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 group A polysaccharide1 5 micrograms
Neisseria meningitidis group C polysaccharide1 5 micrograms
Neisseria meningitidis group W-135 polysaccharide1 5 micrograms
Neisseria meningitidis group 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.

Traceability

To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety monitoring, health professionals should record the time and date of administration, quantity of administered dose (if applicable), anatomical site and route of administration, brand name and generic name of the vaccine, the product lot number and expiry date.

 

Control #: 243834
August 23, 2021