Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella
Merck Sharp & Dohme B.V.
J07BD54
measles, mumps, rubella and varicella vaccine (live)
Vaccines
Chickenpox; Rubella; Measles; Mumps; Immunization
ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age. ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles.,
Revision: 31
Authorised
2006-04-05
38 B. PACKAGE LEAFLET 39 PACKAGE LE AFLET: INFORMATION FOR THE USER PROQUAD POWDER AND SO LVENT FOR SUSPENSION FOR INJECTION Measles, mumps, rubella and varicella vac cine (live) R EAD ALL OF THIS LEAFLE T CAREFULLY BEFORE YOU OR YO UR CHILD IS VACCINA TED BECAUSE IT CONTAINS IMPORTANT INFORMATI ON FOR YOU. - Keep this leaflet. You may ne ed to read it again. - If you have any further questions, ask your doctor or your pharm acist. - This vaccine has been presc ribed for you o r your child only. Do not pass i t on to others. - If you get any of the sid e effects, talk to your doctor or pharmacis t. This inc ludes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Pro Quad is and wha t it is used for 2. What you need to know before you receive ProQuad 3. How to use ProQuad 4. Possible side effects 5. How to store ProQuad 6. Contents of the pack and other information 1. WHAT PROQUAD I S AND WHAT IT IS USED FOR ProQuad is a vaccine co ntaining meas les, mumps, rubella, and chickenpox (varicella) viruses that h ave been weakened. When a person is given the vaccine, the immune system (the body’s natural defences ) will make antibodies agains t the measles, mumps, rubella, and varicella viruses. The antibo dies help protect against diseases caused by these viruses. P roQuad is given to help protect you r child against measles, mumps, rubella , and chickenpox (varicella) . The vaccine may be adminis tered to perso ns from 12 months of age. ProQuad ma y also be adm inistered to infants from 9 months of age under special circum stances (to co nform with national vaccination schedules, outbreak situatio ns, or travel to a region with high prevalence of measle s). Although ProQuad contains liv e viruses, they a re too weak t o cause measles, mumps, rubella, or chickenpox (varicella) in healthy people. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE PROQUAD DO NOT USE PROQUAD If the person to be vaccinated is aller gic to any varicella vaccine or mea sles, mumps, or rubella Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mump s, rubella and varicella vaccin e (live). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one dose (0.5 mL) contains: Measles virus 1 Enders’ Edmonston strain (live, attenuated) ........ not less than 3.00 log 10 TCID 50 * Mumps virus 1 Jeryl Lynn ™ (Le vel B) strain (live, attenua ted) ... not less than 4.30 log 10 TCID 50 * Rubella virus 2 Wistar RA 27/3 strain (live, attenuated) ............... not less than 3.00 log 10 TCID 50 * Varicella virus 3 Oka/Merck strain (live, attenuat ed) ................... not less than 3.99 log 10 PFU** *50% tissue cultur e infectious dose **plaque-f orming units ( 1 ) Produced in chick embryo cells. ( 2 ) Produced in human diploid lung (WI -38) fibroblasts. ( 3 ) Produced in human diploid (MRC -5) cells. The vaccine may contain traces of recombinant human alb umin (rHA). This vacc ine contains a trace amount of neomycin. See section 4.3. Excipient(s) with known effect The vaccine contains 16 milligrams of sorbitol per dose. See section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solve nt for suspension for injection Before r econstitution, the pow der is a white to pale yellow compact crystalline cake and the solvent is a clear colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ProQuad is indicated for simultaneous vaccination against measles, mumps, rub ella and varicella in individuals from 12 months of age. ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination sche dules, outbreak situations, or travel to a region with hig h prevalence of measle s; see sections 4.2, 4.4, and 5.1). 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ProQu ad should be used in accordance to official r Pročitajte cijeli dokument