FrancophonIA/ELRC3.0 huggingface dataset:
English: The apparent volume of distribution is 44.0 ± 3.9 l, suggesting that dexrazoxane distributes mainly in the total body water.
Danish: Det tilsyneladende fordelingsvolumen er 44,0 ± 3,9 l, hvilket tyder på, at dexrazoxan primært distribueres i hele legemets vandfase.
English: This may affect the production of red blood cells, white blood cells, and platelets.
Danish: Dette kan påvirke produktionen af røde og hvide blodlegemer og blodplader.
English: Read all of this leaflet carefully before you are given this medicine.
Danish: Læs denne indlægsseddel grundigt inden du får medicinen.
English: Leukaemia (cancer of the blood)
Danish: Leukæmi (blodkræft)
English: • If you are pregnant or plan to become pregnant (see also “Pregnancy and breast-feeding”).
Danish: • hvis du er gravid eller planlægger at blive gravid (se også “Graviditet og amning”).
English: You or your doctor should immediately rinse the affected area thoroughly with water.
Danish: Det berørte område skal straks skylles grundigt med vand.
English: Fertility The effects of {(Invented) Name} on the fertility of humans and animals have not been studied.
Danish: Fertilitet Virkningen af {Lægemidlets (sær)navn} på fertiliteten hos mennesker og dyr er ikke blevet undersøgt.
English: • If you have or have had liver or kidney problems.
Danish: • hvis du har eller har haft lever- eller nyreproblemer.
English: The total body clearance of dexrazoxane in adults is estimated at 14.4 ± 1.6 l/h.
Danish: Den totale clearance af dexrazoxan hos voksne er anslået til 14,4 ± 1,6 l/t.
English: Your doctor may carry out tests before and during the treatment with {(Invented) Name} to see how well the treatment is working and to check the function of some of your organs, such as your heart, kidneys or liver.
Danish: Du skal også være opmærksom på, at: din læge kan udføre undersøgelser før og under behandlingen med {Lægemidlets (sær)navn} for at se, hvor godt behandlingen virker, og for at kontrollere funktionen af nogle af dine organer, såsom dit hjerte, nyrer eller lever.
English: Effects on CYP450 enzymes or drug transporters have not been studied.
Danish: Virkninger på CYP-enzymer eller lægemiddeltransportere er ikke blevet undersøgt.
English: • If you have or have had a heart attack, heart failure, uncontrolled chest pain and heart valve problems.
Danish: • hvis du har eller har haft hjerteanfald, hjertesvigt, ukontrollerede brystsmerter eller hjerteklap problemer.
English: Previous history of allergy to dexrazoxane or razoxane should be carefully considered prior to administration.
Danish: Anamnese med allergi over for dexrazoxan eller razoxan skal overvejes nøje før administration.
English: Your doctor may carry out blood tests during the treatment with {(Invented) Name} to monitor your bone marrow function.
Danish: din læge kan tage blodprøver under behandlingen med {Lægemidlets (sær)navn} for at overvåge din knoglemarvsfunktion.
English: Animal reproduction studies reveal that razoxane is embryotoxic to mice, rats and rabbits and also teratogenic to rats and mice, although a different dosing schedule was used compared to that used in man.
Danish: Reproduktionsstudier med dyr viser, at razoxane er embryotoksisk hos mus, rotter og kaniner og endvidere teratogent hos rotter og mus, dog blev et andet doseringsskema anvendt i forhold til det, der anvendes hos mennesker.
English: {(Invented) Name} and its metabolites were detected in the plasma and urine of animals and man.
Danish: {Lægemidlets (sær)navn} og dets metabolitter blev påvist i plasma og urin hos dyr og mennesker.
English: Animal studies showed embryotoxic and teratogenic effects (see section 5.3).
Danish: Dyreforsøg har vist embryotoksiske og teratogene virkninger (se pkt.
English: • All were treated for breast cancer
Danish: Alle blev behandlet for brystcancer.
English: Interaction studies with dexrazoxane are limited.
Danish: Interaktionsstudier med dexrazoxan er begrænsede.
English: It is unknown whether dexrazoxane and/or its metabolites are excreted in human milk.
Danish: Det er uvist, om dexrazoxan og/eller dets metabolitter udskilles i human mælk.
English: The majority of the administered dose is eliminated in urine mainly as unchanged dexrazoxane.
Danish: Størstedelen af den administrerede dosis udskilles i urinen, hovedsageligt som uomdannet dexrazoxan.
English: The possibility that dexrazoxane was a contributing factor to the imbalance cannot be ruled out (see section 5.1).
Danish: Muligheden for, at dexrazoxan var en medvirkende faktor til denne ubalance, kan ikke udelukkes (se pkt.
English: Data from adults treated in 8 controlled randomised clinical studies have been reviewed, 780 patients received dexrazoxane plus chemotherapy and 789 received chemotherapy alone.
Danish: Data fra voksne patienter behandlet i 8 kontrollerede, randomiserede kliniske forsøg er blevet gennemgået; 780 patienter fik dexrazoxan plus kemoterapi, og 789 fik kemoterapi alene.
English: Patients receiving chemotherapy alone (n=157)
Danish: Patienter i kemoterapi alene (n = 157):
English: Paediatric population {(Invented) Name} is contraindicated in children and adolescents up to 18 years of age (see section
Danish: Pædiatrisk population {Lægemidlets (sær)navn} er kontraindiceret til børn og unge op til 18-års-alderen (se pkt.
English: Patients should be advised to be cautious when driving or using machines if they experience fatigue during treatment with {(Invented) Name}.
Danish: Patienter skal informeres om at udvise forsigtighed, når de kører bil eller betjener maskiner, hvis de bliver trætte under behandling med {Lægemidlets (sær)navn}.
English: In patients with moderate to severe renal dysfunction (creatinine clearance < 40 ml/min) the dexrazoxane dose should be reduced by 50%.
Danish: Hos patienter med moderat til svær nyreinsufficiens (kreatininclearance <40 ml/min) bør dexrazoxandosis reduceres med 50%.
English: Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment, ATC code: V03AF02.
Danish: Farmakoterapeutisk klassifikation: Antidoter ved cytostatikabehandling, ATC-kode: V03AF02.
English: Standard cardiac monitoring associated with doxorubicin or epirubicin treatment should be continued.
Danish: Standardmonitorering af hjertet i forbindelse med doxorubicin- eller epirubicinbehandling skal fortsættes.
English: Management should include prophylaxis and treatment of infections, fluid regulation, and maintenance of nutrition.
Danish: Behandling bør omfatte profylakse og behandling af infektioner, væskeregulering og indtagelse af næring.
English: The dosage ratio should be kept, i.e. if the anthracycline dose is reduced the dexrazoxane dose should be reduced accordingly.
Danish: Dosisforholdet skal bevares, dvs. hvis antracyklindosis reduceres, skal dexrazoxandosis reduceres tilsvarende.
English: Both dexrazoxane (ICRF-187) and ICRF-198 are capable of chelating metal ions.
Danish: Både dexrazoxan (ICRF-187) og ICRF-198 er kelater, der er i stand til at binde metalioner.
English: Before you are given {(Invented) Name}, tell your doctor
Danish: Før du får {Lægemidlets (sær)navn}, skal du fortælle din læge
English: After intravenous administration to cancer patients, serum kinetics of dexrazoxane generally follow an open two-compartment model with first-order elimination.
Danish: Efter intravenøs administration til cancerpatienter, følger dexrazoxans kinetik i serum generelt en åben to-kompartment model med første-ordens elimination.
English: The maximum plasma concentration observed after a 12-15 minute infusion of 1000 mg/m2 is around 80 μg/ml with area under the plasma concentration-time curve (AUC) of 130 ± 15 mg.h/l.
Danish: Den maksimale plasmakoncentration observeret efter en 12-15 minutters infusion af 1.000 mg/m2 er omkring 80 μg/ml med AUC (arealet under plasmakoncentration-tids-kurven) på 130 ± 15 mg·t/l.
English: The combination of {(Invented) Name} with your cancer treatment may increase the risk of blood clots.
Danish: kombinationen af {Lægemidlets (sær)navn} og din kræftbehandling kan øge risikoen for blodpropper.
English: The total urinary excretion of unchanged dexrazoxane is in the order of 40%.
Danish: Den samlede renale udskillelse af uomdannet dexrazoxan er i størrelsesordenen 40%.
English: The MTD is lower in patients who have been heavily pre-treated with chemotherapy, and those with pre-existing immunosuppression (e.g. AIDS).
Danish: MTD er lavere hos patienter, som er blevet kraftigt forbehandlet med kemoterapi, og hos patienter med allerede eksisterende immunsuppression (fx aids).
English: Clearance of dexrazoxane and its active metabolites may be reduced in patients with decreased creatinine clearance.
Danish: Clearance af dexrazoxan og dets aktive metabolitter kan være nedsat hos patienter med nedsat kreatininclearance.
English: These data are derived from clinical trials in cancer patients where {(Invented) Name} was used in combination with anthracycline-based chemotherapy, and where in some cases a control group of patients receiving chemotherapy alone can be referred to.
Danish: Disse data stammer fra kliniske studier hos cancerpatienter, hvor {Lægemidlets (sær)navn} blev anvendt i kombination med antracyklinbaseret kemoterapi, og hvor der i nogle tilfælde kan være refereret til en kontrolgruppe med patienter, der fik kemoterapi alene.
English: {(Invented) Name} is given as a drip (infusion) into a vein over about 15 minutes.
Danish: {Lægemidlets (sær)navn} gives i et drop (infusion) i en vene i løbet af ca. 15 minutter.
English: Method of administration Intravenous use.
Danish: Intravenøs anvendelse.
English: Dexrazoxane does not protect against non-cardiac toxicities induced by anthracyclines.
Danish: Dexrazoxan beskytter ikke mod ikke-kardiorelateret toksicitet induceret af antracykliner.
English: The rate of death on study was higher with the combination dexrazoxane plus chemotherapy (5.0%) compared to chemotherapy alone (3.4%).
Danish: Hyppigheden af død i studierne var højere med kombinationen af dexrazoxan plus kemoterapi (5,0%) sammenlignet med kemoterapi alene (3,4%).
English: No studies were conducted in the elderly and subjects with hepatic or renal impairment.
Danish: Der er ikke udført studier hos ældre og patienter med nedsat lever- eller nyrefunktion.
English: {(Invented) Name} contains a substance called dexrazoxane.
Danish: {Lægemidlets (sær)navn} indeholder et stof kaldet dexrazoxan.
English: If {(Invented) Name} powder or solution gets on your skin, tell your doctor straight away.
Danish: hvis {Lægemidlets (sær)navn}-pulveret eller opløsningen kommer på din hud, så fortæl det til lægen.
English: There are no data that support the use of dexrazoxane in patients with myocardial infarction within the past 12 months, pre-existing heart failure (including clinical heart failure secondary to anthracycline treatment), uncontrolled angina or symptomatic valvular heart disease.
Danish: Der er ingen data, der understøtter brugen af dexrazoxan til patienter, som har haft myokardieinfarkt inden for de sidste 12 måneder, præeksisterende hjertesvigt (herunder klinisk hjertesvigt sekundært til antracyklinbehandling), ukontrolleret angina eller symptomatisk klapfejl.
English: The following table includes reactions from clinical trials and from post-marketing use.
Danish: Nedenstående tabel inkluderer bivirkninger observeret i kliniske forsøg og ved brug efter markedsføring.
English: Women of childbearing potential/contraception in males and females Both sexually active men and women should use effective methods of contraception during treatment.
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder Både seksuelt aktive mænd og kvinder skal anvende sikker antikonception under behandlingen.
English: Stop breast-feeding while you are receiving {(Invented) Name} treatment.
Danish: Stop med at amme, mens du er i behandling med {Lægemidlets (sær)navn}.
English: There is no specific antidote and symptomatic treatment should be provided.
Danish: Der er ingen specifik antidot.
English: • If you are allergic to dexrazoxane or razoxane.
Danish: • hvis du er overfølsom over for dexrazoxan eller razoxan.
English: Dexrazoxane has been shown to possess mutagenic activity.
Danish: Dexrazoxan er vist at have mutagen aktivitet.
English: Preclinical studies indicate that, with repeated dexrazoxane administration, the primary target organs are those of rapid cell division: bone marrow, lymphoid tissue, testes and gastrointestinal mucosa.
Danish: Prækliniske studier viser, at med gentagen dexrazoxan-administration er de primære målorganer dem med hurtig celledeling: Knoglemarv, lymfevæv, testikler og mave-tarmslimhinden.
English: Use of dexrazoxane in combination with adjuvant breast cancer therapy or chemotherapy intended as curative is therefore not recommended.
Danish: Brug af dexrazoxan i kombination med adjuverende brystcancerterapi eller kurativ kemoterapi anbefales derfor ikke.
English: It is generally thought that they can provide cardioprotection by scavenging metal ions thus preventing the Fe3+-anthracycline complex from redox cycling and forming reactive radicals.
Danish: Den generelle tankegang antager, at de virker kardioprotektive ved at binde metalioner og dermed forhindre Fe3+-antracyklinkomplekset i at undergå en redoxreaktion og dermed dannelsen af reaktive radikaler.
English: Swelling and reddening of a vein
Danish: Hævelse og rødme af en vene
English: There is limited data on pharmacokinetic interactions with chemotherapeutic agents other than doxorubicin, epirubicin, cyclophosphamide, 5-fluorouracil and paclitaxel.
Danish: Der er begrænsede data om farmakokinetiske interaktioner med kemoterapeutika andre end doxorubicin, epirubicin, cyclophosphamid, 5-fluoruracil og paclitaxel.
English: Sudden loss of consciousness
Danish: Pludselig bevidstløshed
English: Since dexrazoxane is a cytotoxic agent, sexually active men should continue using effective methods of contraception for at least 3 months after cessation of treatment with dexrazoxane (see section 4.6).
Danish: Da dexrazoxan er cytotoksisk, bør seksuelt aktive mænd anvende effektiv prævention i mindst 3 måneder efter seponering af dexrazoxan (se pkt.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: BILAG III PRODUKTRESUME OG INDLÆGSSEDDEL
English: The above table shows adverse reactions reported in clinical studies and having a reasonable possibility of a causal relationship with {(Invented) Name}.
Danish: Tabellen ovenfor viser bivirkninger, som er rapporteret i kliniske studier, og for hvilke der er en rimelig sandsynlighed for en kausal sammenhæng med {Lægemidlets (sær)navn}.
English: {(Invented) Name} may increase haematological toxicity induced by chemotherapy or radiation, requiring careful monitoring of haematological parameters during the first two treatment cycles (see section 4.4).
Danish: {Lægemidlets (sær)navn} kan øge den hæmatologiske toksicitet forårsaget af kemoterapi eller strålebehandling og nødvendiggør omhyggelig monitorering af hæmatologiske parametre i de to første behandlingsserier (se pkt.
English: The dose you will receive is decided by your doctor.
Danish: Lægen bestemmer, hvilken dosis du skal have.
English: If you are receiving high-dose cancer treatment (e.g. chemotherapy or radiation) and are also being treated with high doses of {(Invented) Name}, your bone marrow function may be reduced.
Danish: Hvis du får høje doser kræftbehandling (fx kemoterapi eller strålebehandling) og også behandles med høje doser {Lægemidlets (sær)navn}, kan din knoglemarv fungere dårligere.
English: Slight fever
Danish: Let feber
English: Dexrazoxane, an analogue of EDTA (ethylene diamine tetra-acetic acid), is hydrolysed in cardiac cells to the ring-opened product ICRF-198.
Danish: Dexrazoxan, en EDTA-analog (ethylendiamintetraeddikesyre), hydrolyseres i hjertets celler til det ringåbnede produkt ICRF-198.
English: Thus it is recommended that {(Invented) Name} is given at a dose of 500 mg/m2 when the commonly used dosage schedule for doxorubicin of 50 mg/m2 is employed or 600 mg/m2 when the commonly used dosage schedule for epirubicin of 60 mg/m2 is employed.
Danish: Således anbefales det, at {Lægemidlets (sær)navn} gives i en dosis på 500 mg/m2, når det almindeligt anvendte doseringsskema for doxorubicin på 50 mg/m2 anvendes, og 600 mg/m2, når det almindeligt anvendte doseringsskema for epirubicin på 60 mg/m2 anvendes.
English: If you are breast-feeding (see also “Pregnancy and breast-feeding”).
Danish: hvis du ammer (se også “Graviditet og amning”).
English: The evidence from clinical trials to date suggests increasing cardioprotective benefit from dexrazoxane as the cumulative anthracycline dose is increased.
Danish: Data fra kliniske forsøg tyder på en stigende kardioprotektion af dexrazoxan, når den kumulative anthracyclindosis øges.
English: Dexrazoxane's maximum tolerated dose (MTD) when given as monotherapy by short infusion every three weeks for cardioprotection has not been specifically studied.
Danish: Sikkerhedsprofilen ved den maksimale, tolererede dosis Dexrazoxans maksimale tolererede dosis (MTD), når det gives som monoterapi ved kortvarig infusion hver tredje uge som kardioprotektion, er ikke blevet specifikt undersøgt.
English: • {(Invented) Name} treatment: a mean dose of 1010 mg/m² (median: 1000 mg/m²) in combination with doxorubicin, and a mean dose of 941 mg/m² (median: 997 mg/m²) in combination with epirubicin.
Danish: • Behandling med {Lægemidlets (sær)navn}: En gennemsnitsdosis på 1.010 mg/m² (median: 1.000 mg/m²) i kombination med doxorubicin, og en gennemsnitsdosis på 941 mg/m² (median: 997 mg/m²) i kombination med epirubicin.
English: A significant decrease in tumour response rate has been reported in one study in advanced breast cancer patients treated with doxorubicin and dexrazoxane compared to patients treated with doxorubicin and placebo.
Danish: Der er rapporteret et signifikant fald i tumorresponsrate i et studie med patienter med avanceret brystcancer, som blev behandlet med doxorubicin og dexrazoxan, sammenlignet med patienter behandlet med doxirubicin og placebo.
English: {(Invented) Name} may increase the risk of developing leukaemia (cancer of the blood).
Danish: {Lægemidlets (sær)navn} kan øge risikoen for, at du får leukæmi (blodkræft).
English: PHARMACOLOGICAL PROPERTIES
Danish: PHARMAKOLOGISKE EGENSKABER
English: {(Invented) Name} is used to prevent heart damage when medicines called doxorubicin or epirubicin are used during breast cancer treatment in adults.
Danish: {Lægemidlets (sær)navn} anvendes til at forebygge skader på hjertet, når voksne behandles med lægemidlerne doxorubicin eller epirubicin i forbindelse med brystkræftbehandling.
English: Men should continue using contraception for at least three months after {(Invented) Name} treatment has been stopped (see also “Pregnancy and breast-feeding”).
Danish: Mænd skal fortsætte med at bruge prævention i mindst tre måneder efter, at behandlingen med {Lægemidlets (sær)navn} er stoppet (se også “Graviditet og amning”).
English: Second primary malignancies
Danish: Sekundære maligniteter
English: Leucopenia and thrombocytopenia generally reverse quickly upon cessation of treatment with {(Invented) Name}.
Danish: Leukopeni og trombocytopeni er generelt hurtigt reversible efter seponering af {Lægemidlets (sær)navn}.
English: Transaminases increased Skin and subcutaneous tissue disorders Very common Alopecia Common
Danish: Aminotransferaser øget Hud og subkutane væv Meget almindelig Alopeci Almindelig
English: Dexrazoxane-containing medicinal products (See Annex I) 500 mg powder for solution for infusion.
Danish: Lægemidler indeholdende dexrazoxan (Se bilag I) 500 mg pulver til infusionsvæske, opløsning.
English: Cell counts at nadir may be lower in patients treated with dexrazoxane.
Danish: Det hæmatologiske nadirtal kan være lavere hos patienter behandlet med dexrazoxan.
English: Ask your doctor or pharmacist for advice before taking any medicine while you are pregnant or breastfeeding.
Danish: Spørg din læge eller apoteket til råds, før du bruger nogen form for medicin.
English: In some studies, a higher incidence of death has been observed in the groups treated with dexrazoxane plus chemotherapy compared to those treated with chemotherapy alone.
Danish: Der er i nogle studier set en højere frekvens af død i grupper behandlet med dexrazoxan plus kemoterapi sammenlignet med dem, som blev behandlet med kemoterapi alene.
English: Patients receiving chemotherapy and {(Invented) Name} (n=375):
Danish: Patienter i behandling med kemoterapi og {Lægemidlets (sær)navn} (n = 375):
English: {(Invented) Name} is administered together with anthracycline chemotherapy and, consequently, the relative contributions of anthracycline and {(Invented) Name} to the adverse reaction profile may be unclear.
Danish: {Lægemidlets (sær)navn} anvendes sammen med antracyklinbaseret kemoterapi, og de relative bidrag fra antracyclin og {Lægemidlets (sær)navn} til bivirkningsprofilen er derfor uklar.
English: How {(Invented) Name} is given to you This medicine is prepared and given to you by your doctor or other medical staff.
Danish: Denne medicin er klargjort og gives til dig af en læge eller sygeplejerske.
English: Anaphylactic reaction, hypersensitivity Metabolism and nutrition disorders Common
Danish: Anafylaktisk reaktion, overfølsomhed Metabolisme og ernæring Almindelig
English: Other toxic effects were malaise, low grade fever, increased urinary clearance of iron and zinc, anaemia, abnormal blood clotting, transient elevation of serum triglyceride and amylase levels, and a transient decrease in serum calcium level.
Danish: Andre toksiske virkninger var utilpashed, let feber, øget renal udskillelse af jern og zink, anæmi, unormal blodkoagulation, forbigående øgning af serum-triglycerider og amylase, og forbigående fald i serumcalcium.
English: Since both dexrazoxane and doxorubicin are topoisomerase inhibitors, it is possible that dexrazoxane may interfere with the anti-tumour efficacy of doxorubicin.
Danish: Da både dexrazoxan og doxorubicin er topoisomerasehæmmere, er det muligt, at dexrazoxan kan påvirke doxirubicins antitumoreffekt.
English: Because of the potential for serious adverse reactions in infants exposed to {(Invented) Name}, mothers should discontinue breast-feeding during {(Invented) Name} therapy (see section 4.3).
Danish: På grund af risikoen for alvorlige bivirkninger hos spædbørn udsat for {Lægemidlets (sær)navn}, skal mødre afbryde amning under behandling med {Lægemidlets (sær)navn} (se pkt.
English: The {(Invented) Name} dosing schedule is a primary factor in the degree of tissue toxicity produced.
Danish: Doseringsskemaet for {Lægemidlets (sær)navn} er en primær faktor i graden af vævstoksicitet.
English: Frequent infections, fever, sore throat, unexpected bruising and bleeding (signs of blood disorders such as low red blood cell counts, low white blood cell counts, low level of platelets and low level of granulocytes.
Danish: Hyppige infektioner, feber, ondt i halsen, uventede blå mærker og blødning (tegn på blodsygdomme, som fx lavt antal røde og hvide blodlegemer, lavt niveau af blodplader og lavt niveau af granulocytter).
English: Since dexrazoxane is a cytotoxic agent, with topoisomerase II inhibition activity, combination of dexrazoxane with chemotherapy may lead to an increased risk of second primary malignancy.
Danish: Da dexrazoxan er et cytotoksisk stof med topoisomerase II-hæmmende aktivitet, kan en kombination af dexrazoxan og kemoterapi føre til øget risiko for anden primær cancer.
English: Prevention of chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin use in advanced and/or metastatic adult breast cancer patients who have received a prior cumulative dose of 300 mg/m2 of doxorubicin or a prior cumulative dose of 540 mg/m2 of epirubicin when further anthracycline treatment is required.
Danish: Forebyggelse af kronisk kumulativ kardiotoksicitet forårsaget af doxorubicin eller epirubicin hos voksne med avanceret og/eller metastaserende brystcancer, der tidligere har fået en kumulativ dosis på 300 mg doxorubicin/m2 eller 540 mg epirubicin/m2, når yderligere antracyklinbehandling er nødvendig.