Presentation and Status in Health Basket
1 X 0.5 ml
1 X 5 ml
Primary vaccination: From 2 months of age, 3 successive injections of 0.5 ml should be administered at intervals of one or two months.
From 6 weeks of age, IMOVAX POLIO may be administered following the 6-, 10-, 14-week schedule, as per the recommendations of the Expanded Programme on Immunisation of the World Health Organisation.
For nonvaccinated adults, 2 successive injections of 0.5 ml should be given at intervals of one or, preferably, two months.
Booster: For children older than 12 months , a 4th dose (1st booster) is administered 6-12 months after the 3rd injection.
For adults, a 3rd dose (1st booster) is administered 6 to 12 months after the 2nd injection.
A booster is given every 5 years in children and adolescents and every 10 years in adults.
Method of Administration: The preferred route of administration is intramuscular, although the vaccine may also be given subcutaneously.
The preferred site of intramuscular injection is the mid-lateral aspect of the thigh in infants and toddlers and the deltoid muscle in children, adolescents and adults.
This vaccine is indicated for the prevention of poliomyelitis in infants, children and adults, for primary and booster vaccinations.
Known severe hypersensitivity to any component of the vaccine or a vaccine containing the same substances, or to one of the excipients.
Known severe hypersensitivity to neomycin, streptomycin or polymyxine B (each dose may contain undetectable traces of these antibiotics which are used during vaccine production).
Common transient contraindications to any vaccination: in case of fever or acute illness, it is best to postpone vaccination.
Do not inject by the intravascular route: make sure the needle does not penetrate a blood vessel.
Like any injectable vaccine, IMOVAX POLIO should be administered with caution to subjects with thrombocytopenia or a bleeding disorder, because bleeding may occur following an intramuscular administration to these subjects.
As with all injectable vaccines, there is a possibility (though rare) of an anaphylactic event. For this reason, appropriate medical treatment should be readily available, and the subject should be kept under surveillance following administration.
The immune response to the vaccine may be reduced in subjects who are immunodeficient or who are taking an immunosuppressive treatment. In such cases it is recommended to postpone vaccination until the end of the treatment or to make sure that the subject is well protected. Vaccination of subjects with chronic immunodeficiency, such as HIV infection, is nevertheless recommended even if the immune response might be limited by the underlying illness.
IMOVAX POLIO may also be indicated for subjects for whom oral vaccination 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 48-72 h 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.
Local reactions at the injection site were commonly to very commonly reported: redness (in 0.7% to 2.4% of subjects in each trial), pain (0.7% to 34%) and induration (0.4%).
The incidence and severity of local reactions may be affected by the site, route and method of injection and by the number of previous injections.
See prescribing information for full details.
There is no documented evidence against administration of IMOVAX POLIO during a single vaccination session with other usual vaccines. Different syringes and separate injection sites should be used in case of concomitant administration.
Pregnancy and Lactation
Clinical data indicate that this vaccine may be prescribed during pregnancy, only if required.
This vaccine may be used during breast feeding.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life: 3 years.
Storage: Store in the refrigerator (between +2°C and +8°C), protected from light. Do not freeze. It is best to use the product immediately after opening it.