Typhoid Vaccine, USP is a saline suspension containing not more than 1000 million Salmonella typhosa (Ty-2 strain) organisms per mL. After growing on veal infusion agar (containing 0.5 percent sodium chloride, 2 percent peptone, and 5 percent agar), the bacteria are washed off the medium, suspended in buffered sodium chloride injection, and killed by a combination of phenol and heat. Phenol (0.5 percent) is added to the final vaccine as preservative. Typhoid Vaccine, USP is tested for safety, potency, and purity and standardized according to F.D.A. Additional Standards for Bacterial Vaccines, 21 C.F.R. 620.10-620.15.
Typhoid Vaccine, USP is indicated for active immunization against typhoid fever. Based on data obtained from field studies, it has been estimated that typhoid vaccine is 70% or more effective in preventing typhoid fever, depending in part on the degree of exposure.
Routine immunization against typhoid is no longer recommended for persons residing in the United States. Selective immunization is indicated in the following situations:
Administration should be postponed in the presence of acute respiratory or other active infection.
A severe systemic or allergic reaction following a prior dose is a contraindication to further use. 3
A sterile syringe and needle should be used for each patient to prevent transmission of hepatitis B virus and other infectious agents from one person to another.
Specific information concerning use of typhoid vaccine during pregnancy is not available. However, as with other inactivated bacterial vaccines, its use is not contraindicated during pregnancy unless the intended recipient has manifested significant systemic or allergic reactions following administration of prior doses. Use of typhoid vaccine during pregnancy should be individualized to reflect actual need.
Before the injection of any biological, the physician should take all precautions known for prevention of allergic or any other side reactions. This should include: A review of the patient' history regarding possible sensitivity; the ready availability of epinephrine 1:1000 and other appropriate agents used for control of immediate allergic reactions; and a knowledge of the recent literature pertaining to use of the biological concerned.
Most recipients of typhoid vaccine experience some degree of local and systemic response, usually beginning within 24 hours of administration and persisting for one or two days.
Local reactions are usually manifested by erythema, induration, and tenderness and should be expected in all those injected intracutaneously.
Systemic manifestations may include malaise, headache, myalgia, and elevated temperature.
Before injection, the rubber diaphragm of the vial and the skin over the site to be injected should be cleansed and prepared with a suitable germicide.
After insertion of the needle, aspirate to help avoid inadvertent injection into a blood vessel.
Typhoid Vaccine, USP is supplied in vials of 5 mL and 10 mL, each containing 8 units per mL.
A Wyeth-Ayerst Company
Marietta, PA 17547.
U.S. Gov't License No. 3
CI 4229-1 Issued February 9, 1994