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Acthib

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ActHIB

ActHIB®
Haemophilus b Conjugate Vaccine
(Tetanus Toxoid Conjugate)

ActHIB

DRUG DESCRIPTION

Caution: Federal (USA) law prohibits dispensing without prescription.

NOTE: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) - ActHIB (haemophilus b conjugate vaccine) ® 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 Aventis Pasteur SA, is a sterile, lyophilized powder which is reconstituted at the time of use with either saline diluent (0.4% Sodium Chloride) or Aventis Pasteur Inc. (AvP) Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (whole-cell pertussis vaccine D.P. or Tripedia®, AvP 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 (haemophilus b conjugate vaccine) ® 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 (haemophilus b conjugate vaccine) ® 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 (haemophilus b conjugate vaccine) ® 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 (haemophilus b conjugate vaccine) ® is combined with AvP 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 AvP DTP vaccine. (Refer to product insert for AvP whole-cell DTP.)

When ActHIB (haemophilus b conjugate vaccine) ® 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 AvP DTP vaccine, appears whitish in color. TriHIBitTM, the reconstituted vaccine, using Tripedia® is a homogenous white suspension.

What are the possible side effects of this vaccine (Acthib, Hiberix)?

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives another haemophilus B vaccine in the future, you will need to tell the child's doctor if the first shot caused any side effects.

Becoming infected with haemophilus B is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction:...

Read All Potential Side Effects and See Pictures of ActHIB »

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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