Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F
Pfizer Europe MA EEIG
J07AL02
pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Vaccines
Pneumococcal Infections; Immunization
Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly.See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.
Revision: 45
Authorised
2009-12-09
93 B. PACKAGE LEAFLET 94 PACKAGE LEAFLET: INFORMATION FOR THE USER PREVENAR 13 SUSPENSION FOR INJECTION pneumococcal polysaccharide conjugate vaccine (13 valent, adsorbed) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVES 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, pharmacist or nurse. - This vaccine has been prescribed for you or your child only. Do not pass it on to others. - If you or your child 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 Prevenar 13 is and what it is used for 2. What you need to know before you or your child receives Prevenar 13 3. How Prevenar 13 is given 4. Possible side effects 5. How to store Prevenar 13 6. Contents of the pack and other information 1. WHAT PREVENAR 13 IS AND WHAT IT IS USED FOR Prevenar 13 is a pneumococcal vaccine given to: CHILDREN FROM 6 WEEKS TO 17 YEARS to help protect against diseases such as: meningitis (inflammation around the brain), sepsis or bacteraemia (bacteria in the blood stream), pneumonia (lung infection) and ear infections ADULTS AGED 18 YEARS AND OLDER to help prevent disease such as: pneumonia (lung infection), sepsis or bacteraemia (bacteria in the blood stream) and meningitis (inflammation around the brain), caused by 13 types of the bacteria _Streptococcus pneumoniae._ Prevenar 13, provides protection against 13 types of _Streptococcus pneumoniae_ bacteria, and replaces Prevenar, which provided protection against 7 types. The vaccine works by helping the body to make its own antibodies, which protect you or your child against these diseases. _ _ 2. WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD RECEIVES PREVENAR 13 PREVENAR 13 SHOULD NOT BE GIVEN • if you or your child is allergic (hypersensitive) to the active substances or to any of the other ingredients in this Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Prevenar 13 suspension for injection pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: Pneumococcal polysaccharide serotype 1 1 2.2 µg Pneumococcal polysaccharide serotype 3 1 2.2 µg Pneumococcal polysaccharide serotype 4 1 2.2 µg Pneumococcal polysaccharide serotype 5 1 2.2 µg Pneumococcal polysaccharide serotype 6A 1 2.2 µg Pneumococcal polysaccharide serotype 6B 1 4.4 µg Pneumococcal polysaccharide serotype 7F 1 2.2 µg Pneumococcal polysaccharide serotype 9V 1 2.2 µg Pneumococcal polysaccharide serotype 14 1 2.2 µg Pneumococcal polysaccharide serotype 18C 1 2.2 µg Pneumococcal polysaccharide serotype 19A 1 2.2 µg Pneumococcal polysaccharide serotype 19F 1 2.2 µg Pneumococcal polysaccharide serotype 23F 1 2.2 µg 1 Conjugated to CRM 197 carrier protein, adsorbed on aluminium phosphate. 1 dose (0.5 ml) contains approximately 32 µg CRM 197 carrier protein and 0.125 mg aluminium. Excipients with known effect For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. The vaccine is a homogeneous white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by _Streptococcus pneumoniae_ in infants, children and adolescents from 6 weeks to 17 years of age. Active immunisation for the prevention of invasive disease and pneumonia caused by _ Streptococcus _ _pneumoniae _ in adults ≥18 years of age and the elderly. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas. 3 Прочетете целия документ