|
Components of
DTaP•IPV•Hib VaccineExcipients Table
Allergens Table
Components Table
Indication
For active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b
Proprietary Name
Pentacel
Manufacturer
Viability
Inactivated
Microorganism
Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, Hepatitis B virus, Polioviruses type 1, 2, and 3, Haemophilus influenzae type b strain 1482
Ages
6 weeks - 4 years (prior to 5th birthday)
Dose
0.5 mL
Route
Intramuscular
Dose form
Suspension plus powder
Appearance
uniform, cloudy, white to off-white (yellow tinge)
Concentration (per 0.5 mL)
Diphtheria toxoid, 15 Lf U
Tetanus toxoid, 5 Lf U
Detoxified pertussis toxin, 20 mcg
Filamentous hemagglutinin, 20 mcg
Inactivated polioviruses [40 D-antigen units (DU) Type 1 (Mahoney), 8 DU Type 2 (MEF-1), 32 DU Type 3 (Saukett)]
H. influenzae type b, 10 mcg covalently bound to tetanus toxoid, 24 mcg
Preservatives
None
Aluminum phosphate, 0.33 mg
Formaldehyde (residual), ≤5 mcg
Glutaraldhyde (residual), <50 ng
Bovine serum albumin, ≤50 ng
2-phenoxyethanol (not as a preservative), 3.3 mg
Neomycin, <4 pg
Polysorbate 80, 10 ppm
Allergens
Polymyxin B sulfate, <4 pg
Media
Bordetella pertussis
Stainer-Scholte modified by casamino acids and dimethyl-beta-cyclodextrin
Corynebacterium diphtheria
Modified Mueller’s growth medium. Detoxified using formaldehyde Purified using serial ammonium sulfate fractionation and diafiltration
Poliovirus Type 1, Type 2, Type 3
Each grown in separate cultures of MRC-5 cells, a line of normal human diploid cells
Clostridium tetani
Modified Mueller-Miller casamino acid medium without beef heart infusion. Detoxified using formaldehyde and purified using ammonium sulfate fractionation and diafiltration.
Haemophilus influenzae type b strain 1482
Grown in a semi-synthetic medium. The tetanus toxoid for conjugation to PRP is prepared by ammonium sulfate purification, and formalin inactivation of the toxin from cultures of Clostridium tetani (Harvard strain) grown in a modified Mueller and Miller medium. The toxoid is filter sterilized prior to the conjugation process.
Packaging
Dose Package containing 5 vials of DTaP-IPV component to be used to reconstitute five single dose vials of lyophilized ActHIB vaccine component
Routine storage
2 to 8° C (36-46° F)
Do Not Freeze
Package Insert date December 2009 updated June 2011
This page was last updated on October 03, 2011
© 2011 Institute for Vaccine Safety
