human albumin microspheres and perflutren - Generic Medications

Browse 1 brand name versions of human albumin microspheres and perflutren. Review brand names, dosage forms, strengths, and linked product records.

Optison Perflutren Protein-Type A Microspheres HUMAN ALBUMIN MICROSPHERES AND PERFLUTREN
GE HEALTHCARE INC. FDA Rx Only

OPTISON (perflutren protein-type A microspheres) injectable suspension is an ultrasound contrast agent for intravenous use. Perflutren is chemically characterized as 1,1,1,2,2,3,3,3-perflutren with a molecular weight of 188, an empirical formula of C 3 F 8 , and the following structural formula: Each mL contains 5-8×10 8 protein-type A microspheres, 10 mg albumin human, 0.22 ± 0.11 mg perflutren, and the following inactive ingredients: 0.2 mg N-acetyltryptophan and 0.12 mg caprylic acid in 0.9% aqueous sodium chloride. The headspace of the vial is filled with perflutren gas. The pH is adjusted to 6.4 to 7.4. The protein in the microsphere shell makes up approximately 5% to 7% (w/w) of the total protein in the suspension. The microsphere particle size parameters are listed in Table 3. OPTISON is supplied as a clear liquid lower layer, a white liquid upper layer, and a headspace filled with perflutren gas, and after resuspension, OPTISION is a sterile, homogeneous, opaque, and milky-white suspension. Table 3. Microsphere Size Distribution Parameter Mean diameter (range) 3 to 4.5 µm Percent less than 10 µm 95% Maximum diameter 32 µm Chemical Structure

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