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 M?rieux S?rums 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 g of purified capsular polysaccharide conjugated to 24 g 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 g of purified capsular polysaccharide conjugated to 24 g 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 g of purified capsular polysaccharide conjugated to 24 g of inactivated tetanus toxoid, 8.5% of sucrose, 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid and 46.8 g 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...

Read All Potential Side Effects and See Pictures of ActHIB


ActHIB Patient Information Including Side Effects

Brand Names: Acthib, Hiberix

Generic Name: haemophilus b conjugate (PRP-T) vaccine (Pronunciation: hem OFF il us B KON ju gate)

  • What is haemophilus B conjugate (PRP-T) vaccine (ActHIB)?
  • What are the possible side effects of this vaccine (ActHIB)?
  • What is the most important information I should know about this vaccine (ActHIB)?
  • What should I discuss with my healthcare provider before receiving this vaccine (ActHIB)?
  • How is this vaccine given (ActHIB)?
  • What happens if I miss a dose (ActHIB)?
  • What happens if I overdose (ActHIB)?
  • What should I avoid before or after receiving this vaccine (ActHIB)?
  • What other drugs will affect haemophilus B conjugate (PRP-T) vaccine (ActHIB)?
  • Where can I get more information?

What is haemophilus B conjugate (PRP-T) vaccine (ActHIB)?

Haemophilus B is a type of influenza (flu) caused by bacteria.

Haemophilus B bacteria can infect the lungs or throat, and can also spread to the blood, bones, joints, brain, or spinal cord. It can cause breathing problems or meningitis, and these infections can be fatal.

Haemophilus B disease can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The bacteria can also be passed through contact with objects the infected person has touched, such as a door handle, or other surface. The bacteria can also be passed through kissing, or sharing a drinking glass or eating utensil with an infected person.

Haemophilus B conjugate vaccine is used to prevent infection caused by haemophilus B bacteria, and is sometimes combined with vaccines to protect against other diseases. Haemophilus B vaccine will not protect against other types of influenza.

Haemophilus B conjugate vaccine works by exposing your child to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Haemophilus B conjugate vaccine is for use in children between the ages of 2 months and 4 years old.

Like any vaccine, haemophilus B conjugate vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (ActHIB)?

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: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if your child has any of these serious side effects:

  • extreme drowsiness, fainting;
  • fussiness, irritability, crying for an hour or longer;
  • seizure (black-out or convulsions); or
  • high fever (within a few hours or a few days after the vaccine).

Less serious side effects may include:

  • redness, pain, swelling, or a lump where the shot was given;
  • low fever;
  • mild fussiness or crying;
  • joint pain, body aches;
  • drowsiness; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What is the most important information I should know about this vaccine (ActHIB)?

The haemophilus B conjugate vaccine is given in a series of shots. In most cases, this vaccine is given as 2 separate shots, 2 months apart. A booster dose is then given 2 months after the last shot, or no later than 18 months of age.

Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots 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.

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