PRIORIX - powder and solvent for solution for injection Live attenuated measles-mumps-rubella vaccin

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Boleh didapati daripada:

NM Pharma Limited 3/4, Cantrija Complex Triq it-Targa, il-Maghtab Naxxar NXR 6613 , Malta

Kod ATC:

J07BD52

INN (Nama Antarabangsa):

MEASLES VIRUS - SCHWARZ STRAIN 50 % MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) 50 % RUBELLA VIRUS - WISTAR RA27/3 STRAIN 50 %

Borang farmaseutikal:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Komposisi:

MEASLES VIRUS - SCHWARZ STRAIN 50 % MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) 50 % RUBELLA VIRUS - WISTAR RA27/3 STRAIN 50 %

Jenis preskripsi:

POM

Kawasan terapeutik:

VACCINES

Ringkasan produk:

Licence number in the source country: Romania - 4820/2012/03

Status kebenaran:

Authorised

Tarikh kebenaran:

2024-01-05

Risalah maklumat

MARKETING AUTHORIZATION NO. 4820/2012/01-20
_Annex 1_
PROSPECTUS
PACKAGE LEAFLET: USER INFORMATION
PRIORIX, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
LIVE ATTENUATED MEASLES-MUMPS-RUBELLA VACCINE
READ THIS LEAFLET CAREFULLY AND COMPLETELY BEFORE YOU ARE GIVEN THIS
VACCINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to re-read it.
•
If you have any further questions, ask your doctor or pharmacist.
•
This vaccine has been recommended only for you. Do not give it to
other people.
•
If you experience any side effects, contact your doctor or pharmacist.
These include any
possible side effects not mentioned in this leaflet.
See section 4.
This package leaflet has been written assuming that the person reading
it is the one receiving the vaccine,
but the vaccine can be given to adults and children, so you may want
to read it to your child.
WHAT IS IN THIS LEAFLET
1.
What is Priorix and what it is used for
2.
What you need to know before you use Priorix
3.
How to take Priorix
4.
Possible side effects
5.
How to store Priorix
6.
Package contents and other information
1.
WHAT IS PRIORIX AND WHAT IT IS USED FOR
Priorix
is a vaccine used in children starting from the age of 9 months,
adolescents and adults to
protect them
against diseases caused by measles, mumps and rubella viruses.
HOW DOES PRIORIX WORK
When a person is given the vaccine, the immune system (the body's
natural defenses) will produce
antibodies to protect the person against infections caused 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 USE PRIORIX
PRIORIX SHOULD NOT BE GIVEN IF
●
you have ever had an allergic reaction to any of the components of the
vaccine (listed in section
6). Symptoms of an allergic reaction may include an itchy rash,
difficulty breathing, and
swelling of the face and tongue.
•
you have ever had an allergic reaction to neomycin (an antibiotic).

Ciri produk

MARKETING AUTHORISATION NO. 4820/2012/01-20
_Annex 2 _
SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PRIORIX - powder and solvent for solution for injection
Live attenuated measles-mumps-rubella vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 mL) contains:
•
measles virus, live, attenuated (Schwarz strain*):
≥ 10
3.0
CCID 50 *** ,
•
mumps virus, live, attenuated
(strain RIT 4385, obtained from strain Jeryl Lynn):
≥ 10
3.7
CCID 50 ,
•
live, attenuated rubella virus (Wistar strain RA 27/3**):
≥ 10
3.0
CCID 50 .
*propagated on cultures from chicken embryonic tissues
**Propagated on MRC 5 human diploid cells
***
CCID 50
–
Infectious Dose of 50% of cell cultures
This vaccine contains traces 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 list of all excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
Powder: white to pale pink powder.
Solvent: clear and colorless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PRIORIX is indicated for the active immunization of children aged 9
months or older, as well as
adolescents and adults against measles, mumps and rubella.
For use in children aged between 9 and 12 months, see sections 4.2,
4.4 and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The use of PRIORIX will be based on official recommendations.
Persons 12 months of age or older
The dose is 0.5 mL. A second dose should be administered according to
official recommendations.
PRIORIX can be used by people who have previously been vaccinated with
another measles, mumps,
rubella monovalent or combined vaccine.
Children aged between 9 and 12 months
Children in the first year of life may not respond properly to the
components of the vaccine. In case of
an epidemiol