"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(diptheria, tetanus toxoids and pertussis) Vaccine Adsorbed
Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed USP (For Pediatric Use) combines diphtheria and tetanus toxoids adsorbed with pertussis vaccine, for intramuscular use, in a sterile isotonic sodium chloride solution containing sodium phosphate buffer to control pH. The vaccine, after shaking, is a turbid liquid, whitish-gray in color. When used to reconstitute Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), ActHIB ® or OmniHIB, the combined vaccines appear whitish in color.
Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium. 1 Clostridium tetani cultures are grown in a peptone- based medium. Both toxins are detoxified with formaldehyde. The detoxified materials are separately purified by serial ammonium sulfate fractionation and diafiltration.
The pertussis vaccine component is derived from Bordetella pertussis cultures grown on blood-free Bordet Gengou media. The pertussis organisms are harvested and inactivated with thimerosal and resuspended in physiological saline and thimerosal.
The toxoids are adsorbed to aluminum potassium sulfate (alum). The adsorbed diphtheria and tetanus toxoids are combined with pertussis vaccine concentrate, and diluted to a final volume using sterile phosphate-buffered physiological saline. Each 0.5 mL dose contains, by assay, not more than 0.17 mg of aluminum and not more than 100 µg (0.02%) of residual formaldehyde. Thimerosal (mercury derivative) 1:10,000 is added as a preservative.
The total human immunizing dose (the first three 0.5 mL doses administered) contains an estimate of 12 units of pertussis vaccine (4 protective units per single dose). 2 The potency of the pertussis component of each lot of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) is tested in a mouse protection test.
At the time when Connaught Laboratories, Inc. (CLI) DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine is used to reconstitute ActHIB ® or OmniHIB, each single dose of the 0.5 mL mixture is formulated to contain 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, an estimate of 4 protective units of pertussis vaccine, 10 µg of purified capsular polysaccharide conjugated to 24 µg of inactivated tetanus toxoid, and 8.5% of sucrose.
NOTE: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIB ® is identical to Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) OmniHIB (distributed by SmithKline Beecham Pharmaceuticals); both products are manufactured by Pasteur Mérieux Sérums & Vaccins S. A.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional DTP Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.