|
Indication |
Induction of active immunity against rabies
virus, either before or after viral exposure |
|
Proprietary Name |
Imovax Rabies |
RabAvert |
|
Manufacturers |
sanofi pasteur |
Novartis |
|
Viability |
Inactivated |
Inactivated |
|
Microorganism |
Virus, genus
Lyssavirus, family Rhabdoviridae |
Virus, genus
Lyssavirus, family Rhabdoviridae |
|
Dose |
1.0 mL |
1.0 mL |
|
Route |
Intramuscular |
Intramuscular |
|
Dose form |
Powder |
Powder |
|
Appearance |
Creamy white to orange - After reconsitution,
pink - red |
White,
freeze-dried - After reconstitution, clear to
slightly opaque, colorless suspension |
|
Concentration (per 1.0 mL) |
Rabies antigen,
≤
2.5 IU |
Rabies antigen,
≤
2.5 IU |
|
Preservatives |
None |
None |
|
Adjuvant |
None |
None |
|
Excipients |
Phenol red indicator, 20 mg |
Potassium
glutamate, 1 mg
Polygeline, 12 mg
Human Serum
Albumin, <0.3 mg
Sodium EDTA, 0.3
mg |
|
Allergens |
Albumin, <100 mg
Neomycin sulfate,
< 150 mcg |
Neomycin, < 1 mcg
Bovine gelatin (polygeline),
< 12 mg
Ovalbumin, < 3 ng
Bovine serum used
in cell culture process
Chicken protein,
trace amounts
Chlortetracycline,
< 20 ng
Amphotericin B,
< 2 ng |
|
Media |
Human diploid
cells, MRC5 strain |
Synthetic cell
culture medium with the addition of human
albumin, polygeline, antibiotics |
|
Packaging |
Single dose vial
with diluent and syringe/needle |
Single dose vial
with diluent and syringe/needles |
|
Routine Storage |
2 to 8° C (36-46°
F)
Do not freeze |
2 to 8° C (36-46°
F)
Use
immediately after reconstitution |
|
updated August 2005 |