natgillin/translations-raw huggingface dataset:
Hvorfor blev Yescarta godkendt i EU? 
Why is Yescarta authorised in the EU?
Et hovedstudie af 111 patienter med DLBCL og PMBCL, der ikke reagerede på tidligere behandlinger, eller hvis sygdom var vendt tilbage, viste, at Yescarta er effektivt til at fjerne kræften hos mange patienter. 
A main study of 111 patients with DLBCL and PMBCL that was not responding to previous treatment or had returned showed that Yescarta is effective at clearing the cancer in many patients.
Når Yescarta gives til patienten, binder de modificerede T-celler til kræftcellerne og dræber dem og hjælper på den måde med at fjerne kræften fra kroppen. 
When Yescarta is given to the patient, the modified T cells attach to and kill cancer cells, thereby helping to clear the cancer from the body.
Yescarta indeholder det aktive stof axicabtagen-ciloleucel (består af genmodificerede hvide blodlegemer). 
Yescarta contains the active substance axicabtagene ciloleucel (consisting of genetically modified white blood cells).
Hvilke risici er der forbundet med Yescarta? 
What are the risks associated with Yescarta?
Yescarta er beregnet til voksne patienter, hvis blodkræft er vendt tilbage eller ikke længere reagerer på tidligere behandlinger. 
Yescarta is for adult patients whose blood cancer has returned or has stopped responding to previous treatment.
• primært mediastinalt storcellet B-celle-lymfom (PMBCL). 
• primary mediastinal large B-cell lymphoma (PMBCL).
Virksomheden skal sørge for informationsmateriale til sundhedspersoner og patienter, hvad angår bivirkninger, navnlig cytokinfrigivelsessyndrom. 
The company must provide educational materials for healthcare professionals and patients about possible side effects, especially cytokine release syndrome.
Et hovedstudie viste, at Yescarta var effektivt til at fjerne kræften hos mange patienter med DLBCL og PMBCL, der ikke reagerede på tidligere behandling, eller hvis sygdom var vendt tilbage. 
A main study showed that Yescarta is effective at clearing the cancer in many patients with DLBCL and PMBCL that was not responding to previous treatment or had returned.
Tocilizumab skal være tilgængeligt i tilfælde af, at der opstår cytokinfrigivelsessyndrom. 
Tocilizumab must be available in case of cytokine release syndrome.
Yescarta fremstilles ved brug af patientens egne hvide blodlegemer, der udvindes af blodet og genmodificeres i et laboratorium. 
Yescarta is prepared using the patient's own white blood cells which are extracted from the blood and genetically modified in the laboratory.
Den fuldstændige liste over bivirkninger og begrænsninger ved Yescarta fremgår af indlægssedlen. 
For the full list of side effects and restrictions with Yescarta, see the package leaflet.
Yescarta er et avanceret lægemiddel til såkaldt genterapi. 
Yescarta is a type of advanced therapy medicine called a ‘gene therapy product'.
• diffust storcellet B-celle-lymfom (DLBCL) 
• diffuse large B-cell lymphoma (DLBCL);
Yescarta indeholder patientens egne T-celler (en type hvide blodlegemer), der er blevet genmodificeret i et laboratorium, så de danner såkaldt kimærisk antigenreceptor-protein (CAR-protein). 
Yescarta contains the patient's own T cells (a type of white blood cell) that have been modified genetically in the laboratory so that they make a protein called chimeric antigen receptor (CAR).
Lægemidlet tocilizumab samt nødudstyr skal være tilgængeligt i tilfælde af, at patienten får såkaldt cytokinfrigivelsessyndrom, der er en potentielt alvorlig bivirkning (se afsnittet om bivirkninger nedenfor). 
A medicine called tocilizumab and emergency equipment must be available in case the patient has a potentially serious side effect called cytokine release syndrome (see risks section below).
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. 
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.
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. 
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.
Hvordan anvendes Yescarta? 
How is Yescarta used?
Hvilke fordele viser studierne, at der er ved Yescarta? 
What benefits of Yescarta have been shown in studies?
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. 
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.
Hvordan virker Yescarta? 
How does Yescarta work?
De/du kan få brug for at læse den igen. 
You may need to read it again.
To andre studier har vist samme lignende resultater. 
Two other studies have shown similar results.
Forskellige organer påvirkes ved forskellige aldre. 
Different organs are affected at different ages.
Det er vigtigt at tage doseringen så tæt på hver 6. time så muligt. 
It is important to take the dose as close to every 6 hours as possible.
Det kan være skadeligt for andre, selvom de har samme symptomer, som De/du har. 
It may harm them, even if their symptoms are the same as yours.
Cirka 35 % af patienterne kan forvente at opleve bivirkninger. 
Approximately 35% of patients can be expected to experience adverse reactions.
Indomethacin og CYSTAGON har været anvendt samtidig i visse patienter. 
Indomethacin and CYSTAGON have been used simultaneously in some patients.
Spørg lægen til råds for fuldstændig vejledning. 
Consult the doctor for complete directions.
Patienter i dialyse eller post-transplanterede patienter: 
Patients on dialysis or post-transplantation:
Brug af CYSTAGON sammen med mad og drikke: 
Using CYSTAGON with food and drink
Dette blandede disulfid transporteres derefter fra lysosomerne via et intakt lysintransportsystem. 
The mixed disulfide is then exported from the lysosomes by an intact lysine transport system.
Rapporterede bivirkninger er angivet nedenfor, efter system-organklasse og efter frekvens. 
Reported adverse reactions are listed below, by system organ class and by frequency.
Disse omfatter hovedsagelig det gastrointestinale system og centralnervesystemet. 
These mainly involve the gastrointestinal and central nervous systems.
Tag hverken mere eller mindre af medicinen uden lægens godkendelse. 
Do not increase or decrease the amount of medicine without your doctor's approval.
Da nogle af disse bivirkninger er alvorlige, så spørg Deres/din eller Deres/dit barns læge om forklaring på advarselstegnene. 
Since some of these side effects are serious, ask your or your child's doctor to explain their warning signs.
Begyndelsesdosis bør være 1/4 til 1/6 af den forventede vedligeholdelsesdosis, og øges gradvist over 4-6 uger for at undgå intolerance. 
Starting doses should be 1/4 to 1/6 of the expected maintenance dose, increased gradually over 46 weeks to avoid intolerance.
Erfaringer tyder på, at fødemidler såsom mælk, kartofler og andre stivelsesbaserede produkter synes at være passende emner til at blande med pulveret. 
Experience suggests that foods such as milk, potatoes and other starch based products seem to be appropriate for mixing with the powder.
Imidlertid steg væksthastigheden ikke nok til, at patienterne kunne nå op på normerne ifølge deres alder. 
However, growth velocity did not increase enough to allow patients to catch up the normal for their age.
Der er ikke udført interaktionsundersøgelser. 
No interaction studies have been performed
Patienter i behandling voksede i forhold til ubehandlede patienter. 
Patients on treatment maintained growth as compared to untreated patients.
Der foreligger ingen information for patienter med svær nyreinsufficiens. 
No information is available for patients with severe renal insufficiency.
Der kendes ingen antidot. 
No specific antidote is known.
Hvis en medicindosis glemmes, bør den tages så hurtigt så muligt. 
If a dose of medicine is missed, it should be taken as soon as possible.
CYSTAGON bør tages 4 gange dagligt, hver 6. time, og fortrinsvis lige efter lige efter eller sammen med maden. 
CYSTAGON should be taken 4 times a day, every 6 hours, preferably just after or with food.
De primære målinger for effektivitet var serumkreatinin og udregnet kreatinin clearance og vækst (højde). 
The principal efficacy measurements were serum creatinine and calculated creatinine clearance and growth (height).
Læs denne indlægsseddel grundigt, inden De/du begynder at tage medicinen. 
Read all of this leaflet carefully before you start using this medicine.
De bør ikke anvende CYSTAGON, hvis De er gravid. 
You should not use CYSTAGON if you are pregnant.
Når disse virkninger forekommer, ved indledningen af behandlingen med cysteamin, kan midlertidig seponering og trinvis reintroduktion af behandlingen være effektiv til forbedring af tolerance. 
When these effects appear at the initiation of cysteamine therapy, temporary suspension and gradual reintroduction of treatment may be effective in improving tolerance.
De/du må ikke tage en dobbeltdosis som erstatning for den glemte dosis. 
Do not take a double dose to make up for a forgotten dose.
Hvis en graviditet diagnosticeres eller planlægges, bør behandlingen tages op til nøje overvejelse, og patienten skal oplyses om den mulige teratogene risiko ved cysteamin. 
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.
Den anbefalede dosis er 1,30 g/m 2/dag af den frie base fordelt fire gange dagligt. 
The recommended dose is 1.30 g/m 2/day of the free base divided four times daily.
Frekvenser er defineret som: Meget almindelige (≥1/10), almindelige (≥1/100 til <1/10) og usædvanlige (≥1.000 til <1/100). 
Frequencies are defined as: very common (≥ 1/10), common (≥1/100 to 1/10) and uncommon (≥1/1,000 to 1/100).
CYSTAGON kan som al medicin give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines, CYSTAGON can cause side effects, although not everybody gets them.
Meget almindelige: Anorexi 
Very common: Anorexia
Påvirkningen af graviditet af ubehandlet cystinosis er også ukendt. 
The effect on pregnancy of untreated cystinosis is also unknown.
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. 
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).
CYSTAGON kan hos nogle forårsage sløvhed eller få dem til at være mindre årvågen end normalt. 
CYSTAGON may cause some people to become drowsy or less vigilant than they are normally.
Der foreligger ikke tilstrækkelige data om brugen af cysteamin bitartrat hos gravide kvinder. 
There are no adequate data from the use of cysteamine bitartrate in pregnant women.
Brug ikke CYSTAGON efter den udløbsdato, der står på pakningen. 
Do not use after the expiry date which is stated on the label.
Konsekvensen af dette i relation til den kliniske anvendelse er ukendt. 
The consequence of this for the clinical use of the drug is unknown.
Udskillelsen af CYSTAGON i menneskemælk er ukendt. 
CYSTAGON excretion in human's milk is unknown.
Under alle omstændigheder bør den sædvanlige dosis ikke overstige 1,95 g/m2/dag. 
In any case the usual dose should not exceed 1.95 g/m2/day.
Den anførte dosis af CYSTAGON udskrevet til Dem/dig eller Deres/dit barn afhænger af Deres/din eller Deres/dit barns alder og vægt. 
The dose of CYSTAGON prescribed for you or your child will depend on your or your child's age and weight.
Patienter med leverinsufficiens: Dosis justering er normalt ikke påkrævet, men leukocyt cystin niveauet bør kontrolleres. 
Patients with hepatic insufficiency: Dose adjustment is not normally required; however, leucocyte cystine levels should be monitored.
Den tubulære nyrefunktion blev ikke påvirket af behandlingen. 
Renal tubular function was not affected by treatment.
En reduktion i fertilitet blev observeret hos rotter ved 375 mg/kg/dag, en dosis hvor øgning af legemsvægt blev forhalet. 
A reduction of fertility was observed in rats at 375 mg/kg/day, a dose at which body weight gain was retarded.
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. 
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.
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. 
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.
Hvis De/du har glemt at tage CYSTAGON: 
If you forget to take CYSTAGON:
CYSTAGON bør derfor ikke anvendes under graviditet, især ikke under første trimester, medmindre det er klart nødvendigt. 
Therefore, CYSTAGON should not be used during pregnancy, particularly during the first trimester, unless clearly necessary.
Ved denne dosis blev øgning af vægt og ungernes overlevelse under amning også nedsat. 
At this dose, weight gain and survival of the offspring during lactation was also reduced.
Der er ikke udført carcinogenicitets studier med CYSTAGON. 
No carcinogenic studies have been conducted with CYSTAGON.
Meget begrænsede data antyder, at farmakokinetiske parametre for cysteamin ikke bliver væsentlig modificeret hos patienter med mild til moderat nyreinsufficiens. 
Very limited data suggest that cysteamine pharmacokinetic parameters may not be significantly modified in patients with mild to moderate renal insufficiency.
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. 
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.
Inden for hver frekvensgruppe præsenteres bivirkninger efter aftagende alvorlighedsgrad. 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriouness
Dato for første tilladelse: 23. juni 1997. 
Date of first authorisation: 23 June 1997.
Usædvanlige: Nervøsitet, hallucinationer 
Uncommon: Nervousness, hallucination
- For at undgå risiko for udsugning af væske fra lungerne skal kapslerne ikke gives til børn under ca. 6 år. 
- To avoid any risk of aspiration in the lungs, the capsules should not be given to children under the age of approximately 6 years.
Almindelige: Leverfunktionstests abnorme 
Common: Liver function tests abnormal
I tilfælde af overdosering bør åndedrætssystemet og hjerte-kar kredsløbet styrkes. 
Should overdosage occur, the respiratory and cardiovascular systems should be supported appropriately.
CYSTAGON er et lægemiddel, der reagerer med cystin og reducerer dets indhold inden i cellerne. 
CYSTAGON is a medicine that reacts with cystine to decrease its level within the cells.
Meget almindelige:Lethargi, pyrexi Almindelige: Asteni 
Very common: Lethargy, pyrexia Common: Asthenia
Egenundersøgelse af Deres/din eller Deres/dit barns hud anbefales. 
Self examination of your or your child's skin is recommended.
I visse tilfælde viste histologien en membranøs glomerulonefritis af den renale allograft og hypersensitiv interstitiel nefritis. 
In some cases, histology showed a membranous glomerulonephritis of the renal allograft and hypersensitivity interstitial nephritis.
Tag ikke CYSTAGON: - hvis De/du eller Deres/dit barn er overfølsom (allergisk) over for cysteaminbitartrat eller penicillamin eller et af de øvrige indholdsstoffer. 
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.
Høje doser af cysteamin indgivet enten oralt eller parenteralt forårsager ulcus duodeni hos rotter og mus, men ikke hos aber. 
High doses of cysteamine, either by oral or parenteral routes, produce duodenal ulcers in rats and mice but not in monkeys.
Efter start af behandlingen er tilfælde af nefrotisk syndrom blevet rapporteret inden for 6 måneder, med progressiv bedring efter afbrydelse af behandlingen. 
Cases of nephrotic syndrome have been reported within 6 months of starting therapy with progressive recovery after treatment discontinuation.
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. 
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.
Den maksimale CYSTAGON dosis anvendt i kliniske forsøg var 1,95 g/m2/dag. 
The maximum dose of CYSTAGON used in clinical trials was 1.95 g/m2/day.
Administration af cysteamin hos nyfødte rotter inducerede katarakter. 
Administration of cysteamine in neonate rats induced cataracts.
Høje doser af cysteamin forringer ammende mødres evne til at ernære deres hvalpe. 
High doses of cysteamine impair the ability of lactating mothers to feed their pups.
Enkeltdoser af stoffet hæmmer prolactinsekretion hos dyr. 
Single doses of the drug inhibit prolactin secretion in animals.
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. 
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.
Almene forstyrrelser og tilstande ved administrationsstedet 
General disorders and administration site conditions
I alle studier blev det vist, at patienter, som begyndte behandlingen i en tidlig alder med god nyrefunktion havde et bedre behandlingssvar. 
In all studies, patient response was better when treatment was started at an early age with good renal function.
Det anbefales derfor regelmæssigt at overvåge hud samt overveje om røntgenundersøgelser af knogler er nødvendige. 
It is therefore recommended to monitor regularly skin and to consider X-ray examinations of the bone as necessary.
Når behandlingen påbegyndes bør De/du eller Deres/dit barn ikke deltage i potentielt farlige aktiviteter, før virkningen af lægemidlet er velkendt. 
When starting therapy, you or your child should not engage in potentially hazardous activities until the effects of the drug are well known.
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. 
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.
En patient døde siden hen af en cerebral iskæmi med udtalt vaskulopati. 
One patient subsequently died of acute cerebral ischemia with marked vasculopathy.
Cysteamin tåles bedre i forbindelse med fordøjelsen, når det medicinske produkt bliver taget lige efter maden eller sammen med maden. 
Digestive tolerance of cysteamine is improved when the medicinal product is taken just after or with food.
CYSTAGON er kontraindikeret til patienter, som har udviklet overfølsomhed for penicillamin. 
CYSTAGON is contraindicated in patients who have developed hypersensitivity to penicillamine.
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. 
CYSTAGON can be administered with electrolyte and mineral replacements necessary for management of the Fanconi syndrome as well as vitamin D and thyroid hormones.
Bør ikke tilsættes syrlige drikkevarer såsom orange juice. 
Do not add to acidic drinks e.g. orange juice.
I modsætning hertil havde de placebobehandlede patienter en gradvis stigning af serumkreatinin. 
Placebo treated patients, in contrast, experienced a gradual rise in serum creatinine.
Hos disse patienter anbefales en mere nøjagtig monitorering af leukocyt cystin niveauerne. 
A closer monitoring of the leucocyte cystine levels is recommended in these patients.
Hvis du oplever bivirkninger, bør du tale med Din læge, eller apoteket. 
If you get any side effects, talk to your doctor or pharmacist.
I modsætning til phosphocysteamin indeholder CYSTAGON ikke phosphat. 
In contrast to phosphocysteamine, CYSTAGON does not contain phosphate.
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. 
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.
Sure drikkevarer som f.eks. appelsin juice skal i almindelighed undgås, da pulveret er vanskeligt at opblande og kan danne bundfald. 
However, acidic drinks, e.g. orange juice, should generally be avoided as the powder tends not to mix well and may precipitate out.
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside, http://www.ema.europa.eu 
Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
CYSTAGON må kun indtages gennem munden og nøjagtigt som Deres/din eller Deres/dit barns læge har anført. 
CYSTAGON should be taken or given only by mouth and exactly as your or your child's doctor directs.
Teratogene virkninger er blevet beskrevet hos rotter, når der gives cysteamin over organogeneseperioden ved en dosis på 100 mg/kg/dag. 
Teratogenic effects have been described in rats when cysteamine is administered over the period of organogenesis at a dose of 100 mg/kg/day.
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. 
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.
Hvis der opstår lignende hud eller knogle anomalier, anbefales det at nedsætte dosen af CYSTAGON. 
If any similar skin or bone abnormalities appear, it is recommended to decrease the dose of CYSTAGON.