Rx Item-Pedvaxhib 7.5Mcg 0.5 Vial Haemophilus Influenzae Type B (Hib) 10X0.5Ml B

Clinical Information
Gen. Code and Des.
63623 Haemph b polysac conj-menin/PF INTRAMUSC VIAL 7.5MCG/0.5
GCN and Des.
99344 Haemph b polysac conj-menin/PF INTRAMUSC VIAL 7.5MCG/0.5
Strength
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
80120000 VACCINES
Active Ingredients
6319 Haemophilus B polysach conjugat with meningococcal
9870 preservative free
Inactive Ingredients
8921 latex





PedvaxHIB: Package Insert and Label Information
By Merck Sharp & Dohme Corp. | Last revised: 14 April 2014

PEDVAXHIB- haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen injection, suspension
Merck Sharp & Dohme Corp.
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 leading cause of serious, systemic bacterial disease in young children worldwide.{1,2,3,4}

RX ITEM-Pedvaxhib 7.5Mcg 0.5 Vial Haemop
Item No.:RX568360 568360 NDC No.6489700 00006-4897-00 0006-4897-00 00006489700 0006489700 UPC No.:300064897005 NDC No.006489700 UPC/GTIN No.3-00064-89700-5 300064-897005 300064897005 MPN 489700

Pedvaxhib 7.5Mcg 0.5 Vial Haemophilus In
Item No.:RX568360 568360 NDC No.6489700 00006-4897-00 0006-4897-00 00006489700 0006489700 UPC No.:300064897005 NDC No.006489700 UPC/GTIN No.3-00064-89700-5 300064-897005 300064897005 MPN 489700

HAEMPH B POLYSAC CONJ-MEN
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