Manufacturer SERUM INSTITUTE OF INDIA PRIVATE LIMITED(INDIA)
RegistractionNumber MAL20076001AZ
Content:
Active Ingredients: Saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, and 23F individually conjugated to non-toxic diphtheria CRM197 protein.
Inactive Ingredients: L-Histidine, Succinic acid, Sodium chloride, Polysorbate 20, Aluminium phosphate (adjuvant), Thiomersal (preservative), and water for injections.
Indications: Active Immunization: Used for the prevention of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, and 23F in infants and toddlers from 6 weeks up to 2 years of age. Instructions:
Dosage: 0.5 mL given intramuscularly. Shake vigorously before use to obtain a homogenous, whitish turbid liquid.
Administration: Inject into the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in young children. Avoid injection into or near nerves and blood vessels.
Precautions: Do not administer intradermally, subcutaneously, or intravenously. Multi-dose vials should be kept between +2°C and +8°C. Once opened, multi-dose vials can be used for up to 28 days if stored properly.
Malaysia
