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PRESENTATION

Single-dose vial containing, in 0.5 ml, 25 mcg of each polysaccharide type derived from capsules of the 23 most prevalent pneumococci dissolved in isotonic saline containing 0.25% phenol.

USES

A pneumococcal vaccine.

‘Pneumovax’ II is a sterile liquid vaccine consisting of a mixture of highly purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types accounting for at least 90% of pneumococcal blood isolates and at least 85% of all pneumococcal isolates from usually sterile sites determined by ongoing surveillance (see chart).

Nomenclature Pneumococcal types

Protective capsular type-specific antibody levels usually develop by the third week following vaccination.

‘Pneumovax’ II is indicated for immunisation against pneumococcal disease caused by those pneumococcal types included in the vaccine. ‘Pneumovax’ II will not immunise against capsular types of pneumococcus other than those contained in the vaccine. It should be considered for all persons 2 years of age or older in whom there is an increased risk of morbidity and mortality from pneumococcal pneumonia.

‘Pneumovax’ II may not be effective in preventing infection resulting from basilar skull fracture or from external communication with cerebrospinal fluid,

DOSAGE AND ADMINISTRATION

Do nor inject intravenously; avoid intradermal administration

Administer a single 0.5 ml dose of ‘Pneumovax’ II subcutaneously or intramuscularly (preferably in the deltoid muscle or lateral mid-thigh, with appropriate precautions to avoid intravascular administration.

Adults: Routine vaccination of adults with ‘Pneumovax’ II is not recommended because of an increased incidence and seventy of adverse reactions among healthy adults revaccinated with pneumococcal vaccines at intervals under three years. This was probably due to sustained high antibody levels. Also, persons who received the 14-valent vaccine should not be routinely revaccinated with the 23-valent vaccine as increased coverage is modest and duration of protection is not well defined,

Although routine revaccination is not recommended, revaccinaton is recommended for adults with chronic conditions which increase the risk of fatal pneumococcal infection and for those shown to have a rapid decline in pneumococcal antibody levels (eg. patients with nephrotic syndrome, renal failure, or transplant recipients,

Based on clinical study results, revaccination with ‘Pneumovax’ II is recommended for adults at highest risk of fatal pneumococcal infection who were initially vaccinated with ‘Pneumovax (Pneumococcal Vaccine, Polyvalent MSD) four or more years previously without a serious or severe reaction.

In addition, it is recommended that revaccination should be considered for adults at highest risk who received the 23-valent vaccine six or more years previously.

Children: It is recommended that revaccination after three to five years should be considered for children at highest risk for pneumococcal infection (e.g. children with asplenia, sickle cell disease, or nephrotic syndrome) who would be 10 years old or younger at revaccination. Such children should not, however, be revaccinated within three years

Children at highest risk for pneumococcal infection may have lower peak antibody levels and/or more rapid antibody decline than do healthy adults. There is evidence that some of these high-risk children (e.g. asplenic children) benefit from revaccination with vaccine containing antigen 7F, 8, 19F.

Contra-indication

Hypersensitivity to any component of the vaccine. Adrenaline injection BP (1:1,000) must be immediately available should an acute anaphlactoid reaction occur.

Revaccination with ‘Pneumovax’ II is contra-indicated, except as described under Revaccination.

Do not use ‘Pneumovax’ II less than ten days prior to or during immuno-suppressive therapy.

Patients with Hodgkin’s disease who have received extensive chemotherapy and/or nodal irradiation.

‘Pneumovax’ II should not be giver to pregnant women since it is not known whether the vaccine can cause fetal harm, or affect the outcome of pregnancy.

Breast-feeding mothers should not be given ‘Pneumovax II.

Warnings

The expected serum antibody response may not be obtained in patients receiving immuno-uppresive therapy.

lntradermal administration may cause severe local reactions.

Precautions

Caution and appropriate care should be exercised in administering ‘Pneumovax’ II to individuals with severely compromised cardiac and/or pulmonary function in whom a systemic reaction would pose a significant risk.

Delay the use of ‘Pneumvax’ in any febrile respiratory illness or other active infection, except when this delay may involve even greater risk.

Required prophylactic antibiotic therapy against pneumococcal infection should not be stopped after immunisation with ‘Pneumovax’ II.

It is recommended that a clear note of vaccination with ‘Pneumovax’ II be

kept in the patients hospital and general practitioner records.

Children under 2 years of age: ‘Pneumovax’ is not recommended because antibody response to capsular types that most often cause pneumococcal disease in this age group may be poor. Safety and efficacy in children under 2 years have not been established.

Adverse reactions

Adverse reactions occurring commonly are:

Local injection site soreness, erythema, and induration.

Adverse reactions occurring occasionally are:

Body as a whole

Low-grade fever (<100.9°F/38.3C).

Adverse reactions occurring rarely are:

Body as a whole

Headache, fever (>102°F/38.9°C), malaise. asthenia.

Haematologic/Lymphatic

Adenitis.

Hypersensitivity

Anaphytactoid reactions, serum sickness.

Musculoskeletal

Arthralgia, myalgia, arthritis.

Skin

Rash, urticaria.

 On rare occasions, patients with otherwise stabilised idiopathic thrombocytopenic purpura have relapsed with a thrombocytopenia that has recurred 2-14 days after vaccination, and lasted for up to two weeks.

Reactions of greater seventy, duration, or extent are unusual. Neurological disorders such as paraesthesiae and acute radiculoneurooathy, including the Guillain-Barre syndrome, have rarely been reported at the time of vaccination, but with no established cause-and-effect relationship.

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