Antitetanus serum

EQUINE ANTITETANUS SERUM

Equine liquid purified concentrated antitetanus serum (ATS, tetanus anti-toxin, TAT) is a protein fraction isolated from equine blood hyperimmunized with tetanus anatoxin or toxin. The Tetanus toxoid preparation is purified and concentrated after partial enzymatical digestion. 0.5% Chloroform is used as a preservative. Preraration for scheduled immunization against tetanus contains 3000 international units (IU) of the anatoxin. For clinical treatment of tetanus and antitetanic therapy there are provided doses of 10000, 20000 or 50000 IU per vial. Formulation of equine serum (ATS) appears like clear, slightly opalescent, colorless or yellowish fluid without any debree or pellets.

Biological and Immunological Properties: The preparation contains anаtoxins to promote and establish individual self-immunity toward the tetanus toxin. ATS serum containes horse antibodies, which are ready to neutralize tetanus toxins in urgency.

Administration and Dosage: Before administering serum by intracutaneous or intramuscular injection patient’s sensitivity should be tested with 0.1 ml of diluted (1:100) serum from red vial, injected in inner elbow area. The reaction is negative if in 20 min the area of injection is shown as spot with diameter < 1 cm. If the test is positive then use of the serum for such a patient is prohibited.
For scheduled immunization of children since the age of 5 months and older use 0.5 ml Tetanus-anatoxin. The immunization has to be repeated in 2 years with the same dose. If the period after the first immunization was longer than 2 years - the dose for injection is 1 ml of Tetanus anatoxin. Emergency vaccination of the babies yanger then 5 months of age is performed with 3000 IU of the serum rather than Tetanus anatoxin.
Intensive antitetanus therapy can be conducted via intravenous or intraspinal infusion, as soon as possible from the rise of disease symptoms with the dose of ATS up to 100,000-200,000 IU. ATS administrating may be repeated based on symptoms severity until symptoms disappeared or mainly released, especially the reflex seizures.

Side effects and Reactions: Some allergic reactions may be developed after administration of the serum. Short term reactions are developed immediately or in several hours after injection; an mid-term reactions are developeded on the 2nd-6th day after administering the serum. Remote or long term reactions might be developed in two weeks or later. These reactions have a symptoms of fever, itching or skin rashes, swelling joints, pains etc. Administering the serum with positive sensitivy test result may lead to anaphylactic shock. It is desirable the each immunized patient should be closely observed for 1 hour after the serum injection. The proper equipment and medications to conduct counter-allergical measures and antishock therapy must be available near the site of immunization with the serum. Patients where injected with ATS must be instructed to call a physician immediately, if the are in became with fever, harsh itching, skin rash, joint swellings or pains and other symptoms typical for systemic disease.
Both general symptoms of side effects (indisposition and/or fever) and local ones (edema, hyperemia and/or pain that disappear after 24-48 h) have been reported in response to immunization with Tetanus toxoid.

Contraindications:
1.Positive tests for individual sensitivity toward components of the ATS.
2.Recorded history of hyperactivity to the specified preparation.
3.Pregnancy:
- immunization with Tetanus toxoid during the first half-term of pregnancy should be avoided;
- administrating of ATS during the second half-term of pregnancy should be avoided.

Package: Equine antitetanus purified concentrated liquid serum supplied in 2 ml or 5 ml ampoules containing 1 dose (3000 IU per vial) for urgent prevention of tetanus, and in 10 ml or 20 ml ampoules with 10000 or 20000, or 50000 IU for clinical treatment of tetanus. Serum in red vial (diluted 1:100) is used to test for individual sensitivity to the equine proteins. Serum in blue vial is for intracutaneous injection upon the negative sensitivity test. One package (kit) contains 1 ampoule with ATS and 1 ampoule with equine serum diluted 1:100. One box contains 5 kits.

Storage and Shipment: Store at 3-5 oC in atm. with relative humidity 60%. . Shipping and transportation in vehicles under the roof at 3-5 oC.
Notes: Repeatedly frozen / thawed serum may be used if main physical properties (color, appearance) are retained. Keep away from the light.

Expiration in 3 years from date of manufacturing.