FrancophonIA/ELRC3.0 huggingface dataset:
English: It may harm a baby conceived before, during or soon after treatment.
Danish: Et ufødt barn kan blive skadet før, under eller lige efter behandlingen.
English: If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
Danish: Hvis behandlingen tåles godt, kan den fortsættes, indtil sygdommen progredierer (se afsnit 4.8 og 5.1).
English: Before you are given this medicine your doctor needs to know :
Danish: Inden du får denne medicin, skal din læge vide:
English: Talk to your doctor for advice on how to minimise the risk of bleeding.
Danish: Tal med din læge om, hvordan du mindsker risikoen for blødning.
English: This can lead to severe bleeding from relatively small injuries such as a small cut.
Danish: Det kan medføre svær blødning fra relativt små skader som f.eks. et mindre snitsår.
English: Topotecan is not recommended for pregnant women.
Danish: Topotecan bør ikke gives til gravide kvinder.
English: Volume of distribution was slightly decreased and thus half-life only increased by 14 %.
Danish: Distributionsvolumenet var let nedsat, hvorved halveringstiden kun steg med 14 %.
English: Storage, Use, Handling & Disposal of Topotecan Hospira
Danish: Opbevaring, brug, håndtering og bortskaffelse af Topotecan Hospira
English: After opening, the product should be used immediately.
Danish: Efter åbning skal produktet anvendes straks.
English: Log rank p-value
Danish: Log rank, p-værdi
English: Serious side effects: tell your doctor
Danish: Alvorlige bivirkninger: Tal med lægen
English: The dose of topotecan you are given will be worked out by your doctor, based on:
Danish: Den dosis af topotecan, som du vil få, vil blive beregnet af din læge, og afhænger af:
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to ˂1/100); rare (≥1/10,000 to ˂1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ogikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: This medicine is for single use only.
Danish: Denne medicin er til engangsbrug.
English: If not used immediately, Topotecan Hospira can be used for up to 24 hours when stored in the fridge (protected from light) or at room temperature (in normal daylight conditions).
Danish: Hvis det ikke anvendes straks, kan Topotecan Hospira anvendes i op til 24 timer ved opbevaring i køleskab (beskyttet mod lys) eller ved stuetemperatur (ved normale dagslys betingelser).
English: No in vivo human pharmacokinetic interaction studies have been performed.
Danish: Der er ikke udført in vivo farmakokinetiske interaktionsstudier på mennesker.
English: Rarely, it can lead to more severe bleeding (haemorrhage).
Danish: I sjældnere tilfælde kan det medføre en mere alvorlig blødning (hæmorrhagi).
English: • your body size (surface area measured in square metres)
Danish: • din legemsstørrelse (overfladeareal, målt i kvadratmeter ).
English: Pyrexia, asthenia, fatigue
Danish: Pyreksi, astheni, træthed
English: Topotecan also had a high volume of distribution, about 132l (SD 57), and a relatively short half-life of 2-3 hours.
Danish: Topotecan havde ligeledes et højt distributionsvolumen på omkring 132 l (SD 57) og en relativ kort halveringstid på 2-3 timer.
English: Adverse reactions are listed below by system organ class and absolute frequency (all reported events).
Danish: Bivirkningerne, som er nævnt nedenfor, er opdelt efter systemorganklasse og absolutte hyppigheder (alle indberettede hændelser).
English: There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the pharmacokinetics after multiple doses.
Danish: Der er ringe eller ingen akkumulering af topotecan efter gentagen daglig dosering, og der er ingen tegn på ændringer i farmakokinetikken efter multiple doser.
English: Area under the curve increased approximately in proportion to the increase in dose.
Danish: Arealet under kurven øgedes nogenlunde i overensstemmelse med dosisforøgelsen.
English: No studies of the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier om virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: Total or pronounced alopecia was observed in 30 % of patients and partial alopecia in 15 % of patients.
Danish: Der blev set total eller udtalt alopeci hos 30 % af patienterne, og partiel alopeci hos 15 %.
English: • advanced cervical cancer if surgery or radiotherapy treatment is not possible.
Danish: • fremskreden livmoderhalskræft, hvis behandling med kirurgi eller stråleterapi ikke er mulig.
English: Accurate assessment of performance status at the time therapy is given is important, to ensure that patients have not deteriorated to PS 3.
Danish: Det er vigtigt at vurdere performance status omhyggeligt ved påbegyndelse af behandlingen for at sikre, at patienternes performance status ikke forværres til PS 3.
English: Your doctor will tell you whether this is the case, based on the results of your last blood test.
Danish: Det får du at vide af din læge på baggrund af resultaterne af din sidste blodprøve.
English: • Mild pain and inflammation at the site of injection.
Danish: • Lette smerter og betændelse på injektionsstedet
English: Anti-tumour activity was demonstrated primarily in patients with neuroblastoma.
Danish: Der blev primært påvist antitumoraktivitet hos patienter med neuroblastom.
English: Median survivals for the two groups were 25.0 and 24.7 weeks, respectively.
Danish: Den mediane overlevelse for de to grupper var hhv. 25,0 og 24,7 uger.
English: The frequency of some side effects is not known (events from spontaneous reports and the frequency cannot be estimated from the available data):
Danish: Bivirkninger, hvor hyppigheden ikke er kendt Hyppigheden af nogle bivirkninger er ikke kendt (hændelser fra spontane rapporteringer, og hyppigheden kan ikke bestemmes ud fra de tilgængelige data):
English: Topotecan half-life was increased by about 30 % but no clear change in volume of distribution was observed.
Danish: Topotecans halveringstid steg med ca. 30 %, men der blev ikke set nogen sikker ændring i distributionsvolumenet.
English: • the results of blood tests carried out before treatment
Danish: • resultaterne af blodprøverne,der er taget førbehandlingens start.
English: Interstitial lung disease (some cases have been fatal)
Danish: Interstitiel lungesygdom (nogle tilfælde kan være fatale)
English: Do not try to become pregnant until a doctor advises you it is safe to do so.
Danish: Forsøg ikke på at blive gravid før lægen siger, at det er sikkert
English: The following information is intended for medical or healthcare professionals only.
Danish: Nedenstående oplysninger til læger og sundhedspersonale:
English: Topotecan does not inhibit human P450 enzymes (see section 5.2).
Danish: Topotecan hæmmer ikke humane P450-enzymer (se afsnit 5.2).
English: As would be expected, patients with poor performance status (PS>1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Danish: Som forventet har patienter med dårlig performance status (PS > 1) en lavere responsrate og en øget incidens af komplikationer som f.eks. feber, infektion og sepsis (se pkt.
English: Use the aseptic technique during any further dilution of the solution for infusion.
Danish: Brug aseptisk teknik ved yderligere fortynding af infusionsopløsningen.
English: − Personnel should be trained to prepare and administer the medicinal product.
Danish: − Personalet skal oplæres i fremstilling og administration af lægemidlet.
English: Of the patients who received more than 6 cycles of therapy, 91 % completed the study as planned or were treated until disease progression, with only 3 % withdrawn for adverse events.
Danish: Af de patienter, som fik flere end 6 serier kemoterapi, fuldførte 91 % studiet som planlagt eller blev behandlet, indtil sygdommen progredierede, og heraf blev kun 3 % ekskluderet på grund af bivirkninger.
English: In these studies there were no apparent differences in the pharmacokinetics of topotecan among children, adolescents and young adult patients with solid tumours or leukaemia, but data are too limited to draw definite conclusions.
Danish: I disse studier var der ingen synlige forskelle i topotecans farmakokinetik hos børn, unge og yngre voksne med solide tumorer eller leukæmi, men der er for få data til en definitiv konklusion.
English: • Staff should be adequately trained in the preparation, administration and disposal of cytotoxics
Danish: • Personalet skal oplæres tilstrækkeligt i tilberedning, administration og bortskaffelse af cytotoksiske lægemidler.
English: Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Danish: En sammenligning af de farmakokinetiske parametre tydede ikke på farmakokinetiske ændringer i løbet af de 5 doseringsdage.
English: The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16 %.
Danish: Responsraten i hele ovariecancer programmet (n = 392, alle tidligere behandlet med cisplatin eller cisplatin og paclitaxel) var 16 %.
English: Median time to onset of severe neutropenia was nine days and the median duration was seven days.
Danish: Den mediane tid til indtræden af svær neutropeni var ni dage, og den mediane varighed syv dage.
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 hændelserregistreret som relateret eller muligvis relateret til behandlingen med topotecan var anoreksi (12 %), utilpashed (3 %) og hyperbilirubinæmi (1 %).
English: Dosage: Paediatric population Limited data available.
Danish: Dosering: Pædiatrisk population Der foreligger begrænsede data.
English: In a population study, a number of factors including age, weight and ascites had no significant effect on clearance of total topotecan (active and inactive form).
Danish: I et populationsstudie havde flere faktorer, herunder alder, vægt og ascites, ingen signifikant virkning på topotecans totale clearance (aktiv og inaktiv form).
English: As with all cytotoxic chemotherapy, patients being treated with topotecan must be advised that they or their partner must use an effective method of contraception.
Danish: Som med al cytotoksisk kemoterapi, skal patienter, der behandles med topotecan, rådes til, at de eller deres partner skal anvende en effektiv præventionsmetode.
English: Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available.
Danish: Topotecan er også undersøgt hos børn, men der foreligger kun begrænsede data om effekt og sikkerhed.
English: Red cell transfusions were given in 52 % of patients (21 % of courses).
Danish: Der blev givet transfusioner af røde blodlegemer til 52 % af patienterne (21 % af behandlingsserierne).
English: Unopened vial 3 years
Danish: Hætteglas inden åbning 3 år
English: Median survival was 30.3 weeks (95 % CI: 27.6, 33.4).
Danish: Den mediane overlevelse var 30,3 uger (95 % CI: 27,6 og 33,4).
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 (angivet i pkt.
English: Tell your doctor if any of these applies to you.
Danish: Tal med lægen, hvis noget af ovenstående gælder for dig
English: Among all patients treated in clinical studies (including both those with severe neutropenia and those who did not develop severe neutropenia), 11 % (4 % of courses) developed fever and 26 % (9 % of courses) developed infection.
Danish: Blandt alle patienter, der blev behandlet i de kliniske studier (herunder både patienter med svær neutropeni og patienter, der ikke fik svær neutropeni), fik 11 % (4 % af behandlingsserierne) feber, og 26 % (9 % af behandlingsserierne) infektion.
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: Summary of survival, response rate, and time to progression in SCLC patients treated with oral topotecan or intravenous topotecan
Danish: Oversigt over overlevelse, responsrate og tiden indtil progression hos patienter med SCLC, der blev behandlet med oral topotecan eller intravenøs topotecan
English: In vitro data using human liver microsomes indicate the formation of small amounts of Ndemethylated topotecan.
Danish: In vitro data fra humane levermikrosomer tyder på dannelsen af små mængder N-demethyleret topotecan.
English: When combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Danish: Når topotecan gives sammen med andre kemoterapeutika kan det være nødvendigt at reducere dosis af de enkelte lægemidler for at forbedre tolerabiliteten.
English: Although it is not known whether topotecan is excreted in human breast milk, breast-feeding should be discontinued at the start of therapy.
Danish: Selvom det ikke vides, om topotecan udskilles i humant brystmælk, skal amning stoppes ved behandlingsstart.
English: Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks, respectively).
Danish: Den mediane tid til progression var ens i de to grupper (hhv.13,3 uger og 12,3 uger).
English: There were no signs of cumulative haematological or non-haematological toxicity.
Danish: Der blev ikke fundet tegn på kumulativ hæmatologisk eller non-hæmatologisk toksicitet.
English: Approximately 51% was excreted as total topotecan and 3 % was excreted as N-desmethyl topotecan in the urine.
Danish: Omtrent 51 % blev udskilt som uomdannet topotecan og 3 % blev udskilt som Ndesmethyltopotecan i urinen.
English: Limited data indicate that the dose should be reduced in patients with moderate renal impairment.
Danish: Begrænsede data tyder på, at dosis bør reduceres hos patienter med moderat nedsat nyrefunktion.
English: Pharmacotherapeutic group: antineoplastic agents: other antineoplastic agents, ATC code: L01XX17.
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, andre antineoplastiske stoffer, ATC-kode: L01XX17
English: Your doctor will decide with you whether Topotecan Hospira therapy is better than further treatment with your initial chemotherapy.
Danish: Din læge vil tage stilling til om behandling med Topotecan Hospira er bedre end fortsat behandling med kemoterapi.
English: You will have treatment once a day for 3 days.
Danish: Du vil få behandlingen en gang daglig i 3 dage.
English: Moderate to severe (Hb ≤8.0 g/dl) in 37 % of patients (14 % of courses).
Danish: Moderat til alvorlig (hæmoglobin ≤ 8,0 g/dl) hos 37 % af patienterne (14 % af behandlingsserierne).
English: Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma and rhabdomyosarcoma.
Danish: De inkluderede tumortyper var: Ewings sarkom/primitiv neuroektoderm tumor, neuroblastom, osteoblastom og rhabdomyosarcom.
English: • Weight loss and loss of appetite (anorexia); tiredness; weakness.
Danish: • Tab af vægt og appetit (anoreksi), træthed, slaphed.
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 ved brug af ublindede vurderinger viste en klar tendens til symptomforbedring med oral topotecan plus BSC.
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 f.eks. kvalme (52 %), opkastning (32 %), diarre (18 %), obstipation (9 %) og mucositis (14 %).
English: Severe neutropenia lasted beyond seven days in 11 % of courses overall.
Danish: Svær neutropeni varede længere end syv dage i 11 % af alle behandlingsserier.
English: The pharmacokinetics of topotecan given as a 30-minute infusion for 5 days were evaluated in two studies.
Danish: Topotecans farmakokinetik efter intravenøs infusion over 30 minutter i 5 dage blev undersøgt i to studier.
English: Preclinical studies indicate plasma protein binding of topotecan is low (35%) and distribution between blood cells and plasma was fairly homogeneous.
Danish: Prækliniske studier tyder på, at topotecans plasmaproteinbinding er lav (35 %), og at fordelingen mellem blodceller og plasma er omtrent homogen.
English: Signs include: fever serious deterioration ofyour general condition local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be aurinary infection).
Danish: Symptomerne omfatter: feber alvorlig forværring afdingenerelletilstand lokale symptomer, f.eks. ondt i halsen eller vandladningsproblemer (f.eks. en brændende følelse, når du tisser, hvilket kan skyldes en urinvejsinfektion).
English: In patients refractory to or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10 %.
Danish: Hos patienter, som var refraktære, eller fik tilbagefald indenfor 3 måneder efter cisplatinbehandling (n = 186), var responsraten 10 %.
English: Topotecan must be reconstituted and further diluted before use (see section 6.6).
Danish: Topotecan skal rekonstitueres og fortyndes yderligere før brug (se pkt.
English: The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively.
Danish: Hyppigheden af alvorlige (grad 3 eller 4) kvalme, opkastning, diarre og mucositis var henholdsvis 4, 3, 2 og 1 %.
English: The frequencies associated with the haematological and non-haematological adverse events listed below represent the adverse event reports considered to be related/possibly related to topotecan therapy.
Danish: Hyppighederne, som er forbundet med hæmatologiske og ikke-hæmatologiske bivirkninger, er anført nedenfor og repræsenterer de bivirkningsrapporter, som anses for at være relateret eller muligvis relateret til behandling med topotecan.
English: If there is lasting irritation, a doctor should be consulted.
Danish: Hvis der er blivende irritation skal man kontakte en læge.
English: • Pregnant staff should be excluded from working with this medicinal product.
Danish: • Gravide kvinder blandt personalet må ikke arbejde med dette lægemiddel.
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 performance status (se pkt.
English: Faecal elimination of total topotecan accounted for 18 % while faecal elimination of N-desmethyl topotecan was 1.7 %.
Danish: Udskillelsen af uomdannet topotecan med fæces udgjorde 18 %, mens den fækale eliminering af N-desmethyltopotecan var 1,7 %.
English: Dilute before use.
Danish: Fortyndes inden brugen.
English: How topotecan is given A doctor or nurse will administer topotecan as an infusion into your arm lasting about 30 minutes.
Danish: En læge eller sygeplejerske vil give dig topotecan i din arm som en infusion, der varer omkring 30 minutter.
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: The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy.
Danish: Brug af topotecan bør begrænses til afdelinger, som er specialiseret i brug af cytotoksisk kemoterapi.
English: The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were < 2.0 %.
Danish: Topotecan-O-glucuronid og Ndesmethyltopotecan-O-glucuronid i urinen udgjorde mindre end 2,0 %.
English: In clinical studies, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Danish: I de kliniske studier er udslæt rapporteret hos 4 % af patienterne og pruritus hos 1,5 % af patienterne.
English: Neutropenia and thrombocytopenia should be managed.
Danish: Neutropeni og trombocytopeni skal behandles.
English: • Signs of infection: Topotecan may reduce the number of white blood cells and lower your resistance to infection.
Danish: Topotecan kan nedsætte antallet af hvide blodceller og nedsætte din modstandsdygtighed over for infektioner.
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: Sammen med alvorlig neutropeni forekom der feber eller infektion hos 16 % af patienterne under serie 1 og totalt set hos 23 % af patienterne (6 % af behandlingerne).
English: This should be taken into account when prescribing Topotecan Hospira, e.g. if patients at increased risk of tumour bleeds are considered for therapy.
Danish: Det bør der tages hensyn til, når Topotecan Hospira ordineres hvis det f.eks. overvejes at behandle patienter med øget risiko for tumorblødning.
English: In another randomised Phase III trial 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-gruppen sammenlignet med 18,3 % for CAVgruppen.
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: Hvistopotecan anvendes under graviditet, eller hvis graviditet indtræder under behandlingen med topotecan, skal patienten advares om den potentielle risiko for barnet.
English: Topotecan Hospira is a yellow/yellow green solution.
Danish: Topotecan Hospira er en gul/gulgrøn opløsning.
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 patientpopulationen med refraktær SCLC (patienter, som ikke responderer på første linie behandling) var responsraten efter behandling med topotecan 4,0 %.
English: Overall, the N-desmethyl metabolite contributed a mean of < 7% (range 4-9 %) of the total topotecan-related material accounted for in the urine and faeces.
Danish: Samlet set bidrog N-desmethylmetabolitten i gennemsnit med mindre end 7 % (spændvidde 4 - 9 %) af det samlede topotecanrelaterede materiale, som blev fundet i urin og fæces.
English: • Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
Danish: • Unormale blå pletter eller blødning, som skyldes et fald i antallet af de blodlegemer, der får blodet til at størkne.
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: • behandling er slået fejl.patienter med recidiverende, småcellet lungecancer (SCLC) for hvem gentagelse af behandling med første linie behandling ikke anses for hensigtsmæssig (se pkt.