Sero-Tet

Sero-Tet

tetanus immunoglobulin

Manufacturer:

Green Cross

Distributor:

Propharm
Full Prescribing Info
Contents
Tetanus immune globulin (human).
Description
Each vial also contains aminoacetic acid (as a stabilizer) 2.25% w/v, sodium chloride (as an isotonic agent), glacial acetic acid (pH adjustant), dried sodium carbonate, thimerosal (as a preservative) 0.01 w/v% and water for injection.
Sero-Tet 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 eg, hepatitis B virus, hepatitis C virus, human immunodeficiency virus and others. All donor plasma used in preparation are tested that the results of anti-HIV 1/2, anti-HCV and HBsAg are negative.
Indications/Uses
To provide passive immunization against infection caused by Clostridium tetani.
Dosage/Direction for Use
Administer by IM injection only
Usual Dosage: Adults and Children: Prophylaxis: 250 IU. In treatment of tetanus, administer not less than 5000 IU.
Special Precautions
Sero-Tet should not be administered IV.
A separate sterile syringe must be used for each patient to prevent the possible transmission of hepatitis B and other infectious agents.
Administer 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.
Sero-Tet, prepared from human plasma, is pasteurized in its bulk condition to reduce the risk of viral infection but freedom from the risk of unknown viruses (parvovirus B-19, etc) cannot 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.
Storage
Store at 2°-8°C. Do not freeze.
Shelf-Life: 38 months.
ATC Classification
J06BB02 - tetanus immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Presentation/Packing
Vaccine (vial) 250 IU/mL x 1's, 10's.
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