FrancophonIA/ELRC3.0 huggingface dataset:
English: Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral,
Danish: Obstipation, dyspepsi Øvre gastrointestinal blødning, sår i munden, gastritis, abdominal distension, gastroøsofageal refluxsygdom, smerter i munden, dysfagi, rektal blødning, nedre abdominalsmerter, oral dysæstesi, oral paræstesi, oral hypoæstesi, abdominal ubehag
English: How to store Capecitabine Accord Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger Capecitabine Accord indeholder:
English: Gastrooesophageal reflux disease, Colitis, Blood in stool
Danish: Abdominalt ubehag, Gastroøsofageal reflux, Colitis,
English: Talk to your doctor before taking Capecitabine Accord, if you
Danish: Kontakt lægen, før du tager Capecitabine Accord, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Capecitabine Accord 300 mg film-coated tablets capecitabine
Danish: Capecitabine Accord 300 mg filmovertrukne tabletter Capecitabin
English: P=0.45
Danish: 25,5 måneder konfidensinterval p = 0,45
English: Lacrimation increased Visual disorders, Dry eye,
Danish: Øget tåresekretion Synsforstyrrelser, tørre øjne, øjensmerter, synsnedsættelse, sløret syn
English: Blister, Skin ulcer, Rash, Urticaria, Photosensitivity reaction, Palmar erythema, Swelling face, Purpura, Radiation recall syndrome
Danish: Fotosensitivitets-reaktioner, Palmart erythem, Hævelse i ansigtet, Purpura,
English: Rash, Alopecia, Erythema, Dry skin, Pruritus, Skin hyper-pigmentation, Rash macular, Skin desquamation, Dermatitis, Pigmentation disorder, Nail disorder
Danish: Makuløst udslæt, Afskalning af huden, Dermatitis, Pigmentændringer, Neglesygdom
English: Capecitabine Accord 500 mg film-coated tablets
Danish: Capecitabine Accord 500 mg filmovertrukne tabletter.
English: What Capecitabine Accord is and what it is used for What you need to know before you take Capecitabine Accord How to take Capecitabine Accord Possible side effects
Danish: Det skal du vide, før du begynder at tage Capecitabine Accord Sådan skal du tage Capecitabine Accord Bivirkninger
English: Capecitabine Accord 150 mg film-coated tablets Each film-coated tablet contains 7 mg anhydrous lactose.
Danish: Capecitabine Accord 500 mg filmovertrukne tabletter Hver filmovertrukne tablet indeholder 25 mg vandfri lactose.
English: Vaginal haemorrhage
Danish: Mave-tarmkanalen
English: • bowel obstruction, collection of fluid in the abdomen, inflammation of the small or large intestine, the stomach or the oesophagus, pain in the lower abdomen, abdominal discomfort, heartburn (reflux of food from the stomach), blood in the stool
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter) omfatter: fald i indholdet af natrium, magnesium eller kalcium i blodet, øget mængde blodsukker nervesmerter ringen eller summen for ørerne (tinnitus), tab af hørelse betændelse i vener hikke, stemmeændringer smerter eller ændret/unormal følelse i munden, smerter i kæben øget svedtendens, svedeture om natten muskelspasmer vandladningsbesvær, blod eller protein i urinen blå mærker eller reaktioner på injektionsstedet (forårsaget af lægemidler, der indsprøjtes på samme tid)
English: Recommended posology (see section 5.1)
Danish: Anbefalet dosering (se pkt.
English: Do not take a double dose to make up for a forgotten dose.Instead, continue your regular dosing schedule and check with your doctor.
Danish: Tag ikke en dobbeltdosis som erstatning for den glemte dosis.
English: Vascular disorders
Danish: Dysfagi,
English: (listed in section 6)
Danish: (angivet i punkt 6).
English: Povidone (K30),
Danish: Povidon (K30),
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1232/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1232/001
English: 185 Bureaux de la Colline 92213 Saint Cloud Cedex France
Danish: 185 Bureaux de la Colline 92213 Saint Cloud Cedex Frankrig
English: Gelatin,
Danish: Gelatine,
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 november 2017
Danish: Dato for første markedsføringstilladelse: 10. november 2017
English: Magnesium stearate.
Danish: Magnesiumstearat.
English: Among the 41 patients enrolled in the trial 14 patients were treated with miglustat for more than 3 years.
Danish: Af de 41 patienter, der deltog i studiet, blev 14 patienter behandlet med miglustat i mere end 3 år.
English: You should not take Miglustat Gen.Orph if you are pregnant or thinking of becoming pregnant.
Danish: De må ikke tage Miglustat Gen.Orph, hvis De er gravid, eller hvis De overvejer at blive gravid.
English: Manufacturer Delpharm Reims 10 rue Colonel Charbonneaux 51100 Reims
Danish: Delpharm Reims 10 rue Colonel Charbonneaux 51100 Reims
English: Adverse reactions from clinical trials and spontaneous reporting, occurring in >1% of patients, are listed in the table below by system organ class and frequency (very common: ≥ 1/10, common: ≥ 1/100 < 1/10, uncommon: ≥ 1/1,000 to <1/100, rare: ≥ 1/10,000 to <1/1,000, very rare: <1/10,000).
Danish: Bivirkninger fra kliniske undersøgelser og spontane indberetninger, som forekommer hos >1% af patienterne, er angivet i tabellen nedenfor efter systemorganklasse og frekvens (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).
English: There are no pharmacokinetic data available in patients with liver impairment or in the elderly (> 70 years).
Danish: Der foreligger ingen tilgængelige farmakokinetiske data for patienter med leverinsufficiens, eller ældre (>70 år).
English: Miglustat Gen.Orph can be taken with or without food.
Danish: Miglustat Gen.Orph kan tages sammen med eller uden mad.
English: Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Miglustat Gen.Orph.
Danish: Fortæl det til lægen, hvis De tager lægemidler, der indeholder imiglucerase, som nogle gange bruges samtidigt med Miglustat Gen.Orph.
English: Polyamide/aluminium/PVC/Aluminium blister supplied as a box of 12 blisters, each blister containing 7 capsules providing a total of 84 capsules.
Danish: Polyamid/aluminium/PVC/aluminium-blisterpakninger Leveres som en æske med 12 blisterpakninger, hvor hver blisterpakning indeholder 7 kapsler, hvilket giver i alt 84 kapsler.
English: Your doctor will perform the following tests before treatment and during treatment with Miglustat Gen.Orph: - an examination to check the nerves in your arms and legs - measurement of vitamin B12 levels - monitoring growth if you are a child or adolescent with Niemann-Pick type C disease - monitoring of blood platelet counts
Danish: Deres læge vil gennemføre følgende tests, før og under behandling med Miglustat Gen.Orph: - en undersøgelse for at kontrollere nerverne i Deres arme og ben - måling af vitamin B12-niveauerne - kontrollere Deres vækst, hvis De er barn eller ung med Niemann-Picks sygdom, type C - kontrollere antallet af blodplader
English: In type 1 Gaucher disease, these tremors were described as an exaggerated physiological tremor of the hands.
Danish: Gauchers sygdom, type 1 blevdisse tremortilstande beskrevet som en overdreven fysiologisk tremor i hænderne.
English: He or she may reduce the dose of Miglustat Gen.Orph or recommend other medicines to help control side effects.
Danish: Han eller hun kan nedsætte Deres dosis af Miglustat Gen.Orph eller anbefale anden medicin, der kan hjælpe med at kontrollere bivirkningerne.
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 Miglustat Gen.Orph.
Danish: Årsagen til disse prøver er, at visse patients har snurren eller følelsesløshed i hænder og fødder, eller taber i vægt, når de tager Miglustat Gen.Orph.
English: In 11 clinical trials in different indications 247 patients were treated with miglustat at dosages of 50200 mg t.i.d.
Danish: I 11 kliniske undersøgelser med forskellige indikationer blev 247 patienter behandlet med miglustat i doser på 50-200 mg t.i.d.
English: Sodium starch glycolate (Type A),
Danish: Natriumstivelsesglycolat (type A),
English: If you take more Miglustat Gen.Orph than you should If you take more capsules than you were told to, consult your doctor immediately.
Danish: Hvis De har taget for mange Miglustat Gen.Orph Hvis De tager flere kapsler, end De har fået besked på, skal De straks søge læge.
English: This study was conducted over a 6-month randomised comparison period followed by 18 months extension where all patients received miglustat monotherapy.
Danish: Denne undersøgelse blev gennemført over en 6-måneders randomiseret sammenligningsperiode, efterfulgt af 18 måneders forlængelse, hvor alle patienter fik miglustat monoterapi.
English: Body surface area (m²)
Danish: Legemsoverflade (m2)
English: Data to support safety and efficacy of miglustat in Niemann-Pick type C disease come from a prospective open-label clinical trial and a retrospective survey.
Danish: Data, der understøtter miglustat sikkerhed og virkning ved Niemann-Picks sygdom, type C, stammer fra et prospektivt, åbent klinisk studie og en retrospektiv undersøgelse.
English: They could be signs of peripheral neuropathy, due to side effects of Miglustat Gen.Orph or they could be due to existing conditions.
Danish: Dette kan være tegn på perifer neuropati, som skyldes bivirkninger af Miglustat Gen.Orph, eller det kan være på grund af eksisterende lidelser.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Gen.Orph (logo)
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Gen.Orph (logo)
English: If you have diarrhoea, your doctor may ask you to change your diet to reduce your lactose and carbohydrate intake such as sucrose (cane sugar), or not to take Miglustat Gen.Orph together with food, or to temporarily reduce your dose.
Danish: Hvis De har diarré, vil Deres læge måske bede Dem om følgende: At De ændrer Deres kost for at reducere indtagelsen af lactose og kulhydrater såsom saccharose (sukker), at De ikke tager Miglustat Gen.Orph sammen med måltider, eller at De nedsætter Deres dosis midlertidigt.
English: Use of Miglustat Gen.Orph in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Danish: Anvendelse af Miglustat Gen.Orph til patienter med svær nyreinsufficiens (kreatinin-clearance <30 ml/min/1,73 m2) kan ikke anbefales.
English: Your doctor will perform some tests before and during treatment with Miglustat Gen.Orph to assess this (see section 2).
Danish: Deres læge vil gennemføre nogle prøver før og under behandling med Miglustat Gen.Orph for at bedømme dette (se punkt 2).
English: Miglustat has been used in clinical trials at doses ten times higher than the recommended dose: this caused decreases in white blood cells and other side effects similar to those described in section 4.
Danish: Miglustat Gen.Orph er blevet anvendt i kliniske forsøg med doser, der var ti gange højere, end den anbefalede dosis: Dette medførte et fald i antallet af hvide blodlegemer og andre bivirkninger svarende til dem, der er beskrevet i pkt.
English: Small mean reductions in haemoglobin [-0.95 g/dL (95% CI: -1.38, -0.53)] and platelet count [-44.1 × 109/L (95% CI: -57.6,
Danish: Små gennemsnitlige reduktioner i hæmoglobin [-0,95 g/dl (95% CI: -1,38; -0,53)] og trombocyttal [-44,1 × 109/l (95% CI: -57,6; -30,7)] sås mellem baseline og studieafslutning.
English: If you do lose some weight when you start treatment with Miglustat Gen.Orph don't worry.
Danish: Hvis De taber i vægt, når De starter behandling med Miglustat Gen.Orph, skal De ikke blive bekymret.
English: The survey included a case series of 66 patients treated with miglustat 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 miglustat uden for den kliniske undersøgelse med en gennemsnitlig behandlingsvarighed på 1,5 år.
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: They may lower the amount of Miglustat Gen.Orph in your body.
Danish: Imiglucerase kan nedsætte mængden af Miglustat Gen.Orph i kroppen.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Tremor
English: Talk to your doctor or pharmacist before taking Miglustat Gen.Orph if you suffer from kidney disease if you suffer from liver disease
Danish: Kontakt lægen eller apotekspersonalet, før De tager Miglustat Gen.Orph, - hvis De lider af en nyresygdom - hvis De lider af en leversygdom
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Delpharm Reims
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 Miglustat Gen.Orph (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 Miglustat Gen.Orph (se pkt.
English: Due to limited experience, Miglustat Gen.Orph should be used with caution in patients with renal or hepatic impairment.
Danish: På grund af begrænset erfaring bør Miglustat Gen.Orph anvendes med forsigtighed hos patienter med nyre- eller leverinsufficiens.
English: The efficacy of Miglustat Gen.Orph in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Danish: Miglustat Gen.Orphs virkning hos børn og unge i alderen 0-17 år med Gauchers sygdom, type 1, er ikke klarlagt.
English: Sometimes your doctor will need to reduce the dose or stop Miglustat Gen.Orph treatment to stop the tremor.
Danish: Af og til vil det være nødvendigt for lægen at nedsætte dosis eller stoppe behandlingen med Miglustat Gen.Orph for at stoppe denne rysten.
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: This leaflet was last revised in {month YYYY}.
Danish: Denne indlægsseddel blev senest ændret: {måned ÅÅÅÅ}
English: Miglustat Gen.Orph is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Danish: Miglustat Gen.Orph anvendes kun, når en patient anses for uegnet til behandling med enzymsubstitutionsterapi.
English: Miglustat Gen.Orph has negligible influence on the ability to drive and use machines.
Danish: Miglustat Gen.Orph påvirker kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
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 miglustat var perifer neuropati (se pkt.
English: INFORMATION IN BRAILLE Miglustat Gen.Orph
Danish: INFORMATION I BRAILLESKRIFT Miglustat Gen.Orph
English: Elderly There is no experience with the use of Miglustat Gen.Orph in patients over the age of 70.
Danish: Der er ingen erfaring med Miglustat Gen.Orph hos patienter over 70 år.
English: The usual dose of miglustat in adult patients was 200 mg t.i.d., and was adjusted according to body surface area in paediatric patients.
Danish: Den sædvanlige miglustat dosis til voksne patienter var 200 mg 3 gange dagligt, og var justeret i forhold til legemsoverflade hos pædiatriske patienter.
English: email: contact@gen-orph.com
Danish: e-mail: contact@gen-orph.com
English: Miglustat crosses the placenta and should not be used during pregnancy.
Danish: Miglustat passerer placenta, og Miglustat Gen.Orph bør ikke anvendes under graviditet.
English: Other possible side effects are muscular spasms or weakness, fatigue, chills and malaise, depression, difficulty sleeping, forgetfulness and less libido.
Danish: Andre mulige bivirkninger er muskelkramper eller -svaghed, træthed, kulderystelser og utilpashed, depression, søvnbesvær, glemsomhed og nedsat lyst til sex (libido).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg miglustat
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 100 mg miglustat
English: Overall the data show that treatment with miglustat can reduce the progression of clinically relevant neurological symptoms in patients with Niemann-Pick type C disease.
Danish: Generelt viste data, at behandling med Miglustat Gen.Orph kan reducere progressionen af klinisk relevante neurologiske symptomer hos patienter med Niemann-Picks sygdom, type C.
English: Miglustat Gen.Orph contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Danish: Miglustat Gen.Orph indeholder det aktive stof miglustat, som tilhører en gruppe af lægemidler, som påvirker stofskiftet.Det anvendes til behandling af to tilstande:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Miglustat Gen.Orph findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: There was no drug-related increase in tumor incidence in male or female rats in any other organ.
Danish: Der var ingen lægemiddelrelateret stigning i tumorincidensen hos han- eller hunrotter i noget andet organ.
English: Miglustat Gen.Orph works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Danish: Miglustat Gen.Orph virker ved at hæmme et enzym, som kaldes 'glucosylceramidsyntase', som er ansvarlig for det første trin i omdannelsen af de fleste glycosphingolipider.
English: The benefit to the patient of treatment with Miglustat Gen.Orph should be evaluated on a regular basis (see section 4.4).
Danish: Patienternes gavn af behandling med Miglustat Gen.Orph skal evalueres regelmæssigt (se pkt.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om Miglustat Gen.Orph på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: Male patients should use reliable birth control methods during their treatment with Miglustat Gen.Orph, and for 3 months after finishing treatment.
Danish: Mandlige patienter bør anvende pålidelige præventionsmidler under behandling med Miglustat Gen.Orph og i 3 måneder efter, at behandlingen er afsluttet.
English: • Miglustat Gen.Orph is also used to treat progressive neurological symptoms in NiemannPick type C disease in adults and in children.
Danish: • Miglustat Gen.Orph anvendes også til behandling af fremadskridende neurologiske symptomer ved Niemann-Picks sygdom, type C, hos voksne og børn.
English: Do not breastfeed while you are taking Miglustat Gen.Orph.
Danish: De må ikke amme, mens De tager Miglustat Gen.Orph.
English: White opaque cap and body, hard gelatin capsules size 4 of about 14.0 mm length.
Danish: Kapsler med hvid uigennemsigtig overdel og underdel fremstillet af hård gelatine, str. 4, ca. 14 mm lange.
English: There is limited experience with the use of Miglustat Gen.Orph in Niemann-Pick type C disease patients under the age of 4 years.
Danish: Der er begrænset erfaring med anvendelsen af Miglustat Gen til patienter under 4 år med NiemannPicks sygdom, type C.
English: Capsule shell
Danish: Kapselskallen
English: Miglustat Gen.Orph may make you feel dizzy.
Danish: Miglustat Gen.Orph kan forårsage svimmelhed.
English: Common side effects of treatment include headache, dizziness, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets).
Danish: Almindelige bivirkninger - kan forekomme hos op til 1 ud af 10 behandlede Almindelige bivirkninger af behandlingen omfatter hovedpine, svimmelhed, paræstesi (snurrende fornemmelse eller følelsesløshed), koordinationsforstyrrelser, hypoæstesi (nedsat følesans), fordøjelsesbesvær (halsbrand), kvalme (utilpashed), forstoppelse og opkastning, hævelse eller ubehag i underlivet (maven) og trombocytopeni (nedsat antal blodplader).
English: Miglustat Gen.Orph is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
Danish: Miglustat Gen.Orph er indiceret til oral behandling af voksne patienter med let til moderat Gauchers sygdom, type 1.
English: In patients with an adjusted creatinine clearance of 50-70 ml/min/1.73 m2, administration should commence at a dose of 100 mg twice daily in patients with type 1 Gaucher disease and at a dose of 200 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
Danish: Hos patienter med en justeret kreatinin-clearance på 50-70 ml/min/1,73 m2 bør indgivelsen starte med en dosis på 100 mg to gange dagligt hos patienter med Gauchers sygdom, type 1. og en dosis på 200 mg to gange dagligt (justeret efter legemsoverflade hos patienter under 12 år) hos patienter med Niemann-Picks sygdom, type C.
English: Until further information is available, before seeking to conceive, male patients should cease Miglustat Gen.Orph 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 Miglustat Gen.Orph og konsekvent anvende præventive metoder i yderligere 3 måneder.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg miglustat For the full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder 100 mg miglustat.
English: • Miglustat Gen.Orph is used to treat mild to moderate type 1 Gaucher disease in adults.
Danish: • Miglustat Gen.Orph anvendes til behandling af let til moderat Gauchers sygdom, type 1, hos voksne.
English: Miglustat Gen.Orph is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease (see sections 4.4, and 5.1).
Danish: Miglustat Gen.Orph er indiceret til behandling af progressive neurologiske manifestationer hos voksne patienter og pædiatriske patienter med Niemann-Picks sygdom, type C (se pkt.
English: Miglustat Gen.Orph should not be taken during breast-feeding.
Danish: Miglustat Gen.Orph bør ikke tages under amning.
English: Miglustat Gen.Orph may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Danish: Miglustat Gen.Orph må kun bruges til behandling af patienter, hvor enzymsubstitutionsterapi ikke er egnet (se pkt.
English: The pharmacokinetics of miglustat is similar in adult type 1 Gaucher disease patients and NiemannPick type C disease patients when compared to healthy subjects.
Danish: Miglustats farmakokinetik er ens hos voksne patienter med Gauchers sygdom, type 1 og patienter med Niemann-Picks sygdom, type C sammenlignet med raske personer.
English: Miglustat Gen.Orph 100 mg hard capsules miglustat
Danish: Miglustat Gen.Orph 100 mg hårde kapsler miglustat
English: Mild reductions in platelet counts without association to bleeding were observed in some patients with Niemann-Pick type C disease treated with miglustat.
Danish: Der er observeret let nedsat thrombocyttal uden associeret blødning hos nogle patienter med NiemannPicks sygdom, type C, som er behandlet med miglustat.
English: Hepatic impairment Miglustat Gen.Orph has not been evaluated in patients with hepatic impairment.
Danish: Miglustat Gen.Orph er ikke evalueret hos patienter med leverinsufficiens.