natgillin/translations-raw huggingface dataset:
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE CYSTADANE Tag ikke Cystadane Hvis du er overfølsom (allergisk) over for betain.
Do not take Cystadane If you or your child are allergic (hypersensitive) to betaine.
Vær ekstra forsigtig med at tage Cystadane Hvis du har bemærket bivirkninger i form af hovedpine, opkastning eller ændringer af dit syn, skal du straks kontakte din læge, idet det kan være tegn på væskedannelse i hjernen.
Take special care with Cystadane If you notice side effects like headaches, vomiting or a change in your vision, please contact your doctor immediately, they could be signs of a brain oedema.
Det er muligt at din behandling skal stoppes.
Your treatment with betaine may need to be interrupted.
Hvis du behandles med Cystadane og en aminosyreblanding og hvis du tager anden medicin samtidig skal du vente 30 minutter mellem at du tager dem (se ” brug af anden medicin ”).
If you are treated with Cystadane and with an amino-acid mixture and if you need to take other medicines at the same time, leave 30 minutes between the intake (see “ taking other medicines”).
Brug af anden medicin Hvis du tager en aminosyreblanding eller medicin så som vigabatrin eller GABA- analoger, skal du straks fortælle det til din læge, fordi de kan påvirke din behandling med betain.
Taking other medicines If you are taking amino-acid mixture or medicines such as vigabatrin or Gaba analogues, please tell your doctor as they might interact with your treatment with betaine.
Graviditet og amning Oplys din læge hvis du er gravid eller ammer.
16 Pregnancy and breast-feeding Please inform your doctor if you are pregnant or breast-feeding.
Din læge vil beslutte om du må bruge medicinen mens du er gravid eller ammer.
Your doctor will decide if the medicine may be used during pregnancy and breast-feeding.
16 Trafik - og arbejdssikkerhed Der er ikke udført nogen undersøgelser af medicinens effekt på at køre eller bruge maskiner.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
SÅDAN SKAL DU TAGE CYSTADANE
HOW TO TAKE CYSTADANE
Tag altid Cystadane nøjagtigt efter lægens anvisning.
Always take Cystadane exactly as your doctor has told you.
Den daglige dosis hos voksne og hos børn over 10 år er 6 g per dag delt på doser af 3 g to gange om dagen.
The daily dose in adults, adolescents and children over 10 years of age is 6 g per day divided in 2 doses of 3 g per day.
Hos børn under 10 år udregnes dosis ud fra barnets vægt af din læge.
In children less than 10 years of age, the daily dose will be calculated from the child’ s body weight by your doctor.
Du eller dit barn skal derfor have taget regelmæssige blodprøver for at bestemme den korrekte daglige dosis.
You or your child will therefore need regular blood tests to determine the correct daily dose.
Brugen af medicinen følges af en læge, der har erfaring med at behandle patienter med homocysteinuria.
The use of this medicine will be supervised by a physician experienced in the treatment of patients with homocystinuria.
Cystadane skal tages oralt (via munden).
Cystadane should be taken orally (by mouth).
Dosen bestemmes ved at: • Ryst flasken let før åbning, • Tag den korrekte måleske: o Den lille måleske svarer til 100 mg betain, vandfrit pulver o Den midterste måleske svarer til 150 mg betain, vandfrit pulver o Den store måleske svarer til betain, vandfrit pulver. • Tag en toppet måleskefuld fra flasken, • Stryg en glat overflade, fx kanten af en kniv henover kanten af måleskeen, • Det pulver, der er tilbage i måleskeen giver en skefuld • Tag det korrekte antal skefulde fra flasken.
the small spoon measures 100 mg of betaine anhydrous powder; the middle size spoon measures 150 mg of betaine anhydrous powder; the large spoon measures 1 g of betaine anhydrous powder.
Hvis du har glemt at tage Cystadane Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis
Do not take a double dose to make up for forgotten doses.
Cystadane kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Cystadane can cause side effects, although not everybody gets them.
Meget almindelig (≥1/ 10), almindelig (≥1/ 100 til, < 1/ 10), usædvanlig (≥1/ 1. 000 til, < 1/ 100), sjælden (≥1/ 10. 000 til, < 1/ 1. 000) og meget sjælden (< 1/ 10. 000).
The following side effects were reported as follows: very common (more than 1 out of 10 persons), common (more than 1 out of 100 persons and less than 1 out of 10 persons), uncommon (more than 1 out of 1,000 persons and less than 1 out of 100 persons), rare (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons), very rare (less than 1 out of 10,000 persons).
Blodets koncentration af methionin er øget.
Very common: blood methionine increased.
2), tandproblemer, diaré, betændelse af tungen, kvalme, ubehag i maven, opkastning, hårtab, nældefeber, unormal lugt fra huden og inkontinens.
17 Uncommon: decreased appetite, agitation, depression, irritability, personality disorder, sleep disturbance, oedema of the brain (see heading “Take special care with Cystadane” in section 2), dental disorders, diarrhoea, inflammation of the tongue, nausea, stomach discomfort, vomiting, hair loss, hives, skin odour abnormality and urinary incontinence.
Nogle af bivirkningerne er alvorlige, bed derfor din læge om at forklare dig advarselstegnene.
Since some of these side effects are serious, ask your doctor to explain their warning signs.
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
If any of the side effects gets serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
SÅDAN OPBEVARER DU CYSTADANE
HOW TO STORE CYSTADANE
Brug ikke Cystadane efter den udløbsdato, der står på pakningen.
Do not use Cystadane after the expiry date which is stated on the bottle label and the carton after EXP.
Må ikke opbevares over 25°C Hold flasken godt lukket for at beskytte imod fugt.
Keep the bottle tightly closed in order to protect from moisture.
Efter første åbning af flasken skal indholdet bruges i løbet af 1 måned.
After the first opening of the bottle, the product should be used within 1 month.
Spørg på apoteket hvordan du skal aflevere medicinrester.
Medicine should not be disposed of via wastewater or household waste.
Cystadane indeholder:
What Cystadane contains
- Det aktive stof er betain, vandfrit.
- The active substance is betaine anhydrous.
De tre
1 g of oral powder contains 1 g of betaine anhydrous.
måleskeer svarer til 1 g, 150 mg og 100 mg betain, vandfri.
Three measuring spoons dispense 1 g, 150 mg and 100 mg of betaine anhydrous.
Cystadanes udseende og pakningsstørrelse Cystadane er et hvidt krystallinsk oralt pulver.
What Cystadane looks like and contents of the pack Cystadane is a white crystalline oral powder.
Hver flaske indeholder 180 g betain, vandfrit pulver.
Each bottle contains 180 g of betaine anhydrous powder.
Tre måleskeer forefindes i hver pakning for at gøre det lettere for dig at opmåle den dosis din læge har udskrevet.
Three measuring spoons are enclosed in the carton to assist you in measuring out the dose prescribed by your doctor.
Indehaveren af markedsføringstilladelsen og fremstiller Orphan Europe SARL Immeuble “ Le Wilson ” F- 92058 Paris- La Défense Frankrig
Marketing Authorisation Holder and Manufacturer Orphan Europe SARL Immeuble “Le Wilson” F - 92058 Paris-La Défense France
18 Hvis du vil have yderligere oplysninger om Cystadane, skal du henvende dig til den lokale repræsentant:
18 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Tel: +34 93 342 51 20
Gran via de les Cortes Catalanes, 649 Despacho, n°1 E-08010 Barcelona Espanha Tel: +34 93 342 51 20
Hvad er CYSTAGON?
What is CYSTAGON?
CYSTAGON er et lægemiddel, som indeholder det aktive indholdsstof cysteamin.
CYSTAGON is a medicine containing the active ingredient cysteamine bitartrate (also known as mercaptamine bitartrate).
Hvad anvendes CYSTAGON til?
What is CYSTAGON used for?
CYSTAGON anvendes til behandling af patienter, som lider af nefropatisk cystinose, som er en sjælden arvelig sygdom, der kendetegnes ved, at der ophobes cystin i kroppens celler, hvilket forhindrer dem i at fungere rigtigt.
Cystinosis is a rare inherited disorder where cystine builds up within body cells, preventing them from working correctly.
Dette forårsager skade på nyrerne og spreder sig til andre dele af kroppen, herunder øjnene, visse kirtler (skjoldbugskirtel, kønskirtler, bugspytkirtel), det centrale nervesystem, musklerne og leveren.
This leads to kidney problems and spreads to other parts of the body, including the eyes, some glands (thyroid, gonads, pancreas), the central nervous system, muscles and the liver.
Hæmmet vækst er et symptom på sygdommen.
Stunted growth is a symptom of the condition.
Lægemidlet udleveres kun efter recept
The medicine can only be obtained with a prescription.
Hvordan anvendes CYSTAGON?
How is CYSTAGON used?
Behandling med CYSTAGON skal iværksættes under ledelse af en læge med erfaring i behandling af cystinose.
CYSTAGON treatment should be started by a doctor who has experience in the treatment of cystinosis.
Cystinniveauet i de hvide blodceller skal overvåges for at bestemme den nødvendige dosering.
Cystine levels in white blood cells should be monitored to adjust the dose.
For børn i alderen op til 12 år er den anbefalede dosis 1, 30 g/ m2/ dag fordelt på doser fire gange dagligt.
For children up to the age of 12 years, the recommended dose is 1.30 g/ m2/ day divided into 4 daily doses.
For patienter over 12 år og over 50 kg er den anbefalede mængde CYSTAGON 2 g/ dag, fordelt på doser fire gange dagligt.
For patients over the age of 12 and over 50 kg in weight, the recommended dose is 2 g/ day, divided into 4 daily doses.
Startdosis skal være 1/ 4 til 1/ 6 af den beregnede dosis og bør øges gradvist over 4- 6 uger
The starting dose should be increased gradually over 4-6 weeks.
Hvordan virker CYSTAGON?
How does CYSTAGON work?
Cysteamin reagerer med cystin og danner cystein og cystein- cysteaminsalt (blandet disulfid).
CYSTAGON reacts with cystine to form cysteine and a cysteine-cysteamine salt (mixed disulfide).
Dette salt fjernes fra cellerne af et system, som transporterer en anden aminosyre (lysin).
This salt is then removed from the cells by a system that transports another amino acid (lysine).
Mængden af cystin i organerne mindskes, og dette begrænser skaderne på organerne.
The amount of cystine in the organs is reduced and this limits the damage to these organs.
Hvordan blev CYSTAGON undersøgt?
How has CYSTAGON been studied?
CYSTAGON er blevet analyseret i tre kliniske undersøgelser af 234 patienter over en 12- årig periode.
CYSTAGON has been investigated in three clinical studies including 234 patients over a 12-year period.
Undersøgelserne omfattede børn og for nyligt indkaldte patienter, som modtog to forskellige doser.
These studies included children and newly recruited patients in whom two different doses were tested.
Da sygdommen er meget alvorlig, var det af etiske grunde ikke muligt at fortage en direkte sammenligning mellem CYSTAGON og en placebo- behandling.
Because the disease is very serious, it was not possible for ethical reasons to compare CYSTAGON directly to a dummy treatment.
Sammenligningen blev i stedet foretaget med en anden gruppe patienter, som havde modtaget en placebobehandling som del af en
The comparison was done instead with a group of
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(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged patients who had been treated with a dummy treatment as part of another, unrelated trial.
Undersøgelserne så på nyrefunktionen, overlevelsesprocenten og væksten hos patienterne.
The studies looked at the kidney function, the survival and the growth rate of the patients.
Hvilken fordel viser undersøgelserne, at der er ved CYSTAGON?
What benefit has CYSTAGON shown during the studies?
De tre undersøgelser viste, at CYSTAGON forsinker nyreproblemer og behovet for dialyse eller nyretransplantation, når behandlingen påbegyndes i en tidlig alder hos patienter med gode nyrefunktioner.
The three studies have shown that CYSTAGON delays kidney problems, and the need for dialysis or renal transplantation when treatment is started at an early age in patients with good kidney function.
Den forbedrer også overlevelsesprocenten og væksten hos patienter, der har modtaget behandling.
It also improves survival and growth rate in the children treated.
Hvilken risiko er der forbundet med CYSTAGON?
What is the risk associated with CYSTAGON?
Bivirkningerne af CYSTAGON er navnlig forbundet med fordøjelsessystemet.
The side effects of CYSTAGON are mainly connected with the digestive system.
De hyppigste bivirkninger (som ses hos flere end 1 ud af 10 patienter) er anoreksi (appetitløshed), opkastning, kvalme, diarré, apati (manglende energi) and pyrexia (feber).
The most common side effects (seen in more than 1 patient in 10) are anorexia (loss of appetite), vomiting, nausea (feeling sick), diarrhoea, lethargy (lack of energy) and pyrexia (fever).
Den fuldstændige liste over de indberettede bivirkninger ved CYSTAGON fremgår af indlægssedlen.
For the full list of all side effects reported with CYSTAGON, see the Package Leaflet.
CYSTAGON må ikke anvendes hos personer, som er overfølsomme (allergiske) over for cysteamin eller et af de øvrige indholdsstoffer eller penicillamin.
CYSTAGON should not be used in people who may be hypersensitive (allergic) to cysteamine or any of the other ingredients, or to penicillamine.
Det må desuden ikke anvendes til kvinder, der ammer, eller kvinder, der er eller kunne være gravide (navnlig i løbet af de første tre måneder), medmindre det er strengt nødvendigt.
It should also not be used in women who are breast- feeding, or who are or may be pregnant (particularly during the first three months) unless it is clearly necessary.
Hvorfor blev CYSTAGON godkendt?
Why has CYSTAGON been approved?
Cystanose er en sjælden og livstruende sygdom, og CYSTAGON anses for at være et anvendeligt lægemiddel uden nogen alternativ behandling.
Cystinosis is a rare, fatal disease, and CYSTAGON is considered a useful medicine for this disease, for which no alternative treatments are available.
Udvalget for humanmedicinske lægemidler (CHMP) besluttede, at fordelene ved CYSTAGON var større end risiciene og anbefalede derfor udstedelse af en markedsføringstilladelse for CYSTAGON.
The Committee for Medicinal products for Human Use (CHMP) decided that CYSTAGON’ s benefits are greater than its risks and recommended that CYSTAGON be given marketing authorisation.
CYSTAGON blev oprindeligt godkendt under ” særlige omstændigheder ”, da der på godkendelsestidspunktet kun forelå sparsomme oplysninger som følge af sygdommens sjældenhed.
CYSTAGON was originally authorised under "Exceptional Circumstances", because, as the disease is rare, limited information was available at the time of approval.
Efter at firmaet havde forelagt de supplerende oplysninger, det var blevet anmodet om, blev de "særlige omstændigheder" ophævet den 17. april 2007.
As the company had supplied the additional information requested, the "Exceptional Circumstances" ended on 17 April 2007.
Andre oplysninger om CYSTAGON:
Other information about CYSTAGON:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union til Orphan Europe den 23. juni 1997.
The European Commission granted a marketing authorisation valid throughout the European Union for CYSTAGON to Orphan Europe on 23 June 1997.
Tilladelsen blev fornyet den 23. juni 2002 og den 23. juni 2007.
The marketing authorisation was renewed on 23 June 2002 and on 23 June 2007.
Den fuldstændige EPAR for CYSTAGON kan ses her.
The full EPAR for CYSTAGON can be found here.
Hver hård kapsel indeholder 50 mg cysteamin (som mercaptamin bitartrat).
Each hard capsule contains 50 mg of cysteamine (as mercaptamine bitartrate).
4. 1 Terapeutiske indikationer
4.1 Therapeutic indication
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.
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.
Det er behandlingens mål at holde leukocyt cystin niveauerne under 1 nmol hemicystin/ mg protein.
The goal of therapy is to keep leucocyte cystine levels below 1 nmol hemicystine/ mg protein.
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.
• For børn i alderen op til 12 år bør CYSTAGON dosis være baseret på overfladearealet (g/ m2/ dag).
• For children up to age 12 years, CYSTAGON dosing should be on the basis of body surface area (g/ m2/ day).
Den anbefalede dosis er 1, 30 g/ m2/ dag af den frie base fordelt fire gange dagligt. • For patienter over 12 år og over 50 kg er den anbefalede mængde CYSTAGON 2 g/ dag, fordelt på fire doser.
The recommended dose is 1.30 g/ m2/ day of the free base divided four times daily. • For patients over age 12 and over 50 kg weight, the recommended CYSTAGON dose is 2 g/ day, divided four times daily.
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 4- 6 weeks to avoid intolerance.
Doseringen bør øges, hvis der er tilstrækkelig tolerance og leukocyt cystin niveauet forbliver > 1nmol hemicystin/ mg protein.
The dose should be raised if there is adequate tolerance and the leucocyte cystine level remains > 1 nmol hemicystine/ mg protein.
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.
4. 4).
The use of doses higher than 1.95 g/ m2/ day is not recommended (see section 4.4).
6 år og yngre, som ikke kan sluge hårde kapsler, kan kapslerne åbnes og indeholder drysses på mad.
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.
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.
2 Erfaring har sommetider vist, at andre former af cysteamin tolereres dårligere (dvs. fører til flere bivirkninger) af patienter i dialyse.
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.
Anvendelsen af CYSTAGON er kontraindikeret i forbindelse med amning.
Hypersensitivity to the active substance or to any of the excipients The use of CYSTAGON is contra-indicated during breast-feeding.
5. 3), da det er teratogent i dyr.
CYSTAGON should not be used during pregnancy, particularly during the first trimester, unless clearly necessary (see section 4.6 and section 5.3 as it is teratogenic in animals.
Der har været rapporteret enkelte tilfælde, der minder om Ehlers- Danlos syndrom 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.
A few cases of Ehlers-Danlos like syndrome 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.
Disse hudlæsioner har været associeret med striae i huden og knoglelæsioner set ved røntgen.
These skin lesions were associated with skin striae and bone lesions first seen during an X-ray examination.
4. 2 og 4. 8).
The use of doses higher than 1.95g/ m2/ day is not recommended (see sections 4.2 and 4.8).
4. 2).
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).
CYSTAGON kan gives sammen med de elektrolyt - og mineraltilskud, som er nødvendige til behandling af Fanconi syndrom, ligesåvel som det kan gives sammen med D- vitamin og thyroidhormoner.
No interaction studies have been performed CYSTAGON can be administered with electrolyte and mineral replacements necessary for management of the Fanconi syndrome as well as vitamin D and thyroid hormones.
5. 3).
Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3).
5. 3), er amning imidlertid kontraindikeret hos kvinder, der får CYSTAGON.
However, due to the results of animal studies in breast-feeding mothers and neonates (see section 5.3), breast-feeding is contraindicated in women taking CYSTAGON.
Cirka 35% af patienterne kan forvente at opleve bivirkninger.
Approximately 35% of patients can be expected to experience adverse reactions.
Rapporterede bivirkninger er angivet nedenfor, efter system- organklasse og efter frekvens.
Reported adverse reactions are listed below, by system organ class and by frequency.
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).
Undersøgelser Almindelige:
Investigations Blood and lymphatic system disorders Nervous system disorders
Leverfunktionstests abnorme Forstyrrelser i blod - og lymfesystemet Usædvanlige:
Liver function tests abnormal Uncommon:
Leukopeni Forstyrrelser i nervesystemet Almindelige:
Headache, encephalopathy Uncommon:
Hovedpine, encefalopati Usædvanlige:
Gastrointestinal disorders
Somnolens, kramper Gastrointestinale forstyrrelser Meget almindelige:
Very common:
Opkastning, kvalme, diarre Almindelige:
Vomiting, nausea, diarrhoea Common:
Abdominalsmerter, dårlig ånde, dyspepsi, gastroenteritis Usædvanlige:
Gastrointestinal ulcer
Gastrointestinalt ulcus Lidelser i nyrer og urinveje Usædvanlige:
Renal and urinary disorders Skin and subcutaneous tissue disorders
Nefrotisk syndrom Lidelser i hud og subkutant væv Almindelige:
Nephrotic syndrome Common:
Unormal hudlugt, udslæt Usædvanlige:
Skin odour abnormal, rash Uncommon:
Ændringer i hårfarve, striae i huden, skrøbelig hud (molluscoid pseudotumorer på albuerne) Sygdomme i bevægeapparatet og bindevæv Forstyrrelser i metabolisme og ernæring
Hair colour changes, skin striae, skin fragility (molluscoid pseudotumor on elbows)
Usædvanlige: led hyperekstension, smerter i benene, genu valgum (kalveknæ), osteopeni, kompressionsbrud, skoliose Meget almindelige:
Very common:
4 Almene forstyrrelser og tilstande ved administrationsstedet Forstyrrelser i immunsystemet Psykiatriske forstyrrelser
General disorders and administration site conditions Immune system disorders Psychiatric disorders
Meget almindelige: Lethargi, pyrexi Almindelige:
Lethargy, pyrexia Common:
Asteni Usædvanlige:
Asthenia Uncommon:
Anafylaktisk reaktion Usædvanlige:
Anaphylactic reaction Uncommon:
Nervøsitet, hallucinationer
Nervousness, hallucination