FrancophonIA/ELRC3.0 huggingface dataset:
English: A white plastic bottle contains 250 capsules.
Danish: En hvid plastikflaske indeholder 250 kapsler.
English: - Your medical treatment may include, in addition to cysteamine, one or more supplements to replace important electrolytes lost through the kidneys.
Danish: - Foruden cysteamin kan behandlingen bestå i et eller flere kosttilskud som erstatning for vigtige elektrolytter, der tabes gennem nyrerne.
English: Your doctor will routinely monitor your blood counts and liver function.
Danish: Lægen vil rutinemæssigt overvåge dine blodtal og din leverfunktion.
English: If any of the following side effects occur, please contact your doctor immediately.
Danish: Hvis nogen af nedenstående bivirkninger optræder, skal du straks kontakte lægen.
English: This is a condition where there is high pressure in the fluid around the brain.
Danish: Ved denne tilstand er der forhøjet tryk i den væske, der omgiver hjernen.
English: Cysteamine has occasionally been associated with reversible leukopenia and abnormal liver function.
Danish: Cysteamin er undertiden blevet sat i forbindelse med reversibel leukopeni og abnorm leverfunktion.
English: If you missed a dose of medicine, you should take it as soon as possible.
Danish: Hvis du har glemt at tage en dosis af lægemidlet, skal du tage den snarest muligt.
English: A reduction of fertility was observed in rats at 375 mg/kg/day, a dose at which body weight gain was retarded.
Danish: Der sås nedsat fertilitet hos rotter ved 375 mg/kg/dag, en dosis, der forsinkede væksten i kropsvægt.
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: Udskillelsen af uændret cysteamin i urinen er påvist at være mellem 0,3 % og 1,7 % af den totale daglige dosis, baseret på data fra fire patienter; cysteamin udskilles hovedsagelig som sulfat.
English: Uncommon: Leukopenia
Danish: Ikke almindelig: Leukopeni
English: Treatment effect (LS mean ± SE; 95.8% CI; p-value)
Danish: Behandlingseffekt (mindste kvadraters gennemsnit ± standardfejl; 95,8 % SI; p-værdi)
English: Marketing Authorisation Holder Chiesi Farmaceutici S.p.A.
Danish: Indehaver af markedsføringstilladelsen Chiesi Farmaceutici S.p.A.
English: In some cases, these skin lesions were associated with skin striae and bone lesions first seen during an X-ray examination.
Danish: Disse hudlæsioner har i visse tilfælde været forbundet med striae i huden og knogleforandringer, der først blev opdaget ved røntgenundersøgelse.
English: If you are a woman planning a pregnancy or become pregnant, seek immediate advice from your doctor about stopping therapy with this medicine as continued treatment may be harmful to the unborn baby.
Danish: Hvis du er en kvinde, der planlægger graviditet eller bliver gravid, skal du straks tale med lægen om at stoppe med behandlingen med dette lægemiddel, da det kan skade det ufødte barn at fortsætte behandlingen.
English: Physicians should remain alert for signs of ulceration and bleeding and should inform patients and/or guardians about the signs and symptoms of serious GI toxicity and what steps to take if they occur.
Danish: Lægen bør være opmærksom på tegn på ulceration og blødning og bør oplyse patienter og/eller omsorgsgivere om tegnene og symptomerne på alvorlig gastrointestinal toksicitet og om, hvad de skal gøre, hvis de iagttager dem.
English: The targeted maintenance dose of 1.3 g/m2/day can be approximated according to the following table, which takes surface area as well as weight into consideration.
Danish: Den tilsigtede vedligeholdelsesdosis på 1,3 g/m2/dag kan tilnærmes ved hjælp af nedenstående tabel, der både tager hensyn til overfladeareal og vægt
English: Do not give gastro-resistant hard capsules to children under 6 years of age because they may not be able to swallow them and they may choke.
Danish: Giv ikke enterokapsler til børn under 6 år, da de kan have svært ved at synke dem og kan få dem galt i halsen.
English: Two cases of nephrotic syndrome have been reported within 6 months of starting therapy with progressive recovery after treatment discontinuation.
Danish: Der er indberettet to tilfælde af nefrotisk syndrom, der opstod inden for 6 måneder efter initiering af behandlingen og gradvis bedredes efter seponering.
English: This is equivalent to 0.6 g/m2/day in the rat, which is slightly less than the recommended clinical maintenance dose of cysteamine, i.e. 1.3 g/m2/day.
Danish: Dette svarer til 0,6 g/m2/dag hos rotten, hvilket er lidt under det halve af den anbefalede kliniske vedligeholdelsesdosis af cysteamin, dvs. 1,3 g/m2/dag.
English: Warnings and precautions Talk to your doctor or pharmacist before taking PROCYSBI.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager PROCYSBI.
English: After opening do not store above 25°C.
Danish: Må ikke opbevares over 25 °C efter åbning.
English: Therefore, where cysteamine ophthalmic solution is used for that purpose, its usage should continue.
Danish: Når cysteamin-øjendråber anvendes til dette formål, bør behandlingen derfor fortsætte.
English: Different organs are affected at different ages.
Danish: Sygdommen rammer forskellige organer afhængigt af patientens alder.
English: It should be noted that therapeutic targets for cystine depletion are assay-specific and different assays have specific treatment targets.
Danish: Det bør bemærkes, at behandlingsmål for cystindepletion er analysespecifikke, og forskellige analyser har specifikke behandlingsmål.
English: Talk to your doctor if you have any unusual stomach symptoms or changes in stomach symptoms.
Danish: Fortæl det til lægen, hvis du får usædvanlige eller ændrede symptomer fra maven.
English: Cysteamine may cause drowsiness.
Danish: Cysteamin kan forårsage sløvhed.
English: Patients should not engage in potentially hazardous activities until the effects of cysteamine on mental performance are known (see section 4.7).
Danish: Patienterne bør undgå potentielt farlige aktiviteter, indtil virkningerne af cysteamin på deres mentale funktion kendes (se pkt.
English: PROCYSBI may need to be temporarily stopped until the rash goes away.
Danish: Det kan være nødvendigt at stoppe med PROCYSBI midlertidigt, til udslættet er svundet.
English: Do not use this medicine after the expiry date, which is stated on the carton and the bottle label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og på flaskeetiketten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The dose of 1.95 g/m2/day of immediate-release cysteamine bitartrate has been associated with an increased rate of withdrawal from treatment due to intolerance and an increased incidence of adverse events.
Danish: En dosering på 1,95 g/m2/dag af cysteaminbitartrat med hurtig udløsning er forbundet med øget seponering af behandlingen på grund af intolerans og øget forekomst af bivirkninger.
English: PROCYSBI contains sodium
Danish: PROCYSBI indeholder natrium
English: Your doctor will monitor you with eye examinations to find and treat this problem early.
Danish: Lægen vil følge dig med øjenundersøgelser, så problemet kan blive behandlet tidligt.
English: Since oral cysteamine doesn't prevent deposits of cystine crystals in the eye, you should continue taking cysteamine eye drops as prescribed by your doctor.
Danish: Da oral indtagelse af cysteamin ikke forhindrer aflejringer af cystinkrystaller i øjet, skal du derfor fortsætte med at tage de cysteamin øjendråber, du har fået ordineret.
English: The education pack is aimed at strengthening awareness of important identified and potential risks as well as appropriate patient selection, the need for dose titration and patient monitoring.
Danish: Informationsmaterialet skal henlede opmærksomheden på vigtige konstaterede og potentielle risici, hensigtsmæssig patientudvælgelse og nødvendigheden af dosistitrering og overvågning af patienterne.
English: When starting therapy, patients should not engage in potentially hazardous activities until the effects of the medicinal product on each individual are known.
Danish: I begyndelsen af behandlingen bør patienten ikke udføre potentielt farlige aktiviteter, før lægemidlets påvirkning af den pågældende patient kendes.
English: Physicians should routinely monitor the skin and bones of patients receiving cysteamine.
Danish: Lægen bør rutinemæssigt overvåge hud og knogler hos patienter i behandling med cysteamin.
English: Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.
Danish: Cysteamin nedsætter akkumuleringen af cystin i visse celler (f.eks. leukocytter, muskel- og leverceller) hos patienter med nefropatisk cystinose, og når behandlingen indledes tidligt, forsinker cysteamin udviklingen af nyresvigt.
English: Dose administration options are provided below:
Danish: Nedenfor er angivet forskellige administrationsmåder.
English: Cystine build-up causes kidney damage and excretion of excess amounts of glucose, proteins, and electrolytes.
Danish: Ophobning af cystin medfører skade på nyrerne og udskillelse af store mængder glukose, proteiner og elektrolytter.
English: PROCYSBI contains the active substance cysteamine (also known as mercaptamine) and is taken for the treatment of nephropathic cystinosis in children and adults.
Danish: PROCYSBI indeholder det aktive stof cysteamin (der også kaldes mercaptamin) og anvendes til behandling af nefropatisk cystinose hos børn og voksne.
English: Cysteamine participates within lysosomes in a thiol-disulfide interchange reaction converting cystine into cysteine and cysteine-cysteamine mixed disulfide, both of which can exit the lysosome in patients with cystinosis.
Danish: Cysteamin deltager i lysosomerne i en thiol-disulfid-udvekslingsreaktion, hvor cystin omdannes til cystein og det blandede disulfid cystein-cysteamin, der begge kan forlade lysosomet hos patienter med cystinose.
English: Cysteamine can be administered with electrolyte (except bicarbonate) and mineral replacements necessary for management of Fanconi syndrome as well as vitamin D and thyroid hormone.
Danish: Cysteamin kan administreres sammen med substitution af de elektrolytter (bortset fra bikarbonat) og mineraler, der anvendes til behandling af Fanconis syndrom, samt vitamin D og thyroideahormon.
English: Cysteamine bitartrate should not be administered with food rich in fat or proteins, or with frozen food like ice-cream.
Danish: Cysteaminbitartrat bør ikke gives sammen med et måltid med højt fedt- eller proteinindhold eller med frossen mad såsom is.
English: Leukopenia and abnormal liver function
Danish: Leukopeni og abnorm leverfunktion
English: Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet, herunder teratogenese (se pkt.
English: Single doses of the drug inhibit prolactin secretion in animals.
Danish: En enkelt dosis af stoffet hæmmer sekretionen af prolaktin hos dyr.
English: High doses of cysteamine impair the ability of lactating mothers to feed their pups.
Danish: Høje doser cysteamin forringer diegivende moderdyrs evne til at ernære deres unger.
English: If your doctor prescribes bicarbonate, do not take it at the same time as PROCYSBI; take bicarbonate at least one hour before or at least one hour after the medicine.
Danish: Hvis lægen udskriver bikarbonat, skal du ikke tage det samtidig med PROCYSBI, men mindst en time før eller mindst en time efter lægemidlet.
English: Uncommon: Hair colour changes, skin striae, skin fragility (molluscoid pseudotumour on elbows)
Danish: Ikke almindelig: Ændret hårfarve, striae i huden, skrøbelig hud (molluskoide pseudotumorer på albuerne)
English: High doses of cysteamine, either by oral or parenteral routes, produce duodenal ulcers in rats and mice but not in monkeys.
Danish: Ved oral og parenteral indgift af høje doser cysteamin opstår der ulcus duodeni hos rotter og mus, men ikke hos aber.
English: This medicinal product can be administered by swallowing the intact capsules as well as sprinkling the capsule contents (enteric coated beads) on food or delivery through a gastric feeding tube.
Danish: Dette lægemiddel kan administreres ved at sluge de intakte kapsler samt drysse kapselindholdet (enterokorn) på mad eller det kan administreres via en mavesonde.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree.”
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: These mainly involve the gastrointestinal and central nervous systems.
Danish: Bivirkningerne omfatter hovedsagelig mave-tarmsystemet og centralnervesystemet.
English: These tests 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: Prøverne skal tages 12,5 timer efter den foregående dags aftendosis, dvs. 30 minutter efter den påfølgende morgendosis.
English: Whole cysteamine capsules should not be given to children under the age of 6 years due to the risk of choking (refer to section 3 How to take PROCYSBI - Method of administration).
Danish: Hele cysteaminkapsler bør ikke gives til børn under seks år på grund af risikoen for, at de får dem i den gale hals (se afsnit 3 Sådan skal du tage PROCYSBI - Administration).
English: Administration of cysteamine in neonate rats induced cataracts.
Danish: Administration af cysteamin til nyfødte rotter medførte katarakt.
English: Duration of treatment Treatment with PROCYSBI should continue life-long, as instructed by your doctor.
Danish: Behandlingsvarighed Behandlingen med PROCYSBI er livslang og skal følge lægens anvisninger.
English: • Option 1 / Syringe: Mix gently for 5 minutes, then aspirate the mixture of cysteamine granules and acidic fruit juice or water into a dosing syringe.
Danish: • Mulighed 1 / Sprøjte: Der omrøres forsigtigt i 5 minutter, hvorefter blandingen af korn af cysteamin og sur frugtjuice eller vand suges op i en doseringssprøjte.
English: Cystinosis is a disease affecting how the body functions, with an abnormal accumulation of the amino acid cystine in various organs of the body such as the kidney, eye, muscle, pancreas, and brain.
Danish: Cystinose er en stofskiftesygdom, der påvirker kroppens funktioner og medfører unormal ophobning af aminosyren cystin i en række organer, såsom nyrerne, øjnene, musklerne, bugspytkirtlen og hjernen.
English: Low white blood cell count.
Danish: For lavt antal hvide blodlegemer.
English: - Regular blood tests to measure the amount of cystine inside white blood cells and/or the concentration of cysteamine in the blood are necessary to help determine the correct dose of PROCYSBI.
Danish: - Der skal regelmæssigt tages blodprøver til bestemmelse af cystin i de hvide blodlegemer og/eller cysteamin i blodet, for at den rigtige dosis af PROCYSBI kan fastsættes.
English: Food intake reduces the absorption of PROCYSBI at 30 minutes pre-dose (approximately 35% decrease in exposure) and at 30 min post-dose (approximately 16 or 45% decrease in exposure for intact and open capsules respectively).
Danish: Fødeindtagelse nedsætter absorptionen af PROCYSBI: Fødeindtagelse 30 minutter før dosering medfører således ca. 35 % lavere eksponering, og fødeindtagelse 30 minutter efter dosering medfører ca. 16 og 45 % lavere eksponering for henholdsvis hele og åbnede kapsler).
English: Ask your pharmacist how to throw away the medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: Reproduction studies showed embryo-foetotoxic effects (resorptions and post-implantation losses) in rats at the 100 mg/kg/day dose level and in rabbits receiving cysteamine 50 mg/kg/day.
Danish: Reproduktionsundersøgelser viste embryoføtale toksiske effekter (resorptioner og postimplantationstab) hos rotter ved et dosisniveau på 100 mg/kg/dag og hos kaniner ved en cysteamindosis på 50 mg/kg/dag.
English: Regular blood and urine tests to measure the levels of the body's important electrolytes are also necessary to help you or your doctor correctly adjust the doses of these supplements.
Danish: Desuden skal der regelmæssigt tages prøver af blod og urin for at bestemme vigtige elektrolytter, så lægen kan tilpasse doserne af disse kosttilskud.
English: Healthcare professionals should refer to the assay-specific therapeutic targets provided by individual testing laboratories when making decisions regarding diagnosis and PROCYSBI dosing for cystinosis patients.
Danish: Læger og sundhedspersonale skal referere til analysespecifikke behandlingsmål fra de individuelle testlaboratorier, når de tager beslutninger om diagnose og PROCYSBI-dosering for patienter med cystinose.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06 September 2013
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 06.09.2013 Dato for seneste fornyelse: 26.07.2018
English: Common: Liver function tests abnormal
Danish: Almindelig: Leverfunktionsprøver abnorme
English: Important information about some of the excipients of PROCYSBI This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodiumfree.
Danish: Vigtig information om nogle af hjælpestofferne i PROCYSBI Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: Bicarbonate should be administered at least one hour before or one hour after PROCYSBI to avoid potential earlier release of cysteamine.
Danish: Administration af bikarbonat bør finde sted mindst en time før eller en time efter PROCYSBI for at undgå potentiel hurtigere udløsning af cysteamin.
English: If you forget to take PROCYSBI
Danish: Hvis du har glemt at tage PROCYSBI
English: Experimental administration of the drug causes depletion of somatostatin in several animal species.
Danish: Stoffet medfører depletion af somatostatin ved eksperimentel indgift hos flere dyrearter.
English: These include skin striae (which are like stretch marks), bone injuries (such as fractures), bone deformities, and joint problems.
Danish: Forandringerne består i mærker i huden (som ligner strækmærker), knogleskader (såsom brud), knogledeformiteter og ledproblemer.
English: PROCYSBI treatment should be initiated under the supervision of a physician experienced in the treatment of cystinosis.
Danish: Behandlingen med PROCYSBI bør initieres under ledelse af en læge med erfaring i behandling af cystinose.
English: The cap is child resistant and has a foil seal.
Danish: Låget er børnesikret og har folietætning.
English: If a severe skin rash develops such as erythema multiforme bullosa or toxic epidermal necrolysis, cysteamine should not be re-administered (see sections 4.8).
Danish: Hvis der opstår svært hududslæt såsom erythema multiforme bullosa eller toksisk epidermal nekrolyse, bør behandlingen med cysteamin ikke genoptages (se pkt.
English: In clinical studies with healthy volunteers, the most frequent adverse reactions were very common GI symptoms (16%) and occurred primarily as single episodes that were mild or moderate in severity.
Danish: I kliniske undersøgelser med raske forsøgspersoner var de hyppigste bivirkninger gastrointestinale symptomer (16 %), hovedsageligt som enkeltepisoder af let eller moderat sværhed.
English: PROCYSBI is a medicine that reacts with cystine to decrease its level within the cells.
Danish: PROCYSBI er et lægemiddel, der reagerer med cystin og nedsætter cellernes indhold af cystin.
English: The cylinders may be discarded with the bottle after use.
Danish: Cylindrene kan kasseres sammen med flasken efter brug.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism product, ATC code: A16AA04.
Danish: Farmakoterapeutisk klassifikation: Andre stofskiftesygdomme, midler mod cystinose, ATC-kode: A16AA04.
English: For children and patients who have problems to swallow, please refer to section 3 How to take PROCYSBIMethod of administration.
Danish: Hvis børn og patienter har problemer med at synke, henvises til afsnit 3 Sådan skal du tage PROCYSBI - Administration.
English: The physician education pack should contain the Safety Checklist, the Summary of Product Characteristics and Package Leaflet.
Danish: Informationsmaterialet til læger skal indeholde sikkerhedstjeklisten, produktresuméet og indlægssedlen.
English: Administration with food
Danish: Administration sammen med et måltid
English: • Option 2 / Cup: Mix gently for 5 minutes in a cup or shake gently for 5 minutes in a covered cup (e.g., “sippy” cup).
Danish: • Mulighed 2 / Kop: Blandingen omrøres forsigtigt i 5 minutter i en kop eller rystes forsigtigt i fem minutter i en kop med låg (f.eks. med drikketud).
English: • Hypersensitivity to the active substance, any form of cysteamine (mercaptamine), or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof, enhver form for cysteamin (mercaptamin) eller over for et eller flere af hjælpestofferne anført i pkt.
English: Do not double the dose.
Danish: Der må ikke tages en dobbelt 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 der konstateres eller planlægges graviditet, bør behandlingen tages op til nøje overvejelse, og patienten skal oplyses om den teratogene risiko ved cysteamin.
English: • The risk of fibrosing colonopathy and relevant risk minimisation advice: Patients should be informed about the potential risk of fibrosing colonopathy; Patients should be advised of the signs and symptoms of fibrosing colonopathy and to alert the treating physician if they develop any.
Danish: • Anvisninger vedrørende risikoen for fibroserende colonsygdom og relevante anvisninger for risikominimering: patienterne skal informeres om den potentielle risiko for fibroserende colonsygdom patienterne skal informeres om tegn og symptomer på fibroserende colonsygdom og om at kontakte den behandlende læge, hvis sådanne tegn eller symptomer opstår.
English: Capsule content microcrystalline cellulose methacrylic acid - ethyl acrylate copolymer (1:1) hypromellose talc triethyl citrate sodium lauryl sulphate
Danish: Kapselindhold cellulose, mikrokrystallinsk methacrylsyre-ethylacrylat copolymer (1:1) hypromellose talcum triethylcitrat natriumlaurilsulfat
English: This may be followed by 250 mL of an acceptable acidic liquid - fruit juice (e.g., orange juice or any acidic fruit juice) or water.
Danish: Dette kan efterfølges af 250 ml af en acceptabel sur drikfrugtjuice (f.eks. appelsinjuice eller enhver anden sur frugtjuice) eller vand.
English: A periodic eye examination is needed to identify this condition early and timely treatment should be provided when it occurs to prevent vision loss.
Danish: Der kræves jævnlig øjenundersøgelse for at diagnosticere denne tilstand tidligt og i givet fald behandle den rettidigt, så synstab undgås.
English: Patients being transferred from immediate-release cysteamine bitartrate to PROCYSBI should have their WBC cystine levels measured in 2 weeks, and thereafter every 3 months to assess optimal dose as described above.
Danish: Patienter, der overgår fra cysteaminbitartrat med hurtig udløsning til PROCYSBI, bør have kontrolleret leukocytternes cystinindhold inden for 2 uger og efterfølgende hver tredje måned for at vurdere, om dosis er optimal som ovenfor beskrevet.
English: If cysteamine is initially poorly tolerated due to gastrointestinal (GI) tract symptoms or transient skin rashes, therapy should be temporarily stopped, then re-instituted at a lower dose and gradually increased to the appropriate dose (see section 4.4).
Danish: Ved indledende dårlig tolerabilitet af cysteamin på grund af gastrointestinale symptomer eller forbigående hududslæt bør behandlingen midlertidigt seponeres for derefter at genoptages med en lavere dosering, der gradvis øges til det hensigtsmæssige niveau (se pkt.