natgillin/translations-raw huggingface dataset:
Toksiciteten af topotecan hos børn med recidiverende og refraktære solide tumorer svarende til, hvad der tidligere er set for voksne patienter. 
Toxicities of topotecan in paediatric patients with recurrent and refractory solid tumours were similar to those historically seen in adult patients.
9/l og hæmoglobinniveauet er  9 g/dl (om nødvendigt efter transfusion). 
9/l, and the haemoglobin level is 9 g/dl (after transfusion if necessary).
Hætteglas 3 år. 
Vials 3 years.
Det findes i pakninger med 1 eller 5 hætteglas; hvert hætteglas indeholder 1 mg eller 4 mg topotecan. 
It is available in packs containing either 1 or 5 glass vials; each vial contains 1 mg or 4 mg of topotecan.
Median samlet overlevelse var 62 uger for topotecan versus 53 uger for paclitaxel (hazard ratio 0,9 0,6; 1,3). 
Median overall survival was 62 weeks for topotecan versus 53 weeks for paclitaxel (hazard ratio 0.9 [0.6, 1.3]).
Topotecan er blevet associeret med rapporter om interstitiel lungesygdom (ILD), og nogle af disse tilfælde har været letale (se pkt. 
Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
• patienter med metastaserende ovariecancer, hvor 1. linje-behandling eller efterfølgende behandling er slået fejl. 
• patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.
Forsigtighed bør dog udvises ved kørsel med motorkøretøj eller ved betjening af maskiner, hvis træthed og asteni vedvarer. 
However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Det er påvist, at hæmmere af ABCB1 og ABCG2 givet sammen med oral topotecan øger eksponeringen af topotecan. 
Inhibitors of ABCB1 and ABCG2 administered with oral topotecan have been shown to increase topotecan exposure.
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
• patienter med recidiverende småcellet lungecancer (SCLC) for hvem gentagelse af 1. linje behandling ikke anses for hensigtsmæssig (se pkt. 
• 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).
I sjældne tilfælde kan det resultere i en mere alvorlig blødning. 
Rarely, it can lead to more severe bleeding (haemorrhage).
Overordnet genfinding af topotecan-relateret materiale efter fem daglige topotecandoser var 49-72 % (middel 57 %) af den indgivne orale dosis. 
Overall recovery of topotecan-related material following five daily doses of topotecan was 49 to 72% (mean 57%) of the administered oral dose.
Topotecan-monoterapi og topotecan i kombination med cisplatin er sædvanligvis associeret med klinisk relevant trombocytopeni. 
Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Kapslernes prægning er påtrykt med sort blæk som indeholder: Sort jernoxid (E172), shellak, vandfri ethanol, propylenglykol, isopropylalkohol, butanol, koncentreret ammoniakopløsning, kaliumhydroxid. 
The capsules are printed with black ink that contains black iron oxide (E172), shellac, anhydrous ethanol, propylene glycol, isopropyl alcohol, butanol, concentrated ammonia solution and potassium hydroxide.
Topotecan hæmmer topoisomerase-I ved at stabilisere det kovalente kompleks af enzym og strengkløvet DNA, som er et intermediært produkt af den katalytiske mekanisme. 
Topotecan inhibits topoisomerase-I by stabilising the covalent complex of enzyme and strand-cleaved DNA which is an intermediate of the catalytic mechanism.
I tilfælde af diarré efter behandling med oral topotecan, anbefales det, at lægerne behandler diarréen aggressivt. 
Should diarrhoea occur during treatment with oral topotecan, physicians are advised to aggressively manage diarrhoea.
Non-hæmatologisk 
Non-haematological
BLISTER 
BLISTERS
Yderligere behandling bør være som klinisk indiceret eller efter anbefaling fra Giftlinjen. 
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Den hæmatologiske toksicitet er dosisafhængig, og det samlede blodbillede herunder trombocyttal bør fastlægges jævnligt (se pkt. 
Haematological toxicity is dose-related and full blood count including platelets should be determined regularly (see section 4.2).
I kliniske studier med kombinationsbehandling med topotecan og cisplatin til behandling af cervixcancer blev behandlingen kun initieret for patienter med serumkreatinin ≤ 1,5 mg/dl. 
In clinical studies with topotecan in combination with cisplatin for the treatment of cervical cancer, therapy was only initiated in patients with serum creatinine less than or equal to 1.5 mg/dl.
Der blev givet transfusioner af røde blodlegemer til 30 % af patienterne (13 % af serierne). 
Red blood cell transfusions were given in 30% of patients (13% of courses).
Et studie med et doseringsinterval på 1,4 til 2,4 mg/m til børn (fra 2 år og op til 12 år; n = 18), til unge (fra 12 år op til 16 år; n = 9) og yngre voksne (fra 16 år op til 21 år; n = 9) med refraktære solide tumorer. 
One study included a dose range of 1.4 to 2.4 mg/m in children (aged 2 up to 12 years, n = 18), adolescents (aged 12 up to 16 years, n = 9) and young adults (aged 16 to 21 years, n = 9) with refractory solid tumours.
De mest almindeligt rapporterede non-hæmatologiske bivirkninger, uanset deres årsagssammenhæng, var kvalme (37 %), diarré (29 %), træthed (26 %), opkastning (24 %), alopecia (21 %) og anoreksi (18 %). 
The most frequently reported non-haematological effects were nausea (37%), diarrhoea (29%), fatigue (26%), vomiting (24%), alopecia (21%) and anorexia (18%).
Alle genstande brugt under håndtering eller rengøring, herunder handsker, skal anbringes i højrisikoaffaldsposer beregnet til forbrænding ved høj temperatur. 
All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Alvorlige tilfælde af diarré kan kræve oralt eller intravenøst administreret elektrolytter og væsker samt afbrydelse af topotecan-behandlingen (se pkt. 
Severe cases of diarrhoea may require administration of oral or intravenous electrolytes and fluids, and interruption of topotecan therapy (see sections 4.4 and 4.8).
Opbevaring af den tilberedte opløsning. 
Storage of the prepared solution
Moderat til alvorlig anæmi (Hb  8,0 g/dl) hos 37 % af patienterne (14 % af serierne). 
Moderate to severe (Hb 8.0 g/dl) in 37% of patients (14% of courses).
Hycamtin 0,25 mg og 1 mg kapsler findes i pakninger med 10 kapsler. 
Hycamtin 0.25 mg and 1 mg capsules are available in packs containing 10 capsules.
Hvis behandlingen er veltolereret, kan den fortsættes, indtil sygdommen progredierer (se pkt. 
If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
Plasmakoncentrationerne af total-topotecan (dvs. lakton og carboxylater) og topotecanlakton (aktive del) når maksimalværdierne efter henholdsvis ca. 2,0 timer og 1,5 timer og falder bieksponentielt med en middelterminal halveringstid på ca. 3,0-6,0 timer. 
Plasma concentrations of total topotecan (i.e. lactone and carboxylate forms) and topotecan lactone (active moiety) peak at approximately 2.0 hours and 1.5 hours, respectively, and decline bi-exponentially with mean terminal half-life of approximately 3.0 to 6.0 hours.
Overordnet genfinding af topotecan-relateret materiale efter fem daglige doser af topotecan var 71 til 76 % af den administrerede intravenøse dosis. 
Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76% of the administered IV dose.
Disse bivirkninger er anført i indlægssedlen for cisplatin. 
Those effects are described in the cisplatin patient leaflet.
Der blev givet transfusioner af røde blodlegemer til 52 % af patienterne (21 % af serierne). 
Red cell transfusions were given in 52% of patients (21% of courses).
• Følelse af almen slaphed og træthed (forbigående blodmangel). 
• Feeling generally weak and tired (temporary anaemia).
In vitro hæmmede topotecan hverken de menneskelige P450-enzymer CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A eller CYP4A eller de menneskelige cytosoliske enzymer dihydropyrimidin eller xanthinoxidase. 
In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A, nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
I de to studier, hvor der blev givet både oral og intravenøs topotecan, sås dog en stigning i lægemiddelrelateret diarré hos de patienter, der var over 65 år, og som fik oral topotecan, sammenlignet med dem, der var yngre end 65 år (se pkt. 
However in the two studies in which both oral and intravenous topotecan were administered, patients over 65 years old receiving oral topotecan experienced an increase in drugrelated diarrhoea compared to those younger than 65 years of age (see section 4.4 and 4.8).
Patienter, der tidligere har fået cisplatin, skal have et vedvarende behandlingsfrit interval, for at kombinationsbehandlingen er berettiget (se pkt. 
Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination (see section 5.1).
Behandling med topotecan + cisplatin resulterede i en statistisk signifikant forlængelse af den samlede overlevelse i forhold til cisplatin-monoterapi efter justering for interimanalyser (Log-rank p = 0,033). 
Topotecan plus cisplatin had a statistically significant benefit in overall survival relative to cisplatin monotherapy after adjusting for interim analyses (Log-rank p = 0.033).
• Allergi eller overfølsomhedsreaktioner (herunder udslæt). 
• Allergic or hypersensitivity reactions (including rash).
• Gulfarvning af huden. 
• Yellow skin.
HYCAMTIN kapsler bør kun udskrives og administreres under supervision af en læge, der har erfaring med kemoterapeutiske midler. 
HYCAMTIN capsules should only be prescribed and therapy supervised by a physician experienced in the use of chemotherapeutic agents.
Medianoverlevelse (uger) (95 % CI) Hazard ratio (95 % CI) Responsrate (%) (95 % CI) Forskel i responsrate (95 % CI) Mediantid til progression (uger) (95 % CI) Hazard ratio (95 % CI) N = antal behandlede patienter CI = konfidensinterval 
Median survival (weeks) (95% CI) Hazard ratio (95% CI) Response rate (%) (95% CI) Difference in response rate (95% CI) Median time to progression (weeks) (95% CI) Hazard ratio (95% CI) N = total number of patients treated CI = confidence interval
Hyperbilirubinæmi Hud og subkutane væv Meget almindelig Alopeci Almindelig 
Skin and subcutaneous tissue disorders Very common Alopecia Common
Symptomer inkluderer: vejrtrækningsproblemer hoste feber 
Signs include: difficulty in breathing cough fever
• Alvorlige mavesmerter, kvalme, opkastning af blod, sort eller blodig afføring (mulige symptomer på perforering af mave-tarmkanalen). 
• Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
Oral topotecan Intravenøs topotecan 
Oral topotecan Intravenous topotecan
Sepsis Blod og lymfesystem Meget almindelig Febril neutropeni, neutropeni (se “Mave-tarm-kanalen”), trombocytopeni, anæmi, leukopeni 
Sepsis Blood and lymphatic system disorders Very common Febrile neutropenia, neutropenia (see “Gastrointestinal disorders”), thrombocytopenia, anaemia, leucopenia
Ved dosisreduktion hos patienter, som oplever alvorlig neutropeni (neutrofiltal < 0,5 x 10 
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count <0.5 x 10
Du må ikke begynde at amme igen, før lægen har fortalt dig, at der ikke er nogen risiko forbundet hermed. 
Do not restart breast-feeding until the doctor tells you it is safe to do so.
• Øvrige indholdsstoffer: hydrogeneret vegetabilsk olie, glycerolmonostearat, gelatine, titandioxid (E171), samt rød jernoxid (E172) (kun i 1 mg kapsler). 
• The other ingredients are: hydrogenated vegetable oil, glyceryl monostearate, gelatin, titanium dioxide (E171), and for 1 mg capsules only, red iron oxide (E172).
Hvordan får du kapslen ud af emballagen Kapslerne er indpakket enkeltvis i speciel emballage, så de er utilgængelige for børn. 
Taking out a capsule These capsules come in special packaging to prevent children removing them.
Omtrent 51 % blev udskilt som uomdannet topotecan og 3 % blev udskilt som N-desmethyltopotecan i urinen. 
Approximately 51% was excreted as total topotecan and 3% was excreted as N-desmethyl topotecan in the urine.
Der foreligger ingen data fra andre asiatiske patienter med nedsat nyrefunktion. 
There are no data from Asian patients with renal impairment other than Koreans.
Anafylaktisk reaktion, angioødem, urticaria Metabolisme og ernæring Meget almindelig Anoreksi (muligvis alvorlig) Luftveje, thorax og mediastinum Sjælden 
Anaphylactic reaction, angioedema, urticaria Metabolism and nutrition disorders Very common Anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare
Fæcal eliminering af uomdannet topotecan udgjorde 18 % mens fæcal eliminering af N-desmethyltopotecan var 1,7 %. 
Faecal elimination of total topotecan accounted for 18% while faecal elimination of N-desmethyl topotecan was 1.7%.
Hyppighederne forbundet med hæmatologiske og non-hæmatologiske bivirkninger anført nedenfor er repræsentative for de bivirkningsrapporter, som anses for at være relateret eller muligvis relateret til behandling med topotecan. 
The frequencies associated with the haematological and non-haematological adverse events listed below represent the adverse event reports considered to be related/possibly related to topotecan therapy.
I kliniske studier blev topotecan-behandlingen stoppet, hvis dosis var blevet reduceret til 1,0 mg/m 2/dag og yderligere reduktion af dosis var nødvendig for at håndtere bivirkninger. 
topotecan was discontinued if the dose had been reduced to 1.0 mg/m 2/day and a further dose reduction was required to manage adverse effects.
Hårde kapsler 
Hard capsules
Responsraten for topotecan var 20,2 % i det kombinerede program for småcellet lungecancer (n = 480) for patienter med recidiverende sygdom efter 1. linje-behandling. 
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%.
Topotecan bør kun administreres under supervision af en læge, der har erfaring med kemoterapi (se pkt. 
Topotecan should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).
Ethanol, vandfri - For yderligere information se indlægssedlen Propylenglykol 
Anhydrous ethanol - see leaflet for further information Propylene glycol
Patienter uden forudgående cisplatin kemo/stråleterapi cisplatin topotecan/cisplatin 
Patients without prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
9/l og et hæmoglobinniveau på  9 g/dl (om nødvendigt efter transfusion) 
9/l and a haemoglobin level of ≥9 g/dl (after transfusion if necessary).
Symptomer inkluderer: vejrtrækningsproblemer hoste feber. 
Signs include: difficulty breathing cough fever.
I et ikke blindet studie 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/m som intravenøs infusion over 30 minutter i 5 dage. 
In an open-label study 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/m given as a
Hvis serumkreatinin under kombinationsbehandling overstiger 1,5 mg/dl anbefales det at konsultere cisplatins produktinformation vedrørende dosisreduktion/fortsat behandling. 
If, during topotecan/cisplatin combination therapy, serum creatinine exceeds 1.5 mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Intravenøs topotecan 
Intravenous topotecan
I 34 % af serierne med alvorlig neutropeni var varigheden > 7 dage. 
In 34% of courses with severe neutropenia, the duration was >7 days.
Moderat til alvorlig anæmi (grad 3 og 4 - Hb ≤ 8,0 g/dl) sås hos 25 % af patienterne (12 % af serierne). 
Moderate to severe anaemia (Grade 3 and 4 - Hb 8.0 g/dl) occurred in 25% of patients (12% of courses).
Plasmaclearance hos patienter med nedsat leverfunktion (serumbilirubin mellem 1,5 og 10 mg/dl) faldt til ca. 67 % sammenlignet med en kontrolgruppe af patienter. 
Plasma clearance in patients with hepatic impairment (serum bilirubin between 1.5 and 10 mg/dl) decreased to about 67% when compared with a control group of patients.
Middelmetabolit: det oprindelige plasma-AUC-forhold var mindre end 10 % for både total-topotecan og topotecanlakton. 
The mean metabolite: parent plasma AUC ratio was less than 10% for both total topotecan and topotecan lactone.
Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/. 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Før administration af den første serie med topotecan skal patienten have et neutrofiltal på  1,5 x 10 
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of 1.5 x 10
Overdosering er blevet rapporteret hos patienter i behandling med intravenøs topotecan (op til 10 gange den anbefalede dosis) og topotecan kapsler (op til 5 gange den anbefalede dosis). 
Overdoses have been reported in patients being treated with intravenous topotecan (up to 10 fold of the recommended dose) and topotecan capsules (up to 5 fold of the recommended dose).
Ved brug af topotecan i kombination med cisplatin bør cisplatins produktinformation konsulteres. 
When topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Overdosering er blevet rapporteret hos patienter i behandling med topotecan kapsler (op til 5 gange den anbefalede dosis) og intravenøst topotecan (op til 10 gange den anbefalede dosis). 
Overdoses have been reported in patients being treated with topotecan capsules (up to 5 fold of the recommended dose) and intravenous topotecan (up to 10 fold of the recommended dose).
Den anbefalede dosis af topotecan er 0,75 mg/m2legemsoverflade/dag administreret som en intravenøs infusion over 30 minutter på dag 1, 2 og 3. 
The recommended dose of topotecan is 0.75 mg/m2/day administered as a 30-minute intravenous infusion on days 1, 2 and 3.
Overfølsomhedsreaktion herunder udslæt 
Hypersensitivity reaction including rash
Inden for hver enkelt hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er. 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Der foreligger ikke tilstrækkelige data til at give en anbefaling vedrørende dosering hos patienter med kreatinin-clearance < 30 ml/min. 
Insufficient data are available to make a recommendation for patients with a creatinine clearance <30 ml/min.
Sjælden 
Very rare
Cisplatin administreres som intravenøs infusion på dag 1 med en dosis på 50 mg/m2legemsoverflade/dag, efter administration af topotecan. 
Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose.
Farmakokinetikken af topotecan ved oral administration er vurderet hos cancerpatienter efter administration af 1,2-3,1 mg/m2/dag og 4 mg/m2/dag daglig i 5 dage. 
The pharmacokinetics of topotecan after oral administration have been evaluated in cancer patients following doses of 1.2 to 3.1 mg/m2/day and 4 mg/m2/day administered daily for 5 days.
I studier til dosisbestemmelse omfattende 523 patienter med recidiverende ovariecancer og 631 patienter med recidiverende småcellet lungecancer var den dosisbegrænsende toksicitet af topotecan-monoterapi hæmatologisk. 
In dose-finding studies involving 523 patients with relapsed ovarian cancer and 631 patients with relapsed small cell lung cancer, the dose-limiting toxicity of topotecan monotherapy was found to be haematological.
Efterfølgende doser Efterfølgende doser af topotecan bør ikke gives, medmindre neutrofiltallet er  1 x 10 
Subsequent doses Topotecan should not be re-administered unless the neutrophil count is 1 x 10
9/l og/eller et trombocyttal på < 100 x 10 
9/l and/or a platelet count of 100 x 10
Hycamtin 1 mg kapsler er pink og præget med “Hycamtin” og “1 mg”. 
Hycamtin 1 mg capsules are pink and imprinted with “Hycamtin” and “1 mg”.
Ved administration af topotecan (0,75 mg/m legemsoverflade/dag i 5 sammenhængende dage) og cisplatin (60 mg/m 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. 
When topotecan (0.75 mg/m2/day for 5 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.
• Betændelse og sår i mund, på tunge eller gummer. 
• Inflammation and ulcers of the mouth, tongue or gums.
oC efter, at hætteglasset er punkteret første gang. 
0C after the first puncture of the vial.
Der er dog ikke en tilstrækkelig mængde data tilgængelig til at kunne give en anbefaling vedrørende dosering til denne patientgruppe. 
However, there are insufficient data available to make a dose recommendation for this patient group.
Medianoverlevelsen hos patienter behandlet med oral topotecan plus BSC var 25,9 uger (95 % CI: 18,3; 31,6) sammenlignet med 13,9 uger (95 % CI: 11,1; 18,6) for patienter, der fik BSC alene (p = 0,0104). 
Median survival in patients treated with oral topotecan plus BSC was 25.9 weeks (95% CI: 18.3, 31.6) compared to 13.9 weeks (95% CI: 11.1, 18.6) for patients receiving BSC alone (p = 0.0104).
Arealet under kurven (AUC) øges omtrent proportionalt med dosis. 
Area under the curve increased approximately in proportion to the increase in dose.
I sjældne tilfælde er der rapporteret overfølsomhedsreaktioner heriblandt udslæt, urticaria, angioødem og anafylaktiske reaktioner. 
Hypersensitivity reactions including rash, urticaria, angioedema and anaphylactic reactions have been reported rarely.
• En kløende fornemmelse. 
• Itching sensation.
Anti-tumor-aktiviteten af topotecan involverer hæmning af topoisomerase-I, et enzym tæt involveret i DNA-replikation, da den eliminerer den torsionale belastning, der opstår foran den bevægelige replikationsgaffel. 
The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication as it relieves the torsional strain introduced ahead of the moving replication fork.
ADMINISTRATIONESMETODE 
Method of administration
De tegn og symptomer der blev observeret efter overdosering var i overensstemmelse med de kendte bivirkninger forbundet med topotecan (se pkt. 
The signs and symptoms observed following overdose were consistent with the known undesirable events associated with topotecan (see section 4.8).
Som for andre cytostatika kan topotecan forårsage fosterskader, hvorfor kvinder i den fertile alder bør rådes til at undgå graviditet, mens de er i behandling med topotecan. 
As with other cytotoxic medicinal products, topotecan may cause foetal harm and therefore women of childbearing potential should be advised to avoid becoming pregnant during therapy with topotecan.
Meget almindelige bivirkninger 
Very common side effects
Sikkerhedsprofilen fra kliniske studier med topotecan, givet i kombination med cisplatin mod cervixcancer, er i overensstemmelse med, hvad der er set ved topotecan-monoterapi. 
The safety profile of topotecan when given in combination with cisplatin in the cervical cancer clinical studies is consistent with that seen with topotecan monotherapy.