Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - pneumococcal polysaccharide, serotype, conjugated to, crm, b conjugated, to crm, f conjugated, n conjugated, v conjugated, a conjugated, c conjugated - solution for injection in a pre-filled syringe - pneumococcal polysaccharide serotype 1 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 2 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 3 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 4 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 5 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 6b conjugated to crm197 25 µg pneumococcal polysaccharide serotype 7f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 8 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 9n conjugated to crm197 25 µg pneumococcal polysaccharide serotype 9v conjugated to crm197 25 µg pneumococcal polysaccharide serotype 10a conjugated to crm197 25 µg pneumococcal polysaccharide serotype 11a conjugated to crm197 25 µg pneumococcal polysaccharide serotype 12f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 14 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 15b conjugated to crm197 25 µg pneumococcal polysaccharide serotype 17f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 18c conjugated to crm197 25 µg pneumococcal polysaccharide serotype 19a conjugated to crm197 25 µg pneumococcal polysaccharide serotype 19f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 20 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 22f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 23f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 33f conjugated to crm197 25 µg - vaccines

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pharmaniaga lifescience sdn. bhd. - pneumococcal polysaccharide serotype 1; pneumococcal polysaccharide serotype 5; pneumococcal polysaccharide serotype 9v; pneumococcal polysaccharide serotype 14; pneumococcal polysaccharide serotype 19a; pneumococcal polysaccharide serotype 19f; pneumococcal polysaccharide serotype 23f; pneumococcal polysaccharide serotype 7f; pneumococcal polysaccharide serotype 6a; pneumococcal polysaccharide serotype 6b -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pharmaniaga lifescience sdn. bhd. - pneumococcal polysaccharide serotype 1; pneumococcal polysaccharide serotype 5; pneumococcal polysaccharide serotype 9v; pneumococcal polysaccharide serotype 14; pneumococcal polysaccharide serotype 19a; pneumococcal polysaccharide serotype 19f; pneumococcal polysaccharide serotype 23f; pneumococcal polysaccharide serotype 7f; pneumococcal polysaccharide serotype 6a; pneumococcal polysaccharide serotype 6b -

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - pneumococcal polysaccharide, serotype, conjugated to, crm, b conjugated, to crm, f conjugated, n conjugated, v conjugated, a conjugated, c conjugated - solution for injection in a pre-filled syringe - pneumococcal polysaccharide serotype 1 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 2 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 3 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 4 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 5 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 6b conjugated to crm197 25 µg pneumococcal polysaccharide serotype 7f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 8 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 9n conjugated to crm197 25 µg pneumococcal polysaccharide serotype 9v conjugated to crm197 25 µg pneumococcal polysaccharide serotype 10a conjugated to crm197 25 µg pneumococcal polysaccharide serotype 11a conjugated to crm197 25 µg pneumococcal polysaccharide serotype 12f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 14 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 15b conjugated to crm197 25 µg pneumococcal polysaccharide serotype 17f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 18c conjugated to crm197 25 µg pneumococcal polysaccharide serotype 19f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 19a conjugated to crm197 25 µg pneumococcal polysaccharide serotype 20 conjugated to crm197 25 µg pneumococcal polysaccharide serotype 22f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 23f conjugated to crm197 25 µg pneumococcal polysaccharide serotype 33f conjugated to crm197 25 µg - vaccines

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - live attenuated oka/merck strain of varicella-zoster virus - injection, powder, lyophilized, for suspension - 19,400 pfu/dose - live attenuated oka/merck strain of varicella-zoster virus 19,400 pfu/dose

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - polysaccharides of streptococcus pneumoniae (purified) - injection - 25ug for each of the 23 serotypes

United States - English - NLM (National Library of Medicine)

a-s medication solutions - streptococcus pneumoniae type 1 capsular polysaccharide antigen (unii: h9noi61uh1) (streptococcus pneumoniae type 1 capsular polysaccharide antigen - unii:h9noi61uh1), streptococcus pneumoniae type 2 capsular polysaccharide antigen (unii: e11p4f3x4s) (streptococcus pneumoniae type 2 capsular polysaccharide antigen - unii:e11p4f3x4s), streptococcus pneumoniae type 3 capsular polysaccharide antigen (unii: 4fvb62aff1) (streptococcus pneumoniae type 3 capsular polysaccharide antigen - unii:4fvb62aff1), strep - pneumovax® 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6b, 7f, 8, 9n, 9v, 10a, 11a, 12f, 14, 15b, 17f, 18c, 19f, 19a, 20, 22f, 23f, and 33f). pneumovax 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease. pneumovax 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine. do not administer pneumovax 23 to individuals with a history of anaphylactic/anaphylactoid or severe allergic reaction to any component of the vaccine. [see description (11).] risk summary all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. available human data from clinical trials of

United States - English - NLM (National Library of Medicine)

a-s medication solutions - streptococcus pneumoniae type 1 capsular polysaccharide antigen (unii: h9noi61uh1) (streptococcus pneumoniae type 1 capsular polysaccharide antigen - unii:h9noi61uh1), streptococcus pneumoniae type 2 capsular polysaccharide antigen (unii: e11p4f3x4s) (streptococcus pneumoniae type 2 capsular polysaccharide antigen - unii:e11p4f3x4s), streptococcus pneumoniae type 3 capsular polysaccharide antigen (unii: 4fvb62aff1) (streptococcus pneumoniae type 3 capsular polysaccharide antigen - unii:4fvb62aff1), streptococcus pneumoniae type 4 capsular polysaccharide antigen (unii: cgs5ki3q2m) (streptococcus pneumoniae type 4 capsular polysaccharide antigen - unii:cgs5ki3q2m), streptococcus pneumoniae type 5 capsular polysaccharide antigen (unii: n8r9gl539d) (streptococcus pneumoniae type 5 capsular polysaccharide antigen - unii:n8r9gl539d), streptococcus pneumoniae type 6b capsular polysaccharide antigen (unii: 57f7254b6q) (streptococcus pneumoniae type 6b capsular polysaccharide antigen - unii:57f7254b6q), streptococcus pneumoniae type 7f capsular polysaccharide antigen (unii: x1k54r2p9i) (streptococcus pneumoniae type 7f capsular polysaccharide antigen - unii:x1k54r2p9i), streptococcus pneumoniae type 8 capsular polysaccharide antigen (unii: 669818346f) (streptococcus pneumoniae type 8 capsular polysaccharide antigen - unii:669818346f), streptococcus pneumoniae type 9n capsular polysaccharide antigen (unii: 313ljp87et) (streptococcus pneumoniae type 9n capsular polysaccharide antigen - unii:313ljp87et), streptococcus pneumoniae type 9v capsular polysaccharide antigen (unii: dl82pe6ane) (streptococcus pneumoniae type 9v capsular polysaccharide antigen - unii:dl82pe6ane), streptococcus pneumoniae type 10a capsular polysaccharide antigen (unii: 328vnb72t8) (streptococcus pneumoniae type 10a capsular polysaccharide antigen - unii:328vnb72t8), streptococcus pneumoniae type 11a capsular polysaccharide antigen (unii: n967bgt6xw) (streptococcus pneumoniae type 11a capsular polysaccharide antigen - unii:n967bgt6xw), streptococcus pneumoniae type 12f capsular polysaccharide antigen (unii: s46u1cm432) (streptococcus pneumoniae type 12f capsular polysaccharide antigen - unii:s46u1cm432), streptococcus pneumoniae type 14 capsular polysaccharide antigen (unii: g1gfk9898u) (streptococcus pneumoniae type 14 capsular polysaccharide antigen - unii:g1gfk9898u), streptococcus pneumoniae type 15b capsular polysaccharide antigen (unii: 667y1eg6ew) (streptococcus pneumoniae type 15b capsular polysaccharide antigen - unii:667y1eg6ew), streptococcus pneumoniae type 17f capsular polysaccharide antigen (unii: 3red79e75r) (streptococcus pneumoniae type 17f capsular polysaccharide antigen - unii:3red79e75r), streptococcus pneumoniae type 18c capsular polysaccharide antigen (unii: 23036553f6) (streptococcus pneumoniae type 18c capsular polysaccharide antigen - unii:23036553f6), streptococcus pneumoniae type 19f capsular polysaccharide antigen (unii: 5k0vu709jd) (streptococcus pneumoniae type 19f capsular polysaccharide antigen - unii:5k0vu709jd), streptococcus pneumoniae type 19a capsular polysaccharide antigen (unii: 9w2t4osf98) (streptococcus pneumoniae type 19a capsular polysaccharide antigen - unii:9w2t4osf98), streptococcus pneumoniae type 20 capsular polysaccharide antigen (unii: v3fc0dk9xs) (streptococcus pneumoniae type 20 capsular polysaccharide antigen - unii:v3fc0dk9xs), streptococcus pneumoniae type 22f capsular polysaccharide antigen (unii: 7nlv25losi) (streptococcus pneumoniae type 22f capsular polysaccharide antigen - unii:7nlv25losi), streptococcus pneumoniae type 23f capsular polysaccharide antigen (unii: pyd255827t) (streptococcus pneumoniae type 23f capsular polysaccharide antigen - unii:pyd255827t), streptococcus pneumoniae type 33f capsular polysaccharide antigen (unii: 2mgg3xw1l2) (streptococcus pneumoniae type 33f capsular polysaccharide antigen - unii:2mgg3xw1l2) - pneumovax® 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6b, 7f, 8, 9n, 9v, 10a, 11a, 12f, 14, 15b, 17f, 18c, 19f, 19a, 20, 22f, 23f, and 33f). pneumovax 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease. pneumovax 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine. do not administer pneumovax 23 to individuals with a history of anaphylactic/anaphylactoid or severe allergic reaction to any component of the vaccine. [see description (11).] risk summary all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. available human data from clinical trials of pneumovax 23 in pregnancy have not established the presence or absence of a vaccine-associated risk. developmental toxicity studies have not been conducted with pneumovax 23 in animals. risk summary it is not known whether pneumovax 23 is excreted in human milk. data are not available to assess the effects of pneumovax 23 on the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for pneumovax 23 and any potential adverse effects on the breastfed child from pneumovax 23 or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine. pneumovax 23 is not approved for use in children less than 2 years of age. children in this age group do not develop an effective immune response to the capsular types contained in this polysaccharide vaccine. the acip has recommendations for use of pneumovax 23 in children 2 years of age or older, who have previously received pneumococcal vaccines, and who are at increased risk for pneumococcal disease. in one clinical trial of pneumovax 23, conducted post-licensure, a total of 629 subjects who were aged ≥65 years and 201 subjects who were aged ≥75 years were enrolled. in this trial, the safety of pneumovax 23 in adults 65 years of age and older (n=629) was compared to the safety of pneumovax 23 in adults 50 to 64 years of age (n=379). the subjects in this study had underlying chronic illness but were in stable condition; at least 1 medical condition at enrollment was reported by 86.3% of subjects who were 50 to 64 years old, and by 96.7% of subjects who were 65 to 91 years old. the rate of vaccine-related systemic adverse experiences was higher following revaccination (33.1%) than following primary vaccination (21.7%) in subjects ≥65 years of age, and was similar following revaccination (37.5%) and primary vaccination (35.5%) in subjects 50 to 64 years of age. since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out. post-marketing reports have been received in which some elderly individuals had severe adverse experiences and a complicated clinical course following vaccination. some individuals with underlying medical conditions of varying severity experienced local reactions and fever associated with clinical deterioration requiring hospital care. persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to pneumovax 23.