Priorix-Tetra - Measles, mumps, rubella and varicella vaccine (live)

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

VARICELLA VIRUS, OKA STRAIN, LIVE, ATTENUATED, MEASLES VIRUS, SCHWARZ STRAIN, MUMPS VIRUS, JERYL LYNN, LEVEL B, RUBELLA VIRUS, WISTAR RA

MAH:

GlaxoSmithKline Biologicals S.A. Rue de L'Institut 89 B-1330 Rixensart, Belgium

ATC_code:

J07BD54

INN:

MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) RUBELLA VIRUS - WISTAR RA27/3 STRAIN VARICELLA VIRUS OKA STRAIN (LIVE, ATTENUATED) MEASLES VIRUS - SCHWARZ STRAIN

pharmaceutical_form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

composition:

MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) RUBELLA VIRUS - WISTAR RA27/3 STRAIN VARICELLA VIRUS OKA STRAIN (LIVE, ATTENUATED) MEASLES VIRUS - SCHWARZ STRAIN

prescription_type:

POM

therapeutic_area:

VACCINES

authorization_status:

Withdrawn

authorization_date:

2015-01-29

PIL

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRIORIX-TETRA, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Measles, mumps, rubella and varicella vaccine (live)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVE
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 or your child only. Do not
pass it on to others.
-
If you or your child get any side effects, talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
This leaflet has been written assuming the person receiving the
vaccine is reading it, but it can be
given to adults and children so you may be reading it for your child.
WHAT IS IN THIS LEAFLET
1.
What Priorix-Tetra is and what it is used for
2.
What you need to know before you receive Priorix-Tetra
3.
How to use Priorix-Tetra
4.
Possible side effects
5.
How to store Priorix-Tetra
6.
Contents of the pack and other information
1.
WHAT PRIORIX-TETRA IS AND WHAT IT IS USED FOR
Priorix-Tetra is a vaccine for use in individuals from 11 months of
age to protect them against
illnesses caused by measles, mumps, rubella and chickenpox (varicella)
viruses. In some
circumstances, Priorix-Tetra can also be given to children as from 9
months of age.
HOW PRIORIX-TETRA WORKS
When a person is vaccinated with Priorix-Tetra, the immune system (the
body's natural defence
system) will make antibodies to protect the person from being infected
by measles, mumps, rubella
and chickenpox (varicella) viruses.
Although Priorix-Tetra contains live viruses, they are too weak to
cause measles, mumps, rubella, or
chickenpox (varicella) in healthy people.
As with all vaccines, Priorix-Tetra may not fully protect all people
who are vaccinated.
2.
What you need to know before you receive Priorix-Tetra
PRIORIX-TETRA SHOULD NOT BE GIVEN :
•
if you are allergic against any of t

SPC

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
3
1.
NAME OF THE MEDICINAL PRODUCT
Priorix-Tetra – powder and solvent for solution for injection
Measles, mumps, rubella and varicella vaccine (live)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
Measles virus
1
Schwarz strain (live, attenuated)
not less than 10
3.0
CCID
50
3
Mumps virus
1
RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated)
not less than 10
4.4
CCID
50
3
Rubella virus
2
Wistar RA 27/3 strain (live, attenuated)
not less than 10
3.0
CCID
50
3
Varicella virus
2
OKA strain (live, attenuated)
not less than 10
3.3
PFU
4
1
produced on chick embryo cells
2
produced on human diploid (MRC-5) cells
3
Cell culture infective dose 50%
4
Plaque forming units
This vaccine contains a trace amount of neomycin. See section 4.3.
Excipient with known effect
The vaccine contains 14 mg of sorbitol
The vaccine contains 6.5 nanograms of para-aminobenzoic acid per dose
and 583 micrograms of
phenylalanine per dose (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Before reconstitution, the powder is a white to slightly pink coloured
cake and the solvent is a clear
colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Priorix-Tetra is indicated for active immunisation of individuals from
the age of 11 months against
measles, mumps, rubella and varicella.
Use in infants aged 9-10 months could be considered under special
circumstances. See section 4.2.
Note: The use of Priorix-Tetra should be based on official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Individuals from 11 months of age _
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Individuals aged from 11 months should receive two doses (each of 0.5
ml) of Priorix-Tetra. The age
at which individuals may receive Priorix-Tetra should reflect
applicable official recommendations*,
which vary according to the epidemiology of these diseases.
The dose interval should preferably* be between 6 we