natgillin/translations-raw huggingface dataset:
De hyppigst rapporterede bivirkninger var kvalme, opkastning, hovedpine, feber og diarré. 
The most commonly reported adverse reactions were nausea, vomiting, headache, fever, and diarrhea.
Det skal du vide, før du begynder at få Fasturtec 3. 
What you need to know before you are given Fasturtec 3.
Det er ukendt, om rasburikase udskilles i human mælk. 
It is unknown whether rasburicase is excreted in human milk.
Sikkerhedsdata for patienter behandlet med Fasturtec i studium EFC4978 var i overensstemmelse med den bivirkningsprofil, der blev set i tidligere kliniske studier med fortrinsvis pædiatriske patienter. 
The safety results of patients treated with Fasturtec in Study EFC4978 were consistent with the adverse events profile observed in previous clinical studies with predominantly paediatric patients.
Plasmaprøverne tilberedes straks ved centrifugering i en nedkølet centrifuge (4°C). 
Plasma samples should immediately be prepared by centrifugation in a pre-cooled centrifuge (4°C).
Fasturtec skal gives inden eller i begyndelsen af dit kemoterapiforløb. 
Fasturtec is to be given to you before or during the start of your course of chemotherapy.
*En «enzyme activity unit» (EAU) svarer til den enzymaktivitet, der kan omdanne 1 µmol urinsyre til allantoin per minut under følgende forhold: +30°C±1°C TEA pH 8,9 buffer. 
*One enzyme activity unit (EAU) corresponds to the enzyme activity that converts 1 µmol of uric acid into allantoin per minute under the operating conditions described: +30 °C ± 1 °C TEA pH 8.9 buffer.
Efter infusion af rasburikase i doser på 0,20 mg/kg/dag opnås steady state på dag 2-3. 
After infusion of rasburicase at a dose of 0.20 mg/kg/day, steady state is achieved at day 2 - 3.
- Ufrivillige muskelSammentrækninger** 
- Muscle contraction involuntary**
Sanofi Chimie Route d'Avignon 30390 Aramon Frankrig 
Sanofi Chimie Route d'Avignon 30390 Aramon France
Endelig skal plasma opbevares i bad med is/vand og analyseres for urinsyre inden for 4 timer. 
Finally, plasma must be maintained in an ice/water bath and analysed for uric acid within 4 hours.
Rasburikase er et tetramert protein med identiske underenheder af en molekylmasse på ca. 34 kDa. 
Rasburicase is a tetrameric protein with identical subunits of a molecular mass of about 34 kDa.
Farmakoterapeutisk klassifikation: Afgiftningsmidler ved cytostatica-behandling, ATC-kode: V03AF07 
Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment, ATC code: V03AF07.
Særlige populationer Patienter med nedsat nyre- eller leverfunktion: Dosisjustering er ikke nødvendig. 
Special populations Renally or hepatically impaired patients: No dose adjustment is necessary.
Fasturtec indeholder 
What Fasturtec contains
Den gennemsnitlige terminale halveringstid var sammenlignelig for pædiatriske og voksne patienter og i størrelsesordnen 15,7-22,5 timer. 
The mean terminal half-life was similar between paediatric and adult patients and ranged from 15.7 to 22.5 hours.
Rasburikase skal indgives over 30 minutter. 
Rasburicase solution should be infused over 30 minutes.
Koncentrationen af rasburikase i den færdige infusionsopløsning afhænger af patientens legemsvægt. 
The concentration of rasburicase in the final solution for infusion depends on the patient's body weight.
Ved behandling med Fasturtec skal fordelene ved amning afvejes i forhold til den potentielle risiko for barnet. 
During treatment with Fasturtec, the advantage of breastfeeding should be weighted against the potential risk for the infant.
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. 
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.
Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.emea.europa.eu/. 
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Det er imidlertid påvist, at holdbarheden efter anbrud er 24 timer ved opbevaring mellem +2°C og 8°C. 
However, the in-use stability has been demonstrated for 24 hours between +2°C and 8°C.
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN sanofi-aventis groupe 
NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe
* Anafylaktisk shock, eventuelt med dødelig udgang ** Erfaring efter markedsføring + Grad 3/4: Ikke almindelig ++ Grad 3/4: Almindelig 
* Anaphylactic shock including potential fatal outcome ** From post-marketing experience + Uncommon G3/4 ++ Common G3/4
Pædiatrisk population Eftersom dosisjustering ikke er nødvendig, er den anbefalede dosis 0,20 mg/kg/dag. 
Paediatric population As no adjustment is necessary, the recommended dose is 0.20 mg/kg/day.
Graviditet og amning Fortæl din læge hvis du er, eller tror du er gravid, eller hvis du ammer. 
Pregnancy and breast-feeding Tell your doctor if you are, or think you may be pregnant, or if you are breast-feeding.
Den anbefalede dosis er 0,20 mg pr. kg legemsvægt pr. dag både til børn og voksne. 
The recommended dose is 0.20 mg per kg of body weight per day in both children and adults.
Fertilitet Der findes ingen data om, hvorvidt rasburikase påvirker fertiliteten. 
Fertility There are no data regarding the effect of rasburicase on fertility.
Da rasburikase er et protein, forventes det, at dosis til det ammede barn er meget lav. 
As a protein the dose for the infant is expected to be very low.
Sjældne (kan påvirke op til 1 ud af 1.000 personer): − Løbenæse, stoppet næse, nysen, trykken i ansigtet eller smerter (rhinitis). 
Rare (may affect up to 1 in 1,000 people): - runny or blocked nose, sneezing, facial pressure or pain (rhinitis).
Renal elimination af rasburikase formodes at bidrage i mindre grad til clearance. 
Renal elimination of rasburicase is considered to be a minor pathway for rasburicase clearance.
Trafik- og arbejdssikkerhed Der findes ingen tilgængelig information om evnen til at køre eller betjene maskiner. 
Driving and using machines No information on the ability to drive and use machines is available.
Fasturtec indeholder den aktive ingrediens rasburikase. 
Fasturtec contains the active ingredient rasburicase.
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). 
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).
Endvidere ledsages den hurtige regulering af urinsyreniveauet hos denne population af en forbedret nyrefunktion. 
In addition this rapid control of uric acid in this population is accompanied by improvements in renal function.
Hos voksne (≥18 år) havde alderen, kønnet, basisniveauet af leverenzymer og kreatininclearance ingen betydning for farmakokinetikken af rasburikase. 
In adults (≥ the age of 18 years), age, gender, baseline liver enzymes and creatinine clearance did not impact the pharmacokinetics of rasburicase.
I tilfælde af en alvorlig overfølsomhedsreaktion skal Fasturtec seponeres omgående og permanent og passende behandling iværksættes. 
In case of severe allergic reaction, treatment should immediately and permanently be discontinued and appropriate therapy initiated.
Fasturtec er ikke undersøgt hos patienter med hyperurikæmi i forbindelse med myeloproliferative sygdomme. 
Fasturtec has not been investigated in the patients with hyperuricemia in the context of myeloproliferative disorders.
Navn og adresse på fremstillere(n) af det (de) biologisk aktive stof(fer) 
Name and address of the manufacturer(s) of the biological active substance(s)
-Feber ++ 
- Fever++
• besvær med at trække vejret eller synke 
• difficulty in breathing or swallowing
Clearance af rasburikase var ca. 3,5 ml/time/kg. 
Clearance of rasburicase was ca. 3.5 ml/h/kg.
Der blev observeret minimal akkumulering af rasburikase mellem dag 1 og 5 (<1,3 gange). 
Minimal accumulation of rasburicase (<1.3 fold) was observed between days 1 and 5 of dosing.
Behandling med rasburikase medfører ikke behov for at ændre tidspunkt eller behandlingsplan for indledning af cytostatisk kemoterapi. 
Administration of rasburicase does not require any change in the timing or schedule of initiation of cytoreductive chemotherapy.
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. 
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.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug. 
METHODS AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use
Bivirkninger, der måske skyldes Fasturtec og er fremkommet under kliniske forsøg, er opført nedenfor efter systemorganklasse og hyppighed. 
Adverse reactions possibly attributable to Fasturtec and reported in the clinical trials, are listed below, by system organ class and by frequency.
Prøverne nedsænkes i bad med is/vand. 
Samples must be immersed in an ice/water bath.
• hævelse af ansigt, læber, tunge eller svælg 
• swelling of the face, lips, tongue or throat
For instruktioner vedrørende rekonstitution og fortynding af præparatet før administration, se pkt. 
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Den nødvendige mængde færdigblandet opløsning afhænger af patientens legemsvægt. 
The required volume of the reconstituted solution depends on the patient's body weight.
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). 
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).
Rasburikases farmakokinetik blev undersøgt hos både pædiatriske og voksne patienter med leukæmi, lymfomer eller andre maligne hæmatologiske lidelser. 
The pharmacokinetics of rasburicase were evaluated in both paediatric and adult patients with leukaemia, lymphoma or other haematological malignancies.
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. 
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.
Da stoffet forventes at blive omsat via peptidhydrolyse, antages nedsat leverfunktion ikke at have nogen indflydelse på farmakokinetikken. 
As metabolism is expected to occur by peptide hydrolysis, an impaired liver function is not expected to affect the pharmacokinetics.
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 %). 
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%).
Opbevaringsforhold efter rekonstitution eller fortynding af lægemidlet, se pkt. 
For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.
Data fra dyrestudier kunne ikke tolkes på grund af tilstedeværelse af endogen uratoxidase i standard-dyremodeller. 
Results from animal studies could not be interpreted due to the presence of endogenous urate oxidase in standard animal models.
På grund af Fasturtecs virkningsmåde vil overdosering føre til lave eller upåviselige plasmakoncentrationer af urinsyre og øget produktion af hydrogenperoxid. 
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.
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. 
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.
Det fører så igen til effektiv udskillelse af serum-phosphatbelastningen, hvilket forebygger yderligere nedsættelse af nyrefunktionen på grund af henfald af calcium/phosphor. 
In turn, this allows efficient excretion of the serum phosphate load preventing further deterioration of renal function from calcium/phosphorus precipitation.
Når du er i kemoterapi, bliver kræftceller ødelagt, og der frigives store mængder urinsyre til blodet. 
When chemotherapy is given, cancer cells are destroyed, releasing large amounts of uric acid into the bloodstream.
Det kan være nødvendigt at anvende flere hætteglas for at opnå en tilstrækkelig mængde rasburikase til en enkelt infusion. 
The use of several vials may be necessary to obtain the quantity of rasburicase required for one administration.
Hvis det sker, vil din læge nøje overvåge påvirkningen af dine røde blodlegemer og behandle de symptomer, der måtte opstå. 
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.
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. 
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.
I så fald skal behandlingen omgående seponeres permanent, og der skal træffes passende forholdsregler (se pkt. 
In such case, treatment should immediately and permanently be discontinued and appropriate measures initiated (see section 4.8).
ADMINISTRATIONSMETODE 
Method of Administration
Tumorlyse kan også medføre hyperfosfatæmi, hyperkaliæmi og hypocalcæmi. 
Tumour lysis can also result in hyperphosphataemia, hyperkalaemia and hypocalcaemia.
Det skal du vide, før du begynder at få Fasturtec 
What you need to know before you are given Fasturtec
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. 
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.
I lighed med andre proteiner kan rasburikase fremkalde allergiske reaktioner hos mennesker, såsom anafylaksi, inklusive anafylaktisk shock, med potentielt dødelig udgang. 
Rasburicase like other proteins, has the potential to induce allergic responses in humans, such as anaphylaxis, including anaphylactic shock, with potential fatal outcome.
Du må ikke få Fasturtec hvis du: - er allergisk (overfølsom) over for rasburikase, andre urikaser eller et af de øvrige indholdsstoffer i 
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).
Fasturtec skal administreres under supervision af en læge med erfaring i behandling af maligne hæmatologiske lidelser med kemoterapeutika. 
Fasturtec should be administered under the supervision of a physician trained in chemotherapy of haematological malignancies.
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. 
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.
Tolkningen af ikke-kliniske studier begrænses af tilstedeværelsen af endogen uratoxidase i de standardiserede dyreforsøgsmodeller. 
The interpretation of the non-clinical studies is hampered due to the presence of endogenous urate oxidase in standard animal models.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Fasturtec er et rekombinant uratoxidaseenzym fremstillet i en genmanipuleret Saccharomyces cerevisiae-stamme. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Fasturtec is a recombinant urate-oxidase enzyme produced by genetically modified Saccharomyces cerevisiae strain.
Håndtering af prøver: 
Sample handling:
Overfølsomhed over for det aktive indholdsstof eller over for et af hjælpestofferne anført under pkt. 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Lægemidlet skal omgående seponeres permanent hos patienter, der har udviklet methæmoglobinæmi, og der skal træffes passende forholdsregler (se pkt. 
Fasturtec should immediately and permanently be discontinued in patients having developed methaemoglobinaemia, and appropriate measures initiated (see section 4.8).
For at forhindre, at der opstår hæmolytisk anæmi, er rasburikase derfor kontraindiceret hos patienter med disse lidelser. 
In order to prevent possible haemolytic anaemia induced by hydrogen peroxide, rasburicase is contraindicated in patients with these disorders.
Almindelige bivirkninger (kan påvirke flere end 1 ud af 10 personer): − Allergiske reaktioner, primært udslæt og nældefeber. 
Common side effects (may affect up to 1 in 10 people): - allergic reactions, mainly rashes and urticaria.
Der findes ikke tilstrækkelige data til at kunne anbefale gentagne behandlingsserier. 
At present, there is insufficient data available on patients being retreated to recommend multiple treatment courses.
A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLERE ANSVARLIG(E) FOR BATCHFRIGIVELSE 
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Navn og adresse på fremstillere(n) ansvarlig(e) for batchfrigivelse 
Name and address of the manufacturer(s) responsible for batch release
Den enzymatiske oxidation af urinsyre fører til en støkiometrisk dannelse af hydrogenperoxid. 
The enzymatic oxidation of uric acid leads to stoichiometric formation of hydrogen peroxide.
Kliniske erfaringer med Fasturtec har vist, at patienterne skal overvåges nøje for begyndende tegn på allergiske bivirkninger, især alvorlige overfølsomhedsreaktioner inklusive anafylaksi (se pkt. 
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).
- Aktivt stof: rasburikase 1,5 mg/ml. 
- The active substance is rasburicase 1.5 mg/ml.
For at sikre nøjagtig måling af urinsyrekoncentrationen i plasma under behandling med Fasturtec skal proceduren for håndtering af prøver nøje overholdes (se pkt. 
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).
Den anbefalede dosis er 0,20 mg/kg/dag. 
The recommended dose for Fasturtec is 0.20 mg/kg/day.
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). 
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).
Blodet indsamles i nedkølede rør med heparin til modvirkning af koagulation. 
Blood must be collected into pre-chilled tubes containing heparin anticoagulant.
Efter rekonstitution indeholder 1 ml Fasturtec-koncentrat 1,5 mg rasburikase. 
After reconstitution, 1 ml of Fasturtec concentrate contains 1.5 mg rasburicase.
Rasburikase er et meget virksomt urikolytiskt middel, som katalyserer enzymatisk oxidation af urinsyre til allantoin, et vandopløseligt produkt, der let udskilles gennem nyrerne. 
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.
Der er observeret rasburikase-antistoffer hos behandlede patienter og raske personer, der har fået rasburikase. 
Anti-rasburicase antibodies have been detected in treated patients and healthy volunteers administered rasburicase.
Fasturtec bør ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception. 
Fasturtec is not recommended in women of childbearing potential not using contraception.
Hos mennesket er urinsyre sidste trin i puriners stofskifteproces. 
In humans, uric acid is the final step in the catabolic pathway of purines.
Infusion: Den færdige opløsning skal indgives som infusion over 30 minutter. 
Infusion: The final solution should be infused over 30 minutes.
Indehaveren af markedsføringstilladelsen sanofi-aventis groupe 54, rue La Boétie F-75008 Paris Frankrig 
Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F-75008 Paris France
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. 
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.