VARIVAX REFRIGERATED varicella virus vaccine live powder for injection vial with sterile diluent vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

live varicella vaccine, Quantity: 2700 PFU/mL

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

Pharmaceutical form:

Diluent, not applicable

Composition:

Excipient Ingredients: water for injections

Administration route:

Subcutaneous

Units in package:

5 single dose vials and 5 diluent vials, 1 single dose vial and 1 diluent vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

VARIVAX Refrigerated is indicated for vaccination against varicella in healthy individuals 12 months of age and older.,See the Australian Immunisation Handbook for vaccination recommendations and schedule.,Groups who would particularly benefit from vaccination include:,? Non-immune adults, especially those in at-risk occupations such as health-care workers, teachers and workers in children?s day-care centres.,? Non-immune parents of young children.,? Non-immune household contacts, both adults and children, of immunocompromised patients with no history of disease.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-07-30

Patient Information leaflet

VARIVAX
® REFRIGERATED
_Varicella virus vaccine live (live varicella vaccine)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VARIVAX
Refrigerated. It does not contain all
the available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the risks of you being given
VARIVAX Refrigerated against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS VACCINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT VARIVAX
REFRIGERATED IS USED
FOR
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.
Chickenpox is an infectious disease
caused by the varicella-zoster virus,
or otherwise known as varicella
virus. It occurs in millions of people
around the world each year, most
often in children 5 to 9 years of age.
Chickenpox is easily passed from
one person to another. It is
commonly spread from person to
person through the air by sneezing or
coughing. Once a person is infected,
it usually takes about 2 to 3 weeks
before symptoms of the infection
start.
Symptoms of chickenpox include
mild headache, moderate fever and
general discomfort. These are
followed by a rash of itchy, little red
spots which usually start on the
chest, stomach or back, but can
appear anywhere on the body. There
may be only a few spots or groups of
spots, or even hundreds of spots that
develop over the next 3 to 5 days.
The spots will change into clear
blisters filled with fluid which then
become cloudy, break open, dry, scab
and heal, usually within 5 to 20 days.
Although chickenpox is generally a
fairly harmless infection, it may be
associated with serious complications
and/or rarely death. In children, the
most common complications are
bacterial skin infections. Less
frequent but very serious
compl

Summary of Product characteristics

WPC-V210-I-ref-122019
1
AUSTRALIAN PRODUCT INFORMATION –
VARIVAX
® REFRIGERATED
VARICELLA VIRUS VACCINE LIVE (LIVE VARICELLA VACCINE)
1
NAME OF THE MEDICINE
live varicella vaccine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION AND
3
PHARMACEUTICAL FORM
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 MSD
Research Laboratories in human diploid cell cultures (MRC-5) that were
free of adventitious
agents.
VARIVAX Refrigerated, when reconstituted as directed, is a sterile
preparation for subcutaneous
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 (2
½ 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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VARIVAX Refrigerated is indicated for vaccination against varicella in
healthy individuals 12
months of age and older.
See the Australian Immunisation Handbook for vaccination