Adacel/Adacel Polio

Adacel/Adacel Polio Special Precautions




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Special Precautions
General: Before administration of ADACEL-POLIO, health-care providers should inform the recipient or parent or guardian of the recipient of the benefits and risks of immunization, inquire about the recent health status of the patient to be immunized, review the patient’s history concerning possible hypersensitivity to the vaccine or similar vaccine, previous immunization history, the presence of any contraindications to immunization and comply with any local requirements regarding information to be provided to the patient/guardian before immunization.
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.)
Syncope (fainting) has been reported following vaccination with ADACEL-POLIO. Procedures should be in place to prevent falling injury and manage syncopal 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.
As with any vaccine, ADACEL-POLIO may not protect 100% of vaccinated persons.
Administration Route Related Precautions: Do not administer ADACEL-POLIO by intravascular injection: ensure that the needle does not penetrate a blood vessel. Intradermal or subcutaneous routes of administration are not to be utilized.
ADACEL-POLIO should not be administered into the buttocks.
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 haemophilia or thrombocytopenia, or in persons on anticoagulant therapy, intramuscular injections with ADACEL-POLIO 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-POLIO even in persons with no prior history of hypersensitivity to the product components.
As with all other products, epinephrine hydrochloride 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. For instructions on recognition and treatment of anaphylactic reactions, see the current edition of the Canadian Immunization Guide or visit the Health Canada website.
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-POLIO should not be administered to individuals with progressive neurological disorder, uncontrolled epilepsy, or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized.
A review by the US Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barre syndrome. If Guillain-Barre syndrome has occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give ADACEL-POLIO or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.
Use in Pregnancy: The effect of ADACEL-POLIO on the development of the embryo and fetus has not been assessed. Limited post-marketing data is available following administration of ADACEL-POLIO in pregnant women. 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-POLIO 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.
Use in Lactation: The effect of administration of ADACEL-POLIO during lactation has not been assessed. As ADACEL-POLIO is inactivated, any risk to the mother or the infant is improbable. However, the effect on breast-fed infants of the administration of ADACEL-POLIO to their mothers has not been studied. The risks and benefits of vaccination should be assessed before making the decision to immunize a nursing woman.
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