Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nivolumab
Bristol-Myers Squibb Pharmaceuticals Ltd
L01XC17
Nivolumab
10mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 5012712004349
1 _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER OPDIVO 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION nivolumab This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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. - It is important that you keep the Alert Card with you during treatment. - If you have any further questions, ask your doctor. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What OPDIVO is and what it is used for 2. What you need to know before you use OPDIVO 3. How to use OPDIVO 4. Possible side effects 5. How to store OPDIVO 6. Contents of the pack and other information 1. WHAT OPDIVO IS AND WHAT IT IS USED FOR OPDIVO is a medicine used to treat: advanced melanoma (a type of skin cancer) in adults advanced non-small cell lung cancer (a type of lung cancer) in adults advanced renal cell carcinoma (advanced kidney cancer) in adults classical Hodgkin lymphoma that has come back after or has not responded to previous therapies, including an autologous stem-cell transplant (a transplant of your own blood-producing cells) in adults advanced cancer of the head and neck in adults advanced urothelial carcinoma (bladder and urinary tract cancer) in adults. It contains the active substance nivolumab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body. Nivolumab attaches to a target protein called programmed death-1 receptor (PD-1) that can switch off the activity of T cells (a type of white blood cell that forms part of the immune system, the body’s natural defences). By attaching to PD-1, nivolumab bloc Izlasiet visu dokumentu
OBJECT 1 OPDIVO 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 24-May-2018 | Bristol-Myers Squibb Pharmaceuticals limited This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product OPDIVO 10 mg/mL concentrate for solution for infusion. 2. Qualitative and quantitative composition Each mL of concentrate contains 10 mg of nivolumab. One vial of 4 mL contains 40 mg of nivolumab. One vial of 10 mL contains 100 mg of nivolumab. One vial of 24 mL contains 240 mg of nivolumab. Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology. Excipient with known effect Each mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion (sterile concentrate). Clear to opalescent, colourless to pale yellow liquid that may contain few light particles. The solution has a pH of approximately 6.0 and an osmolality of approximately 340 mOsm/kg. 4. Clinical particulars 4.1 Therapeutic indications Melanoma OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Non-Small Cell Lung Cancer (NSCLC) OPDIVO as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. Renal Cell Carcinoma (RCC) OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. Classical Hodgkin Lympho Izlasiet visu dokumentu