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
Acthib Warnings, Precautions, Pregnancy, Nursing, Abuse - Haemophilus b Conjugate Vaccine
Acthib Warnings, Precautions, Pregnancy, Nursing, Abuse - Haemophilus b Conjugate Vaccine
If ActHIB®
or ActHIB®
reconstituted with CLI DTP or ActHIB®
reconstituted with Tripedia®
(TriHIBitTM)
is administered to immunosuppressed persons or persons receiving immunosuppressive
therapy, the expected antibody
responses may not be obtained. This includes patients with asymptomatic
or symptomatic HIV- infection,
21 severe combined immunodeficiency, hypogammaglobulinemia,
or agammaglobulinemia; altered immune
states due to diseases such as leukemia, lymphoma,
or generalized malignancy; or an immune
system compromised by treatment
with corticosteroids, alkylating drugs, antimetabolites or radiation.
22 (Refer to product
inserts for CLI whole-cell DTP and Tripedia®.)
TriHIBitTM
ActHIB®
combined with Tripedia®
by reconstitution should
not be administered to infants younger than 15 months of age.
PRECAUTIONS
General
Care is to be taken by the health-care provider
for the safe and effective use of this vaccine.
EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD
AN ANAPHYLACTIC OR OTHER ALLERGIC
REACTIONS OCCUR DUE TO ANY COMPONENT
OF THE VACCINE.
Prior to an injection of
any vaccine, all known precautions
should be taken to prevent adverse reactions. This includes a review of
the patient's history with respect to possible sensitivity
and any previous adverse reactions to the vaccine
or similar vaccines, previous immunization
history, current health status
(see CONTRAINDICATIONS; WARNINGS
sections) and a current
knowledge of the literature concerning the use of the vaccine
under consideration. (Refer to product
inserts for CLI whole-cell DTP and Tripedia®)
The health-care provider
should ask the parent or guardian
about the recent health status
of the infant or child
to be immunized including the infant's or child's previous immunization
history prior to administration
of ActHIB®
CLI DTP and Tripedia®.
Minor illnesses such as upper respiratory
infection with or without
low grade fever
are not contraindications for use of ActHIB®.23
As reported with Haemophilus
b polysaccharide vaccines,
24 cases of H influenzae type
b disease may occur subsequent
to vaccination and prior to the onset of protective
effects of the vaccine. 18 (See INDICATIONS
AND USAGE section.)
The evidence favors rejection
of a causal relation between
immunization with Hib conjugate
vaccines and earlyonset Hib disease.
25
Antigenuria has been detected in some instances following receipt of
ActHIB®;
therefore, urine antigen
detection may not have definitive
diagnostic value in suspected
H influenzaetype b disease
within one week of immunization. 26
Special care should be taken to ensure that ActHIB®
reconstituted with CLI DTP or Tripedia®
or saline diluent
(0.4% Sodium Chloride) is not injected
into a blood vessel.
Administration of ActHIB®
reconstituted with CLI DTP or ActHIB®
reconstituted with Tripedia®
(TriHIBitTM)
or saline diluent
(0.4% Sodium Chloride) is not contraindicated in individuals with HIV
infection. 22
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 properly disposed.
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