Consumer medicine information

1. Why is my child or I being given VARIVAX Refrigerated?

VARIVAX Refrigerated is a vaccine used to help prevent chickenpox (varicella). It can be given to children 12 months of age and older, teenagers and adults who are healthy.
For more information, see Section 1. Why is my child or I being given VARIVAX Refrigerated? in the full CMI.

2. What should I know before my child or I are given VARIVAX Refrigerated?

Do not receive VARIVAX Refrigerated if you or your child have ever had an allergic reaction to VARIVAX Refrigerated or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you or your child have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before my child or I are given VARIVAX Refrigerated? in the full CMI.

3. What if my child or I are taking other medicines?

Some medicines may interfere with VARIVAX Refrigerated and affect how it works. A list of these medicines is in Section 3. What if my child or I am taking other medicines? in the full CMI.

4. How is VARIVAX Refrigerated given?

• The usual dose of VARIVAX Refrigerated is 0.5 mL. The dose of the vaccine is the same for everyone.

• VARIVAX Refrigerated is given as an injection just under the skin (subcutaneously) or in the muscle (intramuscular) of the upper arm by a doctor or trained nurse.

5. What should I know after my child or I are given VARIVAX Refrigerated?

6. Are there any side effects?

Common side effects include: pain, soreness, swelling, itching, redness, bruising, numbness, stiffness or a hard lump where you had the injection, fever, tingling of the skin, irritability, swollen glands typically located in the neck, armpit or groin.
Serious side effects include: seizures or fits, severe skin conditions, skin infections, allergic reactions, bruising more easily than normal, red or purple, flat, pinhead spots under the skin; severe paleness, nausea, vomiting, chickenpox, difficulty walking. For a complete list of side effects and more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Notes

Distributed by Seqirus (Australia) Pty Ltd

1 Name of Medicine

Live varicella vaccine.

2 Qualitative and Quantitative Composition

Varivax Refrigerated [varicella virus vaccine live (Oka/Merck)] is a lyophilised preparation of the Oka/Merck strain of live, attenuated varicella virus. The virus was initially obtained from a child with wild type varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures, and finally propagated in human diploid cell cultures (WI-38). Further passage of the virus for varicella vaccine was performed at Research Laboratories of Merck Sharp and Dohme, LLC, Rahway, NJ, USA in human diploid cell cultures (MRC-5) that were free of adventitious agents.
Varivax Refrigerated, when reconstituted as directed, is a sterile preparation for intramuscular (IM) or subcutaneous (SC) administration. Each 0.5 mL dose contains a minimum of 1350 PFU (plaque forming units) of Oka/Merck varicella virus when reconstituted and stored at room temperature for 150 minutes (2½ hours).
Powder for Injection.
Varivax Refrigerated when reconstituted is a clear, colourless to pale yellow liquid.
List of excipients with known effect. This vaccine may contain trace quantities of neomycin.
For the full list of excipients, see Section 6.1 List of Excipients.
The product also contains residual components of MRC-5 cells and trace quantities of neomycin, and bovine serum from MRC-5 culture media. The product contains no preservative.
The manufacture of this product includes exposure to bovine derived material. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

3 Pharmaceutical Form

See Section 2 Qualitative and Quantitative Composition.

4 Clinical Particulars

4.9 Overdose

There are no data with regard to overdose.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

Epidemiology. Varicella (chickenpox) is a highly communicable disease in children, adolescents and adults caused by the varicella zoster virus. The disease usually consists of 300 to 500 maculopapular and/or vesicular lesions accompanied by a fever (oral temperature ≥ 37°C) in up to 70% of individuals. Over the period 1993-94 to 1996-97, there has been an average of 73 hospitalisations per month with a principal diagnosis of varicella. Between 1991 and 1996, there was a total of 36 deaths from varicella in Australia. Varicella hospitalisation and deaths occur across all ages. 59% of hospitalisations and 39% of deaths from varicella were of children under 15 years (in the years with data available). The hospitalisation rate for varicella in children has remained consistently over 11 per 100,000 between 1993-94 and 1996-97. Death rates from varicella for children have ranged between 0.05 and 0.08 per 100,000 during the period 1991 to 1996. Although it is generally a benign, self limiting disease, varicella may be associated with serious complications (e.g. bacterial superinfection, pneumonia, encephalitis, Reye syndrome) and/or death.

5.3 Preclinical Safety Data

Genotoxicity. Mutagenicity. Varivax Refrigerated has not been evaluated for its mutagenic potential.
Carcinogenicity. Varivax Refrigerated has not been evaluated for its carcinogenic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Not applicable.
CAS number. Not applicable.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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