Država: Malta
Jezik: engleski
Izvor: Medicines Authority
VARICELLA VIRUS, OKA STRAIN, LIVE, ATTENUATED, MEASLES VIRUS, SCHWARZ STRAIN, MUMPS VIRUS, JERYL LYNN, LEVEL B, RUBELLA VIRUS, WISTAR RA
GlaxoSmithKline Biologicals S.A. Rue de L'Institut 89 B-1330 Rixensart, Belgium
J07BD54
VARICELLA VIRUS OKA STRAIN (LIVE, ATTENUATED) MEASLES VIRUS - SCHWARZ STRAIN MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED)
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
VARICELLA VIRUS OKA STRAIN (LIVE, ATTENUATED) MEASLES VIRUS - SCHWARZ STRAIN MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED)
POM
VACCINES
Authorised
2015-01-29
PACKAGE LEAFLET: INFORMATION FOR THE USER PRIORIX-TETRA, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Measles, mumps, rubella and varicella vaccine (live) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 or your child only. Do not pass it on to others. - If you or your child gets 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-Tetra is and what it is used for 2. What you need to know before you receive Priorix-Tetra 3. How to use Priorix-Tetra 4. Possible side effects 5. How to store Priorix-Tetra 6. Contents of the pack and other information 1. WHAT PRIORIX -TETRA IS AND WHAT IT IS USED FOR Priorix-Tetra is a vaccine for use in individuals from 11 months of age to protect them against illnesses caused by measles, mumps, rubella and chickenpox (varicella) viruses. In some circumstances, Priorix-Tetra can also be given to children as from 9 months of age. HOW PRIORIX-TETRA WORKS When a person is vaccinated with Priorix-Tetra, the immune system (the body's natural defence system) will make antibodies to protect the person from being infected by measles, mumps, rubella and chickenpox (varicella) viruses. Although Priorix-Tetra contains live viruses, they are too weak to cause measles, mumps, rubella, or chickenpox (varicella) in healthy people. As with all vaccines, Priorix-Tetra may not fully protect all people who are vaccinated. 2. What you need to know before you receive Priorix-Tetra PRIORIX-TETRA SHOULD NOT BE GIVEN : • if you are allergic against any Pročitajte cijeli dokument
1. NAME OF THE MEDICINAL PRODUCT Priorix-Tetra – powder and solvent for solution for injection in pre-filled syringe Measles, mumps, rubella and varicella vaccine (live) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Measles virus 1 Schwarz strain (live, attenuated) not less than 10 3.0 CCID 50 3 Mumps virus 1 RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 10 4.4 CCID 50 3 Rubella virus 2 Wistar RA 27/3 strain (live, attenuated) not less than 10 3.0 CCID 50 3 Varicella virus 2 OKA strain (live, attenuated) not less than 10 3.3 PFU 4 1 produced on chick embryo cells 2 produced on human diploid (MRC-5) cells 3 Cell culture infective dose 50% 4 Plaque forming units This vaccine contains a trace amount of neomycin. See section 4.3. Excipient with known effect The vaccine contains 14 mg of sorbitol The vaccine contains 6.5 nanograms of para-aminobenzoic acid per dose and 583 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 pre-filled syringe. Before reconstitution, the powder is a white to slightly pink coloured cake and the solvent is a clear colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Priorix-Tetra is indicated for active immunisation of individuals from the age of 11 months against measles, mumps, rubella and varicella. Use in infants aged 9-10 months could be considered under special circumstances. See section 4.2. Note: The use of Priorix-Tetra should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Individuals from 11 months of age _ Individuals aged from 11 months should receive two doses (each of 0.5 ml) of Priorix-Tetra. The age at which individuals may receive Priorix-Tetra should reflect applicable official recommendations*, which vary according to the epidemiology of these diseases. The dose interval should preferably* be between 6 w Pročitajte cijeli dokument