natgillin/translations-raw huggingface dataset:
Data er dog ikke tilstrækkelige til at kunne lave en dosisrekommendation til denne patientgruppe.
However there are insufficient data available to make a dose recommendation for this patient group.
Unormalt lavt antal af neutrofile granulocytter (en type hvide blodceller) i blodet, med eller uden feber.
Abnormal low number of neutrophil granulocytes (a type of white blood cell) in the blood, with or without fever.
Medianoverlevelse (uger)
Survival (months)
Dette behandlingsmønster gentages hver 21. dag seks gange eller indtil progression af sygdommen.
This treatment schedule is repeated every 21 days for six courses or until progressive disease.
Andre bivirkninger med Topotecan Actavis inkluderer:
Other side effects with Topotecan Actavis include:
Dato for første markedsføringstilladelse: 24. juli 2009 Dato for seneste fornyelse: 6. juni 2014
Date of latest renewal: 6 June 2014
En læge eller en sygeplejerske vil give dig den tilberedte og fortyndede Topotecan Actavis opløsning som infusion (drop), sædvanligvis i armen over en periode på ca. 30 minutter.
A doctor or nurse will give you the reconstituted and diluted Topotecan Actavis solution as an infusion (drip), usually into your arm, over about 30 minutes.
Antitumoraktivitet blev vist primært hos patienter med neuroblastoma.
Antitumour activity was demonstrated primarily in patients with neuroblastoma.
Rekonstitution og fortyndingopløsning før administration
Reconstitution and dilution prior to administration
Milde abdominalsmerter blev også rapporteret blandt 4 % patienterne.
Mild abdominal pain was also reported amongst 4 % of patients.
Der sås ringe eller ingen akkumulering af topotecan efter gentagen daglig dosering og der var ingen tegn på ændring i PK efter multiple doser.
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.
Der blev givet transfusioner af røde blodlegemer til 52 % af patienterne (21 % af behandlingerne).
Red cell transfusions were given in 52 % of patients (21 % of courses).
Det skal rekonstitueres og fortyndes yderligere før brug (se pkt.
It must be reconstituted and further diluted before use (see section 6.6).
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 N-demethylated topotecan.
Der var i disse studier ikke nogen synlige forskelle i farmakokinetiken af topotecan hos børn, unge og yngre voksne med solide tumorer eller leukæmi, men data er for begrænset til en difinitiv konklusion.
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.
Hyppigheden af bivirkninger er større hos patienter med generelt dårligt helbred.
The incidence of side effects is more frequent in patients who are in poor general health.
Farmakoterapeutisk klassifikation: Andre antineoplastiske stoffer, ATC-kode: L01XX17.
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX17.
Blandt alle patienterne, der blev behandlet i de kliniske forsøg (herunder både dem med alvorlig neutropeni og dem, der ikke udviklede alvorlig neutropeni), udviklede 11 % (4 % af behandlingerne) feber, og 26 % (9 % af behandlingerne) udviklede infektion.
Among all patients treated in clinical trials (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.
- Kløe (pruritus)
- Itching (pruritus).
Du skal anvende effektive præventionsmetoder under behandlingen for at undgå at blive gravid/blive far til et barn.
Effective contraception methods should be used to avoid becoming pregnant/fathering a child while on treatment.
Overordnet genvinding af lægemiddelstofrelateret materiale efter fem daglige doser af topotecan var 71 til 76 % af den administrerede IV dosis.
Overall recovery of medicinal product-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Administration af topotecan til den pædiatriske population er undersøgt, men der er kun begrænset data om effekt og sikkerhed tilgængelig.
Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available.
Der skal bæres tilstrækkeligt beskyttende engangshandsker, briller, kittel og maske.
Adequate protective disposable gloves, goggles, gown and mask should be worn.
Andre alvorlige hændelser observeret hos patienterne, som var registreret som relateret til eller muligt relateret til behandling med topotecan omfattede anorexia (12 %), utilpashed (3 %) og hyperbilirubinæmi (1 %).
Other severe events occurring in patients that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %).
Medianoverlevelsen var 30,3 uger (95 % CI: 27,6; 33,4).
The median survival was 30.3 weeks (95 % CI: 27.6, 33.4).
- Hårtab.
- Hair loss.
11 Ion Michalache Blvd Bukarest
11 Ion Mihalache Blvd Bucharest
Som forventet har patienter med dårlig performancestatus (PS > 1) en lavere responsrate og en øget incidens af komplikationer såsom feber, infektion og sepsis (se pkt 4.8).
As 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).
- Vægttab og tab af appetit (anoreksi); træthed; slaphed.
- Weight loss and loss of appetite (anorexia); tiredness; weakness.
Patienter bør monitoreres for pulmonale symptomer, der indikerer ILD (eks. hoste, feber, dyspnø og/eller hypoksi), og topetecan 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.
Hvert hætteglas er beklædt med et beskyttelsesskjold.
Each vial is sheathed in a protective sleeve.
Alt udstyr brugt til administration eller rengøring, inklusiv handsker, bør anbringes i en højrisikoaffaldssæk 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.
In vitro hæmmede topotecan hverken de menneskelige P450-enzymer CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A og CYP4A eller de menneskelige cytosoliske enzymer dihydropyrimidin eller xanthin oxidase.
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.
I en population af patienter med refraktær SCLC (dem som ikke responderer på førstelinjebehandling) var responsraten for topotecan 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 %.
Svære hævelser kan føre til vejrtrækningsproblemer.
If severe it may cause breathing difficulties.
Farmakokinetiken 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.
Reykjavikurvegi 76-78 IS-220 Hafnarfjordur Island
Reykjavíkurvegi 76-78 IS-220 Hafnarfjörður Iceland
- Fald i antallet af cirkulerende hvide blodceller (leukocytter) i blodet.
- Decrese in number of circulating white blood cells (leucotyes) in the blood.
Selvom det ikke vides om topotecan udskilles i humant 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.
En N-desmethyl metabolit, som i en 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.
Pulveret skal opløses, og det færdige koncentrat skal yderligere fortyndes før anvendelse.
The powder must be dissolved, and the resulting concentrate further diluted before administration.
Omtrent 51 % blev udskilt som uomdannet topotecan og 3 % blev udskilt som N-desmethyl topotecan i urinen.
Approximately 51 % was excreted as total topotecan and 3 % was excreted as N-desmethyl topotecan in the urine.
Børn og unge Erfaringen med behandling af børn og unge er begrænset og Topotecan Actavis frarådes derfor.
Use in children and adolescents The experience in children and adolescents is limited and treatment is therefore not recommended.
Der er ikke fundet tegn på kumulativ hæmatologisk eller non-hæmatologisk toksicitet.
There were no signs of cumulative haematological or non-haematological toxicity.
Anæmi: Moderat til alvorlig (Hb ≤ 8,0 g/dl) hos 37 % af patienterne (14 % af behandlingerne).
Anaemia: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Actavis Group PTC ehf.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf.
Oversigt over overlevelse, responsrate og tiden indtil progression hos SCLC-patienter, der er behandlet med oral eller intravenøs topotecan.
Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan
Alvorlig neutropeni varede længere end syv dage i 11 % af alle behandlingerne.
Severe neutropenia lasted beyond seven days in 11 % of courses overall.
I kliniske undersøgelser er hududslæt rapporteret hos 4 % af patienterne og pruritus hos 1,5 % af patienterne.
In clinical trials, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Brugen af topotecan bør begrænses til afdelinger specialiseret i brug af cytotoksisk kemoterapi og bør kun administreres under overvågning af en læge, der har erfaring i brugen af kemoterapi (se pkt.
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).
Ofte rapporterede nonhæmatologiske bivirkninger gastrointestinale, såsom kvalme (52 %), opkastning (32 %) og diare (18 %), konstipation (9 %) og mucositis (14 %).
Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), and diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
Topotecan Actavis bruges til at behandle: - småcellet lungekræft, som er kommet igen efter kemoterapi, eller - fremskreden livmoderhalskræft, hvor behandling med kirurgi eller stråleterapi ikke er mulig.
Topotecan Actavis is used to treat: - small cell lung cancer that has come back after chemotherapy, or - advanced cervical cancer if surgery or radiotherapy is not possible.
- Usædvanlige blå mærker eller blødninger (til tider alvorlig), der er forårsaget af en nedsættelse i antallet af de celler, som får blodet til at størkne (blodplader).
- Unusual bruising or bleeding, sometimes severe, caused by a decrease in the number of blood clotting cells (platelets).
Kontakt lægen før du får Topotecan Actavis: hvis du har nyreproblemer.
Talk to your doctor before using Topotecan Actavis: - if you have any kidney problems.
Inkluderede tumortyperne: Ewing's sarkom/primitiv neuroektoderm tumor, neuroblastoma, osteoblastoma og rhabdomyosarcoma.
Tumour types included were Ewing's Sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma.
Symptomer kan være gulfarvning af huden (gulsot).
Symptoms may include yellow skin (jaundice).
Fæcal eliminering af uomdannet topotecan udgjorde 18 % mens fæcal eliminering af N-desmethyl topotecan var 1,7 %.
Faecal elimination of total topotecan accounted for 18 % while faecal elimination of N-desmethyl topotecan was 1.7 %.
Det kan være nødvendigt at justere din dosis af Topotecan Actavis.
Your dose of Topotecan Actavis may need to be adjusted.
I en anden randomiseret fase III undersøgelse som sammenlignede IV topetecan 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 trial which compared 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.
Samlet set, bidrog N-desmethyl metabolitten i gennemsnit mindre end 7 % (interval 4-9 %) til det lægemiddelstofrelateret materiale i urin og fæces, som der kunne gøres rede for.
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.
Batch nr.:
BATCH NUMBER
Topotecan Actavis kan nedsætte antallet af blodceller (blodplader).
Topotecan Actavis may cause a decrease in the number of blood clotting cells (platelets).
Træthed blev observeret hos ca. 25 % og asteni hos 16 % af patienterne, mens de blev behandlet med topotecan.
Fatigue was observed in approximately 25 % and asthenia in 16 % of patients whilst receiving topotecan.
Endvidere udviklede 5 % (1 % af behandlingerne) af alle de behandlede patienter sepsis (se pkt.
In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
En reduktion i topotecanclearance blev observeret.
A reduction in topotecan clearance was observed.
Hvis du er i behandling for livmoderhalskræft, kan du få bivirkninger af den anden medicin (cisplatin), som du vil få sammen med Topotecan Actavis.
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 Topotecan Actavis.
Topotecan Actavis kan medføre træthed eller svaghed.
Topotecan Actavis can make you feel tired or weak.
Topotecan-induceret netropeni kan medføre neutropenisk colitis.
Topotecan-induced neutropenia can cause neutropenic colitis.
Klargøring af lægemidlet skal foretages i et afmærket område under aseptiske forhold.
The preparation should be performed in a designated area under aseptic conditions.
Der er ikke tilstrækkelig erfaring i brugen af topotecan til patienter med alvorlig nedsat nyrefunktion (kreatinin-clearance < 20 ml/min) eller alvorlig nedsat leverfunktion (serumbilirubin ≥ 10 mg/dl) på grund af cirrose.
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.
pancytopeni
pancytopenia
Mediantiden før indtræden af alvorlig trombocytopeni var dag 15, og medianvarigheden var fem dage.
Median time to onset of severe thrombocytopenia was Day 15 and the median duration was five days.
Topotecan er blevet associeret med rapporter om interstitiel lungesygdom (ILD), nogle af disse har været fatale (se pkt.
Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
Sammen med alvorlig neutropeni forekom der feber eller infektion hos 16 % af patienterne under behandlingsperiode 1 og totalt set hos 23 % af patienterne (6 % af behandlingerne).
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).
I dosisbestemmelsesstudier, der omfattede 523 patienter med recidiverende ovariecancer og 631 patienter med recidiverende småcellet lungecancer, blev den dosisbegrænsende toksicitet af topotecanmonoterapi fundet at være hæmatologisk.
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.
Risiko ratio for overlevelse af IV topotecan relativt til CAV var 1,04 (95 % CI 0,78; 1,40).
The hazard ratio for survival of IV topotecan relative to CAV was 1.04 (95 % CI 0.78 -1.40).
Tal med lægen, hvis du mener, noget af ovenstående gælder for dig.
Tell you doctor if you think any of these could apply to you.
Behandlingen blev gentaget hver 3. uge i op til et år afhængig af terapirespons.
30 minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy.
Frekvenserne forbundet med hæmatologiske og ikke-hæmatologiske bivirkninger anført nedenfor viser de bivirkningsrapporter, som anses for at være relateret eller muligvis relateret til behandling med topotecan.
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.
Hyppigheden af alvorlig (grad 3 eller 4) kvalme, opkastning, diare og mucositis var henholdsvis 4, 3, 2 og 1 %.
Severe (grade 3 or 4) nausea, vomiting, diarrhoea and mucositis incidence was 4, 3, 2 and 1 % respectively.
1 x 1 mg hætteglas; 5 x 1 mg hætteglas 1 x 4 mg hætteglas; 5 x 4 mg hætteglas
1 x 1 mg vial; 5 x 1 mg vial 1 x 4 mg vial; 5 x 4 mg vial
Forsigtighed bør dog udvises ved kørsel med motorkøretøj og ved betjening af maskineri, hvis træthed og asteni vedvarer.
However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Plasmaclearance af total topotecan (aktiv eller inaktiv form) hos patienter med nedsat leverfunktion faldt kun ca. 10 % sammenlignet med kontrolgruppen.
Plasma clearance of total topotecan (active and inactive form) in patients with hepatic impairment only decreased by about 10 % compared with the control group of patients.
Topotecan-O-glucuronid og N-desmethyl topotecan -O-glucuronid i urinen var mindre end 2,0 %.
The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were less than 2.0 %.
Cisplatin 50 mg/m2 d. 1 + Topotecan 0,75 mg/m2 d x 3 q 21
Cisplatin 50 mg/m d.1 + Topotecan 0,75 mg/ m dx3
Doserne bør ligeledes reduceres, hvis trombocyttallet falder til under 25 x 109/l.
Doses should be similarly reduced if the platelet count falls below 25 x 10 9/l.
Der blev givet trombocyttransfusioner i 4 % af behandlingerne.
Platelet transfusions were given in 4 % of courses.
Den samlede hæmatologiske toksicitet er lavere hos patienter behandlet med topotecan i kombination med cisplatin sammenlignet med topotecan-monostrapi, men højere end med cisplatin alene.
The overall haematological toxicity is lower in patients treated with topotecan in combination with cisplatin compared to topotecan monotherapy, but higher than with cisplatin alone.
I kombination med platin-baseret kemoterapi er der dog en særlig sekvens-afhængig interaktion, afhængig af om platin stoffet gives på dag 1 eller 5 i forhold til topotecan doseringen.
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.
Hvis serum-kreatinin under kombinationsbehandling overstiger 1,5 mg/dl anbefales det at konsultere den eksisterende information for cisplatin vedrørende dosisreduktion/fortsat behandling.
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.
I kliniske studier af kombinationsbehandling med topotecan og cisplatin til behandling af cervixcancer blev behandlingen kun initieret for patienter med serum-kreatinin ≤ 1,5 mg/dl.
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.
I kliniske undersøgelser blev topotecanbehandlingen stoppet, hvis dosis var blevet reduceret til 1,0 mg/m2 og yderligere reduktion af dosis var nødvendig, for at håndtere bivirkninger.
topotecan was discontinued if the dose had been reduced to 1.0 mg/m and a further dose reduction was required to manage adverse effects.
Hvis cisplatin eller carboplatin gives på dag 1 for topotecan doseringen, skal der gives en lavere dosis af begge stoffer, for at forbedre tolerabiliteten, i forhold til den indivudielle dosis der kan gives af platin stofferne, hvis de gives på dag 5 for topotecan doseringen.
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.
Standard onkologi praksis for behandling af neutropeni er enten at administrere topotecan sammen med anden medicin (f.eks. G-CSF), eller at dosisreducere af hensyn til neutrofiltallet.
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.
Prækliniske forsøg tyder på, at topotecans plasmaproteinbinding var lav (35 %), og fordelingen mellem blodceller og plasma var rimelig homogen.
Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous.
Topotecan Actavis indeholder det aktive stof topotecan som hjælper til med at ødelægge kræftceller.
Topotecan Actavis contains the active substance topotecan which helps to kill tumour cells.
Hvis du får for meget Topotecan Actavis
If you are given too much Topotecan Actavis
I et randomiseret, sammenlignende fase III-studie, 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 intenderet behandling med kirurgi og/eller stråleterapi ikke var vurderet hensigtsmæssig.
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.
Underliggende risikofaktorer inkluderer tidligere ILD, pulmonal fibrose, lungecancer, eksponering af thorax for stråler og brug af pneumotoksiske lsubstanser 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.
En O-glucuroniseret metabolit af topotecan og N-desmethyl topotecan er identificeret i urin.
An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
Når topotecan gives sammen med andre kemoterapeutika, kan det være nødvendigt, at reducere dosis af de enkelte lægemidler for at forbedre stoffernes tolerabiliteten.
In combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
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.
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.