Country: Malta
Language: English
Source: Medicines Authority
GEMCITABINE
Fresenius Kabi Oncology PLC
L01BC05
GEMCITABINE
CONCENTRATE FOR SOLUTION FOR INFUSION
GEMCITABINE 38 mg
POM
ANTINEOPLASTIC AGENTS
Authorised
2015-02-12
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER GEMCITABINE 38 MG/ML CONCENTRATE 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 is and what it is used for 2. What you need to know before you use Gemcitabine 3. How to use Gemcitabine 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. This medicine may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer. This medicine 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 USE GEMCITABINE DO NOT USE 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: 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 gemcitabine. Your doctor may decide to change the dose or delay treating you depending on your general Page 2 of 9 condition and if your blood cell counts are too lo Read the complete document
Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Gemcitabine 38 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains gemcitabine hydrochloride, equivalent to 38 mg gemcitabine. The quantitative composition of each presentation is provided in the table below: Presentation Strength Quantity of gemcitabine (as hydrochloride) Volume of Solution 200 mg/5.26 ml 38 mg/ml 200 mg 5.26 ml 1000 mg/26.3 ml 38 mg/ml 1000 mg 26.3 ml 2000 mg/52.6 ml 38 mg/ml 2000 mg 52.6 ml Excipient with known effect: 3.16 mg/ml to 3.74 mg/ ml (0.14 mmol/ml to 0.16 mmol/ml) sodium. 30% v/v (310.8 mg/ml) propylene glycol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless to light straw colored solution free from visible particles. pH: 7.0 to 9.0 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. Page 2 of 20 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 ant Read the complete document