FrancophonIA/ELRC3.0 huggingface dataset:
English: 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: 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: 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: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN 22 December 2011
English: − Personnel handling this medicinal product during dilution 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: If you are not sure, talk to your doctor or nurse before using this medicine.
Danish: Hvis du er i tvivl, skal du tale med din læge eller sygeplejerske, før du tager dette lægemiddel.
English: Skin and subcutaneous tissue disorders Very common: alopecia Common: pruritus
Danish: Hud og subkutane væv Meget almindelig: alopecia Almindelig: pruritus
English: This is because you are more likely to get severe lung problems (interstitial lung disease) when using Topotecan Eagle;
Danish: Dette skyldes, at du har større risiko for at få alvorlige lungeproblemer (interstitiel lungesygdom), når du tager Topotecan Eagle;
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation is in place and functioning before and whilst the medicinal product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at lægemiddelovervågningssystemet i markedsføringstilladelsen (Modul 1.8.1), er på plads og fungerer, før og mens produktet markedsføres.
English: Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of a Safety Information Communication with the national competent authority, including the need and the timing of any follow-up Safety Communication Information, as well as the distribution list of such information.
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG Inden produktet markedsføres i medlemsstaten, skal indehaveren af markedsføringstilladelsen aftale sikkerhedsinformationsmeddelelsens indhold og format med den nationale kompetente myndighed, herunder behov og tidspunkt for eventuelle efterfølgende sikkerhedsinformationsmeddelelser samt
English: These may be signs of a drop in the number of your red blood cells (anaemia).
Danish: Dette kan være tegn på et fald i antallet af røde blodceller
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 topotecan
English: Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous.
Danish: Prækliniske forsøg tyder på, at topotecans plasmaproteinbinding er lav (35 %), og fordelingen mellem blodceller og plasma er omtrent homogen.
English: Overall, the N-desmethyl metabolite contributed a mean of less than 7 % (range 4-9 %) of the total medicinal product related material accounted for in the urine and faeces.
Danish: Samlet set bidrog N-desmethylmetabolitten i gennemsnit mindre end 7 % (interval 4-9 %) til det lægemiddelstofrelaterede materiale i urin og fæces, som der kunne gøres rede for.
English: It is important that Topotecan Eagle is further diluted before use (see section 6.6).
Danish: Det er vigtigt at fortynde Topotecan Eagle yderligere inden brug (se pkt 6.6).
English: • Infections (very common) - because Topotecan Eagle may reduce your ability to fight infections.
Danish: Du kan have • Infektioner (meget almindelige) - eftersom Topotecan Eagle kan nedsætte din evne til at
English: You may need to read it again.
Danish: • Gem indlægssedlen.Du kan få brug for at læse den igen.
English: How Topotecan Eagle is prepared
Danish: Sådan forberedes Topotecan Eagle
English: The pharmacokinetics of topotecan given as a 30-minute infusion for 5 days were evaluated in two studies.
Danish: Farmakokinetikken af topotecan givet som intravenøs infusion over 30 minutter i 5 dage er undersøgt i to forsøg.
English: In another randomised phase III trial which compared intravenous topotecan to cyclophosphamide, Adriamycin (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-forsøg, som sammenlignede intravenøs topotecan med cyclophosphamid, Adriamycin (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: The primary complications of overdose are anticipated to be bone marrow suppression and mucositis.
Danish: De primære komplikationer forbundet med en overdosis forventes at være knoglemarvssuppression og mucositis.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Indehaveren af markedsføringstilladelsen skal udføre de lægemiddelovervågningsaktiviteter, som er beskrevet i lægemiddelovervågningsplanen ifølge aftalen i risikostyringsprogrammet (RMP), Modul 1.8.2. i markedsføringstilladelsen, og enhver efterfølgende opdatering af RMP, som er godkendt af
English: This should be taken into account when prescribing topotecan, e.g. in case patients at increased risk of tumour bleeds are considered for therapy.
Danish: Dette bør overvejes, når topotecan ordineres f.eks. i tilfælde, hvor det overvejes at behandle patienter med øget risiko for tumorblødning.
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 og CYP4A eller de menneskelige cytosoliske
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 ikke-hæmatologiske bivirkninger anført nedenfor er repræsentative for de bivirkningsrapporter, som anses for at være relateret eller muligvis relateret til
English: If you are pregnant or think you might be pregnant, tell your doctor immediately.
Danish: Fortæl det straks til lægen, hvis du er gravid eller hvis du tror du kan være gravid.
English: From a microbiological point of view, the solution should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør opløsningen straks anvendes.
English: Severe (grade 3 or 4) nausea, vomiting, diarrhoea and mucositis incidence 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: A clear light yellow to orange solution, pH ≤ 1.2.
Danish: En klar lysegul til orange opløsning, pH <1,2.
English: Oral topotecan plus BSC group had a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p = 0.0104).
Danish: Oral topotecan plus BSC-gruppen oplevede en statistisk signifikant forbedring i samlet overlevelse sammenlignet med gruppen med BSC alene (log-rank p = 0,0104).
English: Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan + BSC.
Danish: Patienternes egen rapportering af symptomer vha. ublindede vurderinger viste en klar tendens mod symptomforbedring med oral topotecan + BSC.
English: In dose-finding trials 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 forsøg til dosisbestemmelse omfattende 523 patienter med recidiverende ovariecancer og 631 patienter med recidiverende småcellet lungecancer blev den dosisbegrænsende toksicitet af topotecanmonoterapi fundet at være hæmatologisk.
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 behandlingsperiode 1 og totalt set hos 23 % af patienterne (6 % af behandlingerne).
English: An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
Danish: En O-glukuroniseret metabolit af topotecan og N-desmethyltopotecan er identificeret i urin.
English: Eagle Laboratories Limited The Clock House Station Approach Marlow, Bucks, SL7 1NT United Kingdom
Danish: Eagle Laboratories Limited The Clock House Station Approach Marlow, Bucks, SL7 1NT Det Forenede Kongerige
English: However there are insufficient data available to make a dose recommendation for this patient group.
Danish: Der er dog ikke en tilstrækkelig mængde data tilgængelig til at kunne give en anbefaling
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: I overensstemmelse med CHMP-retningslinjerne for risikostyringsprogrammer for lægemidler til humant brug skal en opdateret RMP fremsendes samtidig med den efterfølgende periodiske
English: Anaemia: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Danish: Anæmi: Moderat til alvorlig anæmi (Hb  8,0 g/dl) hos 37 % af patienterne (14 % af behandlingerne).
English: Do not use Topotecan Eagle after the expiry date which is stated on the carton and vial after EXP.
Danish: Brug ikke Topotecan Eagle efter den udløbsdato, der står på pakningen og hætteglasset efter EXP. Udløbsdatoen (Exp) er den sidste dag i den nævnte måned.
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må lægemidler ikke bortskaffes via spildevandet eller med husholdningsaffaldet.
English: Pregnancy and breast-feeding - Topotecan Eagle should not be used during pregnancy, unless clearly necessary.
Danish: Topotecan Eagle bør ikke benyttes under graviditet, medmindre det er klart nødvendigt.
English: In an intravenous population study, 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 intravenøst populationsforsøg havde samtidig administration af granisetron, ondansetron, morphin eller kortikosteroider ingen signifikant virkning på farmakokinetikken af total-topotecan (aktiv og inaktiv form).
English: Insufficient data are available to make a recommendation for patients with a creatinine clearance < 20 ml/min.
Danish: Der findes ikke tilstrækkeligt datamateriale til at anbefale behandling af patienter med en kreatininclearance på < 20 ml/min.
English: EXP Read the leaflet for the shelf life of the diluted product.
Danish: EXP Læs indlægssedlen vedrørende opbevaringstiden for det fortyndede produkt.
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted: - Staff should be trained to dilute the medicinal product.
Danish: De normale procedurer for omgang med lægemidler mod kræft skal følges: - Personalet skal være uddannet i at rekonstituere lægemidlet.
English: Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to dose reduce to maintain neutrophil counts.
Danish: Standard onkologisk praksis for behandling af neutropeni er enten at administrere topotecan sammen med anden medicin (f.eks. G-CSF), eller at dosisreducere for at opretholde neutrofiltallet.
English: The prescribing information for cisplatin should be consulted for a full list of adverse events associated cisplatin use.
Danish: Cisplatins produktinformation bør konsulteres for en komplet liste over bivirkninger associeret til brugen af
English: 1 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4)
Danish: 1 Neutropenisk colitis, herunder fatal neutropenisk colitis, er set som en komplikation til topotecan-induceret neutropeni (se pkt.
English: The hazard ratio for survival of IV topotecan relative to CAV was 1.04 (95 % CI 0.78 - 1.40).
Danish: Risiko ratio for overlevelse af intravenøs topotecan relativt til CAV var 1,04 (95 % CI 0,78; 1,40).
English: There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Danish: Der er ikke tilstrækkelig erfaring i brugen af topotecan til patienter med svært nedsat nyrefunktion (kreatinin-clearance < 20 ml/min) eller svært nedsat leverfunktion (serumbilirubin  10 mg/dl) på grund af cirrose.
English: Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available.
Danish: Administration af topotecan til børn er undersøgt, men kun begrænsede data om virkning og sikkerhed
English: - Topotecan Eagle is supplied in cartons containing 1 vial.
Danish: - Topotecan Eagle leveres i kartoner med 1 hætteglas.
English: However, in 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 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: Your dose of Topotecan Eagle may need to be adjusted.
Danish: Der kan være behov for at justere din dosis af Topotecan Eagle.
English: This medicine is not recommended if you have severe liver problems; - if you have lung problems, or if you have had lung problems before from using other medicines or radiation.
Danish: Dette lægemiddel anbefales ikke, hvis du har alvorlige leverproblemer; - hvis du har lungeproblemer eller hvis du har haft lungeproblemer før på grund af brug af andre lægemidler eller strålebehandling.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/744/002
Danish: EU/1/11/744/002
English: The unadjusted hazard ratio for oral topotecan plus BSC group relative to BSC alone group was 0.64 (95 % CI: 0.45, 0.90).
Danish: Det ikke-justerede risikoforhold for oral topotecan plus BSC-gruppen i forhold til gruppen med BSC alene var 0,64 (95 % CI; 0,45; 0,90).
English: Serious side effects
Danish: BIVIRKNINGER
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/744/001
Danish: EU/1/11/744/001
English: There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the PK after multiple doses.
Danish: Der ses ringe eller ingen akkumulering af topotecan ved gentagen daglig dosering, og der er ingen tegn på ændring i farmakokinetikken efter multiple doser.
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 forsøg med kombinationsbehandling med topotecan og cisplatin til behandling af cervixcancer blev behandlingen kun initieret for patienter med serumkreatinin ≤ 1,5 mg/dl.
English: q21 d.
Danish: q 21
English: Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m2 as a 30 minute infusion daily for five days, topotecan demonstrated a high plasma clearance of 62 l/h (SD 22), corresponding to approximately 2/3 of liver blood flow.
Danish: Efter intravenøs administration af topotecandoser på 0,5 til 1,5 mg/m2, som 30 minutters infusion 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: Severe (grade 3 or 4) fatigue and asthenia incidence was 3 and 3 % respectively.
Danish: Hyppigheden af alvorlig (grad 3 eller 4) træthed og asteni var henholdsvis 3 og 3 %.
English: A small number of hepatically impaired patients (serum bilirubin between 1.5 and 10 mg/dl) were given intravenous topotecan at 1.5 mg/m2 for five days every three weeks.
Danish: Et lille antal hepatisk svækkede patienter (serumbilirubin mellem 1,5 og 10 mg/dl) fik topotecan 1,5 mg/m2 intravenøst i fem dage hver tredje uge.
English: The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).
Danish: Brugen af topotecan bør begrænses til enheder, der er specialiseret i administration af cytotoksisk kemoterapi, og bør kun gives under overvågning af en læge, der har erfaring med brug af kemoterapi (se pkt.
English: • An encouragement of reporting of actual medication errors and any safety events that might be a consequence of a medication error.
Danish: • En opfordring til at rapportere faktiske medicineringsfejl og eventuelle sikkerhedshændelser,
English: In this case, it is used with another medicine called cisplatin.
Danish: I så tilfælde bruges det sammen med et andet lægemiddel kaldet cisplatin.
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: Anti-tumor-aktiviteten af topotecan involverer hæmning af topoisomerase-1, et enzym tæt involveret i DNA-replikation, da den eliminerer det torsionale belastning, der opstår foran den bevægelige replikationsgaffel.
English: - Liquid waste may be flushed with large amounts of water.
Danish: - Flydende affaldsmateriale kan skylles ud i vasken med rigelige mængder vand.
English: Very common - feeling generally weak and tired.
Danish: - følelse af almen slaphed og træthed.
English: Concentration must be noticed or life-threatening overdose may occur.
Danish: Læg godt mærke til koncentrationen, da en eventuel overdosering kan være livstruende.
English: A phase III trial (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 + BSC, 90 days for BSC) and for whom retreatment with intravenous chemotherapy was not considered appropriate.
Danish: I et fase III-forsøg (forsøg 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 + BSC, 90 dage for BSC) og for hvem gentagelse af behandling med intravenøs kemoterapi ikke var hensigtsmæssig.
English: : 2.9, 9.6) for the cisplatin arm with an hazard ratio of 1.15 (0.59, 2.23).
Danish: : 2,9; 9,6) i gruppen, der fik cisplatin alene med et risikoforhold på 1,15 (0,59; 2,23).
English: For storage conditions of once-opened and diluted medicinal product, see section 6.3.
Danish: Vedrørende opbevaringsforhold for åbnet og fortyndet lægemiddel, se pkt.
English: The mean metabolite:parent AUC ratio was less than 10 % for both total topotecan and topotecan lactone.
Danish: Det gennemsnitlige forhold mellem hovedmetabolitten og lægemiddelstoffets AUC var mindre end 10 % for såvel topotecan som topotecanlakton.
English: VIAL 5 ml
Danish: HÆTTEGLAS 5 ml
English: When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Danish: Ved brug i kombination med cisplatin bør cisplatins produktinformation konsulteres.
English: - The other ingredients are: hydrochloric acid (E507) (for pH adjustment) and water for injections.
Danish: De øvrige indholdsstoffer er: saltsyre (E507) (til justering af pH) og vand til injektioner.
English: You are more likely to get severe lung problems (interstitial lung disease) if you already have lung problems or have had lung problems before from using other medicines or radiation.
Danish: Du er mere udsat for at få alvorlige lungeproblemer (interstitiel lungesygdom), hvis du allerede har lungeproblemer eller hvis du har haft lungeproblemer før på grund af brug af andre lægemidler eller
English: Very rare - Mild pain and inflammation at the site of injection due to accidental administration of the medicinal product into the surrounding tissue (extravasation) e.g. by leakage.
Danish: Meget sjældne bivirkninger - Milde smerter og betændelse ved injektionsstedet på grund af utilsigtet administration af lægemidler i det omgivende væv (ekstravasation) f.eks. ved udsivning.
English: Read the leaflet for the shelf life of the diluted product.
Danish: Læs indlægssedlen vedrørende opbevaringstiden for det fortyndede produkt.
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: This is because Topotecan Eagle can affect the way some other medicines work.
Danish: Det skal du gøre, fordi Topotecan Eagle kan påvirke den måde, som visse andre lægemidler virker på.
English: Common: hypersensitivity reaction including rash Rare: anaphylactic reaction, angioedema, urticaria
Danish: Almindelig: overfølsomhedsreaktion herunder udslæt Sjælden: anafylaktisk reaktion, angioødem, urticaria
English: : 4.9, 9.5) for the cisplatin arm with an hazard ratio of 0.75 (0.49, 1.16).
Danish: : 4,9; 9,5) i gruppen, der fik cisplatin alene med et risikoforhold på 0,75 (0,49; 1,16).
English: In a randomised, comparative phase III trial conducted by the Gynaecological 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-forsøg, udført af Gynaecological 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: Intravenous use.
Danish: - utilpashed.