Diphtheria and Tetanus Toxoids Adsorbed (DT Adsorbed)

Diphtheria and Tetanus Toxoids Adsorbed (DT Adsorbed)

Connaught

Active Immunizing Agent

Action And Clinical Pharmacology: Immunization against diphtheria and tetanus has been associated with a striking decrease in the incidence of morbidity and mortality from these diseases.

Injection of bacterial proteins such as diphtheria and tetanus toxoids results in the production of protective antibodies. The peak antibody levels achieved with the first dose are usually low, and a primary series is required to prime the immune system and produce a high antibody level. After completion of a primary series, circulating antibodies to tetanus and diphtheria toxoids gradually decline but are thought to persist at protective levels for up to 10 years. Tetanus antitoxin levels of >0.01 IU/mL are generally accepted as good evidence of immunity from tetanus. Diphtheria antitoxin levels of ³0.01 IU/mL are thought to be the minimal level required for protection. Levels >0.05 IU/mL are considered optimal for protection.

Diphtheria is a serious communicable disease caused by toxigenic strains of C. diphtheriae. The organism may be harbored in the nasopharynx, skin or other sites of asymptomatic carriers, making eradication of the disease difficult. Routine immunization against diphtheria in infancy and childhood has been widely practised in Canada since 1930, resulting in a decline in morbidity and mortality. Fewer than 5 cases are now reported annually in Canada. The case-fatality rate remains 5 to 10%, with the highest death rates in the very young and elderly. The disease occurs most frequently in unimmunized or partially immunized individuals. Diphtheria toxoid is a cell-free preparation of diphtheria toxin detoxified with formaldehyde. The immunity conferred is antitoxic, not antibacterial, and thus protects against the potentially lethal systemic effects of diphtheria toxin but not directly against local infection.

Tetanus is an acute and often fatal disease caused by an extremely potent neurotoxin produced by C. tetani. The organism is ubiquitous and its occurrence in nature cannot be controlled. Immunization is highly effective, provides long-lasting protection, and is recommended for the whole population. Only 2 to 3 cases of tetanus are now reported annually in Canada. Tetanus toxoid is prepared by detoxification of tetanus toxin with formaldehyde.

Indications And Clinical Uses: For the primary and booster immunization of infants, at or above the age of 2 months, and of children up to their 7th birthday, against diphtheria and tetanus in whom simultaneous immunization against pertussis is not indicated. Age-appropriate immunization always should be started at once if diphtheria is present in the community.

DT Adsorbed may be administered simultaneously with Hib conjugate vaccines, MMR and IPV each at separate sites with separate syringes, and with OPV.

Contra-Indications: General: Immunization with DT Adsorbed should be deferred in the presence of any acute illness, including febrile illness to avoid superimposing adverse effects from the vaccine on the underlying illness or mistakenly identifying a manifestation of the underlying illness as a complication of vaccine use. A minor afebrile illness such as mild upper respiratory infection is not usually reason to defer immunization.

DT Adsorbed should not be administered to children after their 7th birthday, or to adults because of reactions to diphtheria toxoid.

Absolute: Allergy to any component of DT Adsorbed (see Supplied) an anaphylactic or other allergic reaction to a previous dose of DT Adsorbed or a history of a neurologic reaction following a previous dose are absolute contraindications to vaccination.

Deferral: Elective immunization of persons over 6 months of age should be deferred during an outbreak of poliomyelitis because of the risk of provocation paralysis.

Human Immunodeficiency Virus (HIV) Infected Persons: HIV-infected individuals, both asymptomatic and symptomatic, should be immunized with DT vaccine according to standard schedules (see Warnings).

Manufacturers’ Warnings In Clinical States: Arthus-type hypersensitivity reaction, characterized by severe local reactions (generally starting 2 to 8 hours after an injection) may occur, particularly in persons who have received multiple prior boosters. Persons who have experienced Arthus-type hypersensitivity or fever of >39.4°C following a previous dose of tetanus toxoid usually have high serum tetanus antitoxin levels.

I.M. injections should be given with care in patients suffering from coagulation disorders or on anticoagulant therapy because of the risk of hemorrhage.

If DT Adsorbed is used in persons with malignancies, persons receiving immunosuppressive therapies including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, or persons who are otherwise immunocompromised (including HIV infected individuals, transplant recipients, persons suffering from autoimmune disorders), the expected immune response may not be obtained.

Corticosteroid therapy can result in immunosuppression although the exact dose and duration of therapy required to suppress the immune system is not well defined. Persons treated with high doses of systemic steroids, e.g., ³2 mg/kg/day of prednisone orally for more than 2 weeks, should be considered to have a compromised immune system.

As with any vaccine, immunization with DT Adsorbed may not protect 100% of susceptible individuals.

Precautions: General: The possibility of allergic reactions in individuals sensitive to the components of the product should be evaluated. Epinephrine HCl Solution (1:1 000) and other appropriate agents should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Health care providers should be familiar with current recommendations for the initial management of anaphylaxis in non-hospital settings, including proper airway management.

Before administration of any vaccine, all appropriate precautions should be taken to prevent adverse reactions. This includes a review of the patient’s history with respect to possible hypersensitivity to the vaccine or similar vaccine, determination of previous immunization history, and the presence of any contraindications to immunization, current health status, and a current knowledge of the literature concerning the use of the vaccine under consideration.

Special care should be taken to ensure that the product is not injected into a blood vessel.

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

There have been case reports of transmission of HIV and hepatitis by failure to scrupulously observe sterile technique. In particular, the same needle and/or syringe must never be used to re-enter a multidose vial to withdraw vaccine even when it is to be used for inoculation of the same patient. This may lead to contamination of the vial contents and infection of patients who subsequently receive vaccine from the vial.

Needles should not be recapped and should be disposed of properly.

Before administration of DT Adsorbed, health care personnel should inform the parent or guardian or the patient to be immunized of the benefits and risks of immunization, inquire about the recent health status of the patient and comply with any local requirements with respect to information to be provided to the patient before immunization.

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. If hypersensitivity to the diphtheria component is suspected, tetanus toxoid should be used for reinforcing doses.

Adverse Reactions: Mild local reactions consisting of erythema, pain and tenderness, swelling and induration at the injection site are common, and may be associated with systemic reactions including mild to moderate transient fever and irritability.

Up to 70% of children receiving a booster dose of DPT Adsorbed at 4 to 6 years of age have been reported to develop local redness and/or swelling ³5 cm in diameter. This is generally self limiting and subsides without treatment.

Persistent nodules at the site of injection have occurred following the use of an adsorbed product, but this complication is unusual, and may be related to s.c. administration. Sterile abscess at the site of injection has been reported following use of adsorbed vaccines (6 to 10 per million doses).

Mild systemic reactions such as fever, drowsiness, fretfulness, anorexia, vomiting, irritability and persistent or unusual crying have been reported. The incidence and severity of fever and irritability can be reduced by administration of acetaminophen (15 mg/kg/dose) at the time of inoculation and again 4 and 8 hours after vaccination.

Rarely, an anaphylactic reaction (i.e., hives, swelling of the mouth, difficulty breathing, hypotension, or shock) have been reported after receiving preparations containing diphtheria and/or tetanus toxoids. Death following anaphylaxis has been reported.

On the basis of a single case report and evidence that a vaccine-induced immunologic response can cause Guillain-Barré Syndrome (GBS), the Institute of Medicine (US) concluded that tetanus toxoid-containing vaccines can trigger GBS in adults. No increased risk for GBS has been observed with the use of DTP in children.

The following neurologic illnesses have been reported as temporally associated with vaccine containing tetanus toxoid: neurological complications including cochlear lesion, brachial plexus neuropathies, paralysis of the radial nerve, paralysis of the recurrent nerve, accommodation paresis, and EEG disturbances with encephalopathy. In the differential diagnosis of polyradiculoneuropathies following administration of a vaccine containing tetanus toxoid, tetanus toxoid should be considered as a possible etiology.

Physicians, nurses, and pharmacists should report any adverse occurrences temporally related to the administration of the product in accordance with local requirements and to the Medical Director, Connaught Laboratories Limited, 1755 Steeles Avenue West, Toronto, Ontario, Canada, M2R 3T4.

Dosage And Administration: For primary immunization of infants the following routine DT Adsorbed immunization schedule is recommended: one 0.5 mL dose administered at 2, 4, 6 and 18 months of age.

If for any reason this schedule is delayed, it is recommended that 3 doses of 0.5 mL be administered with an interval 4 to 8 weeks between doses, followed by a 4th dose of 0.5 mL administered approximately 1 year following the 3rd dose.

A booster dose of 0.5 mL should be administered between 4 and 6 years of age (i.e., at the time of school entry). This booster is unnecessary if the 4th primary immunizing dose has been administered after the 4th birthday.

Parenteral biological products should be inspected visually for extraneous particulate matter and/or discoloration before administration. If these conditions exist, the product should not be administered.

Shake the vial or ampul well to distribute uniformly the suspension before withdrawing each dose. Before withdrawing a dose from an ampul, tap the container first to ensure that any vaccine in the ampul neck falls to the lower portion of the ampul. Once the ampul has been opened, any of its contents not used immediately should be discarded. When administering a dose from a rubber-stoppered vial, do not remove either the rubber stopper or the metal seal holding it in place. Aseptic technique must be used for withdrawal of each dose (see Precautions).

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide.

Administer the vaccine i.m. The preferred site is into the anterolateral aspect of the mid-thigh (vastus lateralis muscle) or into the deltoid muscle. The former is the site of choice for infants 1 year of age, the deltoid is the preferred site since use of the anterolateral thigh results in frequent complaints of limping due to muscle pain.

After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel.

Do not inject i.v.

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.

Availability And Storage: Each 0.5 mL dose contains: diphtheria toxoid (25 Lf) tetanus toxoid (5 Lf) and aluminum phosphate 1.5 mg. Thimerosal 0.01% is added as a preservative. Rubber stoppered vials of 5 mL, packages of 1. Glass ampuls of 0.5 mL (single dose), packages of 5. Store between 2 to 8°C. Do not freeze. Product exposed to freezing should not be used. Do not use vaccine after expiration date.

Diphtheria and Tetanus Toxoids Adsorbed (DT Adsorbed Connaught Active Immunizing Agent

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