FrancophonIA/ELRC3.0 huggingface dataset:
English: QR code to be included URL {EMA website corresponding product information not yet known}.
Danish: QR-kode, der skal medtages URL {EMA website med produktoplysninger kendes endnu ikke}.
English: The safety and efficacy of pitolisant in children aged from 0 to 18 years old have not yet been established.
Danish: Pitolisants sikkerhed og virkning hos børn i alderen fra 0 til 18 år er endnu ikke fastlagt.
English: See the end of section 4 for how to report side effects.
Danish: Se slutningen af punkt 4 for, hvordan du indberetter bivirkninger.
English: Pitolisant was neither genotoxic nor carcinogenic.
Danish: Pitolisant var hverken genotoksisk eller karcinogent.
English: If you are unsure whether your condition has a negative effect on your ability to drive, talk to your doctor.
Danish: Hvis du er usikker på, om din tilstand har en negativ virkning på din evne til at køre, så tal med din læge.
English: Final report: 3Q 2023
Danish: Endelig rapport: 3. kvartal 2023
English: 40 Boulevard de Champaret 38300 Bourgoin-Jallieu France
Danish: 40 Boulevard de Champaret 38300 Bourgoin-Jallieu Frankrig
English: Inter individual variability is rather high, some volunteers showing outlier high profile (without tolerance issues).
Danish: Den interindividuelle variation er temmelig høj, og nogle frivillige viste afvigende høj profil (uden toleranceproblemer).
English: Tel: +33 (0)1 47 03 66 33 Fax: +33 (0)1 47 03 66 30 e-mail: contact@bioprojet.com
Danish: Tlf.: +33 (0)1 47 03 66 33 Fax: +33 (0)1 47 03 66 30 e-mail: contact@bioprojet.com
English: Treatment should be initiated by a physician experienced in the treatment of sleep disorders.
Danish: Behandlingen bør initieres af en læge med erfaring i behandling af søvnforstyrrelser.
English: Upon repeated administrations, the steady state is achieved after 5-6 days of administration leading to an increased serum level around 100%.
Danish: Ved gentagen administration opnås steady state efter 5-6 dage, hvilket fører til et øget serumniveau på omkring 100 %.
English: There are no or limited amount of data from the use of pitolisant in pregnant women.
Danish: Der er ingen eller utilstrækkelige data for anvendelse af pitolisant til gravide kvinder.
English: Pitolisant has a plasma half-life of 10-12 hours.
Danish: Pitolisant har en plasmahalveringstid på 10-12 timer.
English: The MWT value in the pitolisant group was 80% higher than in the placebo group.
Danish: MWT-værdien i pitolisantgruppen var 80 % højere end i placebogruppen.
English: In the up-titration scheme, dose increment should take into account this higher exposure.
Danish: I optitreringsplanen bør dosisforøgelsen tage højde for denne højere eksponering.
English: - Substrates of OCT1
Danish: - Substrater for OCT1
English: OUTER CARTON WITH BLUE BOX
Danish: YDRE KARTON - MED BLUE BOX
English: These effects were mostly mild to moderate.
Danish: Disse virkninger var for det meste lette til moderate.
English: - You have severe epilepsy.
Danish: - Du lider af svær epilepsi.
English: The effect of pitolisant on EDS was also assessed in this population using the ESS score.
Danish: Effekten af pitolisant på EDS blev også vurderet i denne population ved hjælp af ESS-scoren.
English: You should continue to take Wakix for as long as instructed by your doctor.
Danish: Du skal fortsætte med at tage Wakix så længe, som din læge har sagt.
English: To date, there are limited amount of data from an open label study on long term efficacy of Wakix in this indication.
Danish: Til dato foreligger der en begrænset datamængde fra et åbent studie til vurdering af langtidsvirkningen af Wakix ved denne indikation.
English: - Are allergic to pitolisant or any of the other ingredients of this medicine (listed in section 6).
Danish: - er allergisk over for pitolisant eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Pitolisant exhibits high serum protein binding (>90%) and demonstrates approximately equal distribution between red blood cells and plasma.
Danish: Pitolisant udviser høj serumproteinbinding (> 90 %) og viser omtrent ligelig fordeling mellem røde blodlegemer og plasma.
English: Narcolepsy is a condition that causes excessive daytime sleepiness and a tendency to suddenly fall asleep in inappropriate situations (sleep attacks).
Danish: Narkolepsi er en tilstand, der forårsager overdreven søvnighed i dagtimerne og en tendens til pludseligt at falde i søvn i uhensigtsmæssige situationer (søvnanfald).
English: Pitolisant should not be used during pregnancy unless the potential benefit outweighs the potential risk for foetus.
Danish: Pitolisant bør ikke anvendes under graviditet, medmindre den potentielle fordel for kvinden opvejer den potentielle risiko for fosteret.
English: Extrasystoles Bradycardia
Danish: Ekstrasystoler Bradykardi
English: Studies in animals have shown reproductive toxicity, including teratogenicity.
Danish: Dyrestudier har påvist reproduktionstoksicitet, herunder teratogenicitet.
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Danish: Polyvinylalkohol Titandioxid (E171) Macrogol 3350 Talcum
English: Limited data are available in elderly.
Danish: Der findes begrænsede data hos ældre.
English: In case of significant weight change, treatment should be re-evaluated by the physician.
Danish: I tilfælde af betydelig vægtændring bør behandlingen reevalueres.
English: The waking effect of the two active substances was established at similar rates (Figure 1).
Danish: De to aktive stoffers virkning på vågenhed blev bestemt til værende af samme omfang (figur 1).
English: If any of these apply to you, talk to your doctor or pharmacist before taking Wakix.
Danish: Hvis noget af dette gælder for dig, så tal med din læge eller apotekspersonalet, før du tager Wakix.
English: Narcolepsy (with or without cataplexy) is a chronic condition.
Danish: Narkolepsi (med eller uden katapleksi) er en kronisk tilstand.
English: There is no clearly identified antidote.
Danish: Der findes ikke nogen specifik antidot.
English: Non-interventional post-authorisation safety study (PASS): A multi-center, observational post-authorization safety study to document the drug utilisation of Wakix and to collect information on the safety of Wakix when used in routine medical practice
Danish: Ikke-interventionssikkerhedsundersøgelse efter tilladelse til markedsføring (PASS): Et multicenter, observationssikkerhedsstudie efter tilladelse til markedsføring for at dokumentere anvendelsen af lægemidlet Wakix og indsamle oplysninger om Wakix' sikkerhed, når det anvendes rutinemæssigt i klinisk praksis.
English: If they persist a corrective treatment with proton pump inhibitor could be initiated.
Danish: Hvis de vedvarer, kan en korrigerende behandling med protonpumpehæmmer indledes.
English: However no increase in dopamine release in the striatal complex including nucleus accumbens was evidenced for pitolisant.
Danish: Øget dopaminfrigivelse i det striatale kompleks, herunder i nucleus accumbens, blev dog ikke påvist for pitolisant.
English: The most serious ADRs are abnormal weight decrease (0.09%) and abortion spontaneous (0.09%).
Danish: De alvorligste bivirkninger er unormalt vægttab (0,09 %) og spontan abort (0,09 %).
English: Above 80 years old, kinetics show a slight variation without clinical relevance.
Danish: Kinetikken hos patienter over 80 år udviser en mindre variation uden klinisk relevans.
English: Race The effect of race on metabolism of pitolisant has not been evaluated.
Danish: Race Indvirkning af race på metabolisering af pitolisant er ikke blevet evalueret.
English: In patients with mild hepatic impairment (Child-Pugh A), there was no significant changes in pharmacokinetics compared with normal healthy volunteers.
Danish: Hos patienter med let nedsat leverfunktion (Child-Pugh A) var der ingen væsentlige ændringer i farmakokinetikken sammenlignet med normale raske frivillige.
English: Pharmacotherapeutic group: Other nervous system drugs, ATC code: N07XX11.
Danish: Farmakoterapeutisk gruppe: Andre midler med virkning på centralnervesystemet, ATC-kode: N07XX11.
English: Wakix contains the active ingredient pitolisant.
Danish: Wakix indeholder det aktive indholdsstof pitolisant.
English: Treatment is normally started with a dose of 9 mg once per day, and gradually increased over three weeks to the most appropriate dose.
Danish: Behandlingen startes normalt med en dosis på 9 mg én gang dagligt, der øges gradvist over tre uger til den mest hensigtsmæssige dosis.
English: - Have severe liver problems, as pitolisant is normally broken down in the liver and excess levels may build up in patients whose liver function is severely reduced.
Danish: - har alvorlige leverproblemer, da pitolisant normalt nedbrydes i leveren, og højere koncentrationer af lægemidlet kan forekomme hos patienter, hvis leverfunktion er kraftigt nedsat.
English: This effect on EDS was confirmed by the results on Maintenance of Wakefulness Test (MWT).
Danish: Denne effekt på EDS-score blev bekræftet af resultaterne på MWT (Maintainence of Wakefulness Test).
English: Harmony Ibis, study with a similar design, was limited to 18 mg once a day.
Danish: Dosis i Harmony Ibis, et studie med et lignende design, var begrænset til 18 mg én gang dagligt.
English: A clinical monitoring should be made when both active substances are combined and, eventually a dosage adjustment during the combination and one week after the inducer treatment.
Danish: Klinisk monitorering bør foretages, når de to aktive stoffer kombineres, og dosis bør eventuelt justeres under kombinationsbehandlingen og en uge efter, induktoren er seponeret.
English: To assess the efficacy of pitolisant on Excessive Daytime Sleepiness (EDS), Epworth Sleepiness Scale (ESS) score was used as primary efficacy criterion.
Danish: For at vurdere effekten af pitolisant på overdreven søvnighed om dagen (Excessive Daytime Sleepiness (EDS)) blev Epworth Sleepiness Scale (ESS)-scoren anvendt som primært kriterium for effektivitet.
English: Cataplexy is the onset of sudden muscle weakness or paralysis without losing consciousness, in response to a sudden emotional reaction such as anger, fear, joy, laughter or surprise.
Danish: Katapleksi er indtræden af pludselig muskelsvækkelse eller lammelse uden at miste bevidstheden, som reaktion på en pludselig følelsesmæssig reaktion såsom vrede, frygt, glæde, latter eller overraskelse.
English: QT-prolonging substances or known to increase the risk of repolarization disorders
Danish: QT-forlængende stoffer og stoffer, som vides at øge risikoen for repolariseringsforstyrrelser
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis ønsker yderligere oplysninger om dette lægemiddel, skal henvende til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: This helps to combat daytime sleepiness and cataplexy and promote wakefulness.
Danish: Dette medvirker til at bekæmpe søvnighed i dagtimerne og katapleksi og fremme vågenhed.
English: A dosage adjustment during the combination could eventually be considered.
Danish: Dosisjustering under kombinationsbehandling kan eventuelt overvejes.
English: Microcrystalline cellulose Crospovidone type A Talc
Danish: Mikrokrystallinsk cellulose Crospovidon type A Talcum
English: In clinical trials, no specific cardiac safety signal was identified at therapeutic doses of pitolisant.
Danish: I kliniske forsøg blev der ikke identificeret specifikke kardiale sikkerhedsproblemer ved terapeutiske doser af pitolisant.
English: Pitolisant also modulates various neurotransmitter systems, increasing acetylcholine, noradrenaline and dopamine release in the brain.
Danish: Pitolisant modulerer også forskellige neurotransmittersystemer og øger frigivelse af acetylcholin, noradrenalin og dopamin i hjernen.
English: Symptoms of Wakix overdose may include headache, insomnia, irritability, nausea and abdominal pain.
Danish: Symptomer på Wakix-overdosering kan omfatte hovedpine, søvnløshed, irritabilitet, kvalme og abdominalsmerter.
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette omfatter eventuelle bivirkninger, som ikke er nævnt i indlægssedlen.
English: Pitolisant has minor influence on the ability to drive and use machines.
Danish: Pitolisant har en beskeden indflydelse på evnen til at føre motorkøretøj og betjene maskiner.
English: Wakix can affect the way other medicines work and other medicines can affect the way Wakix works.
Danish: Wakix kan påvirke den måde, som anden medicin virker på, og anden medicin kan påvirke den måde, som Wakix virker på.
English: Caution should be taken for patients with severe epilepsy.
Danish: Der bør udvises forsigtighed hos patienter med svær epilepsi.
English: The active substance, pitolisant, attaches to receptors on cells in the brain that are involved in stimulating alertness.
Danish: Det aktive stof, pitolisant, binder til receptorer på celler i hjernen, der er involveret i at stimulere årvågenhed.
English: Patients with abnormal levels of sleepiness who take pitolisant should be advised that their level of wakefulness may not return to normal.
Danish: Patienter med unormal søvntrang, som tager pitolisant, bør oplyses om, at deres niveau af vågenhed muligvis ikke vender tilbage til normal.
English: You may experience headaches, stomach pain, feeling sick or irritable.
Danish: Du kan opleve hovedpine, mavesmerter eller kvalme eller blive irritabel.
English: Rebound effect
Danish: Rebound-effekt
English: Headache and insomnia During clinical studies, episodes of headache and insomnia have been reported (7.7 % to 8.4%).
Danish: Hovedpine og søvnløshed Episoder med hovedpine og søvnløshed er blevet rapporteret i kliniske studier (7,7 % til 8,4 %).
English: The exposure to pitolisant in healthy volunteers was assessed in studies involving more than 200 subjects that received doses of pitolisant in single administration up to 216 mg and for a duration up to 28 days.
Danish: Eksponeringen for pitolisant hos raske frivillige blev vurderet i studier med mere end 200 forsøgspersoner, der fik pitolisant i enkeltdoser på op til 216 mg i op til 28 dage.
English: If you take too many tablets of Wakix, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately.
Danish: Hvis du har taget for mange Wakix-tabletter, skal du kontakte den nærmeste skadestue eller fortælle din læge eller apotekspersonalet det med det samme.
English: It is a medicine used to treat adult patients with narcolepsy, with or without cataplexy.
Danish: Det er et lægemiddel til behandling af voksne patienter med narkolepsi med eller uden katapleksi.
English: No rebound effect was reported during clinical trials.
Danish: Der blev ikke rapporteret rebound-effekt i de kliniske forsøg.
English: Teratogenic effect of pitolisant was observed at maternally toxic doses (teratogenicity safety margins < 1 in rats and in rabbits).
Danish: Teratogen effekt af pitolisant blev observeret ved maternelle toksiske doser (teratogenicitetssikkerhedsmargin < 1 hos rotter og kaniner).
English: In vitro studies indicate that pitolisant is neither a substrate nor an inhibitor of human P-glycoprotein and breast cancer resistance protein (BCRP).
Danish: In vitro-studier indikerer, at pitolisant hverken er substrat for eller hæmmer af humant P-glykoprotein og brystkræftresistent protein (BCRP).
English: The elimination is mainly achieved via urine (approximately 63%) through an inactive non conjugated metabolite (BP2.951) and a glycine conjugated metabolite.
Danish: Elimination sker primært via urinen (ca. 63 %) gennem en inaktiv ikke-konjugeret metabolit (BP2.951) og en glycinkonjugeret metabolit.
English: When pitolisant dose is doubled from 27 to 54 mg, AUC0-∞ is increased by about 2.3.
Danish: Når pitolisantdosis fordobles fra 27 til 54 mg, stiger AUC0-∞ med ca. 2,3.
English: The metabolisation of pitolisant in humans is fully characterized.
Danish: Metaboliseringen af pitolisant hos mennesker er fuldstændig klarlagt.
English: What Wakix contains
Danish: Wakix indeholder
English: The major non-conjugated metabolites are hydroxylated derivatives in several positions and cleaved forms of pitolisant leading to inactive major carboxylic acid metabolite found in urine and serum.
Danish: De vigtigste ikke-konjugerede metabolitter er hydroxylerede derivater i flere positioner og spaltede former af pitolisant, der fører til inaktiv større carboxylsyremetabolit, der findes i urin og serum.
English: In 68 to 80 years old patients the pharmacokinetics of pitolisant is not different compared to younger patients (18 to 45 years of age).
Danish: Farmakokinetikken af pitolisant hos patienter i alderen fra 68 til 80 år er sammenlignelig med farmakokinetikken hos yngre patienter (i alderen fra 18 til 45 år).
English: Most of these adverse reactions were mild to moderate.
Danish: De fleste af disse bivirkninger var lette til moderate.
English: Renal impairment In patients with renal impairment, the maximum daily dose should be 18 mg.
Danish: Nedsat nyrefunktion Hos patienter med nedsat nyrefunktion bør den maksimale daglige dosis være 18 mg.
English: Severe hepatic impairment (Child-Pugh C).
Danish: Svært nedsat leverfunktion (Child-Pugh C).
English: Pitolisant blocked hERG channel with an IC50 exceeding therapeutic concentrations and induced a slight QTc prolongation in dogs.
Danish: Pitolisant blokerede hERG-kanalen med en IC50, der var højere end den terapeutiske koncentration, og inducerede en beskeden QTc-forlængelse hos hunde.
English: Even if the clinical relevance of this effect is not established, caution is advised when pitolisant is administered with a substrate of OCT1 (e.g. metformin (biguanides)) (see section 5.2).
Danish: Selvom den kliniske relevans af denne virkning ikke er etableret, tilrådes forsigtighed, når pitolisant administreres sammen med et substrat for OCT1 (f.eks. metformin (biguanider)) (se pkt.
English: The primary efficacy endpoint was the change in the average number of cataplexy attacks per week between the 2 weeks of baseline and the 4 weeks of stable treatment period at the end of study.
Danish: Det primære effektmål var ændringen i det gennemsnitlige antal katapleksianfald om ugen mellem en 2-ugers periode som baseline og en 4-ugers periode med stabil behandling i slutningen af studiet.
English: Patients with excessive daytime sleepiness, including those taking pitolisant should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity.
Danish: Patienter med overdreven søvntrang i dagtimerne, herunder dem, som tager pitolisant, bør jævnligt revurderes for deres grad af søvnighed og eventuelt rådes til at undgå at føre motorkøretøj og anden potentielt farlig aktivitet.
English: Animal study has shown excretion of pitolisant/metabolites in milk.
Danish: Dyrestudier har vist, at pitolisant/metabolitter udskilles i mælk.
English: In clinical trials, one epilepsy aggravation was reported in one epileptic patient.
Danish: I kliniske forsøg blev der rapporteret et tilfælde af forværret epilepsi hos en epilepsipatient.
English: Study in animals has shown effects on semen parameters, without a significant impact on reproductive performance in males and reduction on the percentage of live foetuses in treated females (see section
Danish: Dyrestudier har vist påvirkning af sædparametre uden signifikant indvirkning på reproduktionen hos hanner og reduktion af procentdelen af levende fostre hos behandlede hunner (se pkt.
English: In rats, transient reversible convulsive episodes occurred at Tmax , that may be attributable to a metabolite abundant in this species but not in humans.
Danish: Hos rotter forekom forbigående reversible konvulsive episoder ved Tmax, hvilket muligvis kan tilskrives en metabolit, der er signifikant hos denne art, men ikke hos mennesker.
English: Results from cataplexy rate at 18 mg once a day were not consistent with those of the first pivotal study (36 mg once a day).
Danish: Resultaterne for katapleksifrekvensen ved 18 mg én gang dagligt var ikke i overensstemmelse med resultaterne i det første pivotale studie (36 mg én gang dagligt).
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret denne medicin til dig personligt.
English: In monkeys, at the highest doses, transient CNS related clinical signs including emesis, tremors and convulsions were reported.
Danish: Hos aber blev der ved de højeste doser rapporteret forbigående kliniske CNS-relaterede symptomer, herunder emesis, tremor og konvulsioner.
English: If you forget to take your medicine take the next dose at the usual time, do not take a double dose to make up for the forgotten one.
Danish: Hvis du glemmer at tage din medicin, skal du tage den næste dosis på det sædvanlige tidspunkt.
English: Pitolisant pharmacokinetics after repeated administration in patients with hepatic impairment has not been evaluated yet.
Danish: Pitolisants farmakokinetik efter gentagen administration er endnu ikke blevet evalueret hos patienter med nedsat leverfunktion.
English: No clinically relevant pharmacokinetic drug-drug interaction was evidenced either with modafinil or with sodium oxybate.
Danish: Ingen klinisk relevant farmakokinetisk lægemiddel-lægemiddel-interaktion blev påvist enten med modafinil eller med natriumoxybat.
English: At any time the dose can be decreased (down to 4.5 mg per day) or increased (up to 36 mg per day) according to the physician assessment and the patient's response.
Danish: Dosis kan reduceres (ned til 4,5 mg dagligt) eller øges (op til 36 mg dagligt) når som helst i henhold til lægens vurdering og patientens respons.
English: The other ingredients are microcrystalline cellulose, crospovidone, talc, magnesium stearate, colloidal anhydrous silica, polyvinyl alcohol, titanium dioxide, macrogol 3350.
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon, talcum, magnesiumstearat, kolloid vandfri silica, polyvinylalkohol, titandioxid, macrogol 3350.
English: • Risk Management Plan (RMP) The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Do not change doses of Wakix on your own.
Danish: Du må ikke ændre din Wakix-dosis på egen hånd.
English: Wakix passes into breast milk in animal.
Danish: Wakix udskilles i mælken hos dyr.
English: Several conjugated metabolites were identified, the major ones (inactive) being two glycine conjugates of the acid metabolite of pitolisant and a glucuronide of a ketone metabolite of monohydroxy desaturated pitolisant.
Danish: Flere konjugerede metabolitter blev identificeret, hvoraf de væsentligste (inaktive) er to glycinkonjugater af syremetabolitten af pitolisant og et glukuronid af en ketonmetabolit af monohydroxydesatureret pitolisant.
English: Juvenile toxicity studies in rats revealed that the administration of pitolisant at high doses induced a dose related mortality and convulsive episode that may be attributable to a metabolite abundant in rats but not in humans.
Danish: Toksicitetsstudier hos unge rotter viste, at administration af høje pitolisantdoser inducerer dosisrelateret mortalitet og konvulsive episoder, hvilket muligvis kan henføres til en metabolit, der er signifikant hos rotter, men ikke hos mennesker.
English: 25% of the dose is excreted through expired air and a small fraction (<3%) recovered in faeces where the amount of pitolisant or BP2.951 was negligible.
Danish: 25 % af dosis udskilles gennem udåndingsluft og en lille fraktion (<3 %) i fæces, hvor mængden af pitolisant og BP2.951 var ubetydelig.
English: However, treatment discontinuation should be monitored.
Danish: Dog bør seponering overvåges.