DESCRIPTION

PNEUMOSIL [Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)] (10- valent) is a sterile suspension of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F individually conjugated by using 1 cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry (CDAP) to non-toxic diphtheria CRM197 protein. The polysaccharides are chemically activated and then covalently linked to the protein carrier CRM197 to form the glycoconjugate.
Individual conjugates are compounded and then polysorbate 20 and aluminium phosphate are added to formulate the vaccine. The potency of the vaccine is determined by the quantity of the saccharide antigens and the saccharide-to-protein ratios in the individual glycoconjugates. The vaccine meets the requirements of WHO, IP and BP when tested by the methods outlined in WHO TRS 977, IP and BP.

INDICATION

Active immunization against 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.
The use of vaccine should be determined on the basis of relevant recommendations and take into consideration the disease impact by age and regional epidemiology.

DOSAGE AND ADMINISTRATION (For Intramuscular use only):

The dose is 0.5 ml given intramuscularly, with care to avoid Injection into or near nerves and blood vessels. The product is a suspension containing an adjuvant, shake vigorously immediately prior to use to obtain a homogenous, whitish turbid liquid in the vaccine container. The vaccine should be given by intramuscular injection. The preferred sites are anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in young children. The vaccine should not be injected in the gluteal area. Do not administer PNEUMOSIL (10-valent) intravascularly. The vaccine should not be injected intradermally, subcutaneously or intravenously, since the safety and immunogenicity of these routes have not been evaluated.
Once opened, multi-dose vials should be kept between +2°C and +8°C. Multi-dose vials of PNEUMOSIL (10-valent) from which one or more doses of vaccine have been removed during an immunization session may be used in subsequent immunization sessions for up to a maximum of 28 days, provided that all of the following conditions are met (as described in the WHO policy statement: Handling of multi dose vaccine vials after opening, WHO/IVB/14.07).