Fibrinoplate-S: a Ready-To-Use Suspension Formulation

Fibrinoplate-S (FPS) is also called Fibrinogen-coated Albumin Spheres (or FAS) is a third generation product.

Fibrinoplate-S is a sterile, non-pyrogenic, slightly yellow, milky suspension containing 8 mg/mL of human albumin spheres, suitable for intravenous administration. Fibrinoplate-S consists of submicron-size albumin spheres formed by the polymerization of clinical-grade, soluble human albumin molecules with ethyl alcohol, USP. The spheres are coated with clinical grade human fibrinogen, a coagulation factor, to mimic the activity of activated platelets.

Fibrinoplate-S contains 5% sorbitol USP and its osmotic pressure is compatible with plasma. It is very miscible with physiological fluids such as normal saline.

The average sphere diameter in Fibrinoplate-S is smaller than 1 micron. The product is stabilized with 0.08 millimole sodium caprylate per gram of protein. The spheres are heated at 60 degree Centigrade for ten hours. No positive assertion can be made, however, that this heat treatment completely destroys the causative agents of viral hepatitis. The clinical grade, soluble human albumin solution which is the source of albumin molecules for Fibrinoplate-S has been similarly heat-treated. There are no known cases of viral hepatitis which have resulted from the administration of the heat-treated source albumin solutions.

Strict aseptic technique must always be maintained during handling. Fibrinoplate-S is a single-use parenteral product which contains no preservative. Do not use if contamination is suspected. Discard unused portions.