Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gemcitabine hydrochloride
Sun Pharma UK Ltd
L01BC05
Gemcitabine hydrochloride
1gram
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010300; GTIN: 8718104050082
V025 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ _ GEMCITABINE 200 MG, POWDER FOR SOLUTION FOR INFUSION GEMCITABINE 1000 MG, POWDER FOR SOLUTION FOR INFUSION gemcitabine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Gemcitabine is and what it is used for 2. What you need to know before you are given Gemcitabine 3. How Gemcitabine is given 4. Possible side effects 5. How to store Gemcitabine 6. Contents of the pack and other information 1. WHAT GEMCITABINE IS AND WHAT IT IS USED FOR Gemcitabine 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. Gemcitabine is used in the treatment of the following types of cancer: - 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 ARE GIVEN GEMCITABINE YOU SHOULD NOT BE GIVEN GEMCITABINE: - if you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6) - if you are breast-feeding WARNINGS AND PRECAUTIONS Talk to your doctor before you are given Gemcitabine. Before the first infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function. Before each infusion you will have samples of your blo Прочитать полный документ
OBJECT 1 GEMCITABINE 1000 MG POWDER FOR SOUTION FOR INFUSION Summary of Product Characteristics Updated 10-May-2018 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company 1. Name of the medicinal product Gemcitabine 1000 mg, powder for solution for infusion 2. Qualitative and quantitative composition Each vial contains 1000 mg gemcitabine (as hydrochloride) Excipient with known effect: Each vial contains 17.5 mg sodium. One ml of the reconstituted solution for infusion contains 38 mg gemcitabine (as hydrochloride). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for solution for infusion. White to off-white lyophilized 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. 4.2 Posology and method of administration Gemcitabine should only be prescribed by a physician qualified in the use of anti-cancer chemotherapy. Posology _Bladder cancer _ _Combination use_ The recommended dose for gemcitabine is 1000 Прочитать полный документ