Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Novartis South Africa (Pty) Ltd., Magwa Crescent West, Waterfall City, Jukskei View, Johannesburg, 2090
BONSPRI 20 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
20 mg/0,4 ml Solution for injection in a pre-filled syringe. The single-use solution for injection is sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brownish-yellow. |
Each pre-filled syringe contains 20 mg ofatumumab solution for injection (0,4 ml of 50 mg/ml solution).
Ofatumumab is a recombinant fully human monoclonal immunoglobulin G1 (IgG1) antibody against human CD20 expressed on B cells. Ofatumumab is produced in a murine cell line (NS0) by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ofatumumab |
Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B-cell tumours. The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complement dependent cytotoxicity and resultant lysis of tumour cells. |
| List of Excipients |
|---|
|
L-arginine |
BONSPRI is supplied in a single-use glass syringe, equipped with a stainless steel needle, a plunger stopper and a rigid needle shield, containing 0,4 ml solution. The syringe is assembled with a plunger rod and a needle safety device.
BONSPRI is available in unit packs containing 1 pre-filled syringe and in multipacks containing 3 (3 packs of 1) pre-filled syringes.
Not all pack sizes may be marketed.
Novartis South Africa (Pty) Ltd., Magwa Crescent West, Waterfall City, Jukskei View, Johannesburg, 2090
550368
28 September 2021
| Drug | Countries | |
|---|---|---|
| BONSPRI | South Africa |
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