FrancophonIA/ELRC3.0 huggingface dataset:
English: Qualitative reductions in GL-3 levels were observed in multiple renal cell types: podocytes, mesangial cells, and glomerular endothelial cells, respectively, over 12 months of treatment with Galafold.
Danish: Der blev iagttaget en kvalitativ reduktion i GL-3-niveauet i flere typer af nyreceller: podocytter, mesangiale celler og glomerulære endotelceller, i løbet af 12 måneders behandling med Galafold.
English: Other medicines and Galafold
Danish: Brug af anden medicin sammen med Galafold
English: Reduced -Gal A activity is, therefore, associated with the progressive accumulation of substrate in vulnerable organs and tissues, which leads to the morbidity and mortality associated with Fabry disease.
Danish: Nedsat -Gal A-aktivitet er derfor forbundet med progressiv ophobning af glykosfingolipider i følsomme organer og væv, hvilket fører til den morbiditet og mortalitet, der er forbundet med Fabrys sygdom.
English: In case of meaningful clinical deterioration, further clinical evaluation or discontinuation of treatment with Galafold should be considered.
Danish: Ved signifikant forværring af den kliniske tilstand bør yderligere evaluering af den kliniske tilstand eller seponering af Galafold overvejes.
English: The clinical efficacy and safety of Galafold have been evaluated in two Phase 3 pivotal trials and two open-label extension (OLE) trials.
Danish: Galafolds kliniske virkning og sikkerhed er vurderet i to pivotale fase 3-studier og i to åbne forlængelsesstudier.
English: Furthermore, migalastat is not an inhibitor or a substrate of CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4/5.
Danish: Endvidere er migalastat ikke en hæmmer af eller et substrat for CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 eller 3A4/5.
English: Composite Clinical Outcomes
Danish: Kombinerede kliniske resultater
English: Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat.
Danish: Hver kapsel indeholder migalastathydrochlorid svarende til 123 mg migalastat.
English: The absolute bioavailability (AUC) for a single oral 150 mg migalastat hydrochloride dose or a single 2-hour 150 mg intravenous infusion was approximately 75%.
Danish: Den absolutte biotilgængelighed (AUC) af en enkelt oral dosis migalastathydrochlorid på 150 mg eller en enkelt 2-timers intravenøs infusion af 150 mg var ca. 75 %.
English: 14 hard capsules
Danish: 14 kapsler, hårde
English: From the metabolism and excretion pathways, it is not expected that a decreased hepatic function may affect the pharmacokinetics of migalastat.
Danish: Ud fra metaboliseringsveje og udskillelsesveje forventes nedsat leverfunktion ikke at have indvirkning på migalastats farmakokinetik.
English: Migalastat administered with a high-fat meal, or 1 hour before a high-fat or light meal, or 1 hour after a light meal, resulted in significant reductions of 37% to 42% in mean total migalastat exposure (AUC0-∞) and reductions of 15% to 40% in mean peak migalastat exposure (Cmax) compared with the fasting state.
Danish: Indtagelse af migalastat med et måltid med højt fedtindhold eller 1 time før et måltid med højt fedtindhold eller et let måltid eller 1 time efter et let måltid medførte en signifikant reduktion på 37 % til 42 % i den gennemsnitlige totale migalastateksponering (AUC0-∞) og en reduktion på 15 % til 40 % i den gennemsnitlige maksimale eksponering for migalastat (Cmax) i forhold til fastende tilstand.
English: Pack size of 14 capsules.
Danish: Pakningsstørrelse: 14 kapsler.
English: Accordingly, a risk of migalastat exposure to the breast-feeding infant cannot be excluded.
Danish: Det kan derfor ikke udelukkes, at der er risiko for, at et brystbarn bliver eksponeret for migalastat.
English: Elderly (> 65 years) Clinical studies of Galafold included small number of patients aged 65 and over.
Danish: I de kliniske studier med Galafold indgik et lille antal patienter over 65 år.
English: If you take more capsules than you should, then you should stop taking the medicine and contact your doctor.
Danish: Hvis du har taget for mange kapsler, skal du stoppe med at tage lægemidlet og kontakte lægen.
English: c.207_369+651del814ins231 UNKNOWN (del Exon2?)
Danish: c.207_369+651del814ins231 UKENDT (del Exon2?)
English: You should only take Galafold once every other day.
Danish: Du skal kun tage Galafold én gang hver anden dag.
English: In the rabbit embryo-foetal toxicity study, findings including embryo-foetal death, a reduction in mean foetal weight, retarded ossification, and slightly increased incidences of minor skeletal abnormalities were observed only at doses associated with maternal toxicity.
Danish: I det embryoføtale toksicitetsstudie hos kaniner forekom embryoføtal død, reduceret gennemsnitlig fostervægt, forsinket ossifikation og let forhøjet forekomst af mindre væsentlige skeletabnormiteter kun ved doser forbundet med maternel toksicitet.
English: In the ERT-experienced trial, following 18 months of treatment with Galafold there was a statistically significant decrease in LVMi (p< 0.05).
Danish: I forsøget med ERT-erfarne patienter var der efter 18 måneders behandling med Galafold en statistisk signifikant mindskelse i LVMi (p< 0,05).
English: Migalastat binding stabilizes these mutant forms of -Gal A in the endoplasmic reticulum and facilitates their proper trafficking to lysosomes.
Danish: Binding af migalastat stabiliserer disse -Gal A-mutantformer i det endoplasmatiske reticulum og muliggør transporten af dem til lysosomer.
English: UNKNOWN (delExon3_3'UTR?)
Danish: UKENDT (delExon3_3'UTR?)
English: Swallow the capsule whole.
Danish: Synk kapslen hel.
English: No studies have been carried out in subjects with impaired hepatic function.
Danish: Der er ikke udført studier hos personer med nedsat leverfunktion.
English: Take Galafold capsule every other day and punch out the perforated circle on the blister sleeve on the days you are not taking Galafold.
Danish: Tag Galafold-kapslen hver anden dag og tryk den perforerede cirkel på blisterkortet ud for de dage, hvor du ikke tager Galafold.
English: UNKNOWN (Exon2_4dup?)
Danish: UKENDT (Exon2_4dup?)
English: Then, punch out the left-most capsule labelled Day 1.
Danish: Tryk derefter kapslen længst til venstre ud; den er mærket dag 1.
English: Galafold should not be taken on 2 consecutive days.
Danish: Galafold bør ikke indtages to på hinanden følgende dage.
English: In addition, migalastat is not a substrate for MATE1, MATE2-K, OAT1, OAT3, or OCT2, nor is it an inhibitor of OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1, or MATE2-K human uptake transporters.
Danish: Desuden er migalastat ikke substrat for MATE1, MATE2-K, OAT1, OAT3 eller OCT2 og hæmmer ikke de humane optagelsestransportører OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1 eller MATE2-K.
English: Capsule contents Pregelatinised starch (maize) Magnesium stearate
Danish: Stivelse, pregelatineret (majs) Magnesiumstearat
English: Based upon in vitro data, migalastat is not an inducer of CYP1A2, 2B6, or 3A4.
Danish: Ud fra in vitro-data inducerer migalastat ikke CYP1A2, 2B6 eller 3A4.
English: Plasma migalastat exposure (AUC0-∞) and Cmax demonstrated dose-proportional increases at migalastat hydrochloride oral doses from 50 mg to 1,250 mg.
Danish: Plasmaeksponeringen af migalastat (AUC0-∞) og Cmax steg dosisproportionalt med orale doser af migalastathydrochloridfra 50 mg til 1250 mg.
English: The effects of Galafold on fertility in humans have not been studied.
Danish: Virkningen af Galafold på frugtbarheden hos mennesker er ikke undersøgt.
English: UNKNOWN IVS6-10G>A; IVS6-22C>T c.1000-10G>A/1000-22C>T UNKNOWN
Danish: UKENDT IVS6-10G>A; IVS6-22C>T c.1000-10G>A/1000-22C>T UKENDT
English: Do not eat food at least 2 hours before and 2 hours after taking your medicine to give a minimum 4 hours fast.
Danish: Spis ikke mad i mindst 2 timer før og 2 timer efter, du tager din medicin, for at give en fastetid på mindst 4 timer.
English: The mean extent of exposure to the marketed dose of Galafold 123 mg QOD in patients completing study AT1001-041 was 3.57 (±1.23) years (n=85).
Danish: Den gennemsnitlige eksponering for den markedsførte dosis Galafold 123 mg QOD hos patienter, der gennemførte forsøg AT1001-041, var 3,57 (±1,23) år (n=85).
English: In rabbits, developmental toxicity was observed only at maternally toxic doses (see section 5.3).
Danish: Hos kaniner er udviklingstoksicitet kun iagttaget ved maternelt toksiske doser (se pkt.
English: C]-migalastat hydrochloride in the concentration range between 1 and
Danish: C]-migalastathydrochlorid i koncentrationsområdet
English: Do not take this medicine if you are breast-feeding, until you have spoken with your doctor, pharmacist, or nurse.
Danish: Tag ikke dette lægemiddel, hvis du ammer, før du har talt med din læge, apotekspersonalet eller sundhedspersonalet.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Galafold in one or more subsets of the paediatric population in the treatment of Fabry disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Galafold i en eller flere undergrupper af den pædiatriske population med Fabrys sygdom (se pkt.
English: Migalastat is not a substrate for MDR1 or BCRP, nor is it an inhibitor of BCRP, MDR1, or BSEP human efflux transporters.
Danish: Migalastat er ikke substrat for MDR1 eller BCRP og hæmmer ikke de humane efflukstransportører BCRP, MDR1 eller BSEP.
English: Do not use this medicine after the expiry date, which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og blisterpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In patients with amenable mutations, GL-3 levels tended to decrease in urine and in kidney interstitial capillaries.
Danish: Hos patienter med behandlelige mutationer var der tendens til lavere GL-3-niveau i urinen og i nyrernes interstitielle kapillærer.
English: Printing ink Shellac
Danish: Printblæk Shellac
English: Elderly population No dosage adjustment is required based on age (see section 5.2).
Danish: Ældre Dosisjustering er ikke nødvendig på grundlag af alder (se pkt.
English: If more than 12 hours has passed the patient should resume taking Galafold at the next planned dosing day and time according to the every other day dosing schedule.
Danish: Hvis der er gået mere end 12 timer, skal patienten genoptage behandlingen med Galafold på næste planlagte doseringsdag og -tidspunkt i henhold til planen med dosering hver anden dag.
English: Following a single oral dose of 150 mg migalastat hydrochloride solution, the time to peak plasma concentration was approximately 3 hours.
Danish: Efter en enkelt oral dosis på 150 mg migalastathydrochlorid som opløsning var tiden til indtræden af maksimal plasmakoncentration ca. 3 timer.
English: Fabry disease-causing mutations in the GLA gene result in a deficiency of the lysosomal enzyme -galactosidase A (-Gal A) that is required for glycosphingolipid substrate (e.g., GL-3, lyso-Gb3) metabolism.
Danish: Fabrys sygdom skyldes mutationer i GLA-genet, som medfører mangel på det lysosomale enzym -galaktosidase A (-Gal A), der er nødvendigt for metaboliseringen af glykosfingolipider (f.eks. GL-3, lyso-Gb3).
English: Do not take Galafold on two consecutive days.
Danish: Tag ikke Galafold to på hinanden følgende dage.
English: MINIMUM PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ MELLEMEMBALLAGEN
English: Galafold is to be taken every other day.
Danish: Galafold skal tages hver anden dag.
English: Black iron oxide Potassium hydroxide
Danish: Jernoxid, sort Kaliumhydroxid
English: The GLA mutations amenable and not amenable to treatment with Galafold are listed in Table 2 and Table 3 respectively below.
Danish: GLA-mutationer, der er behandlelige og ikke-behandlelige med Galafold, er anført i henholdsvis tabel 2 og tabel 3 nedenfor.
English: In case of overdose, general medical care is recommended.
Danish: Ved overdosering anbefales understøttende behandling.
English: Headache and dizziness were the most common adverse reactions reported at doses of Galafold of up to 1250 mg and 2000 mg, respectively.
Danish: Hovedpine og svimmelhed var de hyppigst indberettede bivirkninger ved Galafold-doser op til henholdsvis 1.250 mg og 2.000 mg.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DD måned ÅÅÅÅ}Detaljeret information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Take at the same time each day.
Danish: Tages på samme klokkeslæt hver dag.
English: The mutations not amenable to treatment with Galafold are listed in Table 3 below.
Danish: Mutationer, der ikke kan behandles med Galafold, er opført i tabel 3 nedenfor:
English: Treatment with Galafold in Phase 2 pharmacodynamic trials generally resulted in increases in endogenous α-Gal A activity in WBCs, as well as in skin and kidney for the majority of patients.
Danish: I farmakodynamiske fase 2-forsøg medførte behandling med Galafold sædvanligvis forøgelse af den endogene α-Gal A-aktivitet i hvide blodlegemer og i hud og nyrer hos størstedelen af patienterne.
English: Fertility in women It is not yet known if this medicine affects fertility in women.
Danish: Frugtbarhed hos kvinder Det vides ikke, om dette lægemiddel påvirker frugtbarheden hos kvinder.
English: Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat - The other ingredients are: Capsule contents: Pregelatinised maize starch and magnesium stearate Capsule shell: Gelatin, titanium dioxide, and indigotine Printing ink: Shellac, black iron oxide, and potassium hydroxide
Danish: - Øvrige indholdsstoffer: Kapselindhold: Pregelatiniseret majsstivelse og magnesiumstearat Kapsel: Gelatine, titandioxid og indigotin Prægeblæk: Shellac, sort jernoxid og kaliumhydroxid
English: Women of childbearing potential/Contraception in males and females Galafold is not recommended in women of childbearing potential not using contraception.
Danish: Kvinder i den fertile alder/Antikonception til mænd og kvinder Galafold frarådes anvendt hos kvinder i den fertile alder, som ikke anvender antikonception.
English: In the ERT- naïve trial, Galafold showed statistically significant reductions in plasma lyso-Gb3 concentrations and kidney interstitial capillary GL-3 inclusions in patients with amenable mutations.
Danish: I forsøget med ERT-naive patienter medførte Galafold statistisk signifikante reduktioner i plasmakoncentrationen af lyso-Gb3 og i GL-3-inklusioner i de interstitielle kapillærer i nyrerne hos patienter med behandlelige mutationer.
English: UNKNOWN (E66_Y123del; del Exon2)
Danish: UKENDT (E66_Y123del; del Exon2)
English: It is not yet known whether this medicine passes into breast milk.
Danish: Det vides endnu ikke, om dette lægemiddel går over i mælken hos mennesker.
English: The first Phase 3 trial (ATTRACT) was a randomised open-label active comparator trial that evaluated the efficacy and safety of Galafold compared to enzyme replacement therapy (ERT) (agalsidase beta, agalsidase alfa) in 52 male and female patients with Fabry disease who were receiving ERT prior to trial entry and who have amenable mutations (ERT-experienced trial).
Danish: Det første fase 3-forsøg (ATTRACT) var et randomiseret, åbent forsøg med aktiv kontrol, hvor Galafolds virkning og sikkerhed blev sammenlignet med enzymsubstitutionsterapi (ERT) (agalsidase beta, agalsidase alfa) hos 52 mænd og kvinder med Fabrys sygdom, som fik enzymsubstitutionsbehandling før indtræden i forsøget, og som havde behandlelige mutationer (forsøg med ERT-erfarne patienter).
English: Talk to your doctor before taking Galafold if you are currently taking enzyme replacement therapy.
Danish: Kontakt lægen, før du tager Galafold, hvis du får behandling med en erstatning for enzymet.
English: Patient-Reported Outcome - Gastrointestinal Symptoms Rating Scale In the ERT-naïve trial, analyses of the Gastrointestinal Symptoms Rating Scale demonstrated that treatment with Galafold was associated with statistically significant (p<0.05) improvements versus placebo from baseline to month 6 in the diarrhoea domain, and in the reflux domain for patients with symptoms at baseline.
Danish: Patientrapporterede resultater - skala for vurdering af gastrointestinale symptomer I forsøget med ERT-naive patienter viste analyser af skalaen for vurdering af gastrointestinale symptomer, at fra baseline til måned 6 var behandling med Galafold forbundet med statistisk signifikant bedring af diarré og refluks i forhold til placebo (p<0,05) for patienter med symptomer ved baseline.
English: C]-migalastat HCl revealed that 99% of the radiolabeled dose recovered in plasma was comprised of unchanged migalastat (77%) and 3 dehydrogenated O-glucuronide conjugated metabolites, M1to M3 (13%).
Danish: C]-migalastathydrochlorid, blev 99 % af den radioaktivt mærkede dosis genfundet i plasma og bestod af uomdannet migalastat (77 %) og de tre hydrogenerede O-glukuronidkonjugerede metabolitter M1, M2 og M3 (13 %).
English: Marketing Authorisation Holder Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
Danish: Indehaver af markedsføringstilladelsen Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
English: Galafold is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation (see the tables in section 5.1).
Danish: Galafold er indiceret til langtidsbehandling af voksne og unge over 16 år med bekræftet diagnose på Fabrys sygdom (α-galaktosidase A-mangel), som har en behandlelig mutation (se tabellerne i pkt.
English: Weight increased
Danish: • Vægtstigning
English: In the ERT- naïve trial and open-label extension, renal function remained stable for up to 5 years of treatment with Galafold.
Danish: I forsøget med ERT-naive patienter og dets åbne forlængelse forblev nyrefunktionen stabil under op til 5 års behandling med Galafold.
English: c.760-762delGTT or c.761-763del c.760_762delGTT or c.761_763del p.V254del
Danish: c.760-762delGTT eller c.761763del c.760_762delGTT eller c.761_763del p.V254del
English: Protein sequence change
Danish: Ændring i proteinsekvens
English: What you need to know before you take Galafold
Danish: Det skal du vide, før du begynder at tage Galafold
English: • Muscle pain (myalgia)
Danish: • Muskelsmerter (myalgi)
English: The second Phase 3 trial (FACETS) was a 6-month randomised double-blind placebo-controlled trial (through month 6) with an 18-month open-label period to evaluate the efficacy and safety of Galafold in 50 male and female patients with Fabry disease who were naïve to ERT, or had previously been on ERT and had stopped for at least 6 months and who have amenable mutations (ERT-naïve trial).
Danish: Det andet fase 3-forsøg (FACETS) var et 6 måneders randomiseret, dobbeltblindt (til og med måned 6) placebokontrolleret forsøg med en 18-måneders åben periode til vurdering af Galafolds virkning og sikkerhed hos 50 mænd og kvinder med Fabrys sygdom, som enten var ERT-naive, eller som ikke havde fået ERT-behandling i mindst 6 måneder, og som havde behandlelige mutationer (forsøg med ERT-naive patienter).
English: This is a common spontaneous tumour in ad libitum-fed male rats.
Danish: Dette er en almindelig spontan tumor hos hanrotter med fri adgang til foder.
English: Fabry disease is a progressive X-linked lysosomal storage disorder which affects males and females.
Danish: Fabrys sygdom er en progressiv X-bunden lysosomal aflejringssygdom, der rammer begge køn.
English: The second OLE trial (AT1001-042) included patients that both transferred from OLE study AT1001-041 and directly from Phase 3 study ATTRACT, and is ongoing.Renal Function
Danish: Det andet OLE-forsøg (AT1001-042) omfattede både patienter, der overgik fra OLE-forsøget AT1001-041 og direkte fra fase 3-forsøget ATTRACT, og er igangværende.
English: Similar findings have been noted pre-clinically following treatment with other iminosugars (see section 5.3).
Danish: Tilsvarende iagttagelser er gjort præklinisk efter behandling med andre iminosukkerarter (se pkt.
English: How to store Galafold 6.
Danish: Sådan skal du tage Galafold 4.
English: Non-clinical studies suggest no specific hazard for humans on the basis of single-and repeat-dose studies, with the exception of transient and fully reversible infertility in male rats associated with migalastat treatment.
Danish: Prækliniske studier viser ingen speciel risiko for mennesker ved behandling med migalastat, vurderet ud fra studier efter enkeltdoser og gentagne doser, med undtagelse af forbigående, fuldt reversibel infertilitet hos hanrotter.
English: In healthy volunteers, the volume of distribution (Vz/F) of migalastat following ascending single oral doses (25-675 mg migalastat HCl) ranged from 77 to 133 L, indicating it is well distributed into tissues and greater than total body water (42 litres).
Danish: Efter stigende orale enkeltdoser (25-675 mg migalastathydrochlorid) var fordelingsvolumenet (Vz/F) af migalastat mellem 77 og 133 l hos raske forsøgspersoner, hvilket indikerer, at det er velfordelt i vævene og har større fordelingsvolumen end kroppens totale vandfase (42 l).
English: Galafold is not indicated for use in patients with non-amenable mutations (see section 5.1).
Danish: Galafold er ikke indiceret til anvendelse hos patienter med ikke-behandlelige mutationer (se pkt.
English: UNKNOWN (E66_Y123del; del Exon2?)
Danish: UKENDT (E66_Y123del; del Exon2?)
English: During the open-label extension, statistically significant (p<0.05) improvements from baseline were observed in the diarrhoea and indigestion domains, with a trend of improvement in the constipation domain.
Danish: I den åbne forlængelsesperiode sås statistisk signifikant (p<0,05) bedring fra baseline af diarré og fordøjelsesbesvær og en tendens til bedring af obstipation.
English: It is not yet known if this medicine affects fertility in men.
Danish: Det vides ikke, om dette lægemiddel påvirker frugtbarheden hos mænd.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing frequency within each System Organ Class.
Danish: Inden for hver hyppighedsgruppe og systemorganklasse er bivirkningerne opstillet efter aftagende alvorlighedsgrad.
English: In the ERT-experienced trial, renal function remained stable for up to 18 months of treatment with Galafold.
Danish: I forsøget med ERT-erfarne patienter forblev nyrefunktionen stabil under op til 18 måneders behandling med Galafold.
English: You should not take Galafold if you are also receiving enzyme replacement therapy.
Danish: Du må ikke tage Galafold, hvis du også får enzymerstatning.
English: Patients randomised to placebo in Stage 1 and switched to Galafold at month 6 (Stage 2) also demonstrated statistically significant decreases in interstitial capillary GL-3 inclusions at month 12 (-0.33±0.15; -58%) (p=0.014).
Danish: De patienter, der blev randomiseret til placebo i trin 1, og som overgik til Galafold i måned 6 (trin 2), udviste ligeledes et statistisk signifikant fald i GL-3-inklusioner i de interstitielle kapillærer i måned 12 (-0,33±0,15; -58 %; p=0,014).
English: In the ERT-experienced trial, plasma lyso-Gb3 levels slightly increased but remained low in patients with amenable mutations treated with Galafold for the 30 month duration of the study.
Danish: I forsøget med ERT-erfarne patienter var plasmaniveauet let forøget, men forblev lavt hos patienter med behandlelige mutationer, som blev behandlet med Galafold i forsøgets 30 måneders varighed.
English: What Galafold looks like and contents of the pack Opaque, blue, and white hard capsules, marked with “A1001” in black ink, containing white to pale brown powder.
Danish: Uigennemsigtige, blå og hvide hårde kapsler, der er mærket "A1001" med sort prægeblæk og indeholder et hvidt til lysebrunt pulver.