Varivax powder and solvent for suspension for injection in pre-filled syringe

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

VARICELLA VIRUS, OKA, MERCK STRAIN, LIVE, ATTENUATED

थमां उपलब्ध:

Merck Sharp & Dohme B.V. Waarderweg 39, Haarlem Noord-Holland, 2031 BN, Netherlands

ए.टी.सी कोड:

J07BK01

INN (इंटरनेशनल नाम):

VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)

फार्मास्यूटिकल फॉर्म:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

रचना:

VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

VACCINES

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2005-10-07

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VARIVAX POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION IN A
PRE-FILLED SYRINGE
VARICELLA VACCINE (LIVE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD IS
VACCINATED 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 your pharmacist.
−
This vaccine has been prescribed for you or your child. 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 VARIVAX is and what it is used for
2.
What you need to know before you or your child receives VARIVAX
3.
How VARIVAX is given
4.
Possible side effects
5.
How to store VARIVAX
6.
Contents of the pack and other information
1.
WHAT VARIVAX IS AND WHAT IT IS USED FOR
VARIVAX is a vaccine to help protect adults and children against
chickenpox (varicella). Vaccines
are used to protect you or your child against infectious diseases.
VARIVAX can be administered to persons 12 months of age or older.
VARIVAX may also be administered to infants from 9 months of age under
special circumstances,
such as to conform with national vaccination schedules or in outbreak
situations.
It may also be given to persons who have no history of chickenpox, but
who have been exposed to
someone who has chickenpox.
Vaccination within 3 days of exposure may help prevent chickenpox or
reduce the severity of disease,
resulting in fewer skin lesions and shorter duration of illness. In
addition, there is limited information
that being vaccinated up to 5 days after exposure may reduce disease
severity.
As with other vaccines, VARIVAX does not completely protect all
individuals from naturally acquired
chickenpox.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD RECEIVES VARIVAX
DO NOT USE VARIVAX IF:
−
you or y

उत्पाद विशेषताएं

1
SUMMARY OF PRODUCT CHARACTERISTICS
Page
2
of
16
1.
NAME OF THE MEDICINAL PRODUCT
VARIVAX powder and solvent for suspension for injection in a
pre-filled syringe
Varicella Vaccine (live)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one dose (0.5 mL) contains:
Varicella virus
*
Oka/Merck strain (live, attenuated) ≥1350 PFU**
*
Produced in human diploid cells (MRC-5)
** PFU = Plaque-forming units
This vaccine may contain a trace amount of neomycin (see sections 4.3
and 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for suspension for injection.
White to off-white powder and clear, colourless liquid solvent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VARIVAX is indicated for vaccination against varicella in individuals
from 12 months of age (see
sections 4.2 and 5.1).
VARIVAX can be administered to infants from 9 months of age under
special circumstances, such as
to conform with national vaccination schedules or in outbreak
situations (see sections 4.2, 4.5, and
5.1).
VARIVAX may also be administered to susceptible individuals who have
been exposed to varicella.
Vaccination within 3 days of exposure may prevent a clinically
apparent infection or modify the
course of the infection. In addition, there are limited data that
indicate that vaccination up to 5 days
after exposure may modify the course of the infection (see section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
The use of VARIVAX should be based on official recommendations.
Individuals less than 9 months of age
VARIVAX should not be administered to individuals less than 9 months
of age.
Individuals from 9 months of age
Individuals should receive two doses of VARIVAX to ensure optimal
protection against varicella (see
section 5.1).
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3
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16
•
Individuals from 9 to 12 months of age
In settings in which vaccination is initiated between 9 and 12 months
of age, a second dose is
needed and should be given after a minimum interval of 3 months (see
section 5.1).