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Traceability: In order to improve the traceability of biological products, the name and batch number of the administered product should be clearly recorded.
Do not inject via the intravascular route: make sure the needle does not penetrate a blood vessel.
As with all injectable vaccines, IMOVAX POLIO must be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
As with all injectable vaccines, appropriate medical treatment must be readily available and close supervision provided should a rare anaphylactic reaction occur following administration of the vaccine.
Immunosuppressive treatment or an immunodeficiency condition may induce a reduced immune response to the vaccine. It is then recommended to wait until the end of the treatment before vaccinating or to make sure that the subject is well protected. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended even if the immune response may be limited.
IMOVAX POLIO may also be recommended for subjects in whom the oral vaccine is contraindicated, and as a booster for subjects previously vaccinated with the oral vaccine.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be put in place to prevent any injury due to fainting and to manage syncopal reactions.
IMOVAX POLIO contains phenylalanine, ethanol and sodium: IMOVAX POLIO contains 12.5 micrograms of phenylalanine in each dose of 0.5 mL. Phenylalanine may be dangerous for patients with phenylketonuria (PKU), a rare genetic disorder characterised by the accumulation of phenylalanine that cannot be correctly eliminated.
IMOVAX POLIO contains 2 mg alcohol (ethanol) in a dose of 0.5 mL. The low quantity of alcohol contained in this medicinal product is unlikely to cause a notable effect.
IMOVAX POLIO contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially "sodium-free".
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
