NIMENRIX (Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine) Dosage Forms, Composition And Packaging

Medical Information
Canada
 

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Dosage Form

NIMENRIX (meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine) is supplied as a sterile lyophilized white powder or cake in a single dose vial.

The diluent (sodium chloride and water for injections) is a sterile clear and colourless liquid supplied separately in a prefilled syringe or ampoule*.

*Format not available in Canada.

After reconstitution, NIMENRIX is a clear colourless solution.

Composition

After reconstitution, 1 dose (0.5 mL) contains:

Active Ingredients
Neisseria meningitidis serogroup A polysaccharide1 5 micrograms
Neisseria meningitidis serogroup C polysaccharide1 5 micrograms
Neisseria meningitidis serogroup W-135 polysaccharide1 5 micrograms
Neisseria meningitidis serogroup Y polysaccharide1 5 micrograms
1conjugated to tetanus toxoid carrier protein44 micrograms

 

Excipients

Powder:

Sucrose28 mg
Trometamol97 mcg

Diluent:

Sodium chloride4.5 mg
Water for Injectionsq.s. to 0.5 mL

 

Packaging

NIMENRIX is supplied in a 3 mL single dose glass vial. The diluent (0.5 mL) is supplied in a prefilled syringe or ampoule*.

The vials, syringes, and ampoules* are made of neutral glass Type 1.

NIMENRIX is available in pack sizes as follows:

  • Single dose vial packaged with pre-filled syringe of diluent with or without needles in pack sizes of 1 and 10.
  • Single dose vial packaged with ampoule* of diluent in pack sizes of 1, 10 or 100.

*Format not available in Canada.

 

Control #: 232784
September 25, 2020