PNEUMOVAX23

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Primary vaccination:

Adults and children of 2 years of age or older- one single dose of 0.5 millilitre by intramuscular or subcutaneous injection. PNEUMOVAX 23 is not recommended for use in children below 2 years of age as the safety and efficacy of the vaccine have not been established and the antibody response may be poor.

Special dosing:

It is recommended that pneumococcal vaccine should preferably be given at least two weeks before elective splenectomy or the initiation of chemotherapy or other immunosuppressive treatment. Vaccination during chemotherapy or radiation therapy should be avoided.

Following completion of chemotherapy and/or radiation therapy for neoplastic disease, immune responses to vaccination may remain diminished. The vaccine should not be administered any sooner than three months after completion of such therapy. A longer delay may be appropriate for patients who have received intensive or prolonged treatment. Persons with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after their diagnosis is confirmed.

Re-vaccination:

One single dose of 0.5 millilitre by intramuscular or subcutaneous injection. The specific timing of, and need for, re-vaccination should be determined on the basis of available official recommendations. Re-vaccination at an interval of less than three years is not recommended because of an increased risk of adverse reactions. The rates of local and, in persons aged ≥ 65 years, some systemic reactions have been shown to be higher after re-vaccination than after primary vaccination when three to five years have elapsed between doses. There are very limited clinical data regarding administration of more than two doses of PNEUMOVAX 23.

Adults

Healthy adults should not be re-vaccinated routinely. Re-vaccination may be considered for persons at increased risk of serious pneumococcal infection who were given pneumococcal vaccine more than five years earlier or for those known to have a rapid decline in pneumococcal antibody levels.

For selected populations (e.g., asplenics) who are known to be at high risk of fatal pneumococcal infections, re-vaccination at three years may be considered.

Children

Healthy children should not be re-vaccinated routinely. Children of 10 years of age and over may be considered for re-vaccination according to the adult recommendation (see above). Children between the ages of 2 and 10 years should only be considered for re-vaccination after 3 years if they are at high risk of pneumococcal infection (e.g., those with nephrotic syndrome, asplenia or sickle cell disease).

Method of administration1

A dose of 0.5 ml from a single-dose of PNEUMOVAX 23 is to be injected intramuscularly (IM) or subcutaneously (SC).

Adverse Event Reporting

Healthcare professionals are asked to report any suspected adverse reactions via

HPRA Pharmacovigilance,

Earlsfort Terrace,

IRL-Dublin 2

Tel: +353 1 6764971
Fax: +353 1 6762517
Websitewww.hpra.ie
E-mailmedsafety@hpra.ie