Priorix Pdr+Solv for Soln for Inj in a pre-filled syringe Measles, Mumps and Rubella vaccine (live)

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

MUMPS VACCINE, RIT, MEASLES VIRUS, SCHWARZ STRAIN, RUBELLA VIRUS, WISTAR RA

Доступна с:

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

код АТС:

J07BD52

ИНН (Международная Имя):

MUMPS VACCINE RIT 4385 MEASLES VIRUS - SCHWARZ STRAIN RUBELLA VIRUS - WISTAR RA27/3 STRAIN

Фармацевтическая форма:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

состав:

MUMPS VACCINE RIT 4385 MEASLES VIRUS - SCHWARZ STRAIN RUBELLA VIRUS - WISTAR RA27/3 STRAIN

Тип рецепта:

POM

Терапевтические области:

VACCINES

Статус Авторизация:

Authorised

Дата Авторизация:

2006-03-17

тонкая брошюра

1
PACKAGE LEAFLET
2
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
neo

Характеристики продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
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. 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.
Infants between 9 and 12 months of age
3
Infants in their first year of life may not respond sufficiently to
the components of the vaccines. In case
an epi