Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TOPOTECAN HYDROCHLORIDE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
TOPOTECAN HYDROCHLORIDE
10Capsule Capsules
GlaxoSmithKline Manufacturing S.p.A
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ HYCAMTIN ® HARD CAPSULES Topotecan Hydrochloride (0.25mg, 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 no Lestu allt skjalið
Drug Regulatory Affairs HYCAMTIN (Topotecan) 0.25 mg and 1 mg Hard capsules for oral administration Malaysia Package Leaflet IPL Author: Rajitha Boru CDS Author: Goutam Ghoshal GLC approval: 25 Apr 2017 Release date: IPL based on GSK's GDS version 21 Dated 22 May 2017 (Novartis: Global dispatched on 22 -May -2017 ) Tracking Number: 2017 -PSB/GLC -0872 -s Document status: Final Number of pages: 12 Property of Novartis Confidential May not be used, divulged, published or otherwise disclosed without the consent of Novartis Lestu allt skjalið