Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
ADACEL-POLIO should not be administered into the gluteal area; intradermal or subcutaneous routes should not be used (in exceptional cases the subcutaneous route may be considered, see section 4.4).
Precautions to be taken before handling or administering the medicinal product For instructions on handling of the medicinal product before administration, see section 6.6.
ADACEL-POLIO should not be used for primary immunization.
Regarding the interval between a booster dose of ADACEL-POLIO and preceding booster doses of diphtheria and/or tetanus containing vaccines, the official recommendations should generally be followed. Clinical data in adults have demonstrated that there was no clinically relevant difference in rates of adverse reactions associated with administration of ADACEL-POLIO 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-POLIO 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-POLIO should be based on careful consideration of the potential benefits and possible risks.


ADACEL-POLIO should not be administered to individuals with a progressive or unstable neurological disorder, uncontrolled epilepsy or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized.
The rates and severity of adverse events in recipients of tetanus toxoid antigen are influenced by the number of prior doses and level of pre-existing antitoxins.
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 and following official recommendations the administration of ADACEL- POLIO 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-POLIO. Procedures should be in place to prevent falling injury and manage syncopal reactions.
Other considerations
As with any vaccine, a protective immune response may not be elicited in all vaccines (see section 5.1).
Limited data indicate that maternal antibodies may reduce the magnitude of the immune response to some vaccines in infants born to women vaccinated with ADACEL-POLIO during pregnancy.
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 of the administered product should be clearly recorded. It is recommended to record the batch number as well.
Excipients with known effects
ADACEL-POLIO contains 1.01 milligram of alcohol (ethanol) in each 0.5 mL dose. The small amount of alcohol in this medicine will not have any noticeable effects.



Effects on Driving

4.7 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-POLIO has no or negligible influence on the ability to drive and use machines.