FrancophonIA/ELRC3.0 huggingface dataset:
English: Anti-tumour activity was demonstrated primarily in patients with neuroblastoma.
Danish: Anti-tumoraktivitet blev vist primært hos patienter med neuroblastoma.
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 med en omhyggelig vurdering af performancestatus ved påbegyndelse af behandling for at sikre, at patienter ikke forværres til PS 3.
English: Relapsed SCLC
Danish: Recidiverende SCLC
English: Topotecan also had a high volume of distribution, about 132 l (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), samt en relativ kort halveringstid på 2-3 timer.
English: Instructions on how to reconstitute, store and dispose of Hycamtin
Danish: Instruktion i rekonstitution, opbevaring og bortskaffelse af Hycamtin
English: No overall differences in effectiveness were observed between patients aged over 65 years and younger adult patients.
Danish: Der sås ingen generelle forskelle i effektivitet hos patienter i alderen over 65 år i forhold til yngre voksne patienter.
English: • Mild pain and inflammation at the site of injection.
Danish: • Lette smerter og betændelse på injektionsstedet.
English: Hycamtin contains ethanol This medicine contains small amounts of ethanol (alcohol).
Danish: Hycamtin indeholder ethanol Dette lægemiddel indeholder små mængder ethanol (alkohol).
English: Tell your doctor immediately if you get any symptoms of these conditions, as hospitalisation may be necessary.
Danish: Kontakt straks lægen, hvis du får nogle af disse symptomer, da indlæggelse på hospital kan være nødvendig.
English: • This medicine has been prescribed for you.
Danish: • Lægen har ordineret dette lægemiddel til dig personligt.
English: Total exposure (AUC) increases approximately proportionally with dose.
Danish: Total optagelse (AUC) øges omtrent proportionalt med dosis.
English: Korean patients with renal impairment had generally higher exposure than non-Asian patients with the same degree of renal impairment.
Danish: Koreanske patienter med nedsat nyrefunktion havde generelt højere eksponering end ikke-asiatiske patienter med samme grad af nedsat nyrefunktion.
English: Initial dose
Danish: Første dosis
English: Do not try to become pregnant until a doctor advises you it is safe to do so.
Danish: Forsøg ikke at blive gravid før lægen siger, at det er sikkert.
English: Median survivals for the two groups were 25.0 and 24.7 weeks, respectively.
Danish: Medianoverlevelsen for de to grupper var 25,0 henholdsvis 24,7 uger.
English: Camberley, Surrey GU16 7SR United Kingdom
Danish: Camberley, Surrey GU16 7SR Storbritannien
English: Limited data indicate that the dose should be reduced in patients with moderate renal impairment.
Danish: Begrænsede data indikerer, at dosis bør reduceres hos patienter med moderat nedsat nyrefunktion.
English: If you have more than 3 episodes of diarrhoea per day you should contact your doctor immediately.
Danish: Hvis du får diarré mere end 3 gange på en dag, skal du straks kontakte lægen.
English: Survival (months)
Danish: Overlevelse (mdr.)
English: Topotecan is a substrate for both ABCB1 (P-glycoprotein) and ABCG2 (BCRP).
Danish: Topotecan er et substrat for både ABCB1 (P-glycoprotein) og ABCG2 (BCRP).
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 dem med alvorlig neutropeni og dem, der ikke udviklede alvorlig neutropeni), udviklede 11 % (4 % af serierne) feber, og 26 % (9 % af serierne) udviklede infektion.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE / FORNYELSE AF TILLADELSEN
English: • your body size (surface area measured in square metres)
Danish: • din kropsstørrelse (overfladeareal målt i kvadratmeter)
English: • the results of blood tests carried out before treatment The prescribed number of capsules should be swallowed whole, once a day for 5 days.
Danish: • resultaterne af blodprøverne, der er udført inden behandlingens start Det anførte antal kapsler skal tages en gang daglig i 5 dage.
English: Topotecan half-life was increased by about 30% but no clear change in volume of distribution was observed.
Danish: Halveringstiden for topotecan steg med ca. 30 %, men der observeredes ingen åbenbar ændring i distributionsvolumen.
English: The overall incidence of drug-related diarrhoea was 22%, including 4% with Grade 3 and 0.4% with Grade 4.
Danish: Den totale forekomst af lægemiddelrelateret diarré var 22 % herunder 4 % af grad 3 og 0,4 % af grad 4.
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 et antal faktorer, herunder alder, vægt og ascites ingen signifikant virkning på clearance af total-topotecan (aktiv og inaktiv form).
English: Paediatric population The safety and effectiveness of oral topotecan in paediatric patients have not been established.
Danish: Pædiatrisk population Sikkerheden og effektiviteten af oral topotecan er ikke fastlagt for pædiatriske patienter.
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 det ville være forventet har patienter med dårlig performancestatus (PS > 1) en lavere responsrate og en øget forekomst af komplikationer såsom feber, infektion og sepsis (se pkt.
English: Topotecan was also shown to cause embryo-foetal lethality when given to rats and rabbits.
Danish: Topotecan har også vist sig at forårsage embryo- og fosterdødelighed, når det gives til rotter og kaniner.
English: Intravenous use.
Danish: Intravenøs anvendelse.
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: Der var i disse studier ikke nogen synlige forskelle i farmakokinetikken af topotecan hos børn, unge og yngre voksne med solide tumorer eller leukæmi, men data er for begrænsede til en definitiv konklusion.
English: Table 1 Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan
Danish: Tabel 1 Oversigt over overlevelse, responsrate og tid til progression hos SCLC-patienter, der er behandlet med oral eller intravenøs topotecan
English: Your dose of Hycamtin may need to be adjusted.
Danish: Der kan være behov for at justere din dosis af Hycamtin.
English: • if you have any kidney or liver problems.
Danish: • hvis du har nyre- eller leverproblemer.
English: • advanced cervical cancer if surgery or radiotherapy treatment is not possible.
Danish: • fremskreden livmoderhalskræft, hvor behandling med kirurgi eller stråleterapi ikke er mulig.
English: Adverse reactions are listed below, by system organ class and absolute frequency (all reported events).
Danish: Bivirkningerne nævnt herunder er opdelt efter systemorganklasse og absolut hyppighed (alle indberettede hændelser).
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
Danish: De normale procedurer for korrekt håndtering og bortskaffelse af anticancermedicin skal overholdes, dvs.:
English: Drug-related diarrhoea was more frequent in patients 65 years of age (28%) compared to those less than 65 years of age (19%).
Danish: Lægemiddelrelateret diarré var hyppigere hos patienter ≥ 65 år (28 %) sammenlignet med dem, der var yngre end 65 år (19 %).
English: If the capsules are punctured or leaking, you should immediately wash your hands thoroughly with soap and water.
Danish: Hvis en kapsel går i stykker, eller åbner sig, skal du straks vaske hænderne grundigt med vand og sæbe.
English: The bioavailability of oral topotecan (total and lactone) in humans is approximately 40%.
Danish: Biotilgængeligheden ved oral topotecan (totalt og lakton) hos mennesker er ca. 40 %.
English: • Staff should be trained to reconstitute the medicinal product.
Danish: • Personalet skal være uddannet i at rekonstituere lægemidlet.
English: A supplementary retrospective analysis was conducted on data from 523 patients with relapsed ovarian cancer.
Danish: En supplerende retrospektiv analyse blev udført på data fra 523 patienter med recidiverende ovariecancer.
English: This treatment schedule is repeated every 21 days for six courses or until progressive disease.
Danish: Denne serie gentages hver 21. dag seks gange eller indtil progression af sygdommen.
English: Hycamtin helps to destroy tumours.
Danish: Hycamtin hjælper med til at ødelægge tumorer.
English: The carcinogenic potential of topotecan has not been studied.
Danish: Det karcinogene potentiale af topotecan er ikke undersøgt.
English: You will have treatment once a day for 5 days.
Danish: Du vil få behandling en gang daglig i 5 dage.
English: A reduction in topotecan clearance was observed.
Danish: En reduktion i topotecan clearance blev observeret.
English: Isopropyl alcohol
Danish: Isopropylalkohol
English: Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Danish: 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
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 patients presenting with fever, neutropenia and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
Danish: Hos patienter, som har feber, neutropeni og et kompatibelt mønster med mavesmerter, bør risikoen for neutropenisk colitis overvejes.
English: The dose (and number of capsules) of Hycamtin you are given will be worked out by your doctor, based on:
Danish: Den dosis (og antal kapsler) af Hycamtin, som du vil få, vil blive beregnet af din læge på basis af:
English: Patients with creatinine clearance >60 ml/min have been included in efficacy/safety studies of topotecan.
Danish: Patienter med kreatinin-clearance > 60 ml/min er blevet inkluderet i virkning/sikkerheds-studier med topotecan.
English: Light yellow to greenish powder.
Danish: Lysegult til grønligt pulver.
English: 10 capsules
Danish: 10 kapsler
English: Similar results were obtained if glomerular filtration rate (ml/min) was estimated using the MDRD formula corrected for body weight.
Danish: Tilsvarende resultater blev set, når glomerulær filtrationshastighed (ml/min) blev estimeret ved anvendelse af MDRD-formlen korrigeret for patientens vægt.
English: Hycamtin is used to treat:
Danish: Hycamtin bruges til at behandle:
English: Side effects with frequency not known
Danish: Bivirkninger, hvor hyppigheden ikke er kendt
English: Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks, respectively).
Danish: Mediantid til progression var ens i de to grupper (13,3 uger henholdsvis 12,3 uger).
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 ovariecancerprogrammet (n = 392, alle tidligere behandlet med cisplatin eller cisplatin og paclitaxel) var 16 %.
English: Your doctor will decide with you whether Hycamtin therapy is better than further treatment with your initial chemotherapy.
Danish: Din læge vil sammen med dig beslutte, om behandling med Hycamtin er bedre end at fortsætte med den kemoterapibehandling, du tidligere har fået.
English: These data should be evaluated in the context of the overall safety profile of the medicinal product, in particular of the significant haematological toxicity (see section 4.8).
Danish: Disse data bør evalueres i lyset af den totale sikkerhedsprofil af lægemidlet, specielt den signifikante hæmatologiske toksicitet (se pkt.
English: Topotecan monotherapy is indicated for the treatment of:
Danish: Topotecan-monoterapi er indiceret til behandling af:
English: The primary complications of overdose are bone marrow suppression and mucositis.
Danish: De primære komplikationer forbundet med overdosering er knoglemarvssuppression og mucositis.
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: • Severe allergic or anaphylactic reactions.
Danish: • Alvorlige allergiske eller anafylaktiske reaktioner.
English: Death due to sepsis occurred in 1% of patients.
Danish: Dødsfald pga. sepsis sås hos 1 % af patienterne.
English: Handling and disposal
Danish: Håndtering og bortskaffelse
English: Signs include: fever serious deterioration of your general condition local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection).
Danish: Symptomerne omfatter: feber alvorlig forværring af din generelle tilstand lokale symptomer såsom ondt i halsen eller urinvejsproblemer (f.eks. en brændende følelse, når du tisser, hvilket kan skyldes en urinvejsinfektion).
English: Reconstituted and diluted solutions
Danish: Rekonstituerede og fortyndede opløsninger
English: There were no signs of cumulative haematological or non-haematological toxicity.
Danish: Der var ingen tegn på kumulativ hæmatologisk eller non-hæmatologisk toksicitet.
English: There is no known antidote for topotecan overdose.
Danish: Der findes ikke nogen kendt antidot mod topotecan-overdosering.
English: Topotecan-induced neutropenia can cause neutropenic colitis.
Danish: Topotecan-induceret neutropeni kan medføre neutropenisk colitis.
English: If you forget to take Hycamtin
Danish: Hvis du har glemt at tage Hycamtin
English: Push out the capsule: gently push one end of the capsule through the foil layer.
Danish: Tryk kapslen ud ved forsigtigt at trykke den ene ende gennem folien.
English: Metabolism accounts for <10% of the elimination of topotecan.
Danish: Metabolisme udgør < 10 % af topotecans eliminering.
English: The dose of Hycamtin you are given will be worked out by your doctor, based on:
Danish: Den dosis af Hycamtin, som du vil få, vil blive beregnet af din læge på basis af:
English: Diarrhoea related to oral topotecan can occur at the same time as drug-related neutropenia and its sequelae.
Danish: Diarré, der relateres til oral topotecan, kan forekomme på samme tid som lægemiddelrelateret neutropeni og dets følger.
English: Patients should be monitored for pulmonary symptoms indicative of ILD (e.g. cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Danish: Patienter bør monitoreres for pulmonale symptomer, der indikerer ILD (f.eks. hoste, feber, dyspnø og/eller hypoxia), og topotecan bør seponeres, hvis en ny diagnose af ILD bekræftes.
English: Communication with patients prior to drug administration regarding these side effects and proactive management of early and all signs and symptoms of diarrhoea is important.
Danish: Kommunikation med patienterne vedrørende disse bivirkninger og om proaktiv behandling af tidlige tegn, samt alle tegn og symptomer på diarré, er vigtig før administration af lægemidlet.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens anvisning.
English: Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Danish: Sammenligning af farmakokinetiske parametre viste ingen farmakokinetiske ændringer i løbet af de 5 doseringsdage.
English: Total or pronounced alopecia was observed in 30% of patients and partial alopecia in 15% of patients.
Danish: Total eller udtalt alopeci blev observeret hos 30 % af patienterne, og partiel alopeci hos 15 % af patienterne.
English: Infections and infestations Very common Infection Common
Danish: Infektioner og parasitære sygdomme Meget almindelig Infektion Almindelig
English: A cross-study analysis in 217 patients with advanced solid tumours indicated that gender did not affect the pharmacokinetics of HYCAMTIN capsules to a clinically relevant extent.
Danish: Et cross-study studie med 217 patienter med fremskredne solide tumorer tyder på, at kønsforskelle ikke påvirkede farmakokinetikken af HYCAMTIN kapsler i et klinisk relevant omfang.
English: Marketing Authorisation Holder Novartis Europharm Limited Vista Building
Danish: Indehaver af markedsføringstilladelsen Novartis Europharm Limited Vista Building
English: The median time to onset of Grade 2 or worse diarrhoea was 9 days.
Danish: Mediantiden til indtræden af diarré af grad 2 eller værre var 9 dage.
English: Infection, sepsis and febrile neutropenia occurred in 17%, 2%, and 4% of patients, respectively.
Danish: Infektion, sepsis og febril neutropeni sås hos henholdsvis 17 %, 2 % og 4 % af patienterne.
English: You will have treatment once a day for 3 days.
Danish: Du vil få behandling en gang daglig i 3 dage.
English: Hard capsule.
Danish: Hård kapsel.
English: 2, constipation, mucositis, dyspepsia
Danish: 2, forstoppelse, mucositis, dyspepsi
English: Proactive management of diarrhoea with anti-diarrhoeal agents is important.
Danish: Proaktiv behandling af diarré med midler mod diarré er vigtig.
English: In vitro data using human liver microsomes indicate the formation of small amounts of Ndemethylated topotecan.
Danish: In vitro data på humane levermikrosomer indikerer dannelsen af små mængder af 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 tolerancen.
English: Topotecan does not inhibit human P450 enzymes (see section 5.2).
Danish: Topotecan hæmmer ikke humane P450-enzymer (se pkt.
English: If you get the capsule contents in your eyes, wash them immediately with gently flowing water for at least 15 minutes.
Danish: Hvis du får kapslens indhold i øjet, skal du straks skylle forsigtigt med vand i mindst 15 minutter.
English: Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic material.
Danish: Eventuelt ubrugt lægemiddel eller affald bør bortskaffes i overensstemmelse med lokale krav til cytotoksisk materiale.
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 human brystmælk, skal amning stoppes ved behandlingsstart.
English: Capsule contents Hydrogenated vegetable oil Glyceryl monostearate
Danish: Indhold i kapslen Hydrogeneret vegetabilsk olie Glycerolmonostearat
English: The powder needs to be reconstituted and diluted before infusion.
Danish: Pulveret skal opløses og fortyndes før infusion.
English: Pharmacokinetics of HYCAMTIN capsules have not been specifically studied in patients with impaired hepatic function.
Danish: Farmakokinetikken for HYCAMTIN kapsler er ikke undersøgt specifikt hos patienter med nedsat leverfunktion.
English: Combination therapy (cervical carcinoma):
Danish: Kombinationsterapi (cervixcancer):
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 studier.
English: Diarrhoea, including severe diarrhoea requiring hospitalisation, has been reported during treatment with oral topotecan.
Danish: Diarré herunder alvorlig diarré, der kræver hospitalsindlæggelse, er set ved behandling med oral topotecan.
English: • Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
Danish: • Usædvanlige blå mærker eller blødninger, der er forårsaget af en nedsættelse i antallet af de celler, som får blodet til at størkne.
English: Median survival was 30.3 weeks (95% CI: 27.6, 33.4).
Danish: Medianoverlevelsen var 30,3 uger (95 % CI: 27,6; 33,4).
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents: ATC code: L01XX17.
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, andre antineoplastiske stoffer: ATC-kode: L01XX17.
English: Women of childbearing potential / Contraception in males and females
Danish: Kvinder i den fertile alder/prævention til mænd og kvinder
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 er tilgængelige.
English: • Pregnant staff should be excluded from working with this medicinal product.
Danish: • Gravide medarbejdere må ikke arbejde med dette lægemiddel.
English: Severe hypersensitivity to the active substance or to any of the excipients.
Danish: Alvorlig overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
English: White polyvinyl chloride / polychlorotrifluoroethylene blister sealed with aluminium / Polyethylenterephtalate (PET) / paper foil lidding.
Danish: Hvid polyvinylchlorid / polychlorotrifluoroethylen-blister forseglet med aluminium / polyethylenterephtalat (PET) / papir-folie.
English: Pancytopenia
Danish: Pancytopeni
English: Severe neutropenia lasted beyond seven days in 11% of courses overall.
Danish: Alvorlig neutropeni varede længere end syv dage i 11 % af alle serierne.
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 fordelingen mellem blodceller og plasma er omtrent homogen.
English: Hycamtin capsules may be taken with or without food (see section 5.2).
Danish: HYCAMTIN kapsler kan tages med eller uden mad (se pkt.
English: Cancer treatment-induced diarrhoea (CTID) is associated with significant morbidity and may be life-threatening.
Danish: Diarré pga. cancerbehandling forbindes med signifikant morbiditet og kan være livstruende.
English: • Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Danish: • Uforvarende berøring med hud eller øjne skal omgående behandles med rigelige mængder vand.
English: Ovarian and small cell lung carcinoma Initial dose
Danish: Ovariecancer og småcellet lungecancer Første dosis
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution og fortynding af lægemidlet, se pkt.
English: The pharmacokinetics of topotecan were generally unchanged when co-administered with ranitidine.
Danish: Farmakokinetikken for topotecan var generelt uændret, når det blev givet sammen med ranitidin.
English: In course 1 the incidence was 20%, by course 4 the incidence was 8%.
Danish: Under serie 1 var forekomsten 20 %, under serie4 var forekomsten 8 %.