Each 2 ml solution in pre-filled syringe contains: Human anti-D immunoglobulin G (IgG) 1,500 IU (300 micrograms) corresponding to a concentration of 750 IU (150 micrograms) per ml.
The product contains a maximum of 30 mg/ml of human plasma proteins of which 10 mg/ml is human albumin as stabiliser. At least 95% of the other plasma proteins are IgG. Rhophylac contains not more than 5 micrograms/ml IgA.
Rhophylac is a clear, colourless to pale yellow immunoglobulin solution. The solution is slightly hypertonic. Rhophylac has an osmolality of at least 240 mOsmol/kg.
Excipients/Inactive Ingredients: Human albumin 10 mg/ml, Glycine 20.6 mg/ml, Sodium chloride ≤250 mmol/l.