FrancophonIA/ELRC3.0 huggingface dataset:
English: Tafamidis has not specifically been evaluated in patients with renal impairment, but a dosage adjustment in patients with renal impairment is considered not necessary.
Danish: Tafamidis er ikke blevet undersøgt specifikt hos patienter med nedsat nyrefunktion, men dosisjustering hos patienter med nedsat nyrefunktion anses ikke for at være nødvendig.
English: To remove capsule: tear off one individual blister, peel the paper at the curved arrow and push through the aluminium foil.
Danish: Sådan tages kapslen ud: Riv en enkelt blister af, træk papiret af ved den buede pil og tryk kapslen ud gennem aluminiumsfolien.
English: In vitro data also indicated that tafamidis meglumine does not significantly inhibit cytochrome P450 enzymes CYP1A2, CYP3A4, CYP3A5, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6.
Danish: In vitro data indikerer, at tafamidismeglumin ikke signifikant hæmmer CYP-enzymerne CYP1A2, CYP3A4, CYP3A5, CYP2B6, CYP2C8, CYP2C9, CYP2C19 og CYP2D6.
English: Data in the elderly patients are very limited.
Danish: Der er meget begrænsede data for anvendelse til ældre.
English: Pharmacokinetic parameters were similar after single and repeated administration of 20 mg dose, indicating a lack of induction or inhibition of tafamidis metabolism.
Danish: Farmakokinetiske parametre er sammenlignelige efter enkelt og gentagen dosering af 20 mg, hvilket tyder på manglende induktion og hæmning af metabolismen af tafamidis.
English: 4 CLINICAL PARTICULARS 4.1 Therapeutic indication
Danish: 4.1 Terapeutiske indikationer
English: The overall clinical data reflect exposure of 127 TTR amyloid polyneuropathy patients to 20 mg of tafamidis meglumine administered daily for an average of 538 days (ranging from 15 to 994 days).
Danish: De samlede kliniske data stammer fra 127 patienter med TTR amyloid polyneuropati, som fik 20 mg tafamidismeglumin dagligt i gennemsnitligt 538 dage (fra 15-994 dage).
English: The adverse reactions were generally mild or moderate in severity.
Danish: Sværhedsgraden af bivirkningerne var generelt milde til moderate.
English: TTR amyloid polyneuropathy is caused by a protein called TTR that does not work properly.
Danish: TTR amyloid polyneuropati skyldes, at et protein, som hedder TTR, ikke fungerer rigtigt.
English: In repeated dose toxicity studies the liver appeared as a target organ for toxicity in the different species tested.
Danish: I forsøg med toksicitet efter gentagne doser synes leveren at være målorgan for toksicitet hos de undersøgte arter.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: 10 SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLIGE VILKÅR
English: The secondary endpoints demonstrated that tafamidis meglumine treatment resulted in less deterioration of neurologic function and improved nutritional status (mBMI) compared with placebo, as shown in the following table.
Danish: De sekundære resultatmål viste, at tafamidismeglumin-behandling førte til mindre nedbrydelse af neurologisk funktion og forbedrede den ernæringsmæssige status (mBMI) sammenlignet med placebo.
English: Based on preclinical data, it is suggested that tafamidis is metabolised by glucuronidation and excreted via the bile.
Danish: Med baggrund i prækliniske data er der dog en formodning om, at tafamidis metaboliseres via glukuronidering og udskilles via galden.
English: Vyndaqel is available in two pack sizes of PVC/PA/Alu/PVC-Alu/PET/Paper perforated unit dose blisters: a pack of 30 x 1 soft capsules and a multipack of 90 soft capsules comprising of 3 cartons, each containing 30 x 1 soft capsules.
Danish: Vyndaqel findes i 2 pakningsstørrelser af PVC/PA/Alu/PVC-Alu/PET/Papir perforerede enkeltdosisblistre: En pakning med 30 x 1 bløde kapsler og en multipakning med 90 bløde kapsler betående af 3 kartoner, som hver indeholder 30 x 1 bløde kapsler.
English: In a developmental toxicity study in rabbits, a slight increase in skeletal malformations and variations, abortions in few females, and reduction in foetal weights were observed at an AUC0-24 ratio of 3.2-fold, based on the human AUC at steady state.
Danish: I et forsøg af udviklingsmæssig toksicitet på kaniner ses en mindre stigning i antallet af skeletale misdannelser og forandringer, aborter hos nogle få hunner, og nedsat fødselsvægt ses ved en AUC0-24ratio på 3,2 gange baseret på human AUC ved steady state.
English: Although data are limited, (one open label study in 21 patients), taking into account the mechanism of action of tafamidis and the results on TTR stabilisation, tafamidis meglumine is expected to be beneficial in patients with stage 1 TTR amyloid polyneuropathy due to mutations other than V30M.
Danish: Selv om data er begrænsede (1 åbent studie med 21 patienter), kan tafamidismeglumin, under hensyntagen til tafamidis virkningsmekanisme og resultater på TTR-stabilisering, forventes at have gavnlig virkning på patienter med stadie 1 TTR amyloid polyneuropati, som skyldes andre mutationer end V30M.
English: Children and adolescents do not have the symptoms of TTR amyloid polyneuropathy.
Danish: Børn og unge har ikke symptomer på TTR amyloid polyneuropati.
English: Health care professionals are asked to report any suspected adverse reactions.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger.
English: The reported treatment-related adverse events were mild to moderate and included: headache, somnolence, myalgia, insomnia, hordeolum, photosensitivity reaction, and presyncope.
Danish: De rapporterede behandlingsrelaterede bivirkninger var lette til moderate og omfattede hovedpine, søvnighed, myalgi, søvnløshed, hordeolum, lysfølsomhedsreaktioner og præsynkope.
English: Tafamidis binds non-cooperatively to the two thyroxine binding sites on the native tetrameric form of transthyretin preventing dissociation into monomers.
Danish: Tafamidismeglumin binder sig inaktivt til de 2 thyroksinbindingssteder på den naturlige tetrameriske form af transthyretin og forhindrer derved adskillelsen til monomerer.
English: Pharmacokinetic data indicated decreased systemic exposure (approximately 40%) and increased total clearance (0.52 l/h vs. 0.31l/h) of tafamidis in patients with moderate hepatic impairment (Child-Pugh Score of 7-9 inclusive) compared to healthy subjects due to a higher unbound fraction of tafamidis.
Danish: Farmakokinetiske data tyder på nedsat systemisk påvirkning (ca. 40%) og øget total clearance (0,52 l/t vs. 0,31 l/t) af tafamidis hos patienter med moderat nedsat leverfunktion (omfattende Child-Pugh Score 7-9) sammenlignet med raske forsøgspersoner på grund af en højere ubundet fraktion af tafamidis.
English: Results of once-daily dosing with tafamidis meglumine 20 mg for 14 days demonstrated that steadystate was achieved by Day 14.
Danish: Resultater af dosering 1 gang dagligt med tafamidismeglumin 20 mg i 14 dage viser, at steady state opnås på dag 14.
English: • The other ingredients are: gelatin (E441), glycerin (E422), sorbitol (E420), mannitol (E421), sorbitan, yellow iron oxide (E172), titanium dioxide (E171), purified water, macrogol 400 (E1521), sorbitan monooleate (E494), polysorbate 80 (E433), ethyl alcohol, isopropyl alcohol, polyvinyl acetate phthalate, propylene glycol (E1520), carmine (E120), brilliant blue FCF (E133) and ammonium hydroxide (E527).
Danish: • De øvrige indholdsstoffer er: gelatine (E441); glycerol (E422); sorbitol (E420); mannitol (E421); sorbitan; gul jernoxid (E172); titandioxid (E171); vand, renset; macrogol 400 (E1521); sorbitanmono-oleate (E494); polysorbat 80 (E433); ethanol; isopropylalkohol; polyvinylacetatphthalat; propylenglycol (E1520); carmin (E120); blå farve (Brilliant Blue fcfE133) og ammoniumhydroxid (E527).
English: If it is within 6 hours before your next dose, skip the missed dose and take the next dose at the usual time.
Danish: Hvis det sker inden for 6 timer inden Deres næste dosis, skal De springe den glemte dosis over.
English: Vyndaqel contains sorbitol
Danish: Vyndaqel indeholder sorbitol
English: The pivotal study of tafamidis meglumine was an 18-month, multicenter, randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of once-daily 20 mg tafamidis meglumine in 128 patients with TTR amyloid polyneuropathy with the V30M mutation and primarily stage 1 disease (do not routinely require assistance with ambulation).
Danish: Det pivotale studie med tafamidismeglumin er et 18 måneders, multicenter, randomiseret, dobbeltblindt, placebo-kontrolleret studie, der vurderede sikkerhed og virkning af 20 mg tafamidis 1 gang dagligt hos 128 patienter med TTR amyloid polyneuropati med V30M-mutation og sygdom i primær stadie 1 (kræver normalt ikke mobilitetshjælp).
English: 12 MARKETING AUTHORISATION NUMBER(S)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
English: Other outcome measures included composite scores of large nerve fiber (nerve conduction, vibration threshold and heart rate response to deep breathing - HRDB) and small nerve fiber function (heat pain and cooling threshold and HRDB) and nutritional assessments utilizing the modified body mass index (mBMI - BMI multiplied by serum albumin in g/L).
Danish: Andre resultatmål omfatter sammensatte scorer af lange nervefibre (nerveoverledning, vibrationstærskel og hjertefrekvensrespons på dyb vejrtrækning - HRDB) og funktion af små nervefibre (varmesmerte og kuldetærskel og HRDB) og ernæringsmæssig vurdering ved hjælp af den modificerede metode til udregning af idealvægt (mBMI - BMI gange serum-albumin i g/l).
English: Pre-specified ITT Analysis
Danish: Prædefineret ITT-analyse
English: Based on population PK results, subjects older than 60 years old had an average 19% lower estimate of clearance at steady-state compared to subjects less than 60 years old.
Danish: Resultaterne fra en populationsfarmakokinetisk analyse viser, at forsøgspersoner over 60 år har en gennemsnitlig 19% lavere anslået clearance ved steady state end forsøgspersoner under 60 år.
English: The primary outcome measures were the Neuropathy Impairment Score of the Lower Limb (NIS-LL - a physician assessment of the neurologic exam of the lower limbs) and the Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QOL-DN - a patient reported outcome, total quality of life score [TQOL]).
Danish: Det primære resultatmål var “Neuropathy Impairment Score of the Lower Limb” (NIS-LL - en lægelig vurdering af den neurologiske undersøgelse af underekstremiteterne) og livskvalitetsundersøgelsen, Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QOL-DN - en patientvurdering, total livskvalitetsscore [TQOL]).
English: The exposure to tafamidis in patients with severe hepatic impairment is unknown.
Danish: Eksponeringen for tafamidis hos patienter med svært nedsat leverfunktion er ikke kendt.
English: The capsule contains sorbitol (E420).
Danish: Kapslen indeholder sorbitol (E420).
English: There are no data on the use of tafamidis meglumine in pregnant women.
Danish: Der er ingen data fra anvendelse af tafamidismeglumin til gravide kvinder.
English: Tafamidis meglumine should not be used during breast-feeding.
Danish: Tafamidismeglumin må ikke anvendes under amning.
English: Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Danish: Vyndaqel er indiceret til behandling af transtyretin amyloidose hos voksne patienter med stadie 1 symptomatisk polyneuropati for at udsætte perifer neurologisk funktionshæmning.
English: Secondary Endpoints Changes from Baseline to Month 18 LSMean (Standard Error) (Intentto-Treat Population) (Study Fx-005) Placebo N=61
Danish: Sekundære resultatmålsændringer fra baseline til måned 18, gennemsnit (LSMean (standardafvigelse)) (intent-to-treat-population) (Studie Fx-005) Placebo N=61
English: In clinical trials of healthy volunteers, the highest dose of tafamidis given was 480 mg in a single dose and 60 mg once daily for two weeks.
Danish: I kliniske studier med raske, frivillige forsøgspersoner er den højeste dosis, som er givet, 480 mg som engangsdosis og 60 mg dagligt i 2 uger.
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
English: s r.o.
Danish: sr.o.
English: 14 GENERAL CLASSIFICATION FOR SUPPLY
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING
English: TTR amyloid polyneuropathy is a multi-faceted, progressive, axonal degenerative neuropathy characterized by sensory, motor and autonomic impairment.
Danish: TTR amyloid polyneuropati er en progressiv, aksonal degenerativ neuropati med flere facetter karakteriseret ved tab af følesans og motorisk og autonom funktionshæmning.
English: If you take more capsules than you have been told to take, contact your doctor.
Danish: Hvis De har taget flere Vyndaqel-kapsler end lægen har sagt, skal De kontakte lægen.
English: Each soft capsule contains no more than 44 mg of sorbitol (E420).
Danish: Hver blød kapsel indeholder højst 44 mg sorbitol (E420).
English: In the rat peri- and post-natal development study with tafamidis, decreased pup survival and reduced pup weights were noted following maternal treatment during pregnancy and lactation at doses of 15 and 30 mg/kg.
Danish: I peri- og postnatale udviklingsforsøg med tafamidis på rotter ses reduktion i overlevelsesraten hos afkommet og ungernes fødselsvægt er lavere, efter at moderdyret er blevet behandlet under graviditet og amning med doser på 15 og 30 mg/kg.
English: The NOAEL for viability and growth in the F1 generation offspring following maternal treatment during pregnancy and lactation with tafamidis was 5 mg/kg (HED=0.8 mg/kg), a dose approximately 4.6-times the recommended dose.
Danish: Niveauet for ingen observeret effekt (NOAEL) for levedygtighed og vækst hos afkommet (F1-generationen) efter at moderdyret er blevet behandlet med tafamidis under graviditet og amning er 5 mg/kg (humanekvivalent dosis = 0,8 mg/kg), dvs. en dosis ca. 4,6 gange højere end den anbefalede dosis.
English: As Vyndaqel works by stabilizing the TTR protein, if you stop taking Vyndaqel, the protein will no longer be stabilized, and your disease may progress.
Danish: Da Vyndaqel virker ved at stabilisere TTR-proteinet, kan Deres sygdom forværres, hvis De stopper med at tage Vyndaqel, da dette protein så ikke længere bliver stabiliseret.
English: Treatment should be initiated by and remain under the supervision of a physician knowledgeable in the management of patients with transthyretin amyloid polyneuropathy.
Danish: Behandlingen bør indledes og fortsættes under opsyn af en læge, som har erfaring med behandling af patienter med transthyretin amyloid polyneuropati.
English: The recommended dose is one capsule (20 mg Tafamidis meglumine) of Vyndaqel once a day.
Danish: Den anbefalede dosis er 1 kapsel (20 mg tafamidismeglumin) Vyndaqel 1 gang dagligt.
English: Printing ink (Opacode purple) Ethyl alcohol
Danish: Trykkeblæk (Opacode lilla) Ethanol
English: Tafamidis meglumine is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Tafamidismeglumin bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: 1 NAME OF THE MEDICINAL PRODUCT
Danish: LÆGEMIDLETS NAVN
English: • If you are able to become pregnant, you must use birth control during treatment and for one month after stopping treatment.
Danish: • Hvis De er i den fødedygtige alder, skal De bruge sikker prævention, så længe De er i behandling og i 1 måned efter behandlingen er stoppet.
English: In vitro studies with tafamidis meglumine suggest that it is unlikely tafamidis meglumine will cause drug interactions at clinically relevant concentrations with substrates of UDP glucuronosyltransferase (UGT), P-gp transporters, or organic anion-transporting polypeptide transporters (OATP1B1 and 1B3).
Danish: In vitro studier med tafamidismeglumin indikerer, at tafamidismeglumin ved klinisk relevante koncentrationer sandsynligvis ikke forårsager lægemiddelinteraktioner med substrater for UDPglukuronosyltransferase (UGT), P-gp-transportører eller organisk anion-transporterende polypeptidtransportører (OATP1B1 og 1B3).
English: Vyndaqel soft capsules are yellow, opaque, oblong (approximately 21 mm) imprinted with “VYN 20” in red.
Danish: Vyndaqel bløde kapsler er gule, uigennemsigtige, aflange (ca. 21 mm) mærket med ”VYN 20” med rødt blæk.
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: - non-steroidal anti-inflammatory drugs - diuretic medicines (e.g. furosemide, bumetanide) - anti-cancer medicines (e.g. methotrexate, imatinib) - statins (e.g. rosuvastatin) - anti-viral medicines (e.g. oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, lamivudine,
Danish: - non-steroide antiinflammatoriske midler - vanddrivende midler (fx furosemid, bumetanid) - kræftmedicin (fx methotrexat, imatinib) - statiner (fx rosuvastatin) - virushæmmende medicin (fx oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, lamivudin,
English: 5 METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: Likewise, tafamidis meglumine inhibits the uptake transporters OAT1 and OAT3 (organic anion transporters) with IC50=2.9 µM and IC50=2.36 µM, respectively, and may cause drug-drug interactions at clinically relevant concentrations with substrates of these transporters (e.g. non-steroidal anti-inflammatory drugs, bumetanide, furosemide, lamivudine, methotrexate, oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, zidovudine, zalcitabine).
Danish: Ligeledes hæmmer tafamidismeglumin optagelses-transportørerne QAT1 og OAT3 (organisk anion-transportører) med henholdsvis IC50=2,9 µM og IC50=2,36 µM og kan ved klinisk relevante koncentrationer forårsage lægemiddelinteraktioner med substrater for disse transportører (f.eks. non-steroide antiinflammatoriske midler, bumetanid, furosemid, lamivudin, methotrexat, oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, zidovudin, zalcitabin).
English: However, in vitro tafamidis meglumine inhibits the efflux transporter BCRP (breast cancer resistant protein) with IC50=1.16 µM and may cause drug-drug interactions at clinically relevant concentrations with substrates of this transporter (e.g. methotrexate, rosuvastatin, imatinib).
Danish: In vitro hæmmer tafamidismeglumin imidlertid effluks-transportøren BCRP (brystcancerresistent protein) med IC50=1,16 µM og kan ved klinisk relevante koncentrationer forårsage lægemiddelinteraktioner med substrater for denne transportør (f.eks. methotrexat, rosuvastatin og imatinib).
English: Capsule contents
Danish: Blød kapsel
English: Isopropyl alcohol
Danish: Isopropylalkohol Vand, renset
English: NIS-LL Responders (% Patients) Difference (Vyndaqel minus Placebo) 95% CI of Difference (p-value) TQOL Change from Baseline LSMean (SE) Difference in LSMeans (SE) 95% CI of Difference (p-value) Pre-specified Efficacy Evaluable Analysis
Danish: NIS-LL-responder (% patienter) Forskel (Vyndaqel minus placebo) 95% CI af forskel (p-værdi) TQOL ændring fra start, gennemsnit (LSMean (standardafvigelse)) Forskel i gennemsnit (LSMean (standardafvigelse)) 95% CI af forskel (p-værdi) Prædefineret analyse af evaluerbar effekt
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller på apoteket, hvis De bruger anden medicin eller har gjort det for nylig.
English: This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for dette lægemiddel, fordi det drejer sig om en sjælden sygdom.
English: There is no explicit evidence of biliary excretion of tafamidis in humans.
Danish: Der findes ikke noget entydigt bevis for udskillelse af tafamidis via galden hos mennesker.
English: 30 x 1 soft capsules.
Danish: 30 x 1 bløde kapsler.
English: Tafamidis meglumine has not been studied in patients with severe hepatic impairment and caution is recommended (see section 5.2).
Danish: Tafamidismeglumin er ikke undersøgt hos patienter med alvorligt nedsat leverfunktion og forsigtighed tilrådes derfor (se pkt.
English: Fertility No impairment of fertility has been observed in nonclinical studies (see section 5.3).
Danish: Fertilitet Der er ikke set nedsat fertilitet i prækliniske studier (se pkt.
English: Following daily administration of a 20 mg dose of tafamidis meglumine for 14 days in healthy subjects, mean steady-state half-life was 59 h and mean total clearance was 0.42 l/h.
Danish: Efter daglig indtagelse af 20 mg tafamidismeglumin i 14 dage er gennemsnitlig steady state halveringstid hos raske, frivillige forsøgspersoner 59 timer, og gennemsnitlig total clearance er 0,42 l/t.
English: If you stop taking Vyndaqel
Danish: Hvis De holder op med at tage Vyndaqel
English: Sorbitol (E420) Mannitol (E421) Titanium dioxide (E171) Purified water
Danish: Sorbitol (E420) Mannitol (E421) Titandioxid (E171) Vand, renset
English: • Women that can become pregnant should use birth control while taking Vyndaqel and should continue using birth control for one month after stopping treatment with Vyndaqel.
Danish: • Kvinder i den fødedygtige alder skal bruge sikker prævention, så længe de er i behandling med Vyndaqel, og de skal fortsætte med den svangerskabsforebyggende behandling i 1 måned efter behanding med Vyndaqel er stoppet.
English: The recommended dose of tafamidis meglumine is 20 mg orally once daily.
Danish: Dosering Anbefalet dosis af tafamidismeglumin er 20 mg oralt 1 gang dagligt.
English: If no capsule is identified, then no additional dose is necessary, with resumption of dosing the next day as usual.
Danish: Hvis kapslen ikke kan identificeres, er yderligere dosis ikke nødvendig, og Vyndaqel-behandlingen kan genoptages som vanligt den næste dag.
English: Other medicines and Vyndaqel
Danish: Brug af anden medicin sammen med Vyndaqel
English: 4.7 Effects on ability to drive and use machines On the basis of the pharmacodynamic and pharmacokinetic profile, tafamidis meglumine is believed to have no or negligible influence on the ability to drive or use machines.
Danish: På grundlag af den farmakodynamiske og farmakokinetiske profil menes det, at tafamidismeglumin ikke eller kun i ubetydelig grad påvirker evnen til at føre motorkøretøj og betjene maskiner.
English: Macrogol 400 (E1521) Sorbitan monooleate (E494) Polysorbate 80 (E433)
Danish: Kapselindhold Macrogol 400 (E1521) Sorbitanmono-oleat (E494) Polysorbat 80 (E433)
English: Vyndaqel is a medicine which treats a disease called Transthyretin (TTR) amyloid polyneuropathy, also known as TTR familial amyloid polyneuropathy (TTR-FAP).
Danish: Vyndaqel er en medicin til behandling af en sygdom, som kaldes transthyretin (TTR) amyloid polyneuropati, også kendt som TTR familiær amyloid polyneuropati (TTR-FAP).
English: No dosage adjustment is required for patients with renal or mild and moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion eller let til moderat nedsat leverfunktion.
English: If you forget to take Vyndaqel
Danish: Hvis De har glemt at tage Vyndaqel