PNEUMOVAX® 23

Product Information

• Name: PNEUMOVAX® 23
• Type: Pneumococcal vaccine, polyvalent, MSD Standard
• Form: Solution for injection
• Manufacturer: Merck Canada Inc.

Indications and Clinical Use

• Indication: Vaccination against pneumococcal disease caused by the pneumococcal types included in the vaccine.
• Population:
  • Routine vaccination for persons 50 years of age or older.
  • Persons aged ≥ 2 years with chronic cardiovascular or pulmonary diseases, diabetes mellitus, alcoholism, chronic liver disease, cerebrospinal fluid leaks, or functional/anatomic asplenia.
  • Immunocompromised persons (e.g., HIV infection, leukemia, lymphoma, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplant recipients).

Contraindications

• Hypersensitivity to any component of the vaccine.
• Anaphylactic reaction to polysaccharide pneumococcal vaccine.

Warnings and Precautions

• General:
  • Severe hypersensitivity or anaphylactoid reactions; epinephrine must be available.
  • Timing of vaccination is critical for patients undergoing chemotherapy or radiation therapy.
  • Immunocompromised patients may have a reduced antibody response.
  • Vaccine may not prevent disease caused by capsular types not included in the vaccine.

Adverse Reactions

• Common: Injection site reactions (pain, soreness, erythema, warmth, swelling), fever.
• Uncommon: Asthenia, myalgia, headache, lymphadenopathy, nausea, vomiting, rash, chills.
• Rare: Anaphylactoid reactions, serum sickness, angioneurotic edema, thrombocytopenia, hemolytic anemia, Guillain-Barré syndrome, febrile convulsions.

Drug Interactions

• Can be administered with influenza vaccine (separate injection sites).
• Should not be given concurrently with ZOSTAVAX® (zoster vaccine).

Dosage and Administration

• Dose: Single 0.5 mL injection given intramuscularly or subcutaneously.
• Revaccination: Generally not recommended, except for high-risk individuals at least five years after the initial dose.

Storage and Stability

• Store refrigerated at 2°C to 8°C. Do not freeze. Protect from light.
• Multi-dose vials should be used immediately after opening or within 48 hours if stored in a refrigerator.