Land: Storbritannien
Språk: engelska
Källa: myHealthbox
Nivolumab
Bristol-Myers Squibb Pharma EEIG
L01XC17
Nivolumab
10 mg/ml
Concentrate for solution for infusion
Oral use
Pack size of 1 vial
POM - Prescription Only Medicine
Bristol-Myers Squibb S.r.l.
Antineoplastic agents, monoclonal antibodies
As monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults
Authorised
2015-06-19
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. - 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. 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 blocks its action and prevents it from switching off your T cells. This helps increase their activity against the melanoma cells. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPDIVO YOU SHOULD NOT BE GIVEN OPDIVO if you are ALLERGIC Läs hela dokumentet
OPDIVO 10 mg/mL concentrate for solution for infusion Summary of Product Characteristics Updated 22Jun2015 | BristolMyers Squibb Pharmaceutical 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. 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, colorless 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 OPDIVO as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. 4.2 Posology and method of administration Treatment must be initiated and supervised by physicians experienced in the treatment of cancer. Posology The recommended dose of OPDIVO is 3 mg/kg administered intravenously over 60 minutes every 2 weeks. Treatment should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient. Dose escalation or reduction is not recommended. Dosing delay or discontinuation m Läs hela dokumentet