Varilrix powder and solvent for solution for injection in pre-filled syringe varicella vaccine live

Country: Malta

Language: English

Source: Malta Medicines Authority

Available from:

JV Healthcare Limited Navi Buidlings, Pantar Road, Lija, LJA 2021, Malta

ATC code:

J07BK01

INN (International Name):

VARICELLA VIRUS OKA STRAIN (LIVE, ATTENUATED) 10PFU/dose

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Composition:

VARICELLA VIRUS OKA STRAIN (LIVE, ATTENUATED) 10PFU/dose

Prescription type:

POM

Therapeutic area:

VACCINES

Product summary:

Licence number in the source country: Romania - 5064/2012/14

Authorization status:

Authorised

Authorization date:

2024-02-01

Patient Information leaflet

PATIENT LEAFLET: INFORMATION FOR THE USER
VARILRIX, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
VARICELLA VACCINE (LIVE)
READ THIS LEAFLET CAREFULLY AND COMPLETELY BEFORE THIS VACCINE IS
GIVEN TO YOU OR YOUR CHILD BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to re-read it.
-
If you have any further questions, please ask your doctor, pharmacist
or nurse.
-
This vaccine has been prescribed only for you or your child. You must
not give it to other
people.
-
If you or your child experience any side effects, contact your doctor,
pharmacist or nurse.
These include any side effects not mentioned in this leaflet. See
point 4.
WHAT YOU FIND IN THIS PROSPECTUS
1. What Varilrix is and what it is used for
2. What you need to know before Varilrix is given to you or your child
3. How to administer Varilrix
4. Possible side effects
5. How to store Varilrix
6. Contents of the packaging and other information
1.
WHAT VARILRIX IS AND WHAT IT IS USED FOR
Varilrix is a vaccine intended for use in people at least 12 months of
age to protect them
against
chickenpox (chickenpox). Also, under certain conditions, Varilrix can
be administered to infants from
the age of 9 months.
Vaccination within 3 days of contact with a person with chicken pox
can help prevent or reduce the
severity of the disease.
HOW VARILRIX WORKS
When a person is vaccinated with Varilrix, the immune system (the
body's natural defense system) will
produce antibodies to protect the person from infection with the virus
that causes chickenpox (chickenpox).
Varilrix contains attenuated viruses and is very unlikely to cause
wind in healthy people.
As with all vaccines, Varilrix may not fully protect all people who
have been vaccinated.
2.
WHAT YOU NEED TO KNOW BEFORE VARILRIX IS GIVEN TO YOU OR YOUR CHILD
DO NOT USE VARILRIX
•
if you or your child have any disease (such as blood disorders,
cancer, human
immunodeficiency virus (HIV) infection or acquired immunodeficiency
syndrome (AIDS)) or
are taking any med

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINE
Varilrix powder and solvent for solution for injection in pre-filled
syringe
varicella vaccine (live)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one dose (0.5 ml) contains:
Varicella-zoster virus
1
, strain OKA (live, attenuated)
not less than 10
3.3
PFU
2
1
produced in human diploid cells MRC-5
2
plaque forming units
This vaccine contains residual amounts of neomycin (see section 4.3).
Excipients with known effect:
The vaccine contains sorbitol 6 mg per each dose.
The vaccine contains 331 micrograms of phenylalanine per each dose
(see section 4.4).
For the list of all excipients, see point 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection in pre-filled syringe
Before reconstitution, the powder is slighty cream to yellowish or
pinkish coloured cake, and the solvent
is a clear colorless liquid.
4.
CLINICAL DATA
4.1
THERAPEUTIC INDICATIONS
Varilrix is indicated for active immunization against varicella:
-
in healthy people from the age of 9 months to 11 months (see point
5.1), under special
circumstances;
-
in healthy individuals from the age of 12 months (see section 5.1)
-
For post-exposure prophylaxis if administered to healthy, susceptible
individuals exposed to
varicella within 72 hours of contact (see sections 4.4 and 5.1);
- In individuals at high risk of severe varicella (see sections 4.3,
4.4 and 5.1)
The use of Varilrix should be based on official recommendations.
4.2
DOSES AND METHOD OF ADMINISTRATION
Dosage
The immunisation schedules for Varilrix should be based on official
recommendations.
_Healthy people _
_Infants aged 9 months to 11 months (inclusive) _
Infants aged 9 to 11 months (inclusive) should receive two doses of
Varilrix to ensure optimal
protection against varicella (see section 5.1). The second dose should
be given after a minimum
interval of 3 months.
_Children aged from 12 months, teenagers and adults _
In children aged 12 months and older, as well as in adolescents and
adults,