PREVNAR-20 6 Dosage Forms, Strengths, Composition And Packaging

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PREVNAR 20 is a homogeneous white suspension for intramuscular injection supplied in a single-dose pre-filled syringe. Each 0.5 mL dose of the vaccine is formulated to contain approximately 2.2 mcg of each of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F saccharides, 4.4 mcg of 6B saccharide, 51 mcg CRM197 carrier protein, 100 mcg polysorbate 80, 295 mcg succinic acid, 4.4 mg sodium chloride, and 125 mcg aluminum as aluminum phosphate adjuvant.

PREVNAR 20 is supplied in cartons of 1 and 10 single-dose pre-filled syringes, without needles.

The tip cap and plunger stopper of the pre‑filled syringe are not made with natural rubber latex.

 

Table 1. Dosage Forms, Strengths, Composition and Packaging

Route of Administration

Dosage Form/ Strength/Composition

Non-medicinal Ingredients

Intramuscular

Suspension for injection

0.5 mL single-dose syringe

Aluminum phosphate

Polysorbate 80

Sodium chloride

Succinic acid

Water for injection

To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety monitoring, health professionals should record the time and date of administration, quantity of administered dose (if applicable), anatomical site and route of administration, brand name and generic name of the vaccine, the product lot number and expiry date.