Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
topotecan (as hydrochloride)
Eagle Laboratories Ltd.
L01CE01
topotecan
Antineoplastic and immunomodulating agents
Carcinoma; Small Cell Lung Carcinoma
Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.
Revision: 2
Withdrawn
2011-12-22
43 B. PACKAGE LEAFLET _ _ Medicinal Product no longer authorised 44 PACKAGE LEAFLET: INFORMATION FOR THE USER TOPOTECAN EAGLE 3 MG/1 ML CONCENTRATE FOR SOLUTION FOR INFUSION topotecan READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. IN THIS LEAFLET: 1. WHAT TOPOTECAN EAGLE IS AND WHAT IT IS USED FOR 2. BEFORE YOU ARE GIVEN TOPOTECAN EAGLE 3. HOW TO USE TOPOTECAN EAGLE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TOPOTECAN EAGLE 6. FURTHER INFORMATION 1. WHAT TOPOTECAN EAGLE IS AND WHAT IT IS USED FOR The name of your medicine is Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion (called Topotecan Eagle in this leaflet). Topotecan Eagle helps to kill tumour cells. It is a type of chemotherapy. Topotecan Eagle is used to treat: - small cell lung cancer that has come back after chemotherapy - advanced cervical cancer when surgery or radiotherapy are not possible. In this case, it is used with another medicine called cisplatin. 2. BEFORE YOU ARE GIVEN TOPOTECAN EAGLE YOU SHOULD NOT RECEIVE TOPOTECAN EAGLE: - if you are allergic (hypersensitive) to topotecan or to any of the other ingredients of this medicine listed in Section 6 - if you are breast-feeding. You should stop breast-feeding before starting treatment with Topotecan Eagle - if your blood cell count is too low. Your doctor will check this. Do not use Topotecan Eagle if any of the above apply to you. If you are not sure, talk to your doctor or nurse before using this medicine. TAKE SPECIAL CARE WITH TOPOTECAN EAGLE Check with your doctor or nurse before using your medicine: - if you have any kidney problems. Your dose of Topotecan Eagle may Belgenin tamamını okuyun
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal Product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate for solution for infusion contains 3 mg topotecan (as hydrochloride). Each 1 ml single dose vial contains 3 mg of topotecan. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear light yellow to orange solution, pH ≤ 1.2. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topotecan monotherapy is indicated for the treatment of 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). Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted. Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 10 9 /l, a platelet count of ≥ 100 x 10 9 /l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary). _Small Cell Lung Carcinoma _ _Initial dose _ The recommended dose of topotecan is 1.5 mg/m 2 body surface area/day administered by intravenous infusion over 30 minutes daily for five consecutive days with a three week interval between the start of each course. If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1). _Subsequent doses _ Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 10 9 /l, the platelet count is ≥ 100 x 10 9 /l, and the haemoglobin level is ≥ 9 g Belgenin tamamını okuyun