Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
GEMCITABINE HYDROCHLORIDE
Koanaa Healthcare Limited 4th Floor, Cavendish House, 369 Burnt Oak, Broadway, Edgware, HA85AW, Middlesex, United Kingdom
L01BC05
GEMCITABINE HYDROCHLORIDE 1000 mg
POWDER FOR SOLUTION FOR INFUSION
GEMCITABINE HYDROCHLORIDE 1000 mg
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2016-10-28
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER GEMCITABINE KOANAA 200 MG POWDER FOR SOLUTION FOR INFUSION GEMCITABINE KOANAA 1000 MG POWDER FOR SOLUTION FOR INFUSION GEMCITABINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor,nurse or pharmacist. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Gemcitabine Koanaa is and what it is used for 2. What you need to know before you use Gemcitabine Koanaa 3. How to use Gemcitabine Koanaa 4. Possible side effects 5. How to store Gemcitabine Koanaa 6. Contents of the pack and other information 1. WHAT GEMCITABINE KOANAA IS AND WHAT IT IS USED FOR Gemcitabine Koanaa belongs to a group of medicines called ‘cytotoxics’. These medicines kill dividing cells, including cancer cells. Gemcitabine may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer you have. Gemcitabine Koanaa is used in the treatment of the following types of cancers: • non-small cell lung cancer (NSCLC), alone or together with cisplatin • pancreatic cancer • breast cancer, together with paclitaxel • ovarian cancer, together with carboplatin • bladder cancer, together with cisplatin 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GEMCITABINE KOANAA _ _ DO NOT USE GEMCITABINE KOANAA • if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of gemcitabine (listed in section 6). • If you are breast-feeding. WARNINGS AND PRECAUTIONS Before the first infusion you will have samples of your blood taken to check if your liver and kidneys are working well enough for you to receive this medicine. Before each infusion you will have samples of your blood taken to check if you have enough blood cells to receive gemcitab Đọc toàn bộ tài liệu
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Gemcitabine Koanaa 200mg Powder for Solution for Infusion Gemcitabine Koanaa 1000 mg Powder for Solution for Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 200 mg gemcitabine (as hydrochloride). Each vial contains 1000 mg gemcitabine (as hydrochloride). After reconstitution the solution contains 38 mg/ml gemcitabine (as hydrochloride), (see section 6.6). Excipients Each 200 mg vial contains 3.5 mg (<1 mmol) sodium. Each 1,000 mg vial contains 17.5 mg (<1 mmol) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion (powder for infusion) White to off-white lyophilized powder or cake. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin. Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine, in combination with cisplatin, is indicated as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2. Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy. Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. Page 2 of 17 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Gemcitabine should only be prescribed by a physician qualified in the use of anti-canc Đọc toàn bộ tài liệu