natgillin/translations-raw huggingface dataset:
• 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.
Eftersom hætteglasset indeholder et overskud på 10 %, indeholder den klare rekonstituerede opløsning, hvis farve er gul til gulgrøn, 1 mg topotecan pr. ml.
Since the vial contains a 10% overage, the clear, reconstituted solution is yellow to yellow-green in colour and provides 1 mg of topotecan per ml.
Den klare, rekonstituerede opløsning er gul til gulgrøn og indeholder 1 mg topotecan pr. ml.
The clear, reconstituted solution is yellow to yellow-green in colour and provides 1 mg of topotecan per ml.
Første dosis Den anbefalede dosis af HYCAMTIN kapsler er 2,3 mg/m legemsoverflade pr. dag administreret hver dag fem dage i træk, med et interval på tre uger mellem begyndelsen af hver serie.
Initial dose The recommended dose of HYCAMTIN capsules is 2.3 mg/m body surface area per day administered for five consecutive days with a three-week interval between the start of each course.
0,75 mg/m på dag 13, hver 21. dag
Topotecan 0.75 mg/m on days 1-3, every 21 days
• Spørg lægen, hvis der er mere, du vil vide.
• If you have any further questions, ask your doctor.
Et lille antal hepatisk svækkede patienter (serumbilirubin mellem 1,5 og 10 mg/dl) fik topotecan 1,5 mg/m2/dag intravenøst i fem dage hver tredje uge.
A small number of hepatically impaired patients (serum bilirubin between 1.5 and 10 mg/dl) were given intravenous topotecan at 1.5 mg/m2/day for five days every three weeks.
Det totale indhold af aktivt stof i hætteglasset giver 1 mg pr. ml af aktivt stof, når rekonstitutionen foretages som anbefalet (se indlægssedlen).
The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended (see Package Leaflet).
Neutropenisk colitis, herunder letal neutropenisk colitis, er set som en komplikation til topotecaninduceret neutropeni (se pkt.
Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Der blev givet trombocyttransfusioner i 4 % af serierne.
Platelet transfusions were given in 4% of courses.
9/l) hos 25 % af patienterne (15 % af serierne).
9/l) in 25% of patients (15% of courses).
Kapslerne skal sluges hele og må ikke tygges, knuses eller deles.
The capsule(s) must be swallowed whole, and must not be chewed, crushed or divided.
I et fase III-studie (studie 478) blev oral topotecan plus best supportive care (BSC) (n = 71) sammenlignet med BSC alene (n = 70) hos patienter, som havde tilbagefald efter 1. linje-behandling (mediantid til progression [TTP] fra 1. linje-behandling: 84 dage for oral topotecan plus BSC, 90 dage for BSC alene) og for hvem gentagelse af behandling med intravenøs kemoterapi ikke var hensigtsmæssig.
A Phase III study (Study 478) compared oral topotecan plus best supportive care (BSC) (n = 71) with BSC alone (n = 70) in patients who had relapsed following first-line therapy (median time to progression [TTP] from first-line therapy: 84 days for oral topotecan plus BSC, 90 days for BSC alone) and for whom re-treatment with intravenous chemotherapy was not considered appropriate.
Mediantiden til indtræden af alvorlig neutropeni var ni dage, og medianvarigheden syv dage.
Median time to onset of severe neutropenia was nine days and the median duration was seven days.
Shellak
Shellac
Under 18 % af serierne med alvorlig trombocytopeni var varigheden > 7 dage.
In 18% of courses with severe thrombocytopenia the duration was >7 days.
Moderat trombocytopeni (grad 3 - trombocyttal mellem 10,0 og 50,0 x 10
Moderate thrombocytopenia (Grade 3 - platelets between 10.0 and 50.0 x 10
Hvis rekonstitutionen foretages under strenge aseptiske forhold, bør Hycamtin infusionen afsluttes inden for 12 timer ved stuetemperatur (eller inden for 24 timer, hvis produktet opbevares ved 2-8 °C).
If reconstitution is performed under strict aseptic conditions Hycamtin infusion may be completed within 12 hours at room temperature (or 24 hours if stored at 2-8oC).
I kliniske studier blev topotecan-behandlingen stoppet, hvis dosis var blevet reduceret til 1,5 mg/m 2/dag.
In clinical studies, topotecan was discontinued if the dose needed to be reduced below 1.5 mg/m 2/day.
Almene symptomer og reaktioner på administrationsstedet Meget almindelig Pyreksi, asteni, træthed Almindelig
General disorders and administration site conditions Very common Pyrexia, asthenia, fatigue Common
Ved behandling af livmoderhalskræft gives Hycamtin sammen med et andet lægemiddelstof, der kaldes cisplatin.
When treating cervical cancer, Hycamtin is combined with another medicine called cisplatin.
Ammoniakopløsning, koncentreret Kaliumhydroxid
Concentrated ammonia solution Potassium hydroxide
Loperamid blev givet til 13 % af patienterne i 5 % af serierne.
Loperamide was administered to 13% of patients in 5% of courses.
I et sammenlignende studie med topotecan og paclitaxel hos patienter tidligere behandlet for ovariecancer med platinbaseret kemoterapi (henholdsvis n = 112 og n = 114), var responsraten (95 % CI) 20,5 % (13 %, 28 %) versus 14 % (8 %, 20 %) og mediantiden til progression var 19 uger versus 15 uger (hazard ratio 0,7 0,6; 1,0) for henholdsvis topotecan og paclitaxel.
In a comparative study of topotecan and paclitaxel in patients previously treated for ovarian carcinoma with platinum-based chemotherapy (n = 112 and 114, respectively), the response rate (95% CI) was 20.5% (13%, 28%) versus 14% (8%, 20%) and median time to progression 19 weeks versus 15 weeks (hazard ratio 0.7 [0.6, 1.0]), for topotecan and paclitaxel, respectively.
Ved administration i kombination med cisplatin (cisplatin dag 1, topotecan dag 1 til 5) blev topotecanclearance reduceret på dag 5 sammenlignet med dag 1 (19,1 l/time/m legemsoverflade sammenlignet med 21,3 l/time/m legemsoverflade [n = 9]) (se pkt.
When given in combination with cisplatin (cisplatin day 1, topotecan days 1 to 5), the clearance of topotecan was reduced on day 5 compared to day 1 (19.1 l/h/m compared to 21.3 l/h/m
Patienter med forudgående cisplatin kemo/stråleterapi cisplatin topotecan/cisplatin
Patients with prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Samlet set bidrog Ndesmetylmetabolitten i gennemsnit mindre end 6 % (interval 4-8 %) til det lægemiddelstofrelaterede materiale i urin og fæces, som der kunne redegøres for.
Overall, the Ndesmethyl metabolite contributed a mean of less than 6% (range 4-8%) of the total topotecan-related material accounted for in the urine and faeces.
Slimhindeinflammation
Mucosal inflammation
Fæcal eliminering af uomdannet topotecan udgjorde 33 %, mens fæcal eliminering af N-desmetyltopotecan var 1,5 %.
Faecal elimination of total topotecan accounted for 33% while faecal elimination of N-desmethyl topotecan was 1.5%.
Ved samtidig administration af ABCB1 (P-gp)- og ABCG2 (BCRP)-hæmmeren elacridar (GF120918) ved 100-1.000 mg med oral topotecan, steg AUC0-∞ for topotecanlakton og total-topotecan ca. 2,5 gange (se pkt.
Following co-administration of the ABCB1 (P-gp) and ABCG2 (BCRP) inhibitor, elacridar (GF120918) at 100 to 1000 mg with oral topotecan, the AUC0-∞ of topotecan lactone and total topotecan increased approximately 2.5-fold (see section 4.5 for guidance).
Ciclosporin A (en hæmmer af ABCB1, ABCC1 [MRP-1] og CYP3A4) administreret samtidig med oral topotecan medførte en øget topotecan-AUC til ca. 2 til 2,5 gange kontrolgruppen.
Cyclosporin A (an inhibitor of ABCB1, ABCC1 [MRP-1], and CYP3A4) administered with oral topotecan increased topotecan AUC to approximately 2-2.5-fold of control.
Efterfølgende doser Efterfølgende doser af topotecan bør ikke gives, medmindre neutrofiltallet er  1,5 x 10
Subsequent doses Topotecan should not be re-administered unless the neutrophil count is 1.5 x 10
Alvorlig knoglemarvssuppression allerede inden første serie indledes, defineret som et neutrofiltal på < 1,5 x 10
Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils <1.5 x 10
Topotecan er kontraindiceret under amning (se pkt.
Topotecan is contraindicated during breast-feeding (see section 4.3).
9/l, trombocyt tallet er  100 x 10
9/l, the platelet count is 100 x 10
Oral administration af ciclosporin A (15 mg/kg), som er en hæmmer af transportørerne ABCB1 (P-gp) og ABCC1 (MRP-1) samt det metaboliserende enzym CYP3A4, indenfor 4 timer efter oral topotecan, forøgede den dosisnormaliserede AUC0-24t ca. 2,0 og 2,5 gange for henholdsvis topotecanlakton og total-topotecan (se pkt.
Administration of oral cyclosporine A (15 mg/kg), an inhibitor of transporters ABCB1 (P-gp) and ABCC1 (MRP-1) as well as the metabolising enzyme CYP3A4, within 4 hours of oral topotecan increased the dose normalised AUC0-24h of topotecan lactone and total topotecan approximately 2.0and 2.5-fold, respectively (see section 4.5).
Samlet set bidrog Ndesmethylmetabolitten i gennemsnit mindre end 7 % (interval 4-9 %) til det topotecan-relaterede materiale i urin og fæces, som der kunne gøres rede for.
Overall, the N-desmethyl metabolite contributed a mean of less than 7% (range 4-9%) of the total topotecan-related material accounted for in the urine and faeces.
En O-glukuroniseret metabolit af topotecan og Ndesmethyltopotecan er identificeret i urin.
An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
Ca. 20 % blev udskilt som uomdannet topotecan og 2 % blev udskilt som N-desmetyltopotecan i urinen.
Approximately 20% was excreted as total topotecan and 2% was excreted as N-desmethyl topotecan in the urine.
• din sygdom.
• the disease being treated.
I 46 % af serierne med moderat til alvorlig anæmi var varigheden > 7 dage.
In 46% of courses with moderate to severe anaemia, the duration was >7 days.
Erytropoietin blev givet til 10 % af patienterne i 8 % af serierne.
Erythropoietin was administered to 10% of patients in 8% of courses.