Pneumocon 13
Brand Name: Pneumocon 13
Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine, 13- Valent (Adsorbed)
Active
Registration Number
BR-1452
Dosage Form
Suspension for Injection (IM)
Issuance Date
November 3, 2023
Expiry Date
November 3, 2028
Product Information
Philippine FDA product specifications and classification details
Product Specifications
Dosage StrengthEach dose (0.5 mL) contains the capsular polysaccharide of the following Streptococcus pneumoniae serotypes: Pneumococcal Polysaccharide Serotype 6B
Pneumococcal Polysaccharide Serotype 18C
Pneumococcal Polysaccharide Serotype 4, 23F
Pneumococcal Polysaccharide Serotype 7F Pneumococcal Polysaccharide Serotype 14, 19F Pneumococcal Polysaccharide Serotype 1, 19A Pneumococcal Polysaccharide Serotype 3, 5, 6A, 9V
Conjugated to Tetanus Toxoid carrier protein
6.0 με
3.25 μg
3.0 με
2.85 μg
2.75 μg
2.6 μg
Packaging0.5 mL in 1 mL borosilicate glass vial with chlorinated butyl rubber stopper and combined aluminum-plastic cap (Box of 20's)
Classification
C
Classification
Prescription Drug (RX)
A
Application
Monitored Release (MR) [Reapplication]
Philippine FDA Classification
Active Ingredients (1)
Complete list of active ingredients in this pharmaceutical product.
Pneumococcal Polysaccharide Conjugate Vaccine, 13-
Valent (Adsorbed)Active
Monograph: pneumococcal polysaccharide conjugate vaccine, 13- valent (adsorbed)