PEDVAXHIB (haemophilus b conjugate vaccine- meningococcal protein conjugate injection, suspension

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN (UNII: LUY6P8763W) (HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN - UNII:LUY6P8763W)

제공처:

Merck Sharp & Dohme LLC

INN (International Name):

HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN

구성:

HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN 7.5 ug in 0.5 mL

관리 경로:

INTRAMUSCULAR

치료 징후:

Liquid PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age. Liquid PedvaxHIB will not protect against disease caused by Haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis. As with any vaccine, vaccination with Liquid PedvaxHIB may not result in a protective antibody response in all individuals given the vaccine. BECAUSE OF THE POTENTIAL FOR IMMUNE TOLERANCE, Liquid PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE. (See PRECAUTIONS.) Infants completing the primary two-dose regimen before 12 months of age should receive a booster dose (see DOSAGE AND ADMINISTRATION). Hypersensitivity to any component of the vaccine or the diluent. Persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine.

제품 요약:

Liquid PedvaxHIB is supplied as follows: No. 4897 — A box of 10 single-dose vials of liquid vaccine, NDC  0006-4897-00. Store vaccine at 2-8°C (36-46°F). DO NOT FREEZE.

승인 상태:

Biologic Licensing Application

제품 특성 요약

PEDVAXHIB- HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL PROTEIN
CONJUGATE) INJECTION, SUSPENSION
MERCK SHARP & DOHME LLC
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PEDVAXHIB LIQUID
[HAEMOPHILUS B CONJUGATE VACCINE
(MENINGOCOCCAL PROTEIN CONJUGATE)]
DESCRIPTION
PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein
Conjugate)] is a
highly purified capsular polysaccharide (polyribosylribitol phosphate
or PRP) of
_Haemophilus influenzae_ type b (Haemophilus b, Ross strain) that is
covalently bound to
an outer membrane protein complex (OMPC) of the B11 strain of
_Neisseria meningitidis_
serogroup B. The covalent bonding of the PRP to the OMPC which is
necessary for
enhanced immunogenicity of the PRP is confirmed by quantitative
analysis of the
conjugate's components following chemical treatment which yields a
unique amino acid.
The potency of PedvaxHIB is determined by assay of PRP.
_Haemophilus influenzae_ type b and _Neisseria meningitidis_ serogroup
B are grown in
complex fermentation media. The PRP is purified from the culture broth
by purification
procedures which include ethanol fractionation, enzyme digestion,
phenol extraction and
diafiltration. The OMPC from _Neisseria meningitidis_ is purified by
detergent extraction,
ultracentrifugation, diafiltration and sterile filtration.
Liquid PedvaxHIB is ready to use and does not require a diluent. Each
0.5 mL dose of
Liquid PedvaxHIB is a sterile product formulated to contain: 7.5 mcg
of Haemophilus b
PRP, 125 mcg of _Neisseria meningitidis_ OMPC and 225 mcg of aluminum
as amorphous
aluminum hydroxyphosphate sulfate (previously referred to as aluminum
hydroxide), in
0.9% sodium chloride, but does not contain lactose or thimerosal.
Liquid PedvaxHIB is a
slightly opaque white suspension.
This vaccine is for intramuscular administration and not for
intravenous injection. (See
DOSAGE AND ADMINISTRATION.)
CLINICAL PHARMACOLOGY
Prior to the introduction of Haemophilus b Conjugate Vaccines,
_Haemophilus influenzae_
type b (Hib) was the most frequent cause of bacterial meningitis and a
lea