|
Indication |
Booster
dose for immunity against
diphtheria, tetanus, pertussis and Haemophilus influenzae type b |
|
Proprietary Name |
TriHIBit (Diphtheria, Tetanus (acellular)
Pertussis and Haemophilus influenzae type
b combined) |
|
Manufacturer |
sanofi pasteur |
|
Viability |
Inactivated |
|
Microorganism |
Corynebacterium diphtheriae, Clostridium
tetani, Bordetella pertussis, Hepatitis B
virus, Polioviruses type 1, 2, and 3 |
|
Ages
|
2-18 months |
|
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 |
|
Excipients |
Formaldehyde, ≤100 mcg
Gelatin
Polysorbate 80 |
|
Adjuvant |
Aluminum potassium sulfate, ≤0.17 mg |
|
Allergens |
Stopper vial may contain dry natural latex
rubber |
|
Preservatives |
Thimerosal, ≤0.3 mcg |
|
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 date |
November 2009 |
|
updated
June 2011 |