FrancophonIA/ELRC3.0 huggingface dataset:
English: Prins Bernhardplein 200 1097JB Amsterdam Netherlands
Danish: Prins Bernhardplein 200 1097JB Amsterdam Holland
English: The apparent volume of distribution of miglustat is 83 L. Miglustat does not bind to plasma proteins.
Danish: Det tilsyneladende distributionsvolumen for miglustat er 83 L. Miglustat bindes ikke til plasmaproteiner.
English: Miglustat Dipharma can be taken with or without food.
Danish: Miglustat Dipharma kan tages sammen med eller uden mad.
English: You should not take Miglustat Dipharma if you are pregnant or thinking of becoming pregnant.
Danish: De må ikke tage Miglustat Dipharma, hvis De er gravid, eller hvis De overvejer at blive gravid.
English: • monitoring of blood platelet counts
Danish: • kontrollere antallet af blodplader
English: Quinto dè Stampi Rozzano (MI)
Danish: Quinto de Stampi Rozzano (MI)
English: Since some patients have had tingling or numbness in the hands and feet, or a decrease in body weight, while taking Miglustat Dipharma, your doctor will perform the following tests before treatment and during treatment with Miglustat Dipharma:
Danish: Da nogle patienter har haft prikken eller følelsesløshed i hænder og fødder eller et fald i legemsvægt, mens De tager Miglustat Dipharma, vil Deres læge udføre følgende tests før behandling og under behandling med Miglustat Dipharma:
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 Dipharma (see section 4 for further details).
Danish: Testene hjælper lægen med at afgøre, om disse virkninger skyldes din sygdom eller andre eksisterende tilstande eller på grund af bivirkninger af Miglustat Dipharma (se afsnit 4 for yderligere detaljer).
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: Hard capsule 84 capsules 84x1 capsules
Danish: 84 kapsler 84x1 kapsler
English: Most patients get one or more of these side effects mentioned above, usually at the start of treatment or at intervals during treatment.
Danish: De fleste patienter oplever en eller flere af disse bivirkninger, i reglen i starten af behandlingen eller med mellemrum under behandlingen.
English: Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Miglustat Dipharma.
Danish: Fortæl det til lægen, hvis De tager lægemidler, der indeholder imiglucerase, som nogle gange bruges samtidigt med Miglustat Dipharma.
English: Weight loss, decreased appetite
Danish: Vægttab, nedsat appetit
English: PCTFE/PVC and Aluminium blister containing 12 (perforated unit dose) or 21 (non-perforated) capsules.
Danish: PCTFE/PVC og aluminium blister indeholdende 12 (perforeret enhedsdosis) eller 21 (ikke-perforeret) kapsler.
English: • if you suffer from liver disease
Danish: • hvis De lider af en leversygdom
English: 20089 Quinto dè Stampi - Rozzano (MI)
Danish: 20089 Quinto dè Stampi - Rozzano (MI) Italien
English: Your doctor will perform some tests before and during treatment with Miglustat Dipharma to assess this (see section 2).
Danish: Deres læge vil gennemføre nogle prøver før og under behandling med Miglustat Dipharma for at bedømme dette (se punkt 2).
English: The kinetics of miglustat appears to be dose linear and time independent.
Danish: Kinetikken for miglustat lader til at være dosislineær og tidsuafhængig.
English: Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged substance accounting for 70-80% of the dose.
Danish: Miglustat elimineres overvejende ved renal udskillelse, med genfinding i urin af uomdannet stof på 70-80% af dosis.
English: He or she may reduce the dose of Miglustat Dipharma or recommend other medicines to help control side effects.
Danish: Han eller hun kan nedsætte Deres dosis af Miglustat Dipharma eller anbefale anden medicin, der kan hjælpe med at kontrollere bivirkningerne.
English: The neurological symptoms and thrombocytopenia could be due to the underlying disease.
Danish: De neurologiske symptomer og trombocytopeni kan skyldes den underliggende sygdom.
English: Miglustat has been administered at doses of up to 3000 mg/day for up to six months in HIV positive patients during clinical trials.
Danish: Miglustat er indgivet i doser på op til 3000 mg/dag i op til seks måneder hos hiv-positive patienter under kliniske forsøg.
English: - The other ingredients are magnesium stearate, gelatine, titanium dioxide (E171), printing ink (consisting of black iron oxide (E172), propylene glycol (E1520) potassium hydroxide, shellac).
Danish: - De øvrige indholdsstoffer er magnesiumstearat, gelatine, titandioxid (E171), trykfarve (bestående af sort jernoxid (E172), propylenglycol (E1520) kaliumhydroxid, shellak).
English: In vitro, glucosylceramide synthase is inhibited by miglustat with an IC50 of 20-37 μM.
Danish: In vitro hæmmes glucosylceramidsyntesen af miglustat med en IC50 på 20-37 µm.
English: A second open, controlled study randomised 36 patients who had received a minimum of 2 years of treatment with ERT, into three treatment groups: continuation with imiglucerase, imiglucerase in combination with miglustat, or switch to miglustat.
Danish: En anden åben, kontrolleret undersøgelse randomiserede 36 patienter, som havde modtaget minimum 2 års behandling med ERT, i tre behandlingsgrupper: fortsat behandling med imiglucerase, imiglucerase i kombination med miglustat, eller skift til miglustat.
English: If you do lose some weight when you start treatment with Miglustat Dipharma don't worry.
Danish: Hvis De taber i vægt, når De starter behandling med Miglustat Dipharma, skal De ikke blive bekymret.
English: Tabulated list of adverse reactions 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: Elderly There is no experience with the use of miglustat in patients over the age of 70.
Danish: Ældre Der er ingen erfaring med miglustat hos patienter over 70 år.
English: They could be signs of peripheral neuropathy, due to side effects of Miglustat Dipharma or they could be due to existing conditions.
Danish: Dette kan være tegn på perifer neuropati, som skyldes bivirkninger af Miglustat Dipharma, eller det kan være på grund af eksisterende lidelser.
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, -30.7)] were observed between baseline and end of study.
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: • Always take this medicine exactly as your doctor has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens anvisning.
English: In type 1 Gaucher disease, these tremors were described as an exaggerated physiological tremor of the hands.
Danish: Disse tremortilstande blev beskrevet som en overdreven fysiologisk tremor i hænderne.
English: • if you suffer from kidney disease
Danish: • hvis De lider af en nyresygdom
English: Of these, 18 patients at baseline were within established therapeutic goals for liver and spleen volume, haemoglobin levels, and platelet counts, and 16 patients remained within all these therapeutic goals at month 24.
Danish: Af disse havde 18 patienter værdier ved baseline, der lå inden for de fastlagte terapeutiske mål for lever- og miltvolumen, hæmoglobinniveauer og trombocyttal, og 16 patienter opretholdt værdier, der alle lå inden for disse terapeutiske målværdier efter 24 måneder.
English: Limited data suggest that co-administration of miglustat and enzyme replacement with imiglucerase in patients with type 1 Gaucher disease may result in decreased exposure to miglustat (approximate reductions of 22% in Cmax and 14% in AUC were observed in a small parallel-group study).
Danish: Begrænsede data tyder på, at samtidig indgivelse af miglustat og enzymsubstitutionsterapi med imiglucerase hos patienter med Gauchers sygdom, type 1 kan medføre reduceret eksponering for miglustat (reduktioner på cirka 22% i Cmax og 14% i AUC blev observeret i en lilleparallelgruppeundersøgelse).
English: After 3 years of continuous miglustat treatment, mean reductions in liver and spleen organ volume were 17.5% and 29.6%, respectively.
Danish: Efter 3 års kontinuerlig behandling med miglustat var de gennemsnitlige reduktioner i lever- og miltorganvolumen på henholdsvis 17.5% og 29.6%.
English: At 12 months, there was a mean reduction in liver organ volume of 12.1% and a mean reduction in spleen volume of 19.0%.
Danish: Efter 12 måneder var der en gennemsnitlig reduktion i leverorganvolumen på 12.1% og en gennemsnitlig reduktion i miltvolumen på 19.0%.
English: Do not stop taking Miglustat Dipharma without talking to your doctor.
Danish: Stop ikke med at tage Miglustat Dipharma uden at rådføre Dem med lægen.
English: Miglustat Dipharma contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Danish: Miglustat Dipharma indeholder det aktive stof miglustat, som tilhører en gruppe af lægemidler, som påvirker stofskiftet.
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 6måneders randomiseret sammenligningsperiode, efterfulgt af 18 måneders forlængelse, hvor alle patienter fik miglustat-monoterapi.
English: Miglustat Dipharma is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Danish: Miglustat Dipharma anvendes kun, når en patient anses for uegnet til behandling med enzymsubstitutionsterapi.
English: • monitoring growth if you are a child or adolescent with Niemann-Pick type C disease
Danish: • kontrollere Deres vækst, hvis De er barn eller ung med Niemann-Picks sygdom, type C
English: In a pooled analysis of uncontrolled data, bone mineral density Z-scores at the lumbar spine and femoral neck increased by more than 0.1 units from baseline in 27 (57%) and 28 (65%) of the patients with longitudinal bone density measurements.
Danish: I en poolet analyse af ukontrollerede data øgedes knoglemineraltæthedens Z-scores i columna lumbalis og lårbenshovedet med mere end 0.1 enhed fra baseline hos 27 (57%) og 28 (65%) af patienterne med længdegående knogletæthedsmålinger.
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 Dipharma 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 Dipharma sammen med måltider, eller at De nedsætter Deres dosis midlertidigt.
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 Dipharma 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: They may lower the amount of Miglustat Dipharma in your body.
Danish: Imiglucerase kan nedsætte mængden af Miglustat Dipharma i kroppen.
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 miglustats sikkerhed og virkning ved Niemann-Picks sygdom, type C, stammer fra et prospektivt, åbent klinisk studie og en retrospektiv undersøgelse.
English: Use of Miglustat Dipharma in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Danish: Anvendelse af Miglustat Dipharma til patienter med svær nyreinsufficiens (kreatinin-clearance <30 ml/min/1.73 m2) kan ikke anbefales.
English: Black iron oxide (E172) Potassium Hydroxide Shellac
Danish: Sort jernoxid (E172) Kaliumhydroxid Shellak
English: In patients included in the clinical trial, 40%-50% of patients had platelet counts below the lower limit of normal at baseline.
Danish: Hos patienter, der var inkluderet i den kliniskeundersøgelse, havde 40-50% af patienterne ved baseline thrombocyttal, der lå under den nedre normale grænseværdi.
English: The capsules are presented in PCTFE/PVC and Aluminium blister, ain pack size of 84 capsules in non-perforated blisters and 84x1 capsules in perforated unit dose blisters.
Danish: Kapslerne er præsenteret i PCTFE/PVC og aluminium blister i pakningsstørrelse på 84 kapsler i ikke-perforeret blister og 84x1 kapsler i perforeret enkeltdosisblister.
English: Depression, insomnia, libido decreased
Danish: Depression, søvnløshed, nedsat libido
English: Miglustat crosses the placenta and should not be used during pregnancy.
Danish: Miglustat passerer placenta, og Miglustat Dipharma bør ikke anvendes under graviditet.
English: Sometimes your doctor will need to reduce the dose or stop Miglustat Dipharma treatment to stop the tremor.
Danish: Af og til vil det være nødvendigt for lægen at nedsætte dosis eller stoppe behandlingen med Miglustat Dipharma for at stoppe denne rysten.
English: Management In case of overdose general medical care is recommended.
Danish: I tilfælde af overdosering anbefales almen, understøttende behandling.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blister og pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: 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: 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: The efficacy of miglustat in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Danish: Miglustat virkning hos børn og unge i alderen 0-17 år med Gauchers sygdom, type 1, er ikke klarlagt.
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: Capsule content Magnesium stearate
Danish: Kapselindhold Magnesiumstearat
English: Muscle spasms, muscle weakness General disorders and administration site reactions Common
Danish: Muskelspasmer, muskelsvaghed Almene symptomer og reaktioner på administrationsstedet Almindelig
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING, ER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE
English: Pack size of 84 capsules in non-perforated blisters.
Danish: Pakningsstørrelse på 84 kapsler i ikke-perforeret blister.
English: Due to limited experience, miglustat should be used with caution in patients with renal or hepatic impairment.
Danish: På grund af begrænset erfaring bør Miglustat Dipharma anvendes med forsigtighed hos patienter med nyre- eller leverinsufficiens.
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 tager anden medicin eller har gjort det for nylig.
English: Detailed information on this medicinal prodcut is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om Miglustat Dipharma findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Miglustat Dipharma has negligible influence on the ability to drive and use machines.
Danish: Miglustat Dipharma påvirker kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: The efficacy and safety of miglustat has not been specifically evaluated in patients with severe Gaucher disease.
Danish: Miglustat virkning og sikkerhed er ikke specifikt evalueret hos patienter med svær Gauchers sygdom.
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: 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 kan reducere progressionen af klinisk relevante neurologiske symptomer hos patienter med Niemann-Picks sygdom, type C.
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: Diarrhoea, flatulence, abdominal pain
Danish: Diarré, flatulens, abdominalsmerter
English: It is not known if miglustat is secreted in breast milk.
Danish: Amning Det vides ikke, om miglustat udskilles i mælk.
English: Very common side 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: Miglustat Dipharma is a white opaque 100 mg capsule with “DPH02” printed in black on the top and “100” printed in black on the body.
Danish: Miglustat Dipharma er en hvid uigennemsigtig 100 mg kapsel med "DPH02" trykt i sort på hætten og "100" trykt i sort på selve kapslen.
English: The benefit to the patient of treatment with miglustat should be evaluated on a regular basis (see section 4.4).
Danish: Patienternes gavn af behandling med miglustat 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 Dipharma på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: Dosing in patients under the age of 12 years should be adjusted on the basis of body surface area as illustrated below:
Danish: Dosis til patienter under 12 år skal justeres på basis af legemsoverflade som vist nedenfor: Legemsoverflade (m2)
English: White opaque (size 4, 14.3 ± 0.3 mm) capsules with “DPH02” printed in black on the cap and “100” printed in black on the body.
Danish: Hvide, opale kapsler (størrelse 4, 14.3 ± 0.3 mm) med "DPH02" trykt i sort på hætten og "100" trykt i sort på selve kapslen.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products.
Danish: Farmakoterapeutisk klassifikation: Andre fordøjelseskanaler og stofskifteprodukter, forskellige fordøjelseskanaler og stofskifteprodukter.
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 i alderen 3-15 år, og patienter med Niemann-Picks sygdom, type C, i alderen 5-16 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 Miglustatdosis til voksne patienter var 200 mg 3 gange dagligt, og var justeret i forhold til legemsoverflade hos pædiatriske patienter.
English: Common side effects - may affect up to 1 in 10 people 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: The most common serious adverse reaction reported with miglustat treatment in clinical trials was peripheral neuropathy (see section 4.4).
Danish: Den hyppigst rapporterede alvorlige bivirkning i kliniske studier med miglustat var perifer neuropati (se pkt.
English: The most common adverse reactions reported in clinical trials 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: Talk to your doctor or pharmacist before taking Miglustat Dipharma
Danish: Kontakt lægen eller apotekspersonalet, før De tager Miglustat Dipharma,
English: In 11 clinical trials in different indications 247 patients were treated with miglustat at doses of 50-200 mg t.i.d.
Danish: I 11 kliniske undersøgelser med forskellige indikationer blev 247 patienter behandlet med miglustat i doser på 50-200 mg 3 gange dagligt i en periode på gennemsnitligt 2.1 år.
English: 100 mg three times a day 100 mg twice a day
Danish: Anbefalet dosis 200 mg tre gange dagligt 200 mg to gange dagligt 100 mg tre gange dagligt 100 mg to gange dagligt 100 mg én gang dagligt
English: Miglustat Dipharma may make you feel dizzy.
Danish: Miglustat Dipharma kan forårsage svimmelhed.
English: • Miglustat Dipharma is also used to treat progressive neurological symptoms in NiemannPick type C disease in adults and in children.
Danish: • Miglustat Dipharma anvendes også til behandling af fremadskridende neurologiske symptomer ved Niemann-Picks sygdom, type C, hos voksne og børn.
English: Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia headache, dizziness
Danish: Perifer neuropati, ataksi, amnesi, paræstesi, hypæstesi, hovedpine, svimmelhed
English: Package leaflet: Information for the user Miglustat Dipharma 100 mg hard capsules miglustat
Danish: Indlægsseddel: Information til brugeren Miglustat Dipharma 100 mg hårde kapsler miglustat