VARILRIX HSA-FREE varicella vaccine live attenuated 0.5mL powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

live varicella vaccine, Quantity: 4000 PFU/mL; isoleucine, Quantity: 0.355 mg; leucine, Quantity: 0.432 mg

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

live varicella vaccine

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: lactose; sorbitol; mannitol; threonine; serine; proline; glycine; alanine; valine; methionine; tyrosine; phenylalanine; tryptophan; lysine hydrochloride; histidine; arginine

Administration route:

Subcutaneous

Units in package:

10 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

VARILRIX HSA-FREE is indicated for active immunisation against varicella of healthy subjects from 9 months of age. 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 the disease.

Product summary:

Visual Identification: Lyophilised - cream to yellowish or pinkish coloured powder in a glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-04-16

Patient Information leaflet

VARILRIX
®
1
VARILRIX
® (HUMAN
ALBUMIN FREE)
_Live attenuated varicella vaccine _
CONSUMER MEDICINE INFORMATION LEAFLET
WHAT IS IN THIS
LEAFLET
This leaflet answers some of the
common questions about VARILRIX
vaccine. It does not contain all the
available information. It does not
take the place of talking to your
doctor, nurse or pharmacist.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the possible risks of you or
your child having VARILRIX
against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
VARILRIX TALK TO YOUR DOCTOR,
NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS VACCINE.
YOU MAY NEED TO READ IT AGAIN
WHAT VARILRIX IS
USED FOR
VARILRIX is a vaccine used in
children aged 9 months or older,
adolescents and adults to prevent
chickenpox. Groups who would
benefit mostly from vaccination
include:

adults not immunised (protected)
against chickenpox, especially
those in ‘at-risk’ occupations
such as health care workers,
teachers and workers in child care
centres

adults not immunised, who are
parents of young children

adults and children not
immunised, who live in the same
house with people
who have lowered immunity and
have no history of chickenpox.

The vaccine works by causing the
body to produce its own
protection (antibodies) against
this disease.
Chickenpox is caused by a virus
called the varicella-zoster virus.
VARILRIX vaccine contains a
weakened form of the chickenpox
(varicella-zoster) virus.
Chickenpox is a highly infectious
disease, which usually causes an
itchy, red rash with blisters. After
about 1 week, most of the blisters
have normally crusted over. The
rash can appear on the face, scalp,
body, or in the mouth, eyes and
bottom. Other symptoms can include
fever, headaches, chills, and muscle
and/or joint aches and pains.
Sometimes disease complications can
occur such as bacterial infection of
the skin (often due to itching of the
rash/crusts), inflammation of the
brain (varicella encephalitis), and
lung infection (varicella pneumonia).
Com

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
VARILRIX HUMAN SERUM ALBUMIN-FREE (VARICELLA) VACCINE, (LIVE,
ATTENUATED), POWDER AND DILUENT FOR SOLUTION FOR INJECTION.
1
NAME OF THE MEDICINE
Live varicella vaccine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VARILRIX is a lyophilised preparation of the live attenuated Oka
strain of varicella-zoster virus,
obtained by propagation of the virus in MRC
5
human diploid cell culture.
Each 0.5 mL dose of the reconstituted vaccine contains not less than
10
3.3
plaque-forming
units (PFU) of the varicella-zoster virus.
The manufacture of this product includes exposure to bovine derived
materials. 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.
VARILRIX meets the World Health Organisation requirements for
biological substances and
for varicella vaccines.
LIST OF EXCIPIENTS WITH KNOWN EFFECT
VARILRIX also contains the excipient ingredient phenylalanine and
residual amounts of
neomycin sulphate, which is carried over from the manufacturing
process.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder and diluent for solution for injection.
VARILRIX is presented as a slightly cream to yellowish or pinkish
coloured powder for
reconstitution with clear and colourless sterile diluent.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VARILRIX is indicated for active immunisation against varicella of
healthy children and
adults from 9 months of age.
Groups who would particularly benefit from vaccination include:
2
•
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 the disease_ _
4.2
DOSE AND METHOD OF ADMINISTRATION
VARILRIX should be administered as a single dose by subcutaneous
injecti