VARILRIX

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Units in package:

DUS, 1 VIAL @ 1 DOSIS (0,5 ML) + 1 AMPUL PELARUT @ 0,5 ML

Authorization date:

2022-01-03

Summary of Product characteristics

ERS_leaVARinj_Update PI GDS 015 IPI 017_circ2_09Aug22
_Page 1 of 8_
VARILRIX
VARICELLA VACCINE
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
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.
_ _
_VARILRIX_ meets the World Health Organization requirements for
biological substances and for varicella
vaccines.
Each dose of the reconstituted vaccine contains not less than 10
3.3
plaque-forming units (PFU) of the
attenuated varicella-zoster virus.
The powder is slightly cream to yellowish or pinkish.
The solvent is clear and colourless.
CLINICAL INFORMATION
INDICATIONS
Healthy subjects
_VARILRIX_ is indicated for active immunization against varicella of
healthy subjects from the age of 12
months onwards.
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.
Patients at high risk of severe varicella
Patients
suffering
from
leukaemia,
patients
under
immunosuppressive
treatment
(including
corticosteroid therapy) for malignant solid tumour, for serious
chronic diseases (such as chronic renal
failure,
autoimmune
diseases,
collagen
diseases,
severe
bronchial
asthma)
or
following
organ
transplantation, are predisposed to severe natural varicella.
Vaccination with the Oka-strain has been
shown to reduce the complications of varicella in these patients.
There is only limited data from clinical trials available for _
VARILRIX_
_ _
in patients at high risk of severe
varicella; should vaccination be considered, it is advised that:
•
Maintenance
chemotherapy
should
be
withheld
one
week
before
and
one
week
after
immunization of patients in the acute phase of leukaemia. Patients
under radiotherapy should
normally not be vaccinated d