Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Octapharma (IP) SPRL, Allée de la Recherche 65, 1070 Anderlecht, Belgium
Rhesonativ 625 IU/ml, solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. The colour of the solution can vary from colourless to pale-yellow up to light brown. |
Human anti-D immunoglobulin.
1 ml contains:
Human anti-D immunoglobulin 625 IU (125 micrograms).
Human protein content: 165 mg there of immunoglobulin G, at least 95%.
The content of IgA does not exceed 0.05% of the total protein content.
One ampoule of 1 ml contains 625 IU (125 micrograms) of human anti-D immunoglobulin.
One ampoule of 2 ml contains 1250 IU (250 micrograms) of human anti-D immunoglobulin.
The potency is determined using the European Pharmacopoeia assay. The equivalence in International Units of the International Reference Preparation is stated by the World Health Organization.
Distribution of the IgG subclasses (approx. values):
IgG1 70.5%
IgG2 26.0%
IgG3 2.8%
IgG4 0,8%
The maximum IgA content is 82.5 micrograms/ml.
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Anti-D (rh) immunoglobulin |
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. |
| List of Excipients |
|---|
|
Glycine |
1 ml and 2 ml of solution in an ampoule (type I glass).
Pack sizes: 1x1 ml, 1x2 ml and 10x2 ml.
Not all pack sizes may be marketed.
Octapharma (IP) SPRL, Allée de la Recherche 65, 1070 Anderlecht, Belgium
PA2219/003/001
Date of first authorisation: 28th April 2006
Date of last renewal: 1st January 2012
| Drug | Countries | |
|---|---|---|
| RHESONATIV | Austria, Ecuador, Estonia, Finland, Croatia, Ireland, Lithuania, Malta, New Zealand, Poland, Romania, Tunisia, South Africa |
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