Tetanus Antitoxin 1000 I.U. B.P.

Tetanus Antitoxin 1000 I.U. B.P.

tetanus immunoglobulin

Manufacturer:

VINS Bioproducts

Distributor:

Biogenetech
Full Prescribing Info
Contents
Equine Tetanus Antitoxic Immunoglobulin Fragments.
Description
Each mL contains Enzyme Refined, Equine Tetanus Antitoxic Immunoglobulin Fragments not less than 1000 I.U., Cresol B.P. ≤0.25% v/v as a preservative, Glycine as a stabilizer B.P., Sodium Chloride B.P., Water for Injections B.P.
Tetanus antitoxin is prepared by hyperimmunised horses with Tetanus toxin. Plasma obtained from healthy immunized horses is enzyme refined, purified and concentrated. The Tetanus antitoxin has the specific antitoxic globulins which neutralize the toxin formed by Clostridium tetani, the causative organism of Tetanus infection.
Action
Pharmacology: Pharmacodynamics/Pharmacokinetics: Not applicable.
Indications/Uses
Tetanus Antitoxin has been used to provide passive immunity against Tetanus.
Dosage/Direction for Use
Tetanus antitoxin is given prophylactically to persons at the risk of tetanus infection by infected wounds or severe wounds. A dose of 1000 I.U. should be given intramuscularly or subcutaneously and the dose may be doubled or tripled in case of multiple and severe wounds. Prophylactic dose is also given in surgical operations as post operative care.
Along with this passive immunisation, it is advisable to initiate active immunisation with adsorbed Tetanus toxoid.
Overdosage
The dose is usually dependent on the severity of the infection, a symptomatic treatment should be given in case of overdose and supportive therapies are recommended.
Contraindications
Injection of the antitoxin to persons with a history of allergic reactions to equine protein and to individuals with asthma, infantile eczema is contraindicated. Epinephrine and other supportive measures should be available in case of an anaphylactic reaction.
Special Precautions
Serum reaction: In case of patients receiving Tetanus antitoxin, it should be essential to test for hypersensitivity of the individual with a test dose.
Serum sensitivity test is carried out by injecting 0.1 mL Tetanus Antitoxin serum in 1:10 dilution either subcutaneously or intra cutaneously and observing for half an hour for any reaction of local or general. In case of hypersensitive reaction, serum should be given with great caution in small divided dose subcutaneously at regular intervals of half an hour. Adrenaline injection (1:1000) must be had for immediate treatment of shock if it develops. Intravenous administration of serum is not recommended in hypersensitive cases.
Use In Pregnancy & Lactation
Pregnancy: Pregnancy is not a contraindication to the use of Tetanus antitoxin unless clearly indicated.
Lactation: Breastfeeding is not a contraindication to Tetanus antitoxin unless clearly indicated. It is not known if antitoxin antibodies are excreted into breast milk.
Adverse Reactions
In some cases symptoms as itching, urticarial rash, pain in joints and muscles, fever, enlargement of lymph glands, appear about 7-12 days after injection of Tetanus Antitoxin. These should be treated with antihistamines and corticosteroids. Usually these symptoms of serum sickness last a few days and patients recover without complication.
Drug Interactions
Immunoglobulins may interfere with the ability of live vaccines to induce an immune response.
Caution For Usage
Left over antiserum and used vials should be discarded as Biomedical waste.
Storage
The liquid Tetanus antitoxin should be stored at 2°C to 8°C. It should not be allowed to freeze.
ATC Classification
J06AA02 - tetanus antitoxin ; Belongs to the class of immune sera. Used in the treatment of acute infectious diseases caused by toxigenic strains.
Presentation/Packing
Inj (vial) 1,000 IU/mL x 20's.
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