PNEUMOSIL

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

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

Tersedia dari:

BIO FARMA - Indonesia

INN (Nama Internasional):

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

Dosis:

2 MCG /2 MCG /2 MCG /4 MCG /2 MCG /2 MCG /2 MCG /2 MCG /2 MCG /2 MCG

Bentuk farmasi:

SUSPENSI INJEKSI

Unit dalam paket:

DUS, 50 VIAL @ 5 DOSIS (2,5 ML)

Diproduksi oleh:

SERUM INSTITUTE OF INDIA PVT. LTD. - India

Tanggal Otorisasi:

2022-04-23

Karakteristik produk

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