ActHIB

Name: ActHIB

What happens if I overdose?

An overdose of this vaccine is not likely to occur.

Commonly used brand name(s)

In the U.S.

  • ActHIB
  • Hibtiter
  • Pedvaxhib

Available Dosage Forms:

  • Solution
  • Powder for Solution
  • Powder for Suspension

Therapeutic Class: Vaccine

ActHIB Side Effects

Along with its needed effects, a medicine 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:

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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What are some things I need to know or do while I take ActHIB?

For all patients taking ActHIB:

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • This medicine may not protect all people who use it. Talk with the doctor.
  • If you have a latex allergy, talk with your doctor. Some products have latex.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take ActHIB.
  • Some children may need to have more than 1 dose of this vaccine. Talk with your child's doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Children:

  • If your child was born premature, talk with the doctor. Trouble breathing has happened in these children after getting some vaccines.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • A burning, numbness, or tingling feeling that is not normal.
  • Not able to move face muscles as much.
  • Trouble controlling body movements.
  • Very bad dizziness or passing out.
  • Muscle weakness.
  • Change in eyesight.
  • High fever.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How supplied

ActHIB Vaccine Reconstituted with Saline Diluent (0.4% Sodium Chloride)

Single-dose, lyophilized vaccine vial (NDC 49281-547-58) packaged with single-dose diluent vial (NDC 49281-546-05). Supplied as package of 5 vials each (NDC 49281-545-05).

TriHIBit Vaccine, ActHIB Vaccine Reconstituted with Tripedia Vaccine

Single-dose, lyophilized vaccine vial (NDC 49281-545-50) packaged with single-dose diluent vial of Tripedia vaccine (NDC 49281-298-01). Supplied as package of 5 vials each (NDC 49281-59705).

Storage

Store lyophilized vaccine packaged with saline diluent (0.4% Sodium Chloride) or Tripedia vaccine at 2° to 8°C (35° to 46°F). DO NOT FREEZE.

REFERENCES

19 American Academy of Pediatrics. Immunization in Special Clinical Circumstances. In: Peter G, ed. 1994 Red Book: Report of the Committee on Infectious Diseases. 23rd ed. Elk Grove Village, IL 51-52, 1994.

Manufactured by: Sanofi Pasteur SA, Lyon France, US Govt License #1724. Distributed by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA, 1-800-VACCINE (1-800-822-2463). Revised: Jan 2014

Warnings

The stopper of the diluent vial contains natural rubber latex which may cause allergic reactions. The lyophilized vaccine vial is not made with natural rubber latex.

If ActHIB vaccine or ActHIB vaccine reconstituted with Tripedia vaccine (TriHIBit vaccine) 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 infection12, 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.13 (Refer to product insert for Tripedia vaccine.)

Liver Dose Adjustments

Data not available

Dialysis

Data not available

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