IMOVAX RABIES (rabies virus strain pm-1503-3m antigen- propiolactone inactivated and water kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: C4HQF74XMW) (RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:C4HQF74XMW)

Available from:

Sanofi Pasteur Inc.

INN (International Name):

RABIES VIRUS STRAIN PM-1503-3M ANTIGEN - UNII:C4HQF74XMW)

Composition:

RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) 2.5 [iU] in 1 mL

Therapeutic indications:

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. Physicians must evaluate each possible rabies exposure. Local or state public health officials should be consulted if questions arise about the need for prophylaxis. (11) The following factors should be considered before antirabies prophylaxis is initiated. Rabid bats have been documented in the 49 continental states, and bats are increasingly implicated as important wildlife reservoirs for variants of rabies virus transmitted to humans. Transmission of rabies virus can occur from minor, seemingly underappreciated or unrecognized bites from bats (see Table 2). (11) Raccoons, skunks, and foxes are the terrestrial carnivores most often infected with rabies in the United States. Suggestive clinical signs of rabies among wildlife cannot be interpreted reliably. All bites by such wildlife should be considered possible exposures to rabies virus. Post-exposu

Product summary:

Imovax Rabies vaccine is supplied in a tamper evident unit dose box with: Packaged as NDC 49281-250-51 or 49281-252-51. The freeze-dried vaccine is stable if stored in the refrigerator between 2°C and 8°C (35°F to 46°F). Do not freeze.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

IMOVAX RABIES- RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE
INACTIVATED) AND WATER
SANOFI PASTEUR INC.
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RABIES VACCINE
IMOVAX RABIES
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, Philadelphia, PA.
The virus is harvested from infected human diploid cells, MRC-5
strain, concentrated by
ultrafiltration and is inactivated by beta-propiolactone. One dose of
reconstituted vaccine
contains less than 100 mg human albumin, less than 150 mcg neomycin
sulfate and 20
mcg of phenol red indicator. Beta-propiolactone, a residual component
of the
manufacturing process, is present in less than 50 parts per million.
The finished, freeze-dried vaccine is provided for intramuscular
administration in a single
dose vial containing no preservative. After reconstitution,
immediately administer the full
1.0 mL amount of vaccine. If it cannot be administered promptly,
discard.
The potency of one dose (1.0 mL) of Imovax Rabies vaccine is equal to
or greater than
2.5 international units of rabies antigen.
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), France (4)
and Belgium. (5) Seroconversion was often obtained with only one dose.
With two doses
one month apart, 100% of the recipients developed specific antibody,
and the geometric
mean titer of the group was approximately 10 international units. In
the US, Imovax
Rabies vaccine resulted in geometric mean titers (GMT) of 12.9 IU/mL
at Day 49 and 5.1
IU/mL at Day 90 when three doses were given intramuscularly during the
course of one
month. The range of antibody responses was 2.8 to 55.0 IU/mL at Day 49
and 1.8 to
12.4 IU at Day 90. (6) The definition of a minimally accepted antibody
tite