Rifadin 600 mg infusion (rifampicin) is used to treat various infections, including tuberculosis and leprosy. It is indicated for acutely ill patients who are unable to tolerate oral therapy. To prevent emergence of resistant strains, Rifadin should be used in combination with another appropriate antibiotic.
New solvent formulation
The solvent used in the preparation of Rifadin infusion has been reformulated. As a consequence the diluents which may be used to administer the medicine have changed.
An animal-derived product, polysorbate 81 (a surfactant), has been removed from the solvent supplied in the pack. This removal is to comply with European Commission requirements to minimise the risk of transmissible spongiform encephalopathy in medicinal products. For this reason, and in view of the limited data available, the diluents that can be used with the reconstituted powder have been restricted to dextrose 5% and normal saline.
The new formulation is expected to be available in April 2010. The marketing authorisation holder is taking steps to minimise the amount of time that the two formulations are in the supply chain concurrently. Healthcare professionals should use all existing stock before introducing the reformulated product.
The carton has been revised to help identify the reformulated product. It is clearly marked:
Important update on incompatibilities. Please see technical leaflet”.