Tetanus Antitoxin Injection 1500IU

Short Description:

Refined Tetanus Antitoxin is a solution of modified globulin prepared from immunized plasma of healthy horses by peptic digestion and ammonium sul-phate fractionation.

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Indication & Use

1. For those started with tetanus symptoms or in suspicion, tetanus antitox-in should be given immediately together with surgical and other clinical adminis-tration at the same time.
For those openly wounded, especially those wounded deeply and contami-nated seriously, and in danger of being infected with tetanus, prophylactic injec-tion of tetanus antitoxin should be given at once. Patients who have had previ-ous injection of tetanus toxoid should be boosted with one more injection of teta-nus toxoid(but not tetanus antitoxin). To those who haven't had previous tetanus toxoid injection or without a clear history of immunization, both antitoxin and toxoid should be given for prophylaxis and permanent immunocompetence.

2.The right site for subcutaneous injection of the tetanus antitoxin is aroundthe deltoid muscle of the upper arm. If tetanus toxoid is to be given at the same time,separate sites are desirable. The right site for intramuscular injection is the centre area of the deltoid muscle or the lateral upper part of the gluteus max-imum.
Intravenous route should not be used until no untoward reaction occurs after intramuscular or subcutaneous injection. Intravenous injection should be done slowly enough: not more than 1m/min at the beginning and don't exceed 4 m/min afterward.
The total volume for a single dose should be not more than 40ml for adults and not more than 0.8ml/kg of body weight for children. Tetanus antitoxin may be diluted with dextrose solution or physiological saline for intravenous drip. The drip must be stopped at once if any untoward reaction occurs.

Recommended Dosage

1.Prophylactic Use: 1500-30001.U. both for adults and children. injection should be repeated after six days when contamination still persists. In those cases who have been immunized previously with tetanus toxoid, it is advisable to give a booster dose of tetanus toxoid only.
For prophylactic use the antitoxin may be given by subcutaneous or intra-muscular route.

2.Therapeutic use :Tetanus antitoxin should be administered as early as pos-sible. A case usually requires about 100,000-200,000 l.U. on average.
A. Usually, 50,0001.U. of antitoxin should be given on the first and the fol-lowing day of ilness, and 10,000 l.U. is repeated on the third, fourth and eighth day respectively. .
B. The neonates with tetanus should receive 20,000 -100,0001.U. antitoxin within 24 hours of ilness either a single or separate dose.

Adverse effects

1. Type I hypersensitivity reaction: anaphylaxis shock may suddenly occurduring or after the injection of equine antitoxin with symptoms of gloominess or dysphoria, pale or flush face, chest depression or asthma, cold sweat, nausea or abdominal pain, weak and rapid pulses, hypotension or collapse in severe case. The patient will die soon if without emergent treatment.

2. Serum sickness(Type II hypersensitivity reaction) may occur, frequent-ly 7 to 10 days after the injection.The main symptoms are urticaria, high fever, lymphadenopathy, local swelling and occasional albuminuria, vomiting, joint pain as well as erythema, itch and edema at the vaccination site.

Precautions & warnings

Before use the ampoule package must be examined with care.Any broken ampoules, or ampoules containing indispersive precipitates or particles must be discarded.

Before injecting antisera, information should be obtained whenever possi-ble as to whether previous injections of antisera have been received and wheth-er the patient is subject to hypersensitivity disorders. Sensitivity testing should be performed before the administration of antisera. The patient must be kept under observation after the administration of doses of antisera. Adrenaline in-jection and resuscitation facilties should be available.

A sensitivity test should be done by: Dilute the antitoxin to 1:10 with physio-logical saline (i.e. 0.1 ml of antitoxin + 0.9ml of saline), and inject 0.05ml of the dilu-ted antitoxin intracutaneously on the flexor surface of the forearm. A positive reaction characterized by erythema, edema or infiltration appearing in15-30 minutes denotes hypersensitiveness to horses serum preparation.

A negative reactor may be treated in the usual manner. A positive reactor must be desensitized when antitoxin administration is indis pensable. The following desensitization procedure may be recommended: dilute the antitoxin to 1:10 with sterile physiological saline. Inject subcutaneously 0.2ml at first, observe for 30minutes. If no reaction occurs, give another injection with increased dose. If no reaction occurs, give the third injection, and so forth,if still no reaction occurs then the administration of undiluted antitoxin can be started.

Adrenaline should always be at hand.In case of anaphylaxis, adrenaline should be given at once. All patients developed hypersensitive reactions fol-lowing injection should be handled properly.

Package and Storage

Package for prophylactic use, each ampoule contains 1500 l.U.
Store in the dark at +2'Cto +8C, and not be allowed to freeze.
Jiangxilnstitute of Biological Products Inc.,China

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