Pneumovax 23 0,5 mL Solution for Injection

PNEUMOVAX 23 is indicated for vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine. PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine. If it is known that a person has not received any pneumococcal vaccine or if earlier pneumococcal vaccination status is unknown, then persons in the categories listed below should be administered pneumococcal vaccine; however, if a person has received a primary dose of pneumococcal vaccine, before administering an additional dose of vaccine, please refer to the Re-vaccination section.

PNEUMOVAX 23 is recommended for the prevention of pneumococcal pneumonia and pneumococcal systemic infections caused by the serotypes included in the vaccine, in high-risk subjects from 2 years of age. Elderly patients from 65 years of age. Immunocompetent patients with chronic illness (e.g. cardiovascular disease, pulmonary disease, diabetes mellitus, alcoholism, cirrhosis, cerebrospinal fluid leaks). Immunocompromised patients: anatomic or functional asplenia (including patients to be splenectomised), sickle cell disease, Hodgkinu2019s disease, lymphoma, multiple myeloma, chronic renal failure, nephrotic syndrome and organ transplantation. Special groups: persons living in a social or working environment with an identified increased risk of pneumococcal infection or its complications (e.g. hospitalised elderly people or those in institutional care). It should be noted that this vaccine is not indicated for recurrent upper respiratory tract infections, particularly otitis media and sinusitis. Immunocompromised persons 2 years of age and older, leukaemia, lymphoma, Hodgkinu2019s disease, multiple myeloma, generalised malignancy, chronic renal failure or nephrotic syndrome; those receiving immunosuppressive chemotherapy (including corticosteroids); and those who have received an organ or bone marrow transplant (for selected groups, see INDICATIONS, Timing of Vaccination). PNEUMOVAX 23 may not be effective in preventing infection resulting from basilar skull fracture or from external communication with cerebrospinal fluid.

The vaccine is used directly as supplied. No dilution or reconstitution is necessary. All vaccine must be discarded after the expiration date. Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. PNEUMOVAX 23 is a clear, colourless solution. The pre-filled syringe is for single use only. Inject the entire contents of the syringe. Administer a single 0,5 mL dose of PNEUMOVAX 23 subcutaneously or intramuscularly (preferably in the deltoid muscle or lateral mid-thigh), with appropriate precautions to avoid intravascular administration. It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another.

Hypersensitivity to any component of the vaccine. PNEUMOVAX 23 is not recommended for use in children < 2 years of age. Safety and effectiveness in children below the age of 2 years have not been established. Children in this age group respond poorly to the capsular types contained in this vaccine.

Use of this vaccine at the same time as other vaccines that contain endotoxins may provoke a febrile reaction. Caution and appropriate care should be exercised in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk. Any febrile respiratory illness or other active infection is reason for delaying use of PNEUMOVAX 23, except when in the opinion of the doctor, withholding the agent entails even greater risk. In patients who require penicillin (or other antibiotic) prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after vaccination with PNEUMOVAX 23. As with any vaccine, vaccination with PNEUMOVAX 23 may not result in complete protection in all recipients.

It is recommended that pneumococcal vaccine may be administered at the same time as influenza vaccine (by separate injection in the other arm), without an increase in side effects or decreased antibody response to either vaccine. In contrast to pneumococcal vaccine, influenza vaccine is recommended annually, for appropriate populations. PNEUMOVAX 23 and ZOSTAVAX should not be given concurrently because concomitant use in a clinical trial resulted in reduced immunogenicity of ZOSTAVAX. In this trial, the immunogenicity of PNEUMOVAX 23 was not affected by ZOSTAVAX.

Safety in pregnancy and during lactation has not been demonstrated.

Not applicable.

The following adverse experiences have been reported with PNEUMOVAX 23. Injection site reactions consisting of pain, soreness, erythema, warmth, swelling, local induration, decreased limb mobility and peripheral oedema in the injected extremity. Rarely, cellulitis-like reactions were reported. These cellulitis-like reactions, reported in post-marketing experience, show short onset time from vaccine administration. Local reactions may be accompanied by systemic signs and symptoms including fever, leukocytosis and an increase in the laboratory value for serum C-reactive protein. The most common adverse experiences reported in clinical trials were fever (u2264 38,8 u00b0C), injection site reactions including soreness, erythema, warmth, swelling and local induration. The observed generally small increase (u2264 13%) in post-vaccination use of analgesics returned to baseline by day 5.

Not applicable; vaccine is supplied as a single-dose pre-filled syringe.