Varivax powder and solvent for suspension for injection
국가: 몰타
언어: 영어
출처: Medicines Authority
환자 정보 전단 유효 성분:
VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)
제공처:
Merck Sharp & Dohme Limited
ATC 코드:
J07BK01
INN (International Name):
VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)
약제 형태:
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
구성:
VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)
처방전 유형:
POM
치료 영역:
VACCINES
승인 상태:
Authorised
승인 날짜:
2005-10-07
환자 정보 전단
Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
VARIVAX POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
[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
varicella (chickenpox). 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
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
VARIVAX powder and solvent for suspension for injection
[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).
Excipients:
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, colorless 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.
Page 2 of 16
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).
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).
Indi
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