|
Indication |
For immunization against Haemophilus influenzae type b and against infection caused by all known subtypes of Hepatitis B virus in infants born of HBsAg-negative mothers |
|
Proprietary Name |
Comvax |
|
Manufacturer |
Merck |
|
Viability |
Inactivated |
|
Microorganism |
H. influenzae type b, Virus family
Hepadnaviridae |
|
Approved Ages |
6 weeks - 15 months |
|
Dose |
0.5 mL |
|
Route |
Intramuscular |
|
Dose form |
Suspension |
|
Appearance |
Slightly opaque, white suspension |
|
Concentration (per 0.5 mL) |
Hib polysaccharide, 7.5 mcg
Hepatitis B surface antigen, 5 mcg |
|
Excipients |
Aluminum (as amorphous aluminum hydroxide), 225 mcg
Sodium borate (decahydrate) as pH stabilizer, 35 mcg
Yeast protein, ≤1%
Formaldehyde,
≤0.0004% |
|
Adjuvant |
Neisseria meningitides OMP, 125mcg
Aluminum (as amorphous aluminum hydroxide), 225 mcg |
|
Allergens |
Vial stopper contains dry natural latex rubber |
|
Preservatives |
None |
|
Media |
Hib: Complex fermentation media
Hepatitis B: S. cerevisiae |
|
Packaging |
Box of 10 single-dose vials |
|
Routine storage |
2 to 8°
C (36-46°
F)
Do Not Freeze |
|
Package Insert Date |
December 2010 |
|
updated January 2011 |