FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestinal disorders
Danish: Gastrointestinale risici
English: Cysteamine bitartrate can be administered with an acidic fruit juice or water.
Danish: Cysteaminbitratrat kan administreres sammen med en syrlig frugtjuice eller vand.
English: The mixture should then be administered via gastrostomy tube, nasogastric tube or gastrostomy-jejunostomy tube.
Danish: Blandingen gives derefter gennem gastrostomisonde, nasogastrisk sonde eller gastrostomi-jejunostomi-sonde.
English: Therefore, healthcare professionals should refer to the assay-specific therapeutic targets provided by individual testing laboratories.
Danish: Derfor skal læger og sundhedspersonale referere til analysespecifikke behandlingsmål fra de individuelle testlaboratorier.
English: Sprinkling in orange juice or any acidic fruit juice or water Capsules for either the morning or evening dose should be opened and the contents sprinkled into 100 to 150 mL of acidic fruit juice or water.
Danish: Indtagelse sammen med appelsinjuice eller anden sur frugtjuice eller vand Kapslerne til den pågældende morgen- eller aftendosis åbnes, og indholdet drysses i 100-150 ml sur frugtjuice eller vand.
English: The targeted maintenance dose is 1.3 g/m2/day, in two divided doses, given every 12 hours.
Danish: Den tilsigtede vedligeholdelsesdosis er 1,3 g/m2/dag, fordelt på to doser med 12 timers mellemrum.
English: Sprinkling on food
Danish: Indtagelse ved drysning på maden
English: For patients who cannot swallow the whole capsule, the gastro-resistant hard capsule may be opened and the contents may be sprinkled on food (such as apple sauce or berry jelly) or mixed in with an acidic drink (such as orange juice or any acidic juice) or water.
Danish: Til patienter, der ikke kan synke hele kapsler, kan enterokapslerne åbnes, og indholdet drysses over maden (æblemos eller bærgelé) eller blandes i en sur drik (appelsinjuice eller anden sur juice) eller vand.
English: A few cases of Ehlers-Danlos-like syndrome 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 indberettet enkelte tilfælde, der minder om Ehlers-Danlos syndrom, på albuerne af børn i kronisk behandling med høje doser af forskellige cysteaminformuleringer (cysteaminhydrochlorid, cysteamin eller cysteaminbitartrat), hovedsageligt i højere dosis end den maksimale dosis på 1,95 g/m2/dag.
English: Should overdosing occur, the respiratory and cardiovascular systems should be supported appropriately.
Danish: Ved en eventuel overdosering bør der gives passende støttende behandling til opretholdelse af respiration og kredsløb.
English: * measured using the mixed leukocyte assay
Danish: * målt med den blandede leukocytanalyse
English: The other side effects listed below are given with an estimation of the frequency with which they may occur with PROCYSBI.
Danish: De øvrige bivirkninger med PROCYSBI er anført nedenfor sammen med et skøn over deres hyppighed.
English: The determination of WBC cystine and/or plasma cysteamine must be obtained 12.5 hours after the evening dose the day before, and therefore 30 minutes after the following morning dose is given.
Danish: Bestemmelsen af cystin i leukocytter og/eller cysteamin i plasma skal ske 12,5 timer efter den foregående aftendosis, dvs. 30 minutter efter den påfølgende morgendosis.
English: For at least 1 hour before and 1 hour after taking PROCYSBI try to avoid meals, which are rich in fat or proteins as well as any food or liquid that could decrease the acidity in your stomach, like milk or yogurt.
Danish: Brug af PROCYSBI sammen med mad og drikke Du skal forsøge at undgå måltider med højt indhold af fedt eller proteiner i mindst 1 time før og 1 time efter, du tager PROCYSBI, samt madvarer eller væsker, der kan sænke syreindholdet i maven, som f.eks. mælk eller yoghurt.
English: Tell your doctor right away if you get stomach ache, nausea, vomiting, loss of appetite, or throw up blood.
Danish: Fortæl det straks til lægen, hvis du får mavesmerter, kvalme, opkastning, appetitløshed eller blodigt opkast.
English: A closer monitoring of the WBC cystine levels is recommended in these patients.
Danish: Hos disse patienter anbefales tættere overvågning af leukocytternes cystinniveau.
English: Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) was first described in cystic fibrosis patients who were given high doses of pancreatic enzymes in the form of tablets with an enteric coating of methacrylic acid - ethyl acrylate copolymer (1:1), one of the excipients in PROCYSBI.
Danish: Strikturer på ileocøkum og colon (fibroserende colonsygdom) blev først beskrevet hos patienter med cystisk fibrose, der fik høje doser af pankreasenzymer som tabletter med enterocoating af methacrylsyre-ethylacrylat copolymer (1:1), der er et af hjælpestofferne i PROCYSBI.
English: Uncommon: Nervousness, hallucination Common: Headache, encephalopathy
Danish: Ikke almindelig: Nervøsitet, hallucinationer Almindelig: Hovedpine, encefalopati
English: If this is not possible, you can eat a small amount (about 100 grams) of food (preferably carbohydrates e.g. bread, pasta, fruits) during the hour before and after taking PROCYSBI.
Danish: Hvis dette ikke er muligt, kan du spise et lille måltid (ca. 100 g, fortrinsvis kulhydrater, f.eks. brød, pasta, frugt) i tidsrummet fra en time før til en time efter indtagelse af PROCYSBI.
English: You will receive regular eye examinations to identify this condition as early treatment can prevent vision loss.
Danish: Du vil regelmæssigt få undersøgt øjnene med henblik på denne tilstand, da rettidig behandling kan forebygge synstab.
English: Dosing schedule
Danish: Dosisplan
English: PROCYSBI 75 mg hard capsule EU/1/13/861/002
Danish: PROCYSBI 75 mg hård kapsel EU/1/13/861/002
English: EXP Discard 30 days after opening the foil seal.
Danish: EXP Skal kasseres 30 dage efter anbrud af folielukningen.
English: Uncommon: Somnolence, convulsions Very common: Vomiting, nausea, diarrhoea Common: Abdominal pain, breath odour, dyspepsia, gastroenteritis
Danish: Ikke almindelig: Somnolens, kramper Meget almindelig: Opkastning, kvalme, diarré Almindelig: Abdominalsmerter, dårlig ånde, dyspepsi, gastroenteritis
English: An overdose of cysteamine may cause progressive lethargy.
Danish: Overdosering med cysteamin kan medføre tiltagende letargi.
English: Cysteamine bitartrate is not an inhibitor of OAT1, OAT3 and OCT2.
Danish: Cysteaminbitartrat hæmmer ikke OAT1, OAT3 eller OCT2.
English: For the immediate-release formulation of cysteamine bitartrate, approximately 35% of patients can be expected to experience adverse reactions.
Danish: Cysteaminbitartrat i formuleringen med hurtig udløsning forventes at give bivirkninger hos ca. 35 % af patienterne.
English: •The need to advise patients about: The method of administration and timing of medicine intake The need to contact the treating physician if they experience the following events: Problems or changes with their skin Upset in their normal bowel habit, Lethargy, somnolence depression, fits Any suspicion that they might be pregnant
Danish: •Behovet for at instruere patienten om: indtagelsesmåde og tidspunkt for indtagelse af lægemidlet, at patienten skal kontakte lægen: ved hudproblemer eller hudforandringer ved forstyrrelser i afføringsvanerne ved sløvhed, øget søvnbehov, depression eller krampeanfald ved enhver mistanke om at være gravid
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 (see section 4.6).
Danish: Hvis der konstateres eller planlægges graviditet, bør behandlingen tages op til nøje overvejelse, og patienten skal oplyses om den teratogene risiko ved cysteamin (se pkt.
English: Uncommon: Nephrotic syndrome Very common: Lethargy, pyrexia
Danish: Hyppighed: bivirkning Meget almindelig: Letargi, pyreksi
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: Der er beskrevet teratogene virkninger hos rotter ved indgift af cysteamin i en dosis på 100 mg/kg/dag i hele organogeneseperioden.
English: Histology showed a membranous glomerulonephritis of the renal allograft in one case and hypersensitivity interstitial nephritis in the other.
Danish: Histologisk sås i det ene tilfælde membranøs glomerulonefritis af det renale allotransplantat, og i det andet interstitiel nefritis som følge af hypersensitivitet.
English: Oral cysteamine has not been shown to prevent eye deposition of cystine crystals.
Danish: Det er ikke påvist, at oral indtagelse af cysteamin forhindrer aflejringer af cystinkrystaller i øjet.
English: INFORMATION IN BRAILLE PROCYSBI 25 mg
Danish: INFORMATION I BRAILLESKRIFT PROCYSBI 25 mg
English: It cannot be excluded that cysteamine is a clinically relevant inducer of CYP enzymes, inhibitor of P-gp and BCRP at the intestinal level and inhibitor of liver uptake transporters (OATP1B1, OATP1B3 and OCT1).
Danish: Det kan ikke udelukkes, at cysteamin medfører klinisk relevant induktion af CYP-enzymer, hæmning af P-gp og BCRP i tarmen og hæmning af transportproteiner for optagelse i leveren (OATP1B1, OATP1B3 and OCT1).
English: PROCYSBI 25 mg hard capsule EU/1/13/861/001
Danish: PROCYSBI 25 mg hård kapsel EU/1/13/861/001
English: In clinical studies comparing PROCYSBI to the immediate-release cysteamine bitartrate, one third of the patients exhibited very common GI disorders (nausea, vomiting, abdominal pain).
Danish: Erfaringer fra kliniske undersøgelser med PROCYSBI I kliniske undersøgelser, der sammenlignede PROCYSBI med cysteaminbitartrat med hurtig udløsning, fik en tredjedel af patienterne meget hyppige gastrointestinale forstyrrelser (kvalme, opkastning, abdominalsmerter).
English: In vitro: Cysteamine bitartrate is a substrate of P-gp and OCT2, but not a substrate of BCRP, OATP1B1, OATP1B3, OAT1, OAT3 and OCT1.
Danish: In vitro: Cysteaminbitartrat er et substrat for P-gp og OCT2, men ikke for BCRP, OATP1B1, OATP1B3, OAT1, OAT3 eller OCT1.
English: A pivotal phase 3 randomized, crossover PK and PD study (which was also the first ever randomized study with immediate-release cysteamine bitartrate) demonstrated that at steady-state, patients receiving PROCYSBI every 12 hours (Q12H) maintained a comparable depletion of WBC cystine levels compared to immediate-release cysteamine bitartrate every 6 hours (Q6H).
Danish: En randomiseret farmakokinetisk og farmakodynamisk afgørende fase 3-PK og PD overkrydsningsundersøgelse (som også var den første randomiserede undersøgelse nogensinde med cysteaminbitartrat med hurtig udløsning) viste, at patienter i steady-state behandling med PROCYSBI hver 12. time (Q12H) vedvarende var relativt depleteret for cystin i leukocytterne i forhold til cysteaminbitartrat med hurtig udløsning hver 6. time (Q6H).
English: The adverse reactions profile for healthy subjects was similar to the adverse reactions profile in patients relative to GI disorders (diarrhoea and abdominal pain).
Danish: Hos raske forsøgspersoner var bivirkningsprofilen den samme som hos patienter hvad angår gastrointestinale forstyrrelser (diarré og abdominalsmerter).
English: White blood cell (WBC) cystine concentration may for instance be measured by a number of different techniques such as specific WBC subsets (e.g., granulocyte assay) or the mixed leukocyte assay with each assay having different target values.
Danish: Cystinkoncentrationen i leukocytterne kan for eksempel måles ved flere forskellige teknikker, såsom specifikke undergrupper af leukocytter (f.eks. granulocytanalyse) eller den blandede leukocytanalyse, hvor hver analyse har forskellige målværdier.
English: PROCYSBI is indicated for the treatment of proven nephropathic cystinosis.
Danish: PROCYSBI er indiceret til behandling af bevist nefropatisk cystinose.
English: In this study, the WBC cystine measured using the mixed leukocyte assay was always on average under optimal control at < 1 nmol hemicystine/mg protein.
Danish: I denne undersøgelse var leukocytternes cystinindhold, målt med den blandede leukocytanalyse, altid i gennemsnit under optimal kontrol med < 1 nmol hemicystin/mg protein.
English: Transferring patients from immediate-release cysteamine bitartrate hard capsules Patients with cystinosis taking immediate-release cysteamine bitartrate may be transferred to a total daily dose of PROCYSBI equal to their previous total daily dose of immediate-release cysteamine bitartrate.
Danish: Skift fra cysteaminbitartrat, hårde kapsler, med hurtig udløsning Patienter med cystinose, der er i behandling med cysteaminbitartrat med hurtig udløsning, kan skifte til en samlet daglig dosis af PROCYSBI, der svarer til den tidligere samlede daglige dosis af cysteaminbitartrat med hurtig udløsning.
English: The maximum recommended dose of cysteamine is 1.95 g/m2/day.
Danish: Den anbefalede maksimale dosis af cysteamin er 1,95 g/m2/dag.
English: Forty-three (43) patients were randomized; twenty-seven (27) children (ages 6 to 12 years old), fifteen (15) adolescents (ages 12 to 21 years old) and one (1) adult with cystinosis and with native kidney function based on an estimated Glomerular Filtration Rate (GFR) (corrected for body surface area) > 30 mL/minute/1.73 m2
Danish: Der blev randomiseret 43 patienter: 27 børn i alderen 6-12 år, 15 unge voksne i alderen 12-21 år og 1 voksen med cystinose og med nativ nyrefunktion baseret på en skønnet glomerulær filtrationshastighed (GFR) (korrigeret for kropsoverfladeareal) > 30 ml/minut/1,73 m2. Af disse 43 patienter udgik 2 søskende i slutningen af den første overkrydsningsperiode, den ene på grund af en planlagt operation; 41 patienter gennemførte protokollen.
English: In cases of patients with kidney transplants, anti-rejection treatments have been used with cysteamine.
Danish: Hos nyretransplanterede patienter er afstødningshindrende medicin blevet anvendt sammen med cysteamin.
English: Physicians should instruct patients to report any of the following symptoms: headache, tinnitus, dizziness, nausea, diplopia, blurred vision, loss of vision, pain behind the eye or pain with eye movement.
Danish: Patienten bør instrueres om at fortælle om ethvert af følgende symptomer: hovedpine, tinnitus, svimmelhed, kvalme, diplopi, sløret syn, synstab, smerter bag øjnene og smerter ved øjenbevægelser.
English: Drink the mixture of cysteamine granules and acidic fruit juice or water.
Danish: Blandingen af korn af cysteamin og sur frugt juice eller vand drikkes.
English: INFORMATION IN BRAILLE PROCYSBI 75 mg
Danish: INFORMATION I BRAILLESKRIFT PROCYSBI 75 mg
English: Azoospermia has been reported in male cystinosis patients.
Danish: Azoospermi er beskrevet hos mandlige patienter med cystinose.
English: In vitro data suggests that cysteamine bitartrate is likely to be metabolized by multiple CYP enzymes, including CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.
Danish: In vitro-data tyder på, at cysteaminbitartrat metaboliseres af en række forskellige CYP-enzymer, herunder CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP2E1.
English: Patients should try to consistently avoid meals and dairy products for at least 1 hour before and 1 hour after PROCYSBI dosing.
Danish: Måltider og mejeriprodukter bør konsekvent undgås i mindst 1 time før og 1 time efter doseringen med PROCYSBI.
English: Take the capsule with an acidic drink (such as orange juice or any acidic juice) or water.
Danish: Tag kapslen med en sur drik (appelsinjuice eller anden syrlig juice) eller vand.
English: Common side effects: unpleasant breath and body odour heartburn tiredness
Danish: Almindelige bivirkninger: dårlig ånde og kropslugt halsbrand træthed
English: The targeted maintenance dose is 1.3 g/m2/day.
Danish: Den normale vedligeholdelsesdosis er 1,3 g/m2/dag.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION PROCYSBI 25 mg hard capsule
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING PROCYSBI 25 mg hård kapsel
English: What you need to know before you take PROCYSBI
Danish: Det skal du vide, før du begynder at tage PROCYSBI
English: Two (2) patients were excluded from the per-protocol analysis because their WBC cystine level increased over 2 nmol hemicystine/mg protein during the immediate-release cysteamine treatment period.
Danish: 2 patienter blev udelukket fra pr.-protokol analysen, da deres cystinindhold i leukocytterne steg til over 2 nmol hemicystin/mg protein i perioden med behandling med cysteamin med hurtig udløsning.
English: The active substance is cysteamine (as mercaptamine bitartrate).
Danish: Aktivt stof: cysteamin (som mercaptaminbitartrat).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/861/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/861/001
English: 50 mL white HDPE bottle containing 60 capsules with one 2-in-1 desiccant cylinder and one oxygen absorber cylinder, with a child resistant polypropylene closure.
Danish: 50 ml hvid HDPE-flaske indeholdende 60 kapsler med én to-i-en cylinder med tørremiddel og én iltabsorberende cylinder; børnesikret lukke af polypropylen.
English: The target values provided in the SmPC are obtained from using the mixed leucocyte assay.
Danish: Målværdierne angivet i produktresuméet er fastlagt med den blandede leukocytanalyse.
English: WBC cystine is monitored in these patients to determine adequacy of dosing, levels being measured 30 minutes after dosing when treated with PROCYSBI.
Danish: Hos sådanne patienter overvåges leukocytternes cystinindhold for at bestemme doseringens egnethed, idet målingen finder sted 30 minutter efter doseringen med PROCYSBI.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/861/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/861/002
English: The mixture must be administered (drunk) within 30 minutes after preparation and must be refrigerated from the time of preparation to the time of administration.
Danish: Blandingen skal indgives (drikkes) senest 30 minutter efter tilberedning, og opbevares nedkølet fra tilberedningen til indtagelsen.
English: Cysteamine bitartrate is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4 in vitro.
Danish: Cysteaminbitartrat hæmmer ikke CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 eller CYP3A4 in vitro.
English: Common nervous system disorders (headache, somnolence and lethargy) and common general disorders (asthenia) were also seen.
Danish: Desuden sås hyppige symptomer fra nervesystemet (hovedpine, somnolens, letargi) og hyppige generaliserede symptomer (asteni).
English: Cysteamine excretion in human milk is unknown.
Danish: Det er ukendt, om cysteamin udskilles i human mælk.
English: Post-marketing experience with immediate-release cysteamine bitartrate Benign intracranial hypertension (or pseudotumor cerebri (PTC)) with papilledema; skin lesions, molluscoid pseudotumors, skin striae, skin fragility; joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture and scoliosis have been reported with immediate-release cysteamine bitartrate (see section 4.4).
Danish: Erfaringer efter markedsføring med cysteaminbitartrat med hurtig udløsning I forbindelse med cysteaminbitartrat med hurtig udløsning er indberettet benign intrakraniel hypertension (eller pseudotumor cerebri) med papilødem, hudlæsioner, molluskoide pseudotumorer, striae i huden, skrøbelig hud, hyperekstension af led, smerter i benene, genu valgum, osteopeni, kompressionsfrakturer og skoliose (se pkt.
English: Indomethacin and cysteamine have been used simultaneously in some patients.
Danish: Indometacin er hos nogle patienter blevet anvendt samtidig med cysteamin.
English: It is not known if cysteamine is removed by haemodialysis.
Danish: Det er ukendt, om cysteamin fjernes ved hæmodialyse.
English: When these reactions appear at the initiation of cysteamine therapy, temporary suspension and gradual reintroduction of treatment may be effective in improving tolerance.
Danish: Ved optræden af sådanne bivirkninger efter initiering af behandlingen med cysteamin kan der opnås bedre tolerabilitet ved midlertidig seponering og gradvis genoptagelse af behandlingen.
English: There have been reports of benign intracranial hypertension (or pseudotumor cerebri (PTC)) and/or papilledema associated with cysteamine bitartrate treatment that has resolved with the addition of diuretic therapy (post-marketing experience with the immediate-release cysteamine bitartrate).
Danish: Ved behandling med cysteaminbitartrat er indberettet benign intrakraniel hypertension (eller pseudotumor cerebri) og/eller papilødem, der svandt ved tilføjelse af diuretikabehandling (erfaringer efter markedsføring med cysteaminbitartrat med hurtig udløsning).
English: Tell your doctor right away if you develop any of the following symptoms while taking PROCYSBI: headache, buzzing or "whooshing" sound in the ear, dizziness, nausea, double vision, blurry vision, loss of vision, pain behind the eye or pain with eye movement.
Danish: Sig det straks til lægen, hvis du får nogen af følgende symptomer, når du tager PROCYSBI: hovedpine, summen eller susen for ørerne, svimmelhed, kvalme, dobbeltsyn, sløret syn, synstab, smerte bag øjnene eller smerte ved øjenbevægelser.
English: The total usual dose should not exceed 1.95 g/m2/day.
Danish: Den samlede dosis må normalt ikke være over 1,95 g/m2/dag.
English: The mixture must be administered within 2 hours after preparation and may be refrigerated from the time of preparation to the time of administration.
Danish: Blandingen skal administreres senest 2 timer efter tilberedningen og kan opbevares nedkølet fra tilberedningen til indtagelsen.
English: However, if it is within 4 hours of the next dose, skip the missed dose and go back to the regular dosing schedule.
Danish: Hvis der er mindre end 4 timer til næste dosis, skal patienten dog overspringe den glemte dosis og fortsætte efter den faste doseringsplan.
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: Hos dialysepatienter har visse former for cysteamin undertiden været dårligere tolereret (medfører flere bivirkninger).
English: The other ingredients are: o In the capsules: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer
Danish: Øvrige indholdsstoffer: o I kapslerne: mikrokrystallinsk cellulose, methacrylsyre-ethylacrylat copolymer (1:1),
English: (1:1), hypromellose, talc, triethyl citrate, sodium lauryl sulfate.
Danish: hypromellose, talcum, triethylcitrat, natriumlaurilsulfat.
English: Cysteamine therapy should be initiated promptly after confirmation of the diagnosis of cystinosis to achieve maximum benefit.
Danish: Behandlingen med cysteamin skal påbegyndes straks efter bekræftelse af diagnosen nefropatisk cystinose for at patienten skal få størst mulig fordel af behandlingen.
English: Capsules for either the morning or evening dose should be opened and the contents sprinkled onto approximately 100 grams of apple sauce or berry jelly.
Danish: Kapslerne til morgen- eller aftendosis åbnes, og indholdet drysses på ca. 100 gram æblemos eller frugtgelé.
English: The dose should be raised if there is adequate tolerance and the WBC cystine level remains > 1 nmol hemicystine/mg protein (when measured using the mixed leukocyte assay).
Danish: Dosis bør øges, hvis der er tilstrækkelig tolerance, og leukocytternes cystinindhold forbliver > 1 nmol hemicystin/mg protein (målt med den blandede leukocytanalyse).
English: Patients with renal impairment Dose adjustment is not normally required; however, WBC cystine levels should be monitored.
Danish: Patienter med nedsat nyrefunktion Normalt er dosisjustering ikke nødvendig, men leukocytternes cystinniveau bør følges.
English: If the rash is severe, your doctor may discontinue cysteamine treatment.
Danish: Hvis udslættet er af svær grad, skal behandlingen med cysteamin standses.