Varilrix Vaccine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Varicella vaccine 2000 PFU (not less than); Varicella vaccine 2000 PFU (not less than)

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Varicella vaccine 2000 PFU (not less than)

Dosage:

2000 PFU

Pharmaceutical form:

Powder for injection with diluent

Composition:

Active: Varicella vaccine 2000 PFU (not less than) Excipient: Albumin Amino acids Lactose monohydrate Mannitol Sorbitol Water for injection Active: Varicella vaccine 2000 PFU (not less than) Excipient: Amino acids Lactose Mannitol Sorbitol

Units in package:

Ampoule, glass, diluent, 0.5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

GlaxoSmithKline Biologicals SA

Therapeutic indications:

VARILRIX is indicated for active immunisation and prophylaxis against varicella in healthy infants (from the age of 9 months), children, adolescents and adults.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, diluent - 0.5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, 1 vial + 1 diluent - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 90 minutes reconstituted (not refrigerated) stored at or below 25°C protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, 10 vials + 10 diluents - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 90 minutes reconstituted (not refrigerated) stored at or below 25°C protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, needleless - 0.5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, diluent - 0.5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 90 minutes reconstituted (not refrigerated) stored at or below 25°C protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1994-06-10

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 IS VARILRIX
USED FOR
VARILRIX is a vaccine used to
prevent and immunise against the
varicella virus, which causes
chickenpox in infants (from the age
of 9 months), children, adolescents
and adults.
Varicella, commonly known as
chickenpox, is a highly infectious
viral infection, caused by varicella
zoster virus.
Sufferers usually experience a rash,
fever, loss of appetite, headache and
sore throat. The spots of the rash are
initially flat and become blisters with
fluid in them which eventually forms
a crust.
Some groups of people are at a
higher risk of exposure to the
varicella virus. Vaccination is
recommended for these people:
•
some healthcare workers
•
school teachers
•
people in contact with children
•
children who have working
mothers
The virus can be spread by patients
with chickenpox or the herpes zoster
virus. The virus is spread through
the air or direct contact with the
lesions or blisters. It can also be
transmitted from an infected mother
to her unborn child.
Vaccination is the best way to protect
against infection in the longer term.
The risk of complications and death
are greater in people whose
immunity is impaired by illness or by
treatment with drugs known as
immunosuppressants.
VARILRIX will not protect a person
if they are already infected with the
varicella virus at the time of
vaccination. VARILRIX may not
prevent the disease in these

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
VARILRIX (human albumin-free) live attenuated varicella vaccine
Each dose of the reconstituted vaccine contains not less than 10
3.3
plaque-forming units (PFU)
of the varicella-zoster virus.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL) contains:
Live attenuated Oka strain of varicella-zoster virus, obtained by
propagation of the virus in
MRC
5
human diploid cell culture.
VARILRIX meets the World Health Organisation requirements for
biological substances and for
varicella vaccines.
For full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Lyophilised powder: slightly cream to yellowish or pinkish colour.
Sterile diluent: clear and colourless.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VARILRIX is indicated for active immunisation and prophylaxis against
varicella in healthy
infants (from the age of 9 months), children, adolescents and adults.
There are socioeconomic benefits for the more extensive use of
VARILRIX in the community
eg. health workers, school teachers and others exposed to children
should be vaccinated with
VARILRIX if there is no history of varicella. Working mothers should
have their children
vaccinated.
4.2 DOSE AND METHOD OF ADMINISTRATION
0.5 mL of reconstituted vaccine contains one immunising dose.
Dose
PAEDIATRIC POPULATION: CHILDREN FROM THE AGE OF 9 MONTHS UP TO 12
YEARS OF AGE: two
doses of VARILRIX administered at least six weeks apart is recommended
for the benefit of
enhanced immune response against varicella virus._ _
13 YEARS AND ABOVE:_ _two doses with an interval between doses of a
minimum of 6 weeks.
Interchangeability
-
A single dose of VARILRIX may be administered to those who have
already received a
single dose of another varicella-containing vaccine.
2
-
A single dose of VARILRIX may be administered followed by a single
dose of another
varicella-containing vaccine.
Method of administration
VARILRIX SHOULD NEVER BE ADMINISTERED INTRAVENOUSLY.
VARILRIX should be administered by subcuta