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Hizentra - Normal Immunoglobulin (Human)
Hizentra is a 20% solution containing 20 g/100 mL of total human plasma protein with a purity of at least 98% immunoglobulin G (IgG). More than 90% of the IgG consists of monomers and dimers, aggregates (
The maximum IgA content is 0.05 mg/mL (normally below 0.005 mg/mL).
The product contains 250 mmol/L of proline as a stabiliser which is a physiological non-essential amino acid. The product also contains trace amounts of Polysorbate 80 and sodium. Hizentras contains no carbohydrate stabiliser (e.g. sucrose, maltose) and no preservative.
PHARMACEUTICAL FORM
Hizentras is a sterile, clear and colourless or pale-yellow or light-brown solution of human normal immunoglobulin for subcutaneous injection.
Hizentras has a nominal osmolality of 380 mOsm/kg and is approximately isotonic. The pH value of the ready-to-use solution is 4.8.