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Components of
DTaP and Hib Vaccine
Excipients Table
Allergens Table
Components Table
 

Indication

 Booster dose for immunity against diphtheria, tetanus, pertussis and Haemophilus influenzae type b

Proprietary Name

TriHIBit

Manufacturer

sanofi pasteur

Viability

Inactivated

Microorganism

Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, Hepatitis B virus, Polioviruses type 1, 2, and 3

Dose

0.5 mL

Route

Intramuscular

Dose form

Suspension plus powder

Appearance

Homogenous white suspension

Concentration (per 0.5 mL)

Diphtheria, 6.7 Lf U

Tetanus, 5 Lf U

Pertussis toxin, 23.4 mcg

Filamentous hemagglutinin, 23.4 mcg

H. influenzae type b, 10 mcg

Preservatives

Thimerosal, ≤0.3 mcg

Adjuvant

Aluminum potassium sulfate, ≤0.17 mg

Excipients

Formaldehyde, ≤100 mcg

Gelatin

Polysorbate 80

Allergens

Stopper vial may contain dry natural latex rubber

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

Clostridium tetani  

Peptone-based medium containing a bovine extract

Detoxified using formaldehyde

Purified using serial ammonium sulfate fractionation and diafiltration

Packaging

Single dose (0.5 mL) vial

Routine storage

2 to 8° C (36-46° F)

Do Not Freeze

Package Insert last updated

November 2009

Table updated June 2013

 

This page was last updated on June 2013

© 2014 Institute for Vaccine Safety