Pulmozyme
DRUG DESCRIPTION
Pulmozyme® (dornase alfa) Inhalation Solution is a sterile, clear, colorless, highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. The protein is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing DNA encoding for the native human protein, deoxyribonuclease I (DNase). Fermentation is carried out in a nutrient medium containing the antibiotic genta-micin, 100-200 mg/L. However, the presence of the antibiotic is not detectable in the final product. The product is purified by tangential flow filtration and column chromatography. The purified glycoprotein contains 260 amino acids with an approximate molecular weight of 37,000 daltons (1). The primary amino acid sequence is identical to that of the native human enzyme.
Pulmozyme is administered by inhalation of an aerosol mist produced by a compressed air driven nebulizer system (see Clinical Experience, DOSAGE AND ADMINISTRATION). Each Pulmozyme single-use ampule will deliver 2.5 mL of the solution to the nebulizer bowl. The aqueous solution contains 1.0 mg/mL dornase alfa, 0.15 mg/mL calcium chloride dihydrate and 8.77 mg/mL sodium chloride. The solution contains no preservative. The nominal pH of the solution is 6.3.
Generic Name: Dornase alfa
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