Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bevacizumab
Roche Products Ltd
L01XC07
Bevacizumab
25mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 5000471006292
1 uk-ie-mt-pil-avastin-clean-180316-25mg-inf PACKAGE LEAFLET: INFORMATION FOR THE USER AVASTIN 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Bevacizumab 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, pharmacist or nurse. ● 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 Avastin is and what it is used for 2. What you need to know before you use Avastin 3. How to use Avastin 4. Possible side effects 5. How to store Avastin 6. Contents of the pack and other information 1. WHAT AVASTIN IS AND WHAT IT IS USED FOR Avastin contains the active substance bevacizumab, which is a humanised monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer). Bevacizumab binds selectively to a protein called human vascular endothelial growth factor (VEGF), which is found on the lining of blood and lymph vessels in the body. The VEGF protein causes blood vessels to grow within tumours, these blood vessels provide the tumour with nutrients and oxygen. Once bevacizumab is bound to VEGF, tumour growth is prevented by blocking the growth of the blood vessels which provide the nutrients and oxygen to the tumour. Avastin is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum. Avastin will be administered in combination with chemotherapy treatment containing a fluoropyrimidine medicine. Avastin is also used for the treatment of adult patients with metastatic breast cancer. When used for patients with breast cancer, it will be administered with a chemotherapy medicinal product called paclitaxel or capecitabine. Avastin is also used for the treatment of adult patients with advance Prečítajte si celý dokument
OBJECT 1 AVASTIN 25MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 23-Mar-2018 | Roche Products Limited 1. Name of the medicinal product Avastin 25 mg/ml concentrate for solution for infusion. 2. Qualitative and quantitative composition Each ml of concentrate contains 25 mg of bevacizumab*. Each 4 ml vial contains 100 mg of bevacizumab. Each 16 ml vial contains 400 mg of bevacizumab. For dilution and other handling recommendations, see section 6.6. *Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale brown liquid. 4. Clinical particulars 4.1 Therapeutic indications Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Bevacizumab, in combination with erl Prečítajte si celý dokument