Država: Malta
Jezik: angleščina
Source: Medicines Authority
MUMPS VACCINE, RIT, MEASLES VIRUS, SCHWARZ STRAIN, RUBELLA VIRUS, WISTAR RA
GlaxoSmithKline Biologicals S.A. Rue de L'Institut 89 B-1330 Rixensart, Belgium
J07BD52
MUMPS VACCINE RIT 4385 MEASLES VIRUS - SCHWARZ STRAIN RUBELLA VIRUS - WISTAR RA27/3 STRAIN
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
MUMPS VACCINE RIT 4385 MEASLES VIRUS - SCHWARZ STRAIN RUBELLA VIRUS - WISTAR RA27/3 STRAIN
POM
VACCINES
Authorised
2006-03-17
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 Preberite celoten dokument
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 Preberite celoten dokument