FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicinal product contains 10% by volume ethanol (alcohol), i.e. up to 700 mg per dose (for an adult weighing 70 kg), equivalent to 14 millilitres (ml) of beer, or 6 ml of wine per dose.
Danish: Dette lægemiddel indeholder 10 % ethanol (alkohol) efter volumen, dvs. op til 700 mg pr. dosis (for en voksen, der vejer 70 kg), hvilket svarer til 14 milliliter (ml) øl eller 6 ml vin pr. dosis.
English: Caution should be used in patients with moderate (Child-Pugh B) or severe hepatic impairment (Child-Pugh C).
Danish: Der skal udvises forsigtighed hos patienter med moderat (Child-Pugh B) eller svært nedsat leverfunktion (Child-Pugh C).
English: Co-administration of cannabidiol with a high-fat/high calorie meal increased the rate and extent of absorption (5-fold increase in Cmax and 4-fold increase in AUC) and reduced the total variability of exposure compared with the fasted state in healthy volunteers.
Danish: Samtidig administration af cannabidiol og et måltid med højt fedt- og kalorieindhold øgede frekvensen og omfanget af absorption (5 gange stigning i Cmax og 4 gange stigning i AUC) og reducerede den samlede variabilitet af eksponeringen sammenlignet med fastende tilstand hos raske frivillige.
English: Skin and subcutaneous tissue disorders Common
Danish: Hud og subkutane væv
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: The elevations resolved after discontinuation of cannabidiol.
Danish: Forhøjelserne forsvandt efter seponering af cannabidiol.
English: Turn the bottle the right side up, and carefully remove the oral syringe from the adaptor.
Danish: Vend flasken rigtigt igen, og fjern forsigtigt sprøjten fra adapteren.
English: Following the directions from the doctor or pharmacist, the bag containing the other syringes and adapter should be discarded from the pack unless your doctor or pharmacist tells you to keep both syringes until your final dose has been reached.
Danish: Følg anvisningerne fra lægen eller apotekspersonalet, og kassér posen med den anden sprøjte og adapter fra pakken, medmindre lægen eller apotekspersonalet beder dig om at gemme begge sprøjter, indtil du har fået den sidste dosis.
English: In a human abuse potential study, acute administration of cannabidiol to non-dependent adult recreational drug users at therapeutic and supratherapeutic doses produced small responses on positive subjective measures such as Drug Liking and Take Drug Again.
Danish: I et studie vedrørende potentialet for misbrug hos mennesker frembragte akut administration af cannabidiol til voksne brugere af rekreative stoffer, som ikke var afhængige af disse, ved terapeutiske og supraterapeutiske doser små reaktioner vedrørende positive subjektive målepunkter såsom smag for stoffet eller angivelse af at ville tage det igen.
English: If a patient develops clinical signs or symptoms suggestive of hepatic dysfunction, serum transaminases and total bilirubin should be promptly measured and treatment with cannabidiol should be interrupted or discontinued, as appropriate.
Danish: Hvis en patient udvikler kliniske tegn eller symptomer, der tyder på hepatisk dysfunktion, skal serumtransaminaser og total bilirubin måles med det samme og behandlingen med cannabidiol afbrydes eller seponeres efter behov.
English: Suicidal behaviour and ideation have been reported in patients treated with AEDs in several indications.
Danish: Selvmordsadfærd og -tanker er blevet rapporteret hos patienter i behandling med antiepileptika ved flere indikationer.
English: Based on a healthy volunteer study, elevated levels (3- to 4-fold) of N-desmethylclobazam (an active metabolite of clobazam) can occur when combined with cannabidiol, likely mediated by CYP2C19 inhibition.
Danish: På baggrund af et studie med raske frivillige kan der forekomme forhøjede niveauer (3 til 4 gange) af N-desmethylclobazam (en aktiv metabolit af clobazam) ved kombination med cannabidiol, hvilket sandsynligvis er medieret af hæmning af CYP2C19.
English: Cannabidiol can be administered to patients with mild, moderate, or severe renal impairment without dose adjustment (see section 5.2).
Danish: Cannabidiol kan administreres til patienter med let, moderat eller svært nedsat nyrefunktion uden dosisjustering (se pkt.
English: Anhydrous ethanol
Danish: Vandfrit ethanol
English: Epidyolex is used in combination with clobazam or with clobazam and other antiepileptic medicines to treat seizures that occur with two rare conditions, called Dravet syndrome and Lennox-Gastaut syndrome.
Danish: Epidyolex bruges sammen med clobazam eller med clobazam og andre lægemidler mod epilepsi til at behandle anfald, som sker ved to sjældne sygdomme, der hedder Dravets syndrom og Lennox-Gastauts syndrom.
English: The major CYP450 isoforms responsible for the phase I metabolism of cannabidiol are CYP2C19 and CYP3A4.
Danish: De vigtigste CYP450-isoformer, der er ansvarlige for fase I-metabolismen af cannabidiol, er CYP2C19 og CYP3A4.
English: Resolution of transaminase elevations occurred with discontinuation of cannabidiol or reduction of cannabidiol and/or concomitant valproate in about two-thirds of the cases.
Danish: Transaminaseforhøjelserne blev afhjulpet med seponering af cannabidiol eller reduktion af cannabidiol og/eller samtidigt administreret valproat i omkring to tredjedele af tilfældene.
English: In vitro assessment of drug interactions
Danish: In vitro-vurdering af lægemiddelinteraktioner
English: Epidyolex contains cannabidiol, a medicine which can be used to treat epilepsy, a condition where someone has seizures or fits.
Danish: Epidyolex indeholder cannabidiol, som er et lægemiddel, der kan bruges til at behandle epilepsi - en sygdom, hvor patienten får kramper eller anfald.
English: Dose reduction of the substrates may be necessary when cannabidiol is administered concomitantly with substrates of these UGTs.
Danish: Det kan være nødvendigt at reducere dosis af substraterne, hvis cannabidiol administreres samtidigt med substrater af disse UGT'er.
English: 79 mg anhydrous ethanol
Danish: 79 mg vandfrit ethanol
English: Co-administration of cannabidiol is also predicted to cause clinically significant interactions with CYP2C8 (repaglinide) and CYP2C9 (e.g., warfarin) substrates.
Danish: Samtidig administration af cannabidiol forventes også at forårsage klinisk signifikante interaktioner med CYP2C8-substrater (repaglinid) og CYP2C9-substrater (f.eks. warfarin).
English: - feeling drowsy or sleepy - decreased appetite - diarrhoea - fever - feeling tired - vomiting
Danish: - døsighed eller søvnighed - nedsat appetit - diarré - feber - træthed - opkastning
English: Maternal plasma cannabidiol exposures at the no observed-adverse-effect-level (NOAEL) for embryofoetal developmental toxicity in rabbits were less than that in humans at 20 mg/kg/day.
Danish: Maternelle plasmacannabidioleksponeringer på niveauet for ingen observerede bivirkninger (No Observed Adverse Effect Level, NOAEL) for embryoføtal udviklingstoksicitet hos kaniner var mindre end dem for mennesker ved 20 mg/kg/dag.
English: The most frequent cause of discontinuations was transaminase elevation.
Danish: Den hyppigste årsag til seponering var forhøjet transaminase.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Danish: Sundhedspersoner anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Cannabidiol is extensively metabolised by the liver via CYP450 enzymes and the UGT enzymes.
Danish: Cannabidiol metaboliseres ekstensivt af leveren via CYP450-enzymerne og UGT-enzymerne.
English: Fill a cup with warm soapy water and clean the oral syringe by drawing water in and out using the plunger.
Danish: Fyld en kop med varmt sæbevand, og rens sprøjten ved at bruge stemplet til at fylde den med sæbevand og tømme den igen.
English: Subjects with moderate and severe hepatic impairment showed higher plasma concentrations of cannabidiol (approximately 2.5-5.2-fold higher AUC compared to healthy subjects with normal hepatic function).
Danish: Forsøgspersoner med moderat og svært nedsat leverfunktion viste højere plasmakoncentrationer af cannabidiol (ca. 2,5-5,2 gange højere AUC sammenlignet med raske forsøgspersoner med normal leverfunktion).
English: Cannabidiol can cause elevations in serum creatinine.
Danish: Cannabidiol kan forårsage forhøjelser i serumkreatinin.
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.
Danish: Cannabidiol og metabolitten 7-OH-CBD interagerer ikke med de vigtigste renale eller hepatiske optagstransportører og vil derfor sandsynligvis ikke medføre relevante lægemiddelinteraktioner: OAT1, OAT3, OCT1, OCT2, MATE1, MATE2-K, OATP1B1 og OATP1B3.
English: In the case of more than 7 days' missed doses, re-titration to the therapeutic dose should be made.
Danish: Hvis doser er blevet sprunget over i mere end 7 dage, skal der gentitreres til den terapeutiske dosis.
English: In addition, there was an increased exposure to 7-hydroxy-cannabidiol (7-OH-CBD; an active metabolite of cannabidiol), for which plasma area under the curve (AUC) increased by 47% (see section 5.2).
Danish: Desuden var der en øget eksponering for 7-hydroxy-cannabidiol (7-OH-CBD, en aktiv metabolit af cannabidiol), for hvilken arealet under plasmakurven (AUC) øgedes med 47 % (se pkt.
English: Mean age of the study population was 9 years and 94% were taking 2 or more cAEDs during the trial.
Danish: Studiepopulationens gennemsnitsalder var 9 år, og 94 % tog 2 eller flere samtidige antiepileptika under forsøget.
English: Strong inducers of CYP3A4, such as carbamazepine, enzalutamide, mitotane, St. John's wort, and/or strong inducers of CYP2C19, such as rifampin, administered concomitantly with cannabidiol may decrease the plasma concentrations of cannabidiol and decrease the effectiveness of cannabidiol.
Danish: Stærke induktorer af CYP3A4, såsom carbamazepin, enzalutamid, mitotan, perikon og/eller stærke induktorer af CYP2C19, såsom rifampin, der administreres samtidigt med cannabidiol, kan nedsætte plasmakoncentrationerne af cannabidiol og nedsætte virkningen af cannabidiol.
English: No formal drug-drug interaction studies have been conducted with cannabidiol in combination with UGT inhibitors, therefore caution should be taken when co-administering drugs that are known inhibitors of these UGTs.
Danish: Der er ikke udført formelle lægemiddelinteraktionsstudier med cannabidiol i kombination med UGT-hæmmere, og der skal derfor udvises forsigtighed ved samtidig administration af lægemidler, som er kendte hæmmere af disse UGT'er.
English: Inhibition of P-gp mediated efflux by cannabidiol in the intestine cannot be ruled out.
Danish: Cannabidiols hæmning af P-gp-medieret effluks i tarmene kan ikke udelukkes.
English: Cannabidiol is predominantly cleared by metabolism in the liver and gut and excreted in faeces, with renal clearance of parent drug being a minor pathway.
Danish: Cannabidiol elimineres fortrinsvis via metabolisme i leveren og tarmene og udskilles i fæces, og renal clearance af moderstoffet er en mindre udskillelsesvej.
English: Cannabidiol does not require dose adjustment in patients with mild hepatic impairment (Child-Pugh A).
Danish: Nedsat leverfunktion Cannabidiol kræver ikke dosisjustering hos patienter med let nedsat leverfunktion (Child-Pugh A).
English: Lamotrigine is a substrate for UGT enzymes including UGT2B7 which is inhibited by cannabidiol in vitro.
Danish: Lamotrigin er et substrat for UGT-enzymer, herunder UGT2B7, som hæmmes af cannabidiol in vitro.
English: Food may increase cannabidiol levels and therefore it should be taken consistently either with or without food, including the ketogenic diet (see section 5.2).
Danish: Fødevarer kan øge cannabidiol-niveauerne, og derfor skal lægemidlet indtages ensartet, enten med eller uden mad, herunder ved ketogen diæt (se pkt.
English: Screw the child resistant cap back on the bottle tightly, by turning the cap clockwise - you do not need to remove the bottle adaptor, as the cap will fit over it.
Danish: Skru det børnesikrede låg tæt på flasken igen ved at skrue låget med uret - du behøver ikke at fjerne flaskeadapteren, da låget passer over den.
English: The combination of cannabidiol with clobazam caused an elevation in exposure to the active metabolite N-desmethylclobazam.
Danish: Kombinationen af cannabidiol og clobazam medførte en forhøjelse i eksponeringen for den aktive metabolit N-desmethylclobazam.
English: Clobazam (separate analysis) was a significant covariate which caused the probability of GGT to increase, loss of appetite to decrease, and somnolence to increase.
Danish: Clobazam (separat analyse) var en signifikant kovariant, som medførte en øget sandsynlighed for forhøjet GGT og øget døsighed.
English: - lack of energy - cold, sore throat - respiratory tract infections (pneumonia, bronchitis) - blood tests showing increases in levels of certain liver enzymes (which may be signs of liver damage) - shaking of the body or parts of it - feeling bad-tempered (irritable, aggressive) - difficulty in sleeping - cough - rash - increased appetite, weight loss - drooling - urinary tract infection - agitation - abnormal behaviour
Danish: - mangel på energi - forkølelse, ondt i halsen - luftvejsinfektioner (lungebetændelse, bronkitis) - blodprøver, der viser stigninger i antallet af visse leverenzymer (hvilket kan være tegn på leverskade) - rysten af kroppen eller dele af den - dårligt humør (irritabel adfærd, truende evt. voldelig adfærd) - søvnbesvær - hoste - udslæt - øget appetit, vægttab - savlen - urinvejsinfektion - rastløshed - unormal adfærd
English: Prior to starting treatment with cannabidiol, obtain serum transaminases (ALT and AST) and total bilirubin levels.
Danish: Inden behandlingen med cannabidiol påbegyndes, skal niveauerne af serumtransaminaser (ALAT og ASAT) og total bilirubin fastlægges.
English: Mild to moderate diarrhoea and somnolence have been reported in healthy adult subjects taking a single dose of 6000 mg; this equates to a dose of over 85 mg/kg for a 70 kg adult.
Danish: Der er rapporteret om let til moderat diarré og døsighed hos raske voksne forsøgspersoner, der tog en enkelt dosis på 6.000 mg; dette svarer til en dosis på over 85 mg/kg for en voksen, der vejer 70 kg.
English: GWPCARE1
Danish: GWPCARE3 Placebo
English: Valproate
Danish: Valproat
English: Paediatric patients Pharmacokinetics of cannabidiol has not been studied in paediatric patients < 2 years of age.
Danish: Cannabidiols farmakokinetik er ikke blevet undersøgt hos pædiatriske patienter < 2 år.
English: In cannabidiol-treated patients, the incidence of ALT elevations greater than 3 times the ULN was 23% in patients taking both concomitant valproate and clobazam, 17% in patients taking concomitant valproate (without clobazam), 3% in patients taking concomitant clobazam (without valproate), and 2% in patients taking neither drug.
Danish: Hos patienter, der fik behandling med cannabidiol, var forekomsten af forhøjet ALAT over 3 gange ULN 23 % hos patienter, der samtidig tog både valproat og clobazam, 17 % hos patienter, der samtidig tog valproat (uden clobazam), 3 % hos patienter, der samtidig tog clobazam (uden valproat), og 2 % hos patienter, der ikke tog nogen af disse lægemidler.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKE
English: Cannabidiol also does not produce animal self-administration, suggesting it does not produce rewarding effects.
Danish: Cannabidiol frembringer heller ikke selvadministration hos dyr, hvilket tyder på, at misbrugspotentialet er lavt.
English: Cannabidiol causes dose-related elevations of liver transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) (see section 4.8).
Danish: Cannabidiol medfører dosisrelaterede forhøjelser af levertransaminaser (alaninaminotransferase [ALAT] og/eller aspartataminotransferase [ASAT]) (se pkt.
English: The NOAEL was associated with maternal plasma exposures (AUC) approximately 50 times greater than the anticipated exposure in humans at 20 mg/kg/day.
Danish: NOAEL var forbundet med maternelle plasmaeksponeringer (AUC), der var ca. 50 gange større end den forventede eksponering hos mennesker på 20 mg/kg/dag.
English: Epidyolex with food
Danish: Brug af Epidyolex sammen med mad
English: The embryo-foetal development (EFD) study performed in rabbits evaluated doses of 50, 80, or 125 mg/kg/day.
Danish: Studiet af embryoføtal udvikling (EFD) udført med kaniner evaluerede doser på 50, 80 eller 125 mg/kg/dag.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Baseline transaminase elevations
Danish: Forhøjet transaminase ved baseline
English: Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.
Danish: Epidyolex er indiceret til anvendelse som adjuverende behandling af anfald forbundet med Lennox-Gastauts syndrom (LGS) eller Dravets syndrom (DS) sammen med clobazam hos patienter i alderen 2 år og ældre.
English: Instructions for the oral use of Epidyolex
Danish: Anvisninger om oral anvendelse af Epidyolex
English: Discard unused portion 8 weeks after first opening Date of first opening:
Danish: Den ikke anvendte del skal kasseres 8 uger efter første åbning Dato for første åbning:
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).
Danish: Følgende fase I-metabolitter blev påvist i in vitro-standardanalyser: 7-COOH-CBD, 7-OH-CBD og 6-OH-CBD (en ubetydelig cirkulerende metabolit).
English: Ask your pharmacist about how to throw away any medicine that you no longer use.
Danish: Spørg apotekspersonalet, hvordan du skal bortskaffe medicinrester.
English: The primary endpoint was the percentage change from baseline in drop seizures per 28 days over the treatment period for the cannabidiol group compared to placebo.
Danish: Det primære endepunkt var den procentvise ændring i forhold til baseline i anfald, som forårsager fald, i løbet af 28 dage i behandlingsperioden for cannabidiol-gruppen sammenlignet med placebo.
English: Cannabidiol and 7-OH-CBD are not substrates for or inhibitors of efflux transports P-gp/MDR1, BCRP or BSEP at clinically relevant plasma concentrations.
Danish: Cannabidiol og 7-OH-CBD er ikke substrater for eller hæmmere af efflukstransportørerne P-gp/MDR1, BCRP eller BSEP ved klinisk relevante plasmakoncentrationer.
English: In patients, there is a potential additive anticonvulsant effect from the bi-directional pharmacokinetic interaction between cannabidiol and clobazam, which leads to increases in circulating levels of their respective active metabolites, 7-OH-CBD (approximately 1.5-fold) and N-CLB (approximately 3-fold) (see sections 4.5, 5.1 and 5.2).
Danish: Hos patienter er der en potentiel additiv antikonvulsiv virkning fra den farmakokinetiske interaktion (som går begge veje) mellem cannabidiol og clobazam, der fører til stigninger i de cirkulerende niveauer af deres respektive aktive metabolitter, 7-OH-CBD (ca. 1,5 gange) og N-CLB (ca. 3 gange) (se pkt.
English: The bottle is packaged in a carton with two 5 ml and two 1 ml calibrated oral dosing syringes (plunger HDPE and barrel polypropylene) and two bottle adapters (LDPE).
Danish: Flasken er pakket i en karton med to 5 ml og to 1 ml kalibrerede, orale doseringssprøjter (stempel: HDPE, cylinder: polypropylen) samt to flaskeadaptere (LDPE).
English: AST increased, ALT increased, GGT increased, Liver function test abnormal
Danish: Almindelig Øget ASAT, øget ALAT, øget GGT, unormal leverfunktionstest
English: This leaflet was last revised in .
Danish: Denne indlægsseddel blev senest ændret
English: Subgroup analyses were conducted on multiple factors, including cAEDs.
Danish: Der blev udført undergruppeanalyser med flere faktorer, herunder samtidige antiepileptika.
English: Because of potential for both induction and inhibition of enzyme activity, dose adjustment of substrates of CYP1A2 and CYP2B6 should be considered, as clinically appropriate.
Danish: På grund af potentialet for både induktion og hæmning af enzymaktivitet bør det overvejes at justere dosis af substrater af CYP1A2 og CYP2B6 som klinisk relevant.
English: Patients with end-stage renal disease were not studied.
Danish: Der er ikke undersøgt patienter med nyresygdom i slutstadiet.
English: midazolam, phenytoin, stiripentol and valproate that are used to treat seizures - medicines used to treat acid reflux (heartburn or acid regurgitation) such as omeprazole - mitotane (a medicine used to treat tumours in the adrenal gland) - morphine or diflunisal (medicines used to treat pain) - efavirenz (a medicine used to treat HIV/AIDS) - theophylline (a medicine used to treat asthma) - caffeine (a medicine for babies who need help breathing) - propofol (an anaesthetic used for people undergoing surgery) - simvastatin, fenofibrate, gemfibrozil, (medicines used to reduce cholesterol/lipids) - enzalutamide (a medicine to treat prostate cancer) - bupropion (a medicine to help stop smoking or for treating obesity) - St. John's wort (Hypericum perforatum) (a herbal medicine used to treat mild anxiety) - medicines to treat bacterial infections, such as rifampin, clarithromycin and erythromycin
Danish: lamotrigin, lorazepam, midazolam, fenytoin, stiripentol og valproat, som bruges mod anfald - lægemidler, der bruges til at behandle refluks (halsbrand eller sure opstød) som for eksempel omeprazol - mitotan (et lægemiddel, der bruges til at behandle tumorer i binyrer) - morfin eller diflunisal (smertestillende midler) - efavirenz (et lægemiddel, der bruges til at behandle hiv/aids) - teofyllin (et lægemiddel, der bruges til at behandle astma) - koffein (et lægemiddel til små børn, der skal bruge hjælp til at trække vejret) - propofol (et bedøvelsesmiddel, der bruges ved operation) - simvastatin, fenofibrat, gemfibrozil, (lægemidler, der bruges til at sænke indholdet af kolesterol/lipider) - enzalutamid (et lægemiddel, der bruges til at behandle prostatakræft) - bupropion (et lægemiddel, der bruges ved rygestop eller til behandling af svær overvægt) - perikon (Hypericum perforatum) (et naturlægemiddel, der bruges til at behandle let angst) - lægemidler, der bruges til at behandle bakterieinfektioner, som for eksempel rifampicin,
English: There are no human studies on excretion of cannabidiol in breast milk.
Danish: Der foreligger ingen studier med mennesker vedrørende udskillelse af cannabidiol i modermælk.
English: PK/PD analysis also demonstrated that systemic exposures to cannabidiol were correlated with some adverse events namely elevated ALT, AST, diarrhoea, fatigue, GGT, loss of appetite, rash, and somnolence (see section 4.8).
Danish: PK/PD-analyse påviste desuden, at systemiske eksponeringer for cannabidiol korrelerede med visse bivirkninger: forhøjet ALAT, ASAT, diarré, træthed, GGT, nedsat appetit, udslæt og døsighed (se pkt.
English: Cannabidiol induces CYP1A2 and CYP2B6 mRNA expression at clinically relevant concentrations.
Danish: Cannabidiol inducerer CYP1A2- og CYP2B6-mRNA-ekspression ved klinisk relevante koncentrationer.