S359803

PCV, 13-val., 4 dose vial


Pneumococcal conjugate vaccine, 13-valent – 4-dose vial
With Vaccine Vial Monitor (VVM)

Indicative Price 11.00 USD
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General Description:
Pneumococcal conjugate vaccine, 13-valent-4 dose vial

Technical specifications:
PREVENAR 13 (pneumococcal 13-valent conjugate vaccine) is a sterile suspension. The vaccine is composed of saccharides of the capsular antigen of Streptococcus pneumoniae (S. pneumoniae), serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, individually conjugated to diphtheria CRM197 protein, a nontoxic variant of diphtheria toxin.
PREVENAR 13 is manufactured as a liquid preparation. After shaking, the vaccine is a homogenous, white suspension.
PREVENAR 13 4-dose vial contains the preservative 2-Phenoxyethanol

COMPOSITION
Paediatric Dose
Volume per dose0.5mL
Pneumococcal polysaccharide for serotypes
1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F & 23F2.2g of each
Pneumococcal polysaccharide for serotype 6B4.4g

Diphtheria protein CRM197~34g

Aluminum as aluminum phosphate adjuvant0.125mg

2-Phenoxyethanol as preservative4.0mg

Other ingredients:
Polysorbate 80
Sodium chloride
Water-for-injection

Storage and transportation:
Transport and store refrigerated at +2ºC to +8ºC.
DO NOT FREEZE. Discard if the vaccine has been frozen.
Once opened, multi-dose vials should be kept between +2°C and +8°C. Multi-dose vials of Prevenar 13 from which one or more doses of vaccine have been removed during an immunisation 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:

The expiry date has not passed.
The vaccines are stored under appropriate cold chain conditions.
The vaccine vial septum has not been submerged in water.
Aseptic technique has been used to withdraw all doses.
The vaccine vial monitor (VVM), if attached, has not reached the discard point
Vaccine Vial Monitors (VVMs) have been applied to the vial label on all PREVENAR 13 Multidose Vials manufactured by Pfizer Limited. The colour dot which appears on the vial label is the VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its colour will change progressively. As long as the colour of this square is lighter than the colour of the ring, then the vaccine can be used. As soon as the colour of the central square is the same colour as the ring or of a darker colour than the ring, then the vial should be discarded.

Packaging and labeling:
PRESENTATION: Vial, containing 4x0.5ml Doses (25 or 50 vials per package

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