FrancophonIA/ELRC3.0 huggingface dataset:
English: Concentrate for solution for infusion 4 mg/4 ml
Danish: Koncentrat til infusionsvæske, opløsning 4 mg/4 ml
English: 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).
Danish: 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 =
English: 1.25 mg/m 2/day (or subsequently down to 1.0 mg/m 2/day if necessary).
Danish: Dosis bør reduceres med 0,25 mg/m 2/dag til 1,25 mg/m 2/dag (eller derefter om nødvendigt ned til 1,0
English: Use not recommended.
Danish: Bør ikke bruges.
English: BN:
Danish: SN:
English: As with other cytotoxic medicinal products, topotecan can cause severe myelosuppression.
Danish: Topotecan kan som andre cytostatika forårsage svær myelosuppression.
English: Mild abdominal pain was reported in 4 % of patients.
Danish: Der blev rapporteret om lette mavesmerter hos 4 % af patienterne.
English: • Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Danish: • Hvis man ved et uheld får lægemidlet på huden eller i øjnene, skal der straks skylles med rigelige mængder vand.
English: 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/m2 given as a 30minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy.
Danish: I et åbent studie hos børn (n = 108, alder: børn op til 16 år) med recidiverende eller progredierende solide tumorer, blev topotecan givet i en startdosis på 2,0 mg/m2 som intravenøs infusion over 30 minutter i 5 dage.
English: Febrile neutropenia, neutropenia (see “Gastrointestinal disorders”), thrombocytopenia, anaemia, leucopenia
Danish: Febril neutropeni, neutropeni (se mave-tarmkanalen), trombocytopeni, anæmi, leukopeni
English: The approved diluents for the concentrate are sodium chloride 9 mg/ml (0.9%) solution for injection and glucose 50 mg/ml (5%) solution for injection.
Danish: De godkendte fortyndingsmidler til koncentratet er natriumchloridopløsning til injektion 9 mg/ml (0,9 %) og glucoseopløsning til injektion 50 mg/ml (5 %).
English: Hypersensitivity reactions including rash, urticaria, angioedema and anaphylactic reactions have been reported rarely.
Danish: I sjældne tilfælde er der rapporteret overfølsomhedsreaktioner herunder udslæt, urticaria, angioødem og anafylaktiske reaktioner.
English: Topotecan Hospira 4 mg/4 ml is supplied in Type I clear glass vials, each sealed with a chlorobutyl rubber stopper, aluminium seal and plastic flip-off closure.
Danish: Topotecan Hospira 4 mg/4 ml leveres i farveløse hætteglas af type I med en chlorbutylgummiprop, aluminiumforsegling og plastiklukke (flip-off).
English: Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient selfreports on an unblinded symptom scale assessment in each of these two studies.
Danish: I begge studier medførte oral og intravenøs topotecan samme symptomlindring hos patienter med recidiverende, sensitiv SCLC i henhold til patienternes egne rapporteringer på en ublindet symptomskala.
English: Also contains: tartaric acid (E334), water for injections, and hydrochloric acid (E507) or sodium hydroxide (for pH adjustment).
Danish: Indeholder også: vinsyre (E334), vand til injektion og saltsyre (E507) eller natriumhydroxid (til justering af pH).
English: The mean metabolite: parent AUC ratio was < 10 % for both total topotecan and topotecan lactone.
Danish: Det gennemsnitlige forhold mellem hovedmetabolittens og lægemiddelstoffets AUC var ˂ 10 % for både topotecan og topotecanlakton.
English: 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.
Danish: I en sammenlignende undersøgelse med topotecan og paclitaxel, hos patienter som tidligere var behandlet for ovariecancer med platinbaseret kemoterapi (henholdsvis n = 112 og 114), var responsraten (95 % CI) 20,5 % (13 %, 28 %) versus 14 % (8 %, 20 %) og median tid til progression var 19 uger versus 15 uger (risiko ratio 0,7 [0,6, 1,0] for henholdsvis topotecan og paclitaxel.
English: Overall, 87 complete and partial responses were observed, with 13 of these occurring during cycles 5 and 6 and 3 occurring thereafter.
Danish: En supplerende retrospektiv analyse blev udført på data fra 523 patienter med recidiverende ovariecancer.Samlet set blev 87 fuldstændige og partielle responser observeret, heraf 13, som optrådte mellem 5. og 6. serie, og 3, som optrådte derefter.
English: Initial dose: 0.75 mg/m2/day administered as 30 minute intravenous infusion daily, on days 1, 2 and 3.
Danish: Initialdosis: 0,75 mg/m2/dag indgivet som en 30 minutters intravenøs infusion på dag 1, 2 og 3.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en særlig recept (se bilag I: Produktresumé; pkt.
English: Further dilution with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection is required, to obtain a final concentration of between 25 and 50 micrograms/ml prior to administration to the patient.
Danish: Der kræves yderligere fortynding med enten 9 mg/ml (0,9 %) natriumchloridopløsning til injektion eller 50 mg/ml (5 %) glucoseopløsning til injektion for at opnå en slutkoncentration på mellem 25 og 50 mikrogram/ml før indgift til patienten.
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 hæmningen af topoisomerase-1, som er forårsaget af topotecan, er en induktion af proteinassocierede enkelstrengsbrud på DNA.
English: 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.
Danish: Et mindre antal patienter med nedsat leverfunktion (serumbilirubin mellem 1,5 og 10 mg/dl) fik intravenøst 1,5 mg/m2/dag topotecan i fem dage hver tredje uge.
English: − Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Danish: − Hvis man ved et uheld får lægemidlet på huden eller i øjnene, skal der straks skylles med rigelige mængder vand.
English: What Topotecan Hospira looks like and the contents of the pack Topotecan Hospira is a clear, yellow or yellow-green concentrate for solution for infusion supplied in clear glass vials, each containing 4 ml concentrate.
Danish: Topotecan Hospira er et klart, gult eller gulgrønt koncentrat til infusionsvæske, opløsning, som leveres i farveløse hætteglas, som hvert indeholder 4 ml koncentrat.
English: - Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Those effectsaredescribed in the cisplatin patient leaflet.
Danish: Disse bivirkninger er anført i indlægssedlen for cisplatin.
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: Sammenlignet med kontrolgruppen faldt topotecans totale plasmaclearance (aktiv og inaktiv form) kun ca. 10 % hos patienter med nedsat leverfunktion.
English: Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2day 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: I et farmakokinetisk studie af børn med refraktære solide tumorer blev den maximalt tolererede dosis (MTD) fastsat til 2,0 mg/m2/dag med G-CSF og 1,4 mg/m2/dag uden G-CSF på baggrund af den toksiske grænseværdi for myelosuppression (se pkt.
English: • Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach and/or gut [mucosal inflammation]).
Danish: •Mundsår,synkebesvær,mavesmerter,kvalme,opkastning,diarré,blodigafføring(mulige tegnogsymptomerpå betændelseimundslimhinden,mavenog/ellertarmene
English: Patients should be monitored for pulmonary symptoms indicative of ILD (e.g. cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Danish: Patienter bør monitoreres for pulmonale symptomer, der tyder på ILD (f.eks. hoste, feber, dyspnø og/eller hypoksi).
English: 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.
Danish: Sikkerhedsprofilen fra de kliniske studier af behandling af cervixcancer med topotecan i kombination med cisplatin er i overensstemmelse med, hvad der er set efter monoterapi med topotecan.
English: General disorders and administration site conditions Very common
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥1.5 x 10
Danish: Før indgift af den første serie topotecan skal patienterne have et neutrofiltal på ≥1,5 x 10
English: Dosage: Ovarian and Small Cell Lung Carcinoma Initial dose: 1.5 mg/ m2 body surface area/day, administered by intravenous infusion over 30 minutes for 5 consecutive days, with a 3 week interval between the start of each course.
Danish: Dosering: Ovariecancer eller småcellet lungecancer Initialdosis: 1,5 mg/m2 legemsoverflade/dag, indgivet som en 30 minutters intravenøs infusion i 5 konsekutive dage med 3 ugers interval mellem starten af hver serie.
English: An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma and faeces.
Danish: I urin, plasma og fæces er der fundet en N-desmethylmetabolit, som i et cellebaseret assay har vist sig at have samme eller mindre aktivitet end lægemiddelstoffet.
English: Thrombocytopenia: Severe (platelets <25 x 10
Danish: Trombocytopeni: Svær (trombocyttal under 25 x 10
English: Hazard ratio (95% CI) Response rate (%) (95% CI) Difference in response rate (95% CI) Median time to progression (weeks) (95% CI)
Danish: Median overlevelse (uger) (95 % CI) Hazard ratio (95 % CI) Responsrate (%) (95 % CI) Forskel i responsrate (95 % CI) Median tid til progression (uger) (95 % CI) Hazard ratio (95 % CI) N = totalt antal behandlede patienter.
English: When treating cervical cancer, Topotecan Hospira is combined with another medicine called cisplatin.
Danish: Ved behandling af livmoderhalskræft gives Topotectan Hospira sammen med et andet lægemiddelstof, der kaldes cisplatin.
English: The integrated safety data for topotecan monotherapy are presented below.
Danish: De samlede sikkerhedsdata for topotecanmonoterapi fremgår af nedenstående tabel.
English: Nausea, vomiting and diarrhoea (all of which may be severe), constipation, abdominal pain mucositis
Danish: Kvalme, opkastning og diarre (alle muligvis alvorlige), forstoppelse, mavesmerter
English: In patients presenting with fever, neutropenia and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
Danish: Risikoen for neutropenisk colitis bør overvejes hos patienter, som har feber, neutropeni og et kompatibelt mønster med mavesmerter.
English: 9/l, a platelet count of ≥ 100 x 10
Danish: 9/l, et trombocyttal på ≥ 100 x 10
English: Topotecan Hospira is available in pack sizes of 1 vial and 5 vials.
Danish: Topotecan Hospira findes i pakninger med 1 og 5 hætteglas.
English: − Severe hypersensitivity to the active substance or to any of the excipients.
Danish: - Alvorlig overfølsomhed over for det aktive indholdsstof eller over for et eller flere af hjælpestofferne - Amning (se pkt.
English: What you need to know before you are given Topotecan Hospira
Danish: Det skal du vide, før du begynder at tage topotecan hospira
English: Use of topotecan in these patient groups is not recommended (see section
Danish: Anvendelse af topotecan i denne gruppe af patienter anbefales ikke (se pkt.
English: The usual dose • Ovarian and small cell lung cancer: 1.5 milligrams per m2 of body surface area per day.
Danish: • Ovariecancer eller småcellet lungecancer: 1,5 milligram pr. m2 legemsoverflade pr. dag.
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: Femogtres (60 %) fik transfusion af pakket blod, og 50 patienter (46 %) fik transfusion af trombocytter i henholdsvis 139 og 159 behandlingsserier (henholdsvis 30,5 % og 34,9 %).
English: Dosage: Renally impaired patients
Danish: Dosering: Patienter med nedsat nyrefunktion
English: Topotecan monotherapy is indicated for the treatment of:
Danish: Topotecan-monoterapi er indiceret til behandling af
English: Combination therapy (cervical carcinoma):
Danish: Kombinationsbehandling (cervixcancer)
English: There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin
Danish: Der er ikke tilstrækkelig erfaring med brug af topotecan til patienter med svært nedsat nyrefunktion (creatininclearance < 20 ml/min) eller svært nedsat leverfunktion (serumbilirubin ≥ 10 mg/dl) på grund af cirrose.
English: Document Name: Document Title:
Danish: Oversigt over indlægssedlen:
English: What Topotecan Hospira contains
Danish: Topotecan Hospira indeholder:
English: Signs include: difficulty breathing cough fever
Danish: vejrtrækningsproblemer hoste feber
English: • Swelling caused by fluid build up (angioedema).
Danish: • Hævelser under hud eller slimhinder forårsaget af væskeophobninger (angioødem)
English: 9/l) during course 1 in 55% of patients, with duration ≥seven days in 20 % and overall in 77 % of patients (39 % of courses).
Danish: 9/l) under behandlingsserie 1 hos 55 % af patienterne med en varighed ≥ syv dage hos 20 %.
English: Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose.
Danish: Cisplatin gives efter topotecandosis som intravenøs infusion på dag 1 i en dosis på 50 mg/m2 legemsoverflade/dag.
English: Patients with prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Danish: Patienter med forudgående cisplatin- kemoterapi/stråleterapi Cisplatin
English: 9/l and/or a platelet count of < 100 x 10
Danish: 9/l og/eller et trombocyttal på ≤ 100 x 10
English: 9/l, the platelet count is ≥ 100 x 10
Danish: 9/l, trombocyttallet er ≥ 100
English: Respiratory, thoracic and mediastinal disorders Rare
Danish: Anoreksi (muligvis alvorlig) Luftveje, thorax og mediastinum Sjælden
English: Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4).
Danish: Slimhindeinflammation Dødsfald på grund af sepsis er rapporteret for patienter i behandling med topotecan (se pkt.
English: • Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
Danish: •Alvorligemavesmerter,kvalme,opkastning afblod,sort ellerblodigafføring (muligesymptomerpå perforeringafmave-tarmkanalen).
English: Topotecan Hospira 4 mg/4 ml sterile concentrate topotecan
Danish: Topotecan Hospira 4 mg/4 ml sterilt koncentrat topotecan
English: The other ingredients are: tartaric acid (E334), water for injections and hydrochloric acid (E507) or sodium hydroxide (to adjust the pH of the solution).
Danish: Øvrige indholdsstoffer: vinsyre (E334), saltsyre (E507), natriumhydroxid (E524) og vand til injektion.
English: − Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils <1.5 x 10
Danish: 4.6) - Alvorlig knoglemarvssuppression før, den første serie indledes, dvs. har et neutrofiltal på <1,5 x
English: However, as with other cytotoxic medicinal products, topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Danish: Topotecan er dog som andre cytostatika genotoksisk, og påvirkning af fertiliteten, inkl.
English: In those patients (n=102) with recurrence after 180 days, the median survival in the topotecan plus cisplatin arm was 9.9 months (95% CI:: 7, 12.6) versus 6.3 months (95%CI:: 4.9, 9.5) for the cisplatin arm, with a hazard ratio of 0.75 (0.49, 1.16).
Danish: Hos de patienter (n = 102), der fik recidiv efter 180 dage, var medianoverlevelse i gruppen, der fik topotecan + cisplatin, 9,9 måneder (95 % CI: 7 og 12,6) og 6,3 måneder (95 % CI: 4,9 og 9,5) i gruppen, der fik cisplatin alene med en hazard ratio på 0,75 (95 % CI: 0,49 og 1,16).
English: • If you have any further questions, ask your doctor.
Danish: - Spørg lægen, hvis der er mere, du vil vide.
English: These very common side effects may affect more than 1 in 10 people treated with Topotecan Hospira:
Danish: Disse meget almindelige bivirkninger kan forekomme hos flere end 1 ud af 10 personer, der får Topotecan Hospira:
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count ˂ 0.5 x 10
Danish: mg/m2 /dag) hos patienter, som får svær neutropeni (neutrofiltal < 0,5 x 10
English: Fatalities due to neutropenic colitis have been reported in clinical studies with topotecan.
Danish: I de kliniske studier med topotecan har man set dødsfald på grund af neutropenisk colitis.
English: Each ml of concentrate contains 1 mg topotecan (as hydrochloride).
Danish: Hver ml koncentrat indeholder 1 mg topotecan (som hydrochlorid).
English: However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Danish: Hvis der forekommer vedvarende træthed og asteni, bør der dog udvises forsigtighed ved kørsel med motorkøretøj eller ved betjening af maskineri.
English: How to store Topotecan Hospira
Danish: Sådan skal du tage Topotecan Hospira
English: 9/l) in 25 % of patients (8 % of courses); moderate
Danish: 9/l) hos 25 % af patienterne (8 % af behandlingsserierne), moderat (trombocyttal mellem 25,0 og 50,0 x 10
English: Please refer to the SPC for further details.
Danish: Der henvises til produktresumeet for yderligere information.
English: Do not throw away any medicines via wastewater.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet eller, toilettet eller skraldespanden.
English: Patients without prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Danish: Patienter uden forudgående cisplatin-kemoterapi/stråleterapi
English: These may affect more than 1 in 10 people treated with Topotecan Hospira:
Danish: De kan forekomme hos flere end 1 ud af 10 personer, der får Topotecan Hospira
English: Special handling and disposal instructions apply (see package leaflet).
Danish: ADVARSEL: Dette er et cytotoksisk stof, der gælder særlige regler for håndtering og bortskaffelse (se indlægssedlen).
English: The active substance in Topotecan Hospira is topotecan (as hydrochloride).
Danish: Aktivt stof: topotecanhydrochlorid.
English: Each 4 ml vial contains 4 mg topotecan (as hydrochloride).
Danish: Hvert 4 ml hætteglas indeholder 4 mg topotecan (som hydrochlorid).
English: 18.3, 31.6) compared to 13.9 weeks (95 % CI: 11.1, 18.6) for patients receiving BSC alone (p=0.0104).
Danish: Den mediane overlevelse for patienter, som blev behandlet med oral topotecan plus BSC, var 25,9 uger (95 % CI: 18,3 og 31,6) sammenlignet med 13,9 uger (95 % CI: 11,1 og 18,6) for patienter, der fik BSC alene (p = 0,0104).
English: • if you are breast-feeding
Danish: • hvis du ammer.
English: Cisplatin 50 mg/m2 on day 1 + Topotecan 0.75 mg/m2 days 1-3, every 21 days
Danish: 0,75 mg/m2 i 3 dage hver 21. dag
English: Rare side effects These may affect up to 1 in 1,000 people treated with Topotecan Hospira:
Danish: Sjældne bivirkninger De kan forekomme hos op til 1 ud af 1.000 personer, der får Topotecan Hospira:
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% CI:: 2.6, 6.1) versus 4.5 months (95% C.I.
Danish: Hos patienter (n = 39) med recidiv inden for 180 dage efter kemoterapi/stråleterapi med cisplatin, var den mediane overlevelse i den gruppe, der fik topotecan + cisplatin, 4,6 måneder (95 % CI: 2,6 og 6,1) versus 4,5 måneder (95 % CI: 2,9 og 9,6) for gruppen, der fik cisplatin alene med en hazard ratio på 1,15 (0,59 og 2,23).
English: In reproductive toxicity studies with topotecan in rats there was no effect on male or female fertility; however, in females super-ovulation and slightly increased pre-implantation loss were observed.
Danish: I reproduktionstoksiske studier af topotecan til rotter sås ingen effekt på fertiliteten hos hverken hanner eller hunner.
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 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 0.25 mg/m 2/day to
Danish: 9/l) i syv dage eller mere, eller svær neutropeni med feber eller infektion, eller hos patienter, som får behandlingen udskudt på grund af neutropeni.
English: For further details, refer to the SPC.
Danish: For yderligere oplysninger se produktresumeet.
English: This rare side effect may affect up to 1 in 1,000 people treated with Topotecan Hospira:
Danish: Denne sjældne bivirkning kan forekomme hos op til 1 ud af 1.000 personer, der får Topotecan Hospira
English: Additional adverse events were seen when topotecan was given in combination with cisplatin; however, these events were seen with cisplatin monotherapy and were not attributable to topotecan.
Danish: Disse bivirkninger er dog tidligere set som følge af behandling med cisplatinmonoterapi og skyldtes ikke topotecan.
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Danish: Hos patienter, der er behandlet med topotecan, er der rapporteret om myelosuppression, der har ført til sepsis, og om dødsfald på grund af sepsis (se pkt.
English: Signed By:
Danish: NN:
English: Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m2 as a 30-minute infusion daily for five days, topotecan demonstrated a high plasma clearance of 62 l/h (SD 22), corresponding to approximately 2/3 of liver blood flow.
Danish: Topotecan havde en høj plasmaclearance på 62 l/time (SD 22) efter intravenøs indgift af topotecandoser på 0,5 til 1,5 mg/m2, der blev givet som en 30 minutters infusion dagligt i 5 dage.
English: Remember to tell your doctor if you start to take any other medicines while you are on Topotecan Hospira.
Danish: Dette gælder også naturlægemidler og medicin, som ikke er købt på recept.Husk at fortælle din læge, hvis du begynder med at tage anden medicinunder behandlingen med Topotecan Hospira.
English: • Feeling unwell.
Danish: • Utilpashed.
English: Metabolism accounts for <10% of the elimination of topotecan.
Danish: Under 10 % topotecan metaboliseres.
English: Subsequent doses Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 10
Danish: Efterfølgende doser Topotecan bør ikke gives igen, medmindre neutrofiltallet er ≥ 1 x 10