FrancophonIA/ELRC3.0 huggingface dataset:
English: Simultaneous vaccination with live vaccines may increase the risk of severe infections attributable to the immunosuppressive activity of pegaspargase, the presence of the underlying disease and combination chemotherapy (see section 4.4).
Danish: Samtidig vaccination med levende vacciner kan øge risikoen for svære infektioner, der kan tilskrives pegaspargases immunsupprimerende aktivitet, forekomsten af den underliggende sygdom og kombinationskemoterapi (se pkt.
English: Oncaspar may cause central nervous system dysfunctions manifesting as convulsions, and less frequently confusional state and somnolence (mildly impaired consciousness).
Danish: Oncaspar kan forårsage dysfunktion i centralnervesystemet, der manifesterer sig som kramper og mindre hyppigt som en konfusionstilstand og somnolens (let nedsat bevidsthed).
English: It is strongly recommended that every time Oncaspar is administered to a patient, the name and lot number of the product are recorded in order to link the patient and the lot of the product.
Danish: Det anbefales kraftigt, at produktets navn og lotnummer registreres, hver gang Oncaspar administreres til en patient, for at forbinde patienten med produktets lot.
English: Pegaspargase can interfere with metabolism and clearance of other medicinal products, based on its effects on protein synthesis and hepatic function, as well as from its combined use with other chemotherapy products known to interact with CYP enzymes.
Danish: Pegaspargase kan påvirke metabolisme og clearance af andre lægemidler baseret på dets virkninger på proteinsyntese og leverfunktion, samt fra dets kombinerede anvendelse med andre kemoterapilægemidler, der vides at interagere med CYP-enzymer.
English: If these substances are given subsequently, the effect of pegaspargase can be weakened antagonistically.
Danish: Hvis disse stoffer gives efter Oncaspar, kan pegaspargases virkning blive nedsat gennem en antagonistisk effekt.
English: Do not infuse other medicinal products through the same intravenous line during administration of Oncaspar.
Danish: Der må ikke infunderes andre lægemidler i samme intravenøse linje under administrationen af Oncaspar.
English: Anti-leukaemic effect of L-asparaginase is related to a sustained L-asparagine depletion in blood and cerebrospinal fluid (CSF).
Danish: Den antileukæmiske virkning af L-asparaginase er relateret til vedvarende depletering af L-asparagin i blod og cerebrospinalvæske (CSF).
English: Not known: Renal failure acute*
Danish: Ikke kendt: akut nyresvigt*
English: Severe hepatic impairment (bilirubin >3 times upper limit of normal [ULN]; transaminases >10 times ULN).
Danish: Nedsat leverfunktion i svær grad (bilirubin > 3 gange den øvre normalgrænse [ULN], transferaser > 10 gange ULN).
English: Patients should be informed about possible hypersensitivity reactions to Oncaspar, including immediate anaphylaxis.
Danish: Patienterne skal informeres om muligheden for overfølsomhedsreaktioner mod Oncaspar, herunder øjeblikkelig anafylaksi.
English: Therefore, the concomitant use of Oncaspar with oral contraceptives is not recommended.
Danish: Derfor frarådes samtidig anvendelse af Oncaspar med orale kontraceptiva.
English: Inflammation of the pancreas, that in some cases caused death, can occur with Oncaspar treatment.
Danish: Der kan opstå betændelse i bugspytkirtlen, som i nogle tilfælde forårsagede dødsfald, ved behandling med Oncaspar.
English: Oncaspar is to be administered intravenously or intramuscularly after reconstitution of the product.
Danish: Oncaspar administreres intravenøst eller instramuskulært efter rekonstitution af lægemidlet.
English: For smaller volumes, the preferred route of administration is intramuscular.
Danish: Ved mindre mængder anbefales den intramuskulære administrationsvej.
English: At 4-years, the EFS and overall survival (OS) for the Oncaspar treatment arm were 81.8% [95% CI 62.9-91.7%] and 90.4% [95% CI 78.5-95.9%], respectively.
Danish: Efter 4 år var hændelsesfri overlevelse (EFS) og samlet overlevelse (OS) for den behandlingsgruppe, der fik Oncaspar, henholdsvis 81,8 % [95 % CI 62,9-91,7 %] og 90,4 % [95 % CI 78,5-95,9 %].
English: Rare (may affect up to 1 in 1,000 people) - Liver failure.
Danish: Sjældne (kan ses hos op til 1 ud af 1.000 patienter) - Leversvigt
English: There have been rare reports of cholestasis, icterus, hepatic cell necrosis and hepatic failure with fatal outcome.
Danish: Der har været sjældne rapporter om cholestase, icterus, hepatisk cellenekrose og leversvigt med dødelig udgang.
English: The percentage of patients in the Oncaspar treatment arm with evaluable minimal residual disease (MRD) negative status (<0.1% leukaemia cells in bone marrow) at Day 29 of Induction was 80% (40/50).
Danish: Procentdelen af patienter i den behandlingsgruppe, som fik Oncaspar, med en negativ status for evaluerbar minimal restsygdom (MRD) (< 0,1 % leukæmiceller i knoglemarv) på dag 29 i induktionen var 80 % (40/50).
English: During Induction (N=47; Study AALL07P4) PK Parameters
Danish: BSA under induktion (N=47; studiet AALL07P4) FK-parametre
English: MedDRA standard system organ class
Danish: Systemorganklasser i henhold til MedDRAstandarden
English: The medicinal product should be administered intravenously or intramuscularly.
Danish: Lægemidlet skal administreres intravenøst eller intramuskulært.
English: Caution is required when Oncaspar is given in combination with hepatotoxic products, especially if there is pre-existing hepatic impairment.
Danish: Der skal udvises forsigtighed, når Oncaspar gives i kombination med hepatotoksiske produkter, især hvis der i forvejen er nedsat leverfunktion.
English: The mean plasma half-life of Oncaspar was 8 days in non-hypersensitive patients (AUC 10.35 U/ml/day), and 2.7 days in hypersensitive patients (AUC 3.52 U/ml/day).
Danish: Oncaspars gennemsnitlige halveringstid i plasma var 8 dage hos patienter, der ikke var overfølsomme (AUC 10,35 E/ml/dag), og 2,7 dage hos overfølsomme patienter (AUC 3,52 E/ml/dag).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er praktisk talt natriumfrit.
English: There may be an increased risk of hepatotoxicity in Philadelphia chromosome positive patients, for whom treatment with tyrosine kinase inhibitors (e.g., imatinib) is combined with L-asparaginase therapy.
Danish: Der kan være en forhøjet risiko for hepatotoksicitet hos patienter, som er positive for Philadelphiakromosom, hvis behandling med tyrosinkinaseinhibitorer (f.eks. imatinib) kombineres med L-asparaginase-terapi.
English: Figure 1: Mean (± standard error) serum asparagine during Study CCG-1962 induction phase
Danish: Figur 1: Gennemsnitligt (± standardfejl) asparaginniveau i serum i løbet af induktionsfasen i studiet CCG-1962
English: 5.2 ml water for injections are injected into the vial using a syringe and 21 gauge needle.
Danish: 5,2 ml vand til injektionsvæsker injiceres i hætteglasset ved hjælp af en injektionssprøjte og en kanyle på 21 gauge.
English: Patients who receive Oncaspar are at increased risk of bleeding and thrombotic disorders.
Danish: Patienter, der får Oncaspar, har forhøjet risiko for blødninger og trombosesygdomme.
English: When Oncaspar is used in combination with other cancer treatments, liver and central nervous system damage can occur.
Danish: Når Oncaspar bruges i kombination med andre midler mod kræft, kan der opstå skader i leveren eller centralnervesystemet.
English: The active substance is pegaspargase.
Danish: Aktivt stof: pegaspargase.
English: The volume of distribution at steady-state and clearance were estimated at 1.86 L/m2 and 0.169 L/m2 per day, respectively.
Danish: Fordelingsvolumenen ved steady-state og clearance blev estimeret til at være hhv. 1,86 l/m og 0,169 l/m
English: Other medicines and Oncaspar Tell your doctor if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med Oncaspar Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: It is not known whether pegaspargase is excreted into breast milk.
Danish: Det er ukendt, om pegaspargase udskilles i human mælk.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør lægemidlet anvendes straks, medmindre rekonstitutionsmetoden udelukker risiko for mikrobiel kontaminering.
English: The One-year EFS was 98.0 [95%CI 92.3, 99.5]; the One-year OS was 100 [95% CI 100, 100] in this study.
Danish: EFS efter 1 år var 98,0 [95 % CI 92,3, 99,5]; OS efter 1 år var 100 [95 % CI 100, 100] i dette studie.
English: In addition, Oncaspar studies using the intramuscular route of administration (studies CCG-1962 and CCG-1991) were also considered to determine the safety profile (see section 5.1).
Danish: Endvidere blev studier med Oncaspar administreret via den intramuskulære administrationsvej (studierne CCG-1962 og CCG-1991) også taget i betragtning ved bestemmelse af sikkerhedsprofilen (se pkt.
English: As a routine precautionary measure the patient should be monitored for an hour after administration; resuscitation equipment and other appropriate means for the treatment of anaphylaxis should be available (epinephrine, oxygen, intravenous steroids, etc.).
Danish: Som en rutinemæssig forholdsregel skal patienten overvåges i en time efter administrationen; genoplivningsudstyr og andre passende midler til behandling af anafylaksi skal være tilgængelige (adrenalin, oxygen, intravenøse steroider mv.).
English: The PEGylation does not change the enzymatic properties of L-asparaginase, but it influences the pharmacokinetics and immunogenicity of the enzyme.
Danish: Pegyleringen ændrer ikke Lasparaginase-enzymets egenskaber men påvirker enzymets farmakokinetik og immunogenicitet.
English: Inhalation of the vapour and contact with the skin and mucous membranes, especially the eyes, must be avoided.
Danish: Inhalation af damp og kontakt med hud og slimhinder, især øjnene, skal undgås.
English: Oncaspar is usually administered as part of combination chemotherapy protocols with other antineoplastic agents (see also section 4.5).
Danish: Oncaspar administreres sædvanligvis som en del af kemoterapiprotokollerne i kombination med andre antineoplastiske midler (se også pkt.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3,750 U
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 3.750 E
English: ALL patients with several relapses were treated either with Oncaspar or with native asparaginase from E. coli as part of an induction therapy.
Danish: ALL-patienter med flere tilbagefald blev behandlet med enten Oncaspar eller med naturligt forekommende asparaginase fra E. coli som en del af induktionsbehandlingen.
English: An indirect interaction cannot be ruled out between pegaspargase and oral contraceptives due to pegaspargase hepatotoxicity that may impair the hepatic clearance of oral contraceptives.
Danish: En indirekte interaktion kan ikke udelukkes mellem pegaspargase og oralt administrerede kontraceptiva på grund af pegaspargases hepatotoksicitet, der kan svække den hepatiske udskilning af orale kontraceptiva.
English: Acute renal failure may develop in rare cases during treatment with L-asparaginase-containing regimens.
Danish: Akut nyresvigt kan udvikles i sjældne tilfælde i løbet af behandling med regimer, hvori L-asparaginase indgår.
English: About half of all serious haemorrhages and thromboses affect cerebral vessels and can lead to e.g., stroke, seizure, headache or loss of consciousness.
Danish: Omkring halvdelen af alle alvorlige hæmoragier og tromboser påvirker de cerebrale kar og kan føre til f.eks. slagtilfælde, krampe, hovedpine eller bevidstløshed.
English: In this study, 118 paediatric patients aged 1 to 9 years with previously untreated standard-risk ALL were randomised 1:1 to Oncaspar or native E. coli L-asparaginase as part of combination therapy.
Danish: I dette studie blev 118 pædiatriske patienter i alderen 1 til 9 år med tidligere ubehandlet ALL med standardrisiko randomiseret 1:1 til Oncaspar eller naturligt forekommende L-asparaginase fra E. coli som en del af en kombinationsbehandling.
English: As impaired glucose tolerance may occur with concomitant use of Oncaspar with prednisone, blood glucose levels should be monitored.
Danish: Da der kan forekomme nedsat glucosetolerance ved samtidig behandling med Oncaspar og prednison, skal blodglucoseniveauer monitoreres.
English: Parenteral medicinal products should be inspected for particulate matter prior to administration, only a clear, colourless solution free from visible foreign particles should be used.
Danish: Parenterale lægemidler skal inspiceres for partikelmateriale før administration, og opløsningen må kun anvendes, hvis den fremstår klar og farveløs og fri for synlige fremmede partikler.
English: Oncaspar efficacy in ALL in patients with relapse/refractory disease and a history of prior clinical allergic reaction to native E. coli L-asparaginase was based on a pool of 94 patients from six open-label studies [ASP-001, ASP-201A, ASP-302, ASP-304, ASP-400 and ASP-001C/003C].
Danish: Oncaspars virkning på ALL hos patienter med recidiverende/refraktær sygdom og tidligere klinisk allergisk reaktion mod naturligt forekommende L-asparaginase fra E. coli blev baseret på en sammenlægning af 94 patienter i seks åbne studier [ASP-001, ASP-201A, ASP-302, ASP-304, ASP-400 og ASP-001C/003C].
English: Serum asparagine concentrations during the induction phase are shown in Figure 1.
Danish: Asparaginkoncentrationen i serum i løbet af induktionsfasen er vist i figur 1.
English: Talk to your doctor before you are given Oncaspar.
Danish: Kontakt lægen, før du bruger Oncaspar.
English: Since an indirect interaction between oral contraceptives and pegaspargase cannot be ruled out , oral contraceptives are not considered sufficiently safe in such clinical situation.
Danish: Da en indirekte interaktion mellem de orale kontraceptiva og pegaspargase ikke kan udelukkes, anses orale kontraceptiva ikke for tilstrækkeligt sikre i disse kliniske situationer.
English: Central nervous system effects
Danish: Virkninger på centralnervesystemet
English: Women of childbearing potential/Contraception in males and females Men and women should use effective contraception during treatment and for at least 6 months after Oncaspar discontinuation.
Danish: Kvinder i den fødedygtige alder/kontraception hos mænd og kvinder Mænd og kvinder skal anvende effektiv prævention i løbet af behandlingen og i mindst 6 måneder efter seponering af Oncaspar.
English: Adverse reactions and their frequencies are reported in Table 1.
Danish: Bivirkninger og hyppighed er angivet i skema 1.
English: No immunogenic response was detected in a 12-week study in mice in which pegaspargase was administered weekly at the dose of 10.5 U/mouse intramuscular or intraperitoneally.
Danish: Der blev ikke fundet immunogenicitet i et 12-ugers studier med mus, hvor pegaspargase blev administreret ugentligt med en dosis på 10,5 E pr. mus intramuskulært eller intraperitonealt.
English: A population pharmacokinetic evaluation of Oncaspar based on data obtained from Studies AALL07P4 (IV), DFCI 11-001 (IV), and CCG-1962 (IM) identified that clearance (linear and saturable) increased approximately proportional to BSA and volume of distribution increased slightly more proportional to BSA.
Danish: En populationsfarmakokinetisk evaluering af Oncaspar baseret på data indhentet fra studierne AALL07P4 (IV), DFCI 11-001 (IV), og CCG-1962 (IM) viste, at clearance (lineær og mættet) steg omtrent proportionalt med BSA og fordelingsvolumen steg lidt mere end proportionalt med BSA.
English: Table 2: Event-free survival rate at 3, 5 and 7 years (Study CCG-1962)
Danish: Skema 2: Hændelsesfri overlevelsesrate efter 3, 5 og 7 år (studiet CCG-1962)
English: One case of pancreatitis with simultaneous acute parotitis has been described with L-asparaginase treatment.
Danish: Et tilfælde af pancreatitis med samtidig akut parotitis er beskrevet i forbindelse med L-asparaginasebehandling.
English: Reproductive toxicity No studies of reproductive toxicity were conducted with pegaspargase.
Danish: Reproduktionstoksicitet Der blev ikke udført studier af reproduktionstoksicitet med pegaspargase.
English: Pancreatic effects
Danish: Virkninger på pancreas
English: If used at the same time as Oncaspar there is an increased risk of side effects or allergic reactions.
Danish: Hvis dette lægemiddel bruges sammen med Oncaspar, er der øget risiko for bivirkninger eller allergiske reaktioner.
English: Cases of encephalopathy (including reversible posterior leukoencephalopathy syndrome) have been reported (see section 4.8).
Danish: Tilfælde af encefalopati (herunder reversibelt posterior leukoencefalopati-syndrom) er blevet rapporteret (se pkt.
English: Do not use Oncaspar: - if you are allergic to pegaspargase or to any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Oncaspar: - Hvis du er allergisk over for pegaspargase eller over for et af de øvrige indholdsstoffer i
English: If used at the same time as Oncaspar, the effects on the clotting ability of your blood are increased.
Danish: Hvis det bruges samtidigt med Oncaspar, vil virkningen på blodets størkningsevne blive større.
English: Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.
Danish: Oncaspar er indiceret som en komponent af antineoplastisk kombinationsbehandling til behandling af akut lymfoblastisk leukæmi (ALL) hos pædiatriske patienter fra fødslen til 18 år og voksne.
English: The use of disposable gloves and protective garments is recommended when handling Oncaspar.
Danish: Det anbefales at bruge engangshandsker og beskyttelsesbeklædning ved håndtering af Oncaspar.
English: General disorders and administration side conditions Pyrexia can occur after the injection, which usually subsides spontaneously.
Danish: Almene symptomer og reaktioner på administrationsstedet Der kan opstå pyreksi efter injektionen, sædvanligvis fortager den sig spontant.
English: BSA during Induction, Consolidation, Delayed Intensification, and Interim Maintenance phases in patients with high-risk ALL receiving augmented Berlin-Frankfurt-Münster therapy.
Danish: konsolidering, efterfølgende intensifikation (DI) og foreløbig vedligeholdelse hos patienter med ALL med høj risiko, der fik forhøjet behandling efter Berlin-Frankfurt-Münster-regimet.
English: Further detailed information can be found in the SmPC.
Danish: Yderligere information fremgår af pkt.
English: Mild hepatotoxicity was observed with the same dosages.
Danish: Der sås let hepatotoksicitet med de samme doseringer.
English: Caution is therefore needed when anticoagulants such as coumarin, heparin, dipyridamole, acetylsalicylic acid or non-steroidal anti-inflammatory medicinal products are given concomitantly, or when concomitant chemotherapy regimen including methotrexate, daunorubicin, corticosteroids is administered.
Danish: Det er derfor nødvendigt at udvise forsigtighed ved samtidig administration af antikoagulantia som coumarin, heparin, dipyridamol, acetylsalicylsyre eller nonsteroide antiinflammatoriske lægemidler, eller ved samtidig administration af et kemoterapiregimen, herunder methotrexat, daunorubicin, kortikosteroider.
English: The immediate cell death of leukaemic cells in vivo, measured by rhodamine fluorescence, was the same for all three L-asparaginase preparations.
Danish: Øjeblikkelig celledød blandt in vivo-leukæmiceller målt med fluorescerende rhodamin var den samme med alle tre L-asparaginasepræparater.
English: Oncaspar may cause central nervous system signs and symptoms manifesting as somnolence, confusion, convulsions.
Danish: Oncaspar kan forårsage tegn og symptomer i centralnervesystemet, der manifesterer sig som somnolens, forvirring og kramper.
English: The remaining patients were treated with 2,000 or 2,500 U/m2 BSA administered intramuscularly or intravenously.
Danish: De øvrige patienter blev behandlet med 2.000 eller 2.500 E/m2 BSA administreret intramuskulært eller intravenøst.
English: A 4-week study in rats treated with a dose of pegaspargase of 400 U/kg/day intraperitoneal resulted in a fall in food intake and body weight compared to the control group.
Danish: I et 4-ugers studie med rotter behandlet med en dosis pegaspargase på 400 E/kg/dag intraperitonealt faldt foderindtagelsen og legemsvægten sammenlignet med kontrolgruppen.
English: Hypersensitivity reactions to pegaspargase, including life-threatening anaphylaxis, can occur during therapy, including in patients with known hypersensitivity to E. coli derived asparaginase formulations.
Danish: Overfølsomhedsreaktioner over for pegaspargase, herunder livstruende anafylaksi, kan opstå i løbet af behandling, inklusive hos patienter med kendt overfølsomhed over for asparginaseformuleringer, der stammer fra E. coli.
English: 5 ml solution in a vial (type I glass) with stopper (rubber) and a seal (aluminium) with flip-off cap.
Danish: 5 ml opløsning i et hætteglas (type I-glas) med prop (gummi) og forsegling (aluminium) med flip-offlåg.
English: Serum asparagine concentrations of approximately 1 µM persisted for approximately 3 weeks.
Danish: Koncentrationer af asparagin i serum på cirka 1 µmol/l vedvarede i cirka 3 uger.
English: - if you suffer abdominal pain.
Danish: - Hvis du lider af mavesmerter.
English: Pharmacokinetic/pharmacodynamic nonclinical comparability between the two pharmaceutical forms of Oncaspar, solution for injection/infusion, and powder for solution, was demonstrated in dogs after single and repeated doses (500 U/kg), by the intravenous route.
Danish: Den ikke-kliniske farmakokinetiske/farmakodynamiske sammenlignelighed mellem Oncaspars to lægemiddelformer, injektions-/infusionsvæske, opløsning, og pulver til opløsning, blev påvist hos hunde efter intravenøs administration af enkeltdosis og gentagne doser (500 E/kg).
English: CSF asparagine decreased from a mean pre-treatment concentration of 3.1 µM to 1.7 µM on Day 4 ± 1 and 1.5 µM at 25 ± 1 days after administration of Oncaspar.
Danish: CSF-asparagin faldt fra en gennemsnitlig koncentration før behandlingen på 3,1 µmol/l til 1,7 µmol/l på dag 4 ± 1 og 1,5 µmol/l på dag 25 ± 1 dag efter administration af Oncaspar.
English: In addition, by inhibiting protein synthesis and cell division, pegaspargase can disturb the mechanism of action of other substances which require cell division for their effect, e.g., methotrexate.
Danish: Desuden kan pegaspargase gennem inhibering af proteinsyntesen og celledelingen forstyrre virkningsmekanismen for andre stoffer, som bruger celledeling som en del af virkningen, f.eks. methotrexat.
English: The symptoms of hyperammonaemia are often transient in nature and can include: nausea, vomiting, headache, dizziness and rash.
Danish: Symptomerne på hyperammoniæmi er ofte forbigående og kan inkludere: kvalme, opkastning, hovedpine, svimmelhed og udslæt.
English: Additional monitoring tests
Danish: Flere test til overvågning af patienten
English: Fertility No studies investigating the effect of pegaspargase on fertility have been performed.
Danish: Fertilitet Der er ikke udført studier, der undersøger pegaspargases påvirkning af fertiliteten.
English: Rare (may affect up to 1 in 1,000 people) - Reversible posterior leukoencephalopathy syndrome (RPLS), a syndrome characterised by headache, confusion, seizures and visual loss which resolves after some time.
Danish: Sjældne (kan ses hos op til 1 ud af 1.000 patienter) - Reversibelt posterior leukoencefalopati-syndrom (RPLS), et syndrom der er kendetegnet ved hovedpine, forvirring, kramper og synstab, som fortager sig efter nogen tid
English: Women who are able to get pregnant must use reliable contraception during treatment, and for at least 6 months after Oncaspar treatment has been discontinued.
Danish: Kvinder, som kan blive gravide, skal bruge pålidelig prævention i løbet af behandlingen og i mindst 6 måneder efter, at behandlingen med Oncaspar er ophørt.