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The dose is 0.5 ml given intramuscularly, with care to avoid injection into or near nerves and blood vessels. 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 SII 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 (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): The vaccine is currently prequalified by WHO.
The vaccine is approved for use for up to 28 days after opening the vial, as determined by WHO.
The expiry date has not passed.
The vaccine vial has been, and will continue to be, stored at WHO - or manufacturer recommended temperatures; furthermore, the vaccine vial monitor, if one is attached, is visible on the vaccine label and is not past its discard point, and the vaccine has not been damaged by freezing.
Instruction for Use: For 1 dose (Single dose)/5 dose (Multi Dose): 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 visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In event of either being observed, discard the vaccine.
The vaccine should be allowed to reach room temperature before use.
When using a Multi Dose vial, each 0.5 ml dose should be withdrawn using a sterile needle and syringe; precautions should be taken to avoid contamination of the contents.
Vaccination Schedule: SII PNEUMOSIL (10-valent) is to be administered as a three-dose primary series at 6, 10, and 14 weeks of age or 2, 3 and 4 months of age or 2, 4 and 6 months of age, with or without, depending on recommended dosing schedule, a booster dose at 9-10 or 12-15 months of age. The minimum interval between doses should be 4 weeks. If a booster dose is given, it should be at least 6 months after the last primary dose. (See Table 2.)
Click on icon to see table/diagram/imageFor children who are beyond the age of routine infant schedule, the following SII PNEUMOSIL (10-valent) schedule is proposed: The catch-up schedule, for children 7 months through 2 years of age who have not received SII PNEUMOSIL (10-valent): (see Table 3.)
Click on icon to see table/diagram/image