Tetanus Toxoid Adsorbed

TETANUS TOXOID ADSORBED Connaught Vaccine

Indications And Clinical Uses:

For primary and secondary immunization against tetanus.

Contra-Indications:

Immunization with Tetanus Toxoid Adsorbed should be deferred in the presence of any acute illness, including febrile illness.

Warnings in Clinical States:

Elective immunization should be deferred during an outbreak of poliomyelitis.

Individuals receiving corticosteroids or other immunosuppressive drugs may not develop an optimum immunologic response.

Precautions:

The possibility of allergic reactions in individuals sensitive to the components of the vaccine should be borne in mind.

Epinephrine HCl solution 1:1 000 should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Frequent booster doses of tetanus toxoid in the presence of adequate or excessive serum levels of tetanus antitoxin have been associated with increased incidence and severity of reactions and should be avoided.

Caution: A separate sterile syringe and needle or a sterile disposable unit should be used for each individual patient to prevent the transmission of hepatitis or other infectious agents.

Adverse Reactions:

Mild local reactions consisting of pain, erythema, tenderness and induration at the injection site are common and may be associated with systemic reactions including mild to moderate transient fever, chills, malaise and irritability. Persistent nodules at the site of injection have occurred following the use of adsorbed vaccine, but this complication is unusual.

Generalized reactions may develop following injection and may take the form of allergic reactions including urticaria and, less commonly, angioneurotic edema. Influenza-like symptoms have been reported and usually occur within 12 hours of vaccination. Neurological complications such as peripheral neuropathies following tetanus toxoid have been documented but are rare. It has been shown that the incidence of reactions to tetanus toxoid rises according to the number of previously administered doses and occurs mainly in the over-immunized.

Dosage And Administration:

Primary Immunization: To establish active immunity against tetanus it is recommended that 2 doses of 0.5 mL each of Tetanus Toxoid Adsorbed be administered i.m. with an interval of 4 weeks between doses. A third dose of 0.5 mL which is required for primary immunization should be given approximately 6 months to 1 year after the second injection. Active immunization may also be accomplished by the administration of combined vaccines containing tetanus toxoid.

Secondary Immunization: For individuals who have previously been immunized against tetanus, a dose of 0.5 mL should be administered i.m. as a reinforcing dose at approximately 10 year intervals.

Tetanus Prophylaxis in Wound Management: If not clearly documented, a history of immunization should be regarded as “uncertain”. If a tetanus booster is required it is often appropriate to choose a combined preparation such as Tetanus and Diphtheria Toxoids Adsorbed For 7 years and Older containing 5 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid per 0.5 mL dose. Appropriate cleansing and debridement of the wound is imperative. Booster doses given more frequently than recommended above may lead to adverse local and systemic reactions.

Note: Diphtheria and Tetanus Toxoids Adsorbed, containing 25 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid per 0.5 mL dose, should not be administered as a tetanus booster to children over 7 years of age or adults due to the risk of reaction to the high diphtheria toxoid component in this vaccine.

Note: Tetanus toxoid, or a combined vaccine containing tetanus toxoid, and tetanus immune globulin should be administered in separate syringes at different sites.

Administration: The vaccine should be administered i.m. into the deltoid muscle or the mid-lateral aspect of the thigh. The site of the injection should be prepared by a suitable antiseptic. Do not inject s.c. or i.v.

Withdrawing the Preparation from a Sealed Glass Ampul: Shake the ampul to disperse the contents thoroughly immediately before withdrawing the dose. Tap the ampul to ensure that the solution is in the lower portion rather than in the neck of the ampul. Wipe the neck of the ampul with a suitable antiseptic. Using a sterile piece of cotton or a sterile towel, break off the top of the ampul at the scored line (no file is required). Then, with the sterile syringe and needle withdraw the contents of the ampul into the syringe, holding the ampul in such a way that the point of the needle is kept immersed throughout the withdrawal. Once the ampul has been opened, any of its contents not used immediately should be discarded.

Withdrawing the Preparation from a Rubber-stoppered Vial: Do not remove the rubber stopper from the vial. Shake the vial to disperse the contents thoroughly immediately before withdrawing each dose of vaccine. Apply a sterile piece of cotton moistened with a suitable antiseptic to the surface of the rubber stopper and allow to dry. Draw into the sterile syringe a volume of air equal to the amount of preparation to be withdrawn from the vial. Pierce the centre of the rubber stopper with the sterile needle of the syringe, invert the vial, slowly inject into it the air contained in the syringe, and, keeping the point of the needle immersed, withdraw into the syringe the required amount of the preparation. Then hold the syringe plunger steady and withdraw the needle from the vial. Carefully insert the needle i.m. at the prepared injection site. In order to avoid i.v. injection, pull back the plunger of the syringe to make certain that no blood is withdrawn before injecting the desired dose.

Availability And Storage:

Tetanus Toxoid Adsorbed, as supplied by Connaught Laboratories Limited, is a sterile, cloudy, uniform suspension of tetanus toxoid adsorbed on aluminum phosphate and suspended in isotonic sodium chloride solution. Each dose (0.5 mL) contains: tetanus toxoid (5Lf) and aluminum phosphate (1.5 mg). Thimerosal 0.01% is added as a preservative. Ready for use, rubber-stoppered vials of 5 mL. Glass ampuls of 0.5 mL. Store between 2 and 8°C. Do not freeze. Do not use product exposed to freezing.

TETANUS TOXOID ADSORBED Connaught Vaccine

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