RABAVERT- rabies vaccine kit

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

GlaxoSmithKline Biologicals SA

INN (Algemene Internationale Benaming):

RABIES VIRUS STRAIN FLURY LEP ANTIGEN - UNII:FK894Q51YE)

Samenstelling:

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

therapeutische indicaties:

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 1 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 Preexposure Vaccination: See Table 1 and DOSAGE AND ADMINISTRATION. Preexposure vaccination consists of 3 doses of RabAvert 1.0 mL given intramuscularly (deltoid region), 1 each on Days 0, 7, and 21 or 281 (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 DOSAGE AND ADMINISTRATION: Postexposure Prophylaxis of Previously Im

Product samenvatting:

RabAvert product presentation is listed in Table 3. Presentation Carton NDC Number Components Single-dose kit 58160-964-12 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.

Autorisatie-status:

Biologic Licensing Application

Productkenmerken

RABAVERT- RABIES VACCINE
GLAXOSMITHKLINE BIOLOGICALS SA
---------- PRESCRIBING INFORMATION
RABAVERT
RABIES VACCINE
RABIES VACCINE FOR HUMAN USE
DESCRIPTION
RabAvert Rabies Vaccine produced by GlaxoSmithKline GmbH is a sterile,
freeze-dried vaccine
obtained by growing the fixed-virus strain Flury Low Egg Passage (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 that consists of buffered
polygeline and potassium glutamate. One dose of reconstituted vaccine
contains ≤12 mg polygeline
(processed bovine gelatin), ≤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 ≤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 ≤10 mcg, chlortetracycline at ≤200 ng, and amphotericin
B at ≤20 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 National
Institutes of Health (NIH) mouse potency
test using the United States (US) reference standard. The potency of 1
dose (1.0 mL)