Adacel/Adacel Polio Special Precautions

Adacel: ADACEL should not be used for primary immunization.
Regarding the interval between a booster dose of ADACEL and preceding booster doses of diphtheria and/or tetanus containing vaccines, the official recommendations should generally be followed.
Clinical data have demonstrated that there was no clinically relevant difference in rates of adverse reactions associated with administration of a tetanus-, diphtheria- and pertussis-containing booster vaccine as early as 4 weeks, compared to at least 5 years, after a preceding dose of tetanus and diphtheria-containing vaccine.
Prior to immunization: Vaccination should be preceded by a review of the person's medical history (in particular previous vaccinations and possible adverse events). In persons who have a history of serious or severe reaction within 48 hours of a previous injection with a vaccine containing similar components, administration of ADACEL vaccine must be carefully considered.
As with all injectable vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of the vaccine.
If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid, including ADACEL should be based on careful consideration of the potential benefits and possible risks.
ADACEL should not be administered to persons with progressive neurological disorder, uncontrolled epilepsy or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized.
The immunogenicity of the vaccine could be reduced by immunosuppressive treatment or immunodeficiency. It is recommended to postpone the vaccination until the end of such disease or treatment if practical. Nevertheless, vaccination of HIV infected persons or persons with chronic immunodeficiency, such as AIDS, is recommended even if the antibody response might be limited.
Administration precautions: Do not administer by intravascular or intradermal injection.
Intramuscular injections should be given with care in patients on anticoagulant therapy or suffering from coagulation disorders because of the risk of haemorrhage. In these situations administration of ADACEL by deep subcutaneous injection may be considered, although there is a risk of increased local reactions.
Syncope (fainting) can occur following, or even before, administration of injectable vaccines, including ADACEL. Procedures should be in place to prevent falling injury and manage syncopal reactions.
The tip caps of the prefilled syringes contain a natural rubber latex derivative, which may cause allergic reactions in latex sensitive individuals.
Other considerations: As with any vaccine, vaccination with ADACEL may not protect 100% of susceptible individuals.
A persistent nodule at the site of injection may occur with all adsorbed vaccines, particularly if administered into the superficial layers of the subcutaneous tissue.
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive or use machines have been performed. ADACEL has no or negligible influence on the ability to drive and use machines.
Adacel Polio: 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 hemophilia 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-Barré syndrome. If Guillain-Barré 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.