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Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) (Pedvaxhib)

Trade Name : PedvaxHIB

Merck Sharp & Dohme Corp.

INJECTION, SUSPENSION, VACCINE

Strength 7.5 ug/.5mL

HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN Actively Acquired Immunity [PE],Haemophilus Vaccines [CS],Inactivated Haemophilus Influenzae B Vaccine [EPC],Vaccines, Inactivated [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) (Pedvaxhib) which is also known as PedvaxHIB and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 7.5 ug/.5mL per ml. Read more

Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) (Pedvaxhib) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • PedvaxHIBu00ae [Haemophilusu00a0b Conjugate Vaccine (Meningococcal Protein Conjugate)] is a highly purified capsular polysaccharide (polyribosylribitol phosphate or PRP) of typeu00a0b (Haemophilusu00a0b, Ross strain) that is covalently bound to an outer membrane protein complex (OMPC) of the B11u00a0strain of serogroupu00a0B. 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 influenzaen- Neisseria meningitidisn- Neisseria meningitidis
  • Liquid PedvaxHIB is ready to use and does not require a diluent. Each 0.5u00a0mL dose of Liquid PedvaxHIB is a sterile product formulated to contain: 7.5u00a0mcg of Haemophilusu00a0b PRP, 125u00a0mcg of OMPC and 225u00a0mcg 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 .)
  • Prior to the introduction of Haemophilusu00a0b Conjugate Vaccines, typeu00a0b (Hib) was the most frequent cause of bacterial meningitis and a leading cause of serious, systemic bacterial disease in young children worldwide.{}
  • Hib disease occurred primarily in children under 5 years of age in the United States prior to the initiation of a vaccine program and was estimated to account for nearly 20,000 cases of invasive infections annually, approximately 12,000 of which were meningitis. The mortality rate from Hib meningitis is about 5%. In addition, up to 35% of survivors develop neurologic sequelae including seizures, deafness, and mental retardation.{} Other invasive diseases caused by this bacterium include cellulitis, epiglottitis, sepsis, pneumonia, septic arthritis, osteomyelitis and pericarditis.
  • Prior to the introduction of the vaccine, it was estimated that 17% of all cases of Hib disease occurred in infants less than 6 months of age.{} The peak incidence of Hib meningitis occurs between 6 to 11 months of age. Forty-seven percent of all cases occur by one year of age with the remaining 53% of cases occurring over the next four years.{}
  • Among children under 5 years of age, the risk of invasive Hib disease is increased in certain populations including the following:
  • An important virulence factor of the Hib bacterium is its polysaccharide capsule (PRP). Antibody to PRP (anti-PRP) has been shown to correlate with protection against Hib disease.{} While the anti-PRP level associated with protection using conjugated vaccines has not yet been determined, the level of anti-PRP associated with protection in studies using bacterial polysaccharide immune globulin or nonconjugated PRP vaccines ranged from >0.15 to >1.0u00a0mcg/mL.{}
  • Nonconjugated PRP vaccines are capable of stimulating B-lymphocytes to produce antibody without the help of T-lymphocytes (T-independent). The responses to many other antigens are augmented by helper T-lymphocytes (T-dependent). PedvaxHIB is a PRP-conjugate vaccine in which the PRP is covalently bound to the OMPC carrier{} producing an antigen which is postulated to convert the T-independent antigen (PRP alone) into a T-dependent antigen resulting in both an enhanced antibody response and immunologic memory.
  • Liquid PedvaxHIB is indicated for routine vaccination against invasive disease caused by typeu00a0b in infants and children 2 to 71 months of age.
  • Liquid PedvaxHIB will not protect against disease caused by other than typeu00a0b 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 .)
  • Infants completing the primary two-dose regimen before 12 months of age should receive a booster dose (see ).
  • 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.
  • No data
  • No data
  • No data
  • Liquid PedvaxHIB is supplied as follows:
  • No. 4897u00a0u2014 A box of 10 single-dose vials of liquid vaccine, u00a00006-4897-00.
  • Store vaccine at 2-8u00b0C (36-46u00b0F).
  • DO NOT FREEZE.
  • No data
  • Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of n Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 1996-2020 Merck Sharp & Dohme Corp., a subsidiary of u00a0 All rights reserved
  • Revised: 02/2020
  • uspi-v120-i-2002r005
  • This is a representative sample of the packaging. Please see section for a complete list of available packaging.
  • NDC 0006-4897-0010 Single-dose 0.5 mL Vials Vaccine
  • HAEMOPHILUS b CONJUGATE VACCINE(Meningococcal Protein Conjugate)Liquid PedvaxHIBn
  • Each 0.5 mL of vaccine is formulated to contain: 7.5 mcg of type b polysaccharide, 125 mcg of outer membrane protein complex, 225 mcg of amorphous aluminum hydroxyphosphate sulfate in 0.9% sodium chloride.
  • Rx only

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