Hib vaccine,lyop.,vial of single dose

General Description:
Hib vaccine, lyophilized, vial of single dose

The vaccine is a bacterial subunit vaccine containing highly purified, non-infectious Haemophilus influenzae type b (Hib) capsular polysaccharide chemically conjugated to tetanus protein. The polysaccharide is derived from Hib bacteria grown in chemically defined media, and subsequently purified through a series of ultrafiltration steps. The vaccine is available as a freeze-dried monovalent preparation to be diluted with diluent provided separately for that purpose. Each dose contains 10mg Hib conjugate.

For information on product specifications, refer to the WHO website on Prequalified Vaccines.

https://www.who.int/immunization_standards /vaccine_quality/PQ_vaccine_list_en/en/

Administration:
Immunization consists of a single dose of 0.5ml injected intramuscularly into the anterolateral aspect of the thigh in infants or into the deltoid muscles of older children. A sterile needle and sterile syringe must be used for each injection. Once vaccine has been reconstituted, it should be used the same day (preferably immediately but by no means beyond six (6) hours after reconstitution), and only then if the vial has been maintained between +2°C and +8°C and protected from sunlight. Any opened container remaining at the end of a session (within six hours of reconstitution) should be discarded. The vaccine vial monitor, if present, is removed on reconstitution.

The diluent supplied is specially designed for use with this vaccine. Only this diluent may be used to reconstitute the vaccine. Do not use diluents from other types of vaccine or for Hib vaccine from other manufacturers. Water for injection may NOT be used for this purpose. Using an incorrect diluent may result in damage to the vaccine and/or serious reactions to those receiving the vaccine. Diluent must not be frozen but must be cooled between +2°C and +8°C before reconstitution.

Immunization Schedule:
In general, a three dose primary series is given at the same time as the primary series of DTP. The first dose is given to children at 6 weeks of age or older, and the second and third are given at 4-8 week intervals along with DTP. A three-dose primary series will be considered routine.

Hib vaccine can be given safely and effectively at the same time as BCG, DTP, measles, polio (OPV or IPV), hepatitis B and yellow fever vaccines and vitamin A supplementation. If Hib vaccine is given as a separate injection at the same time as other vaccines, it should be administered at a different site. It should not be mixed in the vial or syringe with any other vaccine unless it is manufactured as a combined product (e.g. DTP-Hib).

Transport and Storage:
Hib vaccine should be stored and transported between +2°C and +8°C. The diluent must not be frozen.