Active ingredients: Anti-D (rh) immunoglobulin
Rhophylac 300 micrograms/2 ml, solution for injection in pre-filled syringe.
Solution for injection.
The solution is clear or slightly opalescent and colourless or pale yellow.
Rhophylac has an osmolality of at least 240 mosmol/kg.
Each pre-filled syringe contains 300 micrograms (1500 IU) human anti-D immunoglobulin*.
One ml contains 150 micrograms (750 IU) human anti-D immunoglobulin.
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.
Distribution of the IgG subclasses (approximate values):
The content of immunoglobin A (IgA) is not more than 5 micrograms/ml.
* Produced from the plasma of human donors.
Excipient with known effect:
This medicine contains less than 1 mmol sodium (23 mg) per syringe, that is to say essentially “sodium-free”.
Rhophylac contains no preservatives.
For the full list of excipients, see section 6.1.
Human anti-D immunoglobulin contains specific antibodies (IgG) against the Rh(D) antigen of human erythrocytes. It can also contain antibodies to other Rh antigens, e.g. anti-Rh C antibodies. The mechanism by which anti-D immunoglobulin suppresses immunisation to Rh(D) positive red cells is not known.
Water for injections
2 ml solution in a pre-filled syringe (type I glass) with 1 injection needle in a pack size of 1 or in a multi-pack consisting of 5 single packs.
Not all pack sizes may be marketed.
CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041, Marburg, Germany
01 June 2006