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Adsorbed diphtheria tetanus toxoid with reduced antigenic
content (Td-M toxoid)
The preparation is a mixture of purified diphtheria and tetanus toxoids adsorbed on aluminum hydroxide.
It contains 10 flocculating units of diphtheria toxoid and 10 antitoxin-binding units of tetanus toxoid . 0.01% Merthiolate is used as a preservative. The preparation is a whitish-yellowish suspension separating upon storage into a transparent supernatant and a loose sediment which is readily disintegrated by shaking.
Biological and Immunological Properties
Injection of the preparation according to approved scheme provides specific antitoxic immunity against diphtheria.
Prevention of diphtheria in children over 6 years, adolescents and adults.
Administration and Dosage
D-M toxoid is injected intramuscularly in the upper outer quadrant of the gluteal area, in the anterior outer area of the thigh, or in the subclavian area at a dose of 0.5 ml (a single dose). Before immunization, the ampule should be thoroughly shaken to obtain a homogenous suspension.
D-M toxoid is used for:
1. Scheduled third antidiphtheria reimmunization of children at the age of 11 years.
2. Scheduled reimmunization of children at the age of 6 years and of adolescents at the age of 16-17 years if they were given T toxoid between reimmunization as an urgent prevention of tetanus. The preparation is injected in a single dose.
3. For scheduled reimmunization of adults immunized against tetanus not later than 10 years ago, without age limitations, and for urgent immunization at a diphtheria outburst. If adults were not immunized against diphtheria, they are subjects to a complete course of immunization with D-M toxoid : two immunizations at a 30-day interval and reimmunization after 6-9 months. Scheduled reimmunizations are performed at 10-year intervals with Td-M toxoid.
Immunization with D-M toxoid can be done simultaneously with immunizations against poliomyelitis or other scheduled immunizations.
Preparation in a cracked ampule or in ampule with damaged label as well as preparations with altered physical properties (flakes that cannot be disintegrated, altered color), with expired shelf life and/or stored under incorrect conditions are not allowed for use.
Ampule opening and immunization are performed under strict aseptic and antiseptic conditions.
Do not store partially used ampules.
Injections of D-M toxoid should be registered in approved tally-sheet bearing the date of immunization, dosage, manufacturer of the vaccine, lot number and response to immunization.
Reaction to Preparation
D-M toxoid is a preparation with a low reactogenicity. General (indisposition and/or fever) and local (edema, hyperemia and/or pain) reactions have been reported in some people within 48 hours after injection. Allergic reactions (Quinkee’s edema, urticaria, polymorphous rash) and slight aggravation of allergic diseases have been rarely reported. Bearing in mind the possibility of immediate allergic reactions in hypersensitive people, they should be observed for 30 min after the injection. The means of antishock therapy should be available where immunization or urgent prevention is performed
Scheduled immunization with the preparation is discontinued in people developing severe allergic reactions in response to D-M toxoid.
There are no constant contraindication for the use of D-M toxoid in adults and children. Immunization is not recommended during pregnancy.
People who have had acute disease(s) are immunized 2-4 weeks after recovery. In non-serious diseases immunization can be carried out after disappearance of clinical manifestations.
People with chronic disease(s) are immunized after partial or complete remission has been achieved. People with neurological diseases are immunized after the progression of the disease is ruled out. Stable manifestations of allergic diseases (localized cutaneous manifestations, latent bronchial spasm, etc.) are not contraindications for immunization which can be performed against the background of adequate therapy. People with these diseases can be immunized 2-4 weeks after an aggravation onset.
Immunodeficiency, HIV infection and supporting therapy, including steroids and psychotropic preparations, are not contraindications for immunization.
Scheduled immunization with D-M toxoid is performed not earlier than one month after immunization against other injections.
To reveal contraindications physician or medical assistant examines the people and interrogates parents of children. Body temperature measurement is obligatory. When adults are vaccinated, they can be interrogated as a separate group on the day of immunization. People to whom immunization is contraindicated should be followed-up and immunized in due course.
Nonimmunized people with the above-mentioned diseases that contact diphtheria patients in family, school, hostel, etc. can be immunized after medical examination before recovery (remission) against the background of adequate therapy.
Ampules containing 0.5 ml D-M toxoid (one immunization dose). A pack contains 10 ampules.
Storage and Shipment
Store at (6"2)oC. Protect from light and humidity. Do not freeze. Shipping by all means of covered transport at (6"2)oC.
Shelf life 3 years.