Pentavac

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Diphtheria Toxoid; Haemophilus Influenza Type b Conjugate; hepatitis B, purified antigen; Tetanus Toxoid; Bulk Pertussis Vaccine

Available from:

SM PHARMACEUTICALS SDN. BHD.

INN (International Name):

Diphtheria Toxoid; Haemophilus Influenza Type b Conjugate; hepatitis B, purified antigen; Tetanus Toxoid; Bulk Pertussis Vaccine

Units in package:

50vial Vials; 50vial Vials

Manufactured by:

SERUM INSTITUTE OF INDIA PRIVATE LIMITED

Patient Information leaflet

Not applicable

Summary of Product characteristics

Sii Diphtheria, Tetanus, Pertussis,
Hepatitis B and Haemophilus influenzae type b
Conjugate Vaccine AdsorbedDESCRIPTION
PENTAVAC (Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed)
as supplied by Serum Institute of India Pvt. Ltd., is a homogeneous liquid containing purified diphtheria and tetanus toxoids,
inactivated whooping cough (pertussis) organisms, highly purified, non-infectious particles of Hepatitis B surface antigen (HBsAg)
and Hib component as a bacterial subunit vaccine containing highly purified, non-infectious Haemophilus Influenzae Type b (Hib)
capsular polysaccharide chemically conjugated to a protein (Tetanus Toxoid). Surface antigen of the Hepatitis B virus (HBV) is
obtained by culturing genetically engineered Hansenula polymorpha yeast cells having the surface antigen gene of the Hepatitis
B virus. The Hepatitis B surface antigen (HBsAg) expressed in the cells of Hansenula polymorpha is purified through several
chemical steps using recombinant DNA procedures. Thiomersal is added as preservative.
The Hib polysaccharide is prepared from capsular polysaccharide of H. influenzae type b strain and after activation is coupled to
Tetanus Toxoid.
The vaccine meets the requirements of W.H.O. and B.P. when tested by the methods outlined in W.H.O., TRS. 980 (2014),
978 (2013), 897 (2000) and B.P.
Each dose of 0.5 ml contains
Diphtheria Toxoid 25 Lf ( 30 IU )
Tetanus Toxoid 2.5 Lf ( 40 IU )
B. pertussis (whole cell) 16 OU ( 4.0 IU)*
HBsAg (rDNA) 10 mcg
Purified capsular Hib Polysaccharide (PRP)
Conjugated to Tetanus Toxoid (carrier protein) 10 mcg
+++
Adsorbed on Aluminium Phosphate, Al 1.25 mg
Preservative: Thiomersal 0.005 %
*The lower fiducial limit (P=0.95) of the estimated potency is not less than 2.0 IU.
Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed does not prevent
Hepatitis caused by other agents different from HBV (as virus A, C and E) but it is considered effective in preventing Hepa