ActHIB

Name: ActHIB

What should I discuss with my healthcare provider before taking this vaccine?

Your child should not receive this vaccine if he or she has ever had an allergic reaction to a haemophilus B or meningococcal vaccine.

If your child has any of these other conditions, this vaccine may need to be postponed or not given at all:

  • severe immune suppression caused by disease (such as cancer, HIV, or AIDS), or by receiving certain medicines such as steroids, chemotherapy or radiation;

  • a history of seizures;

  • an allergy to latex rubber; or

  • a bleeding or blood clotting disorder such as hemophilia or easy bruising.

Your child can still receive a vaccine if he or she has a minor cold. 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.

This vaccine should not be given to anyone age 6 or older, and it is not known whether the vaccine is harmful during pregnancy or while breast-feeding.

This vaccine side effects

Get emergency medical help if your child has signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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 shot caused any side effects.

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

Call your doctor at once if your child has:

  • fussiness, irritability, crying for an hour or longer; or

  • high fever (within a few hours or a few days after the vaccine).

Common side effects may include:

  • vomiting, loss of appetite;

  • diarrhea; or

  • pain, swelling, or redness where the shot was given.

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.

Precautions While Using ActHIB

It is very important that your child return to your doctor’s office at the right time for each dose. Be sure to notify your doctor of any side effects that occur after your child receives this vaccine.

This vaccine may interfere with laboratory tests that check for Hib disease. Make sure your doctor knows that your child received the vaccine if a severe infection occurs during the 2 weeks after the vaccine is given.

Tell the doctor right away if your child is allergic to latex rubber. The vaccine syringes and vials may contain dry natural latex rubber. This may cause an allergic reaction in patients who are sensitive to latex.

Uses of ActHIB

  • It is used to prevent Haemophilus influenzae type b disease.

How is this medicine (ActHIB) best taken?

Use ActHIB as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into a muscle.
  • Your doctor will give this medicine.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

Description

ActHIB ®, Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), produced by Sanofi Pasteur SA, is a sterile, lyophilized powder which is reconstituted with either saline diluent (0.4% Sodium Chloride) or Tripedia®, Sanofi Pasteur Inc. Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) (when reconstituted known as TriHIBit®) for intramuscular administration 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 (Hib) strain 1482 grown in a semi-synthetic medium, covalently bound to tetanus toxoid.1 The lyophilized ActHIB 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 culture medium contains milk derived raw materials (casein derivatives). Further manufacturing process steps reduce residual formaldehyde to levels below 0.5 micrograms (mcg) per dose by calculation. The toxoid is filter sterilized prior to the conjugation process. Potency of ActHIB 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 is reconstituted with saline diluent (0.4% Sodium Chloride), each 0.5 mL dose is formulated to contain 10 mcg of purified capsular polysaccharide conjugated to 24 mcg of inactivated tetanus toxoid, and 8.5% of sucrose.

When ActHIB is reconstituted with Tripedia vaccine to formulate TriHIBit vaccine, each 0.5 mL dose contains10 mcg of purified capsular polysaccharide conjugated to 24 mcg of inactivated tetanus toxoid, 8.5% of sucrose, 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, and 46.8 mcg of pertussis antigens. Tripedia vaccine (vial presentation 0.6 mL) is formulated without preservatives but contains a trace amount of thimerosal [(mercury derivative), ( ≤ 0.3 mcg mercury/dose)] from the manufacturing process. (Refer to product insert for Tripedia vaccine.)

REFERENCES

1 Chu CY, et al. Further studies on the immunogenicity of Haemophilus influenzae type b and pneumococcal type 6A polysaccharide-protein conjugate. Infect Immun 40:245-246, 1983.

2 Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 40:21-32, 1941.

Where can i get more information?

Your doctor or pharmacist may have information about haemophilus B conjugate vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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For the Consumer

Applies to haemophilus b conjugate (prp-t) vaccine: intramuscular powder for solution, intramuscular powder for suspension, intramuscular solution

Along with its needed effects, haemophilus b conjugate (prp-t) vaccine (the active ingredient contained in ActHIB) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking haemophilus b conjugate (prp-t) vaccine:

More common
  • Diarrhea
  • loss of appetite
  • vomiting
Less common
  • Earache
  • redness or swelling in the ear
Rare
  • Chest pain
  • chills
  • convulsions (seizures)
  • cough
  • fever over 102 degrees F (39 degrees C)
  • lack or loss of strength
  • shortness of breath
  • sneezing
  • sore throat
  • tightness in the chest
  • troubled breathing
  • wheezing
Incidence not known
  • Bluish lips or skin
  • dizziness
  • fast heartbeat
  • hives
  • itching (especially of the feet or hands)
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • reddening of the skin (especially around the ears)
  • skin rash
  • swelling of the eyes, face, or inside of the nose
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • unusual tiredness or weakness (sudden and severe)

Some side effects of haemophilus b conjugate (prp-t) vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Fever less than 102 degrees F (39 degrees C)
  • irritability
  • redness, pain, swelling, tenderness, or warm feeling at the injection site
  • reduced physical activity
  • restlessness
  • sleepiness
Less common
  • Prolonged crying lasting more than 4 hours
  • unusual high-pitched crying
Incidence not known
  • Hives or welts
  • sleepiness or unusual drowsiness

Renal Dose Adjustments

Data not available

Haemophilus b conjugate (prp-t) vaccine Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Data not available Excreted into animal milk: Data not available Comments: -This vaccine is not intended for adult use.

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