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
Imogam Rabies Warnings, Precautions, Pregnancy, Nursing, Abuse - Rabies Immune Globulin (Human)
Imogam Rabies Warnings, Precautions, Pregnancy, Nursing, Abuse - Rabies Immune Globulin (Human)
WARNINGS
Rabies Immune Globulin (Human) USP, IMOGAM
® RABIES– HT, is made from human
plasma. Products made from human
plasma may contain infectious
agents, such as viruses,
that can cause disease.
The risk that such
products will transmit
an infectious agent
has been reduced by screening plasma
donors for prior exposure
to certain viruses, by testing for the presence of certain current
virus infections, and
by inactivating and/or removing certain viruses. An
alcohol fractionation
procedure used to purify the immunoglobulin
component removes
and or inactivates both
enveloped and non-enveloped viruses. An
added heat treatment
process (60° C, 10 hours) further inactivates both enveloped
and non-enveloped viruses. Despite these measures, it is still theoretically
possible that known or unknown infectious
agents may be present. All infections thought by a physician
possibly to have been transmitted by this product
should be reported by the physician
or other health- care provider
to the Director of Medical Affairs, Connaught Laboratories, Inc.,
Telephone 1-800-822-2463.The physician should discuss the risks
and benefits of this product
with the patient.
IMOGAM ® RABIES– HT should
be given with caution to patients with a history
of prior systemic allergic
reactions following the administration
of human immune
globulin.
Persons with specific
IgA deficiency
have increased potential
for developing antibodies to IgA
and could have anaphylactic reactions to subsequent administration
of blood products containing
IgA. 38,39
PRECAUTIONS
General
Care is to be taken by the health-care provider
for the safe and effective use of this product.
EPINEPHRINE INJECTION (1:1000) MUST
BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR
DUE TO ANY COMPONENT OF THIS
PRODUCT.
IMOGAM ® RABIES– HT should
not be administered intravenously because of the potential
for serious reactions. Injection should be made intramuscularly
and care should be taken to draw back on the plunger of the syringe
before injection in
order to be certain that
the needle is not in
a blood vessel. Although
systemic reactions
to immunoglobulin preparations are rare, epinephrine
should be available for treatment of acute
anaphylactoid reactions. As
with all preparations given intramuscularly, bleeding
complications may be encountered in patients with bleeding
disorders.
HRIG should never be administered in the same syringe
or into the same anatomical site
as vaccine. Because HRIG may partially suppress active production
of antibody, no
more than the recommended dose
should be given. 1
A separate, sterile
syringe and needle
or a sterile disposable
unit should be used for each patient
to prevent transmission
of hepatitis or other
infectious agents
from person to person.
Needles should not be recapped and should be disposed of according
to biohazard waste
guidelines.
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