(Haemophilus type b conjugate vaccine)
Haemophilus influenzae type b bacteria causes serious disease like meningitis in 60% cases and pneumonia, epiglotitis, pericarditis, cellulitis etc in 40% cases. The mortality rate with meningitis is quite high. Post neurological disorders have been seen in many cases after recovery. Under these circumstances vaccine assumes its importance.
Peda Hib™ is a highly purified vaccine prepared from capsular polysaccharide (polyribitol phosphate) short named PRP, covalently bonded to tetanus toxoid protein. Addition of lactose and freeze-drying has resulted in a highly stable vaccine.
This vaccine induces ‘T’- cell dependent immune response in infants that is essential for appropriate initial humoral antibody response and priming for booster effects (anamnestic response) of subsequent vaccinations. Such immune response is lacking in vaccines prepared from unconjugated PRP. Peda Hib™ has been manufactured using the latest technology to remove contaminants eg. L.P.S. pyrogens to make it the least reactogenic but highly immunogenic vaccine. Thus Peda Hib™ is the latest generation vaccine of the best quality in its class.
Peda Hib™ meets the stringent WHO standards for manufacture of Biological Substances, no. 46 and WHO Technical Report Series, No. 897, (2000) and conforms to I.P.
Each Single dose of vaccine contains :
|Purified Polysaccaharide of Haemophilus influenzae type b (PRP)||10 mcg|
|Tetanus Toxoid protein||20 mcg|
|Lactose (I.P.) (Stabilizer)||2 mg|
|Sucrose (I.P.)||42.5 mg|
|Thimerosal (I.P.) ( Preservative)||0.05 mg|
Peda Hib™ is indicated for the prevention, in children from 6 weeks to 5 years age, of invasive diseases caused by Haemophilus influenzae type b e.g. Meningitis, cellulitis, epiglotitis. In no case can the tetanus protein contained in Peda Hib™ replace the routine tetanus vaccination.
One dose in glass vial with appropriate diluent.
DOSAGE AND ADMINISTRATION :
Reconstitute the lyophilisate with the entire content of the diluent provided. Shake gently for full reconstitution. Administer 0.5 ml by intramuscular injection.
|Age at start of immunization||No. of doses ( interval of 1-2 months)||Booster at|
|6 weeks to 6 months||3||15-18 months|
|Between 6 to 12 months||2||15-18 months|
|Between 1 to 5 years||1||Nil|
Children below 24 months, who have invasive Hib disease may not develop adequate Hib antibody concentrations and remain at risk for a second episode of disease. Vaccination of these children is recommended according to current age, ignoring previous Hib doses.
CONTRA- INDICATION :
• Children, with known hypersensitivity to any of the components of the vaccine.
• Children having shown signs of hypersensitivity to previous injection of this vaccine.
• Children with febrile illness should be called for vaccination after recovery.
• Acute infection or febrile illness.
POSSIBLE SIDE EFFECT :
As in the case of any active product, there may be more or less moderate and temporary side effects. Mild local pain, redness, induration or fever may occur during the 48 hrs following injection.
D.P.T. vaccine causes more or less moderate temporary side effects, similar side effects may be observed when Peda HibTM is administered after reconstituting with D.P.T. vaccine.
The vaccine must be stored at 20C to 80C in a refrigerator. Shelf life of Peda HibTM is 3 years from the date of manufacture.