FrancophonIA/ELRC3.0 huggingface dataset:
English: Mild abdominal pain was reported in 4 % of patients.
Danish: Lette abdominalsmerter blev rapporteret hos 4 % patienterne.
English: In a population of patients with refractory SCLC (those not responding to first line therapy), the response rate to topotecan was 4.0 %.
Danish: I en population af patienter med refraktær SCLC (dem som ikke responderer på 1. linje-behandling) var responsraten 4,0 %.
English: Faecal elimination of total topotecan accounted for 18% while faecal elimination of N-desmethyl topotecan was 1.7 %.
Danish: Fæcal eliminering af uomdannet topotecan udgjorde 18 % mens fæcal eliminering af N-desmethyltopotecan var 1,7 %.
English: This leaflet was last revised in MM/YYYY.
Danish: Denne indlægsseddel blev senest ændret MM/YYYY
English: However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Danish: Forsigtighed bør dog udvises ved kørsel med motorkøretøj og ved betjening af maskiner, hvis træthed og asteni vedvarer.
English: One Phase II study (Study 065) and one Phase III study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy (see Table 1).
Danish: Et fase II-studie (studie 065) og et fase III-studie (studie 396) blev gennemført til vurdering af virkningen af oral topotecan versus intravenøs topotecan til patienter, der havde oplevet tilbagefald ≥ 90 dage efter afslutningen af et tidligere behandlingsforløb med kemoterapi (se tabel 1).
English: In patients refractory to, or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10%.
Danish: Hos patienter, der var refraktære eller som fik tilbagefald inden for 3 måneder efter cisplatinbehandling (n = 186), var responsraten 10 %.
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, herunder den mandlige fertilitet, kan ikke udelukkes.
English: Personnel handling this medicinal product during dilution should wear protective clothing including mask, goggles and gloves.
Danish: • Personale, som håndterer dette lægemiddel under fortynding, skal bære beskyttelsesdragt herunder maske, briller og handsker.
English: In clinical studies, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Danish: I kliniske studier er udslæt rapporteret hos 4 % af patienterne og pruritus hos 1,5 % af patienterne.
English: The experience in children is limited and treatment is therefore not recommended.
Danish: Da der er begrænset erfaring med behandling af børn, kan dette ikke anbefales.
English: If either cisplatin or carboplatin is given on day 1 of the topotecan dosing, a lower dose of each agent must be given to improve tolerability compared to the dose of each agent which can be given if the platinum agent is given on day 5 of the topotecan dosing.
Danish: Hvis enten cisplatin eller carboplatin gives på dag 1 for topotecan-doseringen, skal der gives en lavere dosis af begge stoffer for at forbedre tolerancen sammenlignet med den dosis af de enkelte stoffer, der kan gives, hvis platin-stofferne, hvis de gives på dag 5 for topotecandoseringen.
English: The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively.
Danish: Hyppigheden af alvorlig (grad 3 eller 4) kvalme, opkastning, diarré og mucositis var henholdsvis 4, 3, 2 og 1 %.
English: The following information is intended for healthcare professionals only: Instructions on how to dilute, store and dispose of Topotecan Teva Instructions for dilution
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Instruktion i fortynding, opbevaring og bortskaffelse af Topotecan Teva Anvisninger for fortynding
English: 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).
Danish: Overdosering er blevet rapporteret hos patienter i behandling med intravenøs topotecan (op til 10 gange den anbefalede dosis) og topotacan kaspler (op til 5 gange den anbefalede dosis).
English: In the oral topotecan plus BSC group there was a statistically significant improvement in overall survival compared with the BSC alone group (Log- rank p = 0.0104).
Danish: I oral topotecan plus BSC-gruppen var der en statistisk signifikant forbedring i samlet overlevelse sammenlignet med gruppen med BSC alene (log-rank p = 0,0104).
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted:
Danish: De normale procedurer for omgang med anticancer medicin skal følges:
English: The topotecan-O-glucuronide andN-desmethyl topotecan-O-glucuronide in the urine were less than 2.0%.
Danish: Topotecan-O-glukuronid og N-desmethyltopotecan-O-glukuronid i urinen var mindre end 2,0 %.
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Danish: Endvidere udviklede 5 % (1 % af serierne) af alle de behandlede patienter sepsis (se pkt.
English: Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan
Danish: Oversigt over overlevelse, responsrate og tid til progression hos SCLC-patienter, der er behandlet med oral eller intravenøs topotecan Studie 065
English: In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 % of patients (6 % of courses).
Danish: I forbindelse med alvorlig neutropeni forekom feber eller infektion hos 16 % af patienterne under serie 1 og totalt set hos 23 % af patienterne (6 % af serierne).
English: patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Danish: patienter med recidiverende småcellet lungecancer (SCLC) for hvem gentagelse af 1. linjebehandling ikke anses for hensigtsmæssig (se pkt.
English: N = total number of patients treated.
Danish: N = antal behandlede patienter CI = konfidensinterval
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt hyppighedsgruppe skal bivirkningerne opstillet efter, hvor alvorlige de er.
English: CYTOTOXIC, special handling instructions (see package leaflet).
Danish: CYTOTOKSISK, særlige håndteringsinstruktioner (se indlægssedlen).
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, hvis du bruger anden medicin eller har brugt det for nylig.
English: An O-glucuronidation metabolite of topotecan and Ndesmethyl topotecan has been identified in the urine.
Danish: En O-glukuroniseret metabolit af topotecan og Ndesmethyltopotecan er identificeret i urin.
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Topotecan must be further diluted before use (see section 6.6).
Danish: Topotecan skal fortyndes yderligere inden anvendelse (se pkt.
English: In patients with moderate renal impairment topotecan plasma clearance was reduced to 34 % of the value in control patients.
Danish: Hos patienter med moderat nedsat nyrefunktion faldt topotecan plasmaclearance til 34 % af værdien for kontrolgruppens patienter.
English: These data should be evaluated in the context of the overall safety profile of the medicinal product, in particular of the significant haematological toxicity (see section 4.8).
Danish: Disse data bør evalueres i lyset af den totale sikkerhedsprofil af lægemidlet, specielt den signifikante hæmatologiske toksicitet.
English: You must tell your doctor immediately if you experience any of the following serious side effects.
Danish: Kontakt straks din læge, hvis du får nogle af nedenstående alvorlige symptomer.
English: Women of child-bearing potential should use effective contraception to avoid becoming pregnant while on treatment.
Danish: Kvinder i den fødedygtige alder skal bruge en effektiv præventionsmetode, for at undgå at blive gravid under behandlingen.
English: Very common Pyrexia, asthenia, fatigue Common
Danish: Meget almindelig Pyreksi, asteni, træthed Almindelig
English: 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.
Danish: I studier til dosisbestemmelses omfattende 523 patienter med recidiverende ovariecancer og 631 patienter med recidiverende småcellet lungecancer var den dosisbegrænsende toksicitet af topotecanmonoterapi hæmatologisk.
English: 2 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Danish: 2 Neutropenisk colitis, herunder letal neutropenisk colitis, er set som en komplikation til topotecan induceret neutropeni (se pkt.
English: Fatigue was observed in approximately 25 % and asthenia in 16 % of patients receiving topotecan.
Danish: Træthed blev observeret hos ca. 25 % og asteni hos 16 % af patienterne, som blev behandlet med topotecan.
English: Median survival (weeks)
Danish: Medianoverlevelse (uger)
English: This should be taken into account when prescribing Topotecan Teva, e.g. if patients at increased risk of tumour bleeds are considered for therapy.
Danish: Dette bør overvejes, når Topotecan Teva ordineres, f.eks i tilfælde, hvor det overvejes at behandle patienter med øget risiko for tumorblødning.
English: In a randomised, comparative Phase III study conducted by the Gynecologic Oncology Group (GOG 0179), topotecan plus cisplatin (n = 147) was compared with cisplatin alone (n = 146) for the treatment of histologically confirmed persistent, recurrent or Stage IVB carcinoma of the cervix where curative treatment with surgery and/or radiation was not considered appropriate.
Danish: I et randomiseret, sammenlignende fase III-studie, udført af Gynaecologic Oncology Group (GOG 0179), blev topotecan + cisplatin (n = 147) sammenlignet med cisplatin alene (n = 146) for behandling af histologisk bekræftet, persisterende, recidiverende eller stadium IVB-cervixcancer, hvor kurativ behandling med kirurgi og/eller stråleterapi ikke var vurderet hensigtsmæssig.
English: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Danish: Moderat til alvorlig anæmi (Hb ≤ 8,0 g/dl) hos 37 % af patienterne (14 % af serierne).
English: Median overall survival was 62 weeks for topotecan versus 53 weeks for paclitaxel (hazard ratio 0.9 [0.6, 1.3]).
Danish: Median samlet overlevelse var 62 uger for topotecan versus 53 uger for paclitaxel (hazard ratio 0,9 [0,6; 1,3]).
English: Topotecan Teva contains sodium
Danish: Topotecan Teva indeholder natrium
English: Plasma clearance of total topotecan (active and inactive form) in patients with hepatic impairment only decreased by about 10 % compared with the control group of patients.
Danish: Plasmaclearance af total-topotecan (aktiv eller inaktiv form) hos patienter med nedsat leverfunktion faldt kun ca. 10 % sammenlignet med kontrolgruppen.
English: What you need to know before you use Topotecan Teva Do not use Topotecan Teva:
Danish: Det skal du vide, før du begynder at få Topotecan Teva Du må ikke få Topotecan Teva:
English: Abnormally low white blood cell count (leucopenia, neutropenia) which may be accompanied with fever and signs of infections (febrile neutropenia).
Danish: • Meget lavt antal hvide blodceller (leukopeni, neutropeni), som kan være ledsaget af feber og symptomer på infektion (febril neutropeni).
English: In a population study using the intravenous route, the co-administration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form).
Danish: I et populationsstudie med intravenøs administration havde samtidig administration af granisetron, ondansetron, morphin eller kortikosteroider ingen signifikant virkning på farmakokinetikken af total-topotecan (aktiv og inaktiv form).
English: Study results Study GOG-0179 ITT population Cisplatin 50 mg/m2 on day 1, every 21 days
Danish: Resultater studie GOG-0179 ITT-population cisplatin 50 mg/m2 på dag 1, hver 21. dag cisplatin 50 mg/m2 på dag 1 +
English: The unadjusted hazard ratio for the oral topotecan plus BSC group relative to the BSC alone group was 0.64 (95 % CI: 0.45, 0.90).
Danish: Den ikke-justerede hazard ratio for oral topotecan plus BSC-gruppen i forhold til gruppen med BSC alene var 0,64 (95 % CI: 0,45; 0,90).
English: In addition, elevated hepatic enzymes have been reported with intravenous topotecan overdose.
Danish: Yderligere er forhøjede leverenzymer blevet rapporteret ved overdosering med intravenøs topotecan.
English: 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.
Danish: Som for andre cytostatika kan topotecan forårsage fosterskader, hvorfor kvinder i den fertile alder bør rådes til at undgå graviditet, hvis de er i behandling med topotecan.
English: Topotecan Teva is a clear pale yellow liquid in a colourless glass vial with bromobutyl rubber stopper, aluminium seal and snap-cap.
Danish: Topotecan Teva er en klar lysegul væske i et farveløst hætteglas med brombutylgummiprop, aluminiumforsegling og låg.
English: Personnel should be trained to dilute the medicinal product.
Danish: • Personalet skal være uddannet i at fortynde lægemidlet.
English: Based on the doselimiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Danish: På baggrund af den toksiske grænseværdi for myelosuppression blev den maksimalt tolererede dosis (MTD) fastsat til 2,0 mg/m2/dag med G-CSF og 1,4 mg/m2/dag uden G-CSF i et farmakokinetisk studie hos børn med refraktære solide tumorer (se pkt.
English: Itching (pruritus).
Danish: • Kløe (udslæt).
English: You must not breast-feed while on treatment with Topotecan Teva.
Danish: Du må ikke amme, mens du er i behandling med Topotecan Teva.
English: Fever.
Danish: • Feber.
English: Doses should be similarly reduced if the platelet count falls below 25 x 109/l.
Danish: Doserne bør ligeledes reduceres, hvis trombocyttallet falder til under 25 x 109/l.
English: Colourless, type I glass vial with bromobutyl rubber stopper, aluminium seal and polypropylene snapcap containing 1 ml or 4 ml of concentrate.
Danish: Farveløst hætteglas af type I med brombutylgummiprop, aluminiumforsegling og polypropylenlåg indeholdende 1 ml eller 4 ml koncentrat.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Topotecan Teva, skal du henvende dig til den lokale repræsentant af indehaveren af markedsføringstilladelsen:
English: - The active substance is topotecan hydrochloride.
Danish: - Aktivt stof: topotecanhydrochlorid.
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: Efter intravenøs administration af topotecandoser på 0,5 til 1,5 mg/m2, som 30 minutters infusion dagligt i 5 dage, viste topotecan en høj plasmaclearance på 62 l/time (SD 22), hvilket svarer til ca. 2/3 af blodgennemstrømning gennem leveren.
English: One study included a dose range of 1.4 to 2.4 mg/m2 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.
Danish: Et studie med et doseringsinterval på 1,4 til 2,4 mg/m2/dag 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.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: The risk of developing this severe condition (interstitial lung disease) is higher if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs (also see section 2 ‘What you need to know before you use Topotecan Teva').
Danish: Du har en højere risiko for at udvikle denne alvorlige sygdom (interstitiel lungesygdom), hvis du har en eksisterende lungesygdom, har fået strålebehandling af dine lunger eller tidligere har fået medicin, der gav skade på lungerne (se også punkt 2 ”det skal du vide, før du begynder at få Topotecan Teva”).
English: 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.
Danish: 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.
English: Storage of the diluted solution
Danish: Opbevaring af den fortyndede opløsning
English: Monotherapy (ovarian and small cell lung carcinoma) There is insufficient experience with the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min).
Danish: Monoterapi (ovariecancer og småcellet lungecancer) Der er utilstrækkelig erfaring med anvendelsen af topotecan hos patienter med alvorligt nedsat nyrefunktion (kreatininclearance < 20 ml/min).
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, Section 4.2).
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
English: Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Danish: Topotecan monoterapi og topotecan i kombination med cisplatin er sædvanligvis associeret med klinisk relevant trombocytopeni.
English: Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Danish: Patienter, der tidligere har fået cisplatin, skal have et vedvarende behandlingsfrit interval, for at kombinationsbehandlingen er berettiget (se pkt.
English: Topotecan Teva helps to kill tumour cells.
Danish: Topotecan Teva hjælper med til at ødelægge tumorceller.
English: Very common Nausea, vomiting and diarrhoea (all of which may be severe), constipation, abdominal pain2, mucositis
Danish: Meget almindelig Kvalme, opkastning og diarré (alle muligvis alvorlige), forstoppelse, mavesmerter2, mucositis
English: Very common Febrile neutropenia, neutropenia (see “Gastrointestinal disorders”), thrombocytopenia, anaemia, leucopenia
Danish: Meget almindelig Febril neutropeni, neutropeni (se “Mave-tarm-kanalen”), trombocytopeni, anæmi, leukopeni
English: Talk to your doctor or nurse before using Topotecan Teva: if you have any kidney problems.
Danish: Kontakt lægen eller sundhedspersonalet, før du begynder at få Topotecan Teva - hvis du har nyreproblemer.
English: Non-haematological
Danish: Non-hæmatologiske
English: EXP Read the leaflet for the shelf life of the diluted product.
Danish: EXP Læs indlægssedlen for information om holdbarhed for det fortyndede lægemiddel.
English: The hazard ratio for survival with IV topotecan relative to CAV was 1.04 (95 % CI 0.78 - 1.40).
Danish: Hazard ratio for overlevelse med intravenøs topotecan i forhold til CAV var 1,04 (95 % CI: 0,78; 1,40).
English: Haematological toxicity is dose-related and full blood count including platelets should be determined regularly (see section 4.2).
Danish: Den hæmatologiske toksicitet er dosisafhængig, og det samlede blodbillede - herunder trombocyttalbør fastlægges jævnligt (se pkt.
English: The mean metabolite: parent AUC ratio was < 10% for both total topotecan and topotecan lactone.
Danish: Det gennemsnitlige forhold mellem hovedmetabolitten og lægemiddelstoffets AUC var < 10 % for såvel topotecan som topotecanlakton.
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 administreres som intravenøs infusion på dag 1 med en dosis på 50 mg/m2 legemsoverflade/dag, efter administration af topotecan.
English: If you are or think you might be pregnant, tell your doctor immediately.
Danish: Fortæl det straks til lægen, hvis du er gravid eller har mistanke om, at du er gravid.
English: 1 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4).
Danish: 1 Dødsfald på grund af sepsis er rapporteret for patienter i behandling med topotecan (se pkt.
English: Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy.
Danish: Topotecan-monoterapi er indiceret til behandling af: patienter med metastaserende ovariecancer, hvor 1. linjebehandling eller efterfølgende behandling er slået fejl.
English: The response rate to topotecan in the combined small cell lung cancer programme (n=480) for patients with relapsed disease sensitive to first-line therapy, was 20.2 %.
Danish: Responsraten for topotecan var 20,2 % i det kombinerede program for småcellet lungecancer (n = 480) for patienter med recidiverende sygdom efter 1. linje-behandling.
English: 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.
Danish: desmethylmetabolitten i gennemsnit mindre end 7 % (interval 4-9 %) til det topotecan-relateredemateriale i urin og fæces, som der kunne gøres rede for.
English: 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.
Danish: Kombinationsterapi (cervixcancer) 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.
English: Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: - Alvorlig overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne angivet i pkt.
English: In another randomised Phase III study which compared intravenous (IV) topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3 % for topotecan compared to 18.3 % for the CAV group.
Danish: topotecan med cyclophosphamid, doxorubicin og vincristin (CAV) hos patienter med recidiverende, sensitiv SCLC, var den samlede responsrate 24,3 % for topotecan sammenlignet med 18,3 % for CAV-gruppen.
English: Store in a refrigerator.
Danish: Opbevar Topotecan Teva i køleskab.
English: Topotecan Teva may reduce your ability to fight infections.
Danish: Topotecan Teva kan gøre dig mindre modstandsdygtig over for infektioner.