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 Online, Description, Chemistry, Ingredients - Haemophilus b Conjugate Vaccine
Acthib Online, Description, Chemistry, Ingredients - Haemophilus b Conjugate Vaccine
Caution: Federal (USA) law
prohibits dispensing without prescription.
NOTE: Haemophilus
b Conjugate Vaccine (Tetanus Toxoid Conjugate) - ActHIB®
is identical to Haemophilus
b Conjugate Vaccine (Tetanus Toxoid Conjugate) - OmniHIB®
(distributed by SmithKline Beecham Pharmaceuticals); and is manufactured
by Pasteur Mérieux Sérums Vaccins S.A.
ActHIB®, Haemophilus
b Conjugate Vaccine (Tetanus Toxoid Conjugate), produced by Pasteur Mérieux
Sérums Vaccins S.A. is a sterile,
lyophilized powder which is
reconstituted at the time of
use with either saline diluent
(0.4% Sodium Chloride) or Connaught Laboratories, Inc. (CLI) Diphtheria
and Tetanus Toxoids and Pertussis Vaccine Adsorbed (whole-cell pertussis
vaccine D.P.
or Tripedia®, CLI Diphtheria and Tetanus
Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) (when reconstituted
known as TriHIBitTM) for intramuscular
use only. The vaccine consists
of the Haemophilus b capsular
polysaccharide (polyribosyl- ribitol- phosphate, PRP), a high molecular
weight polymer prepared from
the Haemophilus influenzae type
b strain 1482 grown in a semi-synthetic medium, covalently bound
to tetanus toxoid.1
The lyophilized ActHIB® powder
and saline diluent contain
no preservative. The tetanus
toxoid is prepared by extraction,
ammonium sulfate
purification, and formalin
inactivation of the toxin from
cultures of Clostridium tetani (Harvard strain) grown in
a modified Mueller and Miller medium.2 The
toxoid is filter
sterilized prior to the conjugation
process. Potency of ActHIB® is specified
on each lot by limits on the content of PRP polysaccharide
and protein in each dose
and the proportion of polysaccharide
and protein in the vaccine
which is characterized as high molecular weight
conjugate.
When ActHIB® is reconstituted with
saline diluent, each single dose
of 0.5 mL is formulated to contain 10 µg of purified capsular
polysaccharide conjugated
to 24 µg of inactivated tetanus
toxoid, and 8.5% of sucrose.
When ActHIB® is combined with CLI
DTP vaccine by reconstitution,
each single dose (0.5 mL) is
formulated to contain 10 µg of purified capsular
polysaccharide conjugated
to 24 µg of inactivated tetanus
toxoid 8.5% of sucrose
6.7 Lf of diphtheria toxoid, 5 Lf of tetanus
toxoid, and an estimate of 4 protective
units of pertussis vaccine. Thimerosal (mercury derivative) 1:10,000 is
added as a preservative
to CLI DTP vaccine. (Refer to product
insert for CLI whole-cell DTP.)
When ActHIB® is combined with Tripedia®
(TriHIBitTM) by reconstitution
for booster dose, each single dose
(0.5 mL) is formulated to contain 10 µg of purified capsular
polysaccharide conjugated
to 24 µg of inactivated tetanus toxoid, 8.5% of sucrose, 6.7 Lf
of diphtheria toxoid, 5
Lf of tetanus toxoid and 46.8 µg of pertussis
antigens. Thimerosal (mercury derivative) 1:10,000 is added as a preservative
to Tripedia®. (Refer to product
insert for Tripedia®.)
The reconstituted vaccine,
using saline diluent, appears
clear and colorless. The reconstituted vaccine,
using CLI DTP vaccine, appears
whitish in color. TriHIBitTM, the reconstituted
vaccine, using Tripedia® is a homogenous
white suspension.
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