HepB vaccine, pediatric, vial of 1 dose

General Description:
Hepatitis B vaccine, vial of single dose

The vaccine is a sub-unit viral vaccine containing highly purified, non-infectious particles of hepatitis B surface antigen (HBsAg), produced by DNA recombinant technology in yeast cells. The vaccine is adsorbed onto aluminum hydroxide. Thimerosal is used as a preservative (0.01w/v%). Each 0.5ml dose contains 10mg HbsAg.

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:
The vaccine should be shaken before use. It should be injected intramuscularly into the anterolateral aspect of the thigh in infants, or into the deltoid muscles of older children or adults. One dose is 0.5ml. A sterile syringe and sterile needle should be used for each injection.

Once opened, multi-dose vials should be kept between +2°C and +8°C.
Multi-dose vials of hepatitis B vaccine 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 4 weeks, provided that all of the following conditions are met (as described in the WHO policy statement: The use of opened multi dose vials in subsequent immunization sessions. WHO/V&B/00.09):

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

Immunization Schedule:
In countries where perinatal transmission of hepatitis B is common, the first dose should be given as soon as possible after birth. If perinatal transmission is uncommon, or if delivery at birth is not feasible, the first dose can be given with the first dose of DTP. The second dose should be administered one month after the first dose. The third dose should be administered one to twelve months after the second dose.

Hepatitis B vaccine can be given safely and effectively at the same time as BCG, DTP, measles, polio (OPV or IPV), haemophilus influenzae type b, and yellow fever vaccines and vitamin A supplementation. If hepatitis B vaccine is given at the same time as other vaccines, it should be administered at a separate 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- Hep B).

Transport ad Storage:
Hepatitis B vaccine should be stored and transported between +2°C and +8°C. Vaccine must not be frozen.