FrancophonIA/ELRC3.0 huggingface dataset:
English: Contraceptive measures should be used by women of childbearing potential.
Danish: Kvinder i den fertile alder skal anvende prævention.
English: Piramal Critical Care B.V. Rouboslaan 32 (ground floor) 2252 TR, Voorschoten The Netherlands
Danish: Rouboslaan 32 (ground floor) 2252 TR, Voorschoten Holland
English: Mild reductions in platelet counts without association with bleeding were observed in patients with type 1 Gaucher disease who were switched from ERT to miglustat.
Danish: Let nedsat trombocyttal uden forbindelse med blødning blev observeret hos patienter med Gauchers sygdom, type 1, som skiftede fra ERT til miglustat.
English: NAME OF THE MEDICINAL PRODUCT Yargesa 100 mg hard capsules
Danish: LÆGEMIDLETS NAVN Yargesa 100 mg hårde kapsler
English: There was a mean increase of 22.2 × 109/l in platelet count, and a mean increase of 0.95 g/dl in haemoglobin concentration.
Danish: Der var en gennemsnitlig forøgelse af trombocyttallet på 22,2 × 109/l og en gennemsnitlig forøgelse af hæmoglobinkoncentrationen på 0,95 g/dl.
English: Yargesa 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: Yargesa er indiceret til behandling af progressive neurologiske manifestationer hos voksne patienter og pædiatriske patienter med Niemann-Picks sygdom, type C (se pkt.
English: The inhibitory action on glucosylceramide synthase forms the rationale for substrate reduction therapy in Gaucher disease.
Danish: Den hæmmende funktion på glucosylceramidsyntesen danner grundlaget for substratreduktionsterapi ved Gauchers sygdom.
English: There was no drug-related increase in tumour 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: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget De er i tvivl om.
English: Nerve conduction studies abnormal
Danish: Anomal nerveledningsundersøgelse
English: Dosage in Niemann-Pick type C disease
Danish: Dosis ved Niemann-Picks sygdom, type C
English: What you need to know before you take Yargesa
Danish: Det skal De vide, før De begynder at tage Yargesa
English: Until further information is available, it is advised that before seeking to conceive, male patients should cease Yargesa and maintain reliable contraceptive methods for 3 months thereafter.
Danish: Indtil yderligere information foreligger, tilrådes det, at mandlige patienter, før konception, seponerer Yargesa og anvender sikre kontraceptionsmetoder 3 måneder herefter (se pkt.
English: Other medicines and Yargesa 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: 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: Mild reductions in platelet counts without association to bleeding were observed in some patients with Niemann-Pick type C disease treated with Yargesa.
Danish: Der er observeret let nedsat thrombocyttal uden associeret blødning hos nogle patienter med NiemannPicks sygdom, type C, som er behandlet med Yargesa.
English: Studies in the rat have shown that miglustat adversely affects spermatogenesis and sperm parameters, and reduces fertility (see sections 4.6 and 5.3).
Danish: Undersøgelser på rotter har vist, at miglustat har en negativ effekt på spermatogenese og spermparametre samt nedsætter fertiliteten (se pkt.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Bivirkningerne inden for hver frekvensgruppe er angivet i forhold til, hvor alvorlige de er, med de alvorligste først.
English: The recommended dose for the treatment of adult patients with Niemann-Pick type C disease is 200 mg three times a day.
Danish: Den anbefalede dosis til behandling af voksne patienter med Niemann-Picks sygdom, type C, er 200 mg tre gange dagligt.
English: If you take more Yargesa than you should
Danish: Hvis De har taget for mange Yargesa
English: For children less than 12 years old, your doctor will adjust the dose for Niemann-Pick type C disease.
Danish: Lægen vil tilpasse dosis hos børn under 12 år med Niemann-Picks sygdom, type C.
English: Type 1 Gaucher disease
Danish: Gauchers sygdom type 1
English: In addition, inhibitory action on a non-lysosomal glycosylceramidase has been demonstrated experimentally in vitro.
Danish: Ved in vitro undersøgelser er der desuden påvist en hæmmende funktion på en non-lysosomal glucosylceramidase.
English: The pharmacokinetics of miglustat is similar in adult type 1 Gaucher disease patients and Niemann-Pick 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: Growth should be monitored in paediatric and adolescent patients during treatment with Yargesa; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
Danish: Fordel/risiko-balancen ved fortsat behandling skal revurderes på individuel basis.
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).The neurological symptoms and thrombocytopenia could be due to the underlying disease.
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: Warnings and precautions Talk to your doctor or pharmacist before taking Yargesa
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før De tager Yargesa, - hvis De lider af en nyresygdom - hvis De lider af en leversygdom
English: NAME OF THE MEDICINAL PRODUCT Yargesa 100 mg hard capsules miglustat
Danish: LÆGEMIDLETS NAVN Yargesa 100 mg hårde kapsler miglustat
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller apotekspersonalet.
English: Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia Musculoskeletal and connective tissue disorders Common
Danish: Kvalme, opkastning, udspilet mave/ubehag i maven, forstoppelse, dyspepsi Knogler, led, muskler og bindevæv
English: All patients should undergo baseline and repeat neurological evaluation.
Danish: Alle patienter bør vurderes neurologisk ved påbegyndelse af behandling og løbende derefter.
English: The patients were switched to monotherapy with miglustat 100 mg t.i.d.
Danish: Patienterne skiftede til monoterapi med miglustat 100 mg tre gange dagligt.
English: Studies in the rat have shown that miglustat adversely affects sperm parameters (motility and morphology) thereby reducing fertility (see sections 4.4 and 5.3).
Danish: Rottestudier har vist, at miglustat har negativ virkning på sperm-parametre (motilitet og morfologi), hvorved fertiliteten reduceres (se pkt.
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.>
English: Male patients should maintain reliable contraceptive methods while taking Yargesa (see sections 4.4 and 5.3).
Danish: Mandlige patienter bør anvende sikre kontraceptionsmetoder, mens de tager Yargesa (se pkt.
English: Of these patients, 132 had type 1 Gaucher disease, and 40 had Niemann-Pick type C disease.
Danish: Af disse patienter havde 132 Gauchers sygdom, type 1 og 40 havde Niemann-Picks sygdom, type C. Bivirkningerne var generelt af let til moderat sværhedsgrad og forekom med samme hyppighed uafhængigt af indikation og dosering.
English: Dosage in type 1 Gaucher disease
Danish: Dosis ved Gauchers sygdom, type 1
English: The recommended dose for the treatment of adolescent patients (12 years of age and above) with NiemannPick type C disease is 200 mg three times a day.
Danish: Den anbefalede dosis til behandling af unge patienter (på 12 år og derover) med Niemann-Picks sygdom, type C er 200 mg tre gange dagligt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 100 mg miglustat.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hårde kapsel indeholder 100 mg miglustat.
English: Fatigue, asthenia, chills and malaise
Danish: Træthed, asteni, kulderystelser og utilpashed
English: 6.3 Shelf life
Danish: Shellac glaze
English: If your diarrhoea does not respond to these measures, or if you have any other abdominal complaint, consult your doctor.
Danish: Henvend Dem til Deres læge, hvis Deres diarré ikke reagerer på disse foranstaltninger, eller hvis De har andre maveproblemer.
English: In patients with an adjusted creatinine clearance of 30-50 ml/min/1.73 m2, administration should commence at a dose of 100 mg once daily in patients with type 1 Gaucher disease and at a dose of 100 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 30-50 ml/min/1,73 m2 bør indgivelsen starte med en dosis på 100 mg én gang dagligt hos patienter med Gauchers sygdom, type 1 og en dosis på 100 mg to gange dagligt (justeret efter legemsoverflade hos patienter under 12 år) hos patienter med NiemannPicks sygdom, type C. Anvendelse til patienter med svær nyreinsufficiens (kreatinin-clearance < 30 ml/min/1,73 m2) kan ikke anbefales (se pkt.
English: Some patients have had tingling or numbness in the hands and feet (seen commonly).
Danish: Nogle patienter har haft snurren eller følelsesløshed i hænder og fødder (almindelig bivirkning).
English: Depression, insomnia, libido decreased Nervous system disorders Very common
Danish: Depression, søvnløshed, nedsat libido
English: Male patients should maintain reliable contraceptive methods while taking Yargesa.
Danish: Mandlige patienter skal sørge for pålidelige præventionsmidler, så længe de tager Yargesa.
English: Hepatic Impairment Yargesa has not been evaluated in patients with hepatic impairment.
Danish: Yargesa er ikke evalueret hos patienter med leverinsufficiens.
English: Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Yargesa (see section 4).
Danish: Hvis De lider af diarré under behandlingen med Yargesa, vil Deres læge muligvis sætte Deres dosis ned, f.eks. til én kapsel (100 mg) én eller to gange dagligt (se pkt.
English: The pivotal trial of miglustat was conducted in patients unable or unwilling to receive ERT. Reasons for not receiving ERT included the burden of intravenous infusions and difficulties in venous access.
Danish: Årsagerne til ikke at modtage ERT omfattede belastningen ved intravenøse infusioner og vanskelighed ved venøs adgang.
English: The benefit of treatment with Yargesa for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be reappraised after at least 1 year of treatment with Yargesa.
Danish: Fordelen ved behandling med Yargesa ved neurologiske manifestationer hos patienter med NiemannPicks sygdom, type C, skal evalueres regelmæssigt f.eks. hver 6. måned.
English: Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical studies in patients treated with miglustat 100 mg t.i.d.
Danish: Knoglemanifestationer blev evalueret i 3 open-label kliniske undersøgelser hos patienter med Gauchers sygdom type 1, der blev behandlet med miglustat 100 mg 3 gange dagligt i op til 2 år (n=72).
English: Thrombocytopenia Metabolism and nutrition disorders Very common
Danish: Metabolisme og ernæring Meget almindelig Vægttab, nedsat appetit Psykiske forstyrrelser
English: Gastrointestinal disorders Very common
Danish: Meget almindelig Tremor Almindelig
English: Each hard capsule contains 100 mg miglustat.
Danish: - Aktivt stof: miglustat 100 mg. Hver hårde kapsel indeholder 100 mg miglustat.
English: adjusted for body surface area resulted in Cmax and AUCτ values which were approximately twofold those attained after 100 mg t.i.d.
Danish: Dosis til børn på 200 mg 3 gange dagligt, justeret i forhold til legemsoverflade, resulterede i Cmax- og AUCτ-værdier, som var på ca. det dobbelte af det, som blev opnået efter 100 mg 3 gange dagligt hos patienter med Gauchers sygdom, type 1, hvilket er i overensstemmelse med miglustats dosis-lineære farmakokinetik.
English: BN
Danish: Batch
English: Posology
Danish: Nyreinsufficiens
English: Possible side effects
Danish: Tabel over bivirkninger
English: How to store Yargesa
Danish: Brug af anden medicin sammen med Yargesa
English: What Yargesa looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: EXP
Danish: Amning
English: Driving and using machines Yargesa may make you feel dizzy.
Danish: Yargesa kan forårsage svimmelhed.
English: Diarrhoea, flatulence, abdominal pain
Danish: Meget almindelig Diarré, luft i maven, mavesmerter Almindelig
English: How to take Yargesa
Danish: Sådan skal De tage Yargesa
English: What you need to know before you take Yargesa 3.
Danish: Det skal De vide, før De begynder at tage Yargesa Sådan skal De tage Yargesa Bivirkninger
English: Subcutaneous or intravenus use
Danish: Hun og kat Subkutan og intravenøs injektion
English: Bottle (HDPE) with measuring syringe (LDPE)
Danish: Polyethylenfl aske + doserings sprøjte
English: Bottle (Glass with measuring syringe (LDPE)
Danish: Glasflaske + doserings sprøjte
English: Target species
Danish: Type I glasflaske
English: Route of administration
Danish: 1 flaske
English: Strength Pharmaceutical Form
Danish: Injektionsvæske, opløsning
English: 1 ml (180 µg/ml) 4 vials
Danish: 90 µg
English: • At the request of the European Medicines Agency;
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur.
English: These changes may be permanent.
Danish: Disse forandringer kan måske blive permanente.
English: 8 March 2002 / 20 February 2007
Danish: 8. marts 2002 / 20. februar 2007
English: The duration of effect is maintained for at least 24 hours.
Danish: Virkningsvarigheden opretholdes i mindst 24 timer.
English: This is enough for 4 weeks' usage.
Danish: Det er tilstrækkeligt til 4 ugers forbrug.
English: Risk Management Plan (RMP)
Danish: Risikostyringsplan (RMP)
English: Children and adolescents
Danish: Børn og teenagere
English: The frequency of these symptoms is not known.
Danish: Frekvensen af disse symptomer kendes ikke.
English: Tilt your head back and look at the ceiling.
Danish: Læg hovedet tilbage og se op i loftet.
English: This will prevent infections.
Danish: Dette forhindrer infektion.
English: LUMIGAN should not be used during pregnancy unless clearly necessary.
Danish: LUMIGAN bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: If overdose occurs, treatment should be symptomatic and supportive.
Danish: I tilfælde af overdosering skal behandlingen være symptomatisk og støttende.
English: In addition, monitoring is required with prolonged use in such patients.
Danish: Desuden kræves der opfølgning ved langvarigt brug hos sådanne patienter.
English: Some of these changes may be permanent, and may lead to differences in appearance between the eyes when only one eye is treated.
Danish: Nogle af disse ændringer kan være permanente og kan føre til forskelle i øjnenes udseende, når kun det ene øje behandles.
English: It belongs to a group of medicines called prostamides.
Danish: Det tilhører en gruppe lægemidler, der kaldes prostamider.
English: You should not drive or use machines until your sight is clear again.
Danish: Derfor bør De ikke køre bil eller betjene maskiner, før synet er klart igen.
English: Do not store above 25°C.
Danish: Må ikke opbevares ved temperaturer over 25 °C
English: There was no accumulation of bimatoprost in the blood over time and the safety profile was similar in elderly and young patients.
Danish: Der var ingen akkumulering af bimatoprost i blodet over tiden, og sikkerhedsprofilen var nogenlunde den samme hos ældre og unge patienter.
English: No interaction studies have been performed.
Danish: Der er ikke udført interaktionsstudier.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: Put your next dose in at the usual time.
Danish: Næste dosis tages på det sædvanlige tidspunkt.
English: Let go of the lower lid, and close your eye for 30 seconds.
Danish: Slip det nederste øjenlåg, og luk øjet i 30 sekunder.
English: Reduction of the intraocular pressure starts approximately 4 hours after the first administration and maximum effect is reached within approximately 8 to 12 hours.
Danish: Nedsættelsen af det intraokulære tryk indtræder ca. 4 timer efter første administration og maksimal virkning opnås efter ca. 8-12 timer.
English: The requirements for submission of periodic safety update report for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: In human blood, bimatoprost resides mainly in the plasma.
Danish: I humant blod findes bimatoprost hovedsagelig i plasma.
English: • Increased blood pressure
Danish: • Forhøjet blodtryk
English: There are no adequate data from the use of bimatoprost in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af bimatoprost hos gravide kvinder.
English: Other Information
Danish: Andre oplysninger
English: System Organ class
Danish: Systemorganklasse
English: • Difficulty in seeing clearly
Danish: • Besvær med at se klart
English: Side effects where the frequency is not known
Danish: Bivirkninger, hvor hyppigheden ikke er kendt
English: Neither naevi nor freckles of the iris appear to be affected by the treatment.
Danish: Hverken naevi eller fregner i iris synes at blive påvirket af behandlingen.
English: The table also includes those adverse reactions which occurred with both formulations but at a different frequency.
Danish: Tabellen inkluderer også de bivirkninger, der forekom ved begge styrker, men med forskellig hyppighed.
English: Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts become more brownish.
Danish: Typisk breder den brune pigmentering omkring pupillen sig koncentrisk mod periferien af iris, og hele iris eller dele deraf bliver mere brunlig.
English: Liquid is constantly being drained out of the eye and new liquid is made to replace this.
Danish: Væsken løber konstant ud af øjet, og der dannes ny væske som erstatning.
English: • Small breaks in the surface of the eye, with or without inflammation
Danish: • Små brud i øjets overflade, med eller uden betændelse
English: The colour of your iris may also go darker over time.
Danish: Farven på iris kan også blive mørkere med tiden.
English: After ocular administration in adults, the systemic exposure of bimatoprost is very low with no accumulation over time.
Danish: Efter okulær administration hos voksne er den systemiske eksponering for bimatoprost meget lav med ingen akkumulering over tiden.
English: Fertility There are no data on the effects of bimatoprost on human fertility.
Danish: Fertilitet Der foreligger ingen data om bimatoprosts virkning på fertiliteten hos mennesker.
English: Bimatoprost penetrates the human cornea and sclera well in vitro.
Danish: Bimatoprost gennemtrænger human cornea og sclera godt in vitro.
English: These doses resulted in systemic exposures of at least 33- or 97-times higher, respectively, than the intended human exposure.
Danish: Disse doser medførte systemisk eksponering, som var henholdsvis mindst 33 og 97 gange højere end den tilsigtede humane eksponering.
English: Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.
Danish: Kontaktlinser bør tages ud før inddrypning og kan isættes igen 15 minutter efter applikation.
English: • Worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
Danish: • Forværring af lungesygdommen kaldet kronisk obstruktiv lungesygdom (KOL)
English: • An increase in blood-test results that show how your liver is working
Danish: • Højere tal i blodprøver, som viser, hvordan leveren fungerer
English: The prostamide receptor, however, has not yet been structurally identified.
Danish: Prostamidreceptorens struktur er imidlertid endnu ikke bestemt.
English: If the liquid cannot drain out quickly enough, the pressure inside the eye builds up.
Danish: Såfremt væsken ikke kan løbe hurtigt nok væk, stiger trykket i øjet.
English: Thus, it is important to apply LUMIGAN as instructed and avoid it running onto the cheek or other skin areas.
Danish: Det er derfor vigtigt at applicere LUMIGAN som anvist og undgå, at det løber ned på kinden eller andre hudområder.
English: Opened:
Danish: Åbnet:
English: Characteristics in elderly patients
Danish: Egenskaber hos ældre patienter
English: • Worsening of asthma
Danish: • Forværring af astma
English: Your sight may become blurred for a short time just after using LUMIGAN.
Danish: Deres syn kan blive sløret i en kort periode lige efter inddrypning af LUMIGAN.
English: CARTON FOR SINGLE BOTTLE
Danish: ÆSKE MED EN ENKELT FLASKE
English: Neurobehavioural functions of offspring were not affected.
Danish: Ungernes nerveadfærdsfunktion blev ikke påvirket.
English: - The active substance is bimatoprost.
Danish: - Aktivt stof: Bimatoprost.
English: This medicine works by increasing the amount of liquid that is drained.
Danish: Dette lægemiddel virker ved at øge den mængde væske, der løber væk.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen og enhver efterfølgende godkendt opdatering af RMP.
English: Patients with a disruption of the ocular epithelial surface are at greater risk of developing bacterial keratitis.
Danish: Patienter med defekt i øjets epiteloverflade har større risiko for at udvikle bakteriel keratitis.