Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pneumococcal polysaccharide conjugate vaccine (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 Manufacturing Belgium N.V.
J07AL02
pneumococcal polysaccharide conjugate vaccine (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)
2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 4.4mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose
suspension for injection
(50) vials 0,5ml
Prescription
Registered
2019-12-27
PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (ADSORBED), 13-VALENT PREVENAR 13* DESCRIPTION PREVENAR 13 (pneumococcal 13-valent conjugate vaccine) is a sterile suspension. The vaccine is composed of saccharides of the capsular antigen of _Streptococcus pneumoniae _ (_S. pneumoniae_), serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, individually conjugated to diphtheria CRM 197 protein, a nontoxic variant of diphtheria toxin. PREVENAR 13 is manufactured as a liquid preparation. After shaking, the vaccine is a homogenous, white suspension. COMPOSITION PAEDIATRIC DOSE Volume per dose 0.5 mL Pneumococcal polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F & 23F 2.2 g of each Pneumococcal polysaccharide for serotype 6B 4.4 g Diphtheria protein CRM 197 ~32 g Aluminum as aluminum phosphate adjuvant 0.125 mg Other ingredients: Polysorbate 80 Succinic acid Sodium chloride Water-for-injection ADMINISTRATION Shake well before use to homogenize the suspension, and only use if the vaccine is a homogenous, white suspension. Use a sterile syringe and a sterile needle for each injection. The dose is 0.5 mL given intramuscularly, with care to avoid injection into or near nerves and blood vessels. The preferred sites are the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in older children and adults. The vaccine should not be injected in the gluteal area. IMMUNIZATION SCHEDULE Active immunization of infants, children, and adolescents from 6 weeks through 17 years of age against invasive disease, pneumonia and otitis media caused by _S. pneumoniae _ serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F_. _ Active immunization of adults, aged 18 years and older, against pneumonia and invasive disease caused by _S. pneumoniae_ serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. _ _ INFANTS AND CHILDREN PREVENAR 13 may be given to infants and children 6 weeks to 5 years of age at the same time as diphtheria, tetanus, acellular Прочитать полный документ
1 1. NAME OF THE MEDICINAL PRODUCT Prevenar 13 suspension for injection in single dose vial 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 a pproximately 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 in single dose vial. 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. 2 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. 4.2 Прочитать полный документ