NIMENRIX (Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine) 6 Dosage Forms, Strengths, Composition and Packaging

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NIMENRIX 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.

The vaccine does not contain any preservatives or adjuvants.

NIMENRIX is available as a single dose vial packaged with pre-filled syringe of diluent with or without needles in pack sizes of 1 and 10.

Table 1 Dosage Forms, Strengths, Composition and Packaging

Route of Administration

Dosage Form/Strength/Composition

Non-medicinal Ingredients

Intramuscular Injection

Powder and diluent for solution for injection. After reconstitution, one 0.5 mL dose contains:

Neisseria meningitidis group A polysaccharide1 5 mcg

Neisseria meningitidis group C polysaccharide1 5 mcg

Neisseria meningitidis group W-135 polysaccharide1 5 mcg

Neisseria meningitidis group Y polysaccharide1 5 mcg

1 conjugated to tetanus toxoid carrier protein 44 mcg 

After reconstitution, one 0.5 mL dose contains:

  • Sodium chloride 4.5 mg
  • Sucrose 28 mg
  • Trometamol 97 mcg
  • Water for injections q.s. to 0.5 mL

 

 

 

 

 

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.