Clinical Information
Gen. Code and Des.
9679 pneumococcal 23-val p-sac vac INJECTION SYRINGE 25MCG/0.5
GCN and Des.
43859 pneumococcal 23-val p-sac vac INJECTION SYRINGE 25MCG/0.5
Strength
Dose Form
SYRINGE (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80120000 VACCINES
Active Ingredients
3061 pneumococcal 23-valent polysaccharide vaccine
Inactive Ingredients
3199 phenol 108952
PNEUMOVAX 23:pneumococcal vaccine polyvalent inj
PNEUMOVAX 23- streptococcus pneumoniae type 1 capsular polysaccharide antigen, streptococcus pneumoniae type 2 capsular polysaccharide antigen, streptococcus pneumoniae type 3 capsular polysaccharide antigen, streptococcus pneumoniae type 4 capsular polysaccharide antigen, streptococcus pneumoniae type 5 capsular polysaccharide antigen, streptococcus pneumoniae type 6b capsular polysaccharide antigen, streptococcus pneumoniae type 7f capsular polysaccharide antigen, streptococcus pneumoniae type 8 capsular polysaccharide antigen, streptococcus pneumoniae type 9n capsular polysaccharide antigen, streptococcus pneumoniae type 9v capsular polysaccharide antigen, streptococcus pneumoniae type 10a capsular polysaccharide antigen, streptococcus pneumoniae type 11a capsular polysaccharide antigen, streptococcus pneumoniae type 12f capsular polysaccharide antigen, streptococcus pneumoniae type 14 capsular polysaccharide antigen, streptococcus pneumoniae type 15b capsular polysaccharide antigen, streptococcus pneumoniae type 17f capsular polysaccharide antigen, streptococcus pneumoniae type 18c capsular polysaccharide antigen, streptococcus pneumoniae type 19f capsular polysaccharide antigen, streptococcus pneumoniae type 19a capsular polysaccharide antigen, streptococcus pneumoniae type 20 capsular polysaccharide antigen, streptococcus pneumoniae type 22f capsular polysaccharide antigen, streptococcus pneumoniae type 23f capsular polysaccharide antigen and streptococcus pneumoniae type 33f capsular polysaccharide antigen injection, solution
Merck Sharp & Dohme Corp.
INDICATIONS AND USAGE
1.1 Indications and Use
PNEUMOVAX� 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F). PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.
1.2 Limitations of Use
PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.
2 DOSAGE AND ADMINISTRATION
For intramuscular or subcutaneous injection only.
DOSAGE FORMS AND STRENGTHS
PNEUMOVAX 23 is a clear, sterile solution supplied in a (0.5-mL dose) single-dose vial, a 5-dose vial, and a single-dose, prefilled syringe
WARNINGS AND PRECAUTIONS
5.1 Persons with Moderate or Severe Acute Illness
Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.
5.2 Persons with Severely Compromised Cardiovascular or Pulmonary Function
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.
5.3 Use of Antibiotic Prophylaxis
This vaccine does not replace the need for penicillin (or other antibiotic) prophylaxis against pneumococcal infection. In patients who require penicillin (or other antibiotic) prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after vaccination with PNEUMOVAX 23.
5.4 Persons with Altered Immunocompetence
Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23. [See Use in Specific Populations (8.6).]
5.5 Persons with Chronic Cerebrospinal Fluid Leakage
PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.
6 ADVERSE REACTIONS
The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 in clinical trials were: injection-site pain/soreness/tenderness (60.0%), injection-site swelling/induration (20.3%), headache (17.6%), injection-site erythema (16.4%), asthenia/fatigue (13.2%), and myalgia (11.9%).
DESCRIPTION
PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent) is a sterile, liquid vaccine consisting of a mixture of purified capsular polysaccharides from Streptococcus pneumoniae types (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).
PNEUMOVAX 23 is a clear, colorless solution. Each 0.5-mL dose of vaccine contains 25 micrograms of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative. The vaccine is used directly as supplied. No dilution or reconstitution is necessary.
The vial stoppers, syringe plunger stopper and syringe tip cap are not made with natural rubber latex.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
PNEUMOVAX 23 induces type-specific antibodies that enhance opsonization, phagocytosis, and killing of pneumococci by leukocytes and other phagocytic cells. The levels of antibodies that correlate with protection against pneumococcal disease have not been clearly defined.
HOW SUPPLIED/STORAGE AND HANDLING
PNEUMOVAX 23 is supplied as follows:
NDC 0006-4739-00 - one 5-dose vial, color coded with a purple cap and stripe on the vial labels and cartons.
NDC 0006-4943-00 - a box of 10 single-dose vials, color coded with a purple cap and stripe on the vial labels and cartons.
NDC 0006-4837-03 - a box of 10 single-dose, pre-filled Luer-Lok� syringes with tip caps, color coded with a violet plunger rod and purple stripe on the syringe labels and cartons.
NDC 0006-4837-02 - a box of 1 single-dose, pre-filled Luer-Lok� syringe with tip cap, color coded with a violet plunger rod and purple stripe on the syringe label and carton.
Storage and Handling
Store at 2-8�C (36-46�F).
All vaccine must be discarded after the expiration date.
The vial stoppers, syringe plunger stopper and syringe tip cap are not made with natural rubber latex.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform the patient, parent or guardian of the benefits and risks associated with vaccination.
Tell the patient, parent or guardian that vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.
Provide the patient, parent or guardian with the vaccine information statements required by the National Childhood Vaccine Injury Act of 1986, with each immunization.
Instruct the patient, parent or guardian to report any serious adverse reactions to their health care provider who in turn should report such events to the vaccine manufacturer or the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967, or report online at www.vaers.hhs.gov. {10}
Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
