FrancophonIA/ELRC3.0 huggingface dataset:
English: Asparaginase caused an increase in the incidence of malformations (including those of the central nervous system, heart and skeletal system) and foetal death at doses that are similar to or in excess of those proposed clinically (on a U/m² basis) in a number of species including the mouse, rat and/or rabbit.
Danish: Asparaginase forårsagede en større hyppighed af misdannelser (herunder i centralnervesystemet, hjertet og skeletsystemet) og fosterdød ved doser tilsvarende eller større end de anbefalede kliniske doser (på basis af E/m²) hos flere arter, herunder mus, rotter og/eller kaniner.
English: *Produced in Escherichia coli cells by recombinant DNA technology.
Danish: *Fremstillet i Escherichia coli-celler med rekombinant dna-teknologi.
English: Spectrila has moderate influence on the ability to drive and use machines, especially through its potential effects on the nervous and gastrointestinal systems (see section 4.8).
Danish: Spectrila påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner, især via den mulige virkning på nerve- og mave-tarm-systemerne (se pkt.
English: • Other anti-cancer medicines as they may contribute to the release of too much uric acid when tumour cells are destroyed by asparaginase.
Danish: • Andre lægemidler mod kræft, da de kan bidrage til frigivelse af for meget urinsyre, når tumorcellerne ødelægges af asparaginase.
English: Expert advice should be sought.
Danish: Der bør søges ekspertrådgivning.
English: Pharmacokinetic parameters of Spectrila were determined in 7 adult patients after intravenous infusion of 5,000 U/m².
Danish: Farmakokinetiske parametre for Spectrila blev bestemt hos 7 voksne patienter efter en intravenøs infusion på 5.000 E/m².
English: • nervousness (agitation) or somnolence (sleepiness)
Danish: • nervøsitet (agitation) eller døsighed (søvnighed)
English: You should therefore not receive vaccination with live vaccines until at least 3 months after the end of treatment with Spectrila.
Danish: Du bør derfor ikke blive vaccineret med levende vacciner indtil mindst 3 måneder efter behandlingen med Spectrila er ophørt.
English: Table 3: Efficacy results (MC-ASP.5/ALL; Full analysis set)
Danish: Tabel 3: Virkningsresultater (MC-ASP.5/ALL, komplet analysesæt)
English: Complete remission rate at end of induction treatment Yes
Danish: Komplet remissionsrate efter induktionsbehandling Ja
English: After induction treatment, patients continued treatment with chemotherapy regimens which included further treatment with asparaginases.
Danish: Efter induktionsbehandlingen fortsætte patienterne behandling med kemoterapi-programmer, der omfattede yderligere behandling med asparaginaser.
English: Hypoglycaemia mostly without clinical symptoms has been commonly observed in patients treated with asparaginase.
Danish: Hypoglykæmi, for det meste uden kliniske symptomer, er hyppigt blevet observeret hos patienter i behandling med asparaginase.
English: If you are sexually mature you must use contraceptives or remain abstinent during chemotherapy and for up to 3 months after the end of treatment.
Danish: Hvis du er kønsmoden, skal du anvende prævention eller være afholdende i løbet af kemoterapien og i op til 3 måneder efter endt behandling.
English: Concomitant treatment with myelosuppressive medicinal products and those known to cause infections are major contributing factors and patients should be carefully monitored for signs and symptoms of myelosuppression and infection (see section 4.8).
Danish: Samtidig behandling med myelosuppressive lægemidler samt lægemidler, der vides at forårsage infektioner, er primære bidragende faktorer, og patienterne skal overvåges nøje for tegn og symptomer på myelosuppression og infektion (se pkt.
English: Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.
Danish: Spectrila 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: Low asparaginase activity levels are often accompanied by the appearance of anti-asparaginase antibodies.
Danish: Lavt aktivitetsniveau af asparaginase ledsages ofte af fremkomsten af anti-asparaginase-antistoffer.
English: Treatment with asparaginase should be discontinued in patients developing acute pancreatitis.
Danish: Behandlingen med asparaginase bør seponeres hos patienter, der udvikler akut pankreatitis.
English: Efficacy and safety of Spectrila have not been established in Philadelphia chromosome-positive patients.
Danish: Philadelphiakromosom-positive patienter Spectrilas virkning og sikkerhed er ikke klarlagt hos Philadelphiakromosom-positive patienter.
English: Asparaginase-associated hyperlipidaemia should be treated depending on its severity and on clinical symptoms.
Danish: Asparaginase-associeret hyperlipidæmi bør behandles afhængigt af sværhedsgraden og af de kliniske symptomer.
English: Common Depression, hallucination, confusion
Danish: Almindelig Depression, hallucination, forvirring
English: Because of the risk of severe anaphylactic reactions asparaginase should not be administered as a bolus intravenous injection.
Danish: På grund af risikoen for svære anafylaktiske reaktioner må asparaginase ikke administreres som en bolus intravenøs injektion.
English: Spectrila is available in packs containing 1 or 5 vials.
Danish: Spectrila fås i pakninger med 1 eller 5 hætteglas.
English: • coagulation disorders including symptomatic thrombosis related to the use of central venous catheters,
Danish: • koagulationsforstyrrelser, herunder symptomatisk trombose relateret til anvendelsen af centrale venekatetre,
English: Additionally, the urinary pH value and the relative weight of kidneys were increased at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: Desuden var pH-værdien i urin og den relative vægt af nyrerne forhøjet ved eksponeringer, der anses for at overstige den maksimale humane eksponering i væsentlig grad.
English: The following adverse reactions, listed in table 1, have been accumulated from clinical trials with Spectrila in 125 children with newly diagnosed acute lymphoblastic leukaemia as well as postmarketing experience with other E. coli-derived asparaginase preparations in children and adults.
Danish: De følgende bivirkninger, opstillet i tabel 1, er indsamlet fra kliniske studier med Spectrila hos 125 børn med nydiagnosticeret akut lymfoblastisk leukæmi samt erfaring efter markedsføring med andre E. coli-deriverede asparaginase-præparater hos børn og unge.
English: It is unknown whether asparaginase is present in human breast milk.
Danish: Det er ukendt, om asparaginase er til stede i human brystmælk.
English: If allergic symptoms occur, intravenous infusion of Spectrila must be discontinued immediately.
Danish: Hvis der opstår allergiske symptomer, skal den intravenøse infusion af Spectrila straks afbrydes.
English: Patients received 5,000 U/m² asparaginase (Spectrila versus a reference E.coli- asparaginase) at days 12, 15, 18, 21, 24, 27, 30, and 33 of induction treatment.
Danish: Patienterne fik 5.000 E/m² asparaginase (Spectrila versus en reference E. coli- asparaginase) på dag 12, 15, 18, 21, 24, 27, 30 og 33 af induktionsbehandlingen.
English: • Pancreatitis.
Danish: • Pankreatitis.
English: If severe liver problems occur, treatment with Spectrila must be interrupted immediately.
Danish: Hvis der opstår svære leverproblemer, skal behandlingen med Spectrila straks afbrydes.
English: Myelosuppressive agents
Danish: Myelosuppressive stoffer
English: Colourless 20 ml glass vial (Type I glass) closed with butylrubber stopper, aluminium seal and plastic flip-off cap, containing 10,000 units of asparaginase.
Danish: Farveløst 20 ml hætteglas (type I-glas), lukket med en prop af butylgummi, aluminiumsforsegling og plastic flip-off-låg, indeholdende 10.000 enheder asparaginase.
English: Because potential serious adverse reactions may occur in nursing infants, Spectrila should be discontinued during breast-feeding.
Danish: Da der kan opstå mulige alvorlige bivirkninger hos ammende spædbørn, bør Spectrila seponeres i løbet af amningen.
English: Asparaginase lowers asparagine level in blood cancer cells and stops the cancer growing.
Danish: Asparaginase sænker asparaginniveauet i blodets kræftceller og stopper kræftens vækst.
English: • Severe hepatic impairment (bilirubin > 3 times upper limit of normal [ULN]; transaminases
Danish: • Svært nedsat leverfunktion (bilirubin > 3 gange den øvre normalgrænse [ULN], transaminaser
English: Warnings and precautions Talk to your doctor or nurse before you are given Spectrila.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sundhedspersonalet, før du får administreret Spectrila.
English: Liver parameters should be monitored closely before and during treatment with asparaginase.
Danish: Leverparametrene skal overvåges nøje før og under behandlingen med asparaginase.
English: Concomitant use of glucocorticoids and/ or anticoagulants with asparaginase may increase the risk of a change in coagulation parameters (see section 4.4).
Danish: Anvendelse af glukokortikoider og/eller antikoagulantia sammen med asparaginase kan øge risikoen for en ændring i koagulationsparametre (se pkt.
English: If asparaginase activity values fail to reach target levels, a switch to a different asparaginase preparation could be considered (see section 4.4).
Danish: Hvis værdierne for asparaginaseaktiviteten ikke når målniveauerne, kan det overvejes at skifte til et andet asparaginasepræparat (se pkt.
English: Serum and urine glucose levels should be regularly monitored and managed as clinically indicated.
Danish: Glucoseniveauer i serum og urin bør overvåges regelmæssigt og behandles efter klinisk indikation.
English: However, Spectrila should not be used in patients with severe hepatic impairment (see section 4.3).
Danish: Spectrila bør imidlertid ikke anvendes hos patienter med svært nedsat leverfunktion (se pkt.
English: Since Spectrila is usually used in combination therapy with other antineoplastic agents, the demarcation from undesirable effects of other medicinal products is often difficult.
Danish: Da Spectrila normalt anvendes til kombinationsbehandling med andre antineoplastiske stoffer, er det ofte svært at skelne fra bivirkningerne fra andre lægemidler.
English: Immunisation with live vaccines should therefore take place at the earliest 3 months after completion of the course of antileukaemic treatment.
Danish: Immunisering med levende vacciner bør derfor finde sted tidligst 3 måneder efter et behandlingsforløb mod leukæmi er færdigt.
English: Clinical trials with asparaginase have shown that glutamine levels are only moderately affected with a very high interindividual variability.
Danish: Kliniske studier med asparaginase har vist, at glutaminniveauerne kun påvirkes i moderat grad med en meget stor variabilitet fra individ til individ.
English: Asparaginase may increase the toxicity of other medicinal products through its effect on liver function, e.g. increased hepatotoxicity with potentially hepatotoxic medicines, increased toxicity of medicinal products metabolised by the liver or bound to plasma proteins and altered pharmacokinetics and pharmacodynamics of medicines bound to plasma proteins.
Danish: Asparaginase kan øge toksiciteten af andre lægemidler via virkningen på leverfunktionen, f.eks. øget hepatotoksicitet med potentielt hepatotoksiske lægemidler, øget toksicitet af lægemidler, der metaboliseres af leveren eller bindes til plasmaproteiner, og ændret farmakokinetik og farmakodynamik af lægemidler, der er bundet til plasmaproteiner.
English: Median (range) maximum serum concentrations of asparaginase activity were 2,324 U/l (1,6254,819 U/l).
Danish: Mediane (interval) maksimale serumkoncentrationer for asparaginaseaktiviteten var 2.324 E/l (1.6254.819 E/l).
English: The following life-threatening situations may arise during asparaginase treatment in patients of all age groups:
Danish: Der kan opstå de følgende livstruende situationer i løbet af behandlingen med asparaginase hos patienter i alle aldersgrupper:
English: Complete asparagine depletion in CSF Yesc
Danish: Komplet asparagintømning i CSF Ja c
English: • severe liver function abnormalities (determined by laboratory tests),
Danish: • meget unormal leverfunktion (bestemt ved laboratorieprøver),
English: The powder is white and it is supplied in a clear glass vial with a rubber stopper and an aluminium seal and a plastic flip-off cap.
Danish: Pulveret er hvidt, og det leveres i et klart hætteglas med en gummiprop og en aluminiumsforsegling og et flip-off-låg af plastic.
English: Effective contraception must be used during treatment and for at least 3 months after asparaginase discontinuation.
Danish: Der skal anvendes sikker kontraception under behandlingen og i mindst 3 måneder efter seponering af asparaginase.
English: If allergic symptoms occur, administration of asparaginase must be discontinued immediately and appropriate treatment given, which may include antihistamines and corticosteroids.
Danish: Hvis der opstår allergiske symptomer, skal administrationen af asparaginase straks seponeres og der skal gives passende behandling, hvilket kan omfatte antihistaminer og kortikosteroider.
English: • Asparaginase may influence the efficacy of methotrexate or cytarabine (used to treat certain types of cancer): - if asparaginase is given after these agents their effect may be increased.
Danish: • Asparaginase kan påvirke virkningen af methotrexat eller cytarabin (anvendes til at behandle visse kræfttyper): hvis asparaginase gives efter disse stoffer, kan deres virkning være øget.
English: Patients received asparaginase at a dose of 10,000 U/m², adjusted to the current age of the patient at the time of administration (< 6 months: 6,700 U/m²; 6 - 12 months: 7,500 U/m²; > 12 months: 10,000 U/m²) on days 15, 18, 22, 25, 29, and 33 of induction treatment.
Danish: Patienterne fik asparaginase ved en dosis på 10.000 E/m² justeret til patientens aktuelle alder på administrationstidspunktet (< 6 måneder: 6.700 E/m², 612 måneder: 7.500 E/m², > 12 måneder: 10.000 E/m²) på dag 15, 18, 22, 25, 29 og 33 af induktionsbehandlingen.
English: Contraceptives
Danish: Kontraception
English: Similarly to adults, the recommended dose in children and adolescents aged 1 - 18 years is 5,000 U per m² BSA given every third day.
Danish: Som for voksne er den anbefalede dosis til børn og unge i alderen 1 - 18 år 5.000 E pr. m² BSA, der gives hver tredje dag.
English: It is strongly recommended that every time Spectrila is administered to a patient, the tradename and batch number of the product should clearly be recorded in order to link the patient and the batch of the product.
Danish: Det anbefales kraftigt, at præparatets handelsnavn og batchnummer registreres tydeligt, hver gang Spectrila administreres til en patient, for at forbinde patienten med den pågældende batch af præparatet.
English: Peak (Cmax) of asparaginase activity in serum was reached with a delay of approximately 2 hours after the end of the infusion.
Danish: Maksimal (Cmax) asparaginaseaktivitet i serum blev nået med en forsinkelse på ca. 2 timer efter endt infusion.
English: The mean ± SD terminal half-life (elimination half-life) of asparaginase activity in serum was 25.8 ± 9.9 h, with a range between 14.2 and 44.2 h.
Danish: Den gennemsnitlige ± SD terminale halveringstid (eliminationshalveringstiden) for asparaginaseaktiviteten i serum var 25,8 ± 9,9 t med et interval fra 14,2 til 44,2 t.
English: The primary endpoint was the rate of patients with complete asparagine depletion in serum (defined as asparagine serum levels below the lower limit of quantification (< 0.5 µM) at all time points measured from day 12 up to day 33) during induction treatment.
Danish: Det primære endepunkt fra hyppigheden af patienter med fuldstændig asparagintømning i serum (defineret som serumniveauer af asparagin under den nedre kvantificeringsgrænse (< 0,5 µM) på alle tidspunkter målt fra dag 12 op til dag 33) i løbet af induktionsbehandlingen.
English: • Medicines which are metabolised in the liver, because the risk of side effects may increase.
Danish: • Lægemidler, som metaboliseres i leveren, da risikoen for bivirkninger kan forhøjes.
English: Patients with severe hypertriglyceridaemia are at increased risk of developing acute pancreatitis.
Danish: Patienter med svær hypertriglyceridæmi har en øget risiko for at udvikle akut pankreatitis.
English: EXP: In-use stability has been demonstrated for 2 days at 2 °C - 8 °C.
Danish: EXP: Der er blevet påvist stabilitet under brug i 2 dage ved 2 °C - 8 °C.
English: • Reversible posterior leukoencephalopathy syndrome (a condition characterised by headache,
Danish: • reversibelt, posteriort leukoencefalopatisyndrom (en tilstand karakteriseret ved hovedpine,
English: Very common Oedema, fatigue
Danish: Meget almindelig Ødem, træthed
English: Absorption Asparaginase is not absorbed by the gastrointestinal tract, thus Spectrila must be given intravenously.
Danish: Absorption Asparaginase absorberes ikke i mave-tarm-kanalen, derfor skal Spectrila gives intravenøst.
English: During induction treatment, asparaginase-typical adverse drug reactions like elevated liver enzymes/bilirubin (≥ CTCAE Grade III: 44.3 % vs. 39.6 %), haemorrhage or thromboembolism (≥ CTCAE Grade II: 2.1 % vs. 4.0 %), and neurotoxicity (≥ CTCAE Grade III: 4.1 % vs. 5.9 %) were observed in comparable frequencies in both groups (Spectrila versus reference).
Danish: I løbet af induktionsbehandlingen blev der observeret asparaginase-typiske bivirkninger, såsom forhøjede leverenzymer/bilirubin (≥ CTCAE grad III: 44,3 % vs. 39,6 %), blødning eller tromboembolisme (≥ CTCAE grad II: 2,1 % vs. 4,0 %) og neurotoksicitet (≥ CTCAE grad III: 4,1 % vs. 5,9 %) med tilsvarende hyppigheder i begge grupper (Spectrila versus reference).
English: Frequent evaluation of coagulation parameters is important before and during asparaginase treatment.
Danish: Hyppig kontrol af koagulationsparametre er vigtigt før og under behandlingen med asparaginase.
English: The time period following treatment with asparaginase when it is safe to become pregnant or father a child is unknown.
Danish: Det er ukendt, hvor lang tid efter behandling med asparaginase det er sikkert at blive gravid eller undfange et barn.
English: After repeated administration of asparaginase at a dose of 5,000 U/m² every third day, trough asparaginase activity levels in serum ranged from 108 to 510 U/l.
Danish: Efter gentagen administration af asparaginase ved en dosis på 5.000 E/m² hver tredje dag var de minimale aktivitetsniveauer for asparaginase i serum i intervallet fra 108 til 510 E/l.
English: • a serious allergic reaction which causes difficulty in breathing or dizziness,
Danish: • en alvorlig allergisk reaktion, som medfører vejrtrækningsbesvær eller svimmelhed,
English: Median trough serum asparaginase activities were measured in 81 children/adolescents with de novo ALL three days after infusion of asparaginase (just before the next dose had to be given) during induction treatment and ranged from 168 to 184 U/l (study MC-ASP.5/ALL).
Danish: Mediane minimale serum-asparaginase-aktiviteter blev målt hos 81 børn/unge med de novo ALL tre dage efter infusion af asparaginase (umiddelbart før den næste dosis skulle gives) i løbet af induktionsbehandlingen, og den var i intervallet 168 til 184 E/l (studie MC-ASP.5/ALL).
English: If you were given more Spectrila than you should If you think that you received too much Spectrila, tell your doctor or nurse as soon as possible.
Danish: Hvis du tror, at du har fået for meget Spectrila, skal du fortælle det til lægen eller sundhedspersonalet så snart som muligt.
English: As a result of asparaginase-induced asparagine depletion in serum, protein synthesis in lymphoblastic tumour cells is disturbed while sparing most normal cells.
Danish: Som følge af asparaginase-induceret asparagintømning i serum forstyrres proteinsyntesen i lymfoblastiske tumorceller, mens de fleste normale celler skånes.
English: Caution is therefore needed when anticoagulants (e.g. coumarin, heparin, dipyridamole, acetylsalicylic acid or nonsteroidal anti-inflammatory medicinal products) or glucocorticoids are given at the same time.
Danish: Der skal derfor udvises forsigtighed, når antikoagulanter (f.eks. coumarin, heparin, dipyridamol, acetylsalicylsyre eller nonsteroide antiinflammatoriske lægemidler) eller glukokortikoider gives på samme tid.
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential have to use effective contraception and avoid becoming pregnant while being treated with asparaginase-containing chemotherapy.
Danish: Kvinder i den fertile alder / Kontraception hos mænd og kvinder Kvinder i den fertile alder skal anvende sikker kontraception og undgå at blive gravide, mens de behandles med asparaginase-indeholdende kemoterapi.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs http://www.ema.europa.eu hjemmeside.
English: Median (range) serum trough asparaginase activities on days 18, 25, and 33 were 209 (42 - 330) U/l, 130 (6 - 424) U/l, and 32 (1 - 129) U/l, respectively.
Danish: Mediane (interval) serum minimale asparaginase-aktiviteter på dag 18, 25 og 33 var hhv. 209 (42 - 330) E/l, 130 (6 - 424) E/l og 32 (1 - 129) E/l.
English: • History of pancreatitis, serious haemorrhage or serious thrombosis with prior asparaginase therapy.
Danish: • Tidligere pankreatitis, alvorlig blødning eller alvorlig trombose med tidligere asparaginasebehandling.
English: In the study in children/adolescents aged 1 - 18 years with de novo ALL (study MC-ASP.5/ALL), by day 33 of induction treatment 10 patients in the Spectrila group (10.3 %) and 9 in the reference group (8.9 %) were measured positive for anti-asparaginase antibodies at least at one time point.
Danish: I studiet hos børn/unge i alderen 1 - 8 år med de novo ALL (studie MC-ASP.5/ALL) blev 10 patienter i Spectrila-gruppen (10,3 %) og 9 i referencegruppen (8,9 %) på dag 33 af induktionsbehandlingen målt positive for anti-asparaginase-antistoffer på mindst et tidspunkt.
English: • blood clotting disorders such as bleeding, disseminated intravascular coagulation (DIC) or formation of blood clots (thrombosis),
Danish: • blodstørkningsforstyrrelser, såsom blødning, dissemineret intravaskulær koagulation (DIC) eller dannelse af blodpropper (trombose),
English: Acquired or genetically decreased physiologic coagulation inhibitors (protein C, protein S, antithrombin) are also described in relation to vascular complications.
Danish: Erhvervet eller genetisk nedsatte fysiologiske koagulationshæmmere (protein C, protein S, antitrombin) er også beskrevet i relation til vaskulære komplikationer.
English: Evidence from published data with asparaginase renders the mutagenic, clastogenic and carcinogenic potential of asparaginase negligible.
Danish: Evidens fra publicerede data med asparaginase viser, at mutagenicitet, klastogenicitet og karcinogenicitet af asparaginase er ubetydelig.
English: There have been reports of transitory secondary hypothyroidism probably caused by a decrease in the serum thyroxin-binding globulin due to asparaginase-induced protein synthesis inhibition.
Danish: Der har været rapporter om transitorisk sekundær hypotyreoidisme, sandsynligvis forårsaget af en reduktion i serum-tyroxinbindende globulin på grund af asparaginase-induceret proteinsyntesehæmning.