FrancophonIA/ELRC3.0 huggingface dataset:
English: Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to reduce the dose to maintain neutrophil counts.
Danish: Standard onkologisk praksis for behandling af neutropeni er enten at administrere topotecan sammen med andre lægemidler (f.eks. G-CSF), eller at reducere dosis for at opretholde neutrofiltallet.
English: • The active substance is topotecan.
Danish: • Aktivt stof: topotecan.
English: Remember to tell your doctor if you start to take any other medicines while you are on Hycamtin.
Danish: Husk at fortælle lægen, hvis du starter med at tage anden medicin under behandlingen med Hycamtin.
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: Intravenous topotecan should be considered in the following clinical situations: uncontrolled emesis, swallowing disorders, uncontrolled diarrhoea, clinical conditions and medication that may alter gastrointestinal motility and drug absorption.
Danish: Intravenøs topotecan skal overvejes i følgende kliniske situationer: ukontrolleret emesis, synkeforstyrrelser, ukontrolleret diarré, kliniske tilstande og medicinering, som kan ændre den gastrointestinale motilitet og lægemiddelabsorption.
English: Consult your doctor after eye contact or if you experience a skin reaction.
Danish: Kontakt lægen hvis du får noget i øjet eller oplever en forandring i huden.
English: Topotecan must be reconstituted and further diluted before use (see section 6.6).
Danish: Topotecan skal rekonstitueres og fortyndes yderligere inden anvendelse (se pkt.
English: This should be taken into account when prescribing HYCAMTIN, e.g. if patients at increased risk of tumour bleeds are considered for therapy.
Danish: Dette bør overvejes, når HYCAMTIN ordineres f.eks. i tilfælde, hvor det overvejes at behandle patienter med øget risiko for tumorblødning.
English: Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic substances and/or colony stimulating factors.
Danish: Underliggende risikofaktorer inkluderer tidligere ILD, pulmonal fibrose, lungecancer, eksponering af thorax for stråler og brug af pneumotoksiske stoffer og/eller kolonistimulerende faktorer.
English: • ovarian cancer or small cell lung cancer that has come back after chemotherapy.
Danish: • ovariekræft eller småcellet lungekræft, som er kommet igen efter kemoterapi.
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: I et andet randomiseret fase III-studie, som sammenlignede intravenøs (IV) 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: 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 topotecandoseringen, 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-stoffet gives på dag 5 for topotecandoseringen.
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: There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in pharmacokinetics after multiple doses.
Danish: Der ses ringe eller ingen akkumulering af topotecan efter gentagen daglig dosering, og der er ingen tegn på ændring i farmakokinetikken efter multiple doser.
English: Pregnant staff should be excluded from working with this medicinal product.
Danish: Gravide kvinder blandt personalet må ikke arbejde med dette medikament.
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 serie 1 hos 55 % af patienterne med en varighed  syv dage hos 20 % og totalt set hos 77 % af patienterne (39 % af serierne).
English: If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Hycamtin.
Danish: Hvis du er i behandling for livmoderhalskræft, kan du få bivirkninger af den anden medicin (cisplatin), som du vil få sammen med Hycamtin.
English: Other than hydrolysis, topotecan is cleared predominantly renally, with a minor component metabolised to the N-desmethyl metabolite (SB-209780) identified in plasma, urine and faeces.
Danish: Ud over hydrolyse elimineres topotecan overvejende renalt som en mindre komponent, der metaboliseres til N-desmetylmetabolit (SB-209780) og er fundet i plasma, urin og fæces.
English: Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuremberg, Germany
Danish: Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nürnberg, Tyskland
English: Black ink
Danish: Sort blæk
English: • All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Danish: • Alt udstyr brugt til administration eller rengøring, herunder handsker, bør anbringes i en højrisiko-affaldssæk til forbrænding ved høj temperatur.
English: Other severe events that were recorded as related or possibly related to topotecan treatment were anorexia (12%), malaise (3%) and hyperbilirubinaemia (1%).
Danish: Andre alvorlige hændelser registreret som relateret til eller muligvis relateret til behandling med topotecan var anoreksi (12 %), utilpashed (3 %) og hyperbilirubinæmi (1 %).
English: Do not use this medicine after the expiry date which is stated on the carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
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 extent of exposure was similar following a high-fat meal and in the fasted state, while tmax was delayed from 1.5 to 3 hours (topotecan lactone) and from 3 to 4 hours (total topotecan).
Danish: Omfanget af eksponering var den samme efter et måltid med højt fedtindhold og i fastende tilstand, mens tmax blev øget fra 1,5 til 3 timer (topotecanlakton) og fra 3 til 4 timer (total-topotecan).
English: How Hycamtin is given A doctor or nurse will administer Hycamtin as an infusion into your arm lasting about 30 minutes.
Danish: En læge eller sygeplejerske vil give dig Hycamtin i din arm som en infusion, der varer omkring 30 minutter.
English: Safety data are presented based on an integrated data set of 682 patients with relapsed lung cancer administered 2,536 courses of oral topotecan monotherapy (275 patients with relapsed SCLC and 407 with relapsed non-SCLC).
Danish: Sikkerhedsdata præsenteres ud fra et integreret datagrundlag med 682 patienter med recidiverende lungecancer, som havde fået 2.536 serier med oral topotecan-monoterapi (275 patienter med recidiverende SCLC og 407 med recidiverende ikke-SCLC).
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: En N-desmethylmetabolit, som i et cellebaseret assay har vist sig at have samme eller mindre aktivitet end lægemiddelstoffet, er fundet i urin, plasma og fæces.
English: Personnel should be trained to reconstitute the medicinal product.
Danish: Personale skal oplæres i rekonstitution af medikamentet.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
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: • Staff handling this medicinal product during reconstitution should wear protective clothing including mask, goggles and gloves.
Danish: • Personale, som håndterer dette lægemiddel under rekonstitution, skal bære beskyttelsesdragt herunder maske, briller og handsker.
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: • Cervical cancer: 0.75 mg per square metre of body surface area per day.
Danish: • Livmoderhalskræft: 0,75 mg/m af kroppens overfladeareal pr. dag.
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 prescribing information for cisplatin should be consulted for a full list of adverse events associated with cisplatin use.
Danish: Cisplatins produktinformation bør konsulteres for en komplet liste over bivirkninger associeret til brugen af cisplatin.
English: Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma and rhabdomyosarcoma.
Danish: Følgende tumortyper var inkluderet: Ewing's sarkom/primitiv neuroektoderm tumor, neuroblastoma, osteoblastoma og rhabdomyosarcoma.
English: If well tolerated, the dose may be increased to 2.3 mg/m 2/day in subsequent cycles (see section 5.2).
Danish: Hvis dette er veltolereret, kan dosis øges til 2,3 mg/m 2/dag i efterfølgende serier (se pkt.
English: Therapeutic interventions associated with non-haematological effects included anti-emetic agents, given to 47% of patients in 38% of courses and anti-diarrhoeal agents, given to 15% of patients in 6% of courses.
Danish: Terapeutiske interventioner forbundet med non-hæmatologiske virkninger omfattede antiemetika, som blev givet til 47 % af patienterne i 38 % af serierne og midler mod diarré, som blev givet til 15 % af patienterne i 6 % af serierne.
English: Limited data in Korean patients with creatinine clearance less than 50 ml/min suggest a further lowering of dose may be required (see section 5.2).
Danish: Der er begrænsede data for koreanske patienter med kreatinin-clearance under 50 ml/min, som indikerer, at en yderligere dosisnedsættelse kan være nødvendig (se pkt.
English: The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy.
Danish: Brug af topotecan bør begrænses til afdelinger specialiseret i brug af cytotoksisk kemoterapi.
English: • if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for topotecan eller et af de øvrige indholdsstoffer i dette lægemiddel
English: • Occasionally severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (colitis).
Danish: • Lejlighedsvis kan stærke mavesmerter, feber og muligvis diarré (sjældent med blod) være tegn på tyktarmsbetændelse (colitis).
English: Do not breast-feed if you are being treated with Hycamtin.
Danish: Du må ikke amme, hvis du er i behandling med Hycamtin.
English: Separate one capsule: tear along the perforated lines to separate one capsule “pocket” from the strip.
Danish: Adskil en kapsel: Riv langs de perforerede linjer for at adskille en kapsel fra blisterkortet.
English: Hycamtin is used to treat small cell lung cancer that has come back after chemotherapy.
Danish: Hycamtin bruges til at behandle småcellet lungekræft, som er kommet igen efter kemoterapi.
English: Resulting from its mechanism of action, topotecan is genotoxic to mammalian cells (mouse lymphoma cells and human lymphocytes) in vitro and mouse bone marrow cells in vivo.
Danish: Som følge af dets virkemåde er topotecan genotoksisk over for pattedyrsceller (lymfomceller hos mus og lymfocytter hos mennesker) in vitro samt knoglemarvsceller hos mus in vivo.
English: Therefore, use of the normal starting dose in patients with a mild decrease in renal function is considered established (see section 4.2).
Danish: Derfor anses anvendelsen af den normale startdosis til patienter med en let nedsat nyrefunktion at være veletableret (se pkt.
English: Complete alopecia related/possibly related to topotecan administration was observed in 9% of patients and partial alopecia related/possibly related to topotecan administration in 11% of patients.
Danish: Total alopeci relateret/muligvis relateret til administration af topotecan sås hos 9 % af patienterne, og udtalt alopeci relateret/muligvis relateret til administration af topotecan sås hos 11 % af patienterne.
English: As with other cytotoxic medicinal products, topotecan can cause severe myelosuppression.
Danish: Som for andre cytostatika kan topotecan forårsage svær myelosuppression.
English: Serious side effects: tell your doctor These very common side effects may affect more than 1 in 10 people treated with Hycamtin:
Danish: Alvorlige bivirkninger: Tal med lægen Disse meget almindelige bivirkninger kan forekomme hos flere end 1 ud af 10 personer, der får Hycamtin:
English: Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Danish: Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Storbritannien
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: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP
English: The overall haematological toxicity is lower in patients treated with topotecan in combination with cisplatin compared to topotecan monotherapy, but higher than with cisplatin alone.
Danish: Den samlede hæmatologiske toksicitet er lavere hos patienter behandlet med topotecan i kombination med cisplatin sammenlignet med topotecan-monoterapi, men højere end med cisplatin alene.
English: WARNING: Cytotoxic agents, special handling instructions (see Package Leaflet).
Danish: ADVARSEL: Cytotoksisk præparat, specielle håndteringsinstruktioner (se indlægssedlen).
English: Keep the blister in the outer carton in order to protect from light.
Danish: Opbevar blisteren i den ydre karton for at beskytte mod lys.
English: Mild abdominal pain was reported in 4% of patients.
Danish: Lette abdominalsmerter blev rapporteret hos 4 % patienterne.
English: The second study included a dose range of 2.0 to 5.2 mg/m in children (n = 8), adolescents (n = 3) and young adults (n = 3) with leukaemia.
Danish: Det andet studie havde et doseringsinterval på 2,0 til 5,2 mg/m til børn (n = 8), unge (n = 3) og yngre voksne (n = 3) med leukæmi.
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: If cisplatin is discontinued, there are insufficient data regarding continuing monotherapy with topotecan in patients with cervical cancer.
Danish: Hvis behandlingen med cisplatin ophører, er der utilstrækkelige data til at underbygge fortsat monoterapi med topotecan til patienter med cervixcancer.
English: Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease.
Danish: Topotecan i kombination med cisplatin er indiceret til behandling af patienter med cervixcancer, som recidiverer efter strålebehandling eller til patienter i sygdomsstadie IVB.
English: The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were less than 2.0%.
Danish: Topotecan-O-glukuronid og Ndesmethyltopotecan-O-glukuronid i urinen var mindre end 2,0 %.
English: The integrated safety data for topotecan monotherapy are presented below.
Danish: De samlede sikkerhedsdata for topotecan-monoterapi fremgår herunder.
English: Median (95% CI) Hazard ratio (95% CI) Log rank p-value
Danish: Median (95 % CI) Hazard ratio (95 % CI) Log rank p-værdi
English: Patients should be carefully monitored for adverse reactions when oral topotecan is administered with a substance known to inhibit ABCB1 or ABCG2 (see section 5.2).
Danish: Patienterne skal monitoreres omhyggeligt for bivirkninger, når oral topotecan administreres samtidig med et lægemiddelstof, der hæmmer ABCB1 eller ABCG2 (se pkt.
English: A 5-HT3 antagonist was administered to 30% of patients in 24% of courses.
Danish: En 5-HT3-antagonist blev givet til 30 % af patienterne i 24 % af serierne.
English: Topotecan is partly eliminated via renal excretion and renal impairment might lead to increased exposure to topotecan.
Danish: Topotecan udskilles delvist via nyrerne, og nedsat nyrefunktion kan føre til øget eksponering for topotecan.
English: Personnel handling this medicinal product during reconstitution should wear protective clothing including mask, goggles and gloves.
Danish: Personale, som håndterer dette medikament under rekonstitution skal bære beskyttelsesdragt, herunder maske, beskyttelsesbriller og handsker.
English: Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan plus BSC.
Danish: Patienternes egen rapportering af symptomer vha. ublindede vurderinger viste en klar tendens mod symptomforbedring med oral topotecan plus BSC.
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: 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: In addition, elevated hepatic enzymes have been reported with intravenous topotecan overdose.
Danish: Yderligere er forhøjede leverenzymer blevet rapporteret ved overdosering med topotecan intravenøst.
English: The adverse events listed above have the potential to occur with a higher frequency in patients who have a poor performance status (see section 4.4).
Danish: Bivirkningerne ovenfor kan forekomme med større hyppighed hos patienter, som har en dårlig performancestatus (se pkt.
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 administrationen havde samtidig administration af granisetron, ondansetron, morphin eller kortikosteroider ingen signifikant virkning på farmakokinetikken af total-topotecan (aktiv og inaktiv form).
English: For patients who experience Grade 3 or 4 diarrhoea, the dose should be reduced by 0.4 mg/m2/day for subsequent courses (see section 4.4).
Danish: Hos patienter, som oplever grad 3 eller 4 diarré, bør dosis reduceres med 0,4 mg/m2/dag i de efterfølgende serier (se pkt.
English: Do not take Hycamtin:
Danish: Tag ikke Hycamtin:
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: Sealing band Gelatin
Danish: Forseglingsbånd Gelatine
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: 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: Clinical guidelines describing the aggressive management of CTID include specific recommendations on patient communication and awareness, recognition of early warning signs, use of anti-diarrhoeals and antibiotics, changes in fluid intake and diet, and need for hospitalisation (see sections 4.2 and 4.8).
Danish: Kliniske vejledninger i aggressiv behandling af diarré pga. cancerbehandling omfatter særlige rekommandationer om patientkommunikation, opmærksomhed og erkendelse af de tidlige tegn, anvendelse af midler mod diarré og antibiotika, ændringer i væskeindtag og diæt samt behov for hospitalsindlæggelse (se pkt.
English: 30-minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy.
Danish: Behandlingen blev gentaget hver 3. uge i op til et år afhængig af terapirespons.
English: If topotecan is used during pregnancy, or if the patient becomes pregnant during therapy with topotecan, the patient must be warned of the potential hazards to the foetus.
Danish: Hvis topotecan anvendes under graviditet, eller hvis graviditet indtræder under behandlingen med topotecan, skal patienten advares om den potentielle risiko for barnet.
English: Frequently reported non-haematological effects were gastrointestinal, such as nausea (52%), vomiting (32%), diarrhoea (18%), constipation (9%) and mucositis (14%).
Danish: Hyppigt rapporterede non-hæmatologiske bivirkninger var gastrointestinale, såsom kvalme (52 %), opkastning (32 %), diarré (18 %), obstipation (9 %) og mucositis (14 %).
English: Currently there is only limited experience in combining oral topotecan with other chemotherapy agents.
Danish: På nuværende tidspunkt er der ingen begrænsning ved kombination af oral topotecan med andre kemoterapeutika.
English: Asthenia, pyrexia, malaise
Danish: Asteni, pyreksi, utilpashed
English: Monotherapy (ovarian and small cell lung carcinoma):
Danish: Monoterapi (ovariecancer og småcellet lungecancer):
English: Doses should be similarly reduced if the platelet count falls below 25 x 10
Danish: Doserne bør ligeledes reduceres, hvis trombocyttallet falder til under 25 x 10
English: GlaxoSmithKline Manufacturing S.p.A, Strada Provinciale Asolana 90, 43056 San Polo di Torrile, Parma, Italy.
Danish: GlaxoSmithKline Manufacturing S.p.A, Strada Provinciale Asolana 90, 43056 San Polo di Torrile, Parma, Italien.