FrancophonIA/ELRC3.0 huggingface dataset:
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults.
Danish: ETOPOPHOS og relaterede navne er indiceret i kombination med andre godkendte kemoterapimidler til behandling af småcellet lungekræft hos voksne.
English: ETOPOPHOS and associated names is indicated for first line and second line therapy in combination with other approved chemotherapeutic agents for the treatment of high risk gestational trophoblastic neoplasia in adults.
Danish: ETOPOPHOS og relaterede navne er indiceret til førstelinje- og andenlinje-behandling i kombination med andre godkendte kemoterapimidler til behandling af højrisiko neoplasi under graviditet hos voksne.
English: How you will be given ETOPOPHOS and associated names
Danish: Sådan får du ETOPOPHOS og associerede navne
English: 6.3 Shelf life [To be completed nationally]
Danish: 6.3 Opbevaringstid [Skal udfyldes nationalt]
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ETOPOPHOS and associated names 1000 mg powder for solution for infusion [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ETOPOPHOS og relaterede navne 1000 mg pulver til infusionsvæske, opløsning [Se bilag I - Skal udfyldes nationalt]
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ETOPOPHOS and associated names 100 mg powder for solution for infusion [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ETOPOPHOS og relaterede navne100 mg pulver til infusionsvæske, opløsning [Se bilag I - Skal udfyldes nationalt]
English: ETOPOPHOS and associated names 100mg Powder for Solution for Infusion ETOPOPHOS and associated names 1000mg Powder for Solution for Infusion [See Annex I - To be completed nationally]
Danish: ETOPOPHOS og relaterede navne100 mg pulver til infusionsvæske, opløsning ETOPOPHOS og relaterede navne1000 mg pulver til infusionsvæske, opløsning [Se bilag I - Skal udfyldes nationalt]
English: Etoposide phosphate
Danish: Etoposidfosfat
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of non-epithelial ovarian cancer in adults.
Danish: ETOPOPHOS og relaterede navne er indiceret i kombination med andre godkendte kemoterapimidler til behandling af non-epitelial kræft i æggestokkene hos voksne.
English: Gestational trophoblastic neoplasia
Danish: Trofoblastisk neoplasi under graviditet
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Danish: Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er noget, du er i tvivl om.
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of acute myeloid leukaemia in adult and paediatric patients.
Danish: ETOPOPHOS og relaterede navne er indiceret i kombination med andre godkendte kemoterapimidler til behandling af akut myeloid leukæmi hos voksne og pædiatriske patienter.
English: If you are given more ETOPOPHOS and associated names than you should
Danish: Hvis du har fået for meget ETOPOPHOS og associerede navne
English: Etoposide, therefore, is cleared by both renal and nonrenal processes, ie, metabolism and biliary excretion.
Danish: Etoposid elimineres derfor gennem både renale og ikke-renale dosisområde på 80 til 600 mg/m processer, dvs. gennem stofskiftet og galden.
English: In patients with creatinine clearance less than 15 mL/min and on dialysis further dose reduction should be considered.
Danish: Hos patienter i dialyse med kreatinin clearance på under 15 ml/min.
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of Hodgkin's lymphoma in adult and paediatric patients.
Danish: ETOPOPHOS og relaterede navne er indiceret i kombination med andre godkendte kemoterapimidler til behandling af Hodgkins lymfom hos voksne og pædiatriske patienter.
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of non-Hodgkin's lymphoma in adult and paediatric patients.
Danish: ETOPOPHOS og relaterede navne er indiceret i kombination med andre godkendte kemoterapimidler til behandling af non-Hodgkins lymfom hos voksne og pædiatriske patienter.
English: Thrombocytopenia and severe thrombocytopenia (less than 50,000 platelets/mm
Danish: Trombocytopeni og svær trombocytopeni (under 50.000 trombocytter/mm hos hhv. 23 % og 9 % for etoposidfosfat.
English: • increased liver enzymes
Danish: • forhøjede leverenzymer • forhøjet bilirubin
English: ETOPOPHOS and associated names (see Annex 1) 100 mg powder for solution for infusion ETOPOPHOS and associated names (see Annex 1) 1000 mg powder for solution for infusion [See Annex I - To be completed nationally]
Danish: ETOPOPHOS og relaterede navne (se bilag 1) 100 mg pulver til infusionsvæske, opløsning ETOPOPHOS og relaterede navne (se bilag 1) 1000 mg pulver til infusionsvæske, opløsning
English: Breastfeeding
Danish: Natriumcitrat
English: Date
Danish: INDLÆGSSEDDEL
English: common acute leukaemia
Danish: cyster og polypper) almindelig akut leukæmi
English: 8 months.
Danish: 8 måneder.
English: June 2020
Danish: Juni 2020
English: Adults >21 years
Danish: Voksne > 21 år
English: - if you get a fever.
Danish: - Hvis du får feber.
English: Your physician will decide whether your disease requires treatment.
Danish: Din læge vil afgøre, om din sygdom kræver behandling.
English: As your doctor will administer the medicine, it is very unlikely you will be given more than you need.
Danish: Da din læge vil indgive lægemidlet, er det meget usandsynligt, at du vil få mere, end du behøver.
English: There have been isolated reports of formation of pseudocysts (up to four months after the last treatment).
Danish: Der har været enkelte rapporter om dannelse af pseudocyster (op til fire måneder efter den sidste behandling).
English: Allergic reactions can manifest in the skin.
Danish: Allergiske reaktioner kan vise sig i huden.
English: Elderly There are limited data available for patients older than 65 years.
Danish: Ældre Der foreligger begrænsede data om patienter, der er ældre end 65 år.
English: Paediatric patients and adults ≤21 years
Danish: Pædiatriske patienter og voksne ≤ 21 år
English: Aseptic technique must be used.
Danish: Der skal anvendes aseptisk teknik.
English: In very rare cases, mild tremor in the fingers has been described.
Danish: I meget sjældne tilfælde er der beskrevet let tremor i fingrene.
English: t1/2 (day)
Danish: t1/2 (dag)
English: This medicinal product can cause irritation on contact.
Danish: Dette lægemiddel kan forårsage irritation ved kontakt.
English: There are no data available for elderly patients.
Danish: Der foreligger ikke data om ældre patienter.
English: It should only be given in a hospital setting where appropriate resuscitation equipment is available.
Danish: Det må kun gives i hospitalsregi, hvor der er adgang til relevant genoplivningsudstyr.
English: Therapeutic efficacy was defined as a clinical improvement which did not meet the criteria for other beneficial outcomes.
Danish: Behandlingseffekt blev defineret som en klinisk forbedring, som ikke opfyldte kriterierne for andre gavnlige resultater.
English: The clinical study report should be submitted by:
Danish: Rapporten fra den kliniske undersøgelse skal indsendes inden:
English: Not known: Pyrexia
Danish: Ikke kendt: pyreksi
English: If higher volume is given, the dose should be divided and given at several injection sites.
Danish: Hvis der gives en større mængde, skal dosen deles op og gives på flere injektionssteder.
English: Fatty liver can be observed very frequently.
Danish: Fedtlever kan ses meget hyppigt.
English: In such cases, a switch to a different asparaginase preparation should be considered.
Danish: I disse tilfælde skal det overvejes at skifte til et andet asparaginasepræparat.
English: Randomisation of patients was stratified based on risk group (standard/high/very high risk), including both B- and T-cell ALL.
Danish: Randomisering af patienter var stratificeret baseret på risikogruppe (standard/høj/meget høj risiko), inklusive både B- og T-celle ALL.
English: There is no specific pharmacological treatment for the overdose.
Danish: Der er ingen specifik farmakologisk behandling mod overdosering.
English: Alteration of liver parameters is common.
Danish: Ændring af leverparametrene er almindelig.
English: Name and address of the manufacturer of the biological active substance Exelead, Inc.
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Exelead, Inc.
English: All items for administration or cleaning, including gloves, should be placed in high-risk waste disposal bags for high-temperature incineration.
Danish: Alle genstande, som har været brugt ved administration eller rengøring, herunder handsker, skal anbringes i højrisikoaffaldsposer til forbrænding ved høj temperatur.
English: Warning: special handling instructions (see package leaflet)
Danish: Advarsel: særlige instruktioner vedrørende håndtering (se indlægssedlen)
English: Investigations of the effect on fertility and peri- and postnatal development were not conducted.
Danish: Der blev ikke udført undersøgelser af virkningen på fertiliteten og den peri- og postnatale udvikling.
English: Staff should be trained in how to handle and transfer the medicinal product (pregnant staff should be excluded from working with this medicinal product).
Danish: Personalet bør undervises i håndtering og overførsel af lægemidlet (gravide medlemmer af personalet må ikke arbejde med dette lægemiddel).
English: Your doctor will decide what dose of the medicine is needed and how often, based on your age and body surface area which is calculated from your height and weight.
Danish: Lægen vil afgøre, hvilken dosis af lægemidlet, der er behov for, og hvor ofte det skal gives, ud fra din alder og dit legemsoverfladeareal, som beregnes ud fra din højde og vægt.
English: Oncaspar is used together with other medicines.
Danish: Oncaspar bruges sammen med andre lægemidler.
English: Depending on the severity of the symptoms, administration of antihistamines, corticosteroids and vasopressors may be indicated as counter-measure.
Danish: Afhængig af symptomernes sværhedsgrad kan administration af antihistaminer, kortikosteroider og vasopressorer være indiceret som modforanstaltning.
English: Therefore, vincristine should be given at least 12 hours prior to administration of Oncaspar in order to minimise toxicity.
Danish: Vincristin skal derfor gives mindst 12 timer inden administration af Oncaspar for at minimere toksiciteten.
English: This medicine may make you more susceptible to infections.
Danish: Dette lægemiddel kan gøre dig mere modtagelig over for infektioner.
English: - vincristine, another cancer medicine.
Danish: - Vincristin, et andet lægemiddel mod kræft.
English: In case of contact, irrigate with plenty of water for at least 15 minutes.
Danish: I tilfælde af kontakt skylles med rigeligt vand i mindst 15 minutter.
English: Reduced splenic weight might be a sign of potential immunosuppressant effect of the treatment.
Danish: Nedsat miltvægt kan muligvis være et tegn på mulig immunsupprimerende virkning af behandlingen.
English: Due to the risk of hyperbilirubinaemia, it is recommended to monitor bilirubin levels at baseline and prior to each dose.
Danish: På grund af risikoen for hyperbilirubinæmi, anbefales det at monitorere bilirubinniveauer ved baseline og inden hver dosis.
English: - if you suffer from a bleeding disorder or had serious blood clots.
Danish: - Hvis du lider af en blødersygdom eller har haft alvorlige blodpropper.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 January 2016
Danish: Dato for første markedsføringstilladelse: 14. januar 2016
English: Do not drive or use machines when using this medicine because it may make you feel drowsy, tired or confused.
Danish: Du må ikke føre motorkøretøj eller betjene maskiner, når du får dette lægemiddel, da det kan få dig til at føle dig sløv, træt eller forvirret.
English: Ask your doctor for advice on the best contraceptive method that you can use.
Danish: Spørg lægen til råds om, hvilken præventionsmetode der er bedst for dig.
English: Procedures for proper handling of antineoplastic agents should be observed.
Danish: Procedurerne for korrekt håndtering af antineoplastiske midler skal følges.
English: - if you have had poor liver function or are using other medicines which may harm the liver.
Danish: - Hvis du har haft dårlig leverfunktion eller bruger andre lægemidler, der kan skade leveren.
English: Grade 3 or higher febrile neutropenia was 15.4%.
Danish: Andelen med febril neutropeni grad 3 eller højere var 15,4 %.
English: Days After First Dose of L-Asparaginase
Danish: Dage efter første dosis L-asparaginase
English: Based on its pharmacological properties, any risk to the breast-fed newborns/infants cannot be excluded.
Danish: På grund af dets farmakologiske egenskaber kan en eventuel risiko for de ammede nyfødte/spædbørn ikke udelukkes.
English: Treatment was administered during Induction (Day 7), and then every 2 weeks for a total of 30 weeks post-Induction therapy.
Danish: Behandling blev administreret under induktion (dag 7) og derefter hver anden uge i alt 30 uger efter induktionsbehandling.
English: CSF asparagine concentrations were determined in 50 patients during the induction phase.
Danish: Koncentrationerne af CSF-asparagin blev bestemt hos 50 patienter i løbet af induktionsfasen.
English: There are limited data on the use of L-asparaginase and no data on the use of Oncaspar in pregnant women.
Danish: Der er utilstrækkelige data om anvendelse af L-asparaginase og ingen data om anvendelse af Oncaspar til gravide kvinder.
English: You should not use Oncaspar if you are pregnant because its effects during pregnancy have not been studied.
Danish: Du må ikke få Oncaspar, hvis du er gravid, da dets virkning under graviditet ikke er undersøgt.
English: CA Papaellinas Ltd.
Danish: C.A. Papaellinas Ltd.
English: The controlled studies were not designed to formally evaluate the pharmacokinetics of Oncaspar in specific populations.
Danish: De kontrollerede studier var ikke designet til formelt at evaluere farmakokinetikken af Oncaspar i specifikke populationer.
English: Men must also use effective contraception while they or their partners are treated with Oncaspar.
Danish: Mænd skal også bruge effektiv prævention, så længe de selv eller deres partner behandles med Oncaspar.
English: The decrease in the number of circulating lymphoblasts is often quite marked, and normal or too low leukocyte counts are often seen in the first days after the start of therapy.
Danish: Faldet i antallet af lymfoblaster i kredsløbet er ofte ret markant, og normale eller for lave leukocyttal ses ofte i de første dage efter behandlingsstart.
English: There is a dose-independent decrease in serum albumin in the majority of patients during the treatment.
Danish: Der sker et fald, som er uafhængigt af dosis, i albumin i serum hos størstedelen af patienterne i løbet af behandlingen.
English: This should be taken into account when considering the use of Oncaspar in these patient populations.
Danish: Dette bør tages i betragtning, når Oncaspar overvejes til brug hos disse patientpopulationer.
English: This can promote the tendency to bleeding and/or thrombosis.
Danish: Dette kan fremme tendensen til blødninger og/eller trombose.
English: In general, incidence and type of adverse reactions Grade 3 and 4 were similar between the two treatment groups.
Danish: Generelt var incidensen og typen af bivirkninger af grad 3 og 4 ens i de to behandlingsgrupper.
English: Common: Hypoxia
Danish: Almindelig: hypoksi
English: Serum amylase and/or lipase levels should be monitored frequently to identify early signs of pancreatic inflammation.
Danish: Niveauer af amylase og/eller lipase i serum skal monitoreres ofte for at identificere tidlige tegn på pankreatisk inflammation.
English: The medicine is given as a solution by injection into a muscle or, if more suitable, into a vein.
Danish: Lægemidlet gives som en opløsning via injektion i en muskel eller, hvis dette er mere hensigtsmæssigt, i en vene.
English: In the unlikely event of accidental overdose, you will be monitored carefully by medical staff and treated appropriately.
Danish: I det usandsynlige tilfælde, at du ved et uheld får en overdosis, vil du blive overvåget nøje af det sundhedsfaglige personale og få relevant behandling.
English: Patients should be monitored for changes in liver function parameters.
Danish: Patienterne skal monitoreres for ændringer i deres leverfunktionsparametre.
English: Both diabetic ketoacidosis and hyperosmolar hyperglycaemia have been described, which generally respond to administration of insulin.
Danish: Både diabetisk ketoacidose og hyperosmolær hyperglykæmi er beskrevet, som generelt responderer på administration af insulin.
English: Therefore and due to its pharmacological properties, Oncaspar should not be used during pregnancy unless the clinical conditions of the woman require treatment with pegaspargase.
Danish: Af denne årsag og på grund af lægemidlets farmakologiske egenskaber, bør Oncaspar ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med pegaspargase.
English: Blood and urine sugar levels, liver and pancreas function and other tests will be carried out regularly to monitor your health during and after treatment because this medicine can affect your blood and other organs.
Danish: Sukkerindholdet i blod og urin, leverens og bugspytkirtlens funktion og andre test vil blive udført regelmæssigt for at overvåge dit helbred i løbet af og efter behandlingen, da dette lægemiddel kan påvirke blod og organer.
English: Oncaspar has major influence on the ability to drive and use machines.
Danish: Oncaspar påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The vial should be gently swirled until the powder is reconstituted.
Danish: Hætteglasset skal svinges forsigtigt, indtil pulveret er rekonstitueret.
English: Cmax (mU/mL)* Tmax (hr)*
Danish: Cmax (mE/ml)* Tmax (t)*
English: A rise in serum urea occurs regularly, is dose-independent and nearly always a sign of pre-renal metabolic imbalance.
Danish: En stigning i urea i serum opstår jævnligt, den er uafhængig af dosis og næsten altid et tegn på prærenal metabolisk ubalance.
English: An alteration in serum lipid levels was observed and changes in serum lipid values, in most cases without clinical symptoms, are very common.
Danish: En ændring i lipidindholdet i serum er set, og ændringer i lipidværdierne i serum, i de fleste tilfælde uden kliniske symptomer, er meget almindelige.
English: Vaccination with live vaccines should therefore be given no earlier than 3 months after termination of the entire antileukaemic treatment.
Danish: Vaccination med levende vacciner må derfor først gives tidligst 3 måneder efter, at hele den antileukæmiske behandling er afsluttet.
English: The mean half-life after absorption from the injection site was 1.7 days and the elimination half-life was 5.5 days.
Danish: Den gennemsnitlige halveringstid efter absorption fra injektionsstedet var 1,7 dage og eliminationshalveringstiden var 5,5 dage.
English: No statistically significant differences in PK characteristics between male and female subjects were identified in this analysis.
Danish: Der blev ikke set nogen statistisk signifikante forskelle i farmakokinetiske karakteristika mellem mandlige og kvindelige forsøgspersoner i denne analyse.
English: Although they have not been specifically associated with the use of pegaspargase, they may occur with the use of Oncaspar:
Danish: Selvom de ikke er blevet specifikt forbundet med brugen af pegaspargase, kan de forekomme ved brug af Oncaspar:
English: The solution should be administered slowly.
Danish: Opløsningen skal administreres langsomt.
English: When there is a marked decrease in fibrinogen or antithrombin III (ATIII) deficiency, consider appropriate replacement therapy.
Danish: Når der er en markant reduktion i fibrinogen eller mangel på antitrombin III (ATIII), skal relevant substitutionsterapi overvejes.
English: Acute pancreatitis can occur commonly.
Danish: Akut pancreatitis kan være almindeligt forekommende.
English: Adverse reactions were loss of body weight, piloerection and reduced activity.
Danish: Bivirkningerne var nedsat legemsvægt, piloerektion og nedsat aktivitet.
English: In case of overdose, patients must be carefully monitored for signs and symptoms of adverse reactions, and appropriately managed with symptomatic and supportive treatment.
Danish: I tilfælde af overdosering skal patienten overvåges nøje for tegn og symptomer på bivirkninger, og der gives relevant symptomatisk og støttende behandling.
English: ALL is a white blood cell cancer type in which certain immature white cells (named lymphoblasts) start growing out of control thus preventing the production of functional blood cells.
Danish: ALL er en kræfttype i de hvide blodlegemer, hvor visse umodne hvide blodlegemer (de hedder lymfoblaster) begynder at vokse ukontrollabelt, og det forhindrer, at kroppen kan producere funktionsdygtige blodlegemer.
English: Oncaspar can cause mild to moderate myelosuppression, and all three blood cell lines can be affected.
Danish: Oncaspar kan forårsage let til moderat myelosuppression, og alle tre typer af blodlegemer kan være påvirket.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Såfremt lægemidlet ikke anvendes straks, er opbevaringstid og -forhold efter anbrud brugerens eget ansvar.
English: A pilot study was conducted for newly diagnosed patients from 1 to <31 years of age with high risk B-precursor ALL (Study AALL07P4).
Danish: Der blev udført et pilotstudie med nydiagnosticerede patienter i alderen fra 1 til < 31 år med prækursor B ALL med høj risiko (studiet AALL07P4).
English: * The active substance is a covalent conjugate of Escherichia coli-derived L-asparaginase with monomethoxypolyethylene glycol **One unit is defined as the quantity of enzyme required to liberate 1 µmol ammonia per minute at pH 7.3 and 37°C
Danish: * Det aktive stof er et kovalent konjugat af L-asparaginase med monomethoxypolyethylenglycol, der stammer fra Eschericia coli ** En enhed defineres som den mængde af enzym, der kræves for at frigive 1 µmol ammonium pr. minut ved pH 7,3 og 37 °C
English: In severe cases, encephalopathy can develop with or without hepatic impairment, especially in older adults, which can be life-threatening or fatal.
Danish: I alvorlige tilfælde kan der udvikles encefalopati med eller uden nedsat leverfunktion, særligt hos ældre patienter, hvilket kan være livstruende eller dødeligt.
English: Arithmetic Mean (SD)
Danish: Aritmetisk gennemsnit (SD)
English: Intravenous administration of asparaginase may therefore cause serum levels of ammonia to rise sharply following administration.
Danish: Intravenøs administration af asparaginase kan derfor medføre, at serumniveauerne af ammonium stiger markant efter administration.
English: To monitor the therapeutic effect, the peripheral blood count and the patient's bone marrow should be monitored closely.
Danish: For at monitorere den behandlingsmæssige virkning skal det perifere blodtal og patientens knoglemarv monitoreres tæt.
English: Medical equipment to treat allergic reactions will be available nearby.
Danish: Der vil være medicinsk udstyr parat lige i nærheden til behandling af allergiske reaktioner.
English: Patients should be closely monitored and carefully observed for any adverse reactions throughout the administration period (see section 4.4).
Danish: Patienter skal monitoreres nøje og omhyggeligt observeres for eventuelle bivirkninger i hele administrationsperioden (se pkt.
English: BATCH NUMBER
Danish: BATCHNUMMER Batch.