FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood and lymphatic system disorders
Danish: Forstyrrelser i blod- og lymfesystemet
English: Skin and subcutaneous tissue disorders
Danish: Lidelser i hud og subkutant væv
English: The in vitro plasma protein binding of cysteamine, which is mostly to albumin, is independent of plasma drug concentration over the therapeutic range, with a mean ( sd) value of 54.1 % ( 1.5).
Danish: Cysteamins in vitro plasmaproteinbinding, som overvejende er til albumin, er uafhængig af plasmalægemiddelkoncentrationen over det terapeutiske område, med en middelværdi ( SD) på 54,1 % () 1,5).
English: WHAT CYSTAGON IS AND WHAT IT IS USED FOR
Danish: CYSTAGONS VIRKNING OG HVAD DE/DU SKAL BRUGE DET TIL
English: - Hard capsules should not be given to children under approximately six years of age because they may not be able to swallow them and they may choke.
Danish: - De hårde kapsler bør ikke gives til børn under ca. 6 år, da de kan have vanskelighed med at sluge dem og kan risikere at blive kvalt.
English: Uncommon: Leukopenia
Danish: Usædvanlige: Leukopeni
English: In order for CYSTAGON to work correctly, you must do the following: - Follow your doctor's directions exactly.
Danish: For at CYSTAGON skal virke korrekt, er følgende vigtigt: - Lægens anvisning skal følges nøje.
English: In a pharmacokinetic study performed in 24 healthy volunteers for 24 hours, the mean estimate ( sd) for the terminal half-life of elimination was 4.8 ( 1.8) hours.
Danish: I en farmakokinetisk undersøgelse udført med 24 raske frivillige i 24 timer, var middelestimatet ( SD) for den terminale halveringstid for udskillelse 4,8 ( 1,8) timer.
English: An earlier study treated 94 children with nephropathic cystinosis with increasing doses of cysteamine to attain white cell cystine levels of less than 2 nmol hemicystine/mg protein 5 to 6 hours post-dose, and compared their outcome with an historical control group of 17 children treated with placebo.
Danish: Et tidligere studie behandlede 94 børn med nephropatisk cystinosis med stigende mængder af cysteamin for at holde cystinniveauet i de hvide blodlegemer under 2 nmol hemicystin/mg protein 5 til 6 timer efter doseringen og sammenlignede deres resultat med en historisk gruppe på 17 børn behandlet med placebo.
English: - If you are pregnant, this is particularly relevant during the first trimester - if you are breast-feeding.
Danish: - hvis De/du er gravid, især hvis De/du er i første trimester - hvis De/du ammer.
English: Uncommon: Nephrotic syndrome
Danish: Usædvanlige: Nefrotisk syndrom
English: If several doses of the supplements are missed or weakness or drowsiness develops, call the doctor for instructions.
Danish: Hvis flere doser glemmes, eller der udvikles døsighed bør lægen kontaktes.
English: However if it is within two hours of the next dose, skip the missed dose and go back to the regular dosing schedule.
Danish: Hvis dette ikke kan lade sig gøre indenfor 2 timer før næste dosis, overspringes den glemte dosis og man fortsætter efter doseringsanvisningen.
English: The use of doses higher than 1.95 g/m2/day is not recommended (see section 4.4).
Danish: Anvendelse af doser højere end 1,95 g/m2/dag anbefales ikke (se pkt.
English: Among cysteamine patients, glomerular function was maintained over time.
Danish: Mellem patienterne behandlet med cysteamin blev glomerulær funktion opretholdt.
English: Pharmacotherapeutic group: Alimentary tract and metabolism product, ATC code: A16AA04.
Danish: Farmakoterapeutisk gruppe: Behandling af diagnosticeret nephropatisk cystinosis, ATC-kode: A16AA04.
English: CYSTAGON is prescribed to manage this rare inherited disorder.
Danish: CYSTAGON anvendes i behandlingen af denne sjældne arvelige sygdom.
English: The decrease in leucocyte cystine levels is correlated to the cysteamine plasma concentration over the six hours following the administration of CYSTAGON.
Danish: Nedgangen i leukocyt cystinniveauer er korreleret til cysteaminplasmakoncentrationen over de seks 6 timer efter administrationen af CYSTAGON.
English: Experimental administration of the drug causes depletion of somatostatin in several animal species.
Danish: Eksperimentel indgift af stoffet forårsager somatostatinmangel hos flere dyrearter.
English: Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet, inklusive teartogenese (se pkt.
English: For children up to age 12 years, the dose will be based on the body size (surface area), the usual dose being 1.30 g/m2 of body surface area per day.
Danish: For børn op til 12 år, er dosis baseret på kropsstørrelse (overfladeareal), og den sædvanlige dosis er 1,30 g/m af kropsareal per dag.
English: Nervous system disorders
Danish: Forstyrrelser i nervesystemet
English: White blood cell (WBC) cystine levels should therefore be monitored to adjust the dose.
Danish: Cystinniveauet i de hvide blodlegemer (HB) bør derfor overvåges for at kunne bestemme den nødvendige dosering.
English: EXP {month/year}
Danish: Udløbsdato {måned/år}
English: In one clinical study, baseline white cell cystine levels were 3.73 (range 0.13 to 19.8) nmol hemicystine/mg protein and were maintained close to 1 nmol hemicystine/mg protein with a cysteamine dose range of 1.3 to 1.95 g/m2/day.
Danish: I et klinisk studie var cystin baseline i de hvide blodlegemer 3,73 (fra 0,13 til 19,8) nmol hemicystin/mg protein og blev vedligeholdt tæt ved 1 nmol hemicystin/mg protein med en cysteamindosis på fra 1,3 til 1,95 g/m2/dag.
English: Cystine build up causes kidney damage and excretion of excess amounts of glucose, proteins and electrolytes.
Danish: Ophobning af cystein medfører skade på nyrerne med udskillelse af overskud af glukose, proteiner og elektrolytter til følge.
English: How to store CYSTAGON Further information
Danish: Sådan opbevarer De/du CYSTAGON Yderligere oplysninger
English: Self-examination of the skin by the patient or the parents should also be advised.
Danish: Patienten selv eller dennes forældre bør også rådes til at undersøge huden.
English: Reproduction studies showed embryofoetotoxic effects (resorptions and post-implantation losses) in rats at the 100 mg/kg/day dose level and in rabbits receiving cysteamine 50 mg/kg/day.
Danish: Reproduktionsstudier viste embryoføtale toksiske effekter (resorptioner og post implantale tab) hos rotter ved et dosisniveau på 100 mg/kg/dag og hos kaniner der fik cysteamin doser på 50 mg/kg/dag.
English: The dose should be raised if there is adequate tolerance and the leucocyte cystine level remains >1 nmol hemicystine/mg protein.
Danish: Doseringen bør øges, hvis der er tilstrækkelig tolerance og leukocyt cystin niveauet forbliver > 1nmol hemicystin/mg protein.
English: You should contact your or your child's doctor or the hospital emergency department immediately if more medicine has been taken than has been prescribed, drowsiness develops .
Danish: Kontakt omgående lægen eller skadestuen, hvis der er indtaget mere medicin end foreskrevet, eller der optræder unormal sløvhed.
English: HDPE bottles of 100 and 500 hard capsules.
Danish: HDPE flasker med 100 og 500 hårde kapsler.
English: CYSTAGON treatment should be initiated under the supervision of a physician experienced in the treatment of cystinosis.
Danish: Behandling med CYSTAGON bør iværksættes under ledelse af en læge med erfaring i behandling af cystinosis.
English: If any skin or bone abnormalities appear, please inform your doctor immediately.
Danish: Hvis der er hud- eller knogleforandringer, bør De/du straks informere Deres/din læge.
English: Your doctor could require a regular physical and X-ray examination for the skin and the bones to control the effects of the medicinal product.
Danish: Deres/din læge kan jævnligt have brug for undersøgelser og røntgenoptagelser af hud og knogler for at overvære effekten af behandlingen.
English: Monitoring of blood cell count is recommended on a regular basis.
Danish: Det anbefales at måle blodcelletallet jævnligt.
English: Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.
Danish: Cysteamin reducerer cystin akkumuleringen i visse celler (f.eks. leukocytter, muskelceller og leverceller) hos patienter med nephropathisk cystinosis, og hvor behandlingen iværksættes tidligt forsinker det udviklingen af nyresvigt.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé, pkt.
English: You may already be receiving phosphate supplements and the dose of these may need to be changed when CYSTAGON is substituted for phosphocysteamine.
Danish: De/du får måske allerede fosfattilskud, og det vil være nødvendigt at ændre doseringen, når fosfocysteamin udskiftes med CYSTAGON.
English: In cases of patients with kidney transplants, anti-rejection treatments have been used with cysteamine.
Danish: Hos nyretransplanterede patienter er behandling mod afstødning blevet anvendt sammen med cysteamin.
English: • For patients over age 12 and over 50 kg weight, the recommended CYSTAGON dose is 2 g/day, divided four times daily.
Danish: • For patienter over 12 år og over 50 kg er den anbefalede mængde CYSTAGON 2 g/dag, fordelt på fire doser.
English: • For children up to age 12 years, CYSTAGON dosing should be on the basis of body surface area (g/m 2/day).
Danish: • For børn i alderen op til 12 år bør CYSTAGON dosen være baseret på overfladearealet (g/m 2/dag).
English: Following a single oral dose of cysteamine bitartrate equivalent to 1.05 g of cysteamine free base in healthy volunteers, the mean ( sd) values for the time to peak and peak plasma concentration are 1.4 ( 0.5) hours and 4.0 ( 1.0) µg/ml, respectively.
Danish: Efter en enkelt oral dosis cysteaminbitartrat svarende til 1,05 g cysteamin fri base hos raske forsøgspersoner, er middelværdierne ( SD) for tiden til peak og peak plasmakoncentration henholdsvis 1,4 ( 0,5) timer og 4,0 ( 1,0) g/ml.
English: - Your or your child's medical treatment may include, in addition to CYSTAGON, one or more supplements to replace important electrolytes lost through the kidneys.
Danish: - Deres/din eller Deres/dit barns behandling med CYSTAGON kan endvidere kræve erstatningsbehandling for tab af vigtige elektrolytter fra nyrerne.
English: Intact CYSTAGON hard capsules should not be administered to children under the age of approximately 6 years due to risk of aspiration (see section 4.2).
Danish: Hele CYSTAGON hårde kapsler bør ikke gives til børn under ca. 6 år, på grund af aspirationsfaren (se pkt.
English: - Your doctor could require controlling the blood cell count on a regular basis.
Danish: - Deres/din læge kan jævnligt have brug for at kontrollere antallet af celler i blodet.
English: CYSTAGON therapy must be initiated promptly after confirmation of the diagnosis of nephropathic cystinosis to achieve maximum benefit.
Danish: CYSTAGON behandling skal iværksættes umiddelbart efter diagnosen nephropatisk cystinosis er fastslået for at opnå maksimalt udbytte.
English: Date of latest renewal: 23 June 2007.
Danish: Dato for seneste fornyelse af tilladelsen: 23. juni 2007.
English: Bottles of 100 or 500 hard capsules.
Danish: I glas med 100 eller 500 hårde kapsler.
English: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Danish: Fortæl det altid til lægen eller apoteket, hvis De/du bruger anden medicin eller har brugt det for nylig.
English: Cysteamine mechanism of action by interfering with the cross-linking of collagen fibers has been postulated (see section 4.4).
Danish: Det er postuleret, at cysteamins virkningsmekanisme er at interferere med krydsbindingen mellem kollagenfibrene (se pkt.
English: In cases where histopathological examination of the skin was performed, the results suggested angioendotheliomatosis.
Danish: I de tilfælde, hvor histo-/patologisk undersøgelse af huden er blevet udført tydede resultaterne på angioendotheliomatose.
English: CYSTAGON has minor or moderate influence on the ability to drive and use machines CYSTAGON may cause drowsiness.
Danish: CYSTAGON påvirker i mindre eller moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Date of latest renewal: 23 June 2007
Danish: Dato for seneste fornyelse af tilladelsen: 23. juni 2007
English: - A few cases of skin lesions on elbows like little hard lumps have been reported in children treated with high doses of different cysteamine preparations.
Danish: - Der har været tilfælde af hudlæsioner, som små, hårde klumper, på albuer hos børn der har været behandlet med høje doser af forskellige cysteamin formuleringer.
English: Cysteamine reacts with cystine to form the mixed disulfide of cysteamine and cysteine.
Danish: Cysteamin reagerer med cystin og danner et sammensat disulfid mellem cysteamin og cystin, og cystin.
English: Common: Skin odour abnormal, rash Uncommon: Hair colour changes, skin striae, skin fragility (molluscoid pseudotumor on elbows)
Danish: Almindelige: Unormal hudlugt, udslæt Usædvanlige: Ændringer i hårfarve, striae i huden, skrøbelig hud (molluscoid pseudotumorer på albuerne)
English: What CYSTAGON is and what it is used for Before you use CYSTAGON How to use CYSTAGON Possible side effects
Danish: CYSTAGONs virkning, og hvad Du/de skal bruge det til Det skal De/du vide, før De/du begynder at tage CYSTAGON Sådan skal De/du tage CYSTAGON Bivirkninger
English: It is not known if cysteamine is removed by haemodialysis.
Danish: Det vides ikke om cysteamin fjernes ved hæmodialyse.
English: - Uncommon: skin striae, skin lesion (little-hard lumps on elbows), joint laxity, leg pain, bone fracture, scoliosis (deviation of the vertebral column), bone deformity and fragility, hair discoloration, severe allergic reaction, somnolence, fits, nervousness, hallucination, decrease in white blood cells, gastrointestinal ulcer manifested by bleeding in the digestive tract and effect on the kidney manifested by swelling of the extremities and weight gain.
Danish: - Usædvanlige: Strækmærker, hudlæsioner (små hårde klumper på albuer), slaphed i leddene, smerter i benene, knoglebrud, skævhed i ryggen, knogledeformiteter og -skørhed, hårmisfarvning, svær allergisk reaktion, søvnløshed, krampeanfald, nervøsitet, hallucinationer, kraftigt fald i hvide blodlegemer, mavesår manifesteret ved blødning i fordøjelseskanalen og påvirkning af nyrerne, der viser sig ved hævelse af benene og vægtøgning.
English: Regular blood and urine tests to measure the levels of the body's important electrolytes are also necessary to help your or your child's doctor correctly adjust the doses of these supplements.
Danish: Det er ligeledes nødvendigt at foretage regelmæssige blod- og urinprøver for at bestemme kroppens indhold af vigtige elektrolytter, så lægen herved kan tilpasse den korrekte behandling.
English: A desiccant unit containing black activated carbon and silica gel granules is included in the bottle.
Danish: I glasset findes et bundfald, som indeholder sort aktiveret kul og silica gel granulat.
English: An overdose of cysteamine may cause progressive lethargy.
Danish: En overdosering med cysteamin kan medføre tiltagende døsighed.
English: It is important to take or give these supplements exactly as instructed.
Danish: Det er vigtigt at denne erstatningsbehandling tages som foreskrevet.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTATIONSVEJ(E)
English: Most patients will already be receiving phosphate supplements and the dose of these may need to be altered when CYSTAGON is substituted for phosphocysteamine.
Danish: De fleste patienter modtager allerede phosphattilskud, og når phosphocysteamin udskiftes med CYSTAGON, vil det være nødvendigt at ændre doseringen.
English: Normal individuals and heterozygous subjects for cystinosis have white cell cystine levels of < 0.2, and usually below 1 nmol hemicystine/mg protein, respectively.
Danish: Normale individer og personer, som er heterocygote for cystinosis har et cystinniveau i de hvide blodlegemer på henholdsvis < 0,2 og sædvanligvis under 1 nmol hemicystin/mg protein.
English: - Regular blood tests to measure the amount of cystine inside white blood cells are necessary to help determine the correct dose of CYSTAGON.
Danish: - Det er regelmæssigt nødvendigt at måle blodets indhold af cystin for at bestemme den korrekte dosis CYSTAGON.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremspilleren ansvarlig for batchfrigivelse
English: Uncommon: Anaphylactic reaction
Danish: Usædvanlige: Anafylaktisk reaktion
English: What CYSTAGON contains - The active substance is cysteamine bitartrate (mercaptamine bitartrate).
Danish: CYSTAGON indeholder: - Det aktive stof er cysteaminbitartrat (mercaptaminbitartrat).
English: Therefore, where cysteamine ophthalmic solution is used for that purpose, its usage should continue.
Danish: Så hvor cysteamin ophtalisk solution allerede anvendes mod denne indikation, bør behandlingen fortsætte.
English: In some cases, these skin lesions were associated with vascular proliferation, skin striae and bone lesions first seen during an X-ray examination.
Danish: Disse hudlæsioner har i enkelte tilfælde været associeret med vaskulær proliferation, hud striae og knoglelæsioner, der blev opdaget ved en røntgenundersøgelse.
English: - Very common: vomiting, nausea, diarrhoea, loss of appetite, fever and sensation of sleep
Danish: - Meget almindelige: Opkastning, kvalme, diarre, appetitløshed, feber og en søvnlignende fornemmelse.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Denne indlægsseddel blev senest godkendt den Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Make sure you know how you or your child reacts to this medicine before doing anything that could be dangerous if not alert.
Danish: Bemærk, hvorledes Dem/dig selv eller Deres/dit barn reagerer på medicinen, så faretruende situationer kan undgås.
English: CYSTAGON is indicated for the treatment of proven nephropathic cystinosis.
Danish: CYSTAGON anvendes til behandling af diagnosticeret nephropathisk cystinosis.
English: The goal of therapy is to keep leucocyte cystine levels below 1 nmol hemicystine/mg protein.
Danish: Det er behandlingens mål at holde leukocyt cystin niveauerne under 1 nmol hemicystin/mg protein.
English: Keep the container tightly closed in order to protect from light and moisture
Danish: Opbevares i den originale yderpakning for at beskytte mod lys og fugt
English: These skin lesions were associated with vascular proliferation, skin striae and bone lesions.
Danish: Disse hudlæsioner har været associeret med vaskulær proliferation, striae i huden og knoglelæsioner.
English: In patients at steady state, these values are 1.4 ( 0.4) hours and 2.6 ( 0.9) µg/ml, respectively, after a dose ranging from 225 to 550 mg. Cysteamine bitartrate (CYSTAGON) is bioequivalent to cysteamine hydrochloride and phosphocysteamine.
Danish: Hos patienter i steady state er disse værdier henholdsvis 1,4 ( 0,4) timer og 2,6 ( 0,9) g/ml, efter en dose ranging fra 225 til 550 mg.
English: In some patients, the skin lesions on elbows regressed after CYSTAGON dose reduction.
Danish: Hos nogle patienter forsvandt hud- og albuelæsionerne efter at CYSTAGON dosen blev reduceret.
English: In children who are at risk of aspiration, aged approximately 6 years and under, the hard capsules should be opened and the content sprinkled on food.
Danish: Hos børn i aldersgruppen ca. 6 år og yngre, som ikke kan sluge hårde kapsler, kan kapslerne åbnes og indeholder drysses på mad.
English: Treatment with CYSTAGON should continue indefinitely, as instructed by your doctor.
Danish: Behandlingen med CYSTAGON er livslang, som anvist af lægen.
English: Oral cysteamine has not been shown to prevent eye deposition of cystine crystals.
Danish: Cysteamin til oral administration kan ikke forhindre aflejringer af cystinkrystaller i øjet.
English: - If you have further questions, please ask your doctor or your pharmacist.
Danish: Er De/du i tvivl så spørg lægen eller apoteket.
English: Common: Headache, encephalopathy Uncommon: Somnolence, convulsions
Danish: Almindelige: Hovedpine, encefalopati Usædvanlige: Somnolens, kramper
English: Please consult your doctor if you plan to become pregnant.
Danish: Hvis De påtænker at blive gravid, bør De kontakte Deres læge.
English: When starting therapy, patients should not engage in potentially hazardous activities until the effects of the medicinal product on each individual are known.
Danish: Patienter bør ikke udføre potentielle farlige aktiviteter før påvirkningen af CYSTAGON er kendt.
English: These lesions were associated with skin striae and bone lesions such as fracture and bone deformities, and with laxity of joints.
Danish: De læsioner blev forbundet med strækmærker og knoglelæsioner såsom fraktur eller knogledeformationer og med slaphed i leddene.
English: The mean white cell cystine level attained during treatment was 1.7 + 0.2 nmol hemicystine/mg protein.
Danish: Middelværdien for cystinniveauet i de hvide blodlegemer opretholdt under behandlingen var 1,7  0,2 nmol hemicystin/mg protein.
English: Individuals with nephropathic cystinosis have elevations of white cell cystine above 2 nmol hemicystine/mg protein
Danish: Personer med nephropatisk cystinose har stigninger i cystinindholdet i hvide blodlegemer på over 2 nmol hemicystin/mg protein.
English: - Common: abdominal pain or discomfort, unpleasant breath and body odour, skin eruption, gastroenteritis, fatigue, headache, encephalopathy (brain disorder) and liver function test abnormalities.
Danish: - Almindelige: Mavesmerter eller utilpashed, dårlig ånde og kropslugt, huderuptioner, gastroenteritis, træthed, hovedpine, encefalopati (forstyrrelse i hjernen) og anormaliteter ved leverfunktionstests.
English: black ink on hard capsules containing E172
Danish: Gelatine, titandioxid, sort blæk på den hårde kapsel, indeholder E172
English: Very common: Vomiting, nausea, diarrhoea Common: Abdominal pain, breath odour, dyspepsia, gastroenteritis
Danish: Meget almindelige: Opkastning, kvalme, diarre Almindelige: Abdominalsmerter, dårlig ånde, dyspepsi, gastroenteritis Usædvanlige: Gastrointestinalt ulcus
English: Cases of Ehlers-Danlos like syndrome and vascular disorders on elbows have been reported in children chronically treated with high doses of different cysteamine preparations (cysteamine chlorhydrate or cystamine or cysteamine bitartrate) mostly above the maximal dose 1.95 g/m2/day.
Danish: Der er rapporteret tilfælde, der minder om Ehlers-Danlos syndrom og vaskulære sygdomme på albuerne hos børn, der kronisk bliver behandlet med høje doser af forskellige cysteamin formuleringer (cysteamin klorhydrat, cysteamin eller cysteamin bitartrat), hovedsageligt over den maksimale dosis på 1,95 g/m2/dag.
English: Cases of Ehlers-Danlos like syndrome and vascular disorders on elbows have been reported in children treated with high doses of different cysteamine preparations (cysteamine chlorhydrate or cystamine or cysteamine bitartrate) mostly above the maximal dose 1.95 g/m2/day.
Danish: Der har været rapporteret tilfælde, der minder om Ehlers-Danlos syndrom og vaskulære sygdomme på albuer hos børn behandlet med høje doser af forskellige cysteamin formuleringer (cysteamin klorhydrat, cysteamin eller cysteamin bitartrat), hovedsageligt over den maksimale dosis på 1,95 g/m2/dag.
English: Breast-feeding CYSTAGON must not be used during breast-feeding.
Danish: Cystagon må ikke anvendes i forbindelse med amning.
English: If you use more CYSTAGON than you should:
Danish: Hvis De/du har taget for meget CYSTAGON:
English: - Cystagon 150 mg: white, opaque hard capsules with CYSTAGON 150 on the body and MYLAN on the cap.
Danish: - Cystagon 150 mg: hvide, ugennemsigtige hårde kapsler med CYSTAGON 150 på selve glasset og MYLAN på låget.