|
Indication |
For active immunization against diphtheria,
tetanus, and pertussis |
|
Proprietary Name |
ADACEL |
Boostrix |
|
Manufacturer |
sanofi pasteur |
GlaxoSmitKline |
|
Viability |
|
Inactivated |
|
Microorganism |
Bordetella pertussis
Corynebacterium diphtheriae
Clostridium tetani |
Bordetella pertussis
Corynebacterium diphtheriae
Clostridium tetani |
|
Dose |
0.5 mL |
0.5 mL |
|
Route |
Intramuscular |
Intramuscular |
|
Dose form |
Suspension |
Suspension |
|
Appearance |
White, homogenous, cloudy liquid after
shaking |
Homogeneous, turbid white after shaking |
|
Concentration (per 0.5 mL) |
Tetanus toxoid, 5 Lf
Diphtheria toxoid, 2 Lf
Pertussis toxin (detoxified), 2.5 mcg
FHA, 5 mcg
PRN, 3 mcg
Fimbriae types 2 and 3, 5 mcg |
Diphtheria Toxoid, 2.5 Lf
Tetanus Toxoid, 5 Lf
Pertactin, 2.5 mcg
FHA, 8 mcg
PT (inactivated), 8 mcg |
|
Preservatives/dose |
None |
None |
|
Adjuvants/dose |
Aluminum phosphate, 1.5 mg |
Sodium Chloride, 4.5 mg
Aluminum Adjuvant,
≤
0.39 mg |
|
Excipients |
Formaldehyde,
≤ 5 mcg
Glutaraldehyde, <50 ng
2-phenoxyethanol, 3.3 mg |
Formaldehyde, ≤100 mcg
Polysorbate 80 (Tween 80), ≤100 mcg |
|
Allergens |
|
Stopper vial may contain dry natural latex
rubber |
|
Media |
|
|
|
Bordetella pertussis |
Stainer-Scholte |
Stainer-Scholte liquid |
|
Corynebacterium diphtheria |
Mueller's |
Fenton medium containing a bovine extract |
|
Clostridium tetani |
Mueller-Miller casamino acide |
Lantham medium derived from bovine casein |
|
Packaging |
Single dose vials |
Single Dose vials and prefilled syringes |
|
Routine Storage |
2 to 8°
C (35-46°
F)
Do not freeze |
2 to 8°
C (35-46°
F)
Do not freeze |
|
updated July 2005 |