FrancophonIA/ELRC3.0 huggingface dataset:
English: He or she may reduce the dose of Yargesa or recommend other medicines to help control side effects.
Danish: Han eller hun kan nedsætte Deres dosis af Yargesa eller anbefale anden medicin, der kan hjælpe med at kontrollere bivirkningerne.
English: Among the 41 patients enrolled in the trial 14 patients were treated with Yargesa for more than 3 years.
Danish: Af de 41 patienter, der deltog i studiet, blev 14 patienter behandlet med Yargesa i mere end 3 år.
English: If you do lose some weight when you start treatment with Yargesa don't worry.
Danish: Hvis De taber i vægt, når De starter behandling med Yargesa, skal De ikke blive bekymret.
English: Most patients get one or more of these side effects, 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: In type 1 Gaucher disease, these tremors were described as an exaggerated physiological tremor of the hands.
Danish: Ved Gauchers sygdom, type 1 blev disse tremortilstande beskrevet som en overdreven fysiologisk tremor i hænderne.
English: Concomitant administration of food decreases the rate of absorption (Cmax was decreased by 36% and tmax delayed 2 hours), but has no statistically significant effect on the extent of absorption of miglustat (AUC decreased by 14%).
Danish: Samtidig indgivelse af mad mindsker absorptionshastigheden (Cmax blev mindsket 36%, og tmax forsinket 2 timer), men det har ingen statistisk signifikant virkning på absorptionsgraden af miglustat (AUC mindsket 14%).
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, ATC Code: A16AX06
Danish: Farmakoterapeutisk klassifikation: Andre fordøjelseskanal- og stofskifteprodukter, ATC-kode: A16AX06
English: Investigations Common
Danish: Undersøgelser Almindelig
English: Gastrointestinal disturbances
Danish: Gastrointestinale forstyrrelser
English: Following administration of a single dose of 100 mg 14C-miglustat to healthy volunteers, 83% of the radioactivity was recovered in urine and 12% in faeces.
Danish: Efter administration af en enkelt dosis på 100 mg 14C-miglustat til raske frivillige personer blev 83% af radioaktiviteten genfundet i urin og 12% i fæces.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
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:
English: Patients with chronic diarrhoea or other persistent gastrointestinal events that do not respond to these interventions should be investigated according to clinical practice.
Danish: Patienter med kronisk diarré eller andre vedvarende gastrointestinale bivirkninger, som ikke reagerer på disse tiltag, skal undersøges nærmere i overensstemmelse med klinisk praksis.
English: The metabolite accounting for this has not been identified, but may accumulate and reach concentrations exceeding those of miglustat at steady state.
Danish: Denne metabolit er ikke blevet identificeret, men kan akkumulere og nå koncentrationer, der overskrider miglustats ved steady-state.
English: Elderly There is no experience with the use of Yargesa in patients over the age of 70.
Danish: Ældre Der er ingen erfaring med Yargesa hos patienter over 70 år.
English: In healthy subjects miglustat is rapidly absorbed.
Danish: Hos raske personer absorberes miglustat hurtigt.
English: Your doctor will perform some tests before and during treatment with Yargesa to assess this (see section 2).
Danish: Deres læge vil gennemføre nogle prøver før og under behandling med Yargesa for at bedømme dette (se punkt 2).
English: In some patients, temporary dose reduction may be necessary.
Danish: Hos nogle patienter kan en midlertidig dosisnedsættelse være nødvendig.
English: They may lower the amount of Yargesa in your body.
Danish: Imiglucerase kan nedsætte mængden af Yargesa i kroppen.
English: 3 Push product through foil
Danish: Tryk produktet gennem folien
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: Six patients had miglustat treatment prematurely discontinued for potential disease worsening, as defined in the study.
Danish: Seks patienter afsluttede miglustat-behandling før tid på grund af potentiel forværring af sygdommen, som defineret i studiet.
English: Carcinomas in the large intestine occurred occasionally at all doses with a statistically significant increase in the high dose group.
Danish: Carcinomer i tyktarmen forekom lejlighedsvist ved alle doser med en statistisk signifikant stigning ved de høje doser.
English: The kinetics of miglustat appear to be dose linear and time independent.
Danish: Kinetikken for miglustat lader til at være dosislineær og tidsuafhængig.
English: In some cases the doctor may prescribe anti-diarrhoeal medicines such as loperamide.
Danish: I nogle tilfælde vil lægen ordinere et lægemiddel mod diarré, for eksempel loperamid.
English: Both data sets included paediatric, adolescent and adult patients with an age range of 1 year to 43 years.
Danish: Begge datagrupper omfattede pædiatriske, unge og voksne patienter i alderen fra 1 år til 43 år.
English: Yargesa contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Danish: Yargesa indeholder det aktive stof miglustat, som tilhører en gruppe af lægemidler, som påvirker stofskiftet.
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: Do not give this medicine to children and adolescents (below 18 years old) with type 1 Gaucher disease because it is not known if it works in this disease.
Danish: Giv ikke denne medicin til børn og teenagere (under 18 år) med Gauchers sygdom, type 1, da det ikke vides, om den virker.
English: The Netherlands
Danish: Holland
English: This can result in disturbances in neurological functions such as slow eye movements, balance, swallowing, and memory, and in seizures.
Danish: Det kan resultere i forstyrrelser i neurologiske funktioner som f.eks. langsomme øjenbevægelser, balance, synkning og hukommelse samt i krampeanfald.
English: In some patients there were reductions in platelet count and increases in chitotriosidase activity indicating that miglustat monotherapy may not maintain the same control of disease activity in all patients.
Danish: Hos nogle patienter var der reduktioner i trombocyttal og forhøjet chitotriosidaseaktivitet, hvilket tyder på, at miglustat-monoterapi måske ikke opretholder samme kontrol med sygdomsaktiviteten hos alle patienter.
English: Gastrointestinal events, mainly diarrhoea, have been observed in more than 80% of patients, either at the outset of treatment or intermittently during treatment (see section 4.8).
Danish: Gastrointestinale bivirkninger, hovedsageligt diarré, er observeret hos mere end 80% af patienterne, enten ved behandlingsstart eller intermitterende under behandlingen (se pkt.
English: This study also indicated that miglustat has no or limited effect on the pharmacokinetics of imiglucerase.
Danish: Denne undersøgelse tyder også på, at miglustat ingen eller begrænset effekt har på imiglucerases farmakokinetik.
English: There were no events of bone crisis, avascular necrosis or fracture during the treatment period.
Danish: Der var ingen tilfælde af knoglekriser, avaskulær nekrose eller fraktur i behandlingsperioden.
English: When compared to the measurements at 6 months, disease control was unchanged after 18 and 24 months of miglustat monotherapy (20 and 6 patients, respectively).
Danish: Sammenlignet med målingerne efter 6 måneder var sygdomskontrollen uændret efter 18 og 24 måneders miglustat-monoterapi (henholdsvis 20 og 6 patienter).
English: Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged drug accounting for 70-80% of the dose.
Danish: Miglustat elimineres overvejende ved renal udskillelse, med genfinding i urin af uomdannet lægemiddel på 70-80% af dosis.
English: Do not take Yargesa - if you are allergic to miglustat or any of the other ingredients of this medicine (listed in section 6)
Danish: Tag ikke Yargesa - hvis De er allergisk over for miglustat eller et af de øvrige indholdsstoffer i Yargesa (angivet i punkt 6).
English: The main effects common to all species were weight loss and diarrhoea, and, at higher doses, damage to the gastrointestinal mucosa (erosions and ulceration).
Danish: De væsentligste virkninger, der var fælles for alle arter, var vægttab og diarré og, ved højere doser, skader på den gastrointestinale mucosa (erosioner og ulceration).
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret dette lægemiddel til Dem personligt.
English: Temporary dose reduction to 100 mg once or twice a day may be necessary in some patients because of diarrhoea.
Danish: Midlertidig dosisreduktion til 100 mg én eller to gange dagligt kan være nødvendig hos visse patienter på grund af diarré.
English: To remove the capsule:
Danish: Udpakning af kapslen:
English: INFORMATION IN BRAILLE Yargesa 100 mg
Danish: INFORMATION I BRAILLESKRIFT Yargesa 100 mg
English: If you get a slight tremor, usually trembling hands, seek medical advice from your doctor as soon as possible.
Danish: Hvis De får en let rysten, sædvanligvis af hænderne, skal De søge rådgivning hos lægen så hurtigt som muligt.
English: Changes in lactation were observed in female rats in a 1-year study.
Danish: Ændringer i laktation blev observeret hos hunrotter i en 1-årig undersøgelse.
English: An additional monotherapy study was performed in 18 patients at a total daily dose of 150 mg, and results indicate reduced efficacy compared to a total daily dose of 300 mg.
Danish: En supplerende monoterapiundersøgelse blev gennemført på 18 patienter ved en samlet daglig dosis på 150 mg, og resultaterne tyder på reduceret effektivitet sammenlignet med en samlet daglig dosis på 300 mg.
English: Pharmacokinetic data indicate increased systemic exposure to miglustat in patients with renal impairment.
Danish: Farmakokinetiske data tyder på øget systemisk eksponering for miglustat hos patienter med nyreinsufficiens.
English: They could be signs of peripheral neuropathy, due to side effects of Yargesa or they could be due to existing conditions.
Danish: Dette kan være tegn på perifer neuropati, som skyldes bivirkninger af Yargesa, eller det kan være på grund af eksisterende lidelser.
English: Several metabolites were identified in urine and faeces.
Danish: Der blev identificeret flere metabolitter i urin og fæces.
English: In 11 clinical trials in different indications 247 patients were treated with miglustat at dosages of 50-200 mg t.i.d.
Danish: I 11 kliniske undersøgelser med forskellige indikationer blev 247 patienter behandlet med Yargesa i doser på 50-200 mg t.i.d.
English: Thirteen patients discontinued treatment due to an adverse event.
Danish: Tretten patienter afbrød behandlingen på grund af en bivirkning.
English: Twenty-one patients completed 24 months of miglustat treatment.
Danish: Enogtyve patienter fuldførte 24 måneders behandling med miglustat.
English: The neurological manifestations are considered secondary to the abnormal accumulation of glycosphingolipids in neuronal and glial cells.
Danish: De neurologiske manifestationer skønnes at være sekundære til den unormale akkumulation af glycospingolipider i de neurale og gliale celler.
English: Repeated-dose toxicity studies in rats showed effects on the seminiferous epithelium of the testes.
Danish: Gentagne dosis-toksicitetsundersøgelser på rotter viste virkninger på det seminifere epitel i testes.
English: PVC and polychlorotrifluoroethylene (PCTFE) blister sealed with aluminium foil containing 21 capsules.
Danish: Blister af PVC og polychlorotrifluoroethylen (PCTFE) forseglet med aluminiumsfolie indeholdende 21 kapsler.
English: Miglustat did not show any potential for mutagenic or clastogenic effects in the standard battery of genotoxicity tests.
Danish: Miglustat viste ikke noget potentiale for mutagene eller clastogene effekter i et standardbatteri af genotoksicitetstest.
English: Twenty-eight patients with mild to moderate type 1 Gaucher disease were enrolled in this 12-month non-comparative study, and 22 patients completed the study.
Danish: Otteogtyve patienter med let til moderat Gauchers sygdom, type 1 blev inkluderet i denne 12 måneders ikke-komparative undersøgelse, og 22 gennemførte undersøgelsen.
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: Eighteen patients then continued to receive miglustat under an optional extended treatment protocol.
Danish: Atten patienter fortsatte dernæst med at modtage miglustat under en frivillig forlængelse af behandlingsprotokollen.
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 lille parallel-gruppeundersøgelse).
English: A relevance of these findings to humans cannot be excluded.
Danish: Det kan ikke udelukkes, at disse fund har relevans for mennesker.
English: A second open, controlled study of miglustat 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 af miglustat 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: 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: 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: Most serious side effects
Danish: Mest alvorlige bivirkninger:
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 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: Peel back paper at arrows
Danish: Træk papiret tilbage ved pilene
English: Sometimes your doctor will need to reduce the dose or stop Yargesa treatment to stop the tremor.
Danish: Af og til vil det være nødvendigt for lægen at nedsætte dosis eller stoppe behandlingen med Yargesa for at stoppe denne rysten.
English: Other studies revealed changes in sperm parameters (motility and morphology) consistent with an observed reduction in fertility.
Danish: Øvrige undersøgelser afslørede ændringer i spermparametre (motilitet og morfologi) overensstemmende med en observeret reduktion af fertiliteten.
English: A total daily dose of 300 mg miglustat administered in three divided doses was used in the above two studies.
Danish: Der blev benyttet en samlet daglig dosis på 300 mg miglustat fordelt på tre doser i ovennævnte to undersøgelser.
English: Yargesa is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Danish: Yargesa anvendes kun, når en patient anses for uegnet til behandling med enzymsubstitutionsterapi.
English: Limited data in patients with Fabry disease and impaired renal function showed that CL/F decreases with decreasing renal function.
Danish: Begrænsede data hos patienter med Fabrys sygdom og nedsat nyrefunktion viste, at CL/F mindskes med aftagende nyrefunktion.
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 Yargesa 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 Yargesa sammen med måltider, eller at De nedsætter Deres dosis midlertidigt.
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: In the first 6 months in patients who were switched to miglustat, liver and spleen organ volumes and haemoglobin levels were unchanged.
Danish: I de første 6 måneder hos patienter, der skiftede til miglustat, var lever- og miltorganvolumina og hæmoglobinniveauer uændrede.
English: The clinical trial included 29 adult and juvenile patients in a 12-month controlled period, followed by extension therapy for an average total duration of 3.9 years and up to 5.6 years.
Danish: Det kliniske studie omfattede 29 voksne og unge patienter i en 12 måneders kontrolleret periode, efterfulgt af forlænget behandling med en gennemsnitlig varighed fra 3,9 og op til 5,6 år.
English: The most abundant metabolite in urine was miglustat glucuronide accounting for 5% of the dose.
Danish: Den mest fremherskende metabolit i urin var miglustatglucuronid med 5% af dosis.
English: Niemann-Pick type C disease is a very rare, invariably progressive and eventually fatal neurodegenerative disorder characterised by impaired intracellular lipid trafficking.
Danish: Niemann-Picks sygdom, type C, er en meget sjælden, altid progressiv og muligvis dødelig neurodegenererende sygdom, som er karakteriseret ved nedsat intracellulær lipidoverførsel.
English: Miglustat affected embryo/foetal survival in rats and rabbits, dystocia was reported, postimplantation losses were increased, and an increased incidence of vascular anomalies occurred in rabbits.
Danish: Miglustat påvirkede embryo-/føtal overlevelse hos rotter og kaniner, dystoci blev indberettet, postimplantationstab blev forøget, og der var en øget forekomst af vaskulære anomalier hos kaniner.
English: Data to support safety and efficacy of Yargesa in Niemann-Pick type C disease come from a prospective open-label clinical trial and a retrospective survey.
Danish: Data, der understøtter Yargesa sikkerhed og virkning ved Niemann-Picks sygdom, type C, stammer fra et prospektivt, åbent klinisk studie og en retrospektiv undersøgelse.
English: There was no drug-related increase in tumour incidence in any other organ.
Danish: Der var ingen lægemiddelrelateret stigning i tumorincidensen i noget andet organ.
English: Dizziness has been reported as a common adverse reaction, and patients suffering from dizziness should not drive or use machines.
Danish: Svimmelhed er indberettet som en almindelig bivirkning, og patienter, der lider af svimmelhed, bør ikke føre motorkøretøj eller betjene maskiner.
English: The usual treatment for type 1 Gaucher disease is enzyme replacement therapy.
Danish: Den almindelige behandling af Gauchers sygdom, type 1 er enzymsubstitutionsterapi.
English: In case of overdose general medical care is recommended.
Danish: Behandling I tilfælde af overdosering anbefales almen, understøttende behandling.
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: Reduced growth has been reported in some paediatric patients with Niemann-Pick type C disease in the early phase of treatment with miglustat where the initial reduced weight gain may be accompanied or followed by reduced height gain.
Danish: Der har været rapporteret reduceret vækst hos nogle pædiatriske patienter med Niemann-Picks sygdom, type C i den tidlige fase af behandlingen med miglustat, hvor den initialt reducerede vægtøgning kan være ledsaget eller efterfulgt af reduceret højdevækst.
English: This means a daily maximum of six capsules (600 mg).
Danish: Det vil sige maksimalt seks kapsler (600 mg) om dagen.
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: 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 kliniske undersøgelse, havde 40-50% af patienterne ved baseline thrombocyttal, der lå under den nedre normale grænseværdi.
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: Due to limited experience, Yargesa should be used with caution in patients with renal or hepatic impairment.
Danish: På grund af begrænset erfaring bør Yargesa anvendes med forsigtighed hos patienter med nyre- eller leverinsufficiens.
English: Do not stop taking Yargesa without talking to your doctor.
Danish: Hvis De holder op med at tage Yargesa Stop ikke med at tage Yargesa uden at rådføre Dem med lægen.