FrancophonIA/ELRC3.0 huggingface dataset:
English: While the numbers of subjects with mild and moderate renal impairment were very small, the data suggest an approximate decrease in CL/F of 40% and 60% respectively, in mild and moderate renal impairment (see section 4.2).
Danish: Mens antallet af forsøgspersoner med let og moderat nyreinsufficiens var meget lille, tyder dataene på et omtrentligt fald i CL/F på henholdsvis 40% og 60% ved let og moderat nyreinsufficiens (se pkt.
English: People usually stop losing weight as treatment goes on.
Danish: Normalt ophører vægttabet ved fortsat behandling.
English: PHARMACEUTICAL FORM AND CONTENTS 84 x 1 hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 84 x 1 hård kapsel
English: Temporary dose reduction may be necessary in some patients because of diarrhoea.
Danish: Midlertidig dosisreduktion kan være nødvendig hos visse patienter på grund af diarré.
English: No patient showed rapid deterioration of type 1 Gaucher disease following the switch to miglustat monotherapy.
Danish: Ingen patienter udviste hurtig forværring af Gauchers sygdom type 1 efter skift til miglustat-monoterapi.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: The reason for these tests is that some patients have had tingling or numbness in the hands and feet, or a decrease in body weight, while taking Yargesa.
Danish: Årsagen til disse prøver er, at visse patients har snurren eller følelsesløshed i hænder og fødder, eller taber i vægt, når de tager Yargesa.
English: - the other ingredients are sodium starch glycolate (type A), povidone (K-29/32), magnesium stearate, gelatin, purified water, titanium dioxide (E171), printing ink (shellac glaze, iron oxide black (E172), propylene glycol and concentrated ammonia solution)
Danish: - Øvrige indholdsstoffer: natriumstivelsesglycolat (type A), povidon (K-29/32), magnesiumstearat, gelatine, renset vand, titandioxid (E171), trykfarve (shellac glaze, sort jernoxid (E172), propylenglycol og koncentreret ammoniumopløsning).
English: If you have Niemann-Pick type C disease, fats such as glycosphingolipids build up in the cells of your brain.
Danish: Hvis De har Niemann-Picks sygdom, type C, ophobes fedt f.eks. glycosphingolipider i cellerne i Deres hjerne.
English: An open-label, non-comparative, 2-year study enrolled 42 patients with type 1 Gaucher disease, who had received a minimum of 3 years of ERT and who fulfilled criteria of stable disease for at least 2 years.
Danish: Et åbent, non-komparativt studie af 2 års varighed inkluderede 42 patienter med Gauchers sygdom, type 1, som i mindst 3 år havde fået ERT, og som opfyldte kriteriet stabil sygdom i mindst 2 år.
English: This means a daily maximum of three capsules (300 mg).
Danish: Det vil sige maksimalt tre kapsler (300 mg) om dagen.
English: In addition 12 paediatric patients were enrolled in an uncontrolled substudy for an overall average duration of 3.1 years and up to 4.4 years.
Danish: Yderligere 12 pædiatriske patienter blev inkluderet i et ukontrolleret delstudie med en gennemsnitlig varighed fra 3,1 år og op til 4,4 år.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: There is a close relationship between renal function and clearance of miglustat, and exposure to miglustat is markedly increased in patients with severe renal impairment (see section 5.2).
Danish: Der er en nøje sammenhæng mellem nyrefunktion og clearance af miglustat, og eksponering for miglustat er markant øget hos patienter med svær nyreinsufficiens (se pkt.
English: The tests will help the doctor decide whether these effects are due to your disease or other existing conditions, or due to side effects of Yargesa (see section 4 for further details).
Danish: Prøverne vil hjælpe lægen til at beslutte, om disse virkninger skyldes Deres sygdom eller eksisterende tilstande eller er bivirkninger af Yargesa (se pkt.
English: Capsule content sodium starch glycolate (Type A) povidone (K-29/32) magnesium stearate
Danish: Natriumstivelsesglycolat (type A) Povidon (K-29/32) Magnesiumstearat
English: Based on mg/kg/day and corrected for differences in faecal excretion, the doses corresponded to 8, 16 and 33/19 times the highest recommended human dose (200 mg t.i.d.).
Danish: Baseret på mg/kg/dag og korrigeret for forskelle i fækal udskillelse, svarede doserne til 8,16 og 33/19 gange den højeste anbefalede humane dosis (200 mg 3 gange dagligt).
English: Although no direct comparisons with Enzyme Replacement Therapy (ERT) have been performed in treatment-naive patients with type 1 Gaucher disease, there is no evidence of miglustat having an efficacy or safety advantage over ERT. ERT is the standard of care for patients who require treatment for type 1 Gaucher disease (see section 5.1).
Danish: Der er ikke udført direkte sammenligninger med enzymsubstitutionsterapi (ERT) hos behandlingsnaive patienter med Gauchers sygdom, type 1, og der er intet bevis for, at miglustat har fordele med hensyn til effektivitet eller sikkerhed i forhold til ERT. ERT er standardbehandling for patienter, der kræver behandling for Gauchers sygdom type 1 (se pkt.
English: Miglustat has been studied in indications where certain events reported as adverse reactions, such as neurological and neuropsychological symptoms/signs, cognitive dysfunction and thrombocytopenia could also be due to the underlying conditions.
Danish: Miglustat er undersøgt ved indikationer, hvor visse hændelser rapporteret som bivirkninger, som f.eks. neurologiske og neuropsykologiske symptomer/tegn, kognitiv dysfunktion og trombocytopeni, også kunne skyldes de underliggende sygdomme.
English: The mechanism is most likely inhibition of intestinal disaccharidases such as sucrase-isomaltase in the gastrointestinal tract leading to reduced absorption of dietary disaccharides.
Danish: Mekanismen er højst sandsynligt hæmning af intestinale disaccharidaser såsom sucrase-isomaltase i mave-tarmkanalen, som medfører nedsat absorption af disaccharider fra føden.
English: Use of Yargesa in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Danish: Anvendelse af Yargesa til patienter med svær nyreinsufficiens (kreatinin-clearance <30 ml/min/1,73 m2) kan ikke anbefales.
English: This can result in liver and spleen enlargement, changes in the blood and bone disease.
Danish: Dette kan medføre forstørrelse af lever og milt, forandringer i blodet og knoglesygdom.
English: Weight loss has been reported in 55% of patients using miglustat.
Danish: Vægttab er rapporteret hos 55% af de patienter, der fik miglustat.
English: The efficacy and safety of miglustat has not been specifically evaluated in patients with severe Gaucher disease.
Danish: Miglustats virkning og sikkerhed er ikke specifikt evalueret hos patienter med svær Gauchers sygdom.
English: Yargesa has negligible influence on the ability to drive and use machines.
Danish: Yargesa påvirker kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Gaucher disease is an inherited metabolic disorder caused by a failure to degrade glucosylceramide resulting in lysosomal storage of this material and widespread pathology.
Danish: Gauchers sygdom er en nedarvet stofskiftelidelse, som skyldes en manglende evne til at nedbryde glucosylceramid, hvilket resulterer i lysosomal oplagring af dette stof og udbredt patologi.
English: If any of these side effects cause problems, consult your doctor.
Danish: Hvis nogle af disse bivirkninger giver anledning til problemer, skal De rådføre Dem med lægen.
English: Separate at perforations
Danish: Adskil ved perforeringerne
English: In type 1 Gaucher disease, a substance called glucosylceramide is not removed from your body.
Danish: Ved Gauchers sygdom, type 1 er der et stof kaldet glucosylceramid, som ikke fjernes fra kroppen.
English: Marketing Authorisation Holder and Manufacturer Piramal Critical Care B.V.
Danish: Indehaver af markedsføringstilladelsen og fremstiller Piramal Critical Care B.V.
English: Further effects seen in animals at doses that result in exposure levels similar to or moderately higher than the clinical exposure level were: changes in lymphoid organs in all species tested, transaminase changes, vacuolation of thyroid and pancreas, cataracts, nephropathy and myocardial changes in rats.
Danish: Derudover var de virkninger, der sås hos dyr ved doser, som medfører eksponeringsniveauer, som er de samme eller moderat højere end det kliniske eksponeringsniveau: Ændringer i lymfeorganer hos alle testede arter, påvirkning af aminotransferaser, vakuolisering i thyroidea og pancreas, katarakt, nefropati og myokardieændringer hos rotter.
English: Breast-feeding It is not known if miglustat is secreted in breast milk.
Danish: Det vides ikke, om miglustat udskilles i mælk.
English: In clinical practice, miglustat-induced gastrointestinal events have been observed to respond to individualised diet modification (for example reduction of sucrose, lactose and other carbohydrate intake), to taking miglustat between meals, and/or to anti-diarrhoeal medicinal products such as loperamide.
Danish: I klinisk praksis er det observeret, at miglustatinducerede gastrointestinale bivirkninger reagerer på individuelle kostændringer (for eksempel nedsat indtagelse af saccharose, lactose og andre kulhydrater), på indtagelse af miglustat mellem måltiderne og/eller på lægemidler mod diarré, såsom loperamid.
English: Yargesa is a white hard capsule that consists of an opaque white cap and body with “708” printed in black on the body.
Danish: Yargesa er en hvid hård kapsel, der består af en uigennemsigtig hvid overdel og underdel med "708" trykt i sort på underdelen.
English: The capsules are presented in a PVC and polychlorotrifluoroethylene (PCTFE) blister sealed with aluminium foil.
Danish: Kapslerne er pakket i en blister lavet af PVC og polychlorotrifluoroethylen (PCTFE), der er forseglet med aluminiumsfolie.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Piramal Critical Care B.V.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Piramal Critical Care B.V.
English: Muscle spasms, muscle weakness General disorders and administration site reactions Common
Danish: Muskelkramper, muskelsvaghed Almene symptomer og reaktioner på administrationsstedet Almindelig
English: Do not take this medicine after the expiry date which is stated on the blister and carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteren og pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Peripheral neuropathy seems to be more common in patients with type 1 Gaucher disease compared to the general population.
Danish: Perifer neuropati synes at være mere almindelig hos patienter med Gauchers sygdom, type I sammenlignet med befolkningen i almindelighed.
English: The survey included a case series of 66 patients treated with Yargesa outside of the clinical trial for a mean duration of 1.5 years.
Danish: Undersøgelsen omfattede et patientmateriale på 66 patienter, som blev behandlet med Yargesa uden for den kliniske undersøgelse med en gennemsnitlig behandlingsvarighed på 1,5 år.
English: Very common effects - may affect more than 1 in 10 people The most common side effects are diarrhoea, flatulence (wind), abdominal (stomach) pain, weight loss and decreased appetite.
Danish: Meget almindelige bivirkninger - kan forekomme hos flere end 1 ud af 10 behandlede De almindeligste bivirkninger er diarré, flatulens (luft i maven), mavesmerter, vægttab og nedsat appetit.
English: At steady state, the concentration of miglustat in cerebrospinal fluid of six type 3 Gaucher disease patients was 31.4-67.2% of that in plasma.
Danish: Hos seks patienter med Gauchers sygdom, type 3 var koncentrationen af miglustat i cerebrospinalvæske ved steady state 31,4-67,2% af indholdet i plasma.
English: A mean increase in haemoglobin concentration of 0.26 g/dl and a mean platelet count increase of 8.29 × 109/l were observed.
Danish: En gennemsnitlig forøgelse af hæmoglobinkoncentrationen på 0,26 g/dl samt en gennemsnitlig forøgelse af trombocyttallet på 8,29 × 109/l blev observeret.
English: Studies in animals have shown reproductive toxicity, including dystocia (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet, inklusive dystoci (se pkt.
English: The hard capsule consists of an opaque white cap and body with “708” printed in black on the body.
Danish: Den hårde kapsel består af en uigennemsigtig hvid overdel og underdel med "708" trykt i sort på underdelen.
English: The efficacy of Yargesa in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Danish: Yargesas virkning hos børn og unge i alderen 0-17 år med Gauchers sygdom, type 1, er ikke klarlagt.
English: There are no pharmacokinetic data available in patients with liver impairment, in children or adolescents with type 1 Gaucher disease or in the elderly (> 70 years).
Danish: Der foreligger ingen tilgængelige farmakokinetiske data for patienter med leverinsufficiens, børn og unge med Gauchers sygdom, type 1, eller ældre (>70 år).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER
English: Overall the data show that treatment with Yargesa can reduce the progression of clinically relevant neurological symptoms in patients with Niemann-Pick type C disease.
Danish: Generelt viste data, at behandling med Yargesa kan reducere progressionen af klinisk relevante neurologiske symptomer hos patienter med Niemann-Picks sygdom, type C.
English: If you do get any of these effects, please seek medical advice from your doctor as soon as possible.
Danish: Hvis De får nogle af disse bivirkninger, skal De søge rådgivning hos lægen så hurtigt som muligt.
English: Pharmacokinetic data were obtained in paediatric patients with type 3 Gaucher disease aged 3 to 15 years, and patients with Niemann-Pick type C disease aged 5-16 years.
Danish: Farmakokinetiske data blev opnået hos pædiatriske patienter med Gauchers sygdom, type 3 i alderen 3-15 år, og patienter med NiemannPicks sygdom, type C, i alderen 5-16 år.
English: Other possible side effects are muscular spasms or weakness, fatigue, chills and malaise, depression, difficulty sleeping, forgetfulness and reduced libido.
Danish: Andre mulige bivirkninger er muskelkramper eller -svaghed, træthed, kulderystelser og utilpashed, depression, søvnbesvær, glemsomhed og nedsat lyst til sex (libido).
English: • For type 1 Gaucher disease: For adults, the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening).
Danish: • Ved Gauchers sygdom, type 1: Til voksne er den sædvanlige dosis én kapsel (100 mg) tre gange dagligt (morgen, eftermiddag og aften).
English: The benefit to the patient of treatment with Yargesa should be evaluated on a regular basis (see section 4.4).
Danish: Patienternes gavn af behandling med Yargesa skal evalueres regelmæssigt (se pkt.
English: Pack size: 84 x 1 capsules.
Danish: Pakningsstørrelse: 84 x 1 kapsel.
English: Male patients should use reliable birth control methods during their treatment with Yargesa and for 3 months after finishing treatment.
Danish: Mandlige patienter bør anvende pålidelige præventionsmidler under behandling med Yargesa og i 3 måneder efter, at behandlingen er afsluttet.
English: Tremor Approximately 37% of patients in clinical trials in type 1 Gaucher disease, and 58% of patients in a clinical trial in Niemann-Pick type C disease reported tremor on treatment.
Danish: Cirka 37% af patienterne i kliniske studier med Gauchers sygdom, type 1 og 58% af patienterne i kliniske studier med Niemann-Picks sygdom, type C, rapporterede om tremor ved behandling.
English: If you forget to take Yargesa
Danish: Hvis De har glemt at tage Yargesa
English: Miglustat has not been evaluated in patients with a history of significant gastrointestinal disease, including inflammatory bowel disease.
Danish: Miglustat er ikke undersøgt hos patienter med signifikant gastrointestinal sygdom, herunder inflammatorisk tarmsygdom, i anamnesen.
English: Cases of peripheral neuropathy have been reported in patients treated with miglustat with or without concurrent conditions such as vitamin B12 deficiency and monoclonal gammopathy.
Danish: Der er indberettet tilfælde af perifer neuropati hos patienter behandlet med miglustat med eller uden samtidige tilstande som cyanocobalamin-mangel og monoklonal gammopati.
English: The most common adverse reactions reported in clinical studies with miglustat were diarrhoea, flatulence, abdominal pain, weight loss and tremor (see section 4.4).
Danish: De hyppigste bivirkninger, som blev rapporteret i kliniske studier med miglustat, var diarré, flatulens, abdominalsmerter, vægttab og tremor (se pkt.
English: Regular monitoring of vitamin B12 level is recommended because of the high prevalence of vitamin B12 deficiency in patients with type 1 Gaucher disease.
Danish: Regelmæssig monitorering af cyanocobalamin-niveau anbefales på grund af den høje forekomst af cyanocobalamin-mangel hos patienter med Gauchers sygdom, type 1.
English: In patients with type 1 Gaucher disease, monitoring of platelet counts is recommended.
Danish: Hos patienter med Gauchers sygdom, type 1 anbefales monitorering af trombocyttallet.
English: Dosage
Danish: Dosering
English: Until further information is available, before seeking to conceive, male patients should cease Yargesa and maintain reliable contraceptive methods for a further 3 months.
Danish: Indtil yderligere informationer er tilgængelige, bør mandlige patienter, før de søger at undfange, ophøre med Yargesa og konsekvent anvende præventive metoder i yderligere 3 måneder.
English: Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia, headache, dizziness
Danish: Perifer neuropati, ataksi, amnesi, paræstesi, hypæstesi, hovedpine, svimmelhed
English: Pharmacokinetic parameters of miglustat were assessed in healthy subjects, in a small number of patients with type 1 Gaucher disease, Fabry disease, HIV-infected patients, and in adults, adolescents and children with Niemann-Pick type C disease or type 3 Gaucher disease.
Danish: Farmakokinetiske parametre for miglustat blev vurderet hos raske personer, et lille antal patienter med Gauchers sygdom, type 1, Fabrys sygdom, HIV-inficerede patienter og hos voksne, unge og børn med Niemann-Picks sygdom, type C, eller Gauchers sygdom, type 3.
English: Pack size of 84 capsules.
Danish: Pakningsstørrelse: 84 kapsler.
English: You must use effective birth control while taking Yargesa.
Danish: De skal benytte effektiv prævention, mens De tager Yargesa.
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge eller apoteket.
English: Miglustat is an inhibitor of glucosylceramide synthase, the enzyme responsible for the first step in the synthesis of most glycolipids.
Danish: Miglustat er en hæmmer af glucosylceramidsyntase, det enzym, der er ansvarligt for det første trin i syntesen af de fleste glycolipider.
English: Administration of miglustat to male and female Sprague-Dawley rats by oral gavage for 2 years at dose levels of 30, 60 and 180 mg/kg/day resulted in an increased incidence of testicular interstitial cell (Leydig cell) hyperplasia and adenomas in male rats at all dose levels.
Danish: Indgivelse af miglustat til han- og hun-Sprague-Dawley-rotter ved oral gavage i 2 år i dosisniveauer på 30, 60 og 180 mg/kg/dag medførte øget forekomst af hyperplasi i testis' interstitielle celler (Leydigs celler) og adenomer hos hanrotter på alle dosisniveauer.
English: Niemann-Pick type C disease
Danish: Niemann-Picks sygdom, type C
English: • Yargesa is also used to treat progressive neurological symptoms in Niemann-Pick type C disease in adults and in children.
Danish: • Yargesa anvendes også til behandling af fremadskridende neurologiske symptomer ved Niemann-Picks sygdom, type C, hos voksne og børn.
English: Administration of miglustat to male and female CD1 mice by oral gavage at dose levels of 210, 420 and 840/500 mg/kg/day (dose reduction after half a year) for 2 years resulted in an increased incidence of inflammatory and hyperplastic lesions in the large intestine in both sexes.
Danish: Indgivelse af miglustat til han- og hun-CD1-mus ved oral gavage i 2 år (dosisreduktion efter ½ år) i dosisniveauer på 210, 420 og 840/500 mg/kg/dag medførte øget forekomst af inflammatoriske og hyperplastiske læsioner i tyktarmen hos begge køn.
English: Yargesa is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
Danish: Yargesa er indiceret til oral behandling af voksne patienter med let til moderat Gauchers sygdom, type 1.
English: Capsule shell gelatin purified water titanium dioxide (E171)
Danish: Titandioxid (E171)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg miglustat.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver hårde kapsel indeholder 100 mg miglustat.
English: The usual dose of Yargesa in adult patients was 200 mg t.i.d., and was adjusted according to body surface area in paediatric patients.
Danish: Den sædvanlige dosis Yargesa til voksne patienter var 200 mg 3 gange dagligt, og var justeret i forhold til legemsoverflade hos pædiatriske patienter.
English: • For Niemann-Pick type C disease: For adults and adolescents (over 12 years old), the usual dose is two capsules (200 mg) three times a day (morning, afternoon and evening).
Danish: • Ved Niemann-Picks sygdom, type C: Til voksne og unge (over 12 år) er den sædvanlige dosis på to kapsler (200 mg) tre gange dagligt (morgen, eftermiddag og aften).
English: Yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Danish: Yargesa må kun bruges til behandling af patienter, hvor enzymsubstitutionsterapi ikke er egnet (se pkt.
English: Yargesa should not be taken during breast-feeding.
Danish: Yargesa bør ikke tages under amning.
English: Adverse events observed included granulocytopenia, dizziness and paraesthesia.
Danish: De observerede bivirkninger omfattede granulocytopeni, svimmelhed og paræstesi.
English: • Yargesa is used to treat mild to moderate type 1 Gaucher disease in adults.
Danish: • Yargesa anvendes til behandling af let til moderat Gauchers sygdom, type 1, hos voksne.
English: Therapy should be directed by physicians who are knowledgeable in the management of Gaucher disease or Niemann-Pick type C disease, as appropriate.
Danish: Behandlingen bør ledes af læger, der har kendskab til behandling af Gauchers sygdom eller NiemannPicks sygdom, type C.
English: There is limited experience with the use of Yargesa in Niemann-Pick type C disease patients under the age of 4 years.
Danish: Der er begrænset erfaring med anvendelsen af Yargesa til patienter under 4 år med Niemann-Picks sygdom, type C.
English: Yargesa works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Danish: Yargesa virker ved at hæmme et enzym, som kaldes 'glucosylceramidsyntase', som er ansvarlig for det første trin i omdannelsen af de fleste glycosphingolipider.
English: The most common serious adverse reaction reported with miglustat treatment in clinical studies was peripheral neuropathy (see section 4.4).
Danish: Den hyppigst rapporterede alvorlige bivirkning i kliniske studier med miglustatvar perifer neuropati (se pkt.
English: The recommended starting dose for the treatment of adult patients with Type 1 Gaucher disease is 100 mg three times a day.
Danish: Den anbefalede startdosis for behandling af voksne patienter med Gauchers sygdom, type 1, er 100 mg tre gange dagligt.
English: Data in severe renal impairment are limited to two patients with creatinine clearance in the range 18 - 29 ml/min and cannot be extrapolated below this range.
Danish: Data for svær nyreinsufficiens er begrænset til to patienter med kreatinin-clearance i området 18-29 ml/min.