Usual Adult Dose for Pneumococcal Disease Prophylaxis
0.5 mL IM once
Comments:
- Use for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay; continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Use: Active immunization for prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
CONTRAINDICATIONS:
- Severe allergic reaction (e.g. anaphylaxis) to any of the ingredients or to diphtheria toxoid
Safety and efficacy have not been established in patients younger than 18 years.
This drug is not recommended for use in children.
To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS) at: https://vaers.hhs.gov
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- For intramuscular administration only.
Storage requirements:
- Refrigerate; do not freeze. Discard if frozen.
- Administer as soon as possible after removal from refrigeration.
- Vaccine can be used as long as total time out of refrigeration (cumulative multiple excursions) does not exceed 96 hours.
- Store syringes in refrigerator horizontally to minimize resuspension time.
Reconstitution/preparation techniques:
- Resuspend product by shaking vigorously until product is a homogenous white suspension; do not use if vaccine cannot be resuspended.
- Attach a sterile needle after resuspension.
IV compatibility:
- Do not mix with other products in the same syringe.
Patient advice:
- Patients should be informed about the potential benefits and risks of immunization with this drug.
- Patients should report any suspected adverse reactions to their health care professional.
