tetanus immunoglobulin


Green Cross Corp


Vizcarra Pharma
Full Prescribing Info
Tetanus immune globulin (human).
1 vial (250 I.U.) contains: Tetanus immune globulin, human 250 I.U., Aminoacetic acid (as a stabilizer) 2.25 w/v%, Sodium chloride (as an isotonic agent) q.s., Glacial acetic acid (pH adjustant) q.s., Dried sodium carbonate q.s., Thimerosal (as a preservative) 0.01 w/v%, Water for injection q.s.
Tetanus immune globulin is a sterile solution containing tetanus immune globulin which is prepared by Cohn fractionation from plasma of individuals with high titers of antibody to the tetanus antigen and heat inactivation step in manufacturing process (60°C, 10 hrs) is used to inactivate infectious agents such as Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency virus, and so on. All donor plasma used in preparation are tested that the results of Anti-HIV 1/2, Anti-HCV and HBsAg are negative.
Tetanus immune globulin is used to provide passive immunization against infection caused by Clostridium tetani.
Dosage/Direction for Use
Tetanus immune globulin should only be administered by intramuscular injection. The usual dosage in adults and children for prophylaxis is 250 I.U. In treatment of tetanus, should be administered not less than 5,000 I.U.
Special Precautions
Should not be administered intravenously.
A separate sterile syringe must be used for each patient to prevent the possible transmission of hepatitis B and other infectious agents.
Should be administered with caution to individuals who have exhibited previous systemic allergic reactions to immune globulin. Epinephrine (0.1~0.5 ml, 1:1000) should be available for immediate treatment.
Tetanus immune globulin, prepared from human plasma, is pasteurized in its bulk condition to reduce the risk of viruses infection but freedom from the risk of unknown viruses (parvovirus B-19, etc) can not be assumed. The infused patient is continuously checked for long time after injection.
Adverse Reactions
Adverse reactions following administration are infrequent and mild, but severe local and systemic reactions have occurred rarely.
Store at 2 to 8°C.
Maximum Validity: 36 months.
ATC Classification
J06BB02 - tetanus immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Inj 250 IU/mL (vial) x 1's.
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