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Calcium Phosphate Guidelines

1) Human applications for use in vaccines

2) Experimental immunology

Within these fields they may be used in both basic research and R&D, as well as small and large scale production.

(It should be noted that in the U.S.A. material sterilized by irradiation is not accepted for use in humans).

Human applications:

Distinctions are as follows -

1) Profyllactic Vaccines (vaccinating a sound patient to protect against infections).

2) Therapeutic vaccines (vaccinating a patient already sick to cure or treat the disease).

Application of Calcium Phosphate ADJUVANT: Dosing

In veterinary vaccines there is no defined maximum limit for the allowed content of ADJUVANT. Here the dose is normally set from a balance between efficacy and local reactogenicity. However, there are limitations for the content of calcium allowed in vaccines for humans. These limits are 1.30 mg calcium per dose in Europe 1.

1 Ph.Eur. 6.ed. (2009) vaccines for human use, pp. 3971