Uni 5 Description

Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis-B (rDNA) and Haemophilus influenzae Type b Conjugate Vaccine (Adsorbed) is a sterile suspension for injection which contains diphtheria (D), tetanus (T) toxoids, whole cell inactivated pertussis bacteria (wP), purified major surface antigen of the hepatitis B virus (HBV), adsorbed on aluminium salts and conjugated Haemophilus influenzae type b polysaccharide.
The Diphtheria and Tetanus toxoids are prepared from the toxins of cultures of Corynebacterium diphtheriae and Clostridium tetani by formalin inactivation using established technology. The Pw component is obtained by heat inactivation of phase I culture of Bordetella pertussis bacteria.
The surface antigen of HBV (HBsAg) is produced from genetically-engineered yeast cells (Pichia pastoris) which carry the gene coding for the major surface antigen of the HBV. This HBsAg expressed in yeast cells is purified by several physico-chemical steps.
The capsular polysaccharide is produced from cultures of Haemophilus influenzae type b and purified. Purified polysaccharide (PRP) is covalently bound to tetanus toxoid (T) to produce PRP-T conjugate.
1 dose (0.5 mL) contains Diphtheria Toxoid 25 Lf (not less than 30 IU), Tetanus Toxoid 5.5 Lf (not less than 60 IU*), B. Pertussis (Whole cell) 16 IOU (not less than 4 IU**), r-HBsAg 12.5 micrograms, Purified capsular polysaccharide of Hib (PRP) covalently linked to 20-36.7 micrograms of tetanus toxoid 11 micrograms, Al⁺⁺⁺ (as AlPO₄) not more than 1.25 mg. Preservative: Thiomersal BP/Ph. Eur 0.01% w/v.
* Not less than 40 IU when tested in guinea pigs and not less than 60 IU when tested in mice.
** The lower fiducial limit (p=0.95) of the estimated potency is not less than 2.0 IU.
The product is a whitish turbid liquid in which the mineral carriers, tends to settle down slowly on keeping and disperse uniformly upon shaking.
Excipients/Inactive Ingredients: Al⁺⁺⁺ (as AlPO₄) (Adjuvant), Thiomersal BP/Ph. Eur (Preservative), Sodium Chloride (Isotonic agent), Sodium Hydroxide (For pH adjustment), Hydrochloric Acid (For pH adjustment), Water for Injection (q.s.).