Priorix vaccine powder and solvent for solution for injection 0.5ml vials

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Rubella virus live attenuated; Mumps virus live attenuated; Measles virus live attenuated

Commercializzato da:

GlaxoSmithKline UK Ltd

Codice ATC:

J07BD52

INN (Nome Internazionale):

Rubella virus live attenuated; Mumps virus live attenuated; Measles virus live attenuated

Forma farmaceutica:

Powder and solvent for solution for injection

Via di somministrazione:

Intramuscular; Subcutaneous

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 14040000; GTIN: 5000483780203

Foglio illustrativo

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

Scheda tecnica

OBJECT 1
PRIORIX
Summary of Product Characteristics Updated 02-Nov-2017 |
GlaxoSmithKline UK
1. Name of the medicinal product
Priorix - Powder and solvent for solution for injection in a
pre-filled syringe
Measles, 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.
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 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.
Infants between 9 and 12 months of age
Infants in their first year of life may not respond sufficiently to
the components of the vaccines. In case an
epidemiological situation requires vaccinating infants in their first
year of life (e.g. ou