Consumer Information for: AVAXIM - PEDIATRIC -(5ML VIAL)

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

AVAXIM® - Pediatric [Hepatitis A Vaccine Inactivated] is a vaccine that is used to prevent hepatitis A infection. This vaccine may be given to persons 12 months to 15 years of age inclusive.

Hepatitis A is a contagious liver disease that is spread from person to person through drinking water or eating food with the hepatitis A virus (HAV) in it. It is also spread by close personal contact. It is more common in areas of the world with poor sanitation. Hepatitis A can cause a mild illness, but about 1 person in 5 has to be hospitalized and sometimes people die as a result of hepatitis A. Although young children usually are not very ill, they can continue to spread the virus to others for several months.

The majority of persons who are vaccinated with AVAXIM® - Pediatric will produce enough antibodies to help protect them against this disease. However, as with all vaccines, 100% protection cannot be guaranteed.

What it does

AVAXIM® - Pediatric causes the body to produce its own natural protection against hepatitis A infection. After you receive the vaccine, your body begins to make substances called antibodies. Antibodies help the body to fight disease. If a vaccinated person comes into contact with the germ that causes this disease, the body is usually ready to destroy it.

When it should not be used
  • You have a known severe allergy to any ingredient in AVAXIM® - Pediatric or its container, or who have had a severe allergic reaction after receiving a vaccine that contained similar ingredients.

What the medicinal ingredient is

inactivated hepatitis A virus.

What the non-medicinal ingredients are

aluminum hydroxide, formaldehyde, neomycin, 2-phenoxyethanol, and polysorbate 80.

What dosage form it comes in

AVAXIM® - Pediatric is a suspension for injection (80U/0.5mL), supplied in 0.5 mL prefilled syringes and 5 mL vials.

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you or your child take AVAXIM® - Pediatric. Talk about any health conditions or problems you may have, including if you:

  • Have a high fever or serious illness. Wait until the person is better to receive the vaccination.
  • Have an allergy to any component of the vaccine or the container.
  • Have a weakened immune system. The vaccine may provide you with a lower level of protection than it does for people with healthy immune systems.
  • Have a bleeding disorder or taking blood thinning medications. Tell the person giving you the injection about your condition. The injection must be done carefully to prevent excessive bleeding.
  • Are pregnant or breast-feeding. It is important that you understand the risks and benefits of vaccination. AVAXIM® - Pediatric should be given to a pregnant or nursing woman only if it is clearly needed. Tell the person giving you the injection if you are pregnant or breastfeeding.
  • Have fainted with a previous injection. Fainting can occur following vaccination. Appropriate measures should be taken to prevent falling injury.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication
  • DO NOT mix AVAXIM® - Pediatric with other vaccines or medicinal products in the same syringe.

Proper use of this medication

Usual Dose

A single dose of 0.5 mL is recommended for immunization in persons 12 months to 15 years of age inclusive.

For long-term protection against hepatitis A, a booster dose of 0.5 mL will be required. This booster dose should be given preferably 6 to 36 months after the first dose of AVAXIM® - Pediatric, but can be given up to 7 years after the first dose.

The vaccination should be given in the muscle, preferably in the deltoid (shoulder) region.

Overdose

If you think you have taken too much AVAXIM® - Pediatric, contact a health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss the second dose, contact your doctor to schedule a visit.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking AVAXIM® - Pediatric. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

A vaccine, like any medicine, may cause serious problems, such as severe allergic reactions. The risk of AVAXIM® - Pediatric causing serious harm is extremely small. The small risks associated with AVAXIM® - Pediatric are much less than the risks associated with getting the diseases.

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well after receiving AVAXIM® - Pediatric.

Serious side effects are very rare.

Some children who receive AVAXIM® - Pediatric may have mild side effects such as mild pain at the injection site, associated with redness and swelling. Other common side effects include headache, gastro-intestinal tract disorders such as abdominal pain, diarrhea, nausea and vomiting, muscle or joint ache, behavioural changes such as decreased appetite and nervousness, fever, and weakness. These side effects usually go away within a few days.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

Store AVAXIM® - Pediatric in a refrigerator at 2° to 8°C (35° to 46°F). Do not freeze. Throw the product away if it has been exposed to freezing.

Do not use after the expiration date.

Keep out of reach and sight of children.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information
  • Talk to your healthcare professional.
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the Sanofi Canada website (http://www.sanofi.ca), or by calling the Sanofi Pasteur Limited Vaccine Information Service at 1-888-621-1146 (no charge) or at 416- 667-2779 (Toronto area).

This leaflet was prepared by Sanofi Pasteur Limited.

Date modified: