VAXNEUVANCE (Pneumococcal 15-Valent Conjugate Vaccine) Suspension For Injection Prefilled Syringe

देश: मलेशिया

भाषा: अंग्रेज़ी

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

इसे खरीदें

सूचना पत्रक (PIL)

23-02-2022

उत्पाद विशेषताएं (SPC)

15-09-2023

सक्रिय संघटक:

Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 1; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 3; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 4; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 5; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 6A; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 6B; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 7F; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 9V; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 14; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 18C; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 19A; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 19F; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 22F; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 23F; Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 33F

थमां उपलब्ध:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (इंटरनेशनल नाम):

पैकेज में यूनिट:

10 Pre-Filled Syringes; 1 Pre-Filled Syringes

द्वारा बनाया गया:

MERCK SHARP & DOHME B.V.

सूचना पत्रक

NOT APPLICABLE

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उत्पाद विशेषताएं

LOCAL PRODUCT CIRCULAR
LPC-V114-I-122021A-MALAYSIA
VAXNEUVANCE™
(
PNEUMOCOCCAL 15
-
VALENT CONJUGATE VACCINE [CRM
197
PROTEIN], ADSORBED
)
[SUSPENSION FOR INJECTION]
1.
THERAPEUTIC CLASS
VAXNEUVANCE
is a conjugated polysaccharide vaccine that protects a
gainst invasive
disease,
pneumonia
and acut
e otitis media
caused by
Streptococcus pneumoniae
.
2.
ACTIVE INGREDIENT
S
Each 0.5 mL dose
contains
32 mcg of total
pneumococcal
polysaccharide
(2.0 mcg each of
polysaccharide
serotypes
1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and
4.0
mcg of polysaccharide serotype 6B) conjugated to 30
mcg of CRM
197
carrier protein.
3.
INACTIVE INGREDIENTS
Each 0.5 mL dose contains 1.55 mg L-histidine, 1 mg of
polysorbate
20, 4.50 mg sodium
chloride, wat
er for injection and 125
mcg of aluminum (as aluminum phosphate adjuvant).
4.
PHARMACOLOGY
MECHANISM OF ACTION
V
AXNEUVANCE
contains
15
purified
pneumococcal
capsular
polysaccharides
from
Streptococcus
pneumoniae
(1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, with the
additional
serotypes
22F
and
33F),
each
conjugated
to
a
carrier
protein
(CRM
197
).
V
AXNEUVANCE
elicits a T-cell
dependent
immune response to induce
antibodies
that
enhance
opsonization
,
phagocytosis,
and
killing
of
pneumococci
to
protect
against
pneumococcal disease.
Immune
responses
following natural
exposure
to
Streptococcus
pneumoniae
or following
pneumococcal
vaccination
can be
determined
by
measuring
opsonophagocytic
activity
(OPA) and
immunoglobulin
G (IgG)
responses.
OPA repre
sents functional
antibodies
and is
considered
an
important
immunologic
surrogate
measure
of
protection
against
pneumococcal
disease
in
adults.
In
children,
a
serotype-specific
IgG
antibody
level
corresponding to ≥0.35
μg/mL using the WHO enzyme linked i
mmu
nosorbent assay (ELISA)
has been used as the threshold value for the clinical
evaluation
of
pneumococcal
conjugate
vaccines.
CLINICAL STUDIES
CLINICAL TRIALS EXPERIENCE IN CHILDREN
6
WEEKS THROUGH 17
YEARS OF AGE
Five double-blind, clinical studies (Proto

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