Vaccine Information: IMOVAX RABIES (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 1 mL Vial Label

Rabies
Vaccine
IMOVAX® RABIES

RABIES
(HDCV)

single-dose
vial
(1 mL)

IM only

Rx only

Mfd by: Sanofi Pasteur SA

Lyon France US Govt Lic #1724
Dist by: Sanofi Pasteur Inc.
Swiftwater PA 18370 USA 1-800-VACCINE (1-800-822-2463)

PRINCIPAL DISPLAY PANEL -- 1 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mL Syringe Label

Sterile
Water,
diluent for
reconstitution
USP

single-
dose (1 mL)

Rx only

Contains no preservative

Sanofi Pasteur

PRINCIPAL DISPLAY PANEL -- 1 mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Kit Carton

NDC 49281-252-51
List No 2501

RABIES
(HDCV)

Rabies Vaccine
IMOVAX® RABIES
PRE- AND POSTEXPOSURE
INTRAMUSCULAR IMMUNIZATION ONLY

single-dose
(1 mL)

NOT FOR INTRADERMAL USE

Wistar Rabies Virus Strain PM-1503-3M-Grown in Human Diploid Cell
Cultures-Single Dose-Lyophilized Vaccine, Luer Syringe with Sterile water, diluent for reconstitution USP, one needle for reconstitution.

Rx only

FOR INTRAMUSCULAR INJECTION

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mL Vial Label

NDC 49281-248-58

Rabies
Vaccine
IMOVAX
® RABIES

RABIES
(HDCV)

1
mL

IM only

Rx only

Mfd by: Sanofi Pasteur SA

Lyon France US Govt Lic #1724
Dist by: Sanofi Pasteur Inc.
Swiftwater PA 18370 USA1-800-VACCINE (1-800-822-2463)

PRINCIPAL DISPLAY PANEL -- 1 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mL Syringe Label

NDC 49281-249-01

Sterile
Water,
diluent for
reconstitution

USP

1 mL

Rx only

Contains no preservative

Sanofi Pasteur

PRINCIPAL DISPLAY PANEL -- 1 mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Kit Carton

NDC 49281-250-51
List No 2501

Rabies Vaccine
IMOVAX® RABIES
PRE- AND POSTEXPOSURE
INTRAMUSCULAR IMMUNIZATION ONLY

NOT FOR INTRADERMAL USE

Wistar Rabies Virus Strain PM-1503-3M-Grown in Human Diploid Cell
Cultures-Single Dose-Lyophilized Vaccine, Luer Syringe with Sterile water, diluent for reconstitution
USP, one needle for reconstitution.

FOR INTRAMUSCULAR INJECTION

RABIES
(HDCV)

1 Dose (1 mL)

Rx only

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
IMOVAX RABIES rabies virus strain pm-1503-3m antigen (propiolactone inactivated) and water kit
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-250
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-250-51 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, SINGLE-USE 1 mL
Part 2 1 SYRINGE 1 mL
Part 1 of 2
IMOVAX RABIES rabies virus strain pm-1503-3m antigen (propiolactone inactivated) injection, powder, lyophilized, for suspension
Product Information
Item Code (Source) NDC:49281-248
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) (RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED)) RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) 2.5 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN 100 mg in 1 mL
NEOMYCIN SULFATE 150 ug in 1 mL
PHENOLSULFONPHTHALEIN 20 ug in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-248-58 1 mL in 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103931 06/09/1980 12/07/2021
Part 2 of 2
WATER water injection, solution
Product Information
Item Code (Source) NDC:49281-249
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-249-01 1 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103931 06/09/1980 12/07/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103931 06/09/1980 12/07/2021
IMOVAX RABIES rabies virus strain pm-1503-3m antigen (propiolactone inactivated) and water kit
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-252
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-252-51 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, SINGLE-USE 1 mL
Part 2 1 SYRINGE 1 mL
Part 1 of 2
IMOVAX RABIES rabies virus strain pm-1503-3m antigen (propiolactone inactivated) injection, powder, lyophilized, for suspension
Product Information
Item Code (Source) NDC:49281-246
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) (RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED)) RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) 2.5 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN 100 mg in 1 mL
NEOMYCIN SULFATE 150 ug in 1 mL
PHENOLSULFONPHTHALEIN 20 ug in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-246-58 1 mL in 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103931 10/25/2019
Part 2 of 2
WATER water injection, solution
Product Information
Item Code (Source) NDC:49281-263
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-263-58 1 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103931 10/25/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103931 10/25/2019
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur 578763542 MANUFACTURE (49281-250), MANUFACTURE (49281-252)

Revised: 10/2020 Sanofi Pasteur Inc.

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