• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu

Vaccines

UNII Code Request Email, April 11, 2012 - MenHibrix

From:                        UNII_REQUEST
To:                             Staten, David;  CBER SRS
Cc:                             Callahan, Lawrence;  Borodina, Yulia ;  Peryea, Tyler
Subject:                    RE: UNII Code request
Date:                         Wednesday, April 11, 2012 2:19:26 PM


Hi David,

Here are the product UNIIs based on the MENHIBRIX package insert information. Active Ingredients
NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN                                                 ----(b)(4)----

NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN                                                 -------(b)(4)-------

HAEMOPHILUS INFLUENZAE TYPE B -----(b)(4)------ CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN                                         -----(b)(4)------

Inactive Ingredients

-----------------------------(b)(4)-----------------------------------
SUCROSE                               ------(b)(4)--------
---------------(b)(4)-----------------------------------
 

FORMALDEHYDE                         ------(b)(4)-----
 

Frank

Frank L Switzer, PhD

Chemist, Substance Registration System

WO 32 Room 4156

10903 New Hampshire Ave

Silver Spring, MD 20993

Office: 301.796.8506

Blackberry: 240.401.5897


From: Staten, David
Sent: Wednesday, April 11, 2012 12:58 PM
To: CBER SRS
Subject: UNII Code request

MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine), for intramuscular injection, is a sterile, lyophilized powder which is reconstituted at the time of use with the accompanying saline diluent. MENHIBRIX contains Neisseria meningitidis serogroup C and Y capsular polysaccharide antigens and Haemophilus b capsular polysaccharide (polyribosyl-ribitol-phosphate [PRP]). The Neisseria meningitidis
C strain and Y strain are grown in semi-synthetic media and undergo heat inactivation and purification. The PRP is a high molecular weight polymer prepared from the Haemophilus influenzae type b strain 20,752 grown in a synthetic medium that undergoes heat inactivation and purification. The tetanus toxin, prepared from Clostridium tetani grown in a semi- synthetic medium, is detoxified with formaldehyde and purified. Each capsular polysaccharide is individually covalently bound to the inactivated tetanus toxoid. After purification, the conjugate is lyophilized in the presence of sucrose as a stabilizer. The diluent for MENHIBRIX is a sterile saline solution (0.9% sodium chloride) supplied in vials.

When MENHIBRIX is reconstituted with the accompanying saline diluent, each dose is formulated to contain 5 mcg of purified Neisseria meningitidis C capsular polysaccharide conjugated to approximately 5 mcg of tetanus toxoid, 5 mcg of purified Neisseria meningitidis Y capsular polysaccharide conjugated to approximately 6.5 mcg of tetanus toxoid, and 2.5 mcg of purified Haemophilus b capsular polysaccharide conjugated to approximately 6.25 mcg of tetanus toxoid,. Each dose also contains 96.8 mcg of Tris (trometamol)-HCl, 12.6 mg of sucrose, and £0.72 mcg of residual formaldehyde.

MENHIBRIX does not contain preservatives.

<< File: menhibrix label draft-clean.doc >>