Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TOPOTECAN HYDROCHLORIDE
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
TOPOTECAN HYDROCHLORIDE
10Capsule Capsules
GlaxoSmithKline Manufacturing S.p.A
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ HYCAMTIN ® HARD CAPSULES Topotecan Hydrochloride (1mg) 1 WHAT IS IN THIS LEAFLET 1. What Hycamtin is used for 2. How Hycamtin works 3. Before you use Hycamtin 4. How to use Hycamtin 5. While you are using Hycamtin 6. Side effects 7. Storage and Disposal of Hycamtin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT HYCAMTIN IS USED FOR Hycamtin is used to treat small cell lung cancer that has come back after chemotherapy. Your doctor will decide with you whether Hycamtin therapy is better than further treatment with your initial chemotherapy. HOW HYCAMTIN WORKS Hycamtin helps to destroy tumours. BEFORE YOU USE HYCAMTIN_ _ _- When you must not use it _ • if you are allergic (hypersensitive) to topotecan or any of the other ingredients of Hycamtin. • if you are breast feeding. • if your blood cell counts are too low. Your doctor will tell you whether this is the case, based on the results of your last blood test. Tell your doctor if any of these applies to you. _ _ _Pregnancy _ Hycamtin is not recommended for pregnant women. It may harm the baby if conceived before, during or soon after treatment. You should use an effective method of contraception. Ask your doctor for advice. Do not try and become pregnant until a doctor advises you it is safe to do so. Male patients who may wish to father a child, should ask their doctor for family planning advice or treatment. If pregnancy occurs during treatment, tell your doctor immediately. _Breast-feeding _ Do not breast-feed if you are being treated with Hycamtin. Do not restart breast-feeding until the doctor tells you it is safe to do so. _- Before you start to use Hycamtin _ Before you are given this medicine your doctor needs to know: • if you have any kidney or liver problems. Your dose of Hycamtin may need to be adjusted. _- Taking Hycamtin with food and drink _ Hycamtin may be taken with or without food. The capsule must be swallowed whole, and must not be che Прочетете целия документ
Novartis Page 2 Malaysian Package Leaflet 22-May-2017 Hycamtin Hard Capsules 2 1. NAME OF THE MEDICINAL PRODUCT HYCAMTIN 1 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 1 mg of topotecan (as hydrochloride). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. The capsules are opaque, pink and imprinted with “HYCAMTIN” and “1 mg”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYCAMTIN capsules are indicated as monotherapy for the treatment of adult 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION HYCAMTIN capsules should only be prescribed and therapy supervised by a physician experienced in the use of chemotherapeutic agents. Posology 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). _ _ _Initial dose _ The recommended dose of HYCAMTIN capsules is 2.3 mg/m 2 body surface area per day administered 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). The capsule(s) must be swallowed whole, and must not be chewed crushed or divided. Hycamtin capsules may be taken with or without food (see section 5.2). _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/dl (after transfusion if necessary). Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal product (e.g. G-CSF) or to reduce the dose to maintain neutrophil counts. Novartis Page 3 Malaysian Package Leaflet 22-May-2017 Hycamtin Hard Capsules Прочетете целия документ