natgillin/translations-raw huggingface dataset:
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.
Der findes ikke tilstrækkelige data for HYCAMTIN kapsler til at kunne give doseringsrekommandationer for denne patientgruppe (se pkt. 
There are insufficient data available with HYCAMTIN capsules to make a dose recommendation for this patient group (see section 4.4).
O-glukuronider af både topotecan og Ndesmetyltopotecan er fundet i urinen. 
O-glucuronides of both topotecan and N-desmethyl topotecan have been identified in the urine.
Hætteglas af type I flintglas med grå butylgummiprop og aluminiumsforsegling med plastik flip-off låg indeholdende 1 mg topotecan. 
Type I flint glass vial with grey butyl rubber stopper and aluminium seal with plastic flip-off cap containing 1 mg of topotecan.
Sådan bruges Hycamtin 
How Hycamtin is used
Se afsnittet ”Graviditet og amning” nedenfor. 
• if you plan to father a child. See section “Pregnancy and breast-feeding” below.
Der er ikke fastlagt en rekommandation for dosering til patienter, der får oral topotecan og har kreatinin-clearance under 30 ml/min. 
Dosing recommendations for patients receiving oral topotecan with creatinine clearance less than 30 ml/min have not been established.
Kapslerne er uigennemsigtige lyserøde og præget med “HYCAMTIN” og “1 mg”. 
The capsules are opaque, pink and imprinted with “HYCAMTIN” and “1 mg”.
• Hævelser under hud eller slimhinder forårsaget af væskeophobning (angioødemer). 
• Swelling caused by fluid build-up (angioedema).
Den anbefalede dosis af topotecan er 1,5 mg/m legemsoverflade pr. dag administreret som intravenøs infusion over 30 minutter hver dag fem dage i træk, med et interval på tre uger mellem begyndelsen af hver serie. 
The recommended dose of topotecan is 1.5 mg/m body surface area per day administered by intravenous infusion over 30 minutes daily for five consecutive days with a three-week interval between the start of each course.
Hætteglas af type I flintglas med grå butylgummiprop og aluminiumsforsegling med plastik flip-off låg indeholdende 4 mg topotecan. 
Type I flint glass vial, with grey butyl rubber stopper and aluminium seal with plastic flip-off cap containing 4 mg of topotecan.
(eller derefter om nødvendigt ned til 1,0 mg/m 2/dag). 
1.25 mg/m 2/day (or subsequently down to 1.0 mg/m 2/day if necessary).
Den rekommanderede topotecandosis ved monoterapi hos patienter med ovariecancer eller småcellet lungecancer og en kreatinin-clearance mellem 20 og 39 ml/min er 0,75 mg/m2/dag i fem sammenhængende dage. 
The recommended monotherapy dose of topotecan in patients with ovarian or small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/min is 0.75 mg/m2/day for five consecutive days.
Gastrointestinal perforation Lever- og galdeveje Almindelig 
Gastrointestinal perforation Hepatobiliary disorders Common
Sort jernoxid (E172) 
Black iron oxide (E172)
Det passende volumen af den rekonstituerede opløsning bør fortyndes med enten 0,9 % w/v natriumchloridinfusionsvæske eller 5 % w/v glucoseinfusionsvæske til en endelig koncentration mellem 25 og 50 mikrogram pr. ml. 
The appropriate volume of the reconstituted solution should be diluted with either 0.9 % w/v sodium chloride intravenous infusion or 5 % w/v glucose intravenous infusion, to a final concentration of between 25 and 50 microgram per ml.
9/l) i syv dage eller mere, eller alvorlig neutropeni forbundet med feber eller infektion, eller hvis behandling er blevet udskudt på grund af neutropeni, bør dosis reduceres med 20 % til 0,60 mg/m 2/dag i de efterfølgende serier (eller derefter om nødvendigt ned til 0,45 mg/m 2/dag). 
9/l) for seven days or more or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 20% to 0.60 mg/m 2/day for subsequent courses (or subsequently down to 0.45 mg/m 2/day if necessary).
Hyppigheden af alvorlig (grad 3 eller 4) træthed og asteni var i begge tilfælde 3 %. 
Severe (Grade 3 or 4) fatigue and asthenia both occurred with an incidence of 3%.
• Vægttab og appetitløshed, udmattelse (træthed), slaphed. 
• Weight loss and loss of appetite (anorexia); tiredness; weakness.
Der blev givet trombocyttransfusioner til 10 % af patienterne i 4 % af serierne. 
Platelet transfusions were given to 10% of patients in 4% of courses.
Interstitiel lungesygdom (nogle tilfælde har været letale) Mave-tarm-kanalen Meget almindelig Kvalme, opkastning og diarré (alle muligvis alvorlige), der kan føre til dehydrering (se pkt. 
Interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common Nausea, vomiting and diarrhoea (all of which may be severe), which may lead to dehydration (see sections 4.2 and 4.4)
Cervixcancer 
Cervical carcinoma
De nævnte hyppigheder for hæmatologiske og non-hæmatologiske bivirkninger er for de bivirkninger, der anses for at have en sammenhæng eller en mulig sammenhæng med behandling med oral topotecan. 
The frequencies associated with the haematological and non-haematological adverse events presented are for adverse events considered to be related/possibly related to oral topotecan therapy.
Kapslerne er uigennemsigtige hvide til gullig-hvide og præget med “HYCAMTIN” og “0.25 mg”. 
The capsules are opaque, white to yellowish white and imprinted with “HYCAMTIN” and “0.25 mg”.
Krydsanalyse af studiedata tyder på, at eksponeringen for topotecanlacton, den aktive komponent, er højere hos patienter med nedsat nyrefunktion. 
Results of a cross-study analysis suggest that the exposure to topotecan lactone, the active moiety following topotecan administration, increases with decreased renal function.
9/l) sås hos 32 % af patienterne i 13 % af serierne. 
9/l) occurred in 32% of patients in 13% of courses.
Der er utilstrækkelig erfaring med anvendelsen af topotecan hos patienter med alvorligt nedsat nyrefunktion (kreatininclearance <20 ml/min). 
There is insufficient experience with the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min).
En vigtig eliminationsvej for topotecan er hydrolyse af laktonringen, så der dannes ringåbnet carboxylat. 
A major route of clearance of topotecan is by hydrolysis of the lactone ring to form the ring-opened carboxylate.
• Mavesmerter, forstoppelse, fordøjelsesbesvær. 
• Stomach pain, constipation, indigestion.
Den cellulære følge af topotecans hæmning af topoisomerase-I skyldes proteinassocierede enkelstrengsbrud på DNA. 
The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of protein-associated DNA single-strand breaks.
Mediantiden før indtræden af alvorlig trombocytopeni var dag 15, og medianvarigheden var fem dage. 
Median time to onset of severe thrombocytopenia was day 15 and the median duration was five days.
Yderligere fortynding af den rekonstituerede opløsning med enten natriumchlorid 9 mg/ml (0,9 %) eller 5 % w/v glucose er påkrævet for at opnå en endelig koncentration på mellem 25 og 50 mikrogram/ml. 
Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9%) or 5% w/v glucose is required to give a final concentration of between 25 and 50 microgram/ml.
Mediantiden til indtræden af alvorlig trombocytopeni var dag 15 med en medianvarighed på 2,5 dage. 
Median time to onset of severe thrombocytopenia was day 15 with a median duration of 2.5 days.
Hver kapsel indeholder topotecanhydrochlorid svarende til 1 mg topotecan. 
Each capsule contains topotecan hydrochloride equivalent to 1 mg of topotecan.
Neutropeni Alvorlig neutropeni (grad 4 - neutrofiltal < 0,5 x 10 
Neutropenia Severe neutropenia (Grade 4 - neutrophil count <0.5 x 10
65 patienter (60 %) fik transfusion af pakket blod, og 50 patienter (46 %) fik transfusion af trombocytter henholdsvis over 139 og 159 serier (henholdsvis 30,5 % og 34,9 %). 
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.
Mediantiden til indtræden af moderat til alvorlig anæmi var dag 12 med en medianvarighed på 7 dage. 
Median time to onset of moderate to severe anaemia was day 12 with a median duration of 7 days.
Det gennemsnitlige forhold mellem hovedmetabolitten og lægemiddelstoffets AUC var < 10 % for såvel topotecan som topotecanlakton. 
The mean metabolite:parent AUC ratio was <10% for both total topotecan and topotecan lactone.
Hvis opløsning og fortynding udføres under strikt aseptisk teknik (f.eks. i LAFbænk), skal produktet anvendes (infusion afsluttes) inden for 12 timer ved opbevaring ved stuetemperatur eller inden for 24timer, hvis det opbevares ved 2-8 
If reconstitution and dilution is performed under strict aseptic conditions (e.g. an LAF bench) the product should be used (infusion completed) within 12 hours at room temperature or 24 hours if stored at 2-8
Indholdet af HYCAMTIN 4 mg hætteglas skal rekonstitueres med 4 ml vand til injektionsvæske. 
The contents of HYCAMTIN 4 mg vials must be reconstituted with 4 ml water for injections.
Trombocytopeni Alvorlig trombocytopeni (grad 4 - trombocyttal < 10 x 10 
Thrombocytopenia Severe thrombocytopenia (Grade 4 - platelets <10 x 10
Hycamtin kapsler må ikke åbnes eller knuses. 
Hycamtin capsules must not be opened or crushed.
Det totale indhold af aktivt lægemiddelstof i hætteglasset giver 1 mg pr. ml aktivt lægemiddelstof, når det rekonstitueres som anbefalet. 
The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended.
ITT-population cisplatin 50 mg/m på dag 1, hver 21. dag cisplatin 50 mg/m på dag 1 + topotecan 
ITT population Cisplatin 50 mg/m on day 1, every 21 days
Hvis rekonstitution og fortynding udføres under strenge aseptiske forhold (fx i en LAF-bænk), skal lægemidlet anvendes (infusion fuldført) inden for 24 timer, hvis lægemidlet opbevares ved 2 °C - 8 °C efter den første åbning. 
If reconstitution and dilution are performed under strict aseptic conditions (e.g. an LAF bench) the product should be used (infusion completed) within 24 hours if stored at 2ºC - 8ºC after the first puncture of the vial.
Det geometriske gennemsnit af topotecanlacton dosisnormaliseret AUC(0-∞) var hhv. 9,4; 11,1 og 12,0 ng∙time/ml hos patienter med kreatinin-clearance over 80 ml/min, 50-80 ml/min og 30-49 ml/min. 
Geometric mean topotecan lactone dose-normalised AUC(0-) values were 9.4, 11.1 and 12.0 ng*h/ml in subjects with creatinine clearance values of more than 80 ml/min, 50 to 80 ml/min and 30 to 49 ml/min, respectively.
9/l) sås hos 6 % af patienterne i 2 % af serierne. 
9/l) occurred in 6% of patients in 2% of courses.
Der blev givet vækstfaktorer til 19 % af patienterne i 8 % af serierne (se pkt. 
Growth factors were administered to 19% of patients in 8% of courses.
Kapslen/kapslerne skal synkes hele og må ikke tygges, knuses eller deles. 
The capsule(s) must be swallowed whole, and must not be chewed crushed or divided.
Den sædvanlige dosis er • Ovariecancer eller småcellet lungecancer: 1,5 mg/m af kroppens overfladeareal pr. dag. 
• Ovarian and small cell lung cancer: 1.5 mg per square metre of body surface area per day.
Topotecanlacton dosis-normaliseret AUC(0-∞) for koreanske patienter var hhv. 7,9; 12,9 og 19,7 ng∙time/ml hos patienter med kreatinin-clearance over 80 ml/min, 50-80 ml/min og 30-49 ml/min (se pkt. 
Geometric mean topotecan lactone dose-normalised AUC(0-) values for Korean patients were 7.9, 12.9 and 19.7 ng*h/ml in subjects with creatinine clearance values of more than 80 ml/min, 50 to 80 ml/min and 30 to 49 ml/min, respectively (see section 4.2 and 4.4).
Denne sjældne bivirkning kan forekomme hos op til 1 ud af 1.000 personer, der får Hycamtin: 
This rare side effect may affect up to 1 in 1,000 people treated with Hycamtin:
Mediantiden til indtræden af alvorlig neutropeni var dag 12 med en medianvarighed på 7 dage. 
Median time to onset of severe neutropenia was day 12 with a median duration of 7 days.
Indholdet af HYCAMTIN 1 mg hætteglas skal rekonstitueres med 1,1 ml vand til injektionsvæske. 
The contents of HYCAMTIN 1 mg vials must be reconstituted with 1.1 ml water for injections.
Patienter med nedsat nyrefunktion 
Patients with renal impairment
Det skal du vide, før du begynder at tage Hycamtin 
What you need to know before you take Hycamtin
Recidiverende ovariecancer 
Relapsed ovarian cancer
Den anbefalede orale dosis af topotecan som monoterapi hos patienter med småcellet lungecancer og kreatinin-clearance mellem 30 og 49 ml/min er 1,9 mg/m2/dag i fem på hinanden følgende dage. 
The recommended monotherapy dose of oral topotecan in patients with small cell lung carcinoma with creatinine clearance between 30 and 49 ml/min is 1.9 mg/m2/day for five consecutive days.
Rekonstitution 
Reconstitution
Hvis man ved et uheld får medikamentet på huden eller i øjnene, skal der straks skylles med rigelige mængder vand. 
Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Hver kapsel indeholder topotecanhydrochlorid svarende til 0,25 mg topotecan. 
Each capsule contains topotecan hydrochloride equivalent to 0.25 mg of topotecan.
I kliniske studier af monoterapi med oral topotecan til patienter med recidiverende småcellet lungecancer var den dosisbegrænsende toksicitet hæmatologisk. 
In clinical studies involving patients with relapsed small cell lung cancer, the dose-limiting toxicity of oral topotecan monotherapy was found to be haematological.
Neutropeni Alvorlig neutropeni (neutrofiltal < 0,5 x 10 
Neutropenia Severe (neutrophil count <0.5 x 10
Farmakokinetikken for oral topotecan er ikke undersøgt hos patienter med nedsat leverfunktion (se pkt. 
The pharmacokinetics of oral topotecan have not been studied in patients with hepatic impairment (see section 4.2 and 4.4).
Vinsyre (E334) Mannitol (E421) Saltsyre (E507) Natriumhydroxid 
Tartaric acid (E334) Mannitol (E421) Hydrochloric acid (E507) Sodium hydroxide
Trombocytopeni Alvorlig trombocytopeni (trombocyttal < 25 x 10 
Thrombocytopenia Severe (platelets <25 x 10
HYCAMTIN 1 mg hårde kapsler 
HYCAMTIN 1 mg hard capsules