natgillin/translations-raw huggingface dataset:
Hos patienter, som har feber, neutropeni og et kompatibelt mønster med mavesmerter, bør risikoen for neutropenisk colitis overvejes.
In patients presenting with fever, neutropenia and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
Den dosis (og antal kapsler) af Hycamtin, som du vil få, vil blive beregnet af din læge på basis af:
The dose (and number of capsules) of Hycamtin you are given will be worked out by your doctor, based on:
Patienter med kreatinin-clearance > 60 ml/min er blevet inkluderet i virkning/sikkerheds-studier med topotecan.
Patients with creatinine clearance >60 ml/min have been included in efficacy/safety studies of topotecan.
Lysegult til grønligt pulver.
Light yellow to greenish powder.
10 kapsler
10 capsules
Tilsvarende resultater blev set, når glomerulær filtrationshastighed (ml/min) blev estimeret ved anvendelse af MDRD-formlen korrigeret for patientens vægt.
Similar results were obtained if glomerular filtration rate (ml/min) was estimated using the MDRD formula corrected for body weight.
Hycamtin bruges til at behandle:
Hycamtin is used to treat:
Bivirkninger, hvor hyppigheden ikke er kendt
Side effects with frequency not known
Mediantid til progression var ens i de to grupper (13,3 uger henholdsvis 12,3 uger).
Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks, respectively).
Responsraten i hele ovariecancerprogrammet (n = 392, alle tidligere behandlet med cisplatin eller cisplatin og paclitaxel) var 16 %.
The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16%.
Din læge vil sammen med dig beslutte, om behandling med Hycamtin er bedre end at fortsætte med den kemoterapibehandling, du tidligere har fået.
Your doctor will decide with you whether Hycamtin therapy is better than further treatment with your initial chemotherapy.
Disse data bør evalueres i lyset af den totale sikkerhedsprofil af lægemidlet, specielt den signifikante hæmatologiske toksicitet (se pkt.
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).
Topotecan-monoterapi er indiceret til behandling af:
Topotecan monotherapy is indicated for the treatment of:
De primære komplikationer forbundet med overdosering er knoglemarvssuppression og mucositis.
The primary complications of overdose are bone marrow suppression and mucositis.
Som med al cytotoksisk kemoterapi skal patienter, der behandles med topotecan, rådes til, at de eller deres partner skal anvende en effektiv præventionsmetode.
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.
• Alvorlige allergiske eller anafylaktiske reaktioner.
• Severe allergic or anaphylactic reactions.
Dødsfald pga. sepsis sås hos 1 % af patienterne.
Death due to sepsis occurred in 1% of patients.
Håndtering og bortskaffelse
Handling and disposal
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).
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).
Rekonstituerede og fortyndede opløsninger
Reconstituted and diluted solutions
Der var ingen tegn på kumulativ hæmatologisk eller non-hæmatologisk toksicitet.
There were no signs of cumulative haematological or non-haematological toxicity.
Der findes ikke nogen kendt antidot mod topotecan-overdosering.
There is no known antidote for topotecan overdose.
Topotecan-induceret neutropeni kan medføre neutropenisk colitis.
Topotecan-induced neutropenia can cause neutropenic colitis.
Hvis du har glemt at tage Hycamtin
If you forget to take Hycamtin
Tryk kapslen ud ved forsigtigt at trykke den ene ende gennem folien.
Push out the capsule: gently push one end of the capsule through the foil layer.
Metabolisme udgør < 10 % af topotecans eliminering.
Metabolism accounts for <10% of the elimination of topotecan.
Den dosis af Hycamtin, som du vil få, vil blive beregnet af din læge på basis af:
The dose of Hycamtin you are given will be worked out by your doctor, based on:
Diarré, der relateres til oral topotecan, kan forekomme på samme tid som lægemiddelrelateret neutropeni og dets følger.
Diarrhoea related to oral topotecan can occur at the same time as drug-related neutropenia and its sequelae.
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.
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.
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.
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.
Tag altid lægemidlet nøjagtigt efter lægens anvisning.
Always take this medicine exactly as your doctor has told you.
Sammenligning af farmakokinetiske parametre viste ingen farmakokinetiske ændringer i løbet af de 5 doseringsdage.
Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Total eller udtalt alopeci blev observeret hos 30 % af patienterne, og partiel alopeci hos 15 % af patienterne.
Total or pronounced alopecia was observed in 30% of patients and partial alopecia in 15% of patients.
Infektioner og parasitære sygdomme Meget almindelig Infektion Almindelig
Infections and infestations Very common Infection Common
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.
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.
Indehaver af markedsføringstilladelsen Novartis Europharm Limited Vista Building
Marketing Authorisation Holder Novartis Europharm Limited Vista Building
Mediantiden til indtræden af diarré af grad 2 eller værre var 9 dage.
The median time to onset of Grade 2 or worse diarrhoea was 9 days.
Infektion, sepsis og febril neutropeni sås hos henholdsvis 17 %, 2 % og 4 % af patienterne.
Infection, sepsis and febrile neutropenia occurred in 17%, 2%, and 4% of patients, respectively.
Du vil få behandling en gang daglig i 3 dage.
You will have treatment once a day for 3 days.
Hård kapsel.
Hard capsule.
2, forstoppelse, mucositis, dyspepsi
2, constipation, mucositis, dyspepsia
Proaktiv behandling af diarré med midler mod diarré er vigtig.
Proactive management of diarrhoea with anti-diarrhoeal agents is important.
In vitro data på humane levermikrosomer indikerer dannelsen af små mængder af N-demethyleret topotecan.
In vitro data using human liver microsomes indicate the formation of small amounts of Ndemethylated topotecan.
Når topotecan gives sammen med andre kemoterapeutika, kan det være nødvendigt at reducere dosis af de enkelte lægemidler for at forbedre tolerancen.
When combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Topotecan hæmmer ikke humane P450-enzymer (se pkt.
Topotecan does not inhibit human P450 enzymes (see section 5.2).
Hvis du får kapslens indhold i øjet, skal du straks skylle forsigtigt med vand i mindst 15 minutter.
If you get the capsule contents in your eyes, wash them immediately with gently flowing water for at least 15 minutes.
Eventuelt ubrugt lægemiddel eller affald bør bortskaffes i overensstemmelse med lokale krav til cytotoksisk materiale.
Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic material.
Selvom det ikke vides, om topotecan udskilles i human brystmælk, skal amning stoppes ved behandlingsstart.
Although it is not known whether topotecan is excreted in human breast milk, breast-feeding should be discontinued at the start of therapy.
Indhold i kapslen Hydrogeneret vegetabilsk olie Glycerolmonostearat
Capsule contents Hydrogenated vegetable oil Glyceryl monostearate
Pulveret skal opløses og fortyndes før infusion.
The powder needs to be reconstituted and diluted before infusion.
Farmakokinetikken for HYCAMTIN kapsler er ikke undersøgt specifikt hos patienter med nedsat leverfunktion.
Pharmacokinetics of HYCAMTIN capsules have not been specifically studied in patients with impaired hepatic function.
Kombinationsterapi (cervixcancer):
Combination therapy (cervical carcinoma):
Farmakokinetikken af topotecan givet som intravenøs infusion over 30 minutter i 5 dage er undersøgt i to studier.
The pharmacokinetics of topotecan given as a 30-minute infusion for 5 days were evaluated in two studies.
Diarré herunder alvorlig diarré, der kræver hospitalsindlæggelse, er set ved behandling med oral topotecan.
Diarrhoea, including severe diarrhoea requiring hospitalisation, has been reported during treatment with oral topotecan.
• Usædvanlige blå mærker eller blødninger, der er forårsaget af en nedsættelse i antallet af de celler, som får blodet til at størkne.
• Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
Medianoverlevelsen var 30,3 uger (95 % CI: 27,6; 33,4).
Median survival was 30.3 weeks (95% CI: 27.6, 33.4).
Farmakoterapeutisk klassifikation: antineoplastiske stoffer, andre antineoplastiske stoffer: ATC-kode: L01XX17.
Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents: ATC code: L01XX17.
Kvinder i den fertile alder/prævention til mænd og kvinder
Women of childbearing potential / Contraception in males and females
Administration af topotecan til børn er undersøgt, men kun begrænsede data om virkning og sikkerhed er tilgængelige.
Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available.
• Gravide medarbejdere må ikke arbejde med dette lægemiddel.
• Pregnant staff should be excluded from working with this medicinal product.
Alvorlig overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
Severe hypersensitivity to the active substance or to any of the excipients.
Hvid polyvinylchlorid / polychlorotrifluoroethylen-blister forseglet med aluminium / polyethylenterephtalat (PET) / papir-folie.
White polyvinyl chloride / polychlorotrifluoroethylene blister sealed with aluminium / Polyethylenterephtalate (PET) / paper foil lidding.
Pancytopeni
Pancytopenia
Alvorlig neutropeni varede længere end syv dage i 11 % af alle serierne.
Severe neutropenia lasted beyond seven days in 11% of courses overall.
Prækliniske studier tyder på, at topotecans plasmaproteinbinding er lav (35 %), og fordelingen mellem blodceller og plasma er omtrent homogen.
Preclinical studies indicate plasma protein binding of topotecan is low (35%) and distribution between blood cells and plasma was fairly homogeneous.
HYCAMTIN kapsler kan tages med eller uden mad (se pkt.
Hycamtin capsules may be taken with or without food (see section 5.2).
Diarré pga. cancerbehandling forbindes med signifikant morbiditet og kan være livstruende.
Cancer treatment-induced diarrhoea (CTID) is associated with significant morbidity and may be life-threatening.
• Uforvarende berøring med hud eller øjne skal omgående behandles med rigelige mængder vand.
• Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Ovariecancer og småcellet lungecancer Første dosis
Ovarian and small cell lung carcinoma Initial dose
Opbevaringsforhold efter rekonstitution og fortynding af lægemidlet, se pkt.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Farmakokinetikken for topotecan var generelt uændret, når det blev givet sammen med ranitidin.
The pharmacokinetics of topotecan were generally unchanged when co-administered with ranitidine.
Under serie 1 var forekomsten 20 %, under serie4 var forekomsten 8 %.
In course 1 the incidence was 20%, by course 4 the incidence was 8%.
Standard onkologisk praksis for behandling af neutropeni er enten at administrere topotecan sammen med andre lægemidler (f.eks. G-CSF), eller at reducere dosis for at opretholde neutrofiltallet.
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.
• Aktivt stof: topotecan.
• The active substance is topotecan.
Husk at fortælle lægen, hvis du starter med at tage anden medicin under behandlingen med Hycamtin.
Remember to tell your doctor if you start to take any other medicines while you are on Hycamtin.
Hos patienter, der var refraktære eller som fik tilbagefald inden for 3 måneder efter cisplatinbehandling (n = 186), var responsraten 10 %.
In patients refractory to or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10%.
Intravenøs topotecan skal overvejes i følgende kliniske situationer: ukontrolleret emesis, synkeforstyrrelser, ukontrolleret diarré, kliniske tilstande og medicinering, som kan ændre den gastrointestinale motilitet og lægemiddelabsorption.
Intravenous topotecan should be considered in the following clinical situations: uncontrolled emesis, swallowing disorders, uncontrolled diarrhoea, clinical conditions and medication that may alter gastrointestinal motility and drug absorption.
Kontakt lægen hvis du får noget i øjet eller oplever en forandring i huden.
Consult your doctor after eye contact or if you experience a skin reaction.
Topotecan skal rekonstitueres og fortyndes yderligere inden anvendelse (se pkt.
Topotecan must be reconstituted and further diluted before use (see section 6.6).
Dette bør overvejes, når HYCAMTIN ordineres f.eks. i tilfælde, hvor det overvejes at behandle patienter med øget risiko for tumorblødning.
This should be taken into account when prescribing HYCAMTIN, e.g. if patients at increased risk of tumour bleeds are considered for therapy.
Underliggende risikofaktorer inkluderer tidligere ILD, pulmonal fibrose, lungecancer, eksponering af thorax for stråler og brug af pneumotoksiske stoffer og/eller kolonistimulerende faktorer.
Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic substances and/or colony stimulating factors.
• ovariekræft eller småcellet lungekræft, som er kommet igen efter kemoterapi.
• ovarian cancer or small cell lung cancer that has come back after chemotherapy.
I et andet randomiseret fase III-studie, som sammenlignede intravenøs (IV) topotecan med cyclophosphamid, doxorubicin og vincristin (CAV) hos patienter med recidiverende, sensitiv SCLC, var den samlede responsrate 24,3 % for topotecan sammenlignet med 18,3 % for CAV-gruppen.
In another randomised Phase III study which compared intravenous (IV) topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3% for topotecan compared to 18.3% for the CAV group.
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 topotecandoseringen.
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.
I en population af patienter med refraktær SCLC (dem som ikke responderer på 1. linje-behandling) var responsraten 4,0 %.
In a population of patients with refractory SCLC (those not responding to first-line therapy), the response rate to topotecan was 4.0%.
Der ses ringe eller ingen akkumulering af topotecan efter gentagen daglig dosering, og der er ingen tegn på ændring i farmakokinetikken efter multiple doser.
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in pharmacokinetics after multiple doses.
Gravide kvinder blandt personalet må ikke arbejde med dette medikament.
Pregnant staff should be excluded from working with this medicinal product.
9/l) under serie 1 hos 55 % af patienterne med en varighed  syv dage hos 20 % og totalt set hos 77 % af patienterne (39 % af serierne).
9/l) during course 1 in 55% of patients, with duration  seven days in 20%, and overall in 77% of patients (39% of courses).
Hvis du er i behandling for livmoderhalskræft, kan du få bivirkninger af den anden medicin (cisplatin), som du vil få sammen med Hycamtin.
If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Hycamtin.
Ud over hydrolyse elimineres topotecan overvejende renalt som en mindre komponent, der metaboliseres til N-desmetylmetabolit (SB-209780) og er fundet i plasma, urin og fæces.
Other than hydrolysis, topotecan is cleared predominantly renally, with a minor component metabolised to the N-desmethyl metabolite (SB-209780) identified in plasma, urine and faeces.
Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nürnberg, Tyskland
Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuremberg, Germany
Sort blæk
Black ink
• Alt udstyr brugt til administration eller rengøring, herunder handsker, bør anbringes i en højrisiko-affaldssæk til forbrænding ved høj temperatur.
• All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Andre alvorlige hændelser registreret som relateret til eller muligvis relateret til behandling med topotecan var anoreksi (12 %), utilpashed (3 %) og hyperbilirubinæmi (1 %).
Other severe events that were recorded as related or possibly related to topotecan treatment were anorexia (12%), malaise (3%) and hyperbilirubinaemia (1%).
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the carton.
I oral topotecan plus BSC-gruppen var der en statistisk signifikant forbedring i samlet overlevelse sammenlignet med gruppen med BSC alene (log-rank p = 0,0104).
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).
Omfanget af eksponering var den samme efter et måltid med højt fedtindhold og i fastende tilstand, mens tmax blev øget fra 1,5 til 3 timer (topotecanlakton) og fra 3 til 4 timer (total-topotecan).
The extent of exposure was similar following a high-fat meal and in the fasted state, while tmax was delayed from 1.5 to 3 hours (topotecan lactone) and from 3 to 4 hours (total topotecan).
En læge eller sygeplejerske vil give dig Hycamtin i din arm som en infusion, der varer omkring 30 minutter.
How Hycamtin is given A doctor or nurse will administer Hycamtin as an infusion into your arm lasting about 30 minutes.
Sikkerhedsdata præsenteres ud fra et integreret datagrundlag med 682 patienter med recidiverende lungecancer, som havde fået 2.536 serier med oral topotecan-monoterapi (275 patienter med recidiverende SCLC og 407 med recidiverende ikke-SCLC).
Safety data are presented based on an integrated data set of 682 patients with relapsed lung cancer administered 2,536 courses of oral topotecan monotherapy (275 patients with relapsed SCLC and 407 with relapsed non-SCLC).
En N-desmethylmetabolit, som i et cellebaseret assay har vist sig at have samme eller mindre aktivitet end lægemiddelstoffet, er fundet i urin, plasma og fæces.
An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma and faeces.
Personale skal oplæres i rekonstitution af medikamentet.
Personnel should be trained to reconstitute the medicinal product.
Læs denne indlægsseddel grundigt, inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Et fase II-studie (studie 065) og et fase III-studie (studie 396) blev gennemført til vurdering af virkningen af oral topotecan versus intravenøs topotecan til patienter, der havde oplevet tilbagefald ≥ 90 dage efter afslutningen af et tidligere behandlingsforløb med kemoterapi (se tabel 1).
One Phase II study (Study 065) and one Phase III study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥90 days after completion of one prior regimen of chemotherapy (see Table 1).
• Personale, som håndterer dette lægemiddel under rekonstitution, skal bære beskyttelsesdragt herunder maske, briller og handsker.
• Staff handling this medicinal product during reconstitution should wear protective clothing including mask, goggles and gloves.
Endvidere udviklede 5 % (1 % af serierne) af alle de behandlede patienter sepsis (se pkt.
In addition, 5% of all patients treated (1% of courses) developed sepsis (see section 4.4).
• Livmoderhalskræft: 0,75 mg/m af kroppens overfladeareal pr. dag.
• Cervical cancer: 0.75 mg per square metre of body surface area per day.
Hyppigheden af alvorlig (grad 3 eller 4) kvalme, opkastning, diarré og mucositis var henholdsvis 4, 3, 2 og 1 %.
The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1%, respectively.
Cisplatins produktinformation bør konsulteres for en komplet liste over bivirkninger associeret til brugen af cisplatin.
The prescribing information for cisplatin should be consulted for a full list of adverse events associated with cisplatin use.
Følgende tumortyper var inkluderet: Ewing's sarkom/primitiv neuroektoderm tumor, neuroblastoma, osteoblastoma og rhabdomyosarcoma.
Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma and rhabdomyosarcoma.
Hvis dette er veltolereret, kan dosis øges til 2,3 mg/m 2/dag i efterfølgende serier (se pkt.
If well tolerated, the dose may be increased to 2.3 mg/m 2/day in subsequent cycles (see section 5.2).
Terapeutiske interventioner forbundet med non-hæmatologiske virkninger omfattede antiemetika, som blev givet til 47 % af patienterne i 38 % af serierne og midler mod diarré, som blev givet til 15 % af patienterne i 6 % af serierne.
Therapeutic interventions associated with non-haematological effects included anti-emetic agents, given to 47% of patients in 38% of courses and anti-diarrhoeal agents, given to 15% of patients in 6% of courses.
Der er begrænsede data for koreanske patienter med kreatinin-clearance under 50 ml/min, som indikerer, at en yderligere dosisnedsættelse kan være nødvendig (se pkt.
Limited data in Korean patients with creatinine clearance less than 50 ml/min suggest a further lowering of dose may be required (see section 5.2).
Brug af topotecan bør begrænses til afdelinger specialiseret i brug af cytotoksisk kemoterapi.
The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy.
• hvis du er allergisk over for topotecan eller et af de øvrige indholdsstoffer i dette lægemiddel
• if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6).