SII PNEUMOSIL Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (10-Valent) SUSPENSION FOR INJECTION (SINGLE DOSE - 1 DOSE)

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ingredients actius:

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

Disponible des:

PHARMANIAGA LIFESCIENCE SDN. BHD.

Designació comuna internacional (DCI):

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

Unidades en paquete:

10 Vials; 1 Vials

Fabricat per:

SERUM INSTITUTE OF INDIA PRIVATE LIMITED

Informació per a l'usuari

Not Applicable

Fitxa tècnica

Item Code number:
Colour:
K,
and
CMY
Pantone 072 C
Pantone 7442 C
Dimensions: 123 x 360 mm
Product:
Reason for issue: Text revised
Customer: Malaysia
Specification No.:
Artwork made to: 100%
QUALITY
CONTROL
PACKAGING
DEVELOPMENT
REGULATORY
AFFAIRS
QUALITY
ASSURANCE
File Name: E:\Packaging artworks as on 090212\Artworks SII Pvt Ltd
231015\Insert\Malaysia\PNEUMOSIL Insert, Malaysia.cdr Rev. on:
16.04.2021
Supercedes Item Code: 20017103/1
MEDICAL
DEPARTMENT
Specification: Printed on bible paper 40 gsm.
20017103/2
SII
The dose is 0.5 ml given intramuscularly, with care to avoid injection
into or near nerves and blood vessels. 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 SII PNEUMOSIL
(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.
·
The vaccine is approved for use for up to 28 days after opening the
vial, as determined by WHO;
DESCRIPTION
Other ingredients: L-Histidine, Succinic acid, Sodium chloride,
Polysorbate 20 and water for injections.
SII PNEUMOSIL
Active immunization for the prevention of invasive disease, pneumonia
and acute otitis media caused by _ Streptococcus _
_pneumoniae_ serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F in
infants and toddlers from 6 weeks up to 2 years of age. 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.
·
The vaccine is currently prequalified by WHO;
METHOD OF ADMINISTRATION
Individual conjugates are compounded and then polysorbate 20 and
aluminium phosphate are added to formulate the vaccine.
The potency of the vaccine is determined by the quantity of the
saccharide antigens and the saccharide-to-protein ratios in the
individual glycoconjugates. The vaccine meets the req