FrancophonIA/ELRC3.0 huggingface dataset:
English: The duration of treatment with Fasturtec may be up to 7 days, the exact duration should be based upon adequate monitoring of uric acid levels in plasma and clinical judgment.
Danish: Behandlingen med Fasturtec kan vare op til 7 dage, den præcise varighed skal baseres på fyldestgørende monitorering af urinsyre niveauet i plasma samt klinisk vurdering.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.emea.europa.eu/.
English: However, the in-use stability has been demonstrated for 24 hours between +2°C and 8°C.
Danish: Det er imidlertid påvist, at holdbarheden efter anbrud er 24 timer ved opbevaring mellem +2°C og 8°C.
English: NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN sanofi-aventis groupe
English: * Anaphylactic shock including potential fatal outcome ** From post-marketing experience + Uncommon G3/4 ++ Common G3/4
Danish: * Anafylaktisk shock, eventuelt med dødelig udgang ** Erfaring efter markedsføring + Grad 3/4: Ikke almindelig ++ Grad 3/4: Almindelig
English: Paediatric population As no adjustment is necessary, the recommended dose is 0.20 mg/kg/day.
Danish: Pædiatrisk population Eftersom dosisjustering ikke er nødvendig, er den anbefalede dosis 0,20 mg/kg/dag.
English: Pregnancy and breast-feeding Tell your doctor if you are, or think you may be pregnant, or if you are breast-feeding.
Danish: Graviditet og amning Fortæl din læge hvis du er, eller tror du er gravid, eller hvis du ammer.
English: The recommended dose is 0.20 mg per kg of body weight per day in both children and adults.
Danish: Den anbefalede dosis er 0,20 mg pr. kg legemsvægt pr. dag både til børn og voksne.
English: Fertility There are no data regarding the effect of rasburicase on fertility.
Danish: Fertilitet Der findes ingen data om, hvorvidt rasburikase påvirker fertiliteten.
English: As a protein the dose for the infant is expected to be very low.
Danish: Da rasburikase er et protein, forventes det, at dosis til det ammede barn er meget lav.
English: Rare (may affect up to 1 in 1,000 people): - runny or blocked nose, sneezing, facial pressure or pain (rhinitis).
Danish: Sjældne (kan påvirke op til 1 ud af 1.000 personer): − Løbenæse, stoppet næse, nysen, trykken i ansigtet eller smerter (rhinitis).
English: Renal elimination of rasburicase is considered to be a minor pathway for rasburicase clearance.
Danish: Renal elimination af rasburikase formodes at bidrage i mindre grad til clearance.
English: Driving and using machines No information on the ability to drive and use machines is available.
Danish: Trafik- og arbejdssikkerhed Der findes ingen tilgængelig information om evnen til at køre eller betjene maskiner.
English: Fasturtec contains the active ingredient rasburicase.
Danish: Fasturtec indeholder den aktive ingrediens rasburikase.
English: Tell your doctor if you have ever had any allergic type reactions due to other medicines; Fasturtec can cause allergic-type reactions, such as severe anaphylaxis including anaphylactic shock (sudden lifethreatening or fatal allergic reactions).
Danish: Fortæl din læge, hvis du nogensinde har haft allergiske reaktioner på grund af andre typer medicin: Fasturtec kan forårsage allergi-lignende reaktioner som for eksempel alvorlig anafylaksi inklusive anafylaktisk shock (pludselig livstruende eller dødelig allergisk reaktion).
English: In addition this rapid control of uric acid in this population is accompanied by improvements in renal function.
Danish: Endvidere ledsages den hurtige regulering af urinsyreniveauet hos denne population af en forbedret nyrefunktion.
English: In adults (≥ the age of 18 years), age, gender, baseline liver enzymes and creatinine clearance did not impact the pharmacokinetics of rasburicase.
Danish: Hos voksne (≥18 år) havde alderen, kønnet, basisniveauet af leverenzymer og kreatininclearance ingen betydning for farmakokinetikken af rasburikase.
English: In case of severe allergic reaction, treatment should immediately and permanently be discontinued and appropriate therapy initiated.
Danish: I tilfælde af en alvorlig overfølsomhedsreaktion skal Fasturtec seponeres omgående og permanent og passende behandling iværksættes.
English: Fasturtec has not been investigated in the patients with hyperuricemia in the context of myeloproliferative disorders.
Danish: Fasturtec er ikke undersøgt hos patienter med hyperurikæmi i forbindelse med myeloproliferative sygdomme.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Danish: Navn og adresse på fremstillere(n) af det (de) biologisk aktive stof(fer)
English: - Fever++
Danish: -Feber ++
English: • difficulty in breathing or swallowing
Danish: • besvær med at trække vejret eller synke
English: Clearance of rasburicase was ca. 3.5 ml/h/kg.
Danish: Clearance af rasburikase var ca. 3,5 ml/time/kg.
English: Minimal accumulation of rasburicase (<1.3 fold) was observed between days 1 and 5 of dosing.
Danish: Der blev observeret minimal akkumulering af rasburikase mellem dag 1 og 5 (<1,3 gange).
English: Administration of rasburicase does not require any change in the timing or schedule of initiation of cytoreductive chemotherapy.
Danish: Behandling med rasburikase medfører ikke behov for at ændre tidspunkt eller behandlingsplan for indledning af cytostatisk kemoterapi.
English: In case of disorders of the blood in which red blood cells are abnormally broken down (haemolysis) or abnormal blood pigment levels (methaemoglobinaemia), your doctor will immediately and permanently discontinue treatment with Fasturtec.
Danish: I tilfælde af blodsygdomme, hvor de røde blodlegemer unormalt bliver nedbrudte (hæmolyse), eller unormale blodpigmentniveauer (methæmoglobinæmi), vil din læge øjeblikkeligt og permanent stoppe behandlingen med Fasturtec.
English: METHODS AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: Adverse reactions possibly attributable to Fasturtec and reported in the clinical trials, are listed below, by system organ class and by frequency.
Danish: Bivirkninger, der måske skyldes Fasturtec og er fremkommet under kliniske forsøg, er opført nedenfor efter systemorganklasse og hyppighed.
English: Samples must be immersed in an ice/water bath.
Danish: Prøverne nedsænkes i bad med is/vand.
English: • swelling of the face, lips, tongue or throat
Danish: • hævelse af ansigt, læber, tunge eller svælg
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner vedrørende rekonstitution og fortynding af præparatet før administration, se pkt.
English: The required volume of the reconstituted solution depends on the patient's body weight.
Danish: Den nødvendige mængde færdigblandet opløsning afhænger af patientens legemsvægt.
English: A cross-study comparison revealed that after administration of rasburicase at 0.15 or 0.20 mg/kg, the geometric mean values of body-weight normalized clearance were approximately 40% lower in Japanese (n=20) than that in Caucasians (n=26).
Danish: Et sammenlignende, krydset studium viste, at efter administration af rasburikase 0,15 eller 0,20 mg/kg var den geometriske middelværdi af legemsvægt-normaliseret-clearance ca. 40% lavere hos japanere (n=20) end hos kaukasere (n=26).
English: The pharmacokinetics of rasburicase were evaluated in both paediatric and adult patients with leukaemia, lymphoma or other haematological malignancies.
Danish: Rasburikases farmakokinetik blev undersøgt hos både pædiatriske og voksne patienter med leukæmi, lymfomer eller andre maligne hæmatologiske lidelser.
English: Thus patients suspected of receiving an overdose should be monitored for haemolysis, and general supportive measures should be initiated as no specific antidote for Fasturtec has been identified.
Danish: Ved mistanke om overdosering bør patienter monitoreres med henblik på hæmolyse, og relevant understøttende behandling iværksættes da der ikke er identificeret nogen specifik antidot til Fasturtec.
English: As metabolism is expected to occur by peptide hydrolysis, an impaired liver function is not expected to affect the pharmacokinetics.
Danish: Da stoffet forventes at blive omsat via peptidhydrolyse, antages nedsat leverfunktion ikke at have nogen indflydelse på farmakokinetikken.
English: At 4 hours post first dose, there was a significant difference in the mean percentage change from baseline plasma uric acid concentration (p <0.0001) in the Fasturtec group (86.0%) compared to that for the allopurinol group (-12.1%).
Danish: 4 timer efter første dosis var der en signifikant forskel i den gennemsnitlige procentvise ændring i forhold til plasmakoncentrationen af urinsyre ved baseline (p< 0,0001) i gruppen, som fik Fasturtec (86 %), sammenlignet med allopurinol-gruppen (-12,1 %).
English: For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution eller fortynding af lægemidlet, se pkt.
English: Results from animal studies could not be interpreted due to the presence of endogenous urate oxidase in standard animal models.
Danish: Data fra dyrestudier kunne ikke tolkes på grund af tilstedeværelse af endogen uratoxidase i standard-dyremodeller.
English: In view of the mechanism of action of Fasturtec, an overdose will lead to low or undetectable plasma uric acid concentrations and increased production of hydrogen peroxide.
Danish: På grund af Fasturtecs virkningsmåde vil overdosering føre til lave eller upåviselige plasmakoncentrationer af urinsyre og øget produktion af hydrogenperoxid.
English: The mean volume of distribution ranged from 110 - 127 ml/kg in paediatric patients and from 75.8 to 138 ml/kg in adult patients, respectively, which is comparable to the physiological vascular volume.
Danish: Det gennemsnitlige fordelingsvolumen varierede fra 110 til127 ml/kg hos pædiatriske patienter og fra 75,8 til138 ml/kg hos voksne patienter, hvilket svarer til det fysiologiske vaskulære volumen.
English: In turn, this allows efficient excretion of the serum phosphate load preventing further deterioration of renal function from calcium/phosphorus precipitation.
Danish: Det fører så igen til effektiv udskillelse af serum-phosphatbelastningen, hvilket forebygger yderligere nedsættelse af nyrefunktionen på grund af henfald af calcium/phosphor.
English: When chemotherapy is given, cancer cells are destroyed, releasing large amounts of uric acid into the bloodstream.
Danish: Når du er i kemoterapi, bliver kræftceller ødelagt, og der frigives store mængder urinsyre til blodet.
English: The use of several vials may be necessary to obtain the quantity of rasburicase required for one administration.
Danish: Det kan være nødvendigt at anvende flere hætteglas for at opnå en tilstrækkelig mængde rasburikase til en enkelt infusion.
English: If you are given more Fasturtec than you should be If it does occur, the doctor will closely monitor the effects on your red blood cells and treat any symptoms that follow.
Danish: Hvis det sker, vil din læge nøje overvåge påvirkningen af dine røde blodlegemer og behandle de symptomer, der måtte opstå.
English: The uric acid response rate (proportion of patients with plasma uric acid levels ≤7.5 mg/dl from day 3 to day 7 after initiation of antihyperuricemic treatment) was 87% in arm A, 78% in arm B, and 66% in arm C. The response rate in arm A was significantly greater than in arm C (p=0.0009); the response rate was higher for arm B compared to arm C although this difference was not statistically significant.
Danish: Responsraten med hensyn til niveauet af urinsyre (andel af patienter med plasma-urinsyre ≤7,5 mg/dl (≤0,42 mmol/l) fra dag 3 til dag 7 efter initiering af behandling for hyperurikæmi) var 87% i arm A, 78% i arm B og 66% i arm C. Responsraten i arm A var signifikant højere end i arm C (p=0,0009); responsraten var højere i arm B end i arm C, dog var forskellen ikke statistisk signifikant.
English: In such case, treatment should immediately and permanently be discontinued and appropriate measures initiated (see section 4.8).
Danish: I så fald skal behandlingen omgående seponeres permanent, og der skal træffes passende forholdsregler (se pkt.
English: Method of Administration
Danish: ADMINISTRATIONSMETODE
English: Tumour lysis can also result in hyperphosphataemia, hyperkalaemia and hypocalcaemia.
Danish: Tumorlyse kan også medføre hyperfosfatæmi, hyperkaliæmi og hypocalcæmi.
English: What you need to know before you are given Fasturtec
Danish: Det skal du vide, før du begynder at få Fasturtec
English: Fasturtec is concomitantly administered as supportive care to cytoreductive chemotherapy of advanced malignancies, the causality of adverse events is therefore difficult to assess due to the significant burden of adverse events expected from the underlying disease and its treatment.
Danish: Fasturtec gives som understøttende behandling ved administration af cytostatika mod fremskredne, maligne lidelser, og det kan derfor være svært at påvise en årsagssammenhæng for bivirkningerne på grund af de betydelige bivirkninger, der må forventes fra den underliggende sygdom og dens behandling.
English: Rasburicase like other proteins, has the potential to induce allergic responses in humans, such as anaphylaxis, including anaphylactic shock, with potential fatal outcome.
Danish: I lighed med andre proteiner kan rasburikase fremkalde allergiske reaktioner hos mennesker, såsom anafylaksi, inklusive anafylaktisk shock, med potentielt dødelig udgang.
English: Do not use Fasturtec if you: - are allergic (hypersensitive) to rasburicase, other uricases or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få Fasturtec hvis du: - er allergisk (overfølsom) over for rasburikase, andre urikaser eller et af de øvrige indholdsstoffer i
English: Fasturtec should be administered under the supervision of a physician trained in chemotherapy of haematological malignancies.
Danish: Fasturtec skal administreres under supervision af en læge med erfaring i behandling af maligne hæmatologiske lidelser med kemoterapeutika.
English: Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
Danish: Behandling og profylakse af akut hyperurikæmi for at forebygge akut nyresvigt hos voksne, børn og unge (i alderen 0 til 17 år) med maligne hæmatologiske lidelser med høj tumorload og risiko for hastig tumorlyse eller -svind i begyndelsen af kemoterapeutisk behandling.
English: The interpretation of the non-clinical studies is hampered due to the presence of endogenous urate oxidase in standard animal models.
Danish: Tolkningen af ikke-kliniske studier begrænses af tilstedeværelsen af endogen uratoxidase i de standardiserede dyreforsøgsmodeller.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Fasturtec is a recombinant urate-oxidase enzyme produced by genetically modified Saccharomyces cerevisiae strain.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Fasturtec er et rekombinant uratoxidaseenzym fremstillet i en genmanipuleret Saccharomyces cerevisiae-stamme.
English: Sample handling:
Danish: Håndtering af prøver:
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive indholdsstof eller over for et af hjælpestofferne anført under pkt.
English: Fasturtec should immediately and permanently be discontinued in patients having developed methaemoglobinaemia, and appropriate measures initiated (see section 4.8).
Danish: Lægemidlet skal omgående seponeres permanent hos patienter, der har udviklet methæmoglobinæmi, og der skal træffes passende forholdsregler (se pkt.
English: In order to prevent possible haemolytic anaemia induced by hydrogen peroxide, rasburicase is contraindicated in patients with these disorders.
Danish: For at forhindre, at der opstår hæmolytisk anæmi, er rasburikase derfor kontraindiceret hos patienter med disse lidelser.
English: Common side effects (may affect up to 1 in 10 people): - allergic reactions, mainly rashes and urticaria.
Danish: Almindelige bivirkninger (kan påvirke flere end 1 ud af 10 personer): − Allergiske reaktioner, primært udslæt og nældefeber.
English: At present, there is insufficient data available on patients being retreated to recommend multiple treatment courses.
Danish: Der findes ikke tilstrækkelige data til at kunne anbefale gentagne behandlingsserier.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLERE ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på fremstillere(n) ansvarlig(e) for batchfrigivelse
English: The enzymatic oxidation of uric acid leads to stoichiometric formation of hydrogen peroxide.
Danish: Den enzymatiske oxidation af urinsyre fører til en støkiometrisk dannelse af hydrogenperoxid.
English: Clinical experience with Fasturtec demonstrates that patients should be closely monitored for the onset of allergic-type undesirable effects, especially severe hypersensitivity reactions including anaphylaxis (see section 4.8).
Danish: Kliniske erfaringer med Fasturtec har vist, at patienterne skal overvåges nøje for begyndende tegn på allergiske bivirkninger, især alvorlige overfølsomhedsreaktioner inklusive anafylaksi (se pkt.
English: - The active substance is rasburicase 1.5 mg/ml.
Danish: - Aktivt stof: rasburikase 1,5 mg/ml.
English: To ensure accurate measurement of uric acid plasma level during treatment with Fasturtec, a strict sample handling procedure must be followed (see section 6.6).
Danish: For at sikre nøjagtig måling af urinsyrekoncentrationen i plasma under behandling med Fasturtec skal proceduren for håndtering af prøver nøje overholdes (se pkt.
English: The recommended dose for Fasturtec is 0.20 mg/kg/day.
Danish: Den anbefalede dosis er 0,20 mg/kg/dag.
English: In a randomized (1:1:1), multi-center, open-label study, 275 adult patients with leukemia and lymphoma at risk for hyperuricemia and tumour lysis syndrome (TLS) were treated with either rasburicase at a dose of 0.2 mg/kg/day, intravenously, for 5 days (arm A: n=92), rasburicase at a dose of 0.2 mg/kg/day, intravenously, from day 1 through day 3 followed by oral allopurinol at a dose of 300 mg once a day from day 3 through day 5 (overlap on day 3: rasburicase and allopurinol administered approximately 12 hours apart) (arm B: n=92), or oral allopurinol at a dose of 300 mg once a day for 5 days (arm C: n=91).
Danish: I et randomiseret (1:1:1), multi-center, open-label studium blev 275 voksne patienter med leukæmi og lymfomer samt risiko for at udvikle hyperurikæmi og tumorlysesyndrom (TLS) behandlet med enten rasburikase intravenøst 0,2 mg/kg/dag i 5 dage (arm A: n=92), rasburikase intravenøst 0,2 mg/kg/dag fra dag 1 til dag 3 efterfulgt af allopurinol 300 mg oralt en gang dagligt fra dag 3 til dag 5 (overlap på dag 3: rasburikase og allopurinol administreret med ca. 12 timers mellemrum) (arm B: n=92) eller allopurinol 300 mg oralt en gang dagligt i 5 dage (arm C: n=91).
English: Blood must be collected into pre-chilled tubes containing heparin anticoagulant.
Danish: Blodet indsamles i nedkølede rør med heparin til modvirkning af koagulation.
English: After reconstitution, 1 ml of Fasturtec concentrate contains 1.5 mg rasburicase.
Danish: Efter rekonstitution indeholder 1 ml Fasturtec-koncentrat 1,5 mg rasburikase.
English: Rasburicase is a highly potent uricolytic agent that catalyses enzymatic oxidation of uric acid into allantoin, a water soluble product, easily excreted by the kidneys in the urine.
Danish: Rasburikase er et meget virksomt urikolytiskt middel, som katalyserer enzymatisk oxidation af urinsyre til allantoin, et vandopløseligt produkt, der let udskilles gennem nyrerne.
English: Anti-rasburicase antibodies have been detected in treated patients and healthy volunteers administered rasburicase.
Danish: Der er observeret rasburikase-antistoffer hos behandlede patienter og raske personer, der har fået rasburikase.
English: Fasturtec is not recommended in women of childbearing potential not using contraception.
Danish: Fasturtec bør ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: In humans, uric acid is the final step in the catabolic pathway of purines.
Danish: Hos mennesket er urinsyre sidste trin i puriners stofskifteproces.
English: Infusion: The final solution should be infused over 30 minutes.
Danish: Infusion: Den færdige opløsning skal indgives som infusion over 30 minutter.
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F-75008 Paris France
Danish: Indehaveren af markedsføringstilladelsen sanofi-aventis groupe 54, rue La Boétie F-75008 Paris Frankrig
English: The enzymatic digestion of uric acid to allantoin by rasburicase produces hydrogen peroxide and haemolytic anaemia or methaemoglobinaemia have been observed in certain at risk populations such as those with G6PD deficiency.
Danish: Ved den enzymatiske omsætning af urinsyre til allantoin katalyseret af rasburikase dannes der hydrogenperoxid, og der er observeret hæmolytisk anæmi og methæmoglobinæmi hos visse højrisikopopulationer såsom personer med G6PD-mangel.
English: Fasturtec is provided as a powder for concentrate for solution for infusion (powder for sterile concentrate) with a solvent.
Danish: Fasturtec leveres som pulver til koncentrat til infusionsvæske, opløsning (pulver til sterilt koncentrat) med solvens.
English: sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris France
Danish: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris Frankrig
English: - have a history of haemolytic anaemia (an illness caused by red blood cells being abnormally broken down).
Danish: - lider af hæmolytisk anæmi (en blodsygdom med unormal nedbrydning af røde blodlegemer).
English: In a randomised comparative phase III study, performed in 52 paediatric patients, 27 patients were treated with rasburicase at the recommended dose of 0.20 mg/kg/day, intravenously, for 4 to 7 days (< 5 years: n=11; 6-12 years: n=11; 13-17 years: n=5), and 25 patients with allopurinol daily oral doses for 4 to 8 days.
Danish: I et randomiseret komparativt fase III-studium med 52 pædiatriske patienter blev 27 patienter behandlet med den anbefalede intravenøse dosis af rasburikase på 0,20 mg/kg/dag i 4 til 7 dage (< 5 år: n=11; 6-12 år: n=11; 13-17 år: n=5), og 25 patienter med daglig oral dosis af allopurinol i 4 til 8 dage.
English: Powder in vial: store in a refrigerator (2°C - 8°C).
Danish: Pulver i hætteglas: opbevares i køleskab (ved 2°C - 8°C).
English: Rasburicase is used to treat or prevent high blood levels of uric acid from occurring in adults, children and adolescents (aged 0 to 17 years) with disorders of the blood cells (haematological diseases) who are about to receive or are receiving chemotherapy treatment.
Danish: Rasburikase bruges til at nedsætte eller forebygge høje niveauer af urinsyre i blodet hos voksne, børn og unge (i alderen 0 til 17 år) med blodsygdomme (hæmatologiske sygdomme) lige før eller under kemoterapeutisk behandling.
English: If it is necessary to monitor a patient's uric acid level, a strict sample-handling procedure must be followed to minimise ex vivo degradation of the analyte.
Danish: Hvis det er nødvendigt at overvåge urinsyreværdier, skal følgende procedurer for håndtering af prøver følges nøje for at undgå ex vivo nedbrydning af analytten.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 7.5 mg
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 7,5 mg