FrancophonIA/ELRC3.0 huggingface dataset:
English: In the initial type II variation dossier submitted by MRP (FR/H/246/01-02/001), the applicant claimed the following indication: “Stable coronary artery disease: Reduction of risk of cardiovascular events in patients with stable coronary artery disease”.
Danish: I den første dokumentation for ansøgningen om type II-ændringen, der blev indgivet under den gensidige anerkendelsesprocedure (FR/H/246/01-02/001), påberåbte ansøgeren sig følgende indikation:
English: Pharmaceutical form Route of administration
Danish: Lægemiddel-form
English: Haemodialysis patients:
Danish: Hæmodialysepatienter
English: 6.3 Shelf life <[To be completed nationally]> 6.4 Special precautions for storage <[To be completed nationally]> 6.5 Nature and contents of container <[To be completed nationally]> 6.6 Instructions for use and handling < and disposal> <[To be completed nationally]>
Danish: 6.5 Emballage (art og indhold) <[Udfyldes nationalt]>
English: Common: rash, pruritus
Danish: Almindelige: udslæt, kløe
English: The maximum exposure was 5.6 years.
Danish: Den maksimale eksponering var 5,6 år.
English: Not all mutations have been tested.
Danish: Ikke alle mutationer er testet.
English: The study was structured in two periods.
Danish: Forsøget blev struktureret i to perioder.
English: This will help you remember which day you did not take the medicine.
Danish: Det vil hjælpe dig med at huske, hvilken dag du ikke tog medicin.
English: Clear liquids, including carbonated drinks, can be consumed during this period.
Danish: Klare væsker, herunder drikke med brus, kan indtages i denne periode.
English: Titanium dioxide (E171) Indigotine (E132)
Danish: Titandioxid (E171) Indigotin (E132)
English: There was no detectable plasma protein binding following administration of [
Danish: Der var ingen målelig plasmaproteinbinding efter administration af [
English: You may get a headache and feel dizzy.
Danish: Du kan få hovedpine og blive svimmel.
English: PUSH card back into holder
Danish: TRYK kortet tilbage i holderen
English: Starting date:
Danish: Startdato:
English: This medicine has not been studied in children and adolescents under the age of 16 years; therefore, the safety and efficacy in this age group has not been established.
Danish: Dette lægemiddel er ikke undersøgt hos børn og unge under 16 år; dets sikkerhed og virkning i denne aldersgruppe er derfor ikke fastlagt.
English: This will allow quick identification of new safety information.
Danish: Dermed kan nye oplysninger om sikkerheden hurtigt tilvejebringes.
English: In these cases, the question marks in the accompanying parentheses indicate that the changes provided therein have not been experimentally confirmed and may not be correct.
Danish: I disse tilfælde angiver spørgsmålstegnene i de tilhørende parenteser, at ændringerne heri ikke er bekræftet eksperimentelt og muligvis ikke er korrekte.
English: Galafold should be taken every other day at the same time of day to ensure optimal benefits to the patient.
Danish: Galafold bør tages hver anden dag på samme klokkeslæt for at sikre optimale fordele for patienten.
English: PUSH capsule through the foil 4.
Danish: TRYK kapslen gennem folien 4.
English: Complete reversibility was seen after 4 weeks off-dose.
Danish: Der blev iagttaget fuld reversibilitet efter 4 uger uden dosering.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder (if you cannot reach your Amicus representative by phone please contact via the e-mail address listed below):
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen (hvis din Amicus-repræsentant ikke er telefonisk tilgængelig bedes du kontakte denne vha. den nedenfor anførte e-mailadresse):
English: The safety and efficacy of Galafold in children aged 0 to 15 years has not yet been established.
Danish: Galafolds sikkerhed og virkning hos børn i alderen fra 0 til 15 år er endnu ikke klarlagt.
English: There is very limited experience with the use of this medicine in pregnant women.
Danish: Der er meget begrænset erfaring med brug af dette lægemiddel hos gravide kvinder.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1 000 til < 1/100), sjælden (≥ 1/10 000 til < 1/1 000), meget sjælden (< 1/10 000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: PULL out card on the right 3.
Danish: TRÆK kortet ud i højre side 3.
English: This minimum 4 hours fast around taking your medicine is needed to allow your medicine to be fully absorbed.
Danish: Denne fastetid på mindst 4 timer omkring tidspunktet, hvor du tager din medicin, er nødvendig, for at din medicin absorberes helt.
English: • Protein in the urine
Danish: • Protein i urinen
English: After Day 2, continue moving right on the blister sleeve.
Danish: Efter dag 2 skal du fortsætte mod højre på blisterkortet.
English: Approximately 9% of the total radioactivity was unassigned.
Danish: Ca. 9 % af den totale mængde radioaktivitet kunne ikke specificeres nærmere.
English: However, migalastat has been shown to be expressed in the milk of lactating rats.
Danish: Migalastat er imidlertid påvist i mælken hos ammende rotter.
English: A pharmacokinetic trial in healthy male volunteers with 150 mg [
Danish: I et farmakokinetisk forsøg hos raske mandlige forsøgspersoner, der fik 150 mg [
English: There are limited data from the use of Galafold in pregnant women.
Danish: Der er kun begrænsede data fra anvendelse af Galafold til gravide kvinder.
English: The baseline values were 95.3 g/m for the Galafold arm and
Danish: Baseline-værdierne var 95,3 g/m for Galafold-gruppen og
English: Capsules must be swallowed whole.
Danish: Kapslerne skal synkes hele.
English: If your condition worsens, your doctor may evaluate you further or may discontinue your treatment with Galafold.
Danish: Hvis din tilstand bliver værre, vil lægen muligvis vurdere dig yderligere eller stoppe din behandling med Galafold.
English: Treatment with Galafold should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of Fabry disease.
Danish: Behandling med Galafold bør påbegyndes og superviseres af speciallæger med erfaring i diagnosticering og behandling af Fabrys sygdom.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines because certain other medicines may increase or decrease the amount of Galafold in your body.
Danish: Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig, da visse andre lægemidler muligvis kan øge eller nedsætte virkningen af Galafold.
English: The difference in clearance between Fabry patients ≥ 65 years and those < 65 years was 20%, which was not considered clinically significant.
Danish: Forskellen i clearance mellem Fabry-patienter over 65 og under 65 år var 20 %, hvilket ikke blev anset for at have klinisk betydning.
English: Following administration of the same doses, the mean elimination half-life (t1/2) ranged from approximately 3 to 5 hours.
Danish: Efter administration af de samme doser var den gennemsnitlige eliminationshalveringstid (t1/2) mellem 3 og 5 timer.
English: The frequency of events in patients treated with Galafold over 30 months (32%) was similar to the 18 month period.
Danish: Frekvensen af hændelser hos patienter, der blev behandlet med Galafold i 30 måneder (32 %), svarede til 18 måneders perioden.
English: This medicine works by stabilising the enzyme that your body produces naturally, so that it can work better to reduce the amount of GL-3 that has accumulated in your cells and tissues.
Danish: Dette lægemiddel virker ved at stabilisere det enzym, der naturligt produceres af kroppen, så det virker bedre og nedsætter mængden af GL-3, der er aflejret i dine celler og væv.
English: UNKNOWN in the column of ‘protein sequence change' indicate that the changes to the protein sequence caused by the mutations cannot be readily deduced from the nucleotide changes and need to be experimentally determined.
Danish: UKENDT i kolonnen "Ændring i proteinsekvens" angiver, at de af mutationerne forårsagede ændringer i proteinsekvensen ikke umiddelbart kan udledes af nukleotidændringerne, men skal fastlægges eksperimentelt.
English: The nucleotide changes listed represent potential DNA sequence changes that result in the amino acid mutation.
Danish: De anførte nukleotidændringer repræsenterer potentielle ændringer af DNA-sekvensen, der resulterer i en mutation af aminosyren.
English: Galafold is not recommended during pregnancy.
Danish: Galafold frarådes under graviditet.
English: It is unlikely that this medicine will affect your ability to drive and use machines.
Danish: Det er ikke sandsynligt, at dette lægemiddel vil påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: On the next day, punch out the perforated white circle labelled Day 2.
Danish: Næste dag skal du trykke den perforerede hvide cirkel, der er mærket dag 2, ud.
English: Plasma lyso- Gb3 levels also remained low in patients on ERT for up to 18 months.
Danish: Plasma lyso-Gb3 niveauet forblev også lavt hos patienter på ERT i op til 18 måneder.
English: Your doctor will monitor your condition and whether your medicine is working every 6 months while you are taking Galafold.
Danish: Lægen vil overvåge din tilstand og virkningen af medicinen hver sjette måned, mens du er i behandling med Galafold.
English: Punch out the perforated circles on days you are not taking Galafold.
Danish: Tryk de perforerede cirkler ud for de dage, hvor du ikke tager Galafold.
English: Very common: may affect more than 1 in 10 people • Headache
Danish: Meget almindelig: forekommer hos flere end 1 ud af 10 personer • Hovedpine
English: The GLA mutations are also accessible by health care providers at www.galafoldamenabilitytable.com.
Danish: GLA-mutationerne er endvidere tilgængelige for sundhedspersoner på www.galafoldamenabilitytable.com.
English: Table 1: Adverse reactions with Galafold in clinical trials System Organ Class
Danish: Tabel 1: Bivirkninger med Galafold i de kliniske forsøg Systemorganklasse
English: All patients received the recommended dosage of 123 mg Galafold every other day.
Danish: Alle patienter fik den anbefalede dosis på 123 mg Galafold hver anden dag.
English: • raised levels of creatine phosphokinase in blood tests
Danish: • Forhøjet kreatinkinase i blodprøver
English: QR code to be included + www.galafoldsmpc.co.uk
Danish: QR-kode, som skal indlæses + www.galafoldsmpc.co.uk
English: Galafold exposure is decreased by approximately 40% when taken with food and therefore food should not be consumed at least 2 hours before and 2 hours after taking Galafold to give a minimum 4 hours fast.
Danish: Eksponeringen for Galafold nedsættes med ca. 40 % ved indtagelse sammen med føde, og derfor må der ikke indtages føde i mindst 2 timer før og 2 timer efter, Galafold tages, for at give en fastetid på mindst 4 timer.
English: The infertility associated with migalastat treatment was reported at clinically relevant exposures.
Danish: Den med migalastat-behandling forbundne infertilitet blev rapporteret ved klinisk relevant eksponering.
English: Do not eat food at least 2 hours before and 2 hours after taking your medicine.
Danish: Undlad at spise mad i mindst 2 timer før og 2 timer efter du tager din medicin.
English: Approximately 20% of the total radiolabeled dose was excreted in faeces, with unchanged migalastat being the only measured component.
Danish: Ca. 20 % af den totale radioaktivt mærkede dosis blev udskilt i fæces, hvor uomdannet migalastat var den eneste målte komponent.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Galafold, taking into account the benefit of breast-feeding for the child relative to the benefit of therapy for the mother.
Danish: Det skal besluttes, om amning skal ophøre eller Galafold seponeres, idet der tages hensyn til fordelene ved amning for barnet i forhold til den terapeutiske fordel for moderen.
English: Galafold has no or negligible influence on the ability to drive and use machines.
Danish: Galafold påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Your doctor will decide whether you need to stop breast-feeding or temporarily stop your medicine.
Danish: Lægen vil afgøre, om du skal holde op med at amme eller midlertidigt holde op med at tage lægemidlet.
English: No clinically significant differences were observed during the initial 6-month placebo-controlled period.
Danish: Der blev ikke fundet klinisk signifikante forskelle i den indledende 6-måneders placebokontrollerede periode.
English: If you forget to take your capsule at the usual time but remember later, you can take the capsule only if it is within 12 hours of your normal dosing time.
Danish: Hvis du glemmer at tage en kapsel til sædvanlig tid, men kommer i tanker om det senere, kan du kun tage kapslen, hvis det er inden for 12 timer fra din normale doseringstid.
English: If you stop taking Galafold Do not stop taking this medicine without talking to your doctor.
Danish: Hvis du holder op med at tage Galafold Du må ikke holde op med at tage dette lægemiddel uden først at tale med lægen.
English: Depending upon the kind of mutation (change) in the gene that produces α-Gal A, the enzyme does not work properly or is completely absent.
Danish: Alt efter ændringen (mutationen) i det gen, der koder for α-Gal A, virker enzymet ikke, som det skal, eller det mangler helt.
English: At the 150 mg dose, CL/F was approximately 11 to 14 L/hr.
Danish: Ved dosen på 150 mg var CL/F ca. 11 til 14 l/time.
English: Fertility in men
Danish: Frugtbarhed hos mænd
English: If a double mutation is present on different chromosomes (only in females) that patient is amenable if either one of the individual mutations is present in Table 2.
Danish: Hvis der er en dobbeltmutation på forskellige kromosomer (kun hos kvinder), kan patienten behandles, hvis den ene af mutationerne findes i tabel 2).
English: The effect of age was evaluated in a population pharmacokinetic analysis on plasma migalastat clearance in the ERT-naïve study population.
Danish: Alderens betydning blev vurderet i en populationsfarmakokinetisk analyse af migalastats plasmaclearance hos den ERT-naive studiepopulation.
English: Galafold is available in a blister pack containing 14 capsules.
Danish: Galafold fås i en blisterpakning med 14 kapsler.
English: Based upon in vivo data, migalastat is a substrate for UGT, being a minor elimination pathway.
Danish: Baseret på in vivo-data er migalastat substrat for UGT, der er en mindre vigtig udskillelsesvej.
English: • are allergic to migalastat or any of the other ingredients of this medicine (listed in section 6) Warnings and precautions
Danish: • hvis du er allergisk over for migalastat eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6)
English: It is advised to periodically monitor renal function, echocardiographic parameters and biochemical markers (every 6 months) in patients initiated on or switched to Galafold.
Danish: Det tilrådes at monitorerere nyrefunktion, ekkokardiografiske parametre og biokemiske markører regelmæssigt (hver 6. måned) hos patienter, der er sat i behandling med eller har skiftet til Galafold.
English: If a double mutation is present on the same chromosome (males and females), that patient is amenable if the double mutation is present in one entry in Table 2 (e.g., D55V/Q57L).
Danish: Hvis der er en dobbeltmutation på samme kromosom (både mænd og kvinder), kan patienten behandles, hvis dobbeltmutationen findes i én indgang i tabel 2) (f.eks. D55V/Q57L).
English: On your first day of taking this medicine from a new blister sleeve, record the date on the blister sleeve.
Danish: Den første dag, du tager medicin fra et nyt blisterkort, skal du skrive datoen på blisterkortet.
English: Do not take Galafold if you:
Danish: Tag ikke Galafold:
English: Left Ventricular Mass Index (LVMi)
Danish: Masseindeks for venstre ventrikel (LVMi)
English: The recommended dosage regimen in adults and adolescents 16 years and older is 123 mg migalastat (1 capsule) once every other day at the same time of day.
Danish: Den anbefalede dosering for voksne og unge over 16 år er 123 mg migalastat (1 kapsel) én gang hver anden dag på samme klokkeslæt.
English: The first OLE trial (AT1001-041) included patients from Phase 2 and Phase 3 studies and has completed.
Danish: Det første OLE-forsøg (AT1001-041) omfattede patienter fra fase 2- og fase 3-forsøg og er afsluttet.
English: This medicine is used for the long-term treatment of Fabry disease in adults and adolescents aged 16 years and older who have certain genetic mutations (changes).
Danish: Dette lægemiddel anvendes til langtidsbehandling af Fabrys sygdom hos voksne og unge over 16 år, der har visse forandringer (mutationer) i generne.
English: One Galafold blister sleeve = 14 hard capsules = 28 days of therapy
Danish: Én blisterpakning med Galafold = 14 hårde kapsler = 28-dages behandling
English: No reduction in proteinuria was observed in patients treated with Galafold.
Danish: Der er ikke iagttaget aftagende proteinuri hos patienter ved behandling med Galafold.
English: Instructions to open
Danish: Anvisninger for åbning
English: The capsules must not be cut, crushed, or chewed.
Danish: Kapslerne må ikke skæres over, knuses eller tygges.
English: Tel: +353 (0) 1 588 6850
Danish: Tlf.: +353 (0) 1 588 6850
English: Take one capsule every other day at the same time of the day.
Danish: Tag én kapsel hver anden dag på samme klokkeslæt.
English: Alternate daily between taking the capsule on odd numbered days and punching out the perforated white circles on even numbered days, up to and including day 28.
Danish: Skift mellem at tage en kapsel på dage med ulige nummer og trykke den perforerede hvide cirkel ud på dage med lige nummer, til og med dag 28.
English: It is not known whether Galafold is secreted in human milk.
Danish: Det vides ikke, om Galafold udskilles i human mælk.
English: This study also indicated that agalsidase has no effect on the pharmacokinetics of migalastat.
Danish: Studiet indikerede også, at agalsidase ikke påvirker farmakokinetikken af migalastat.
English: No clinically significant differences in LVMi were observed during the initial 6-month placebo-controlled period.
Danish: Der blev ikke iagttaget klinisk signifikante forskelle i LVMi i den indledende 6-måneders placebokontrollerede periode.
English: If you forget to take Galafold
Danish: Hvis du har glemt at tage Galafold
English: The amino acid mutation (protein sequence change) is most relevant when determining amenability.
Danish: Mutationen af aminosyren (ændring af proteinsekvensen) er mest relevant,
English: Certain GLA mutations can result in the production of abnormally folded and unstable mutant forms of α-Gal A. Migalastat is a pharmacological chaperone that is designed to selectively and reversibly bind with high affinity to the active sites of certain mutant forms of -Gal A, the genotypes of which are referred to as amenable mutations.
Danish: Visse GLA-mutationer kan medføre dannelse af abnormt foldede og ustabile mutantformer af α-Gal A. Migalastat er en farmakologisk beskyttelse (chaperone), der er designet til med høj affinitet at binde selektivt og reversibelt til de aktive steder på visse mutantformer af -Gal A, de genotyper, der kaldes behandlelige mutationer.
English: The most common adverse reaction was headache, which was experienced by approximately 10% of patients who received Galafold.
Danish: Sammenfatning af sikkerhedsprofilen Den hyppigste bivirkning var hovedpine, som optrådte hos ca. 10 % af de patienter, der fik Galafold.
English: The pharmacokinetic characteristics of migalastat were not significantly different between females and males in either healthy volunteers or in patients with Fabry disease.
Danish: Migalastats farmakokinetiske egenskaber udviste ikke signifikante forskelle mellem kvinder og mænd, hverken hos raske forsøgspersoner eller hos patienter med Fabrys sygdom.
English: Migalastat is not a substrate for P-glycoprotein (P-gP) in vitro and it is considered unlikely that migalastat would be subject to drug-drug interactions with cytochrome P450s.
Danish: Migalastat er ikke substrat for P-glykoprotein (P-gP) in vitro, og det anses for usandsynligt, at migalastat vil være underlagt lægemiddelinteraktioner med CYP-enzymerne.
English: Table 3: Mutations not amenable to Galafold (migalastat)
Danish: Tabel 3: Mutationer, der ikke kan behogles med Galafold (migalastat)
English: Following ascending single oral doses (25-675 mg migalastat hydrochloride), no trends were found for clearance, CL/F).
Danish: Efter stigende orale enkeltdoser (25-675 mg migalastathydrochlorid) fandtes ingen tendens i clearance (CL/F).
English: In a rat 104-week carcinogenicity study, there was an increased incidence of pancreatic islet cell adenomas in males at a dose level 19-fold higher than the exposure (AUC) at the clinically efficacious dose.
Danish: I et 104-ugers karcinogenicitetsstudie hos rotter var der øget forekomst af adenomer i øcellerne i pancreas hos handyr ved en dosis svarende til 19 gange højere eksponering (AUC) end ved den klinisk effektive dosis.
English: Pharmacotherapeutic group: Various alimentary tract and metabolism products ATC code: A16AX14
Danish: Farmakoterapeutisk klassifikation: Diverse midler til fordøjelsesorganer og stofskifte ATC kode:A16AX14
English: What you need to know before you take Galafold 3.
Danish: Det skal du vide, før du begynder at tage Galafold 3.
English: If a dose is missed entirely for the day, the patient should take the missed dose of Galafold only if it is within 12 hours of the normal time the dose is taken.
Danish: Hvis en dosis helt glemmes en dag, skal patienten kun tage den glemte dosis Galafold, hvis det er inden for 12 timer fra det tidspunkt, hvor dosen normalt tages.
English: In the ERT-experienced trial, an analysis of a composite clinical outcome composed of renal, cardiac, and cerebrovascular events, or death, showed that the frequency of events observed in the Galafold treatment group was 29% compared to 44% in the ERT group over 18 months.
Danish: I forsøget med ERT-erfarne patienter viste en analyse af de kombinerede kliniske resultater, der var sammensat af renale, kardiale og cerebrovaskulære hændelser eller dødsfald, viste det sig, at hyppigheden af hændelser var 29 % i Galafold-gruppen sammenlignet med 44 % i ERT-gruppen i 18 måneder.
English: Limited data suggest that co-administration of a single dose of Galafold and a standard enzyme replacement therapy infusion results in an increased exposure to agalsidase of up to 5-fold.
Danish: Begrænsede data tyder på, at samtidig administration af en enkelt dosis Galafold og standardenzymsubstitutionsterapi medfører en øget på 1 til 5 gange eksponering for agalsidase.
English: Fabry disease is caused by the lack of or a faulty enzyme called alpha-galactosidase A (α-Gal A).
Danish: Fabrys sygdom skyldes mangel på eller fejl i enzymet alfa-galaktosidase A (α-Gal A).