Priorix-Tetra powder and solvent for solution for injection in pre-filled syringe Measles, mumps, rubella and varicella vaccine (live)

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Live attenuated measles virus (schwarz strain); Live attenuated mumps virus (rit 4385 strain); Live attenuated rubella virus (wistar ra 27/3 strain); Live attenuated varicella virus (oka strain)

Dostupno od:

GlaxoSmithKline (Ireland) Limited

ATC koda:

J07BD; J07BD54

INN (International ime):

Live attenuated measles virus (schwarz strain); Live attenuated mumps virus (rit 4385 strain); Live attenuated rubella virus (wistar ra 27/3 strain); Live attenuated varicella virus (oka strain)

Doziranje:

Unknown

Farmaceutski oblik:

Powder and solvent for solution for injection in pre-filled syringe

Tip recepta:

Product subject to prescription which may not be renewed (A)

Područje terapije:

Measles vaccines; measles, combinations with mumps, rubella and varicella, live attenuated

Status autorizacije:

Not marketed

Datum autorizacije:

2007-08-10

Uputa o lijeku

Reason for Update: TIB/129 Excipient update
Market: Ireland
Agency Approval Date: 26/01/2022
Text Date: 25-Nov-2021
Text Issue and Draft No.: Issue 9 Draft 1
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRIORIX-TETRA POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE
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 gets 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 al

Svojstava lijeka

Health Products Regulatory Authority
20 May 2022
CRN00CQK4
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Priorix-Tetra powder and solvent for solution for injection in
pre-filled syringe 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 per dose.
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 in a pre-filled syringe.
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_
Health Products Regulatory Authority
20 May 2022
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Page 2 of 11
Individuals aged from 11 months should receive two doses (each of 0.5
ml) of Priorix-Tetra. The age at which individuals may
rece