Patient Medication Information: uses, side effects, how to take - Avaxim - Pediatric -(5mL Vial)
What is AVAXIM® - Pediatric 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.
How does AVAXIM® - Pediatric work?
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.
What are the ingredients in AVAXIM® - Pediatric?
Medicinal ingredients: inactivated hepatitis A virus.
Non-medicinal ingredients: aluminum hydroxide, formaldehyde, neomycin, 2-phenoxyethanol, and polysorbate 80.
AVAXIM® - Pediatric comes in the following dosage forms:
AVAXIM® - Pediatric is a suspension for injection (80U/0.5mL), supplied in 0.5 mL prefilled syringes and 5 mL vials.
Do not use AVAXIM® - Pediatric if:
- 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.
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 breast-feeding.
- 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.
The following may interact with AVAXIM® - Pediatric:
- DO NOT mix AVAXIM® - Pediatric with other vaccines or medicinal products in the same syringe.
How to take AVAXIM® - Pediatric:
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.
What are the possible side effects from using AVAXIM® - Pediatric?
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.
Reporting Suspected Side Effects
For the general public: Should you experience a side effect following immunization, please report it to your doctor, nurse, or pharmacist. Should you require information related to the management of the side effect, please contact your healthcare provider. The Public Health Agency of Canada, Health Canada and Sanofi Pasteur Limited cannot provide medical advice. For healthcare professionals: If a patient experiences an adverse event following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (http://www.phac-aspc.gc.ca/im/aefi-essi-form-eng.php) and send it to your local Health Unit. |
Storage:
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.
If you want more information about AVAXIM® - Pediatric:
- 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).
Last revised:
R6-0319 Canada