FrancophonIA/ELRC3.0 huggingface dataset:
English: It is given as a single infusion (drip) into a vein and must only be given to the patient whose cells were used to make it. Before having Yescarta, the patient should have a short course of chemotherapy to clear away their existing white blood cells, and just before the infusion they are given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion.
Danish: Inden patienten får Yescarta, skal han/hun gennemgå et kort kemoterapiforløb for at få fjernet sine eksisterende hvide blodlegemer, og lige inden infusionen skal han/hun have paracetamol og antihistamin for at reducere risikoen for infusionsreaktioner.
English: The number of patients who were cleared of the cancer or had at least a partial response was higher than in patients receiving standard care.
Danish: Antallet af tilfælde, hvor kræften blev fjernet, eller hvor der sås i hvert fald delvist respons, var større blandt Yescarta-behandlede patienter end blandt patienter, der fik standardbehandling.
English: How is Yescarta used?
Danish: Hvordan anvendes Yescarta?
English: What benefits of Yescarta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Yescarta?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yescarta have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Yescarta.
English: How does Yescarta work?
Danish: Hvordan virker Yescarta?
English: You may need to read it again.
Danish: De/du kan få brug for at læse den igen.
English: Two other studies have shown similar results.
Danish: To andre studier har vist samme lignende resultater.
English: Different organs are affected at different ages.
Danish: Forskellige organer påvirkes ved forskellige aldre.
English: It is important to take the dose as close to every 6 hours as possible.
Danish: Det er vigtigt at tage doseringen så tæt på hver 6. time så muligt.
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har samme symptomer, som De/du har.
English: Approximately 35% of patients can be expected to experience adverse reactions.
Danish: Cirka 35 % af patienterne kan forvente at opleve bivirkninger.
English: Indomethacin and CYSTAGON have been used simultaneously in some patients.
Danish: Indomethacin og CYSTAGON har været anvendt samtidig i visse patienter.
English: Consult the doctor for complete directions.
Danish: Spørg lægen til råds for fuldstændig vejledning.
English: Patients on dialysis or post-transplantation:
Danish: Patienter i dialyse eller post-transplanterede patienter:
English: Using CYSTAGON with food and drink
Danish: Brug af CYSTAGON sammen med mad og drikke:
English: The mixed disulfide is then exported from the lysosomes by an intact lysine transport system.
Danish: Dette blandede disulfid transporteres derefter fra lysosomerne via et intakt lysintransportsystem.
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Danish: Rapporterede bivirkninger er angivet nedenfor, efter system-organklasse og efter frekvens.
English: These mainly involve the gastrointestinal and central nervous systems.
Danish: Disse omfatter hovedsagelig det gastrointestinale system og centralnervesystemet.
English: Do not increase or decrease the amount of medicine without your doctor's approval.
Danish: Tag hverken mere eller mindre af medicinen uden lægens godkendelse.
English: Since some of these side effects are serious, ask your or your child's doctor to explain their warning signs.
Danish: Da nogle af disse bivirkninger er alvorlige, så spørg Deres/din eller Deres/dit barns læge om forklaring på advarselstegnene.
English: Starting doses should be 1/4 to 1/6 of the expected maintenance dose, increased gradually over 46 weeks to avoid intolerance.
Danish: Begyndelsesdosis bør være 1/4 til 1/6 af den forventede vedligeholdelsesdosis, og øges gradvist over 4-6 uger for at undgå intolerance.
English: Experience suggests that foods such as milk, potatoes and other starch based products seem to be appropriate for mixing with the powder.
Danish: Erfaringer tyder på, at fødemidler såsom mælk, kartofler og andre stivelsesbaserede produkter synes at være passende emner til at blande med pulveret.
English: However, growth velocity did not increase enough to allow patients to catch up the normal for their age.
Danish: Imidlertid steg væksthastigheden ikke nok til, at patienterne kunne nå op på normerne ifølge deres alder.
English: No interaction studies have been performed
Danish: Der er ikke udført interaktionsundersøgelser.
English: Patients on treatment maintained growth as compared to untreated patients.
Danish: Patienter i behandling voksede i forhold til ubehandlede patienter.
English: No information is available for patients with severe renal insufficiency.
Danish: Der foreligger ingen information for patienter med svær nyreinsufficiens.
English: No specific antidote is known.
Danish: Der kendes ingen antidot.
English: If a dose of medicine is missed, it should be taken as soon as possible.
Danish: Hvis en medicindosis glemmes, bør den tages så hurtigt så muligt.
English: CYSTAGON should be taken 4 times a day, every 6 hours, preferably just after or with food.
Danish: CYSTAGON bør tages 4 gange dagligt, hver 6. time, og fortrinsvis lige efter lige efter eller sammen med maden.
English: The principal efficacy measurements were serum creatinine and calculated creatinine clearance and growth (height).
Danish: De primære målinger for effektivitet var serumkreatinin og udregnet kreatinin clearance og vækst (højde).
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Læs denne indlægsseddel grundigt, inden De/du begynder at tage medicinen.
English: You should not use CYSTAGON if you are pregnant.
Danish: De bør ikke anvende CYSTAGON, hvis De er gravid.
English: When these effects appear at the initiation of cysteamine therapy, temporary suspension and gradual reintroduction of treatment may be effective in improving tolerance.
Danish: Når disse virkninger forekommer, ved indledningen af behandlingen med cysteamin, kan midlertidig seponering og trinvis reintroduktion af behandlingen være effektiv til forbedring af tolerance.
English: Do not take a double dose to make up for a forgotten dose.
Danish: De/du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: If a pregnancy is diagnosed or planned, the treatment should be carefully reconsidered and the patient must be advised of the possible teratogenic risk of cysteamine.
Danish: Hvis en graviditet diagnosticeres eller planlægges, bør behandlingen tages op til nøje overvejelse, og patienten skal oplyses om den mulige teratogene risiko ved cysteamin.
English: The recommended dose is 1.30 g/m 2/day of the free base divided four times daily.
Danish: Den anbefalede dosis er 1,30 g/m 2/dag af den frie base fordelt fire gange dagligt.
English: Frequencies are defined as: very common (≥ 1/10), common (≥1/100 to 1/10) and uncommon (≥1/1,000 to 1/100).
Danish: Frekvenser er defineret som: Meget almindelige (≥1/10), almindelige (≥1/100 til <1/10) og usædvanlige (≥1.000 til <1/100).
English: Like all medicines, CYSTAGON can cause side effects, although not everybody gets them.
Danish: CYSTAGON kan som al medicin give bivirkninger, men ikke alle får bivirkninger.
English: Very common: Anorexia
Danish: Meget almindelige: Anorexi
English: The effect on pregnancy of untreated cystinosis is also unknown.
Danish: Påvirkningen af graviditet af ubehandlet cystinosis er også ukendt.
English: The following side effects were reported as follows: very common (occurring in at least one in 10 patients), common (occurring in at least one in 100 patients), uncommon (occurring in at least one in1,000 patients), rare (occurring in at least one in 10,000 patients), very rare (occurring in at least one in 100,000 patients).
Danish: Følgende bivirkninger blev rapporteret som værende: meget almindelige (forekommer i mindst 1 ud af 10 patienter), almindelige (forekommer i mindst 1 ud af 100 patienter), usædvanlige (forekommer i mindst 1 ud af 1.000 patienter), meget usædvanlige (forekommer i mindst 1 ud af 10.000 patienter) og sjældne (forekommer i mindst 1 ud af 100.000 patienter.
English: CYSTAGON may cause some people to become drowsy or less vigilant than they are normally.
Danish: CYSTAGON kan hos nogle forårsage sløvhed eller få dem til at være mindre årvågen end normalt.
English: There are no adequate data from the use of cysteamine bitartrate in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af cysteamin bitartrat hos gravide kvinder.
English: Do not use after the expiry date which is stated on the label.
Danish: Brug ikke CYSTAGON efter den udløbsdato, der står på pakningen.
English: The consequence of this for the clinical use of the drug is unknown.
Danish: Konsekvensen af dette i relation til den kliniske anvendelse er ukendt.
English: CYSTAGON excretion in human's milk is unknown.
Danish: Udskillelsen af CYSTAGON i menneskemælk er ukendt.
English: In any case the usual dose should not exceed 1.95 g/m2/day.
Danish: Under alle omstændigheder bør den sædvanlige dosis ikke overstige 1,95 g/m2/dag.
English: The dose of CYSTAGON prescribed for you or your child will depend on your or your child's age and weight.
Danish: Den anførte dosis af CYSTAGON udskrevet til Dem/dig eller Deres/dit barn afhænger af Deres/din eller Deres/dit barns alder og vægt.
English: Patients with hepatic insufficiency: Dose adjustment is not normally required; however, leucocyte cystine levels should be monitored.
Danish: Patienter med leverinsufficiens: Dosis justering er normalt ikke påkrævet, men leukocyt cystin niveauet bør kontrolleres.
English: Renal tubular function was not affected by treatment.
Danish: Den tubulære nyrefunktion blev ikke påvirket af behandlingen.
English: A reduction of fertility was observed in rats at 375 mg/kg/day, a dose at which body weight gain was retarded.
Danish: En reduktion i fertilitet blev observeret hos rotter ved 375 mg/kg/dag, en dosis hvor øgning af legemsvægt blev forhalet.
English: The elimination of unchanged cysteamine in the urine has been shown to range between 0.3 % and 1.7% of the total daily dose in four patients; the bulk of cysteamine is excreted as sulphate.
Danish: Eliminationen af uændret cysteamin i urinen har vist sig at ligge i området mellem 0,3 % og 1,7 % af den totale daglige dosis hos fire patienter; hovedparten af cysteamin bliver udskilt som sulfat.
English: For children under approximately six years of age, the hard capsule may be opened and the contents sprinkled on food (e.g. milk, potatoes or starch based foods) or mixed in formula.
Danish: Hos børn under 6 år, kan de hårde kapsler åbnes og indholdet drysses på føden (f.eks. mælk, kartofler eller stivelsesbaserede fødevarer) eller blandes i føden.
English: If you forget to take CYSTAGON:
Danish: Hvis De/du har glemt at tage CYSTAGON:
English: Therefore, CYSTAGON should not be used during pregnancy, particularly during the first trimester, unless clearly necessary.
Danish: CYSTAGON bør derfor ikke anvendes under graviditet, især ikke under første trimester, medmindre det er klart nødvendigt.
English: At this dose, weight gain and survival of the offspring during lactation was also reduced.
Danish: Ved denne dosis blev øgning af vægt og ungernes overlevelse under amning også nedsat.
English: No carcinogenic studies have been conducted with CYSTAGON.
Danish: Der er ikke udført carcinogenicitets studier med CYSTAGON.
English: Very limited data suggest that cysteamine pharmacokinetic parameters may not be significantly modified in patients with mild to moderate renal insufficiency.
Danish: Meget begrænsede data antyder, at farmakokinetiske parametre for cysteamin ikke bliver væsentlig modificeret hos patienter med mild til moderat nyreinsufficiens.
English: The WBC levels should be measured 5 to 6 hours after dosing and should be checked frequently when initiating therapy (e.g. monthly) and every 3-4 months when on a stable dose.
Danish: Niveauet i de HB bestemmes 5 til 6 timer efter administration og bør bestemmes ofte i begyndelsen af behandlingen (f.eks. månedligt), og derefter hver 3-4 måned ved stabil dosering.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriouness
Danish: Inden for hver frekvensgruppe præsenteres bivirkninger efter aftagende alvorlighedsgrad.
English: Date of first authorisation: 23 June 1997.
Danish: Dato for første tilladelse: 23. juni 1997.
English: Uncommon: Nervousness, hallucination
Danish: Usædvanlige: Nervøsitet, hallucinationer
English: - To avoid any risk of aspiration in the lungs, the capsules should not be given to children under the age of approximately 6 years.
Danish: - For at undgå risiko for udsugning af væske fra lungerne skal kapslerne ikke gives til børn under ca. 6 år.
English: Common: Liver function tests abnormal
Danish: Almindelige: Leverfunktionstests abnorme
English: Should overdosage occur, the respiratory and cardiovascular systems should be supported appropriately.
Danish: I tilfælde af overdosering bør åndedrætssystemet og hjerte-kar kredsløbet styrkes.
English: CYSTAGON is a medicine that reacts with cystine to decrease its level within the cells.
Danish: CYSTAGON er et lægemiddel, der reagerer med cystin og reducerer dets indhold inden i cellerne.
English: Very common: Lethargy, pyrexia Common: Asthenia
Danish: Meget almindelige:Lethargi, pyrexi Almindelige: Asteni
English: Self examination of your or your child's skin is recommended.
Danish: Egenundersøgelse af Deres/din eller Deres/dit barns hud anbefales.
English: In some cases, histology showed a membranous glomerulonephritis of the renal allograft and hypersensitivity interstitial nephritis.
Danish: I visse tilfælde viste histologien en membranøs glomerulonefritis af den renale allograft og hypersensitiv interstitiel nefritis.
English: Do not use CYSTAGON - if you -or your child- are allergic (hypersensitive) to cysteamine bitartrate or penicillamine or any of the other ingredients of Cystagon.
Danish: Tag ikke CYSTAGON: - hvis De/du eller Deres/dit barn er overfølsom (allergisk) over for cysteaminbitartrat eller penicillamin eller et af de øvrige indholdsstoffer.
English: High doses of cysteamine, either by oral or parenteral routes, produce duodenal ulcers in rats and mice but not in monkeys.
Danish: Høje doser af cysteamin indgivet enten oralt eller parenteralt forårsager ulcus duodeni hos rotter og mus, men ikke hos aber.
English: Cases of nephrotic syndrome have been reported within 6 months of starting therapy with progressive recovery after treatment discontinuation.
Danish: Efter start af behandlingen er tilfælde af nefrotisk syndrom blevet rapporteret inden for 6 måneder, med progressiv bedring efter afbrydelse af behandlingen.
English: This is equivalent to 0.6 g/m2/day in the rat, which is less than half the recommended clinical maintenance dose of cysteamine, i.e. 1.30 g/ m2/day.
Danish: Dette svarer til 0,6 g/m2/dag hos rotten, hvilket er mindre end halvdelen af den anbefalede kliniske vedligeholdelsesdosis af cysteamin, dvs. 1,30 g/m2/dag.
English: The maximum dose of CYSTAGON used in clinical trials was 1.95 g/m2/day.
Danish: Den maksimale CYSTAGON dosis anvendt i kliniske forsøg var 1,95 g/m2/dag.
English: Administration of cysteamine in neonate rats induced cataracts.
Danish: Administration af cysteamin hos nyfødte rotter inducerede katarakter.
English: High doses of cysteamine impair the ability of lactating mothers to feed their pups.
Danish: Høje doser af cysteamin forringer ammende mødres evne til at ernære deres hvalpe.
English: Single doses of the drug inhibit prolactin secretion in animals.
Danish: Enkeltdoser af stoffet hæmmer prolactinsekretion hos dyr.
English: Genotoxicity studies have been performed: although in published studies using cysteamine, induction of chromosome aberrations in cultured eukaryotic cell lines has been reported, specific studies with cysteamine bitartrate did not show any mutagenic effects in the Ames test or any clastogenic effect in the mouse micronucleus test.
Danish: Gentoksicitets undersøgelser er blevet udført: Selvom der i publicerede studier med cysteamin er blevet rapporteret induktion af kromosom-forandringer i dyrkede eukaryote cellelinier, viste specifikke studier med cysteaminbitartrat hverken mutagene effekter ved Ames test eller clastogene effekter ved mikronucleus test hos mus.
English: General disorders and administration site conditions
Danish: Almene forstyrrelser og tilstande ved administrationsstedet
English: In all studies, patient response was better when treatment was started at an early age with good renal function.
Danish: I alle studier blev det vist, at patienter, som begyndte behandlingen i en tidlig alder med god nyrefunktion havde et bedre behandlingssvar.
English: It is therefore recommended to monitor regularly skin and to consider X-ray examinations of the bone as necessary.
Danish: Det anbefales derfor regelmæssigt at overvåge hud samt overveje om røntgenundersøgelser af knogler er nødvendige.
English: When starting therapy, you or your child should not engage in potentially hazardous activities until the effects of the drug are well known.
Danish: Når behandlingen påbegyndes bør De/du eller Deres/dit barn ikke deltage i potentielt farlige aktiviteter, før virkningen af lægemidlet er velkendt.
English: Take special care with CYSTAGON - When your or your child's disorder has been confirmed by leucocyte cystine measurements, the therapy with CYSTAGON must be started as soon as possible.
Danish: Vær ekstra forsigtig med at tage CYSTAGON: - når Deres/din eller Deres/dit barns sygdom er blevet bekræftet ved leukocyt cystein målinger skal behandling med CYSTAGON begynde så hurtigt som muligt.
English: One patient subsequently died of acute cerebral ischemia with marked vasculopathy.
Danish: En patient døde siden hen af en cerebral iskæmi med udtalt vaskulopati.
English: Digestive tolerance of cysteamine is improved when the medicinal product is taken just after or with food.
Danish: Cysteamin tåles bedre i forbindelse med fordøjelsen, når det medicinske produkt bliver taget lige efter maden eller sammen med maden.
English: CYSTAGON is contraindicated in patients who have developed hypersensitivity to penicillamine.
Danish: CYSTAGON er kontraindikeret til patienter, som har udviklet overfølsomhed for penicillamin.
English: CYSTAGON can be administered with electrolyte and mineral replacements necessary for management of the Fanconi syndrome as well as vitamin D and thyroid hormones.
Danish: CYSTAGON kan gives sammen med de elektrolyt- og mineraltilskud, som er nødvendige til behandling af Fanconi syndrom, lige såvel som det kan gives sammen med D-vitamin og thyroidhormoner.
English: Do not add to acidic drinks e.g. orange juice.
Danish: Bør ikke tilsættes syrlige drikkevarer såsom orange juice.
English: Placebo treated patients, in contrast, experienced a gradual rise in serum creatinine.
Danish: I modsætning hertil havde de placebobehandlede patienter en gradvis stigning af serumkreatinin.
English: A closer monitoring of the leucocyte cystine levels is recommended in these patients.
Danish: Hos disse patienter anbefales en mere nøjagtig monitorering af leukocyt cystin niveauerne.
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med Din læge, eller apoteket.
English: In contrast to phosphocysteamine, CYSTAGON does not contain phosphate.
Danish: I modsætning til phosphocysteamin indeholder CYSTAGON ikke phosphat.
English: The plasma protein binding in patients at steady state is similar: 53.1 % ( 3.6) and 51.1 % ( 4.5) at 1.5 and 6 hours post-dose, respectively.
Danish: Plasmaproteinbindingen hos patienter i steady state er magen til: Henholdsvis 53,1 % ( 3,6) og 51,1 % ( 4,5) ved henholdsvis 1,5 og 6 timer efter dosering.
English: However, acidic drinks, e.g. orange juice, should generally be avoided as the powder tends not to mix well and may precipitate out.
Danish: Sure drikkevarer som f.eks. appelsin juice skal i almindelighed undgås, da pulveret er vanskeligt at opblande og kan danne bundfald.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside, http://www.ema.europa.eu
English: CYSTAGON should be taken or given only by mouth and exactly as your or your child's doctor directs.
Danish: CYSTAGON må kun indtages gennem munden og nøjagtigt som Deres/din eller Deres/dit barns læge har anført.
English: Teratogenic effects have been described in rats when cysteamine is administered over the period of organogenesis at a dose of 100 mg/kg/day.
Danish: Teratogene virkninger er blevet beskrevet hos rotter, når der gives cysteamin over organogeneseperioden ved en dosis på 100 mg/kg/dag.
English: Cystinosis is a metabolic disease called ‘nephropathic cystinosis' which is characterized by an abnormal accumulation of the amino acid cystine in various organs of the body such as the kidney, eye, muscle, pancreas, and brain.
Danish: Cystinosis er en metabolisk sygdom, der hedder ”nephropatisk cystinosis”, som karakteriseres ved en unormal ophobning af aminosyren cystein i visse organer f.eks. nyrer, øjne, bugspytkirtlen og hjernen.
English: If any similar skin or bone abnormalities appear, it is recommended to decrease the dose of CYSTAGON.
Danish: Hvis der opstår lignende hud eller knogle anomalier, anbefales det at nedsætte dosen af CYSTAGON.
English: 100 hard capsules (with a desiccant unit in the bottle) 500 hard capsules (with a desiccant unit in the bottle)
Danish: 100 hårde kapsler (med et tørremiddel i glasset) 500 hårde kapsler (med et tørremiddel i glasset)
English: Metabolism and nutrition disorders
Danish: Forstyrrelser i metabolisme og ernæring
English: - In contrast to phosphocysteamine, another active substance close to cysteamine bitartrate, CYSTAGON does not contain phosphate.
Danish: - I modsætning til fosfocysteamin, et andet aktivt stof nært beslægtet til cysteaminbitartrat, indeholder CYSTAGON ikke fosfat.
English: CYSTAGON may cause some drowsiness.
Danish: CYSTAGON kan forårsage sløvhed.
English: Experience has occasionally shown that some forms of cysteamine are less well tolerated (i.e. leading to more adverse events) when patients are on dialysis.
Danish: Erfaring har sommetider vist, at andre former af cysteamin tolereres dårligere (dvs. fører til flere bivirkninger) af patienter i dialyse.
English: Nephropathic cystinosis must have been diagnosed by both clinical signs and biochemical investigations (leucocyte cystine measurements).
Danish: Diagnosen nephropatisk cystinosis skal være bestemt ud fra både kliniske tegn og biokemiske undersøgelser (leukocyt cystin målinger).
English: Do not store above 25°C and keep the container tightly closed in order to protect from light and moisture.
Danish: Må ikke opbevares over 25°C og opbevares i den originale pakning for at beskytte mod lys og fugt.
English: For patients over age 12 and over 50 kg weight, the usual dose is 2g/day.
Danish: For patienter over 12 år og over 50 kg, er den sædvanlige dosis 2 g/dag.
English: The leucocyte cystine level reaches its minimum (mean ( sd) value: 1.8  0.8 hours) slightly later than the peak plasma cysteamine concentration (mean ( sd) value: 1.4  0.4 hours) and returns to its baseline level as the plasma cysteamine concentration decreases at 6 hours post-dose.
Danish: Leukocyt cystinniveauet når dets minimum (middelværdi ( SD): 1,8  0,8 timer) en anelse senere end peak plasmacysteaminkoncentrationen (middelværdi ( SD): 1,4  0,4 timer) og vender tilbage til basisniveauet som plasmacysteaminkoncentrationen falder 6 timer efter dosering.