FrancophonIA/ELRC3.0 huggingface dataset:
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: Ved kombination med platin-baseret kemoterapi er der dog en særlig sekvens-afhængig interaktion, afhængigt af om platin-stoffet gives på dag 1 eller 5 i forhold til topotecan-doseringen.
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 Gynecologic 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: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse
English: Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m 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 daglig 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: You should not receive Hycamtin:
Danish: Du må ikke få Hycamtin:
English: HYCAMTIN capsules are indicated as monotherapy for the treatment of adult 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: HYCAMTIN kapsler er indiceret som monoterapi til behandling af voksne patienter med recidiverende småcellet lungecancer (SCLC) for hvem gentagelse af 1. linje-behandling ikke anses for hensigtsmæssig (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
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: • Betændelseslignende reaktion (inflammation) i lungevævet (interstitiel lungesygdom): 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: 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 relativt til CAV var 1,04 (95 % CI: 0,78, 1,40).
English: If you feel tired or weak, do not drive or use machines.
Danish: Kør ikke bil og brug ikke værktøj eller maskiner, hvis du føler dig træt eller svag.
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
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 svarende til, hvad der tidligere er set for voksne patienter.
English: 9/l, and the haemoglobin level is 9 g/dl (after transfusion if necessary).
Danish: 9/l og hæmoglobinniveauet er  9 g/dl (om nødvendigt efter transfusion).
English: Vials 3 years.
Danish: Hætteglas 3 år.
English: It is available in packs containing either 1 or 5 glass vials; each vial contains 1 mg or 4 mg of topotecan.
Danish: Det findes i pakninger med 1 eller 5 hætteglas; hvert hætteglas indeholder 1 mg eller 4 mg topotecan.
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 has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
Danish: Topotecan er blevet associeret med rapporter om interstitiel lungesygdom (ILD), og nogle af disse tilfælde har været letale (se pkt.
English: • patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.
Danish: • patienter med metastaserende ovariecancer, hvor 1. linje-behandling eller efterfølgende behandling er slået fejl.
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 eller ved betjening af maskiner, hvis træthed og asteni vedvarer.
English: Inhibitors of ABCB1 and ABCG2 administered with oral topotecan have been shown to increase topotecan exposure.
Danish: Det er påvist, at hæmmere af ABCB1 og ABCG2 givet sammen med oral topotecan øger eksponeringen af topotecan.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER
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. linje behandling ikke anses for hensigtsmæssig (se pkt.
English: Rarely, it can lead to more severe bleeding (haemorrhage).
Danish: I sjældne tilfælde kan det resultere i en mere alvorlig blødning.
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 49 to 72% (mean 57%) of the administered oral dose.
Danish: Overordnet genfinding af topotecan-relateret materiale efter fem daglige topotecandoser var 49-72 % (middel 57 %) af den indgivne orale dosis.
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: The capsules are printed with black ink that contains black iron oxide (E172), shellac, anhydrous ethanol, propylene glycol, isopropyl alcohol, butanol, concentrated ammonia solution and potassium hydroxide.
Danish: Kapslernes prægning er påtrykt med sort blæk som indeholder: Sort jernoxid (E172), shellak, vandfri ethanol, propylenglykol, isopropylalkohol, butanol, koncentreret ammoniakopløsning, kaliumhydroxid.
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-I ved at stabilisere det kovalente kompleks af enzym og strengkløvet DNA, som er et intermediært produkt af den katalytiske mekanisme.
English: Should diarrhoea occur during treatment with oral topotecan, physicians are advised to aggressively manage diarrhoea.
Danish: I tilfælde af diarré efter behandling med oral topotecan, anbefales det, at lægerne behandler diarréen aggressivt.
English: Non-haematological
Danish: Non-hæmatologisk
English: BLISTERS
Danish: BLISTER
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Danish: Yderligere behandling bør være som klinisk indiceret eller efter anbefaling fra Giftlinjen.
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 trombocyttal bør fastlægges jævnligt (se pkt.
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: 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: Red blood cell transfusions were given in 30% of patients (13% of courses).
Danish: Der blev givet transfusioner af røde blodlegemer til 30 % af patienterne (13 % af serierne).
English: One study included a dose range of 1.4 to 2.4 mg/m 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/m 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: The most frequently reported non-haematological effects were nausea (37%), diarrhoea (29%), fatigue (26%), vomiting (24%), alopecia (21%) and anorexia (18%).
Danish: De mest almindeligt rapporterede non-hæmatologiske bivirkninger, uanset deres årsagssammenhæng, var kvalme (37 %), diarré (29 %), træthed (26 %), opkastning (24 %), alopecia (21 %) og anoreksi (18 %).
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 brugt under håndtering eller rengøring, herunder handsker, skal anbringes i højrisikoaffaldsposer beregnet til forbrænding ved høj temperatur.
English: Severe cases of diarrhoea may require administration of oral or intravenous electrolytes and fluids, and interruption of topotecan therapy (see sections 4.4 and 4.8).
Danish: Alvorlige tilfælde af diarré kan kræve oralt eller intravenøst administreret elektrolytter og væsker samt afbrydelse af topotecan-behandlingen (se pkt.
English: Storage of the prepared solution
Danish: Opbevaring af den tilberedte opløsning.
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: Hycamtin 0.25 mg and 1 mg capsules are available in packs containing 10 capsules.
Danish: Hycamtin 0,25 mg og 1 mg kapsler findes i pakninger med 10 kapsler.
English: If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
Danish: Hvis behandlingen er veltolereret, kan den fortsættes, indtil sygdommen progredierer (se pkt.
English: Plasma concentrations of total topotecan (i.e. lactone and carboxylate forms) and topotecan lactone (active moiety) peak at approximately 2.0 hours and 1.5 hours, respectively, and decline bi-exponentially with mean terminal half-life of approximately 3.0 to 6.0 hours.
Danish: Plasmakoncentrationerne af total-topotecan (dvs. lakton og carboxylater) og topotecanlakton (aktive del) når maksimalværdierne efter henholdsvis ca. 2,0 timer og 1,5 timer og falder bieksponentielt med en middelterminal halveringstid på ca. 3,0-6,0 timer.
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76% of the administered IV dose.
Danish: Overordnet genfinding af topotecan-relateret materiale efter fem daglige doser af topotecan var 71 til 76 % af den administrerede intravenøse dosis.
English: Those effects are described in the cisplatin patient leaflet.
Danish: Disse bivirkninger er anført i indlægssedlen for cisplatin.
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 serierne).
English: • Feeling generally weak and tired (temporary anaemia).
Danish: • Følelse af almen slaphed og træthed (forbigående blodmangel).
English: In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A, nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
Danish: In vitro hæmmede topotecan hverken de menneskelige P450-enzymer CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A eller CYP4A eller de menneskelige cytosoliske enzymer dihydropyrimidin eller xanthinoxidase.
English: However in the two studies in which both oral and intravenous topotecan were administered, patients over 65 years old receiving oral topotecan experienced an increase in drugrelated diarrhoea compared to those younger than 65 years of age (see section 4.4 and 4.8).
Danish: I de to studier, hvor der blev givet både oral og intravenøs topotecan, sås dog en stigning i lægemiddelrelateret diarré hos de patienter, der var over 65 år, og som fik oral topotecan, sammenlignet med dem, der var yngre end 65 år (se pkt.
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 plus cisplatin had a statistically significant benefit in overall survival relative to cisplatin monotherapy after adjusting for interim analyses (Log-rank p = 0.033).
Danish: Behandling med topotecan + cisplatin resulterede i en statistisk signifikant forlængelse af den samlede overlevelse i forhold til cisplatin-monoterapi efter justering for interimanalyser (Log-rank p = 0,033).
English: • Allergic or hypersensitivity reactions (including rash).
Danish: • Allergi eller overfølsomhedsreaktioner (herunder udslæt).
English: • Yellow skin.
Danish: • Gulfarvning af huden.
English: HYCAMTIN capsules should only be prescribed and therapy supervised by a physician experienced in the use of chemotherapeutic agents.
Danish: HYCAMTIN kapsler bør kun udskrives og administreres under supervision af en læge, der har erfaring med kemoterapeutiske midler.
English: Median survival (weeks) (95% CI) Hazard ratio (95% CI) Response rate (%) (95% CI) Difference in response rate (95% CI) Median time to progression (weeks) (95% CI) Hazard ratio (95% CI) N = total number of patients treated CI = confidence interval
Danish: Medianoverlevelse (uger) (95 % CI) Hazard ratio (95 % CI) Responsrate (%) (95 % CI) Forskel i responsrate (95 % CI) Mediantid til progression (uger) (95 % CI) Hazard ratio (95 % CI) N = antal behandlede patienter CI = konfidensinterval
English: Skin and subcutaneous tissue disorders Very common Alopecia Common
Danish: Hyperbilirubinæmi Hud og subkutane væv Meget almindelig Alopeci Almindelig
English: Signs include: difficulty in breathing cough fever
Danish: Symptomer inkluderer: vejrtrækningsproblemer hoste feber
English: • Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
Danish: • Alvorlige mavesmerter, kvalme, opkastning af blod, sort eller blodig afføring (mulige symptomer på perforering af mave-tarmkanalen).
English: Oral topotecan Intravenous topotecan
Danish: Oral topotecan Intravenøs topotecan
English: Sepsis Blood and lymphatic system disorders Very common Febrile neutropenia, neutropenia (see “Gastrointestinal disorders”), thrombocytopenia, anaemia, leucopenia
Danish: Sepsis Blod og lymfesystem Meget almindelig Febril neutropeni, neutropeni (se “Mave-tarm-kanalen”), trombocytopeni, anæmi, leukopeni
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count <0.5 x 10
Danish: Ved dosisreduktion hos patienter, som oplever alvorlig neutropeni (neutrofiltal < 0,5 x 10
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 lægen har fortalt dig, at der ikke er nogen risiko forbundet hermed.
English: • The other ingredients are: hydrogenated vegetable oil, glyceryl monostearate, gelatin, titanium dioxide (E171), and for 1 mg capsules only, red iron oxide (E172).
Danish: • Øvrige indholdsstoffer: hydrogeneret vegetabilsk olie, glycerolmonostearat, gelatine, titandioxid (E171), samt rød jernoxid (E172) (kun i 1 mg kapsler).
English: Taking out a capsule These capsules come in special packaging to prevent children removing them.
Danish: Hvordan får du kapslen ud af emballagen Kapslerne er indpakket enkeltvis i speciel emballage, så de er utilgængelige for børn.
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 N-desmethyltopotecan i urinen.
English: There are no data from Asian patients with renal impairment other than Koreans.
Danish: Der foreligger ingen data fra andre asiatiske patienter med nedsat nyrefunktion.
English: Anaphylactic reaction, angioedema, urticaria Metabolism and nutrition disorders Very common Anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare
Danish: Anafylaktisk reaktion, angioødem, urticaria Metabolisme og ernæring Meget almindelig Anoreksi (muligvis alvorlig) Luftveje, thorax og mediastinum Sjælden
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: 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 forbundet med hæmatologiske og non-hæmatologiske bivirkninger anført nedenfor er repræsentative for de bivirkningsrapporter, som anses for at være relateret eller muligvis relateret til behandling 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 kliniske studier blev topotecan-behandlingen stoppet, hvis dosis var blevet reduceret til 1,0 mg/m 2/dag og yderligere reduktion af dosis var nødvendig for at håndtere bivirkninger.
English: Hard capsules
Danish: Hårde kapsler
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: 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 supervision af en læge, der har erfaring med kemoterapi (se pkt.
English: Anhydrous ethanol - see leaflet for further information Propylene glycol
Danish: Ethanol, vandfri - For yderligere information se indlægssedlen Propylenglykol
English: Patients without prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Danish: Patienter uden forudgående cisplatin kemo/stråleterapi cisplatin topotecan/cisplatin
English: 9/l and a haemoglobin level of ≥9 g/dl (after transfusion if necessary).
Danish: 9/l og et hæmoglobinniveau på  9 g/dl (om nødvendigt efter transfusion)
English: Signs include: difficulty breathing cough fever.
Danish: Symptomer inkluderer: vejrtrækningsproblemer hoste feber.
English: In an open-label study involving children (n = 108, age range: infant to 16 years) with recurrent or progressive solid tumours, topotecan was administered at a starting dose of 2.0 mg/m given as a
Danish: I et ikke blindet studie af børn (n = 108; aldersgruppe: børn op til 16 år) med recidiverende eller progredierende solide tumorer, blev topotecan administreret med en startdosis på 2,0 mg/m som intravenøs infusion over 30 minutter i 5 dage.
English: If, during topotecan/cisplatin combination therapy, serum creatinine exceeds 1.5 mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Danish: Hvis serumkreatinin under kombinationsbehandling overstiger 1,5 mg/dl anbefales det at konsultere cisplatins produktinformation vedrørende dosisreduktion/fortsat behandling.
English: Intravenous topotecan
Danish: Intravenøs topotecan
English: In 34% of courses with severe neutropenia, the duration was >7 days.
Danish: I 34 % af serierne med alvorlig neutropeni var varigheden > 7 dage.
English: Moderate to severe anaemia (Grade 3 and 4 - Hb 8.0 g/dl) occurred in 25% of patients (12% of courses).
Danish: Moderat til alvorlig anæmi (grad 3 og 4 - Hb ≤ 8,0 g/dl) sås hos 25 % af patienterne (12 % af serierne).
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: The mean metabolite: parent plasma AUC ratio was less than 10% for both total topotecan and topotecan lactone.
Danish: Middelmetabolit: det oprindelige plasma-AUC-forhold var mindre end 10 % for både total-topotecan og topotecanlakton.
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 findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of 1.5 x 10
Danish: Før administration af den første serie med topotecan skal patienten have et neutrofiltal på  1,5 x 10
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 topotecan kapsler (op til 5 gange den anbefalede dosis).
English: When topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Danish: Ved brug af topotecan i kombination med cisplatin bør cisplatins produktinformation konsulteres.
English: Overdoses have been reported in patients being treated with topotecan capsules (up to 5 fold of the recommended dose) and intravenous topotecan (up to 10 fold of the recommended dose).
Danish: Overdosering er blevet rapporteret hos patienter i behandling med topotecan kapsler (op til 5 gange den anbefalede dosis) og intravenøst topotecan (op til 10 gange den anbefalede dosis).
English: The recommended dose of topotecan is 0.75 mg/m2/day administered as a 30-minute intravenous infusion on days 1, 2 and 3.
Danish: Den anbefalede dosis af topotecan er 0,75 mg/m2legemsoverflade/dag administreret som en intravenøs infusion over 30 minutter på dag 1, 2 og 3.
English: Hypersensitivity reaction including rash
Danish: Overfølsomhedsreaktion herunder udslæt
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Insufficient data are available to make a recommendation for patients with a creatinine clearance <30 ml/min.
Danish: Der foreligger ikke tilstrækkelige data til at give en anbefaling vedrørende dosering hos patienter med kreatinin-clearance < 30 ml/min.
English: Very rare
Danish: Sjælden