Nchi: Singapoo
Lugha: Kiingereza
Chanzo: HSA (Health Sciences Authority)
Nivolumab
BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
L01XC17
INFUSION, SOLUTION CONCENTRATE
Nivolumab 10 mg/mL
INTRAVENOUS DRIP
Prescription Only
Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company
ACTIVE
2016-11-09
1 _ _ NIVOLUMAB BMS CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML 1. NAME OF THE MEDICINAL PRODUCT Nivolumab BMS 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 Melanoma Nivolumab 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) 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) Nivolumab as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. Renal Cell Carcinoma (RCC) Nivolumab as monotherapy is indicated for the treatment of of advanced renal cell carcinoma after prior therapy in adults. 2 _ _ Classical Hodgkin Lymphoma (cHL) Nivolumab as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin (see section 5.1). Squamous Cell Cancer of the Head and Neck (SCCHN) Nivolumab as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell ca Soma hati kamili