FrancophonIA/ELRC3.0 huggingface dataset:
English: The systemic exposures (Cmax and AUC) to rolapitant increased in a dose-proportional manner when the dose of rolapitant increased from 4.5 mg to 180 mg. With an increase in dose by 4 times from the recommended clinical dose of 180 mg, the Cmax and AUC of rolapitant increased by 3.1 fold and 3.7 fold, respectively.
Danish: Den systemiske eksponering (Cmax og AUC) for rolapitant steg dosisproportionalt, når rolapitantdosis blev øget fra 4,5 mg til 180 mg. Ved en stigning i dosis på 4 gange den anbefalede kliniske dosis på 180 mg steg Cmax og AUC for rolapitant henholdsvis 3,1 gange og 3,7 gange.
English: There are limited data in patients with severe renal impairment and no data in patients with end stage renal disease undergoing haemodialysis.
Danish: Der foreligger kun begrænsede data for patienter med svært nedsat nyrefunktion og ingen data for patienter med terminal nyresygdom (ESRD), som er i hæmodialyse.
English: Rolapitant is metabolised by CYP3A4 to form a major active metabolite, M19.
Danish: Rolapitant metaboliseres af CYP3A4 og danner en aktiv metabolit, M19.
English: Other medicines and Varuby
Danish: Brug af anden medicin sammen med Varuby
English: Figure 2: Kaplan-Meier Plot of Proportions of Patients without Emesis or Use of Rescue Medication (Study 3--MEC)
Danish: Figur 2: Kaplan-Meier-plot af andelen af patienter uden emese eller brug af nødmedicin (studie 3MEC)
English: Following administration of a single dose of 180 mg rolapitant to patients with mild hepatic impairment (Child-Pugh Class A), the pharmacokinetics of rolapitant were comparable with those of healthy subjects.
Danish: Efter administration af en enkelt dosis på 180 mg rolapitant til patienter med let nedsat leverfunktion (Child-Pugh-klasse A) var rolapitants farmakokinetik sammenlignelig med farmakokinetikken hos raske frivillige forsøgsdeltagere.
English: In vitro studies suggest that rolapitant is not an inhibitor of CYP2E1.
Danish: In vitro-studier tyder på, at rolapitant ikke hæmmer CYP2E1.
English: A single dose of 180 mg rolapitant had no significant effects on the pharmacokinetics of midazolam compared to oral midazolam 3 mg alone on Day 1, Day 8 and Day 11.
Danish: En enkelt dosis på 180 mg rolapitant havde ingen signifikante virkninger på midazolams farmakokinetik sammenlignet med oral midazolam 3 mg alene på dag 1, dag 8 og dag 11.
English: Rolapitant is metabolised by CYP3A4 to form a major active metabolite, M19 (C4-pyrrolidinehydroxylated rolapitant).
Danish: Rolapitant metaboliseres af CYP3A4 og danner en aktiv metabolit, M19 (C4-pyrrolidin-hydroxyleret rolapitant).
English: Pack size of two tablets.
Danish: Pakningsstørrelse med to tabletter.
English: Anxiety Bruxism
Danish: Angst Bruksisme
English: Rolapitant is an inhibitor of P-glycoprotein (P-gp).
Danish: Rolapitant hæmmer P-glykoprotein (P-gp).
English: Following multiple oral doses 9 to 45 mg once daily of rolapitant; accumulation of rolapitant was approximately 5-fold.
Danish: Efter flere orale doser på 9-45 mg rolapitant én gang dagligt var akkumulationen af rolapitant ca. 5-doblet.
English: See the Summary of Product Characteristics for the co-administered 5-HT3 receptor antagonist for appropriate dosing information.
Danish: Se produktresuméet til den samtidigt administrerede 5-HT3-antagonist for doseringsinformation.
English: Rolapitant is an inhibitor of Breast-Cancer-Resistance Protein (BCRP).
Danish: Rolapitant hæmmer brystcancerresistensprotein (BCRP).
English: Concomitant administration of a high fat meal did not significantly affect the pharmacokinetics of rolapitant after administration of 180 mg rolapitant.
Danish: Administration sammen med et måltid med højt fedtindhold påvirkede ikke rolapitants farmakokinetik i signifikant grad efter administration af 180 mg rolapitant.
English: This medicinal product contains 230 mg of lactose (as monohydrate) per dose (two tablets).
Danish: Hjælpestof, som behandleren skal være opmærksom på Dette lægemiddel indeholder 230 mg lactose (som monohydrat) pr. dosis (to tabletter).
English: No clinically significant interaction is expected with the following medicinal products when administered with a single dose of 180 mg rolapitant on Day 1 and without rolapitant on Day 8: repaglinide 0.25 mg (a CYP2C8 substrate), efavirenz 600 mg (a CYP2B6 substrate), tolbutamide 500 mg (a CYP2C9 substrate) or omeprazole 40 mg (a CYP2C19 substrate).
Danish: Der forventes ingen klinisk signifikant interaktion med følgende lægemidler, når de administreres sammen med en enkelt dosis på 180 mg rolapitant på dag 1 og uden rolapitant på dag 8: repaglinid 0,25 mg (CYP2C8-substrat), efavirenz 600 mg (CYP2B6-substrat), tolbutamid 500 mg (CYP2C9substrat) eller omeprazol 40 mg (CYP2C19-substrat).
English: 180 mg orally; Within 2 hours prior to chemotherapy
Danish: 180 mg oralt Højst 2 timer inden kemoterapi
English: Figure 1: Kaplan-Meier Plot of Proportions of Patients without Emesis or Use of Rescue Medication (Study 1 and Study 2 Combined - HEC)
Danish: Figur 1: Kaplan-Meier-plot af andelen af patienter uden emese eller brug af nødmedicin (studie 1 og studie 2 kombineret (HEC))
English: Coadministration of a single dose of 180 mg rolapitant with sulfasalazine, a BCRP substrate, resulted in an approximately 2-fold increase in Cmax and AUC of sulfasalazine.
Danish: Samtidig administration af en enkelt dosis rolapitant på 180 mg og sulfasalazin, som er et BCRP-substrat, resulterede i en omtrentlig fordobling af Cmax og AUC for sulfasalazin.
English: The effect of moderate inducers (e.g. efavirenz, rifabutin) is not established; therefore, the use of rolapitant in patients already given a moderate inducer is not recommended (see section 4.4).
Danish: Effekten af moderate induktorer (f.eks. efavirenz, rifabutin) er ikke klarlagt, og derfor anbefales rolapitant ikke til patienter, der er i behandling med en moderat induktor (se pkt.
English: At rolapitant plasma concentrations of >15 ng/mL and 348 ng/mL, the NK1 receptor occupancies in the cortical regions were approximately >50% and 90% respectively.
Danish: Ved rolapitantkoncentrationer i plasma på > 15 nanogram/ml og 348 nanogram/ml var henholdsvis ca. > 50 % og 90 % af NK1-receptorerne i de kortikale områder okkuperet.
English: Taking Varuby before chemotherapy prevents sickness and feelings of sickness.
Danish: Når Varuby tages før kemoterapien, forebygger det kvalme eller opkastning.
English: A dose-dependent increase in mean NK1 receptor occupancy was observed in the dose range from 4.5 mg to 180 mg of rolapitant.
Danish: Der blev observeret en dosisafhængig stigning i gennemsnitlig okkupation af NK1-receptorer i dosisintervallet 4,5 mg til 180 mg rolapitant.
English: No dose adjustment is necessary for patients with mild or moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion.
English: In a three-month rat study, clonic convulsions were observed in a single animal at 125 mg/kg/day (approximately 6 times the recommended human dose on a body surface area basis).
Danish: I et tremåneders studie med rotter blev der observeret kloniske konvulsioner hos et enkelt dyr ved 125 mg/kg/dag (ca. 6 gange den anbefalede dosis til mennesker ud fra kropsareal).
English: BCRP substrates
Danish: BCRP-substrater
English: Polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.
Danish: Polyvinylchlorid/polychlortrifluorethylen/aluminiumsfolie dobbeltblister.
English: Following single oral doses (4.5 to 180 mg) of rolapitant, the mean terminal half-life (t1/2) of rolapitant ranged from 169 to 183 hours (approximately 7 days) and was independent of dose.
Danish: Efter en enkelt oral dosis (4,5 til 180 mg) af rolapitant var den gennemsnitlige halveringstid (t½) for rolapitant 169 til 183 timer (ca. 7 dage) og uafhængig af dosis.
English: CYP3A4 substrates
Danish: CYP3A4-substrater
English: - you have severe liver or kidney problems - you need to take certain medicines which may reduce the effectiveness of Varuby, such as: - rifampicin, to treat tuberculosis and other infections - carbamazepine, to treat epilepsy and nerve pain - phenobarbital, to treat epilepsy - enzalutamide, to treat prostate cancer - phenytoin, to treat epilepsy - efavirenz, to treat human immunodeficiency virus (HIV) - rifabutin, to treat tuberculosis and other infections - other medicines that contain an NK1 antagonist, such as aprepitant and a combination of netupitant and palonosetron hydrochloride (for the prevention of nausea and vomiting associated with cancer chemotherapy) (see section 2 under ‘Other medicines and Varuby')
Danish: • du skal tage nogle bestemte lægemidler, som kan nedsætte virkningen af Varuby, f.eks.: rifampicin, til at behandle tuberkulose og andre infektioner carbamazepin, til at behandle epilepsi og nervesmerter phenobarbital, til at behandle epilepsi enzalutamid, til at behandle prostatakræft phenytoin, til at behandle epilepsi efavirenz, til at behandle hiv (humant immundefektvirus) rifabutin, til at behandle tuberkulose og andre infektioner andre lægemidler, der indeholder en NK1-antagonist, f.eks. aprepitant eller en kombination af netupitant og palonosetronhydrochlorid (til at forebygge kvalme og opkastning i forbindelse med kemoterapi mod kræft) (se punkt 2 under ”Brug af anden medicin sammen med Varuby”).
English: The pharmacokinetics of Varuby was not studied in patients with end-stage renal disease requiring haemodialysis.
Danish: Varubys farmakokinetik blev ikke undersøgt hos patienter med terminal nyresygdom med behov for hæmodialyse.
English: Rolapitant is eliminated primarily through the hepatobiliary route.
Danish: Rolapitant elimineres primært via lever/galde.
English: At a dose equivalent to 4.5 mg/kg per day free base (approximately 0.2 times the recommended human dose on a body surface area basis), there were decreases in the number of corpora lutea and implantation sites.
Danish: Ved en dosis svarende til 4,5 mg/kg fri base pr. dag (ca. 0,2 gange den anbefalede dosis til mennesker ud fra kropsareal) var der fald i antallet af corpora lutea og implantationssteder.
English: In patients with moderate hepatic impairment (Child-Pugh Class B), the mean Cmax was 25% lower while mean AUC of rolapitant was similar compared to those of healthy subjects.
Danish: Hos patienter med moderat nedsat leverfunktion (Child-Pughklasse B) var den gennemsnitlige Cmax 25 % lavere, mens det gennemsnitlige AUC for rolapitant var sammenligneligt med AUC hos raske frivillige forsøgsdeltagere.
English: Dizziness Disturbance in attention Dysgeusia Somnolence
Danish: Svimmelhed Koncentrationsbesvær Dysgeusi
English: Tablet content
Danish: Tabletindhold
English: Varuby helps prevent feeling sick and being sick when you have chemotherapy.
Danish: Varuby hjælper med til at forebygge kvalme og opkastning, når du får kemoterapi.
English: The active substance is rolapitant.
Danish: Aktivt stof: rolapitant.
English: What Varuby is and what it is used for What Varuby is
Danish: Virkning og anvendelse Hvad er Varuby?
English: In the one-month monkey study, convulsions were observed at 60 mg/kg/day (approximately 5.8 times the recommended human dose on a body surface area basis).
Danish: I et studie på en måned med aber blev der observeret konvulsioner ved 60 mg/kg/dag (ca. 5,8 gange den anbefalede humane dosis ud fra kropsareal).
English: The following adverse reactions were observed in a pooled analysis of the Highly Emetogenic Chemotherapy (HEC) and Moderately Emetogenic Chemotherapy (MEC) studies.
Danish: Følgende bivirkninger er observeret i en puljet analyse af studier af stærkt emetogen kemoterapi og moderat emetogen kemoterapi.
English: Each tablet contains 90 mg of rolapitant.
Danish: En tablet indeholder 90 mg rolapitant.
English: Decreased appetite Dehydration Hypomagnesaemia
Danish: Dehydrering Hypomagnesiæmi
English: Neutrophil count decreased Thrombocytopenia
Danish: Nedsat neutrofiltal Trombocytopeni
English: If you have symptoms of an allergic reaction, such as sudden shortness of breath, swelling of the lips or tongue or change in taste, swelling of skin or tissue or sudden rash or fever, or faster heartbeats, tell your doctor or nurse immediately.
Danish: Sjældne: kan forekomme hos op til 1 ud af 1.000 personer Hvis du får symptomer på en allergisk reaktion, f.eks. kortåndethed, hævelse af læber eller tunge eller smagsforandringer, hævelse i hud eller væv, pludseligt hududslæt, pludselig feber eller hurtigere hjerterytme (puls), skal du fortælle det til lægen eller sundhedspersonalet med det samme.
English: Study 3 - MEC Rolapitant (N=666) Rate (%)
Danish: Studie 3 (MEC) Rolapitant (N = 666), andel (%)
English: N.S.
Danish: I.S.
English: Pack size of two tablets in a polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.
Danish: Pakningsstørrelse med to tabletter i dobbeltblister af polyvinylchlorid/polychlortrifluorethylen/aluminiumsfolie.
English: Rolapitant, the active substance in Varuby, blocks substance P from attaching to these nerve cells and this helps prevent nausea and vomiting.
Danish: Substans P sætter sig fast på nerveceller i hjernens opkastningscenter, så du får kvalme eller kaster op. Rolapitant, det aktive stof i Varuby, blokerer for substans P, så det ikke kan sætte sig fast på disse nerveceller, og dette hjælper med til at forebygge kvalme og opkastning.
English: Prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults
Danish: Profylakse af forsinket kvalme og opkastning hos voksne i forbindelse med stærkt og moderat emetogen kemoterapi mod cancer.
English: Following a single dose administration of 180 mg rolapitant under fasting conditions to healthy subjects, rolapitant was measurable in plasma between 30 minutes and the peak plasma concentration (Cmax) for rolapitant which was reached in about 4 hours and mean Cmax was 968 ng/mL (%CV:28%).
Danish: Efter administration af en enkelt dosis på 180 mg rolapitant til fastende, raske frivillige forsøgspersoner var rolapitant målbart i plasma efter 30 minutter, den maksimale plasmakoncentration (Cmax) for rolapitant blev nået efter ca. 4 timer, og den gennemsnitlige Cmax var 968 nanogram/ml (%CV 28 %).
English: The other ingredients are: - Tablet core: lactose monohydrate (see section 2 under ‘Varuby contains lactose'), pregelatinised starch, microcrystalline cellulose (E460), povidone (K-30), croscarmellose sodium, colloidal silicon dioxide and magnesium stearate.
Danish: • Tabletkerne: lactosemonohydrat (se punkt 2 under ”Varuby indeholder lactose”), prægelatineret stivelse, mikrokrystallinsk cellulose (E 460), povidon (K-30), croscarmellosenatrium, kolloid silica og magnesiumstearat.
English: Varuby is not recommended in patients who require chronic administration of strong (e.g. rifampicin, carbamazepine, phenobarbital, enzalutamide, phenytoin) or moderate enzyme inducers (e.g. efavirenz, rifabutin) (see section 4.5)
Danish: Varuby anbefales ikke til patienter med behov for kronisk administration af potente (f.eks. rifampicin, carbamazepin, phenobarbital, enzalutamid, phenytoin) eller moderate enzyminduktorer (f.eks. efavirenz, rifabutin) (se pkt.
English: Control (N=666) Rate (%)
Danish: Kontrol (N = 666), andel (%)
English: TESARO Bio Netherlands B.V. Joop Geesinkweg 901
Danish: Joop Geesinkweg 901
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking this medicine.
Danish: Hvis du er i tvivl, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet, før du tager dette lægemiddel.
English: Balance disorder Movement disorder Syncope
Danish: Balanceforstyrrelser Bevægelsesforstyrrelser Synkope
English: Varuby should be used with caution in these patients (see section 5.2).
Danish: Varuby skal anvendes med forsigtighed til disse patienter (se pkt.
English: In the pre- and postnatal developmental study, at a dose equivalent to half of the recommended human dose, there was a decrease in memory in female pups in a maze test and a decrease in pup body weight (see section 5.3).
Danish: I det præ- og postnatale udviklingsstudie med en dosis svarende til halvdelen af den anbefalede dosis til mennesker blev det set en dårligere hukommelse hos hununger i en labyrinttest og et fald i ungernes legemsvægt (se pkt.
English: If use cannot be avoided, patients should be monitored for adverse reactions to Varuby (see section 4.8).
Danish: Hvis det er nødvendigt at anvende Varuby, skal patienterne overvåges for bivirkninger ved lægemidlet (se pkt.
English: Acute phase: 0 to 24 hours after AC or non-AC regimen; Delayed phase: >24 to 120 hours after AC or non-AC regimen; Overall phase: 0 to 120 hours after AC or non-AC regimen b Unadjusted P-values are obtained from Cochran-Mantel-Haenszel test, stratified by sex. N.S.=Not significant (p>0.05) * N.S. after pre-specified multiplicity adjustment.
Danish: Akut fase: 0 til 24 timer efter ACeller ikke-AC-regime, sen fase: > 24 til 120 timer efter AC- eller ikke-AC-regime, samlede fase: 0 til 120 timer efter AC- eller ikke-AC-regime c Ikke-justerede P-værdier opnået vha.Cochran-Mantel-Haenszel-test, stratificeret efter køn.
English: The primary endpoint was complete response (defined as no emetic episodes and no rescue medicinal product) in the delayed phase (>24 to 120 hours) of chemotherapy-induced nausea and vomiting.
Danish: Det primære endepunkt var fuldstændigt respons (defineret som ingen emetiske episoder og ingen nødmedicin) i den sene fase (> 24 til 120 timer) af kemoterapiinduceret kvalme og opkastning.
English: The primary endpoint in both studies was complete response (defined as no emetic episodes and no rescue medicinal product) in the delayed phase (>24 to 120 hours) of chemotherapy-induced nausea and vomiting.
Danish: Det primære endepunkt i begge studier var fuldstændigt respons (defineret som ingen emetiske episoder og ingen nødmedicin) i den sene fase (> 24 til 120 timer) af kemoterapiinduceret kvalme og opkastning.
English: In vivo, rolapitant is not expected to exhibit any inhibitory or inducing effect on CYP3A4.
Danish: Rolapitant forventes ikke at hæmme eller inducere CYP3A4 in vivo.
English: The efficacy and safety of rolapitant with concurrent use of another NK1 receptor antagonist (e.g. aprepitant and a combination of netupitant and palonosetron hydrochloride) is not established and therefore not recommended (see section 4.5).
Danish: Rolapitants virkning og sikkerhed med samtidig brug af en anden NK1-antagonist (f.eks. aprepitant eller en kombination af netupitant og palonosetronhydrochlorid) er ikke klarlagt og anbefales derfor ikke (se pkt.
English: Rolapitant had no effects on the pharmacokinetics of caffeine (a CYP1A2 substrate) when an oral dose of 200 mg caffeine was administered with a single dose of 180 mg rolapitant on Day 1, and without rolapitant on Day 8 and Day 15.
Danish: Rolapitant havde ingen indvirkning på koffeins farmakokinetik (et CYP1A2-substrat) ved administration af en oral dosis koffein på 200 mg sammen med en enkeltdosis rolapitant på 180 mg dag 1, og uden rolapitant dag 8 og dag 15.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Varuby is used to help prevent adults with cancer feeling sick (nauseous) or being sick (vomiting) while having cancer treatment chemotherapy.
Danish: Varuby bruges til at forebygge kvalme eller opkastning hos voksne med kræft, mens de får kemoterapi.
English: Rolapitant (N=535) Rate (%)
Danish: Rolapitant (N = 535), andel (%)
English: The following additional pre-specified endpoints were also evaluated: complete response in the acute phase (0 to 24 hours) and overall phase (0 to 120 hours); no emesis in each CINV phase, no significant nausea in each CINV phase and time to first emesis or use of rescue medicinal product.
Danish: Følgende yderligere præspecificerede endepunkter blev også evalueret: fuldstændigt respons i den akutte fase (0 til 24 timer) og i den samlede fase (0 til 120 timer); ingen emese i de enkelte CINV-faser, ingen signifikant kvalme i de enkelte CINV-faser og tid til første emese eller brug af nødmedicin.
English: In two multicentre, randomised, double-blind, parallel group, controlled clinical studies (Study 1 and Study 2), the rolapitant regimen (180 mg rolapitant, 10 mcg/kg intravenous granisetron and 20 mg oral dexamethasone) was compared with control therapy (placebo, 10 mcg/kg intravenous granisetron and 20 mg oral dexamethasone) on Day 1 in patients receiving a chemotherapy regimen that included cisplatin ≥60 mg/m2.
Danish: I to randomiserede, dobbeltblinde, kontrollerede kliniske multicenterstudier med parallelgrupper (studie 1 og studie 2) blev rolapitantregimet (180 mg rolapitant, 10 mikrog/kg intravenøs granisetron og 20 mg oral dexamethason) sammenlignet med kontrolbehandling (placebo, 10 mikrog/kg intravenøs granisetron og 20 mg oral dexamethason) på dag 1 hos patienter, der fik et kemoterapiregime, som inkluderede cisplatin ≥ 60 mg/m2.
English: Rolapitant had no significant effects on the pharmacokinetics of intravenous ondansetron when concomitantly administered with a single 180 mg dose of rolapitant on the same day.
Danish: Rolapitant havde ingen signifikant indvirkning på farmakokinetikken af intravenøs ondansetron, når det blev administreret samtidig med en enkelt dosis på 180 mg rolapitant samme dag.
English: In a fertility and early embryonic development study in female rats, rolapitant hydrochloride at an oral dose equivalent to 9 mg/kg per day free base (approximately 0.5 times the recommended human dose on a body surface area basis) caused a transient decrease in maternal body weight gain and increases in the incidence of pre- and post-implantation loss.
Danish: I et studie hos hunrotter til evaluering af fertilitet og tidlig fosterudvikling forårsagede rolapitanthydrochlorid ved en oral dosis svarende til 9 mg/kg fri base pr. dag (ca. 0,5 gange den anbefalede dosis til mennesker ud fra kropsareal) et forbigående fald i maternel vægtøgning og et øget antal præ- og postimplantationstab.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
English: Rolapitant administered orally to lactating female rats was present in milk.
Danish: Rolapitant var til stede i mælken efter oral administration til diegivende hunrotter.
English: Other CYPs
Danish: Andre CYP'er
English: Patients with severe renal impairment
Danish: Patienter med svært nedsat nyrefunktion
English: How to take Varuby
Danish: Sådan skal du tage Varuby
English: In a pre- and post-natal development rat study, maternal toxicity was evident based on mortality/moribund condition, decreased body weight and food consumption, total litter loss, prolonged parturition, decreased length of gestation, and increased number of unaccounted for implantation sites at a dose equivalent to 22.5 mg/kg per day free base (approximately 1.2 times the recommended human dose on a body surface area basis).
Danish: I et studie af præ- og postnatal udvikling hos rotter var den maternelle toksicitet evident baseret på mortalitet/moribund tilstand, nedsat kropsvægt og fødeindtagelse, totalt kuldtab, langvarig fødsel, nedsat gestationslængde og forhøjet antal uforklarede implantationssteder ved en dosis svarende til
English: Lactose monohydrate Pregelatinised starch Microcrystalline cellulose (E460) Povidone (K-30) Croscarmellose sodium Colloidal silicon dioxide Magnesium stearate
Danish: Lactosemonohydrat Prægelatineret stivelse Mikrokrystallinsk cellulose (E 460) Povidon (K-30)