FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Danish: Endvidere fik 5 % af alle de behandlede patienter sepsis (1 % af behandlingerne) (se pkt.
English: If visible particles are observed, the product should not be administered.
Danish: Hvis der er synlige partikler, bør produktet ikke bruges.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: − Pregnant staff should be excluded from working with this medicinal product.
Danish: − Gravide kvinder blandt personalet må ikke arbejde med dette lægemiddel.
English: − Personnel handling this medicinal product should wear protective clothing including mask, goggles and gloves.
Danish: − Personale, som håndterer dette lægemiddel skal bære beskyttelsesdragt, herunder maske, beskyttelsesbriller og handsker.
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 i det kombinerede program for småcellet lungecancer (n=480) for patienter med recidiverende sygdom efter første linie behandling var 20,2 %.
English: Topotecan should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).
Danish: Topotecan bør kun administreres under overvågning af en læge, der har erfaring i brugen af kemoterapi (se pkt.
English: 9/l) in 25 % of patients (15 % of courses).
Danish: 9/l) hos 25 % af patienterne (15 % af behandlingsserierne).
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 dosisbestemmelse omfattende 523 patienter med recidiverende ovariecancer og 631 patienter med recidiverende, småcellet lungecancer, var den dosisbegrænsende toksicitet af topotecanmonoterapi hæmatologisk.
English: Parenteral products should be visually inspected for particulate matter and discolouration prior to administration.
Danish: Parenterale produkter skal undersøges visuelt for partikler og misfarvning før indgiften.
English: • Inflammation and ulcers of the mouth, tongue or gums.
Danish: • Betændelse og sår i mund, tunge og gummer.
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 topotecanmonoterapi, men højere end med cisplatin alene.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedssgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
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 og til patienter i sygdomsstadie IVB.
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, som blev udført af Gynaecological Oncology Group (GOG 0179), blev topotecan + cisplatin (n=147) sammenlignet med cisplatin alene (n=146) i behandlingen af histologisk bekræftet, persisterende, recidiverende eller stadium IVB cervixcancer, hvor kurativ behandling med kirurgi og/eller stråleterapi ikke var vurderet hensigtsmæssig.
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 om fortsat behandling med topotecanmonoterapi til patienter med cervixcancer.
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 fødedygtige alder bør rådes til at undgå graviditet, hvis de er i behandling med topotecan.
English: • All items used in the preparation, administration, and cleaning of the medicinal product, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Danish: • Alle genstande, som er brugt under forberedelse, håndtering eller rengøring, herunder handsker, skal anbringes i højrisikoaffaldsposer beregnet til forbrænding ved høj temperatur.
English: Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Danish: Neutropenisk colitis, herunder fatal neutropenisk colitis,er set som en om komplikation til topotecan-induceret neutropeni (se pkt.
English: Each vial contains 4 ml of concentrate.
Danish: Hvert hætteglas indeholder 4 ml koncentrat.
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, morfin eller kortikosteroider ingen signifikant virkning på farmakokinetikken af total-topotecan (aktiv og inaktiv form).
English: An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
Danish: Der er fundet en O-glucuroniseret metabolit af topotecan og Ndesmethyltopotecan i urinen.
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 topotecans plasmaclearance til 34 % af værdien for kontrolgruppens patienter.
English: However, when combining with platinum agents, there is a distinct sequence-dependent interaction depending on whether the platinum agent is given on day 1 or 5 of the topotecan dosing.
Danish: I kombination med et platinstof er der dog en særlig sekvensafhængig interaktion, som afhænger af om platinstoffet gives på dag 1 eller 5 i forhold til behandlingen med topotecan.
English: Immune system disorders
Danish: Immunsystemet Almindelig
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C under normal light conditions and at 2°C -8°C when protected from light.
Danish: Der er påvist kemisk og fysisk stabilitet i 24 timer ved 25°C under normale lysforhold og ved 2 °C - 8 °C ved beskyttelse mod lys.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C under normal light conditions and at 2°C-8°C when protected from light.
Danish: Der er påvist kemisk og fysisk stabilitet i 24 timer ved 25 °C under normale lysforhold og ved 2°C8°C ved beskyttelse mod lys.
English: Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
Danish: Topotecan er blevet forbundet med rapporter om tilfælde af interstitiel lungesygdom (ILD), hvoraf nogle var fatale (se pkt.
English: Topotecan inhibits topoisomerase-I by stabilising the covalent complex of enzyme and strand-cleaved DNA which is an intermediate of the catalytic mechanism.
Danish: Topotecan hæmmer topoisomerase-1 ved at stabilisere det kovalente kompleks af enzym og strengkløvet DNA, som er et intermediært produkt af den katalytiske mekanisme.
English: Do not restart breast-feeding until the doctor tells you it is safe to do so.
Danish: Du må ikke begynde at amme igen før, din læge har fortalt dig, at det er sikkert gøre det.
English: Median time to onset of severe thrombocytopenia, was day 15 and the median duration was five days.
Danish: Den mediane tid til indtræden af svær trombocytopeni var 15 dage, og den mediane varighed fem dage.
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 1.5mg/dl.
Danish: I de kliniske studier af kombinationsbehandling med topotecan og cisplatin til behandling af cervixcancer blev behandlingen kun initieret hos patienter med serumcreatinin ≤ 1,5 mg/dl.
English: Do not use Topotecan Hospira after the expiry date stated on the vial and carton after EXP.
Danish: Brug ikke Topotecan Hospira efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: If you feel tired or weak, do not drive or use machines.
Danish: Kør ikke bil eller betjen ikke maskiner, hvis du føler dig træt eller svag.
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 trombocyttallet, bør fastlægges jævnligt (se pkt.
English: • Staff handling this medicinal product should wear adequate protective clothing including mask, goggles and gloves.
Danish: • Personale, som håndterer dette lægemiddel skal bære beskyttelsesdragt, herunder maske, beskyttelsesbriller og handsker.
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 cisplatin eller carboplatin gives på den første behandlingsdag med topotecan, skal der gives en lavere dosis af begge stoffer for at forbedre tolerabiliteten, sammenlignet med den dosis, der kan gives af platinstofferne, hvis de gives på dag 5 under topotecanbehandlingen.
English: Blood and lymphatic system disorders Very common
Danish: Blod og lymfesystem Meget almindelig
English: ITT population Cisplatin 50 mg/m2 on day 1, every 2l days.
Danish: ITT population Cisplatin 50 mg/m2 på dag 1 hver 21. dag
English: Toxicities of topotecan in paediatric patients with recurrent and refractory solid tumours were similar to those historically seen in adult patients.
Danish: Toksiciteten af topotecan hos børn med recidiverende og refraktære solide tumorer svarer til, hvad der tidligere er set for voksne patienter.
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 og 1,40).
English: • Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: • Medicinrester og affald heraf skal bortskaffes i overensstemmelse med de lokale krav.
English: Your dose of Topotecan Hospira may need to be adjusted.
Danish: Der kan være behov for at justere din dosis af Topotecan Hospira.
English: Doses should be similarly reduced if the platelet count falls below 25 x 10
Danish: Dosis skal ligeledes reduceres, hvis trombocyttallet falder til under 25 x 10
English: • Allergic or hypersensitivity reactions (including rash).
Danish: • Allergi eller overfølsomhedsreaktioner (herunder udvikling af udslæt)
English: Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Danish: Saltsyre (E507) (til justering af pH) Natriumhydroxid (til justering af pH) Vand til injektionsvæsker
English: The prescribing information for cisplatin should be consulted for a full list of adverse events associated with cisplatin use.
Danish: Den tilgængelige information om cisplatin bør konsulteres for at få oplysninger om alle bivirkninger, som er forbundet med brugen af cisplatin.
English: Platelet transfusions were given in 4 % of courses.
Danish: Der blev givet trombocyttransfusioner i 4 % af behandlingsserierne.
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 almindeligt forbundet med klinisk relevant trombocytopeni.
English: • Lung inflammation (interstitial lung disease): You are most at risk if you have existing lung disease, have had radiation treatment to your lungs, or have previously taken medicines that caused lung damage.
Danish: Du er mest udsat, hvis du har eksisterende lungesygdom, har fået strålebehandling af dine lunger eller tidligere har fået medicin, der gav skade på lungerne.
English: • Occasionally severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (colitis) 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: 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: Do not breast-feed if you are being treated with topotecan.
Danish: Du må ikke amme, hvis du bliver behandlet med topotecan.
English: topotecan was discontinued if the dose had been reduced to 1.0 mg/m 2/day and a further dose reduction was required to manage adverse effects.
Danish: I de kliniske studier blev behandlingen med topotecan stoppet, hvis dosis var blevet reduceret til 1,0 mg/m 2, og det blev nødvendigt med yderligere reduktion af dosis for at håndtere bivirkninger.
English: Topotecan Hospira is provided as a sterile concentrate containing 4 mg topotecan in 4 ml solution (1 mg/ml).
Danish: Topotecan Hospira leveres som et sterilt koncentrat, som indeholder 4 mg topotecan i 4 ml opløsning (1 mg/ml).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Danish: Opbevaringstiden vil normalt ikke være længere end 24 timer ved 2°C - 8°C, medmindre rekonstitutionen/fortyndingen er sket under kontrollerede og validerede aseptiske forhold.
English: The second study included a dose range of 2.0 to 5.2 mg/m2 in children (n = 8), adolescents (n = 3), and young adults (n = 3) with leukaemia.
Danish: Det andet studie brugte et doseringsinterval på 2,0 mg/m2 - 5,2 mg/m2 til børn (n = 8), unge (n = 3) og yngre voksne (n = 3) med leukæmi.
English: Topotecan-induced neutropenia can cause neutropenic colitis.
Danish: Neutropeni, som er induceret af topotecan, kan medføre neutropenisk colitis.
English: If, during topotecan/cisplatin combination therapy, serum creatinine exceeds 1.5mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Danish: Hvis serumcreatinin under kombinationsbehandlingen med topotecan og cisplatin overstiger 1,5 mg/dl, anbefales det at konsultere den eksisterende information om cisplatin vedrørende dosisreduktion og fortsat behandling.
English: If you are being treated for cervical cancer, you may get side effects from the othermedicine (cisplatin)that you willbe given along with Topotecan Hospira.
Danish: Hvis du er i behandling for livmoderhalskræft, kan du få bivirkninger af den anden medicin (cisplatin), som du vil få sammen med Topotecan Hospira.
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: Det ene studie brugte et doseringsinterval på 1,4 mg/m2 - 2,4 mg/m2/dag til børn (fra 2 år op til 12 år, n = 18), til unge (fra 12 år til 16 år, n = 9) og til yngre voksne (fra 16 år til 21 år, n = 9) med refraktære, solide tumorer.
English: Ovarian and small cell lung carcinoma
Danish: Ovariekarcinom og småcellet lungecancer
English: This treatment schedule is repeated every 21 days for six courses or until progressive disease.
Danish: Dette behandlingsskema gentages hver 21. dag i 6 serier, eller indtil sygdommen progredierer.
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 ikkejusterede hazard ratio for gruppen, der fik oral topotecan plus BSC i forhold til gruppen, der kun fik BSC var 0,64 (95 % CI: 0,45 og 0,90).
English: − All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Danish: − Alle genstande, som er brugt under håndtering eller rengøring, herunder handsker, skal anbringes i højrisikoaffaldsposer beregnet til forbrænding ved høj temperatur.
English: Fatigue was observed in approximately 25 % and asthenia in 16 % of patients receiving topotecan.
Danish: Der forekom træthed hos ca. 25 % og asteni hos 16 % af patienterne, mens de blev behandlet med topotecan.
English: When given in combination with cisplatin (cisplatin day 1, topotecan days 1 to 5), the clearance of topotecan was reduced on day 5 compared to day 1 (19.1 l/h/m 2 compared to 21.3 l/h/m 2 [n=9]) (see section 4.5).
Danish: Ved indgift af topotecan i kombination med cisplatin (cisplatin på dag 1, topotecan på dag 1 til 5) blev topotecans clearance reduceret på dag 5 sammenlignet med dag 1 (19,1 l/time/m2 legemsoverflade sammenlignet med 21,3 l/h/m 2 legemsoverflade [n = 9]) (se pkt.
English: Dosage: Cervical Carcinoma
Danish: Dosering: Cervixcancer
English: • Cervical cancer: 0.75 milligrams per m2 of body surface area per day.
Danish: • Livmoderhalskræft: 0,75 milligram pr. m2 legemsoverflade pr. dag.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Topotecan Hospira, skal du henvende dig til den lokale repræsentant for indehaveren af markedsfølringstilladelsen:
English: The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication as it relieves the torsional strain introduced ahead of the moving replication fork.
Danish: Topotecans anti-tumoraktivitet involverer hæmning af topoisomerase-1, et enzym, som er stærkt involveret i DNA-replikationen, da det eliminerer den torsionale kæde, der opstår foran den bevægelige replikationsgaffel.
English: Unopened vial: Store in a refrigerator (2°C-8°C).
Danish: Uåbnede hætteglas: Opbevares i køleskab (2°C - 8°C).
English: • if you have any kidney or liver problems.
Danish: • hvis du har nyreproblemer.
English: There is insufficient experience with the use of topotecan in patients with severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Danish: Der er utilstrækkelig erfaring med brugen af topotecan hos patienter med alvorlig nedsat leverfunktion (serum bilirubin ≥ 10 mg/dl) på grund af cirrose.
English: Extravasation
Danish: Ektravasation
English: A clear yellow to yellow-green solution.
Danish: Klar gul til gulgrøn opløsning.
English: • patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.
Danish: • patienter med metastaterande ovariekarcinom, hvor 1. linje-behandling eller efterfølgende
English: The recommended monotherapy dose of topotecan in patients with ovarian or small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/min is 0.75 mg/m2/day for five consecutive days.
Danish: Den anbefalede topotecandosis ved monoterapi til patienter med ovariekarcinom eller småcellet lungecancer og en creatininclearance mellem 20 og 39 ml/min er 0,75 mg/m2/dag i fem sammenhængende dage.
English: Topotecan Hospira is used to treat:
Danish: Topotecan Hospira bruges til at behandle:
English: • Feeling generally weak and tired (temporary anaemia).
Danish: • Følelse af træthed og slaphed (forbigående blodmangel).
English: Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion requires dilution to a final concentration of 25-50 micrograms/ml, prior to administration to the patient.
Danish: Topotecan Hospira 4 mg/4 ml koncentrat til infusion, opløsning, kræver fortynding til en slutkoncentration på 25-50 mikrogram/ml før indgift til patienten.
English: Haematological Neutropenia: Severe (neutrophil count <0.5 x 10
Danish: Svær neutropeni (neutrofiltal < 0,5 x 10
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Danish: Efter fem daglige topotecandoser blev der i alt genfundet 71 til 76 % af den indgivne intravenøse dosis.
English: Plasma clearance in patients with hepatic impairment (serum bilirubin between 1.5 and 10 mg/dl) decreased to about 67 % when compared with a control group of patients.
Danish: Plasmaclearance hos patienter med nedsat leverfunktion (serumbilirubin mellem 1,5 og 10 mg/dl) faldt til ca. 67 %, sammenlignet med en kontrolgruppe af patienter.
English: You should use an effective method of contraception.
Danish: Du skal bruge en sikker præventionsform.
English: Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination (see section 5.1).
Danish: For at berettige kombinationsbehandling skal patienter, der tidligere har fået cisplatin, have et vedvarende behandlingsfrit interval, for at kombinationsbehandlingen er berettiget (se pkt.
English: Median overall survival was 62 weeks for topotecan versus 53 weeks for paclitaxel (hazard ratio 0.9 [0.6, 1.3]).
Danish: Median tid for samlet overlevelse var 62 uger for topotecan versus 53 uger for paclitaxel (risiko ratio 0,9 [0,6,
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: Der var en statistisk signifikant forbedring i samlet overlevelse i gruppen, der fik oral topotecan plus BSC sammenlignet med gruppen, der kun fik BSC (log-rank, p=0,0104).
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: For at opretholde neutrofiltallet er det standard onkologisk praksis ved behandling af neutropeni enten at administrere topotecan sammen med andre lægemidler (f.eks. G-CSF) eller at reducere dosis.
English: Topotecan Hospira is available in two pack sizes, containing either 1 vial or 5 vials.
Danish: Topotecan Hospira leveres i to pakningsstørrelser, som indeholder 1 eller 5 hætteglas.
English: You should not receive Topotecan Hospira:
Danish: Tag ikke Topotecan Hospira: