Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
NM Pharma Limited 3/4, Cantrija Complex Triq it-Targa, il-Maghtab Naxxar NXR 6613 , Malta
J07BD52
MEASLES VIRUS - SCHWARZ STRAIN 50 % MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) 50 % RUBELLA VIRUS - WISTAR RA27/3 STRAIN 50 %
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
MEASLES VIRUS - SCHWARZ STRAIN 50 % MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) 50 % RUBELLA VIRUS - WISTAR RA27/3 STRAIN 50 %
POM
VACCINES
Licence number in the source country: Romania - 4820/2012/03
Authorised
2024-01-05
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). Soma hati kamili
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 Soma hati kamili