A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Imovax Warnings, Precautions, Pregnancy, Nursing, Abuse - Rabies Vaccine
Imovax Warnings, Precautions, Pregnancy, Nursing, Abuse - Rabies Vaccine
WARNINGS
SYRINGES IN THIS PACKAGE TO
DELIVER INTRADERMALlY ONE DOSE (0.1 ML) OF IMOVAX R.B.E.
I.D., R.B.E. VACCINE
MUST NOTE USED FOR POST-EXPOSURE
IMMUNIZATION.
The full 0.1 ml dose
should be given intradermally.
Recently a significant
increase has been noted of “immune complex-like” reactions in persons
receiving booster doses
of HDCV by the intradermal
(0.1 ml) or intramuscular
(1.0 ml) route. (10,11) The illness
characterized by onset 2-21 days post-booster, presents with a generalized
urticaria and may also include arthralgia,
arthritis, angioedema,
nausea, vomiting, fever
and malaise. In no
cases were the illnesses life-threatening. Preliminary data suggest
this “immune complex- like” illness
may occur in up to 6% of persons receiving booster
doses of Rabies Vaccines and much less frequently in persons receiving
primary immunization.
There is preliminary evidence that beta
propiolactone
altered human albumin
induces most of the allergic reactions. (9,12)
Persons who travel from the U.S. to developing countries and receive
their pre-exposure vaccination
abroad or within 30 days before leaving should be immunized by the
intramuscular
(IM) route (3 X 1.0 ml). Two cases of neurologic illness
resembling Guillain-Barré syndrome
(13,14), a transient
neuroparalytic illness, that resolved without sequelae in 12 weeks,
and a focal subacute
central nervous
system disorder
temporarily associated with HDCV, have been reported. (15) All serious
systemic neuroparalytic
or anaphylactic reactions to a Rabies Vaccine should be immediately
reported to the state
health department or
the Division of Viral Diseases, Center for Infectious Diseases,
C.C. 404-329-3095 during
working hours, or 404-329-2888 at other times. (9)
Persons previously vaccinated successfully against rabies
and who come in contact
with a rabid or potentially
rabid animal
should have the wounds cleansed and receive a post-exposure dose
of 1.0 ml of Rabies Vaccine
intramuscularly, followed by a second 1.0 ml
dose on Day 3. Intradermal
immunization must
not be used. Rabies Immune Globulin should NOT be given.
PRECAUTIONS
General
When a person with a
history of hypersensitivity
must be given Rabies Vaccine, antihistamines may be given; epinephrine
(1:1000) should be readily available to counteract
anaphylactic reactions, and the person should be carefully observed
after immunization. While the concentration of antibiotics in each
dose of vaccine
is extremely small, persons with known hypersensitivity
to any of these agents could manifest
an allergic reaction. While the risk
is small, it should be weighed in light
of potential risk of contracting rabies.
Drug Interactions
Antimalarial drugs such
as chloroquine have been associated with a reduction
in the antibody response
to Rabies Vaccine administered by the intradermal
route. Although it is apparent
that antimalarial agents are not the sole
factor responsible for
the reduced antibody
response, it is recommended that persons on corticosteroids and
other immunosuppressive drugs receive Rabies Vaccine (3 doses/1.0
ml each) by the intramuscular
route until more definitive
data is available. (16,17,18)
Pregnancy Category C
Animal reproduction
studies have not been conducted with Imovax Rabies I.D., Rabies
Vaccine. It is also not known whether the product
can cause fetal
harm when administered to a pregnant woman or can affect
reproductive capacity.
Rabies Vaccine should be given to a pregnant
woman only if clearly
needed. Pre-exposure immunization
should be carefully considered and may be indicated if there is
substantial risk of rabies
exposure.
Pediatric Use
Although specific
intradermal studies
in children have not been conducted, vaccine
given to children intramuscularly (1.0 ml) has been shown to be
safe. There are no known
specific hazards expected
from intradermal
use of the vaccine in
children. (19)
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