Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2022 Publisher: CSL Behring (NZ) Ltd, PO Box 62590, Greenlane, Auckland 1546, New Zealand customerservice@cslbehring.com.au www.cslbehring.com.au Manufacturer: CSL Behring (Australia) Pty Ltd, 189–209 Camp Road, Broadmeadows, ...
Intragam P 6% solution for infusion.
| Pharmaceutical Form |
|---|
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Intragam P is a solution for intravenous infusion. Intragam P is isotonic, with an approximate osmolality of >240 mOsm/kg. The solution has a pH of 4.25. |
Human Normal Immunoglobulin.
Intragam P is a sterile, preservative-free solution containing 6 g of human protein in each 100 mL. At least 98% of the protein has the electrophoretic mobility of immunoglobulin G (IgG). At least 90% of the protein is IgG monomer and dimer.
Based on three preclinical and four clinical batches, the distribution of IgG subclasses present in Intragam P is, on the average, 61% IgG1, 36% IgG2, 3% IgG3 and 1% IgG4.
Intragam P contains only trace amounts of IgA (nominally <0.025 mg/mL).
Intragam P is manufactured from human plasma donated by New Zealand’s voluntary and non-remunerated donors.
Intragam P contains 10 g of maltose in each 100 mL.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Immunoglobulins, normal human, IV |
Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects. |
| List of Excipients |
|---|
|
Maltose |
Solution in a single vial (type I glass), with a rubber closure, an aluminium seal, a flip-top cap (plastic).
Pack sizes:
One bottle of 10 mL solution containing 0.6 g human normal immunoglobulin.
One bottle of 50 mL solution containing 3 g human normal immunoglobulin.
One bottle of 200 mL solution containing 12 g human normal immunoglobulin.
One bottle of 500 mL solution containing 30 g human normal immunoglobulin.
Not all pack sizes may be marketed.
CSL Behring (NZ) Ltd, PO Box 62590, Greenlane, Auckland 1546, New Zealand
customerservice@cslbehring.com.au
www.cslbehring.com.au
Manufacturer: CSL Behring (Australia) Pty Ltd, 189–209 Camp Road, Broadmeadows, VIC, 3047, Australia
Distributor: New Zealand Blood Service, 71 Great South Road, Epsom, Auckland, New Zealand
Date of first approval: 23 March 2000
| Drug | Countries | |
|---|---|---|
| INTRAGAM | Hong Kong, New Zealand, Singapore, South Africa |
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