FrancophonIA/ELRC3.0 huggingface dataset:
English: In an uncontrolled study in patients in a different non-epilepsy indication, 2 elderly patients experienced elevations of alkaline phosphatase levels above 2 times the ULN in combination with transaminase elevations.
Danish: I et ikke-kontrolleret studie med patienter med en anden ikke-epilepsi-indikation oplevede 2 ældre patienter forhøjelser af niveauerne af alkalisk fosfatase på over 2 gange ULN i kombination med transaminaseforhøjelser.
English: Abuse
Danish: Misbrug
English: You should not drive, use machines or take part in activities that require you to be alert and have fine control, until it is established that your ability to perform such activities is not affected.
Danish: Du må ikke føre motorkøretøj, betjene maskiner eller deltage i aktiviteter, der kræver, at du er opmærksom og har præcis kontrol, indtil det er bevist, at din evne til at udføre disse aktiviteter ikke er påvirket.
English: For an adult weighing 70 kg, this is equivalent to 14 millilitres (ml) of beer, or 6 ml of wine per dose.
Danish: For en voksen, der vejer 70 kg, svarer dette til 14 milliliter (ml) øl eller 6 ml vin pr. dosis.
English: Contact your doctor if you are unsure of your dose or if you think your dose may need to be changed.
Danish: Tal med lægen, hvis du er i tvivl om din dosis, eller hvis du tror, den skal ændres.
English: Your doctor may do blood tests to check your liver before you start taking this medicine and during treatment, as Epidyolex can cause liver problems.
Danish: Lægen kan beslutte at tage blodprøver for at kontrollere din lever, inden du tager dette lægemiddel og under behandlingen, da Epidyolex kan være årsag til leverproblemer.
English: Increases in creatinine
Danish: Stigninger i kreatinin
English: Patients should be advised not to drive or operate machinery until they have gained sufficient experience to gauge whether it adversely affects their abilities (see section 4.8).
Danish: Patienterne skal rådes til ikke at føre motorkøretøj eller betjene maskiner, indtil de har nok erfaring til at kunne vurdere, om det har en negativ indvirkning på deres evner (se pkt.
English: If you have any solution left in the bottle more than 8 weeks after it was first opened, you should not use it.
Danish: Hvis der er mere væske tilbage i flasken 8 uger efter første åbning, må du ikke bruge det.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Epidyolex or during treatment if: - you have or have had liver problems, as your doctor may need to change the dose of Epidyolex or may decide that Epidyolex is not appropriate for you.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Epidyolex eller under behandlingen, hvis: - du har eller har haft leverproblemer, da det kan være nødvendigt for lægen at ændre dosis af Epidyolex, eller lægen kan beslutte, at Epidyolex ikke er egnet til dig.
English: There are only limited data from the use of cannabidiol in pregnant women.
Danish: Der er kun utilstrækkelige data fra anvendelse af cannabidiol til gravide kvinder.
English: In clinical trials, cannabidiol discontinuation was achieved by reducing the dose by approximately 10% per day for 10 days (see section 4.4).
Danish: I kliniske forsøg blev seponering af cannabidiol opnået ved at reducere dosis med ca. 10 % pr. dag i 10 dage (se pkt.
English: Continuous weight loss/absence of weight gain should be periodically checked to evaluate if cannabidiol treatment should be continued.
Danish: Vedvarende vægttab/manglende vægtstigning skal kontrolleres med jævne mellemrum med henblik på at beslutte, om behandling med cannabidiol skal fortsætte.
English: Patients and caregivers of patients should be advised to seek medical advice should any signs of suicidal behaviour and ideation emerge.
Danish: Patienter og deres omsorgspersoner skal rådes til at søge læge, hvis der opstår tegn på selvmordsadfærd og -tanker.
English: Slowly pull back the plunger of the syringe, so the volume (number of ml) of solution needed is drawn into the syringe.
Danish: Træk langsomt sprøjtens stempel tilbage, så mængden af væske (antal ml) trækkes ind i sprøjten.
English: Of the patients that were not taking clobazam, the majority had previously taken and subsequently discontinued clobazam treatment.
Danish: Af de patienter, der ikke tog clobazam, havde størstedelen tidligere taget og efterfølgende seponeret behandling med clobazam.
English: Cannabidiol can cause somnolence and sedation, which occur more commonly early in treatment and may diminish with continued treatment.
Danish: Cannabidiol kan forårsage døsighed og sedation, som kan forekomme mere almindeligt tidligt i behandlingen og kan aftage ved fortsat behandling.
English: Decreased appetite and weight loss may result in slightly reduced height gain.
Danish: Nedsat appetit og vægttab kan medføre en let reduceret højdestigning.
English: Therefore, dose adjustments of cannabidiol or clobazam may be required.
Danish: Derfor kan det være nødvendigt at justere dosis af cannabidiol eller clobazam.
English: If you miss many doses, please talk to your doctor about the correct dose to take.
Danish: Hvis du glemmer at tage mange doser, skal du tale med lægen om, hvilken dosis du skal tage.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Elderly (65 years of age and above) The safety and efficacy of cannabidiol in patients ≥ 65 years of age have not been established.
Danish: Ældre (65 år og derover) Cannabidiols sikkerhed og virkning hos patienter ≥ 65 år er ikke klarlagt.
English: In clinical trials, the majority of ALT elevations occurred in patients taking concomitant valproate.
Danish: I kliniske forsøg forekom størstedelen af ALAT-forhøjelser hos patienter, der samtidig tog valproat.
English: There is no experience in patients with end-stage renal disease.
Danish: Der er ingen erfaring med patienter med nyresygdom i slutstadiet.
English: Approximately 65% of the patients were taking concomitant clobazam.
Danish: Omtrent 65 % af patienterne tog samtidigt clobazam.
English: Tell your doctor if you have liver problems because the doctor may need to adjust the dose.
Danish: Fortæl det til lægen, hvis du har problemer med leveren, da det kan være nødvendigt at lægen ændrer dosis.
English: The mechanism of this interaction is unknown.
Danish: Mekanismen bag denne interaktion er ukendt.
English: Shake off any water from both parts and allow them to dry in the air until the next use.
Danish: Ryst overskydende vand af begge dele, og lad dem lufttørre, indtil de skal bruges igen.
English: Concomitant use of cannabidiol and valproate increases the incidence of diarrhoea and events of decreased appetite.
Danish: Samtidig brug af cannabidiol og valproat øger forekomsten af diarré og hændelser med nedsat appetit.
English: 3821AL Amersfoort, The Netherlands
Danish: 3821AL Amersfoort, Holland
English: The calculated dose should be rounded to the nearest graduated increment.
Danish: Den beregnede dosis skal afrundes til nærmeste markering.
English: Although no formal drug-drug interaction studies have been performed for other AEDs, phenytoin and lamotrigine are addressed based on in vitro data.
Danish: Der er ikke udført nogen formelle lægemiddelinteraktionsstudier for andre antiepileptika, men fenytoin og lamotrigin behandles på baggrund af in vitro-data.
English: Decreased growth, delayed sexual maturation, behavioural changes (decreased activity), and adverse effects on male reproductive organ development (small testes in adult offspring) and fertility were observed in the offspring at doses ≥ 150 mg/kg/day.
Danish: Hæmmet vækst, forsinket kønsmodning, adfærdsændringer (nedsat aktivitet) og negative påvirkninger af udvikling af hanners kønsorganer (små testes hos voksne unger) samt fertilitet blev observeret hos ungerne ved doser på ≥ 150 mg/kg/dag.
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.
Danish: Potentielle interaktioner mellem cannabidiol (750 mg to gange dagligt til raske frivillige og 20 mg/kg/dag til patienter) og andre antiepileptika blev undersøgt i lægemiddelinteraktionsstudier med raske frivillige og patienter samt i en farmakokinetisk populationsanalyse af plasmakoncentrationer af lægemidlet fra placebokontrollerede studier af behandling af patienter med LGS.
English: There were cases of transaminase elevations associated with hospitalisation in patients taking cannabidiol.
Danish: Der var tilfælde af forhøjet transaminase, som var forbundet med hospitalsindlæggelse af patienter, der tog cannabidiol.
English: Line up the end of the plunger with the volume marking required, as shown opposite.
Danish: Ret enden af stemplet ind efter den ønskede mængdeangivelse, som vist overfor.
English: Remove the plunger from the barrel of the syringe, and rinse both parts under tap water.
Danish: Fjern stemplet fra sprøjtens cylinder, og skyl begge dele under vandhanen.
English: The alcohol content should be taken into account in pregnancy and high-risk groups such as patients with liver disease.
Danish: Der skal tages højde for alkoholindholdet hos gravide og højrisikogrupper som f.eks. patienter med leversygdom.
English: In about one-third of the cases, transaminase elevations resolved during continued treatment with cannabidiol, without dose reduction.
Danish: I omkring en tredjedel af tilfældene forsvandt transaminaseforhøjelserne under fortsat behandling med cannabidiol og uden dosisreduktion.
English: Across both randomised LGS studies, 99.5% of patients who completed the studies were enrolled into the long-term open-label extension study (GWPCARE5).
Danish: I begge randomiserede LGS-studier deltog 99,5 % af de patienter, der gennemførte studierne, i det langsigtede åbne forlængelsesstudie (GWPCARE5).
English: When cannabidiol was combined with stiripentol there was a minor increase in stiripentol levels of 28% for Cmax and 55% for AUC.
Danish: Ved kombination af cannabidiol og stiripentol var der en mindre stigning i stiripentolniveauerne på 28 % i Cmax og 55 % for AUC.
English: Management of overdose
Danish: Behandling af overdosering
English: In some patients, a synergistic effect of concomitant treatment with valproate upon baseline elevated transaminases resulted in a higher risk of transaminase elevations.
Danish: Hos nogle patienter medførte en synergistisk virkning af samtidig behandling med valproat efter forhøjede transaminaser ved baseline en højere risiko for forhøjede transaminaser.
English: Do not take Epidyolex - if you are allergic to cannabidiol or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Epidyolex - hvis du er allergisk over for cannabidiol eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Interaction resulting in an approximate 28% increase in Cmax and 55% increase in AUC.
Danish: Interaktion resulterende i en stigning på ca. 28 % i Cmax og 55 % i AUC.
English: What Epidyolex contains - The active substance is cannabidiol.
Danish: Epidyolex indeholder: - Aktivt stof: cannabidiol.
English: You should not breast-feed whilst taking Epidyolex, as Epidyolex is likely to be present in breast milk.
Danish: Du må ikke amme, mens du tager Epidyolex, da Epidyolex sandsynligvis udskilles i modermælk.
English: Insufficient data are available to assess the risk of concomitant administration of other hepatotoxic medicinal products and cannabidiol (see section 4.4).
Danish: Der foreligger utilstrækkelige data til at vurdere risikoen ved samtidig administration af andre hepatotoksiske lægemidler og cannabidiol (se pkt.
English: In controlled studies in healthy adults and in patients with LGS and DS, an increase in serum creatinine of approximately 10% was observed within 2 weeks of starting cannabidiol.
Danish: I kontrollerede studier med raske voksne og med patienter med LGS og DS blev der observeret en stigning i serumkreatinin på ca. 10 % inden for 2 uger efter påbegyndelse af cannabidiol.
English: Tell your doctor if you are taking any of the following medicines, as your dose may need to be adjusted: - other epilepsy medicines, such as carbamazepine, clobazam, lamotrigine, lorazepam,
Danish: Fortæl det til lægen, hvis du tager nogen af følgende lægemidler, da det kan være nødvendigt at ændre din dosis: - andre lægemidler til behandling af epilepsi, som for eksempel carbamazepin, clobazam,
English: In this population, efficacy has not been established.
Danish: Virkningen er ikke blevet fastlagt for denne population.
English: Dose adjustment or discontinuation of valproate or dose adjustment of clobazam should be considered if transaminase elevations occur.
Danish: Dosisjustering eller seponering af valproat eller dosisjustering af clobazam bør overvejes, hvis der forekommer transaminaseforhøjelser.
English: Do not reduce the dose or stop this medicine unless the doctor tells you to.
Danish: Tag ikke en mindre dosis, og hold ikke op med at tage lægemidlet, medmindre lægen fortæller dig, at du skal.
English: The Cmax and AUC of cannabidiol are close to dose-proportional over the therapeutic dose range.
Danish: Cannabidiols Cmax og AUC er stort set dosisproportionale over det terapeutiske dosisinterval.
English: Epidyolex is an oral solution (a liquid to be swallowed).
Danish: Epidyolex er en oral opløsning (en væske, der skal synkes).
English: Refined sesame oil
Danish: Raffineret sesamolie
English: The alcohol content should be taken into account in pregnant women, children and high-risk groups such as patients with liver disease.
Danish: Der skal tages højde for alkoholindholdet hos gravide, børn og andre højrisikogrupper som f.eks. patienter med leversygdom.
English: Approximately 50% of the patients were taking concomitant clobazam.
Danish: Omtrent 50 % af patienterne tog samtidigt clobazam.
English: cannabidiol and/or concomitant AED treatment should therefore be adjusted during regular medical supervision and the patient should be closely monitored for adverse drug reactions.
Danish: Cannabidiol og/eller samtidig behandling med antiepileptika skal derfor justeres under regelmæssig medicinsk kontrol, og patienten skal monitoreres nøje for lægemiddelbivirkninger.
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).
Danish: Syvogtyve procent (27 %) af de patienter, der fik cannabidiol, udviklede en ny laboratoriedefineret anæmi i løbet af studiet (defineret som en normal hæmoglobinkoncentration ved baseline, med en rapporteret værdi under den nedre grænse for normal på et efterfølgende tidspunkt).
English: A meta-analysis of randomised placebo-controlled trials with AEDs has shown a small increased risk of suicidal behaviour and ideation.
Danish: En metaanalyse af randomiserede, placebokontrollerede forsøg med antiepileptika har vist en lidt øget risiko for selvmordsadfærd og -tanker.
English: Across both randomised DS studies, 97.7% of patients who completed the studies were enrolled into GWPCARE5.
Danish: På tværs af begge randomiserede DS-studier deltog 97,7 % af de patienter, der gennemførte studierne, i GWPCARE5.
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.
Danish: Potentialet for lægemiddelinteraktioner med andre samtidigt administrerede antiepileptika er blevet vurderet hos raske frivillige og patienter med epilepsi for clobazam, valproat og stiripentol.
English: CYP3A4 or CYP2C19 inducers
Danish: CYP3A4- eller CYP2C19-induktorer
English: A slower or faster down titration may be required, as clinically indicated, at the discretion of the prescriber.
Danish: Der kan være behov for en langsommere eller hurtigere nedtitrering som klinisk indiceret; dette er den ordinerende læges ansvar.
English: Do not drive, operate machinery, or take part in activities that require you to be alert and have fine control, such as cycling, until you know how Epidyolex affects you.
Danish: Du må ikke føre motorkøretøj, betjene maskiner eller deltage i aktiviteter, der kræver, at du er opmærksom og har præcis kontrol, som for eksempel at cykle, indtil du ved, hvordan Epidyolex påvirker dig.
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.
Danish: In vitro-data har påvist, at cannabidiol hæmmer CYP2C19, hvilket kan forårsage øgede plasmakoncentrationer af lægemidler, som metaboliseres af dette isoenzym, såsom clobazam, og omeprazol.
English: The key secondary endpoint for GWPCARE1 was the proportion of patients with at least a 50% reduction in convulsive seizure frequency.
Danish: Det vigtige sekundære endepunkt for GWPCARE1 var andelen af patienter med mindst 50 % reduktion i hyppigheden af krampeanfald.
English: Elderly patients Pharmacokinetics of cannabidiol have not been studied in patients > 55 years of age.
Danish: Ældre patienter Cannabidiols farmakokinetik er ikke blevet undersøgt hos patienter > 55 år.
English: In the case of one or more missed doses, the missed doses should not be compensated.
Danish: Hvis en eller flere doser er blevet sprunget over, må der ikke kompenseres for den glemte dosis.
English: No human data on the effect of cannabidiol on fertility are available.
Danish: Der foreligger ingen humane data om cannabidiols virkning på fertilitet.
English: Studies in animals have shown toxicological changes in lactating animals, when the mother was treated with cannabidiol (see section 5.3).
Danish: Dyreforsøg har påvist toksikologiske ændringer i diegivende dyr, hvis moderen havde fået behandling med cannabidiol (se pkt.
English: Concomitant Valproate and Clobazam
Danish: Samtidig administration af valproat og clobazam
English: Although exposure to cannabidiol was not notably affected by clobazam use, the levels of an active metabolite, 7-OH-CBD, were elevated by this combination.
Danish: Eksponering for cannabidiol blev ikke påvirket markant af anvendelsen af clobazam, men niveauerne af en aktiv metabolit, 7-OH-CBD, forhøjedes ved denne kombination.
English: DROP SEIZURES PER 28 DAYS Percentage Reduction from Baselinea
Danish: KRAMPEANFALD PR. 28 DAGE Procent reduktion i forhold til baselinea
English: PHARMACEUTICAL FORM Oral solution
Danish: LÆGEMIDDELFORM Oral opløsning
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).
Danish: Cannabidiol reducerer neuronal hyper-excitabilitet gennem modulation af intracellulært calcium via kanalerne G-proteinkoblet receptor 55 (GPR55) og transient receptor-potential vanilloid 1 (TRPV1), samt modulation af adenosin-medieret signalering gennem hæmning af celleoptag af adenosin via den ækvilibrerende nukleosid-transportør 1 (ENT1).
English: The responder rate analysis also showed a correlation in the exposure-response relationship for the active metabolite of cannabidiol (7-OH-CBD).
Danish: Analysen af responderfrekvens viste også en korrelation i forholdet mellem eksponering og respons for den aktive metabolit af cannabidiol (7-OH-CBD).
English: Less than 1% of cannabidiol-treated patients had ALT or AST levels greater than 20 times the ULN.
Danish: Færre end 1 % af de patienter, der fik behandling med cannabidiol, havde ALAT- eller ASAT-niveauer over 20 gange ULN.
English: Somnolence and sedation events have been observed in controlled trials with cannabidiol in LGS and DS.
Danish: Der er observeret hændelser med døsighed og sedation i kontrollerede forsøg med cannabidiol ved LGS og DS.
English: Taking Epidyolex with certain other medicines may cause side effects, affect how the other medicines work, or affect how Epidyolex works.
Danish: Hvis du tager Epidyolex sammen med visse andre lægemidler, kan du få bivirkninger, Epidyolex kan påvirke den måde, det eller de andre lægemidler virker på, eller det eller de andre lægemidler kan påvirke den måde, Epidyolex virker på.
English: Talk to your doctor about driving, using machines or when children undertake activities such as cycling or other sports, because you may feel sleepy after taking this medicine.
Danish: Tal med lægen, inden du fører motorkøretøj eller betjener maskiner, eller når børn deltager i aktiviteter som for eksempel cykling eller anden sport, da lægemidlet kan medføre søvnighed.
English: Convulsive seizures were defined as atonic, tonic, clonic, and tonic-clonic seizures.
Danish: Krampeanfald blev defineret som atoniske, kloniske og tonisk-kloniske anfald.
English: The pharmacokinetics of cannabidiol are complex and may cause interactions with the patient's concomitant AED treatments.
Danish: Cannabidiols farmakokinetik er kompleks og kan medføre interaktioner med patientens samtidige behandlinger med antiepileptika.
English: Always take Epidyolex according to your doctor's instructions and consistently either with or without food including high-fat meals (such as ketogenic diet).
Danish: Tag altid Epidyolex efter lægens anvisning og på samme måde, enten med eller uden mad, herunder måltider med højt fedtindhold (for eksempel en ketogen diæt).
English: In another study, cannabidiol was dosed to juvenile rats from PND 4-21 (as a subcutaneous injection) and from PND 22-50 (as an intravenous injection).
Danish: I et andet studie blev cannabidiol doseret til juvenile rotter fra dag 4-21 postnatalt (som subkutan injektion) og fra dag 22-50 postnatalt (som intravenøs injektion).
English: Each ml of Epidyolex contains 79 mg of ethanol.
Danish: En ml Epidyolex indeholder 79 mg ethanol.
English: Effects of alcohol in children less than 6 years old may include sleepiness, behavioural changes, and impaired ability to concentrate and participate in school activities.
Danish: Virkningerne af alkohol på børn under 6 år kan omfatte døsighed, adfærdsændringer og nedsat koncentrationsevne og evne til at deltage i skoleaktiviteter.
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).
Danish: Da der ikke var et konsekvent dosisrespons mellem 10 mg/kg/dag og 20 mg/kg/dag i LGS- og DS-studierne, skal cannabidiol titreres indledningsvis til den anbefalede vedligeholdelsesdosis på 10 mg/kg/dag (se pkt.
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.
Danish: Studier med raske forsøgspersoner viste, at der ikke var nogen store forskelle i plasmaeksponering for cannabidiol i intermediære og ultrahurtige CYP2C19-metabolisatorer sammenlignet med ekstensive metabolisatorer.