Priorix - Powder and solvent for solution for injection in a pre-filled syringeMeasles, Mumps and Rubella vaccine (live)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Measles virus - schwarz strain live attenuated; Mumps vaccine rit 4385 live attenuated; Rubella virus (ra 27/3 strain)

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

J07BD; J07BD52

INN (International Name):

Measles virus - schwarz strain live attenuated; Mumps vaccine rit 4385 live attenuated; Rubella virus (ra 27/3 strain)

Dosage:

0 percent

Pharmaceutical form:

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

Prescription type:

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

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

1998-07-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PRIORIX, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
Measles, Mumps and Rubella vaccine (live)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 only. Do not pass it on to
others.
-
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.
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 is and what it is used for
2.
What you need to know before you receive Priorix
3.
How Priorix is given
4.
Possible side effects
5.
How to store Priorix
6.
Contents of the pack and other information
1.
WHAT PRIORIX IS AND WHAT IT IS USED FOR
Priorix is a vaccine for use in children from 9 months up, adolescents
and adults to protect them
against illnesses caused by measles, mumps and rubella viruses.
HOW PRIORIX WORKS
When a person is vaccinated with Priorix, the immune system (the
body’s natural defence system) will
make antibodies to protect the person from being infected by measles,
mumps and rubella viruses.
Although Priorix contains live viruses, they are too weak to cause
measles, mumps or rubella in
healthy people.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE PRIORIX
PRIORIX SHOULD NOT BE GIVEN IF
•
you are allergic against any of the components of this vaccine (listed
in section 6). Signs of an
allergic reaction may include itchy skin rash, shortness of breath and
swelling of the face or
tongue,
•
you are known to be allergic to neomycin (an antibiotic agent). A
known contact dermatitis
(skin rash when the skin is in direct contact with allergens such as
neomycin) should not b

Summary of Product characteristics

Health Products Regulatory Authority
14 December 2023
CRN00DY6V
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Priorix - Powder and solvent for solution for injection in a
pre-filled syringeMeasles, Mumps and Rubella vaccine (live)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
Live attenuated measles virus
1
(Schwarz strain) not less than 10
3.0
CCID
50
3
Live attenuated mumps virus
1
(RIT 4385 strain, derived from Jeryl Lynn strain) not less than 10
3.7
CCID
50
3
Live attenuated rubella virus
2
(Wistar RA 27/3 strain) not less than 10
3.0
CCID
50
3
1
produced in chick embryo cells
2
produced in human diploid (MRC-5) cells
3
Cell Culture Infective Dose 50%
This vaccine contains a trace amount of neomycin. See section 4.3
Excipients with known effect
The vaccine contains 9 mg of sorbitol.
The vaccine contains 6.5 nanograms of para-aminobenzoic acid per dose
and 334 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.
The lyophilised Measles-Mumps-Rubella component is a white to slightly
pink powder.
The solvent is a clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PRIORIX is indicated for the active immunisation of children from the
age of 9 months or older, adolescents and adults against
measles, mumps and rubella.
For use in children between 9 to 12 months of age see sections 4.2,
4.4 and 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The use of PRIORIX should be based on official recommendations.
Individuals 12 months of age or older
The dose is 0.5 ml. A second dose should be given according to
official recommendations.
PRIORIX may be used in individuals who have previously been vaccinated
with another monovalent or combined measles,
mumps and rubella vaccine.
Health Products Regulatory Authority
14 December 2023
CRN00DY6V
Page 2 of 9
Infants between