|
Indication |
Induction of active immunity against invasive
diseases caused by encapsulated Haemophilus
influenzae type b |
|
Proprietary Name |
HibTITTER |
PedvaxHIB |
ActHIB/OmniHIB |
|
Manufacturers |
Wyeth-Lederly |
Merck |
sanofi pasteur/
GlaxoSmithKline |
|
Viability |
Inactivated |
Inactivated |
Inactivated |
|
Microorganism |
Haemophilus influenzae
Corynebacterium diptheriae |
H. influenza
Neisseria meningitidis |
H. influenza (tetanus toxoid conjugate) |
|
Dose |
0.5 mL |
0.5 mL |
0.5 mL |
|
Route |
Intramuscular |
Intramuscular |
Intramuscular |
|
Dosage form |
Solution |
Suspension |
Powder for solution |
|
Appearance |
Clear, Colorless |
Slightly opaque white |
Clear, Colorless after mixing |
|
Concentration (per 0.5 mL) |
Haemophilus b saccharide, 10 mcg |
Haemophilus b PRP, 7.5 mcg
Neisseria meningitides
OMPC, 125 mcg
Aluminum hydrosyphosphate sulfate, 225 mcg
Sodium chloride, 0.9% |
Polysaccharide, 10 mcg |
|
Preservatives |
None |
None |
None |
|
Adjuvant |
CRM197 protein, 25 mcg |
N.meningitidis OMP125
Aluminium hydoxide, 225 mcg |
Tetanus toxoid, 24 mcg |
|
Excipients |
None |
None |
8.5% sucrose, Ammonium sulfate
Formalin |
|
Allergens |
None |
None |
None |
|
Media |
Casamino acids
Yeast Extract |
Complex fermentation |
Semisynthetic |
|
Packaging |
Vial, 1 Dose (5 per package) |
Box of 10 single-dose vials |
Box of 5 single dose vials packaged with diluent |
|
Routine Storage |
2 to 8°
C (36-46°
F)
Do Not Freeze |
2 to 8°
C (36-46°
F)
Do Not Freeze |
2 to 8°
C (36-46°
F)
Do Not Freeze |
|
updated July 2005 |