|
Indication |
Induction of active immunity against invasive
diseases caused by Haemophilus
influenzae type b |
|
Proprietary Name |
PedvaxHIB |
ActHIB/OmniHIB |
Hiberix |
|
Manufacturers |
Merck |
sanofi pasteur/
GlaxoSmithKline |
GlaxoSmithKline |
|
Viability |
Inactivated |
Inactivated |
Inactivated
|
|
Microorganism |
H. influenza
Neisseria meningitidis |
H. influenza (tetanus toxoid conjugate) |
Haemophilus b
Conjugate Vaccine (Tetanus Toxoid Conjugate)
Clostridium
tetani
|
|
Dose |
0.5 mL |
0.5 mL |
0.5 mL
|
|
Route |
Intramuscular |
Intramuscular |
Intramuscular
|
|
Dosage form |
Suspension |
Powder for solution |
Sterile,
Lyophilized powder
|
|
Appearance |
Slightly opaque white |
Clear, Colorless after mixing |
Clear, Colorless
after reconstitution
|
|
Concentration (per 0.5 mL) |
Haemophilus b PRP, 7.5 mcg
|
Polysaccharide, 10 mcg |
Hib
Polysaccharide, 10 mcg
|
|
Preservatives |
None |
None |
None
|
|
Adjuvant |
Neisseria meningitides
OMPC, 125 mcg
Aluminum hydrosyphosphate sulfate, 225 mcg
Sodium chloride, 0.9% |
Tetanus toxoid, 24 mcg |
Tetanus toxoid, 25 mcg
|
|
Excipients |
None |
8.5% sucrose, Ammonium sulfate
Formalin |
Lactose, 12.6 mg
Formaldehyde,
Residual ≤0.05mcg
|
|
Allergens |
None |
None |
None
|
|
Media |
Complex fermentation |
Semisynthetic medium |
Synthetic medium
|
|
Packaging |
Box of 10 single-dose vials |
Box of 5 single dose vials packaged with diluent |
Pakcage of 10
Single-dose vials
|
|
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)
Protect from light
Do Not Freeze |
|
updated May 2010 |