FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastric disorders Gastric disorders caused by hyperacidity have been reported during clinical studies in 3.5% of the patients receiving pitolisant.
Danish: Gastriske lidelser Gastriske lidelser forårsaget af hyperaciditet er blevet rapporteret hos 3,5 % af de patienter, der fik pitolisant i kliniske studier.
English: The combination of pitolisant with modafinil or sodium oxybate, usual treatments of narcolepsy was evaluated in healthy volunteers, at therapeutic doses.
Danish: Kombinationen af pitolisant med modafinil eller natriumoxybat, sædvanlige behandlinger af narkolepsi, blev vurderet hos raske frivillige ved terapeutiske doser.
English: Women of childbearing potential have to use effective contraception during treatment and at least up to 21 days after treatment discontinuation (based on pitolisant/metabolites half-life).
Danish: Fertile kvinder skal anvende effektiv prævention under behandlingen og i mindst 21 dage efter behandlingsophør (baseret på halveringstiden for pitolisant/metabolitter).
English: With oral contraceptives, the combination with pitolisant should be avoided and a further reliable contraceptive method used.
Danish: Samtidig behandling med orale svangerskabsforebyggende midler bør undgås, og yderligere en pålidelig svangerskabsforebyggende metode anvendes.
English: 105 narcoleptic patients with high frequency weekly cataplexy rates at baseline were included (54 patients treated with pitolisant and 51 with placebo).
Danish: 105 narkolepsipatienter med høj ugentlig frekvens af katapleksi ved baseline blev inkluderet (54 patienter fik pitolisant, og 51 fik placebo).
English: Wakix should be used at the lowest effective dose, depending on individual patient response and tolerance, according to an up-titration scheme, without exceeding the dose of 36 mg/day: - Week 1: initial dose of 9 mg (two 4.5 mg tablets) per day.
Danish: Wakix skal anvendes i den laveste effektive dosis, afhængigt af patientens respons og tolerance, ifølge et optitreringsskema, uden at overskride en dosis på 36 mg dagligt: - Uge 1: initialdosis på 9 mg (to 4,5 mg tabletter) dagligt.
English: If you are a woman, you have to take a contraceptive during your treatment with Wakix and at least up to 21 days after treatment discontinuation.
Danish: Kvinder skal bruge et præventionsmiddel under behandling med Wakix og i mindst 21 dage efter behandlingsophør.
English: On liver microsomes, pitolisant and its major metabolites do not significantly inhibit the activities of the cytochromes CYP1A2, CYP2C9, CYP2C19, CYP2C8, CYP2B6, CYP2E1 or CYP3A4 and of uridine diphosphate glucuronosyl transferases isoforms UGT1A1, UGT1A4, UGT1A6, UGT1A9 and UGT2B7 up to the concentration of 13.3 µM, a level considerably higher than the levels achieved with therapeutic dose.
Danish: På levermikrosomer hæmmer pitolisant og dets vigtigste metabolitter ikke signifikant aktiviteterne for cytochromerne CYP1A2, CYP2C9, CYP2C19, CYP2C8, CYP2B6, CYP2E1 eller CYP3A4 og for uridindiphosphat-glukuronosyltransferaseisoformerne UGT1A1, UGT1A4, UGT1A6, UGT1A9 og UGT2B7 i en koncentration på op til 13,3 µM, et betydeligt højere niveau end de niveauer, der opnås med terapeutisk dosis.
English: - You have a gastric ulcer or you take medicines that can irritate your stomach such as medicines against inflammations, since gastric reactions have been reported with Wakix.
Danish: - Du har mavesår, eller du tager medicin, der kan irritere din mave, såsom antiinflammatoriske lægemidler (mod betændelseslignende reaktioner), da der er blevet rapporteret mavegener med
English: Pitolisant should be administered with caution in patients with history of psychiatric disorders such as severe anxiety or severe depression with suicidal ideation risk.
Danish: Pitolisant bør administreres med forsigtighed hos patienter med en anamnese med psykiske lidelser såsom svær angst eller svær depression med risiko for selvmordstanker.
English: Renal impairment In patients with impaired renal function (stages 2 to 4 according to the international classification of chronic kidney disease, i.e. creatinine clearance between 15 and 89 ml/min), Cmax and AUC tended to be increased by a factor of 2.5 without any impact on half-life (see section 4.2).
Danish: Nedsat nyrefunktion Hos patienter med nedsat nyrefunktion (trin 2 til 4 i henhold til den internationale klassifikation af kronisk nyresygdom, dvs. kreatininclearance mellem 15 og 89 ml/min) havde Cmax og AUC tendens til at blive forøget med en faktor på 2,5 uden nogen indvirkning på halveringstiden (se pkt.
English: If symptoms persist a reduced daily dose or discontinuation should be considered.
Danish: Hvis symptomerne vedvarer, bør det overvejes at nedsætte dosis eller seponere behandlingen.
English: Pitolisant is not a substrate of OATP1B1, OATP1B3.
Danish: Pitolisant er ikke substrat for OATP1B1 eller OATP1B3.
English: - Week 3: the dose may be increased to 36 mg (two 18 mg tablets) per day.
Danish: - Uge 3: dosis kan øges til 36 mg (to 18 mg tabletter) dagligt.
English: Bioprojet Pharma 9, rue Rameau 75002 Paris France
Danish: Bioprojet Pharma 9, rue Rameau 75002 Paris Frankrig
English: - Week 2: the dose may be increased to 18 mg (one 18 mg tablet) per day or decreased to 4.5 mg (one 4.5 mg tablet) per day.
Danish: - Uge 2: dosis kan øges til 18 mg (én 18 mg tablet) dagligt eller reduceres til 4,5 mg (én 4,5 mg tablet) dagligt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Wakix in one or more subsets of the paediatric population in narcolepsy with or without cataplexy (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Wakix i en eller flere undergrupper af den pædiatriske population ved narkolepsi med eller uden katapleksi (se pkt.
English: The exposure to Pitolisant was higher in the CYP2D6 poor metabolisers after a single dose and at steady state; Cmax and AUC(0-tau) was approximately 2.7-fold and 3.2-fold greater on Day 1 and 2.1fold and 2.4-fold on Day 7.
Danish: Eksponeringen for Pitolisant var højere hos langsomme CYP2D6-omsættere efter en enkeltdosis og ved steady state; Cmax and AUC(0-tau) var cirka 2,7 gange og 3,2 gange større på dag 1 og 2,1 gange og 2,4 gange på dag 7.
English: In a clinical multiple dose study, the combination of pitolisant with probenecid decreases the AUC of pitolisant by about 34%.
Danish: I en klinisk flerdosisundersøgelse nedsætter kombinationen af pitolisant med probenecid AUC for pitolisant med ca. 34 %.
English: Anti-histamines
Danish: Antihistaminer
English: The second pivotal study (Harmony Ibis) included 165 patients (67 treated with pitolisant, 33 with placebo and 65 with modafinil).
Danish: Det andet pivotale studie (Harmony Ibis) omfattede 165 patienter (67 fik pitolisant, 33 placebo og 65 modafinil).
English: Convulsions were reported at high doses in animal models (see section 5.3).
Danish: Der blev rapporteret kramper ved høje doser i dyremodeller (se pkt.
English: Cataplexy attacks frequency in patients displaying this symptom was decreased significantly (p=0.034) with pitolisant (-65%) compared to placebo (-10%).
Danish: Hyppigheden af katapleksi hos patienter, der udviser dette symptom, blev reduceret signifikant (p = 0,034) med pitolisant (-65 %) sammenlignet med placebo (-10 %).
English: Do not take Wakix if you
Danish: Tag ikke Wakix, hvis du:
English: Pitolisant is an inhibitor of CYP2D6 with moderate potency (IC50 = 2.6 µM).
Danish: Pitolisant er en CYP2D6-hæmmer af moderat grad (IC50 = 2,6 µM).
English: Pitolisant is a potent, orally active histamine H3-receptor antagonist/inverse agonist which, via its blockade of histamine auto-receptors enhances the activity of brain histaminergic neurons, a major arousal system with widespread projections to the whole brain.
Danish: Pitolisant er en potent, oral histamin-H3-receptorantagonist/invers antagonist, som via blokering af histamin-autoreceptorer øger aktiviteten af histaminerge neuroner i hjernen, et større system til regulering af opvågning med udbredte forgreninger til hele hjernen.
English: Most patients (65%) reached the 36 mg once a day dosage.
Danish: De fleste patienter (65 %) nåede en dosis på 36 mg én gang dagligt.
English: Therefore, dosing should be adjusted according to their renal and hepatic status.
Danish: Derfor bør doseringen justeres i henhold til patientens nyre- og leverstatus.
English: Electrocardiogram QT prolonged Heart rate increased Gammaglutamyltransferase increased
Danish: QT-forlængelse i elektrokardiogram Øget hjertefrekvens Forhøjet gammaglutamyltransferase
English: Medicinal products affecting pitolisant metabolism
Danish: Lægemidler, der påvirker metaboliseringen af pitolisant
English: Wakix may reduce the effectiveness of hormonal contraceptives, an alternative method of effective contraception has to be used (see section “Pregnancy).
Danish: Wakix kan nedsætte effektiviteten af hormonelle præventionsmidler, så en anden effektiv præventionsmetode skal anvendes (se punktet “Graviditet”).
English: Wakix 18 mg: Available in packs containing 1 bottle of 30 tablets or packs containing 1 bottle of 90 tablets or multi-packs containing 90 (3 bottles of 30) tablets.
Danish: Wakix 18 mg: Fås i pakninger med 1 tabletbeholder med 30 tabletter eller pakninger med 1 tabletbeholder med 90 tabletter eller multipakninger med 90 (3 tabletbeholdere med 30) tabletter.
English: Harmony CTP, a supportive double blind, randomized, parallel group study of pitolisant versus placebo, was designed to establish pitolisant efficacy in patients with high frequency cataplexy in narcolepsy.
Danish: Harmony CTP, et understøttende dobbeltblindt, randomiseret, parallelgruppestudie af pitolisant versus placebo, var designet til at klarlægge pitolisants virkning hos patienter med narkolepsi og en høj frekvens af katapleksi.
English: The effect on Epworth was supported in two laboratory tests of vigilance and attention (Maintenance of Wakefulness Test (MWT) (p=0.044) and Sustained Attention to Response (SART) (p=0.053, almost but not significant)).
Danish: Effekten på Epworth-score blev understøttet af to laboratorietest af årvågenhed og opmærksomhed (MWT) (p = 0,044) og (SART) (p = 0,053, omtrent, men ikke signifikant).
English: Tri or tetracyclic antidepressants (e.g. imipramine, clomipramine, mirtazapine) may impair the efficacy of pitolisant because they display histamine H1-receptor antagonist activity and possibly cancel the effect of endogenous histamine released in brain by the treatment.
Danish: Tri- eller tetracykliske antidepressiva (f.eks. imipramin, clomipramin, mirtazapin) kan nedsætte pitolisants virkning, fordi de udviser histamin-H1-receptorantagonistaktivitet og eventuelt kan ophæve virkningen af endogent histamin, der frigives i hjernen som følge af behandlingen.
English: Most patients (60%) reached the 36 mg once a day dosage.
Danish: De fleste patienter (60 %) nåede en dosis på 36 mg én gang dagligt.
English: Maintenance of efficacy
Danish: Opretholdelse af virkning
English: The effectiveness of pitolisant up to 36 mg once a day, for the treatment of narcolepsy with or without cataplexy was established in two main, 8 weeks, multicenter, randomized, double-blind, placebo-controlled, parallel group trials (Harmony I and Harmony CTP).
Danish: Effektiviteten af pitolisant i en dosis på op til 36 mg én gang dagligt til behandling af narkolepsi med eller uden katapleksi blev bestemt i to primære 8-ugers randomiserede, dobbeltblinde, placebokontrollerede multicenterforsøg med parallelle grupper (Harmony I og Harmony CTP).
English: Pitolisant/metabolites may reduce the effectiveness of hormonal contraceptives.
Danish: Pitolisant/metabolitter kan nedsætte virkningen af hormonelle præventionsmidler.
English: In preclinical studies, drug dependence and drug abuse liability studies were conducted in mice, monkeys and rats.
Danish: Der er udført prækliniske studier af tilbøjeligheden til afhængighed og misbrug af lægemidlet på mus, aber og rotter.
English: The geometric mean of the ratios (MWTFinal/MWTBaseline) was 1.8 (95%CI 1.19; 2.71, p=0.005).
Danish: Det geometriske gennemsnit af forholdene (MWTEndelig/MWTBaseline) var 1,8 (95 % CI 1,19; 2,71; p=0,005).
English: The most frequent adverse drug reactions (ADRs) reported with pitolisant were insomnia (8.4%), headache (7.7%), nausea (4.8%), anxiety (2.1%), irritability (1.8%), dizziness (1.4%), depression (1.3%), tremor (1.2%), sleep disorders (1.1%), fatigue (1.1%), vomiting (1.0%), vertigo (1.0%), dyspepsia (1.0%), weight increase (0.9%), abdominal pain upper (0.9%).
Danish: De hyppigste bivirkninger, der er rapporteret med pitolisant, er søvnløshed (8,4 %), hovedpine (7,7 %), kvalme (4,8 %), angst (2,1 %), irritabilitet (1,8 %), svimmelhed (1,4 %), depression (1,3 %), tremor (1,2 %), søvnforstyrrelser (1,1 %), træthed (1,1 %), opkastning (1,0 %), vertigo (1,0 %), dyspepsi (1,0 %), vægtøgning (0,9 %), øvre abdominalsmerter (0,9 %).
English: In patients with moderate hepatic impairment (Child-Pugh B) two weeks after initiation of treatment, the daily dose can be increased without exceeding a maximal dose of 18 mg (see section 5.2).
Danish: Hos patienter med moderat nedsat leverfunktion (Child-Pugh B) kan den daglige dosis øges to uger efter behandlingsstart uden at overskride en maksimal dosis på 18 mg (se pkt.
English: The pivotal study (Harmony 1), double-blind, randomized, vs placebo and modafinil (400 mg/day), parallel group studies with flexible dose adaptation, included 94 patients (31 patients treated with pitolisant, 30 with placebo and 33 with modafinil).
Danish: Det pivotale studie (Harmony 1), et dobbeltblindet, randomiseret studie med parallelle gruppe vs. placebo og modafinil (400 mg/dag) med fleksibel dosistilpasning, omfattede 94 patienter (31 patienter fik pitolisant, 30 placebo og 33 modafinil).
English: During the stable period (until the end of treatment), geometric mean WRC decreased to 6.79 (median=6 [3; 15]) and 3.28 (median=3 [1.3; 6]) in the placebo and pitolisant groups respectively in patients who had experienced at least one episode of cataplexy.
Danish: I den stabile periode (indtil behandlingens afslutning) faldt det geometriske gennemsnit af WRC til 6,79 (median = 6 [3; 15]) og 3,28 (median = 3 [1,3; 6]) i henholdsvis placeboog pitolisantgruppen hos patienter, der havde oplevet mindst én katapleksiepisode.
English: Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy (see also section
Danish: Wakix er indiceret til behandling af narkolepsi med eller uden katapleksi hos voksne (se også pkt.
English: Pitolisant is not a significant inhibitor of OAT1, OAT3, OCT2, OATP1B1, OATP1B3, MATE1, or MATE2K at the tested concentration.
Danish: Pitolisant er ikke en signifikant hæmmer af OAT1, OAT3, OCT2, OATP1B1, OATP1B3, MATE1 eller MATE2K ved den testede koncentration.
English: In patients with moderate hepatic impairment (Child-Pugh B), AUC increased by a factor 2.4, while half-life doubled (see section 4.2).
Danish: Hos patienter med moderat nedsat leverfunktion (Child-Pugh B) steg AUC med faktor 2,4, mens halveringstiden blev fordoblet (se pkt.
English: Abdominal distension Dysphagia Flatulence Odynophagia Enterocolitis
Danish: Abdominal distension Dysfagi Flatulens Odynofagi Enterocolitis
English: At high doses, pitolisant induced sperm morphology abnormalities and decreased motility without any significant effect on fertility indexes in male rats and it decreased the percentage of live conceptuses and increased post-implantation loss in female rats (safety margin of 1).
Danish: Ved høje doser inducerede pitolisant abnormiteter i sædmorfologi og nedsat motilitet uden signifikant indvirkning på fertilitetsindeks hos hanrotter, og det nedsatte procentdelen af levende fostre og øgede postimplantationstabet hos hunrotter (sikkerhedsmargin på 1).
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE, DER ER ANSVARLIGE FOR BATCHFRIGIVELSE
English: In two dedicated QT studies, supra-therapeutic doses of pitolisant (3-6-times the therapeutic dose, that is 108 mg to 216 mg) produced mild to moderate prolongation of QTc interval (10-13 ms).
Danish: I to studier til evaluering af pitolisants indvirkning på QT-intervallet inducerede supraterapeutiske pitolisantdoser (108 mg til 216 mg, dvs. 3-6 gange den terapeutiske dosis) let til moderat forlængelse af QTc-intervallet (10-13 ms).
English: Pitolisant should be administered with caution in patients with either renal impairment or moderate hepatic impairment (Child-Pugh B) and dosing regimen should be adapted according to section 4.2.
Danish: Pitolisant bør administreres med forsigtighed hos patienter med nedsat nyrefunktion eller moderat nedsat leverfunktion (Child-Pugh B), og dosisregimet skal tilpasses i henhold til pkt.
English: Pitolisant may reduce the effectiveness of hormonal contraceptives.
Danish: Pitolisant kan nedsætte effektiviteten af hormonelle præventionsmidler.
English: At baseline, the geometric mean of WRC was 7.31 (median=6.5 [4.5; 12]) and 9.15 (median=8.5 [5.5; 15.5]) in the placebo and pitolisant groups respectively.
Danish: Ved baseline var det geometriske gennemsnit af WRC 7,31 (median = 6,5 [4,5; 12]) og 9,15 (median = 8,5 [5,5; 15,5]) i henholdsvis placebo- og pitolisantgruppen.
English: - CYP3A4 and CYP2B6 substrates
Danish: - CYP3A4- og CYP2B6-substrater
English: Based on in vitro data, pitolisant and its main metabolites may induce CYP3A4 and CYP2B6 at therapeutic concentrations and by extrapolation, CYP2C, UGTs and P-gp.
Danish: Baseret på in vitro-data kan pitolisant og dets vigtigste metabolitter inducere CYP3A4 og CYP2B6 ved terapeutiske koncentrationer og - ved ekstrapolation - CYP2C, UGT'er og P-gp.
English: Pitolisant induces CYP3A4, CYP1A2 and CYP2B6 in vitro.
Danish: Pitolisant inducerer CYP3A4, CYP1A2 og CYP2B6 in vitro.
English: The results with pitolisant were significantly superior to those in the placebo group (mean difference: -3.33; 95%CI [-5.83 to -0.83]; p < 0.05) but did not differ significantly from the results in the modafinil group (mean difference: 0.12; 95%CI [-2.5 to 2.7]).
Danish: Resultaterne i pitolisantgruppen var signifikant bedre end i placebogruppen (gennemsnitlig forskel: -3,33; 95 % CI [-5,83 til -0,83]; p < 0,05), men ikke væsentligt forskellige fra resultaterne i modafinilgruppen (gennemsnitlig forskel: 0,12; 95 %CI [-2,5 til 2,7]).
English: No dosage adjustment is required in patients with mild hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion.
English: Pain Night sweats Sense of oppression
Danish: Smerter Nattesved Følelse af nedtrykthed
English: Other medicines and Wakix
Danish: Brug af anden medicin sammen med Wakix
English: As Wakix may reduce the effectiveness of hormonal contraceptive, an alternative method of effective contraception has to be used.
Danish: Da Wakix kan nedsætte effektiviteten af hormonelle præventionsmidler, skal en anden effektiv præventionsmetode anvendes.
English: Multipack: 90 (3 bottles of 30) film-coated tablets
Danish: Multipakning: 90 (3 tabletbeholdere med 30) filmovertrukne tabletter
English: Creatine phosphokinase increased
Danish: Forhøjet kreatinkinase
English: Patients taking Wakix must stop breastfeeding.
Danish: Kvinder, der tager Wakix, skal stoppe med at amme.
English: On the primary efficacy endpoint, Weekly Rate of Cataplexy episodes (WRC), the results with pitolisant were significantly superior to those in the placebo group (p < 0.0001), with a progressive 64% decrease from baseline to end of treatment (Figure 2).
Danish: For det primære effektmål, ugentlig forekomst af katapleksi-episoder (WRC), var resultaterne signifikant bedre i pitolisantgruppen end i placebogruppen (p < 0,0001) med et progressivt fald på 64 % fra baseline til behandlingens afslutning (figur 2).
English: What you need to know before you take Wakix
Danish: Det skal du vide, før du begynder at tage Wakix
English: Co-administration of pitolisant with paroxetine significantly increases pitolisant mean Cmax and AUC0-72h ratio about 47% and 105%, respectively.
Danish: Samtidig administration af pitolisant og paroxetin øger den gennemsnitlige pitolisant-Cmax og -AUC072h med henholdsvis ca. 47 % og 105 %.
English: They are formed under the action of CYP3A4 and CYP2D6.
Danish: Den er dannet under påvirkning af CYP3A4 og CYP2D6.
English: Poor metabolizers By comparison to CYP2D6 extensive metabolisers, higher systemic exposure (up to 3 fold) is observed in CYP2D6 poor metabolisers.
Danish: Langsomme omsættere I sammenligning med normale CYP2D6-omsættere er der observeret højere systemisk eksponering (op til 3 gange) hos langsomme CYP2D6-omsættere.
English: Pitolisant is contra-indicated in patients with severe hepatic impairment (Child-Pugh C) (see section
Danish: Pitolisant er kontraindiceret til patienter med svært nedsat leverfunktion (Child-Pugh C) (se pkt.
English: Pitolisant is well and rapidly absorbed with peak plasma concentration reached approximately three hours after administration.
Danish: Den maksimale plasmakoncentration nås cirka tre timer efter administration.
English: Improvement of the two objective tests of wakefulness and attention, MWT and SART, with pitolisant was significant versus placebo (p=0.009 and p=0.002 respectively) and non-significant versus modafinil (p=0.713 and p=0.294 respectively).
Danish: I de to objektive test af vågenhed og opmærksomhed, MWT og SART viste pitolisant en signifikant forbedring i forhold til placebo (p=0,009 og p=0,002 henholdsvis) og en ikke-signifikant forbedring versus modafinil (p=0,713 og p=0,294 henholdsvis).
English: The daily cataplexy rate (geometric means) was 0.52 at baseline and 0.18 at final visit for pitolisant and 0.43 at baseline and 0.39 at final visit for placebo, with a rate ratio rR=0.38 [0.16 ; 0.93] (p=0.034).
Danish: Den daglige katapleksifrekvens (geometrisk gennemsnit) var 0,52 ved baseline og 0,18 ved sidste besøg for pitolisant og 0,43 ved baseline og 0,39 ved sidste besøg for placebo, med en risikorate (RR) = 0,38 [0,16; 0,93] (p = 0,034).
English: Hypertension Hypotension Hot flush
Danish: Hypertension Hypotension Hedeture
English: The observed WRC in pitolisant group was about half of WRC in the placebo group: the effect size of pitolisant compared with placebo was summarized by the ratio rate rR(Pt/Pb), rR=0.512; 95%CI [0.435 to 0.603]; p < 0.0001).
Danish: Den observerede WRC i pitolisantgruppen var cirka de halve af WRC i placebogruppen: Størrelsen af effekt ved pitolisant (Pt) sammenlignet med placebo (Pb) blev opsummeret i risikoraten RR (Pt/Pb), RR = 0,512; 95 % CI [0,435 til 0,603]; p <0,0001.
English: Do not stop taking Wakix suddenly on your own.
Danish: Du må ikke på egen hånd pludseligt stoppe med at tage Wakix.
English: The serum Pitolisant half-life was longer in CYP2D6 poor metabolisers compared to the extensive metabolisers.
Danish: Serumhalveringstiden for Pitolisant var længere hos dårlige CYP2D6-omsættere sammenlignet med de normale omsættere.
English: After 1 month in mice, 6 months in rats and 9 months in monkeys, no adverse effect level (NOAEL) were 75, 30 and 12 mg/kg/day, p.o., respectively, providing safety margins of 9, 1 and 0.4, respectively when compared to the drug exposure at therapeutic dose in human.
Danish: Efter 1 måned var niveauet uden observerede bivirkninger (NOAEL) 75 mg/kg/dag oralt hos mus, efter 6 måneder var NOAEL 30 mg/kg/dag oralt hos rotter, og efter 9 måneder var NOAEL 12 mg/kg/dag oralt hos aber, hvilket giver sikkerhedsmarginer på henholdsvis 9, 1 og 0,4 ved sammenligning med lægemiddeleksponeringen ved terapeutisk dosis hos mennesker.
English: Wakix is available in a bottle of 30 tablets or 90 tablets.
Danish: Wakix fås i en tabletbeholder med 30 eller 90 tabletter.
English: Your doctor will need to check this regularly while you are taking
Danish: Det er nødvendigt, at din læge regelmæssigt kontrollerer dig, mens du tager Wakix.