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Draft guideline on the core SmPC for human Anti-D immunoglobulin for intramuscular use

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for a human anti-D immunoglobulin for intramuscular use. With respect to the previous version, this Core SmPC has been adapted to the current QRD template. The method of administration for overweight patients has been specified. Furthermore, although thromboembolic events have not been observed with products intended for intramuscular use, new special warnings have been added regarding the potential risk of thromboembolism, and about the need of an adequate hydration, in particular in patients with risk factors and/or treated with higher doses. With respect to the i.v.anti D Ig, this Core SmPC is specific for anti D Ig intended for intramuscular use.

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