Country: Ինդոնեզիա
language: ինդոնեզերեն
source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 PROTEIN, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 PROTEIN, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197 PROTEIN, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGA
BIO FARMA - Indonesia
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 PROTEIN, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 PROTEIN, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197 PROTEIN, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGA
2 MCG /2 MCG /2 MCG /4 MCG /2 MCG /2 MCG /2 MCG /2 MCG /2 MCG /2 MCG
SUSPENSI INJEKSI
DUS, 1 VIAL @ 1 DOSIS (0,5 ML)
SERUM INSTITUTE OF INDIA PVT. LTD. - India
2022-04-23
CORPORATE PLANT FORMAT TITLE FORMAT NO. EFFECTIVE DATE Artwork Format 2002-0001-F0003-000 09/11/2020 PAGE NO. 1 of 2 • Water for injection (WFI) • Sodium Chloride • Hydrochloric Acid • Polysorbate-20 • Succinic acid • L-Histidine • Sodium Hydroxide EXCIPIENTS: • Aluminium Phosphate gel 2% The use of vaccine should be determined on the basis of relevant recommendations and take into consideration the disease impact by age and regional epidemiology. • Thiomersal (only for Multidose formulation) The dose is 0.5 ml given intramuscularly, with care to avoid Injection into or near nerves and blood vessels. The product is a suspension containing an adjuvant, shake vigorously immediately prior to use to obtain a homogenous, whitish turbid liquid in the vaccine container. The vaccine should be given by intramuscular injection. The preferred sites are anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in young children. The vaccine should not be injected in the gluteal area. Do not administer Bio-PCV (10-valent) intravascularly. The vaccine should not be injected intradermally, subcutaneously or intravenously, since the safety and immunogenicity of these routes have not been evaluated. INDICATIONS: Once opened, multi-dose vials should be kept between +2ºC and +8ºC. Multi-dose vials of Bio-PCV (10-valent) from which one or more doses of vaccine have been removed during an immunization session may be used in subsequent immunization sessions for up to a maximum of 28 days, provided that all of the following conditions are met (as described in the WHO policy statement: Handling of multi dose vaccine vials after opening, WHO/IVB/14.07): • The vaccine is currently prequalified by WHO; DOSAGE AND ADMINISTRATION: FOR INTRAMUSCULAR USE ONLY : • The vaccine is approved for use for up to 28 days after opening the vial, as determined by WHO; Active immunization against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7 read_full_document