Details for: VAQTA
Company: MERCK CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02229702 | VAQTA | HEPATITIS A VACCINE, INACTIVATED | 50 UNIT / ML | SUSPENSION | INTRAMUSCULAR |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
VAQTA® helps protect you or your child against hepatitis A disease, an infection of the liver caused by the hepatitis A virus. The vaccine can be administered to children 12 months of age and older, adolescents, and adults.
What it does
VAQTA® is a highly purified inactivated whole virus injectable vaccine that helps prevent infection of the liver caused by hepatitis A virus.
When it should not be used
If you are allergic to any component of the vaccine.
What the medicinal ingredient is
Each 0.5 mL dose of the Pediatric/Adolescent formulation contains approximately 25 Units of hepatitis A virus antigen as the active ingredient. Each 1 mL dose of the Adult formulation contains approximately 50 Units of hepatitis A virus antigen as the active ingredient.
What the non-medicinal ingredients are
Aluminum provided as amorphous aluminum hydroxyphosphate sulfate, sodium borate and sodium chloride. The vaccine may contain trace amounts of neomycin.
The vial stopper contains latex.
What dosage form it comes in
Pediatric/Adolescent Presentation - 0.5 mL single-use vials containing 25 U of hepatitis A virus antigen on an amorphous aluminum hydroxyphosphate sulfate adjuvant packaged in ones.
Adult Presentation - 1.0 mL single-use vials containing 50 U of hepatitis A virus protein on an amorphous aluminum hydroxyphosphate sulfate adjuvant, packaged in ones.
Warnings and precautions
BEFORE you use VAQTA® talk to your doctor or pharmacist if:
- You are allergic to any component of the vaccine.
- You are allergic to latex.
- You are pregnant or intend to become pregnant.
- You are breast-feeding.
Use in children
VAQTA® can be used in children and adolescents 12 months
through 17 years of age.
Use in pregnancy
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 VAQTA® only if your
doctor decides it is clearly needed.
Use in breast-feeding
Tell your doctor if you are breast-feeding. If you are breastfeeding,
you should be vaccinated with VAQTA® only if your
doctor decides it is clearly needed.
Can I drive or operate machinery after vaccination with
VAQTA®?
There is no specific information on this; however,
weakness/tiredness and headache have been reported following
vaccination with VAQTA®.
Other considerations
Because hepatitis A 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 A in these individuals.
Interactions with this medication
VAQTA® may be given concomitantly with yellow fever, typhoid, measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate, oral or inactivated polio, diphtheria toxoid, tetanus toxoid, acellular pertussis, and Haemophilus influenzae b vaccines; however, data on concomitant use with other vaccines are limited. VAQTA® may also be given at the same time as immune globulin. Separate injection sites and syringes should be used for concomitant administration of injectable vaccines and immune globulin.
Proper use of this medication
Usual Dose
VAQTA® is given by injection. Two doses, each given on two different dates, are needed to complete the series. The schedule for children/adolescents and for adults is as follows:
Children and adolescents 12 months to 17 years of age should receive a 0.5 mL single dose (~25 Units) at any time and a 0.5 mL booster dose (~25 Units) 6 to 18 months later.
Adults 18 years of age and older should receive a 1.0 mL single dose (~50 Units) at any time and a 1.0 mL booster dose (~50 Units) 6 to 18 months later.
HIV-infected adults should receive a single 1.0 mL (~50 Units) dose of vaccine at elected date and a booster dose of 1.0 mL (~50 Units) 6 months later.
A booster dose of VAQTA® may be given at 6 to 12 months following the initial dose of other inactivated hepatitis A vaccines.
Overdose
Missed Dose
If you miss a 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. VAQTA® has been shown to be generally well tolerated. Side effects include injection-site reactions such as soreness, redness, and swelling, and generalized reactions including weakness/tiredness, fever, irritability, upper respiratory infection, nausea, abdominal pain, diarrhea, vomiting, sore throat, cold, headache and muscle pain.
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 or your child experienced any symptoms that suggest an allergic reaction (such as itching, hives, or rash) after any dose in the vaccination series.
This is not a complete list of side effects. For any unexpected effects, contact your doctor or pharmacist.
How to store
Store vaccine refrigerated at 2°C to 8°C (36°F - 46°F).
Do not freeze since freezing destroys potency.
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: 1-866-844-0018
By toll-free fax: 1-866-844-5931
By email: caefi@phac-aspc.gc.ca
At the following website:
www.phac-aspc.gc.ca/im/vs-sv/index-eng.php
By regular mail:
The Public Health Agency of Canada
Vaccine Safety Section
130 Colonnade Road
Ottawa, Ontario
K1A 0K9 Address Locator 6502A
or atMerck Canada Inc. by one of the following 2 ways:
- Call toll-free at 1-800-567-2594
- Complete an Adverse Events following Immunization (AEFI) Form and:
- Fax toll-free to 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.
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:
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
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: March 12, 2013
® Registered trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Used under license.
* All other trademarks are the property of their respective owners.
© 2011, 2013 Merck Canada Inc., a subsidiary of Merck & Co., Inc. All rights reserved.