Patient Medication Information: uses, side effects, how to take - Recombivax Hb (with Preservative)
What the vaccine 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: Patients who are 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 important nonmedicinal ingredients are:
Thimerosal (only in the adult multi-dose vial), aluminum (as amorphous aluminum hydroxyphosphate), sodium chloride and sodium borate.
What dosage forms it comes in:
RECOMBIVAX HB® is supplied as a slightly cloudy, white suspension for injection in glass vials. Four 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: multi-dose vial containing 30 μg hepatitis B surface antigen in 3.0 mL (contains thimerosal)
- 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; and
- 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 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.
What should I know about the inactive ingredients in RECOMBIVAX HB®?
Thimerosal (a mercury-containing compound) is used as a preservative in some of the formulations. Tell your doctor if you have ever experienced an allergic reaction to thimerosal.
IMPORTANT: PLEASE READ
Consumer information – RECOMBIVAX HB® Page 25 of 25 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 VACCINE |
In general, simultaneous administration of certain childhood vaccines has not decreased their effectiveness or increased their side effects.
| PROPER USE OF THIS VACCINE |
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.
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 high fever, and fainting.
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 IT
Store refrigerated at 2-8°C. Do not freeze.
All vaccines must be discarded after the expiration date.
REPORTING SUSPECTED SIDE EFFECTS
To monitor vaccine safety, the Public Health Agency of Canada collects information on serious and unexpected effects of vaccines. If you suspect you have had a serious or unexpected reaction to this vaccine you should contact your physician or pharmacist. You may also notify:
The Public Health Agency of Canada
Vaccine Safety Unit
130 Colonnade Road
Ottawa, ON K1A 0K9
A/L 6502A
Telephone: 613-954-5590
Toll-free telephone: 1-866-844-0018
Fax: 613-954-9874
Toll-free fax: 1-866-844-5931
E-mail: CAEFI@phac-aspc.gc.ca
or Merck Frosst Canada Ltd. by:
Toll-free telephone: 1-800-567-2594
Toll-free fax: 1-877-428-8675
By regular mail:
Merck Frosst Canada Ltd.
P.O. Box 1005
Pointe-Claire - Dorval, QC H9R 4P8
NOTE: Before contacting Health Canada or Merck Frosst, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.merckfrosst.com
or by contacting the sponsor, Merck Frosst Canada Ltd., at: 1-800-567-2594.
Last revised:.
RECOMBIVAX HB® is a Registered Trademark of Merck & Co., Inc. Used under license.