Šalis: Europos Sąjunga
kalba: anglų
Šaltinis: EMA (European Medicines Agency)
meningococcal group A, C, W-135 and Y conjugate vaccine
GSK Vaccines S.r.l.
J07AH08
meningococcal group A, C, W-135 and Y conjugate vaccine
BACTERIAL VACCINES
Immunization, Meningitis, Meningococcal
Prefilled syringe Menveo is indicated for active immunisation of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease. The use of this vaccine should be in accordance with official recommendations. Vials Menveo is indicated for active immunisation of children (from two years of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease. The use of this vaccine should be in accordance with official recommendations.,
Revision: 23
Authorised
2010-03-14
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE USER MENVEO POWDER AND SOLUTION FOR SOLUTION FOR INJECTION Meningococcal Group A, C, W135 and Y conjugate vaccine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE GIVEN THIS MEDICINE 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, pharmacist or nurse. - This vaccine has been prescribed for you or your child only. - If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Menveo is and what it is used for 2. What you need to know before you or your child are given Menveo 3. How to use Menveo 4. Possible side effects 5. How to store Menveo 6. Contents of the pack and other information 1. WHAT MENVEO IS AND WHAT IT IS USED FOR Menveo is a vaccine that is used for active immunization of children (from 2 years of age), adolescents and adults at risk of exposure to a bacterium named _Neisseria meningitidis_ serogroups A, C, W135 and Y, to prevent invasive disease_. _The vaccine works by causing your body to make its own protection (antibodies) against these bacteria. _Neisseria meningitidis_ serogroup A, C, W135 and Y bacteria can cause serious and sometimes life-threatening infections such as meningitis and sepsis (blood poisoning). Menveo cannot cause bacterial meningitis. This vaccine contains a protein (called CRM 197 ) from the bacteria that cause diphtheria. Menveo does not protect against diphtheria. This means that you (or your child) should receive other vaccines to protect against diphtheria when these are due or when advised by your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD ARE GIVEN MENVEO DO NOT USE MENVEO IF YOU OR YOUR CHILD HAS: - ever had an allergic reaction to the active substances or any of the other ingredients of this vaccine (listed in section 6) - ever had an allergic re Perskaitykite visą dokumentą
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Menveo powder and solution for solution for injection Meningococcal Group A, C, W135 and Y conjugate vaccine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml of the reconstituted vaccine) contains: (Originally contained in the powder) Meningococcal group A oligosaccharide 10 micrograms Conjugated to_ Corynebacterium diphtheriae _CRM 197 protein 16.7 to 33.3 micrograms_ _ (Originally contained in the solution) Meningococcal group C oligosaccharide 5 micrograms_ _ Conjugated to_ Corynebacterium diphtheriae _CRM 197 protein 7.1 to 12.5 micrograms_ _ Meningococcal group W135 oligosaccharide 5 micrograms Conjugated to_ Corynebacterium diphtheriae _CRM 197 protein 3.3 to 8.3 micrograms Meningococcal group Y oligosaccharide 5 micrograms_ _ Conjugated to_ Corynebacterium diphtheriae _CRM 197 protein 5.6 to 10.0 micrograms_ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solution for solution for injection (powder and solution for injection). The powder is a white to off- white cake. The solution is a colourless clear solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Menveo is indicated for active immunization of children (from 2 years of age), adolescents and adults at risk of exposure to _Neisseria meningitidis_ groups A, C, W135 and Y, to prevent invasive disease. The use of this vaccine should be in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Children (from 2 years of age), adolescents and adults _ Menveo should be administered as a single dose (0.5 ml). To ensure optimal antibody levels against all vaccine serogroups, the primary vaccination schedule with Menveo should be completed one month prior to risk of exposure to _Neisseria meningitidis_ groups A, C, W135 and Y. Bactericidal antibodies (hSBA≥1:8) were observed in at least 64% of subjects at 1 week post vaccination (see section 5.1 for immunogenicity data Perskaitykite visą dokumentą