natgillin/translations-raw huggingface dataset:
Dette gentages hver 21. dag, indtil patienten har fået 6 kure, eller indtil sygdommen skrider frem.
This is repeated every 21 days for six courses or until the disease gets worse.
Yderligere oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR.
For full details, see the Summary of Product Characteristics, also part of the EPAR.
Det aktive stof i Hycamtin, topotecan, er et kræftmiddel, der tilhører gruppen af topoisomerasehæmmere.
The active substance in Hycamtin, topotecan, is an anticancer medicine that belongs to the group ‘ topoisomerase inhibitors’.
De blokerer et enzym kaldet topoisomerase I, der medvirker ved delingen af dna.
It blocks an enzyme called topoisomerase I, which is involved in the division of DNA.
Når enzymet blokeres, opstår der brud på dna- strengene.
When the enzyme is blocked, the DNA strands break.
Derved forhindres kræftcellerne i at dele sig, så de til sidst dør.
This prevents the cancer cells from dividing and they eventually die.
Hycamtin givet som infusion blev undersøgt hos over 480 kvinder, som havde kræft i æggestokkene og som var blevet behandlet med platinholdig kræftmedicin uden resultat.
Hycamtin as an infusion has been studied in more than 480 women with ovarian cancer who had failed one treatment with platinum-containing anticancer medicines.
Tre af undersøgelserne var åbne, hvilket vil sige, at lægemidlet ikke blev sammenlignet med nogen anden behandling, og at patienterne godt vidste, de fik Hycamtin.
Three studies were ‘ open ’, meaning that the medicine was not compared to any other treatment and the patients knew that they were receiving Hycamtin.
Den fjerde undersøgelse omfattede 226 kvinder.
The fourth study involved 226 women, and compared Hycamtin with paclitaxel (another anticancer medicine).
Her blev Hycamtin sammenlignet med paclitaxel (et andet kræftmiddel).
The main measure of effectiveness was the number of patients whose tumours responded to treatment.
16%.
In ovarian cancer, the studies showed the effectiveness of Hycamtin, with an overall response rate of about 16%.
Af de patienter, der fik paclitaxel, reagerede 14% positivt (16 ud af 114).
In the main study, 21% of the patients who received Hycamtin (23 out of 112) responded to treatment, compared with 14% of the paclitaxel patients (16 out of 114).
Hvis resultaterne for lungekræft fra alle tre undersøgelser lægges sammen (480 patienter, der fik Hycamtin), var responsraten 20%.
In lung cancer, looking at the results obtained in all three studies, the response rate was 20% (480 patients received Hycamtin).
I forhold til symptomkontrol alene forlængede Hycamtin overlevelsestiden med 12 uger.
Compared to symptom control alone, Hycamtin prolonged survival by 12 weeks.
Ved livmoderhalskræft overlevede de patienter, der fik Hycamtin kombineret med cisplatin, gennemsnitligt i 9, 4 måneder, sammenlignet med 6, 5 måneder for de patienter, der kun fik cisplatin.
In cervical cancer, patients receiving the combination of Hycamtin and cisplatin survived an average of 9.4 months, compared with 6.5 months for the patients who received cisplatin only.
De almindeligste bivirkninger (der ses hos flere end 1 ud af 10 patienter), er neutropeni (mangel på hvide blodlegemer, der bekæmper infektioner), neutropeni med feber, trombocytopeni (for lavt antal blodplader), anæmi (mangel på røde blodlegemer), leukopeni (mangel på hvide blodlegemer), kvalme, opkastning og diarré (som alle kan forekomme i svær grad), forstoppelse, mavepine, mundsår, hårtab, anoreksi (appetitløshed, som kan forekomme i svær grad), feber, kraftesløshed og træthed.
The most common side effects with Hycamtin (seen in more than 1 patient in 10) are neutropenia (too few of the white blood cells that fight infection), febrile neutropenia (neutropenia that causes fever), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), leucopenia (low white blood cell counts), nausea (feeling sick), vomiting and diarrhoea (all of which may be severe), constipation, abdominal (tummy) pain, mucositis (mouth sores), alopecia (hair loss), anorexia (loss of appetite, which may be severe), pyrexia (fever), asthenia (weakness) and fatigue (tiredness).
Neutropeni kan som bivirkning ved Hycamtin føre til neutropenisk colitis (betændelse i tarmen), hvilket forårsager svære mavesmerter, feber og muligvis diarré, og som kan gøre hospitalsbehandling nødvendig.
Neutropenia as a side-effect of Hycamtin can lead to neutropenic colitis (inflammation of the bowel), causing severe abdominal pain, fever and possibly diarrhoea, and which may need hospital treatment.
Den fuldstændige liste over de indberettede bivirkninger for Hycamtin fremgår af indlægssedlen.
For the full list of all side effects reported with Hycamtin, see the Package Leaflet.
Hycamtin bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for topotecan eller andre af indholdsstofferne.
Hycamtin should not be used in people who may be severely hypersensitive (allergic) to topotecan or any of the other ingredients.
Det bør ikke anvendes til patienter, der ammer, eller til patienter, der før behandlingen har svært knoglemarvssvigt (for lavt antal hvide blodlegemer og blodplader).
It should not be used in patients who are breast-feeding, or in patients who have severe bone marrow depression (low white blood cell and platelet counts) before treatment.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Hycamtin opvejer risiciene ved behandling af metastatisk kræft i æggestokkene og tilbagefald af småcellet lungekræft samt til behandling af livmoderhalskræft i kombination med cisplatin.
The Committee for Medicinal Products for Human Use (CHMP) decided that Hycamtin’ s benefits are greater than its risks for treatment of metastatic carcinoma of the ovary or relapsed small cell lung cancer, and for the treatment of cervical cancer (in combination with cisplatin).
Udvalget anbefalede udstedelse af markedsføringstilladelse for Hycamtin.
The Committee recommended that Hycamtin be given marketing authorisation.
2/ 3 Andre oplysninger om Hycamtin:
2/ 3 Other information about Hycamtin:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Hycamtin til SmithKline Beecham den 12. november 1996.
The European Commission granted a marketing authorisation valid throughout the European Union for Hycamtin to SmithKline Beecham on 12 November 1996.
Denne tilladelse blev fornyet den 12. november 2001 og den 12. november 2006.
The marketing authorisation was renewed on 12 November 2001 and on 12 November 2006.
Den fuldstændige (EPAR) for Hycamtin findes her.
The full EPAR for Hycamtin is available here.
5 vials (17 ml)
5 vials (17 ml)
1 vial (17 ml)
1 vial (17 ml)
5 vials
5 vials
1 vial
1 vial
blister (PVC/ PCTFE/ Alu)
blister (PVC/ PCTFE/ Alu)
Hvert hætteglas indeholder 1 mg topotecan (som hydrochlorid) samt 10% overskud.
Each vial contains 1 mg topotecan (as hydrochloride), with a 10% overage of fill.
5. 1).
Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
5. 1).
Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
6. 6).
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).
Ved brug i kombination med cisplatin, skal den fulde tilgængelige information om cisplatin være bekendt.
When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Før administration af den første behandling med topotecan skal patienten have et baseline- neutrofiltal på ≥ 1, 5 x 109/ l, et trombocyttal på ≥ 100 x 109/ l og et hæmoglobinniveau på ≥ 9 g/ dl (om nødvendigt efter transfusion).
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/ l, a platelet count of ≥ 100 x 109/ l and a haemoglobin level of ≥ 9 g/ dl (after transfusion if necessary).
Topotecan skal rekonstitueres og fortyndes yderligere før brug (se afsnit 6. 6).
Topotecan must be reconstituted and further diluted before use (see section 6.6).
Ovariecarcinom og småcellet lungecancer:
Ovarian and Small Cell Lung Carcinoma
Første dosis Den anbefalede dosis af topotecan er 1, 5 mg/ m2 legemsoverflade/ dag administreret som intravenøs infusion over 30 minutter hver dag 5 dage i træk, med et interval på 3 uger mellem begyndelsen af hver behandling.
Initial dose The recommended dose of topotecan is 1.5 mg/ m2 body surface area/ day administered by intravenous infusion over 30 minutes daily for 5 consecutive days with a 3 week interval between the start of each course.
Hvis behandlingen er veltolereret, kan den fortsættes, indtil sygdommen progredierer (se afsnit 4. 8 og 5. 1).
If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
2 Efterfølgende doser Topotecan bør ikke gives igen, medmindre neutrofiltallet er ≥ 1 x 109/ l, trombocyttallet er ≥ 100 x 109/ l og hæmoglobinniveauet er ≥ 9 g/ dl (om nødvendigt efter transfusion).
2 Subsequent doses Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 109/ l, the platelet count is ≥ 100 x 109/ l, and the haemoglobin level is ≥ 9 g/ dl (after transfusion if necessary).
Standard onkologi praksis for behandling af neutropeni er enten at administrere topotecan sammen med anden medicin (f. eks.
Standard oncology practice for the management of neutropenia is either to administer topotecan with other medications (e. g.
G- CSF), eller at dosisreducere af hensyn til neutrofiltallet.
G-CSF) or to dose reduce to maintain neutrophil counts.
Ved dosisreduktion hos patienter, som oplever alvorlig neutropeni (neutrofiltal < 0, 5 x 109/ l) i 7 dage eller mere, eller alvorlig neutropeni forbundet med feber eller infektion, eller hvis behandling er blevet udskudt på grund af neutropeni, bør dosis reduceres med 0, 25 mg/ m2/ dag til 1, 25 mg/ m2/ dag (eller derefter om nødvendigt ned til 1, 0 mg/ m2 / dag).
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/ l) for 7 days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.25 mg/ m2/ day to 1.25 mg/ m2/ day (or subsequently down to 1.0 mg/ m2/ day if necessary).
Doserne skal ligeledes reduceres, hvis trombocyttallet falder til under 25 x 109/ l.
Doses should be similarly reduced if the platelet count falls below 25 x 109/ l.
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.
In clinical trials, topotecan was discontinued if the dose had been reduced to 1.0 mg/ m2 and a further dose reduction was required to manage adverse effects.
Første dosis Den anbefalede dosis af topotecan er 0, 75 mg/ m2 legemsoverflade/ dag administreret som intravenøs infusion over 30 minutter på dag 1, 2 og 3.
Initial dose The recommended dose of topotecan is 0.75 mg/ m2/ day administered as 30 minute intravenous infusion daily on days 1, 2 and 3.
Cisplatin administreres som intravenøs infusion på dag 1 med en dosis på 50 mg/ m2 legemsoverflade/ dag, efter administration af topotecan.
Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/ m2/ day and following the topotecan dose.
Dette behandlingsmønster gentages hver 21. dag 6 gange eller indtil progression af sygdommen.
This treatment schedule is repeated every 21 days for 6 courses or until progressive disease.
Efterfølgende doser Efterfølgende doser af topotecan bør ikke gives, medmindre neutrofiltallet er ≥ 1, 5 x 109/ l, trombocyt - tallet er ≥ 100 x 109/ l og hæmoglobinniveauet er ≥ 9 g/ dl (om nødvendigt efter transfusion).
Subsequent doses Topotecan should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 109/ l, the platelet count is more than or equal to 100 x 109/ l, and the haemoglobin level is more than or equal to 9g/ dl (after transfusion if necessary).
Ved dosisreduktion hos patienter, som oplever alvorlig neutropeni (neutrofiltal < 0, 5 x 109/ l) i 7 dage eller mere, eller alvorlig neutropeni forbundet med feber eller infektion, eller hvis behandling er blevet udskudt på grund af neutropeni, bør dosis reduceres med 20% til 0, 60 mg/ m2 / dag i de efterfølgende behandlinger (eller derefter om nødvendigt ned til 0, 45 mg/ m2 / dag).
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count less than 0.5 x 109/ l) for 7 days or more, or severe neutropenia associated with fever or infection or who have had treatment delayed due to neutropenia, the dose should be reduced by 20% to 0.60 mg/ m2/ day for subsequent courses (or subsequently down to 0.45 mg/ m2/ day if necessary).
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 109/ l.
Der findes ikke tilstrækkeligt datamateriale til at anbefale behandling af patienter med en kreatinin - clearance på < 20 ml/ min.
Dosage in renally impaired patients Monotherapy (Ovarian and Small cell lung carcinoma) Insufficient data are available to make a recommendation for patients with a creatinine clearance < 20 ml/ min.
Den rekommenderede topotecandosis ved monoterapi hos patienter med ovariecarcinom eller småcellet lungecancer og en kreatinin clearance mellen 20 og 39 ml/ min er 0, 75 mg/ m2/ dag i 5 sammenhængende dage.
The recommended monotherapy dose of topotecan in patients with ovarian or small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/ min is 0.75 mg/ m2 / day for 5 consecutive days.
I kliniske studier af kombinationsbehandling med topotecan og cisplatin til behandling af cervixcancer blev behandlingen kun initieret for patienter med serumkreatinin ≤ 1, 5 mg/ dl.
Combination therapy (Cervical carcinoma) 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.
Hvis serumkreatinin 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.
5. 1 og 5. 2).
3 Paediatrics The experience in children is limited, therefore no recommendation for treatment of paediatric patients with HYCAMTIN can be given (see sections 5.1 and 5.2).
4. 6). − før den første serie indledes, lider af alvorlig knoglemarvssuppression, defineret som et baseline- neutrofiltal på < 1, 5 x 109/ l og/ eller et trombocyttal på ≤ 100 x 109/ l.
HYCAMTIN is contraindicated in patients who − have a history of severe hypersensitivity to the active substance or to any of the excipients − are breast feeding (see section 4.6) − already have severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 109/ l and/ or a platelet count of < 100 x 109/ l.
4. 2).
Haematological toxicity is dose-related and full blood count including platelets should be monitored regularly (see section 4.2).
4. 8).
Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Topotecan- induceret netropeni kan medføre neutropenisk colitis.
Topotecan-induced neutropenia can cause neutropenic colitis.
4. 8).
Topotecan has been associated with reports of interstitial lung disease, some of which have been fatal (see section 4.8).
Underliggende risikofaktorer inkluderer tidligere ILD, pulmonal fibrose, lungecancer, eksponering af thorax for stråler og brug af pneumotoksiske lægemidler og/ eller kolonistimulerende faktorer.
Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic drugs and/ or colony stimulating factors.
Patienter bør monitoreres for pulmonale symptomer, der indikerer interstitiel lungesygdom (f. eks. hoste, feber, dyspnø og/ eller hypoxia), og topotecan bør seponeres, hvis en ny diagnose af ILD er bekræftet.
Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease (e. g. cough, fever, dyspnoea and/ or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Topotecan og topotecan i kombination med cisplatin er i almindelighed associeret med klinisk relevant trombocytopeni.
Topotecan and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Dette bør overvejes ved valg af terapi til f. eks. patienter med øget risiko for tumorblødning.
This should be taken into account, e. g. in case patients at increased risk of tumour bleeds are considered for therapy.
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).
Der er ikke tilstrækkelig erfaring i brugen af topotecan til patienter med alvorlig nedsat nyrefunktion (kreatininclearance < 20 ml/ min) eller alvorlig nedsat leverfunktion (serum bilirubin ≥ 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.
Et lille antal af hepatisk svækkede patienter (serum bilirubin mellem 1, 5 og 10 mg/ dl) fik 1, 5 mg/ m2 i fem dage hver tredje uge.
A small number of hepatically impaired patients (serum bilirubin between 1.5 and 10 mg/ dl) were given 1.5 mg/ m2 for five days every three weeks.
En reduktion i topotecan clearance blev observeret, men der er ikke tilstrækkelig tilgængelig data til at kunne lave en dosisrekommendation til denne patientgruppe.
A reduction in topotecan clearance was observed however there are insufficient data available to make a dose recommendation for this patient group.
4 4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction
Der er ikke udført “ in vivo ” humane farmakokinetiske interaktionsundersøgelser.
No in vivo human pharmacokinetic interaction studies have been performed.
Topotecan hæmmer ikke humane P450- enzymer (se afsnit 5. 2).
Topotecan does not inhibit human P450 enzymes (see section 5.2).
I en populationsundersøgelse påvistes, ved samtidig administration af granisetron, ondansetron, morfin eller kortikosteroider, ingen signifikant påvirkning af farmakokinetikken af total topotecan (aktiv og inaktiv form).
In a population study, the co- 4 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).
Når topotecan gives sammen med andre kemoterapeutika kan det være nødvendigt at reducere doseringen af hvert af de enkelte lægemidler for at forbedre stoffernes tolerabilitet.
In combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
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.
Ved administration af topotecan (0, 75 mg/ m2 legemsoverflade/ dag i 5 sammenhængende dage) og cisplatin (60 mg/ m2 legemsoverflade/ dag på dag 1) til 13 patienter med ovariecancer, blev en svag stigning set i AUC (12%, n = 9) og Cmax (23%, n = 11) på dag 5.
When topotecan (0.75 mg/ m2/ day for 5 consecutive days) and cisplatin (60 mg/ m2/ day on Day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12%, n=9) and Cmax (23%, n=11) was noted on day 5.
Prækliniske forsøg har vist, at topotecan medfører embryo/ fosterdødelighed og misdannelser (se pkt.
Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3).
Som for andre cytostatika kan topotekan forårsage fosterskader, hvorfor kvinder i den fødedygtige alder bør rådes til at undgå graviditet, hvis de er i behandling med topotecan.
As with other cytotoxic medicinal products, topotecan may cause foetal harm and therefore women of child bearing potential should be advised to avoid becoming pregnant during therapy with topotecan.
4. 3).
Topotecan is contra-indicated during breast-feeding (see section 4.3).
I dosisbestemmelsesstudier, der omfattede 523 patienter med recidiverende ovariecancer og 631 patienter med recidiverende småcellet lungecancer, blev den dosisbegrænsende toksicitet af topotecan - monoterapi 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.
Der er ikke fundet tegn på kumulativ hæmatologisk eller non- hæmatologisk toksicitet.
There were no signs of cumulative haematological or non-haematological toxicity.
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.
Disse bivirkninger er dog tidligere set som følge af behandling med cisplatin- monoterapi og skyldes ikke topotecan.
Additional adverse events were seen when topotecan was given in combination with cisplatin, however, these events were seen with cisplatin monotherapy and not attributable to topotecan.
De samlede sikkerhedsdata for topotecan- monoterapi fremgår herunder.
5 The integrated safety data for topotecan monotherapy are presented below.
Bivirkningerne er nævnt herunder, opdelt efter systemorganklasse og absolutte frekvenser/ hyppighed (alle indberettede hændelser).
Adverse reactions are listed below, by system organ class and absolute frequency (all reported events).
Hyppigheden defineres som: meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100, < 1/ 10), ikke almindelig (≥ 1/ 1, 000, < 1/ 100), sjælden (≥ 1/ 10, 000, < 1/ 1, 000), meget sjælden (< 1/ 10, 000), herunder enkeltstående indberetninger og ikke kendt (kan ikke beregnes ud fra tilgængelige data).
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), including isolated reports and not known (cannot be estimated from the available data).
Blod og lymfesystem Meget almindelig: febril neutropeni, neutropeni (se Mave- tarmkanalen), trombocytopeni, anæmi, leukopeni.
Blood and lymphatic system disorders Very common: febrile neutropenia, neutropenia (see Gastrointestinal disorders), thrombocytopenia, anaemia, leucopenia.
Luftveje, thorax og mediastinum Sjælden: interstitiel lungesygdom
Respiratory, thoracic and mediastinal disorders Rare: interstitial lung disease