Varilrix vaccine powder and solvent for solution for injection 0.5ml vials

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Varicella-Zoster virus live attenuated (Oka strain)

可用日期:

GlaxoSmithKline UK Ltd

ATC代码:

J07BK01

INN（国际名称）:

Varicella-Zoster virus live attenuated (Oka strain)

药物剂型:

Powder and solvent for solution for injection

给药途径:

Intramuscular; Subcutaneous

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 14040000; GTIN: 5000483111144

资料单张

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
VARILRIX
10
3.3
PFU/0.5 ml, powder and solvent for solution for injection.
Varicella/chickenpox vaccine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS VACCINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This vaccine has been prescribed for you. Do not pass it on to others.
It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1 What Varilrix is and what it is used for
2 What you need to know before you receive Varilrix
3 How Varilrix is given
4 Possible side effects
5 How to store Varilrix
6 Contents of the pack and other information
1
WHAT VARILRIX IS AND WHAT IT IS USED FOR
Varilrix is a chickenpox or ‘varicella’ vaccine. It is used to
boost the body’s immune system
to stop infection from chickenpox.
This vaccine can be given to both adults and children older than 9
months. In this leaflet any
reference to ‘you’ can also mean ‘your child’.
HOW VARILRIX WORKS
Varilrix contains a small amount of a live but weakened
‘varicella-zoster’ virus which is the
cause of chickenpox.
•
There is not enough virus in the vaccine to make you ill.
•
There is just enough to trigger the body’s immune system to prepare
itself to protect
against these viruses in the future.
•
Varilrix does not always completely protect you from catching
chickenpox. People
who catch chickenpox after receiving the vaccine usually get a mild
form. They will
have very few spots and blisters compared to people who have not had
the vaccine.
•
Varilrix is normally given to healthy children (as of 9 months),
teenagers and adults.
•
Varilrix may sometimes be given to healthy individuals who live with,
or spend a lot of
time with, people who have

产品特点

OBJECT 1
VARILRIX
Summary of Product Characteristics Updated 19-Sep-2017 |
GlaxoSmithKline UK
1. Name of the medicinal product
Varilrix 10
3.3
PFU/0.5ml, powder and solvent for solution for injection.
2. Qualitative and quantitative composition
One dose (0.5 ml) contains:
Live attenuated varicella-zoster (Oka strain) virus* 10
3.3
plaque forming units (PFU)
*propagated in MRC5 human diploid cells
For excipients, see 6.1.
3. Pharmaceutical form
Powder and solvent for solution for injection.
Clear peach to pink coloured solution.
4. Clinical particulars
4.1 Therapeutic indications
Varilrix is indicated for active immunisation against varicella of
healthy subjects (from the age of 9
months).
Vaccination of susceptible healthy close contacts of subjects at risk
of severe varicella is recommended,
in order to reduce the risk of transmission of wild-type virus to
these patients. Close contacts include
parents and siblings of high-risk patients, and medical and
paramedical personnel.
4.2 Posology and method of administration
POSOLOGY
Children 9 months up to and including 12 years
Two doses (each of 0.5 ml of reconstituted vaccine) should be given to
ensure optimal protection against
varicella (see section 5.1).
_- Children from 9 to 12 months of age_
The second dose should be given after a minimum interval of 3 months.
_- Children from 12 months to 12 years of age_
The second dose should be given after an interval of at least 6 weeks
but in no circumstances less than 4
weeks.
Varilrix should not be administered to children aged less than 9
months.
Adolescents and adults from 13 years of age and above
Two doses (each of 0.5 ml of reconstituted vaccine). It is preferable
to administer the second dose at least
6 weeks after the first dose but in no circumstances less than 4
weeks.
Elderly
There are no data on immune responses to Varilrix in the elderly.
Interchangeability:
A single dose of Varilrix may be administered after a first dose of
another varicella containing vaccine
(see section 5.1).
A single dose of Varilrix ma