Consumer Information for: RECOMBIVAX HB

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

RECOMBIVAX HB® [hepatitis B vaccine (recombinant)] is an injectable vaccine that helps prevent infection of the liver caused by hepatitis B virus.

The vaccine can be administered to infants, children, adolescents, and adults.

What it does

Your doctor has recommended or administered RECOMBIVAX HB® to help protect you or your child against hepatitis B, an infection of the liver caused by the hepatitis B virus (HBV).

You could catch this disease by coming into contact with an infected person's blood, semen, vaginal secretions, or other body fluids. For example, if these infected fluids enter your blood stream through a cut, you could become infected. Other circumstances that could lead to infection include:

  • being born to a mother who carries the HBV
  • living in the same household as someone who carries the HBV
  • sexual/close contact with someone who is infected
  • having a job that involves exposure to human blood or body fluids
  • sharing needles for injecting drugs
  • traveling to areas of high frequency of HBV disease
Individuals who have hepatitis B may not look or feel sick when infected. In fact, a person could be infected by the virus six weeks to six months before symptoms occur. Some individuals develop mild, flu-like symptoms. Others may become very ill and extremely tired, develop jaundice (yellow appearance of the skin, eyes, etc.), dark urine and other symptoms that require hospitalization.

Most people recover completely from HBV infection. However, there are some individuals, particularly children, who may not have symptoms but continue to carry the virus in their blood. They are called chronic carriers. These chronic carriers are infectious and can spread the disease to others throughout their lives. All chronic carriers run the risk of developing life threatening liver disease, cirrhosis, or liver cancer.
When it should not be used

RECOMBIVAX HB® should not be used by anyone who is hypersensitive to this drug or to any ingredient in the formulation or component of the container.

What the medicinal ingredient is

Pediatric presentation: Each 0.5 mL dose contains 5 μg of hepatitis B surface antigen as the active ingredient.
Adult presentation: Each 1 mL dose contains 10 μg of hepatitis B surface antigen as the active ingredient.
Adult dialysis presentation: Each 1 mL dose contains 40 μg of hepatitis B surface antigen as the active ingredient.

What the non-medicinal ingredients are

Aluminum (as amorphous aluminum hydroxyphosphate), sodium chloride and sodium borate. Each dose contains less than 1% yeast protein.

The vial stopper contains latex.

What dosage form it comes in

RECOMBIVAX HB is supplied as a slightly cloudy, white suspension for injection in glass vials. Three formats are available:

  • Pediatric: single-dose vial containing 5 μg hepatitis B surface antigen in 0.5 mL (thimerosal-free)
  • Adult: single-dose vial containing 10 μg hepatitis B surface antigen in 1.0 mL (thimerosal-free)
  • Adult dialysis: single-dose vial containing 40 μg hepatitis B surface antigen in 1 mL (thimerosal-free).
Warnings and precautions

Before you or your child receive RECOMBIVAX HB®, it is very important to tell your healthcare provider:

  • if you or your child are allergic to any component of the vaccine
  • if you or your child are allergic to latex
  • about any medical problem you or your child have or have had, including any allergies
  • if you are pregnant or intend to become pregnant
Use in children
RECOMBIVAX HB® can be used in newborns, infants, and children of all ages.

Use in elderly
Hepatitis B vaccines may not be as effective in individuals 65 years of age and older, as they are with younger subjects.

Use in pregnancy and breast-feeding
It is not known whether the vaccine is harmful to an unborn baby when administered to a pregnant woman. If you are pregnant, you should be vaccinated with RECOMBIVAX HB® only if your doctor decides it is clearly needed.

Tell your doctor if you are breast feeding.

Can I drive or operate machinery after vaccination with RECOMBIVAX HB®?
RECOMBIVAX HB® should not ordinarily interfere with your ability to drive or operate machinery. However, as with any vaccination, it is advisable to wait in your doctor's office about 20 minutes after vaccination in case an immediate allergic reaction develops.

Other Considerations
Because hepatitis B infection can go undetected for a long period of time, it is possible that an individual may already be infected at the time the vaccine is given. The vaccine may not prevent hepatitis B in these individuals.
Interactions with this medication

In general, simultaneous administration of certain childhood vaccines has not decreased their effectiveness or increased their side effects.

Proper use of this medication

Usual Dose

RECOMBIVAX HB® is given by injection. A three-dose series should be given according to the following schedule:

  • First dose: at elected date
  • Second dose: >1 month after first injection
  • Third dose >1 month after second injection
For adolescents, 11 to 15 years of age, a two-dose series may be given according to the following schedule:
  • First dose: at elected date
  • Second dose: 4 to 6 months later
NOTE: For infants born to mothers infected with HBV, the first dose of the hepatitis B vaccination series should be given at birth, or as soon thereafter as possible, in addition to an injection of hepatitis B immune globulin.

At present, it is not known whether a booster dose will be necessary. See your doctor for more details.

Overdose

In case of overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

Your doctor will decide when to give the missed dose

Side effects and what to do about them

Any vaccine may have unintended or undesirable effects, so-called side effects. RECOMBIVAX HB® is generally well tolerated. The side effects seen in children, adolescents, and adults include injection-site reactions such as soreness, redness, swelling, itching, bruising, warmth and a hard lump. Generalized reactions include fatigue, headache, fever, nausea, diarrhea, and vomiting. Serious side effects occur less frequently and can include allergic reactions, certain severe types of rash, joint pain, muscle disorders, and nerve disorders such as Guillain-Barré Syndrome, seizure, or convulsion accompanied by a very high fever, and fainting. Other side effects also reported include bleeding or bruising more easily than normal.

Your doctor has a more complete list of side effects. Tell your doctor promptly about these or any other unusual symptoms. If the condition persists or worsens, seek medical attention.

In addition, tell your doctor if you experienced any symptoms that suggest an allergic reaction after any dose in the vaccination series.

How to store

Store refrigerated at 2-8°C. Do not freeze.

All vaccines must be discarded after the expiration date.

Reporting side effects

To monitor vaccine safety, the Public Health Agency of Canada collects case reports on adverse events following immunization.

For health care professionals:
If a patient experiences an adverse event following immunization, please complete the appropriate Adverse Events following Immunization (AEFI) Form and send it to your local Health Unit in your province/territory.

For the General Public:
Should you experience an adverse event following immunization, please ask your doctor, nurse, or pharmacist to complete the Adverse Events following Immunization (AEFI) Form.

If you have any questions or have difficulties contacting your local health unit, please contact Vaccine Safety Section at Public Health Agency of Canada
By toll-free telephone: 866-844-0018
By toll-free fax: 866-844-5931
Email: caefi@phac-aspc.gc.ca
Web: http://www.phac-aspc.gc.ca/im/vs-sv/indexeng.php__http://www.phac-aspc.gc.ca/im/vs-sv/index-eng.php

Mail:
The Public Health Agency of Canada
Vaccine Safety Section 130 Colonnade Road ,
A/L 6502A
Ottawa , ON K1A 0K9

or at Merck Canada Inc. by one of the following 2 ways:

  • Call toll-free: 1-800-567-2594
  • Complete an Adverse Events following Immunization (AEFI) Form and:
    • Fax toll-free 1-800-369-3090, or
    • Mail to: Merck Canada Inc.
      Pharmacovigilance
      P.O. Box 1005
      Pointe-Claire - Dorval, QC H9R 4P8
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying the Public Health Agency of Canada. The Public Health Agency of Canada does not provide medical advice.
More information

This document plus the full product monograph, prepared for health professionals can be found at:
http://www.merck.ca
or by contacting the sponsor, Merck Canada Inc.,
at: 1-800-567-2594.

This leaflet was prepared by Merck Canada Inc.

Last revised: May 15, 2012

® Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Used under license.

© 2011, Merck Canada Inc., a subsidiary of Merck & Co., Inc. All rights reserved.

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