FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, caution should be exercised in patients receiving other medicines metabolised by the liver.
Danish: Derfor bør der udvises forsigtighed hos patienter, der får andre lægemidler, som metaboliseres af leveren.
English: These patients should no longer be treated with any asparaginase preparation.
Danish: Disse patienter bør ikke længere blive behandlet med noget asparaginasepræparat.
English: Based on limited data, the recommended dose in infants is as follows: - age less than 6 months:
Danish: Baseret på begrænsede data er den anbefalede dosis til spædbørn følgende: - alder under 6 måneder:
English: There are no data on the use of asparaginase in pregnant women.
Danish: Der er ingen data fra anvendelse af asparaginase til gravide kvinder.
English: Table 4: Pharmacokinetic parameters of Spectrila in 14 children/adolescents
Danish: Tabel 4: Farmakokinetiske parametre for Spectrila hos 14 børn/unge
English: In such cases, a switch to a different asparaginase preparation should be considered.
Danish: I sådanne tilfælde bør det overvejes at skifte til et andet asparaginase-præparat.
English: The lower median activity level on day 33 compared to the former two measurements was in part due to the fact that this last serum sample was taken 4 days after the last infusion of asparaginase instead of three days on the other occasions.
Danish: Det lavere mediane aktivitetsniveau på dag 33 sammenlignet med de to tidligere målinger skyldtes delvist det faktum, at denne sidste serumprøve blev taget 4 dage efter den sidste infusion af asparaginase i stedet for tre dage for de andre tilfælde.
English: • diabetic ketoacidosis (complication due to uncontrolled blood sugar)
Danish: • diabetisk ketoacidose (komplikation som følge af ukontrolleret blodsukker)
English: However, treatment with other chemotherapeutic agents should also be taken into consideration.
Danish: Behandling med anden kemoterapi bør også tages i betragtning.
English: OTHER Store in a refrigerator.
Danish: ANDET Opbevares i køleskab.
English: This syndrome is characterised in magnetic resonance imaging (MRI) by reversible (from a few days to months) lesions/oedema, primarily in the posterior region of the brain.
Danish: Dette syndrom karakteriseres ved magnetisk resonansscanning (MR-scanning) af reversible (fra et par dage til måneder) læsioner/ødemer, primært i hjernens posteriore region.
English: Treatment group
Danish: Behandlingsgruppe
English: • mild tremor (shaking) of the fingers
Danish: • let tremor (rysten) af fingrene
English: All cells need an amino acid called asparagine to stay alive.
Danish: Alle celler har behov for en aminosyre, der kaldes asparagin, for at holde sig i live.
English: - if asparaginase is given before these agents their effect may be weakened.
Danish: hvis asparaginase gives før disse stoffer, kan deres virkning være svækket.
English: RPLS is treated symptomatically, including measures to treat any seizures.
Danish: RPLS behandles symptomatisk, herunder foranstaltninger til at behandle krampeanfald.
English: Intravenous use after further dilution.
Danish: Intravenøs anvendelse efter yderligere fortynding.
English: The following life-threatening situations could arise during treatment with Spectrila:
Danish: De følgende livstruende situationer kan opstå i løbet af behandlingen med Spectrila:
English: In addition, treatment with asparaginase can result in disturbances in organ systems which exhibit a high level of protein synthesis.
Danish: Desuden kan behandlingen med asparaginase føre til forstyrrelser i organsystemer, der udviser et højt niveau af proteinsyntese.
English: CI = confidence interval; CSF = cerebrospinal fluid; MRD = minimal residual disease a
Danish: CI = konfidensinterval, CSF = cerebrospinalvæske, MRD = minimal residualsygdom a
English: • infections
Danish: • infektioner
English: Adverse reactions are ranked under headings of frequency, the most frequent first.
Danish: Bivirkningerne er klassificeret efter hyppighed, de hyppigste først.
English: Name and address of the manufacturer of the biological active substance Wacker Biotech GmbH
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Wacker Biotech GmbH
English: Asparaginase may also be toxic to normal cells that divide rapidly and are dependent to some degree on exogenous asparagine supply.
Danish: Asparaginase kan også være toksisk for normale celler, der hurtigt deler sig, og som i en vis udstrækning er afhængige af en eksogen forsyning af asparagin.
English: • if you have or previously had inflammation of the pancreas (pancreatitis),
Danish: • hvis du har eller tidligere har lidt af betændelse i bugspytkirtlen (pankreatitis),
English: Volume of distribution
Danish: Fordelingsvolumen
English: It is unclear whether the RPLS is caused by asparaginase, concomitant treatment or the underlying diseases.
Danish: Det er uklart, om RPLS er forårsaget af asparaginase, samtidig behandling eller de underliggende sygdomme.
English: Normal cells can make asparagine for themselves, while some cancer cells cannot.
Danish: Normale celler kan selv danne asparagin, men nogle kræftceller kan ikke.
English: Asparaginase is distributed mainly within the intravascular space.
Danish: Asparaginase fordeles primært i det intravaskulære rum.
English: Spectrila is used to treat adults and children with acute lymphoblastic leukaemia (ALL) which is a form of blood cancer.
Danish: Spectrila anvendes til at behandle voksne og børn med akut lymfoblastisk leukæmi (ALL), som er en type af blodkræft.
English: You may be given anti-allergic medicines and, if necessary, medicines to stabilise your circulation.
Danish: Du vil måske få lægemidler mod allergi og lægemidler til at stabilisere kredsløbet, hvis det er nødvendigt.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.>
English: Glucocorticoids and/ or anticoagulants
Danish: Glukokortikoider og/eller antikoagulantia
English: Co-administration of other antineoplastic medicinal products contributes to this effect.
Danish: Samtidig administration af andre antineoplastiske lægemidler bidrager til denne virkning.
English: MRD status at end of induction treatment MRD negative
Danish: MRD-status efter induktionsbehandling MRD-negativ
English: Marketing Authorisation Holder and Manufacturer medac
Danish: Indehaver af markedsføringstilladelsen og fremstiller medac
English: Therefore, vincristine should be given 3 to 24 hours before administration of asparaginase in order to minimise toxicity.
Danish: Derfor skal vincristin gives 3 til 24 timer før administration af asparaginase for at minimere toksiciteten.
English: The mean (Standard Deviation, SD) of the volume of distribution at steady state (Vdss) was 2.47 l (0.45 l).
Danish: Det gennemsnitlige (standardafvigelse, SD) fordelingsvolumen ved steady-state (Vdss) var 2,47 l (0,45 l).
English: Spectrila is used as part of a combination therapy.
Danish: Spectrila anvendes som en del af en kombinationsbehandling.
English: Complete asparagine depletion in serum Yes
Danish: Komplet asparagintømning i serum Ja
English: Pancreatitis with fatal outcome, pancreatic pseudocyst
Danish: Pankreatitis med dødeligt udfald, pankreatisk pseudocyste
English: Pharmacotherapeutic group: Antineoplastic agents; Other antineoplastic agents ATC code: L01XX02
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, Andre antineoplastiske stoffer ATC-kode: L01XX02.
English: No reproduction studies in animals with asparaginase were performed but studies with asparaginase preparations in mice, rats, chicken and rabbits have shown embryotoxic and teratogenic effects (see section 5.3).
Danish: Der blev ikke udført reproduktionsstudier med asparaginase hos dyr, men studier med asparaginase-præparater hos mus, rotter, kyllinger og kaniner har vist embryotoksiske og teratogene virkninger (se pkt.
English: Increased blood sugar values may require treatment with intravenous fluids and/or insulin.
Danish: Det kan være nødvendigt at behandle forhøjet blodsukker med intravenøse væsker og/eller insulin.
English: Concomitant treatment with corticosteroids contributes to this effect.
Danish: Samtidig behandling med kortikosteroider bidrager til denne virkning.
English: Asparaginase does not seem to penetrate the blood-brain barrier in measurable amounts.
Danish: Det ser ikke ud til, at asparaginase gennemtrænger blod-hjernebarrieren i målbare mængder.
English: Fertility No human data on the effect of asparaginase on fertility are available.
Danish: Fertilitet Der foreligger ingen humane data for virkningen af asparaginase på fertiliteten.
English: Symptomatic thromboses related to the use of central venous catheters have been described, too.
Danish: Symptomatiske tromboser relateret til anvendelsen af centrale venekatetre er også blevet beskrevet.
English: Tell your doctor if you are using, have recently used or might use any other medicines.
Danish: Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: • depression, hallucination or confusion
Danish: • depression, hallucination eller forvirring
English: These antibodies may induce clinical allergic reactions, inactivate the enzymatic activity or accelerate the elimination of asparaginase.
Danish: Disse antistoffer kan inducere kliniske allergiske reaktioner, inaktivere den enzymatiske aktivitet eller accelerere eliminationen af asparaginase.
English: In very rare cases, severe hyperammonaemia has been reported which may induce neurologic disorders such as seizures and coma.
Danish: I meget sjældne tilfælde er svær hyperammonæmi blevet rapporteret, hvilket kan inducere neurologiske forstyrrelser som krampeanfald og koma.
English: Because of a higher frequency of comorbidities such as liver and/or renal impairment, patients > 55 years of age usually tolerate asparaginase treatment worse than paediatric patients.
Danish: Grundet en større hyppighed af komorbiditeter, såsom nedsat lever- og/eller nyrefunktion, tolererer patienter > 55 år normalt behandlingen med asparaginase dårligere end pædiatriske patienter.
English: Ischaemic strokes are rare.
Danish: Iskæmiske slagtilfælde er sjældne.
English: Unconditional exact test of non-inferiority for binomial differences based on restricted maximum likelihood estimates c Patients were considered as responders if asparagine values in CSF on protocol day 33 were below the lower limit of quantification.
Danish: Ubetinget nøjagtig test af non-inferioritet for binomiale forskelle baseret på estimater af begrænset maksimal sandsynlighed c Patienter blev anset for at respondere, hvis asparaginværdier i CSF på protokoldag 33 var under den nedre kvantificeringsgrænse.
English: Spectrila contains asparaginase, which is an enzyme that interferes with natural substances necessary for cancer cell growth.
Danish: Spectrila indeholder asparaginase, som er et enzym, der påvirker naturlige stoffer, der er nødvendige for væksten af kræftceller.
English: Expert advice should first be sought.
Danish: Der bør først søges ekspertrådgivning.
English: Treatment may be monitored based on the trough serum asparaginase activity measured three days after administration of Spectrila.
Danish: Behandlingen kan overvåges baseret på den minimale serum-asparaginaseaktivitet målt tre dage efter administration af Spectrila.
English: Spectrila should be prescribed and administered by physicians and health care personnel experienced in the use of antineoplastic products.
Danish: Spectrila skal ordineres og administreres af læger og sundhedspersonale med erfaring i at anvende antineoplastiske præparater.
English: Non-clinical repeat-dose toxicity and safety pharmacology studies in rats revealed no special hazard for humans, except a slight but significant saluretic effect at doses below the recommended dose for ALL/LBL patients.
Danish: Prækliniske studier med gentagne doser af toksicitet og sikkerhedsfarmakologi hos rotter afdækkede ingen specielle farer for mennesker, undtagen en lille, men signifikant saluretisk virkning ved doser under den anbefalede dosis for ALL/LBL-patienter.
English: A few cases of asparaginase-induced parotitis have been reported in the literature.
Danish: Der er blevet rapporteret nogle få tilfælde af asparaginase-induceret parotitis i litteraturen.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for asparaginase (centrally authorised product), the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for asparaginase (centralt godkendt præparat) er CHMP nået frem til følgende videnskabelige konklusioner:
English: Asparaginase must not be administered as a bolus dose.
Danish: Asparaginase må ikke administreres som en bolusdosis.
English: • changes in the electroencephalogram (a trace of the electrical activity of your brain)
Danish: • ændringer i elektroencefalogrammet (en afbildning af den elektriske aktivitet i din hjerne)
English: Laboratory in vitro and in vivo data indicate that the efficacy of high-dose cytarabine is reduced by prior administration of asparaginase.
Danish: Laboratorie in vitro- og in vivo-data indikerer, at virkningen af højdosis cytarabin reduceres ved forudgående administration af asparaginase.
English: To avoid this, vincristine is usually given 3 - 24 hours before asparaginase.
Danish: For at undgå dette gives vincristin normalt 3 - 24 timer før asparaginase.
English: Serum amylase and lipase are usually elevated, although in some patients they can be normal due to impaired protein synthesis.
Danish: Serum-amylase og lipase er normalt forhøjet, selvom de kan være normale hos nogle patienter på grund af en hæmmet proteinsyntese.
English: However, in rare cases severe hypertriglyceridaemia (triglycerides > 1,000 mg/dl) has been reported which increases the risk of development of acute pancreatitis.
Danish: Der er imidlertid blevet rapporteret sjældne tilfælde af svær hypertriglyceridæmi (triglycerider > 1.000 mg/dl), hvilket øger risikoen for udvikling af akut pankreatitis.
English: Allergic reactions within 12 hours after asparaginase infusion during induction treatment Any allergic event* within 24 hours after asparaginase infusion during induction treatment
Danish: Allergisk reaktion inden for 12 timer efter asparaginaseinfusion i løbet af induktionsbehandlingen Enhver allergisk hændelse* inden for 24 timer efter asparaginaseinfusion i løbet af induktionsbehandlingen
English: Storage would normally not be longer than 24 hours at 2 °C - 8 °C.
Danish: Opbevaringstiden vil normalt ikke være længere end 24 timer ved temperaturer fra 2 °C - 8 °C.
English: Simultaneous vaccination with live vaccines may increase the risk of a serious infection.
Danish: Samtidig vaccination med levende vacciner kan øge risikoen for en alvorlig infektion.
English: Children 0 - 12 months old
Danish: Børn i alderen 0 - 12 år
English: In a clinical trial in children with newly diagnosed ALL (study MC-ASP.5/ALL), the following frequencies of allergic events were observed (table 2).
Danish: I et klinisk studie hos børn med nydiagnosticeret ALL (studie MC-ASP.5/ALL) blev der observeret de følgende hyppigheder af allergiske hændelser (tabel 2).
English: Changes in endocrine pancreatic function are observed very commonly during treatment with asparaginase and manifest predominantly as hyperglycaemia.
Danish: Ændringer i endokrin pankreasfunktion observeres hyppigt i løbet af behandlingen med asparaginase og manifesterer sig primært som hyperglykæmi.
English: Data on efficacy and safety of Spectrila in adults are limited.
Danish: Data for virkning og sikkerhed af Spectrila hos voksne er begrænset.
English: In addition to asparagine, asparaginase is also able to cleave the amino acid glutamine to glutamic acid and ammonia, however with much less efficiency.
Danish: I tillæg til asparagin er asparaginase også i stand til at kløve aminosyren glutamin til glutaminsyre og ammoniak, men med meget mindre effektivitet.
English: Due to the asparagine concentration gradient between the extra- and intravascular space, asparagine levels are subsequently also reduced in the extravascular spaces, e.g. the cerebrospinal fluid.
Danish: På grund af koncentrationsgradienten af asparagin mellem det ekstra- og intravaskulære rum reduceres asparaginniveauerne efterfølgende også i de ekstravaskulære rum, f.eks. cerebrospinalvæsken.
English: Conversely, the antitumour effects of methotrexate are enhanced when asparaginase is administered 24 hours following methotrexate treatment.
Danish: Omvendt forstærkes antitumor-virkningen af methotrexat, når asparaginase administreres 24 timer efter behandling med methotrexat.
English: The toxicity of vincristine may be additive with that of asparaginase if both agents are administered concomitantly.
Danish: Toksiciteten af vincristin kan være additiv med aktiviteten af asparaginase, hvis begge stoffer administreres samtidigt.
English: During treatment with asparaginase-containing regimens, myelosuppression, potentially affecting all three cell lines, and infections can occur.
Danish: I løbet af behandling med asparaginase-indeholdende behandlingsprogrammer kan der opstå myelosuppression, der muligvis påvirker alle tre cellelinjer, samt infektioner.
English: Asparaginase is produced by recombinant DNA technology in a microorganism named Escherichia coli.
Danish: Asparaginase fremstilles ved hjælp af rekombinant dna-teknologi i en mikroorganisme, der kaldes Escherichia coli.
English: There is no known case of an overdose with asparaginase where patients showed any signs of an overdose.
Danish: Der er ingen kendte tilfælde af overdosering med asparaginase, hvor patienterne viste nogen tegn på en overdosering.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering er bivirkningerne opstillet efter faldende alvorlighedsgrad.
English: Blood clotting disorders may require you to receive fresh plasma or a certain type of protein (antithrombin III) in order to reduce the risk of bleeding or formation of blood clots (thrombosis).
Danish: Blodstørkningsforstyrrelser kan kræve, at du får frisk plasma eller en bestemt type protein (antitrombin III) for at reducere risikoen for blødning eller dannelse af blodpropper (trombose).
English: The recommended dose in infants aged 0 - 12 months is as follows: - age less than 6 months:
Danish: Den anbefalede dosis til spædbørn i alderen 0 - 12 måneder er følgende: - alder under 6 måneder:
English: This antagonism is observed if asparaginase is administered prior to or concurrently with methotrexate.
Danish: Denne antagonisme observeres, hvis asparaginase administreres før eller samtidigt med methotrexat.
English: Spectrila should not be used during pregnancy unless the clinical condition of the woman requires treatment with asparaginase.
Danish: Spectrila må ikke anvendes i løbet af graviditeten medmindre kvindens kliniske tilstand kræver behandling med asparaginase.
English: A comparable proportion of patients in both groups developed anti-asparaginase antibodies before the start of the post-induction treatment phase (Spectrila 54.6 % vs. reference E. coli-asparaginase 52.5 %).
Danish: En tilsvarende andel patienter i begge grupper udviklede anti-asparaginase-antistoffer før behandlingsfasen efter induktion blev påbegyndt (Spectrila 54,6 % vs. reference E. coli-asparaginase 52,5 %).
English: Based on results from animal studies and its mechanism of action, Spectrila should not be used during pregnancy unless the clinical condition of the woman requires treatment with asparaginase.
Danish: Baseret på resultater fra dyrestudier og virkningsmekanismen må Spectrila ikke anvendes i løbet af graviditeten medmindre kvindens kliniske tilstand kræver behandling med asparaginase.
English: In contrast to normal cells, lymphoblastic tumour cells have a very limited capacity for synthesising asparagine because of a significantly reduced expression of asparagine synthetase.
Danish: I modsætning til normale celler har lymfoblastiske tumorceller en meget begrænset kapacitet for at syntetisere asparagin, på grund af en signifikant reduceret ekspression af asparaginsyntetase.
English: The mean asparagine concentrations in serum remained below 0.5 µM from immediately after the end of first infusion of asparaginase until at least three days after the last infusion.
Danish: De gennemsnitlige asparaginkoncentrationer i serum forblev under 0,5 µM fra, straks efter den første infusion af asparaginase var endt, indtil mindst tre dage efter den sidste infusion.
English: Data on efficacy and safety of Spectrila in the post-induction treatment phases are very limited.
Danish: Data for virkning og sikkerhed af Spectrila i behandlingsfaserne efter induktion er meget begrænset.
English: • abnormal laboratory tests including changes in protein levels in the blood, changes in blood fat or in liver enzyme values or high level of urea in the blood
Danish: • unormale laboratorieprøver, herunder ændrede proteinniveauer i blodet, ændringer i blodfedt eller i leverenzymværdier eller høje niveauer af urinstof i blodet
English: This regimen has been shown to reduce the gastrointestinal and haematological effects of methotrexate.
Danish: Dette behandlingsprogram har vist sig at reducere den gastrointestinale og hæmatologiske virkning af methotrexat.
English: The primary toxicity of asparaginase results from immunologic reactions caused by exposure to the bacterial protein.
Danish: Den primære toksicitet af asparaginase stammer fra immunologiske reaktioner forårsaget af eksponeringen for bakterielt protein.
English: The majority of anti-asparaginase antibodies developed in the time gap between the last asparaginase infusion on day 33 and start of post-induction treatment at day 79.
Danish: Hovedparten af anti-asparaginase-antistoffer blev udviklet i tidsrummet fra den sidste asparaginaseinfusion på dag 33, og til behandlingen efter induktion blev påbegyndt på dag 79.
English: Concomitant vaccination with live vaccines increases the risk of serious infection.
Danish: Samtidig vaccination med levende vacciner øger risikoen for en alvorlig infektion.
English: This can promote tendency to bleeding (anticoagulants) or thrombosis (glucocorticoids).
Danish: Dette kan fremme tendensen til blødning (antikoagulantia) eller trombose (glukokortikoider).
English: Most hypersensitivity reactions to asparaginase are observed during subsequent treatment phases (reinduction treatment, delayed intensification).
Danish: De fleste overfølsomhedsreaktioner over for asparaginase observeres i løbet af efterfølgende behandlingsfaser (behandling med gentagen induktion, forsinket intensivering).
English: The metabolism of asparaginase is not known but thought to occur via degradation within the reticulohistiocytic system and by serum proteases.
Danish: Metabolismen for asparaginase er ukendt, men menes at finde sted via nedbrydning i det retikulohistiocytiske system og af serum-proteaser.
English: Preferably, levels should be measured three days after the last asparaginase administration, i.e. usually directly before the next dose of asparaginase is given.
Danish: Niveauerne skal helst måles tre dage efter den sidste administration af asparaginase, dvs. normalt lige før den næste dosis asparaginase gives.
English: On the basis of the scientific conclusions for asparaginase (centrally authorised product) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing asparaginase (centrally authorised product) is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for asparaginase (centralt godkendt præparat) er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder asparaginase (centralt godkendt præparat), forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.