FrancophonIA/ELRC3.0 huggingface dataset:
English: In these studies, there were no apparent differences in the pharmacokinetics of topotecan among children, adolescents, and young adult patients with solid tumours or leukaemia, but data are too limited to draw definite conclusions.
Danish: Der var i disse forsøg ikke nogen synlige forskelle i farmakokinetikken af topotecan hos børn, unge og yngre voksne med solide tumorer eller leukæmi,
English: One Phase 2 study (Study 065) and one Phase 3 study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy (see Table 1).
Danish: Et fase II-forsøg (forsøg 065) og et fase III-forsøg (forsøg 396) blev gennemført til vurdering af virkningen af oral topotecan versus intravenøs topotecan til patienter, der havde oplevet tilbagefald > 90 dage efter afslutningen af et tidligere behandlingsforløb med kemoterapi (se tabel 1).
English: The response rate to topotecan in the combined small cell lung cancer programme (n = 480) for patients with relapsed disease sensitive to first-line therapy, was 20.2 %.
Danish: Responsraten for topotecan var 20,2 % i det kombinerede program for småcellet lungecancer (n = 480) for patienter med recidiverende sygdom efter 1. linje-behandling.
English: VIAL 1 ml
Danish: HÆTTEGLAS 1 ml
English: − Personnel should be trained to dilute the medicinal product.
Danish: Personalet skal være uddannet i at rekonstituere lægemidlet.
English: − All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Danish: Alt udstyr brugt til administration eller rengøring, herunder handsker, bør anbringes i en højrisiko-affaldssæk til forbrænding ved høj temperatur.
English: When topotecan (0.75 mg/m2/day for five consecutive days) and cisplatin (60 mg/m2/day on Day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12 %, n = 9) and Cmax (23 %, n = 11) was noted on day 5.
Danish: Ved administration af topotecan (0,75 mg/m2 legemsoverflade/dag i 5 sammenhængende dage) og cisplatin (60 mg/m2 legemsoverflade/dag på dag 1) til 13 patienter med ovariecancer, blev en svag stigning set i AUC (12 %, n = 9) og Cmax (23 %, n = 11) på dag 5.
English: Take special care with Topotecan Eagle Check with your doctor or nurse before using your medicine: - if you have any kidney problems.
Danish: Vær ekstra forsigtig med at tage Topotecan Eagle Inden du får denne medicin, skal lægen eller sygeplejersken vide: - hvis du har nyreproblemer.
English: The recommended dose of topotecan is 0.75 mg/m2/day administered as 30 minute intravenous infusion daily on days 1, 2 and 3.
Danish: Den anbefalede dosis af topotecan er 0,75 mg/m2 legemsoverflade/dag administreret som intravenøs infusion over 30 minutter på dag 1, 2 og 3.
English: Neutropenia: Severe (neutrophil count < 0.5 x 109/l) during course 1 was seen in 55 % of the patients and with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Danish: Neutropeni: Alvorlig neutropeni (neutrofiltal < 0,5 x 109/l) under behandlingsperiode 1 blev observeret hos 55 % af patienterne og med en varighed  syv dage hos 20 % og totalt set hos 77 % af patienterne (39 % af behandlingerne).
English: Manufacturer
Danish: Fremstiller.
English: Topotecan Eagle must be diluted to a final concentration between 25 µg/ml and 50 µg/ml (see section 6.6 for dilution instructions).
Danish: Topotecan Eagle skal fortyndes til en endelig koncentration mellem 25 µg/ml og 50 µg/ml (se pkt.
English: − Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Danish: - Uforvarende berøring med hud eller øjne skal omgående behandles med rigelige mængder vand
English: Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Danish: På baggrund af den toksiske grænseværdi for myelosuppression blev den maksimalt tolererede dosis (MTD) fastsat til 2,0 mg/m2/dag med GCSF og 1,4 mg/m2/dag uden G-CSF i et farmakokinetisk forsøg hos børn med refraktære solide
English: Topotecan Eagle is supplied as a concentrate for solution for infusion.
Danish: Topotecan Eagle leveres som et koncentrat til infusionsvæske, opløsning.
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Danish: Endvidere udviklede 5 % (1 % af behandlingerne) af alle de
English: One study included a dose range of 1.4 mg/m2 to 2.4 mg/m2 in children (aged 2 up to 12 years,
Danish: Et forsøg med et doseringsinterval på 1,4-2,4 mg/m2 til børn (fra 2 år og op til 12 år; n = 18),
English: Plasma clearance of total topotecan (active and inactive form) in patients with hepatic impairment only decreased by about 10 % compared with the control group of patients.
Danish: Plasmaclearance af total-topotecan (aktiv eller inaktiv form) hos patienter med nedsat leverfunktion faldt kun ca. 10 %
English: Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Danish: Topotecan-monoterapi er indiceret til behandling af patienter med recidiverende småcellet lungecancer (SCLC) for hvem gentagelse af 1. linje-behandling ikke anses for hensigtsmæssig (se pkt.
English: − Pregnant staff should be excluded from working with this medicinal product.
Danish: Gravide medarbejdere må ikke arbejde med dette lægemiddel.
English: How likely these side effects may happen, is as follows: - very common affects more than 1 user in 10 - common - uncommon affects 1 to 10 users in 1,000 - rare - very rare - not known frequency cannot be estimated from the available data.
Danish: Hvor sandsynligt det er, at disse bivirkninger opstår, er som følger: - meget almindelig (forekommer hos flere end 1 ud af 10 brugere - almindelig forekommer hos 1 til 10 ud af 100 brugere - ualmindelig forekommer hos 1 til 10 ud af 1.000 brugere
English: Rare - severe allergic (anaphylactic) reactions causing swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives, anaphylactic shock (a severe reduction in blood pressure, paleness, agitation, weak pulse, decreased consciousness) - sudden swelling of the skin and mucosa (e.g. throat or tongue) caused by fluid build up (angioedema) - itchy rash (or hives).
Danish: Sjældne bivirkninger - alvorlige allergiske (anafylaktiske) reaktioner, der forårsager hævning af læber, ansigt eller hals, der fører til alvorlige vejrtrækningsproblemer, hududslæt eller nældefeber, anafylaktisk chok (alvorligt nedsat blodtryk, bleghed, uro, svag puls, nedsat bevidsthed) - pludselig hævelse i hud og slimhinder (f.eks. svælg eller tunge) forårsaget af væskeophobning (angioødem) - kløende udslæt (eller nældefeber).
English: As with all cytotoxic chemotherapy, effective contraceptive methods must be advised when either partner is treated with topotecan.
Danish: Som for andre cytostatika bør effektive præventionsmetoder tilrådes, når den ene partner er i
English: Thrombocytopenia: Severe (platelets less than 25 x 109/l) in 25 % of patients (8 % of courses); moderate (platelets between 25.0 and 50.0 x 109/l) in 25 % of patients (15 % of courses).
Danish: Trombocytopeni: Alvorlig trombocytopeni (trombocyttal under 25 x 109/l) hos 25 % af patienterne (8 % af behandlingerne), moderat (trombocyttal mellem 25,0 og 50,0 x 109/l) hos 25 % af patienterne (15 % af behandlingerne).
English: Topotecan Eagle contains a higher dose concentration (3 mg/ml) than other topotecan products for intravenous infusion (usually 1 mg/ml).
Danish: Topotecan Eagle indeholder en højere dosiskoncentration (3 mg/ml) end andre topotecan-midler til intravenøs infusion (sædvanligvis 1 mg/ml).
English: Topotecan Eagle helps to kill tumour cells.
Danish: Topotecan Eagle er med til at dræbe kræftceller.
English: Topotecan Eagle is used to treat: - small cell lung cancer that has come back after chemotherapy - advanced cervical cancer when surgery or radiotherapy are not possible.
Danish: - småcellet lungecancer, der er kommet tilbage efter kemoterapi - avanceret cervixcancer, når kirurgi eller strålebehandling ikke er mulig.
English: Further dilution of Topotecan Eagle is required with either sodium chloride 9 mg/ml (0.9 % w/v) solution for injection or glucose 50 mg/ml (5 % w/v) solution for injection in order to reach a final topotecan concentration of between 25 µg/ml and 50 µg/ml in the solution for infusion to the patient.
Danish: Yderligere fortynding af Topotecan Eagle er nødvendig med enten natriumchlorid 9 mg/ml (0,9 % w/v) opløsning til injektion eller glukose 50 mg/ml (5 % w/v) opløsning til injektion for at nå en endelig topotecankoncentration på mellem 25 µg/ml og 50 µg/ml i opløsningen til infusion til patienten.
English: Very common: febrile neutropenia, neutropenia (see Gastrointestinal disorders),
Danish: Meget almindelig: febril neutropeni, neutropeni (se Mave-tarm-kanalen), trombocytopeni,
English: Very common: nausea, vomiting and diarrhoea (all of which may be severe), constipation,
Danish: Meget almindelig: kvalme, opkastning og diarré (alle muligvis alvorlige), forstoppelse, mavesmerter, mucositis
English: - Pregnant staff should be excluded from working with this medicinal product.
Danish: - Gravide medarbejdere må ikke arbejde med dette lægemiddel.
English: : 2.6, 6.1) versus 4.5 months (95 % C.I.
Danish: : 2,6; 6,1) versus 4,5 mdr.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 20°C - 25°C and ambient lighting conditions.
Danish: Hvis opløsningen ikke anvendes omgående, er opbevaringstid og -betingelser før anvendelse brugerens ansvar og må normalt ikke overstige 24 timer ved 20°C - 25°C og omgivende lysforhold.
English: The second study included a dose range of 2.0 mg/m2 to 5.2 mg/m2 in children (n = 8), adolescents (n = 3), and young adults (n = 3) with leukaemia.
Danish: Det andet forsøg havde et doseringsinterval på 2,0-5,2 mg/m2 til børn (n = 8), unge (n
English: 2 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4)
Danish: 2 Dødsfald på grund af sepsis er rapporteret for patienter i behandling med topotecan (se pkt.
English: What Topotecan Eagle looks like and contents of the pack - Topotecan Eagle is a clear yellow to orange liquid in a colourless glass vial with a butyl rubber stopper, aluminium seal and blue snap-cap and with yellow vial ring collar.
Danish: Topotecan Eagles udseende og pakningsstørrelse - Topotecan Eagle er en klar gul til orange væske i et farveløst hætteglas med en butylgummiprop, aluminiumsforsegling og blå hætte til afrivning, og med gul ringkrave på hætteglasset.
English: - fever - sudden decline of your general health - sore throat or burning sensation when passing water - severe stomach pain, fever and possibly diarrhoea (rarely with blood in it) - these can be signs of bowel inflammation (neutropenic colitis).
Danish: - ondt i halsen eller brændende fornemmelse ved vandladning - stærke mavesmerter, feber og muligvis diarré (i sjældne tilfælde med blod) - dette kan være tegn på tyktarmsbetændelse (neutropenisk colitis).
English: For more information about cisplatin, please read its Package Leaflet.
Danish: Hvis du ønsker yderlige oplysninger om cisplatin, kan du læse indlægssedlen.
English: In this study, forty-six (43 %) patients received G-CSF over 192 (42.1 %) courses; sixty-five (60 %) received transfusions of Packed Red Blood Cells and fifty (46 %) of platelets over 139 and 159 courses (30.5 % and 34.9 %) respectively.
Danish: 65 patienter (60 %) fik transfusion af pakket blod, og 50 patienter (46 %) fik transfusion af trombocytter henholdsvis over 139 og 159 behandlingsserier (henholdsvis 30,5 % og 34,9 %).
English: In an open-label trial involving children (n = 108, age range: infant to 16 years) with recurrent or progressive solid tumours, topotecan was administered at a starting dose of 2.0 mg/m2 given as a
Danish: I et ikke blindet forsøg af børn (n = 108; aldersgruppe: børn op til 16 år) med recidiverende eller progredierende solide tumorer, blev topotecan administreret med en startdosis på 2,0 mg/m2 som intravenøs infusion over 30 minutter i 5 dage.
English: In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % C.I.
Danish: For patienter (n = 39) med recidiv inden for 180 dage efter kemo/stråleterapi med cisplatin, var medianoverlevelsen 4,6 mdr.
English: This is caused by a drop in the number of blood
Danish: Dette er forårsaget af et fald i antallet af de celler, som får blodet til at størkne (blodplader).
English: - Accidental contact with the skin or eyes should be treated immediately with copious amounts of
Danish: Uforvarende berøring med hud eller øjne skal omgående behandles med rigelige mængder
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 5 ml multidose vial
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE 5 ml multidosishætteglas
English: Cisplatin 50mg/m d.1 + Topotecan 0.75mg/m2 dx3 q21
Danish: cisplatin 50 mg/m2 d. 1 + topotecan 2 d x 3 0,75 mg/m q 21
English: - Staff handling this medicinal product during dilution should wear protective clothing including
Danish: - Personale, som håndterer dette lægemiddel under rekonstitution, skal bære beskyttelsesdragt
English: Topotecan Eagle 3 mg/1 ml is for single use only.
Danish: Topotecan Eagle 3 mg/1 ml er kun til engangsbrug.
English: For cervical cancer Topotecan Eagle will be used with another medicine called cisplatin.
Danish: Ved behandling af cervixcancer gives Topotecan Eagle sammen med et andet lægemiddel, der kaldes cisplatin.
English: - Men having Topotecan Eagle who wish to father a child should ask their doctor for family
Danish: Mandlige patienter, som tager Topotecan Eagle og som ønsker at blive fædre, bør spørge
English: Chemical and physical in-use stability has been demonstrated for 14 days at 20°C - 25°C when stored in the outer carton to protect from light.
Danish: Kemisk og fysisk stabilitet er blevet påvist i 14 dage ved 20°C - 25°C ved opbevaring i den ydre Fra et mikrobiologisk synspunkt kan produktet efter åbning opbevares i højst 14 dage ved 20°C25°C.
English: The incidence of adverse events listed above have the potential to occur with a higher frequency in patients who have a poor performance status (see section 4.4).
Danish: Bivirkningerne ovenfor kan forekomme med større hyppighed hos patienter, som har en dårlig
English: 4.6 Fertility, pregnancy and lactation
Danish: Graviditet og amning
English: Each vial contains 15 mg topotecan (as hydrochloride) in 5 ml concentrate.
Danish: Hvert hætteglas indeholder 15 mg topotecan (som hydrochlorid) i 5 ml koncentrat.
English: However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Danish: Forsigtighed bør dog udvises ved kørsel med motorkøretøj eller ved betjening af maskineri,
English: If cisplatin is discontinued, there are insufficient data regarding continuing monotherapy with topotecan in patients with cervical cancer.
Danish: Hvis behandlingen med cisplatin ophører, er der utilstrækkelige data til at underbygge fortsat monoterapi med topotecan til
English: Each vial contains 3 mg topotecan (as hydrochloride) in 1 ml concentrate.
Danish: Hvert hætteglas indeholder 3 mg topotecan (som hydrochlorid) i 1 ml koncentrat.
English: Patients without prior Cisplatin chemoradiotherapy Cisplatin
Danish: Patienter uden forudgående cisplatin kemo/stråleterapi topotecan/cisplatin (n = 44)
English: Topotecan is contra-indicated during breast-feeding (see section 4.3).
Danish: Topotecan er kontraindiceret under amning (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1 ml vial
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE 1 ml hætteglas
English: Each 5 ml multi dose vial contains 15 mg of topotecan.
Danish: Hvert 5 ml multidosishætteglas indeholder 15 mg topotecan.
English: Common - mild allergic reactions (including rash) - yellow skin (jaundice) caused by liver problems - itching (pruritus)
Danish: Almindelige bivirkninger - milde allergiske reaktioner (inklusive udslæt) - gulfarvning af huden (gulsot) forårsaget af leverproblemer - kløe (pruritus) - alvorlig infektion (sepsis)
English: - Do not breast-feed while using Topotecan Eagle.
Danish: Du må ikke amme, hvis du er i behandling med Topotecan Eagle.
English: 5 ml concentrate in type 1 clear glass vial, together with grey butyl rubber stopper and aluminium seal with yellow polypropylene flip-off cap, and with yellow vial ring collar.
Danish: 5 ml koncentrat i gennemsigtigt hætteglas af type 1 med grå butylgummiprop og aluminiumsforsegling med gul "flip-off"-hætte af polypropylen, og med gul ringkrave på hætteglasset.
English: Other severe events occurring in patients that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %).
Danish: Andre alvorlige hændelser registreret som relateret til eller muligvis relateret til behandling med topotecan blev observeret hos  1 % af patienterne og omfattede anoreksi (12 %), utilpashed (3 %) og I sjældne tilfælde er der rapporteret overfølsomhedsreaktioner heriblandt hududslæt, urticaria, angioødem og anafylaktiske reaktioner.
English: If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Topotecan Eagle.
Danish: Hvis du er i behandling for cervixcancer, kan du få bivirkninger af det andet lægemiddel (cisplatin),
English: Your dose of Topotecan Eagle will depend on: - the disease being treated - the size of your body (measured in ‘square meters' or ‘m2') - the results of blood tests before and during treatment - how well your body responds to the medicine.
Danish: - din kropsstørrelse (overfladeareal målt i kvadratmeter) - resultaterne af blodprøverne, der er udført før og under behandlingen
English: Contraception in males and females
Danish: Infektioner og parasitære sygdomme
English: You should not receive Topotecan Eagle: - if you are allergic (hypersensitive) to topotecan or to any of the other ingredients of this
Danish: - hvis du er overfølsom (allergisk) over for topotecan eller et af de øvrige indholdsstoffer i dette
English: Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Danish: Signifikante følger af trombocytopeni herunder dødelig tumorblødning er sjældent rapporteret.
English: 1 ml concentrate in type 1 clear glass vial, together with grey butyl rubber stopper and aluminium seal with blue polypropylene flip-off cap, and with yellow vial ring collar.
Danish: 1 ml koncentrat i gennemsigtigt hætteglas af type 1 med grå butylgummiprop og aluminiumsforsegling med blå "flip-off"-hætte af polypropylen, og med gul ringkrave på hætteglasset.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé, pkt.
English: ITT population Cisplatin 50mg/m d.1
Danish: ITT-population cisplatin 50 mg/m d. 1 q 21 d.
English: surface area
Danish: Station Approach
English: 2 body surface area/day administered by intravenous The recommended dose of topotecan is 1.5 mg/m infusion over 30 minutes daily for five consecutive days with a three week interval between the start of each course.
Danish: Den anbefalede dosis af topotecan er 1,5 mg/m2 legemsoverflade/dag administreret som intravenøs infusion over 30 minutter hver dag fem dage i træk, med et interval på tre uger mellem begyndelsen af hver behandling.
English: Multidose vial: once opened, store for a maximum of 14 days at 20°C-25°C.
Danish: Multidosishætteglas, må højst opbevares i 14 dage ved 20°C-25°C efter åbning.
English: The adverse event profile for topotecan when given in combination with cisplatin in the cervical cancer clinical trials is consistent with that seen with topotecan monotherapy.
Danish: Bivirkningsprofilen fra kliniske forsøg med topotecan, givet i kombination med cisplatin mod cervixcancer, er i overensstemmelse med hvad der er set ved topotecan-monoterapi.
English: Each 1 ml single dose vial contains 3 mg of topotecan.
Danish: Hvert enkeltdosishætteglas indeholder 3 mg topotecan.
English: The concentration of topotecan in Topotecan Eagle differs from other topotecan products (see section 6.6 for further instructions on dilution).
Danish: Koncentrationen af topotecan i Topotecan Eagle adskiller sig fra andre topotecan-midler (se pkt.
English: Cervical cancer - The usual dose is 0.75 mg of the medicine for each square meter of your body.
Danish: - Den sædvanlige dosis er 0,75 mg af kroppens overfladeareal pr. dag.
English: Hydrochloric acid (E507) (for pH adjustment) Water for injections
Danish: De øvrige indholdsstoffer er: saltsyre (E507) (til justering af pH) og vand til
English: In a population of patients with refractory SCLC (those not responding to first line therapy), the response rate to topotecan was 4.0 %.
Danish: I en population af patienter med refraktær SCLC (dem som ikke responderer på 1. linje-behandling)
English: Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Danish: Patienter, der tidligere har fået cisplatin, skal have et vedvarende behandlingsfrit interval, for at kombinationsbehandlingen er
English: What Topotecan Eagle contains - The active substance is topotecan.
Danish: Det aktive stof er topotecan.
English: If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
Danish: Hvis behandlingen er veltolereret, kan den fortsættes, indtil sygdommen progredierer
English: Topotecan Eagle concentrate is clear yellow to orange in colour and contains 3 mg/ml of topotecan, which is a higher concentration than found in other topotecan products for intravenous infusion.
Danish: Topotecan Eagle koncentratet har en klar gul til orange farve og indeholder 3 mg/ml topotecan, hvilket er en højere koncentration end hvad der findes i andre topotecan-midler til intravenøs infusion.
English: (95 % CI)
Danish: Risikoforhold (95% CI)
English: In those (n = 102) with recurrence after 180 days, the median survival in the topotecan plus cisplatin arm was 9.9 months (95 % C.I.
Danish: For de patienter (n = 102) med recidiv efter 180 dage, var medianoverlevelse 9,9 mdr.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate for solution for infusion contains 3 mg topotecan (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En ml koncentrat til infusionsvæske indeholder 3 mg topotecan (som hydrochlorid).
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/l, a platelet count of ≥ 100 x 109/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary).
Danish: Før administration af den første behandling med topotecan skal patienten have et neutrofiltal på  1,5 x 109/l, et trombocyttal på  100 x 109/l og et hæmoglobinniveau på  9 g/dl (om nødvendigt
English: Infections and infestations Very common: infection Common: sepsis2
Danish: Meget almindelig: infektion
English: The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of protein-associated DNA single-strand breaks.
Danish: Den cellulære følge af topotecans hæmning af topoisomerase-1 skyldes proteinassocierede
English: For reduced dose '1.25 mg/m2'
Danish: For reduceret dosis '1,25 mg/m2'