvor mange gange du har fyldt sprøjten (ved for eksempel at sætte et kryds på et stykke papir, hver gang du har taget en dosis på 5 ml), så du tager den rigtige dosis.
English: Your doctor or pharmacist will let you know which syringe to use depending on the dose that has been prescribed.
Danish: Lægen eller apotekspersonalet vil fortælle dig, hvilken sprøjte du skal bruge, afhængigt af den dosis, du har fået ordineret.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with cannabidiol in one or more subsets of the paediatric population in treatment of seizures associated with DS and LGS.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med cannabidiol i en eller flere undergrupper af den pædiatriske population ved behandling af anfald forbundet med DS og LGS.
English: Patients with prolonged elevations of serum transaminases should be evaluated for other possible causes.
Danish: Patienter med længerevarende forhøjelser af serumtransaminaser skal evalueres for andre mulige årsager.
English: The half-life of cannabidiol in plasma was 56-61 hours after twice daily dosing for 7 days in healthy volunteers.
Danish: Cannabidiols halveringstid i plasma var 56-61 timer efter dosering to gange dagligt i 7 dage hos raske frivillige.
English: You should not take Epidyolex while you are pregnant unless the doctor decides the benefits outweigh the potential risks.
Danish: Du må ikke tage Epidyolex, mens du er gravid, medmindre lægen beslutter, at fordelene opvejer de mulige risici.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics; ATC code: N03AX24
Danish: Farmakoterapeutisk klassifikation: antiepileptika, andre antiepileptika; ATC-kode: N03AX24
English: Common side effects (may affect more than 1 in 100 people):
Danish: Almindelige bivirkninger (kan forekomme hos flere end 1 ud af 100 personer):
English: In vitro, > 94% of cannabidiol and its phase I metabolites were bound to plasma proteins, with preferential binding to human serum albumin.
Danish: In vitro var > 94 % af cannabidiol og dets fase I-metabolitter bundet til plasmaproteiner med præferentiel binding til humant serumalbumin.
English: Adult population
Danish: Den voksne population
English: (See also section 3, How to take Epidyolex).
Danish: (Se også afsnit 3, Sådan skal du tage Epidyolex).
English: It is important that you use the correct oral syringe to measure your dose.
Danish: Det er vigtigt, at du bruger den rigtige sprøjte til at afmåle din dosis.
English: Take the next dose at your regular time.
Danish: Tag den næste dosis på det planlagte tidspunkt.
English: As a precautionary measure, cannabidiol should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the foetus.
Danish: For en sikkerheds skyld bør må cannabidiol ikke bruges under graviditeten, medmindre den potentielle fordel for moderen tydeligt opvejer den potentielle risiko for fosteret.
English: Suicidal behaviour and ideation
Danish: Selvmordsadfærd og -tanker
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.
Danish: DS-populationen i studierne GWPCARE2 og GWPCARE1 var fortrinsvis pædiatriske patienter - kun 5 voksne patienter var 18 år gamle (1,6 %) - og derfor blev der indhentet begrænsede data om virkning og sikkerhed hos den voksne DS-population.
English: The safety and efficacy of cannabidiol in children aged 6 months to 2 years have not yet been established.
Danish: Cannabidiol sikkerhed og virkning hos børn i alderen 6 måneder til 2 år er endnu ikke klarlagt.
English: Paediatric population There is no relevant use of cannabidiol in children aged below 6 months.
Danish: Pædiatrisk population Det er ikke relevant at anvende cannabidiol til børn under 6 måneder.
English: Genotoxicity studies have not detected any mutagenic or clastogenic activity.
Danish: Genotoksicitetsstudier har ikke påvist mutagen eller klastogen aktivitet.
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.
Danish: Den maksimale anbefalede enkeltdosis af Epidyolex (10 mg/kg) vil øge koncentrationen af ethanol i kroppen med ca. 13 mg/l.
English: There are no clinical data on the presence of cannabidiol or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
Danish: Der foreligger ingen kliniske data om tilstedeværelsen af cannabidiol eller dettes metabolitter i human mælk, virkningerne på det ammede barn eller virkningerne på mælkeproduktionen.
English: No effect on cannabidiol levels.
Danish: Ingen virkning på cannabidiolniveauer.
English: To minimise the variability in the bioavailability of cannabidiol in the individual patient, administration of cannabidiol should be standardised in relation to food intake including a ketogenic diet (high-fat meal).
Danish: For at minimere variabiliteten i cannabidiols biotilgængelighed hos den enkelte patient skal administration af cannabidiol standardiseres for så vidt angår indtagelse af mad, herunder en ketogen diæt (måltider med højt fedtindhold).
English: Patients should be monitored for signs of suicidal behaviour and ideation and appropriate treatment should be considered.
Danish: Patienterne skal monitoreres for tegn på selvmordsadfærd og -tanker, og passende behandling skal overvejes.
English: Concomitant use of clobazam also increased the incidence of transaminase elevations, although to a lesser extent than valproate.
Danish: Samtidig anvendelse af clobazam øgede også forekomsten af transaminaseforhøjelser, men i mindre grad end valproat.
English: The plasma clearance of cannabidiol following a single 1500 mg dose of cannabidiol is about 1,111 L/h.
Danish: Cannabidiols plasmaclearance efter en enkelt dosis på 1.500 mg cannabidiol er ca. 1.111 l/t.
English: If you have these thoughts at any time, contact your doctor
Danish: Hvis du på noget tidspunkt får sådanne tanker, skal du tale med lægen.
English: After single dosing, exposure over the range 750-6000 mg increases in a less than dose-proportional manner, indicating that absorption of cannabidiol may be saturable.
Danish: Efter en enkelt dosis øges eksponering i intervallet 750-6.000 mg på en mindre end dosisproportional måde, hvilket tyder på, at absorption af cannabidiol kan blive mættet.
English: - If your seizures happen more often, or if you experience a severe seizure while taking Epidyolex.
Danish: - dine anfald sker hyppigere, eller du oplever et alvorligt anfald, mens du tager Epidyolex.
English: Cannabidiol appears rapidly in plasma with a time to maximum plasma concentration of 2.5-5 hours at steady state.
Danish: Cannabidiol viser sig hurtigt i plasma, og tiden til maksimal plasmakoncentration er 2,5-5 timer ved steady state.
English: 4.7 Effects on ability to drive and use machines Cannabidiol has major influence on the ability to drive and operate machines because it may cause somnolence and sedation (see section 4.4).
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Cannabidiol påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner, da det kan forårsage døsighed og sedation (se pkt.
English: The doctor will explain how to gradually stop taking Epidyolex.
Danish: Lægen vil forklare, hvordan du gradvist skal holde op med at tage Epidyolex.
English: Population pharmacokinetic analyses demonstrated that there were no clinically relevant effects of age, body weight, sex, or race on exposure to cannabidiol.
Danish: Farmakokinetiske populationsanalyser påviste, at der ikke var nogen klinisk relevante virkninger af alder, legemsvægt, køn eller race på eksponering for cannabidiol.
English: Very common Decreased appetite Common
Danish: Nedsat appetit Almindelig Øget appetit
English: Results of the subgroup analysis of patients treated with clobazam compared to patients treated without clobazam, indicated that there is residual statistical uncertainty regarding the treatment effect of cannabidiol in patients not taking clobazam.
Danish: Resultaterne af undergruppeanalysen af patienter, som fik behandling med clobazam, sammenlignet med patienter, som fik behandling uden clobazam, indikerede, at der stadig er en statistisk usikkerhed vedrørende virkningen af behandling med cannabidiol hos patienter, som ikke tager clobazam.
English: Upon changes in cannabidiol dose above 10 mg/kg/day or changes in medicinal products (dose change or additions) that are known to impact the liver, this monitoring schedule should be restarted.
Danish: Efter ændring af cannabidiol-dosis over 10 mg/kg/dag eller ændringer i lægemidler (dosisændringer eller tilføjelser), som vides at påvirke leveren, skal dette monitoreringsskema genstartes.
English: Do not start or stop other medicines without talking to your doctor or pharmacist.
Danish: Du må ikke begynde eller holde op med at tage andre lægemidler uden at tale med lægen eller apotekspersonalet.
English: Drop seizures were defined as atonic, tonic, or tonic-clonic seizures that led or could have led to a fall or injury.
Danish: Anfald, som forårsager fald, blev defineret som atoniske, toniske eller tonisk-kloniske anfald, som førte eller kunne føre til et fald eller en skade.
English: Given that cannabidiol is highly protein bound and will likely pass freely from plasma into milk, as a precaution, breast-feeding should be discontinued during treatment.
Danish: Da cannabidiol i høj grad er proteinbundet og sandsynligvis vil passere frit fra plasma til mælk, skal amning for en sikkerheds skyld ophøre under behandlingen.
English: 736 mg refined sesame oil
Danish: 736 mg raffineret sesamolie
English: Additional secondary outcome measures in the subgroup of patients treated with concomitant clobazam
Danish: Yderligere sekundære resultatmål i undergruppen af patienter, som samtidig fik behandling med clobazam
English: A corresponding decrease in haematocrit was also observed, with a mean change of −1.4% in cannabidiol-treated patients.
Danish: Der blev også observeret et tilsvarende fald i hæmatokrit, med en gennemsnitlig ændring på -1,4 % hos patienter, der fik cannabidiol.
English: Dose reduction should be considered for concomitant medicinal products that are sensitive CYP2C19 substrates or that have a narrow therapeutic index.
Danish: Det bør overvejes at reducere dosis for samtidigt administrerede lægemidler, som er følsomme CYP2C19-substrater, eller som har et smalt terapeutisk indeks.
English: In the phase 3 clinical trials, the observed frequency of status epilepticus was similar between the cannabidiol and placebo groups.
Danish: I de kliniske fase 3-forsøg var den observerede hyppighed af status epilepticus den samme i cannabidiol- og placebogrupperne.
English: Make sure the oral syringe is completely dry before the next use, or it could make the solution appear cloudy if water gets in the bottle.
Danish: Sørg for, at sprøjten er helt tør inden næste brug; ellers kan væsken virke uklar, hvis der kommer vand i flasken.
English: In general, transaminase elevations of greater than 3 times the ULN in the presence of elevated bilirubin without an alternative explanation are an important predictor of severe liver injury.
Danish: Generelt er transaminaseforhøjelser på over 3 gange ULN ved tilstedeværelse af forhøjet bilirubin uden anden forklaring en vigtig prædiktor for svær leverskade.
English: The mechanism of this interaction remains unknown.
Danish: Mekanismen bag denne interaktion er stadig ukendt.
English: The dose level of 125 mg/kg/day induced decreased foetal body weights and increased foetal structural variations associated with maternal toxicity.
Danish: Dosisniveauet på 125 mg/kg/dag inducerede nedsat føtal legemsvægt og et øget antal føtale strukturelle variationer forbundet med maternel toksicitet.