ADACEL PRESCRIBING INFORMATION PDF

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Manufacturer: sanofi pasteur. Distributor: DKSH. Full Prescribing Info. Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed. ADACEL Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed , is a sterile, uniform, cloudy, white suspension of tetanus and diphtheria toxoids adsorbed separately on aluminum phosphate, combined with acellular pertussis vaccine and suspended in water for injection.

Composition: Each single dose 0. Excipients: Aluminum Phosphate adjuvant 1. Manufacturing Process Residuals: Formaldehyde and glutaraldehyde are present in trace amounts. Tetanus and Diphtheria: Tetanus is an acute and often fatal disease caused by an extremely potent neurotoxin produced by C. The toxin causes neuromuscular dysfunction, with rigidity and spasms of skeletal muscles. Protection against disease attributable to C.

A serum tetanus antitoxin level of at least 0. A tetanus antitoxin level of at least 0. Strains of C. A serum diphtheria antitoxin level of 0.

Antitoxin levels of at least 0. Pertussis: Pertussis whooping cough is a respiratory disease caused by B. This Gram-negative coccobacillus produces a variety of biologically active components, though their role in either the pathogenesis of, or immunity to, pertussis has not been clearly defined. The mechanism of protection from B. In the same study, the protective efficacy against mild disease was A household contact study that was nested in this efficacy trial demonstrated that there were statistically significant correlations between clinical protection and the presence of antibodies against PT, PRN and FIM in pre-exposure sera.

Minimum serum antibody levels to specific pertussis vaccine components that confer protection against the development of clinical pertussis have not been identified. Nevertheless, a number of studies have demonstrated a correlation between the presence of serum antibody responses to pertussis vaccine components and protection against clinical disease.

In a clinical study, individuals 65 years of age and older received a single dose of Adacel vaccine. Nevertheless, their post-immunization anti-pertussis antibody levels were 4. While protective levels against pertussis have not yet been clearly defined, pertussis antibody levels remain 2 to 9 fold higher than pre-immunization levels after 5 years.

However at 10 years post-vaccination pertussis antibody levels were observed to decline towards pre-vaccination levels. Tetanus and diphtheria toxoid boosters are recommended every 10 years. The serology follow-up and redosing data for ADACEL suggests that it can be used instead of tetanus and diphtheria toxoid vaccine for boosting at year intervals in adults. ADACEL is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis whooping cough in persons 4 years of age and older.

ADACEL may be considered as an alternative for the fifth dose of tetanus, diphtheria and acellular pertussis vaccine DTaP in children 4 through 6 years of age, concomitantly administered with Inactivated Poliomyelitis Vaccine IPV at separate sites to complete the vaccination series for this age, when indicated.

Persons who have had tetanus, diphtheria or pertussis should still be immunized since these clinical infections do not always confer immunity. Human Immunodeficiency Virus HIV -infected persons, both asymptomatic and symptomatic, should be immunized against tetanus, diphtheria and pertussis according to standard schedules. The preferred site is into the deltoid muscle. The effect of fractional doses on the safety and efficacy has not been determined.

See Table 1. Persons who have completed primary immunization against tetanus and who sustain wounds that are minor and uncontaminated, should receive a booster dose of a tetanus toxoid-containing preparation if they have not received tetanus toxoid within the preceding 10 years.

For tetanus-prone wounds e. See Description. If these conditions exist, the product should not be administered. Shake the vial well until a uniform, cloudy, suspension results. Cleanse the vial stopper with a suitable germicide prior to withdrawing the dose. Do not remove either the stopper or the metal seal holding it in place. Aseptic technique must be used. Use a separate sterile needle and syringe, or a sterile disposable unit for each individual recipient, to prevent disease transmission.

Needles should not be recapped but should be disposed of according to biohazard waste guidelines see Precautions. Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. Administer the total volume of 0. The preferred site of injection is the deltoid muscle. Hypersensitivity: Known systemic hypersensitivity reaction to any component of ADACEL or a life threatening reaction after previous administration of the vaccine or a vaccine containing one or more of the same components are contraindications to vaccination see Dosage Forms, Composition and Packaging.

Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such persons may be referred to an allergist for evaluation if further immunizations are considered. Acute Neurological Disorders: Encephalopathy eg, coma, decreased level of consciousness, prolonged seizures within 7 days of a previous dose of a pertussis-containing vaccine not attributable to another identifiable cause is a contraindication to vaccination with any pertussis-containing vaccine, including ADACEL.

Special Precautions. It is extremely important that the recipient, parent or guardian be questioned concerning any signs or symptoms of an adverse reaction after a previous dose of vaccine see Contraindications and Adverse Reactions.

The rates and severity of adverse events in recipients of tetanus toxoid are influenced by the number of prior doses and level of pre-existing antitoxins. Intradermal or subcutaneous routes of administration are not to be utilized. Febrile and Acute Disease: Vaccination should be postponed in cases of an acute or febrile disease. However, a disease with low-grade fever should not usually be a reason to postpone vaccination.

Hematologic: Because any intramuscular injection can cause an injection site hematoma in persons with any bleeding disorders, such as hemophilia or thrombocytopenia, or in persons on anticoagulant therapy, intramuscular injections with ADACEL should not be administered to such persons unless the potential benefits outweigh the risk of administration. If the decision is made to administer any product by intramuscular injection to such persons, it should be given with caution, with steps taken to avoid the risk of hematoma formation following injection.

Immune: The possibility of allergic reactions in persons sensitive to components of the vaccine should be evaluated. Hypersensitivity reactions may occur following the use of ADACEL even in persons with no prior history of hypersensitivity to the product components.

As with all other products, epinephrine hydrochloride solution , 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. Immunocompromised persons whether from disease or treatment may not achieve the expected immune response.

If possible, consideration should be given to delaying vaccination until after the completion of any immunosuppressive treatment. Nevertheless, vaccination of persons with chronic immunodeficiency such as HIV infection is recommended even if the immune response might be limited. Neurologic: ADACEL should not be administered to individuals with progressive or unstable neurological disorders, uncontrolled epilepsy or progressive encephalopathy until a treatment regimen has been established, the condition has stabilized and the benefit clearly outweighs the risk.

If GBS occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give ADACEL or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks. Vaccination in pregnancy is not recommended unless there is a definite risk of acquiring pertussis.

As the vaccine is inactivated, risk to the embryo or the fetus is improbable. The benefits versus the risks of administering ADACEL during pregnancy should be carefully evaluated when there is a high probable risk of exposure to a household contact or during an outbreak in the community. The risks and benefits of vaccination should be assessed before making the decision to immunize a nursing woman.

Adverse Reactions. Clinical Trial Adverse Reactions: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.

Pain at the injection site was the most common solicited injection site reaction. Most injection site reactions occurred within 3 days following vaccination and their mean duration was less than 3 days. The most frequent systemic reaction was tiredness in children and headache in adolescents and adults years. These reactions were usually transient and of mild to moderate intensity.

In addition, in adolescents and adults the incidence of injection site and systemic reactions following ADACEL was comparable to those observed with a Td vaccine booster. Except for fever, the observed rates for the systemic reactions were comparable between the two vaccines.

The frequency of the solicited injection site and systemic reactions reported in two clinical trials are shown in Table 2. Two serious adverse events were reported during Study Td which were considered related to the vaccination: a case of severe migraine with unilateral facial paralysis, and a diagnosis of nerve compression in the neck and left arm. Both of these conditions resolved spontaneously or with treatment see Tables 2 and 3. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

Decisions to include these events in labelling were based on one or more of the following factors: 1 severity of the event, 2 frequency of reporting, or 3 strength of causal connection to ADACEL. Immune System Disorders: Hypersensitivity anaphylactic reaction angioedema, edema, rash, hypotension.

Cardiac Disorders: Myocarditis. Skin and Subcutaneous Tissue Disorders: Pruritus, urticarial. Musculoskeletal and Connective Tissue Disorders: Myositis, muscle spasm. These reactions usually start within hrs after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within days. The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccine. Injection site bruising, sterile abscess.

Drug Interactions. Vaccine-Drug Interactions: Immunosuppressive treatments may interfere with the development of the expected immune response see Precautions. Concomitant Vaccine Administration: In clinical studies, Adacel was administered concomitantly with one of the following vaccines: Hepatitis B vaccine or trivalent inactivated influenza vaccine.

The concomitant use of ADACEL and trivalent inactivated influenza vaccine was evaluated in a clinical trial involving adults 19 to 64 years of age.

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