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Details for: ZOSTAVAX II

Company: MERCK CANADA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02375516ZOSTAVAX IIVARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA/MERCK STRAIN)19400 PFU / 0.65 MLPOWDER FOR SUSPENSIONSUBCUTANEOUS
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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

ZOSTAVAX® II is indicated for the prevention of shingles (zoster).

ZOSTAVAX® II is indicated for vaccination of individuals 50 years of age or older

ZOSTAVAX® II boosts your immune system to help protect you from shingles

ZOSTAVAX® II cannot be used to treat existing shingles or the pain associated with existing shingles.

What it does

Your doctor has recommended or administered ZOSTAVAX® II to prevent shingles (also known as zoster).

If you do get shingles even though you have been vaccinated, ZOSTAVAX® II can reduce the intensity and length of time your pain from shingles will last.

When it should not be used
  • if you are allergic to any of the components of the vaccine (see ingredients), including gelatin or neomycin
  • if you have a blood disorder or any type of cancer that weakens your immune system
  • if you have been told by your doctor that you have a weakened immune system as a result of a disease, medications, or other treatment
  • if you have active untreated tuberculosis
  • if you are pregnant (see Pregnancy)
What the medicinal ingredient is

Active ingredient: a weakened form of the varicella-zoster virus

What the non-medicinal ingredients are

Powder:
Sucrose, hydrolyzed porcine gelatin, urea, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate and anhydrous disodium phosphate.

Solvent:
Water for injection

What dosage form it comes in

ZOSTAVAX® II is supplied as a white to off-white powder in a single-dose vial.

The diluent for reconstitution is supplied as a clear, colourless liquid in a single-dose vial.

When reconstituted, ZOSTAVAX® II is a semi-hazy to translucent, off-white to pale yellow liquid.

Warnings and precautions

BEFORE you use ZOSTAVAX® II talk to your doctor or pharmacist if:

  • you have or have had any medical problems and about any allergies
  • you are taking or have taken any medications that might weaken your immune system
  • you have a fever
  • you have HIV infection
  • you have had shingles in the past.

It is not known how long ZOSTAVAX® II will protect you from shingles. Studies with ZOSTAVAX® II beyond 4 years have not been completed. It is not known if you will need to be vaccinated again in the future.

ZOSTAVAX® II does not protect all individuals against the development of shingles or its consequences.

There may be a small chance of spreading the weakened vaccine virus to other people after receiving ZOSTAVAX® II.

Pregnancy
ZOSTAVAX® II should not be given to pregnant women. Women of child-bearing age should take the necessary precautions to avoid pregnancy for 3 months following vaccination.

Ask the doctor or pharmacist for advice before taking any medicine.

Breast-feeding
Inform your doctor if you are breast-feeding or intending to breast-feed. Your doctor will decide if ZOSTAVAX® II should be given.

Ask the doctor or pharmacist for advice before taking any medicine.

Driving and using machines:
There is no information to suggest that ZOSTAVAX® II affects the ability to drive or operate machinery.

Interactions with this medication

Important information about the ingredients of ZOSTAVAX® II:
Tell your doctor if you have ever had an allergic reaction to any of the ingredients before you receive this vaccine.

Using other medicines and other vaccines:
ZOSTAVAX® II should not be given at the same time as PNEUMOVAX® 23 (pneumococcal vaccine, polyvalent, MSD Std.). For more information about these vaccines, talk to your doctor or healthcare provider because it may be better to get these vaccines at least 4 weeks apart.

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Proper use of this medication

Usual Dose

Individuals should receive a single dose.

The vaccine is to be given as a single dose by injection under the skin.

ZOSTAVAX® II is not a treatment for shingles or the pain associated with shingles. If you get shingles, even though you have been vaccinated, see your health care provider promptly

It is recommended that the vaccine be administered immediately after reconstitution to minimize loss of potency. Discard if reconstituted vaccine is not used within 30 minutes.

Do not freeze the reconstituted vaccine

DO NOT INJECT INTRAVASCULARLY

Any unused product or waste material should be disposed of in accordance with local requirements

Overdose

There are no data with regard to overdose.

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

Missed Dose

Not applicable

Side effects and what to do about them

Like all vaccines, ZOSTAVAX® II can have side effects.

In studies, the most common side effects reported were at the injection site. These side effects included redness, pain, swelling, hard lump, itching, warmth, and bruising at the injection site. Headache and pain in an arm or leg were also reported.

The following additional side effects have been reported with ZOSTAVAX® II:

  • allergic reactions, which may be serious and may include difficulty in breathing or swallowing. If you have an allergic reaction, call your doctor right away
  • chicken pox
  • fever
  • hives at the injection site
  • joint pain
  • muscle pain
  • nausea
  • rash
  • rash at the injection site
  • shingles
  • swollen glands near the injection site (that may last a few days to a few weeks)
  • Guillain-Barré syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body)
  • loss of facial muscle movements

Your doctor or pharmacist has a more complete list of side effects for ZOSTAVAX® II.

If you noticed any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

If any of the conditions above persists or worsens, seek medical attention.

Reporting Suspected Vaccine Adverse Events

For the general public:
If you suspect you have had a serious or unexpected event following receipt of a vaccine, please ask your healthcare professional to complete the Adverse Events Following Immunization (AEFI) Form and send it to your local health unit in your province/territory.

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

If you have any questions or have difficulty contacting your local health unit, please contact Vaccine Safety Section at Public Health Agency of Canada:

Toll-free telephone: 1-866-844-0018
Toll-free fax: 1-866-844-5931
By email: caefi@phac-aspc.gc.ca

NOTE: Should you require information related to the management of the adverse events, please contact your health professional before notifying the Public Health Agency of Canada. The Public Health Agency of Canada does not provide medical advice.

How to store

Keep this vaccine out of the reach and sight of children.

Vial of powder: Store and transport refrigerated at 8ºC or colder (especially when taken from the pharmacy to the physician’s office) and keep the vial in the outer carton in order to protect from light.

Diluent: Store separately from the vaccine vial in a refrigerator (2 to 8°C) or at room temperature (20 to 25°C). Do not freeze.

Do not use after the expiry date stated on the label.

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 3 ways:

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

Disease information on shingles:

Why should I receive ZOSTAVAX® II?
Shingles can be a very painful and potentially debilitating disease. Shingles can cause long-lasting nerve pain and other serious complications. It is an unpredictable disease that can occur at any time, with no warning. Almost every adult has had chickenpox and so is at risk for shingles. The risk increases as you get older. This is especially true if you are over 50 years of age. ZOSTAVAX® II is the only product approved to prevent shingles. If you do get shingles even though you have been vaccinated, ZOSTAVAX® II can help reduce the intensity and length of time your nerve pain will last.

What is shingles?
Shingles is a painful, blistering rash. It usually occurs in one part of the body and can last for several weeks. It may result in scarring. The nerve pain that comes from shingles can last for months or even years after the rash heals.

What causes shingles?
Shingles is caused by the same virus that causes chickenpox. After your chickenpox blisters heal, the virus that caused them stays in your body in nerve cells. The virus may be there for many years and not cause a problem. Sometimes, for unknown reasons, it becomes active again and causes shingles.

Is shingles serious?
Shingles can be serious. In addition to the rash-associated pain, the nerve pain caused by shingles may be severe and last for months or years (postherpetic neuralgia). For some people, this nerve pain can get in the way of normal day-to-day activities such as walking, sleeping, and social activities. The pain from shingles can also lead to emotional distress. People who suffer from shingles have described their pain in many ways. Some say the pain burns or throbs. Others say it stabs, shoots, and/or feels sharp. Severe pain can result from things as minor as a breeze or the touch of clothing against the skin. In addition to severe pain, people with shingles may have other complications. These include:

  • scarring
  • bacterial skin infections
  • weakness
  • muscle paralysis
  • loss of hearing or vision.

Shingles can result in hospitalization. In rare cases, shingles can even result in death.

Am I at risk for shingles?
Almost every adult has had chickenpox and so is at risk for shingles. The risk increases as you get older, especially if you are over 50 years of age. It is estimated that in the general population, the lifetime risk of getting shingles is as high as 30%. For people who reach 85 years of age, one out of every two will have had shingles.

If you want more information about ZOSTAVAX® II:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website or Merck Canada website www.merck.ca. or by calling Merck Canada at 1-800-567-2594

To report an adverse event related to ZOSTAVAX® II, please contact 1-800-567-2594.

This leaflet was prepared by Merck Canada Inc.

Last revised: August 14, 2018

© Merck Sharp & Dohme Corp. Used under license.

© 2011, 2018 Merck Canada Inc. All rights reserved.

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