INTRON A - interferon alfa-2b
INTRON A - interferon alfa-2b injection, solution
Schering Corporation
INTRON® A
Interferon alfa-2b, recombinant
For Injection
PRODUCT INFORMATION
WARNING
Alpha interferons, including INTRON® A, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory eva luations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping INTRON A therapy. See WARNINGS and ADVERSE REACTIONS.
DESCRIPTION
INTRON® A (Interferon alfa-2b) for intramuscular, subcutaneous, intralesional, or intravenous Injection is a purified sterile recombinant interferon product.
INTRON A recombinant for Injection has been classified as an alpha interferon and is a water-soluble protein with a molecular weight of 19,271 daltons produced by recombinant DNA techniques. It is obtained from the bacterial fermentation of a strain of Escherichia coli bearing a genetically engineered plasmid containing an interferon alfa-2b gene from human leukocytes. The fermentation is carried out in a defined nutrient medium containing the antibiotic tetracycline hydrochloride at a concentration of 5 to 10 mg/L; the presence of this antibiotic is not detectable in the final product. The specific activity of interferon alfa-2b, recombinant is approximately 2.6 × 108 IU/mg protein as measured by the HPLC assay.
Powder for Injection
|
Vial Strength Million IU |
mL Diluent |
Final Concentration after Reconstitution million IU/mL* |
mg INTRON A† per vial |
Route of Administration |
|
|
|
10 |
1 |
10 |
0.038 |
IM, SC, IV, IL |
|
18 |
1 |
18 |
0.069 |
IM, SC, IV |
|
50 |
1 |
50 |
0.192 |
IM, SC, IV |
Prior to administration, the INTRON A Powder for Injection is to be reconstituted with the provided Diluent for INTRON A (Sterile Water for Injection USP) (see DOSAGE AND ADMINISTRATION). INTRON A Powder for Injection is a white to cream-colored powder.
Solution Vials for Injection
|
Vial Strength |
Concentration* |
mg INTRON A† per vial |
Route of Administration |
|
|
