Diphtheria and Tetanus Toxoids Absorbed

DIPHTHERIA AND TETANUS TOXOIDS ADSORBED

BioChem Vaccines

Vaccine

Indications And Clinical Uses: Diphtheria and Tetanus Toxoids (d2T5) Adsorbed is the preferred immunizing agent for persons aged 7 years or older. It is recommended for: primary immunization of older children and adults against diphtheria and tetanus; regular booster doses for children at 14 to 16 years of age and every 10 years to adults; and management of wounds when tetanus toxoid is indicated.

Contra-Indications: Immunization with d2T5 Adsorbed Toxoids should be postponed in the presence of any acute illness, including febrile illness.

It is a contraindication to administer this vaccine to individuals known to be sensitive to thimerosal.

Manufacturers’ Warnings In Clinical States: If the vaccine is administered to persons receiving immunosuppressive therapy, it should be borne in mind that the expected antigenic response may not be obtained.

Precautions: Individuals who are hypersensitive to the components of the vaccine may develop allergic reactions. Sterile epinephrine HCl solution 1:1 000 should always be readily available in case an acute anaphylactic reaction should occur. If hypersensitivity to the diphtheria component is suspected it is recommended to utilize Diphtheria Toxin for Schick Test and Diphtheria Toxoid for Control as diagnostic aids.

In the case of tetanus, frequent reinforcing (booster) doses of tetanus toxoid in the presence of adequate or excessive serum levels of tetanus antibodies 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 always be used for each patient to prevent transmission of hepatitis B virus, HIV virus or other infectious agent from one person to another.

Pregnancy: When there are clear indications for their use, toxoids may be given to pregnant women. It is preferable, however, to defer immunization until after delivery unless immediate risk is involved.

Adverse Reactions: Mild local reactions such as 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 injection site have occurred following the use of adsorbed vaccine, but this reaction is unusual.

Systemic reactions may develop and 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 administration have been reported 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.

Notification of Reactions: It is advisable to report any unusual reactions immediately or shortly following any vaccination to the product manufacturer and the provincial epidemiologist.

Dosage And Administration: Primary Immunization: The preferred agent for primary immunization of persons 7 years of age or older is combined adsorbed diphtheria and tetanus toxoids (d2T5) containing less diphtheria toxoid than vaccine preparations given to younger children. This is less likely to cause reactions in older persons. Two doses of 0.5 mL are given at least 8 weeks apart and a further dose 1 year later to complete the course.

Reinforcing (booster) Doses: For children of 14 to 16 years of age who have completed the primary immunization course against diphtheria and tetanus, a single dose of 0.5 mL of combined d2T5 adsorbed toxoids should be administered i.m. as a reinforcing (booster) dose, at 10 year intervals. It is the same for adult persons unless there are contraindications to the administration of tetanus toxoid. When d2T5 adsorbed toxoids are to be used, a prior Schick test or sensitivity test is unnecessary.

Procedure at Time of Injury: No additional dose of d2T5 Adsorbed Toxoids or Tetanus Toxoid is recommended, at the time of injury, for those who, within the previous 5 years, have received a complete primary immunization course or a reinforcing dose against tetanus with either the Combined Toxoids or with Tetanus Toxoid alone.

If more than 5 years have elapsed since the completion of a primary course of immunization or receipt of the last reinforcing dose against tetanus, a single dose of Tetanus Toxoid or an appropriate Combined Vaccine containing tetanus toxoid should be administered.

Should information about previous administration of tetanus toxoid be inadequate or unavailable, a prophylactic dose of 250 U of Tetanus Immune Globulin of human origin (TIG) should be administered in addition to Tetanus Toxoid Adsorbed in cases of clean minor wounds. If the wounds are severe or grossly contaminated, a dose of 500 U of Human Tetanus Immune Globulin (TIG) is recommended along with Tetanus Toxoid Adsorbed.

Should Human Tetanus Immune Globulin (TIG) and Tetanus Toxoid Adsorbed, or a combined vaccine containing tetanus toxoid, be required simultaneously, the 2 preparations should never be mixed in the same syringe. They should be administered in separate syringes and at different sites.

Administration: The skin at the injection site should be cleaned with a suitable antiseptic and dried with a piece of dry sterile cotton. The vaccine should be administered i.m. into the deltoid muscle or the mid-lateral aspect of the thigh.

Do not inject i.v. or s.c.

In order to avoid i.v. injection, the plunger of the syringe should be pulled back to ensure that no blood is being withdrawn before injecting the desired dose.

Withdrawal from an Ampul: Shake the ampul to disperse the contents thoroughly immediately before withdrawing the dose of vaccine.

Tap the ampul to ensure that the contents are in the lower portion rather than in the neck of the ampul.

Using a sterile piece of cotton or a sterile towel, break off the top of the ampul at the colored line (no file is required). Then, using aseptic technique to prevent contamination, and using a sterile needle affixed to a sterile syringe, withdraw the contents of the ampul into the syringe, holding the ampul in such a way that the tip of the needle is kept immersed throughout the withdrawal.

Once the ampul has been opened, any of its unused contents should immediately be discarded.

Withdrawal from a 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.

Tear off the central part of the metallic cover-seal. Moisten the exposed surface of the rubber stopper with a sterile piece of cotton soaked with a suitable antiseptic and allow a few minutes for it to take effect. Draw into a sterile syringe a volume of air equal to the amount of vaccine to be withdrawn from the vial, and pierce the center of the rubber stopper with the sterile needle affixed to the syringe. Invert the vial and slowly inject into it the air contained in the syringe. Keeping the tip of the needle immersed, withdraw into the syringe the required amount of vaccine, then, holding the plunger of the syringe steady, withdraw the needle from the vial.

It is desirable that the entire contents of a multidose container be used at the same vaccination session. Only good aseptic technique allows for the sampling of a partially used multidose vial from a previous vaccination session.

Each person who is immunized should be given a permanent personal immunization record. In addition, it is essential that the physician or nurse record the immunization history in the permanent medical record of each patient. This permanent office record should contain the name of the vaccine, date given, dose, manufacturer and lot number.

Disposal: Diphtheria and tetanus toxoids (d2T5) adsorbed and related materials used for vaccination can be disposed of in the same way as other medicines. Because d2T5 is an inactivated product, there is no risk of infection from subsequent handling.

Availability And Storage: The d2T5 adsorbed vaccine is supplied as a sterile, cloudy, uniform suspension of diphtheria and tetanus toxoids adsorbed on aluminum phosphate, in an isotonic sodium chloride solution. Each dose (0.5 mL) contains: diphtheria toxoid 2 Lf, tetanus toxoid 5 Lf, aluminum phosphate 1.5 mg and 0.01% thimerosal as preservative. Scored ampuls of 0.5 mL, boxes of 5. Vials of 5 mL.

Store in the refrigerator between 2 and 8°C. Do not freeze. Carefully check the expiry date, and take note that this date applies to unopened containers only. Outdated vaccine should never be used.

DIPHTHERIA AND TETANUS TOXOIDS ADSORBED BioChem Vaccines Vaccine

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