RABAVERT- rabies vaccine

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RABIES VIRUS STRAIN FLURY LEP ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: FK894Q51YE) (RABIES VIRUS STRAIN FLURY LEP ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:FK894Q51YE)

Available from:

A-S Medication Solutions

INN (International Name):

RABIES VIRUS STRAIN FLURY LEP ANTIGEN - UNII:FK894Q51YE)

Composition:

RABIES VIRUS STRAIN FLURY LEP ANTIGEN (PROPIOLACTONE INACTIVATED) 2.5 [iU] in 1 mL

Therapeutic indications:

RabAvert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups. Usually, an immunization series is initiated and completed with one vaccine product. No clinical studies have been conducted that document a change in efficacy or the frequency of adverse reactions when the series is completed with a second vaccine product. However, for booster immunization, RabAvert was shown to elicit protective antibody level responses in persons tested who received a primary series with HDCV (4,11). (see also Dosage and Administration section below) Preexposure vaccination consists of three doses of RabAvert 1.0 mL, intramuscularly (deltoid region), one each on days 0, 7, and 21 or 28 (1) (see also Table 1 for criteria for preexposure vaccination). Preexposure vaccination does not eliminate the need for additional therapy after a known rabies exposure (see also Dosage and Administration section, subsection C). Preexposure vaccina

Product summary:

RabAvert product presentation is listed in Table 3 below: Presentation Carton NDC Number Components Single dose kit 63851-501-02 1 vial of freeze-dried vaccine containing a single dose [NDC 63851-511-11] 1 disposable pre-filled syringe of Sterile Diluent for reconstitution (1 mL) [NDC 63851-512-12] 1 small needle for injection (25 gauge, 1 inch) and 1 long needle for reconstitution (21 gauge, 1 ½ inch) CAUTION: Federal law prohibits dispensing without a prescription. RabAvert should be stored protected from light at 2°C to 8°C (36°F to 46°F). After reconstitution the vaccine is to be used immediately. The vaccine may not be used after the expiration date given on package and container.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

RABAVERT- RABIES VACCINE
A-S MEDICATION SOLUTIONS
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RABAVERT
RABIES VACCINE
RABIES VACCINE FOR HUMAN USE
DES CRIPTION
RabAvert, Rabies Vaccine, produced by Novartis Vaccines and
Diagnostics GmbH is a sterile freeze-
dried vaccine obtained by growing the fixed-virus strain Flury LEP in
primary cultures of chicken
fibroblasts. The strain Flury LEP was obtained from American Type
Culture Collection as the 59th egg
passage. The growth medium for propagation of the virus is a synthetic
cell culture medium with the
addition of human albumin, polygeline (processed bovine gelatin) and
antibiotics. The virus is
inactivated with β-propiolactone, and further processed by zonal
centrifugation in a sucrose density-
gradient. The vaccine is lyophilized after addition of a stabilizer
solution which consists of buffered
polygeline and potassium glutamate. One dose of reconstituted vaccine
contains less than 12 mg
polygeline (processed bovine gelatin), less than 0.3 mg human serum
albumin, 1 mg potassium glutamate
and 0.3 mg sodium EDTA. Small quantities of bovine serum are used in
the cell culture process. Bovine
components originate only from the United States, Australia and New
Zealand. Minimal amounts of
chicken protein may be present in the final product; ovalbumin content
is less than 3 ng/dose (1 mL),
based on ELISA. Antibiotics (neomycin, chlortetracycline, amphotericin
B) added during cell and virus
propagation are largely removed during subsequent steps in the
manufacturing process. In the final
vaccine, neomycin is present at < 1 μg, chlortetracycline at < 20 ng,
and amphotericin B at < 2 ng per
dose. RabAvert is intended for intramuscular (IM) injection. The
vaccine contains no preservative and
should be used immediately after reconstitution with the supplied
Sterile Diluent for RabAvert (Water
For Injection). The potency of the final product is determined by the
NIH mouse potency test using the
US reference standard. The potency of one dose (1.0 mL) RabAvert is at
least 2.5 IU of rabies antigen.
RabAvert i