Clinical Information
Gen. Code and Des.
63833 rabies vacc, human diploid/PF INTRAMUSC VIAL 2.5 UNIT
GCN and Des.
99542 rabies vacc, human diploid/PF INTRAMUSC VIAL 2.5 UNIT
Strength
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80120000 VACCINES
Active Ingredients
3041 rabies vaccine, human diploid cell
9870 preservative free
SPL UNCLASSIFIED SECTION
WISTAR RABIES VIRUS STRAIN PM-1503-3M - GROWN IN HUMAN DIPLOID CELL CULTURES
DESCRIPTION
The Imovax® Rabies Vaccine produced by Sanofi Pasteur SA is a sterile, stable, freeze-dried suspension of rabies virus prepared from strain PM-1503-3M obtained from the Wistar Institute ...
CLINICAL PHARMACOLOGY
Pre-exposure immunization - High titer antibody responses to the Imovax Rabies vaccine made in human diploid cells have been demonstrated in trials conducted in England (1), Germany (2) (3) ...
INDICATIONS AND USAGE
Imovax Rabies is a vaccine indicated for pre-exposure and post-exposure prophylaxis against rabies. Imovax Rabies vaccine is approved for use in all age groups. 1. Rationale of ...
CONTRAINDICATIONS
Pre-exposure Prophylaxis - Do not administer to anyone with a known life-threatening systemic hypersensitivity reaction to any component of the vaccine (see WARNINGS, PRECAUTIONS, and DESCRIPTION ...
WARNINGS
Do not inject the vaccine into the gluteal area as administration in this area may result in lower neutralizing antibody titers. (11) The product is provided in a single dose vial. Because the ...
PRECAUTIONS
IN ADULTS AND CHILDREN THE VACCINE SHOULD BE INJECTED INTO THE DELTOID MUSCLE. IN INFANTS AND SMALL CHILDREN, THE ANTEROLATERAL ASPECT OF THE THIGH MAY BE PREFERABLE. When a person with a history ...
ADVERSE REACTIONS
Once initiated, rabies prophylaxis should not be interrupted or discontinued because of local or mild systemic adverse reactions to rabies vaccine. Usually such reactions can be successfully ...
DOSAGE AND ADMINISTRATION
The package contains a vial of freeze-dried vaccine, a Luer-Lok™ syringe containing 1.0 mL of diluent with a plunger rod either inserted into the syringe or provided separately, and a sterile ...
HOW SUPPLIED
Imovax Rabies vaccine is supplied in a tamper evident unit dose box with: - One vial of freeze-dried vaccine containing a single dose (NDC 49281-248-58 or 49281-246-58). - One sterile syringe ...
REFERENCES
1 - Aoki FY, Tyrell DAJ, Hill LE. Immunogenicity and acceptability of a human diploid cell culture rabies vaccine in volunteers. The Lancet. 1975 Mar 22;1(7908):660-2. 2 - Cox JH, Schneider LG ...
SPL UNCLASSIFIED SECTION
Product information as of December 2019. US Govt License #1724 - Manufactured by: Sanofi Pasteur SA - Lyon France Distributed by: Sanofi Pasteur Inc. Swiftwater PA 18370 USA - 1-800-VACCINE ...
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 ...
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 - 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 ...
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 ...
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 - 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 ...
INGREDIENTS AND APPEARANCE
