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HSA Approval

NIMENRIX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

SIN14534P

NIMENRIX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

NIMENRIX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

April 3, 2014

PFIZER PRIVATE LIMITED

PFIZER PRIVATE LIMITED

Regulatory Information

PFIZER PRIVATE LIMITED

PFIZER PRIVATE LIMITED

Therapeutic

Prescription Only

Formulation Information

INJECTION, POWDER, FOR SOLUTION

**4.2. Dosage and Administration** Posology **Nimenrix™** should be used in accordance with available official recommendations. ![Nimenrix Dosage Table 1](https://cdn.medpath.com/drug/dosage/20240520/080e7bbc58008f11b6ef8c0d80594f84.png) _Previously vaccinated children from 12 months of age, adolescents and adults_ **Nimenrix™** may be given as a booster dose to individuals who have previously received primary vaccination with a conjugated or plain polysaccharide meningococcal vaccine (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Special populations Individuals who have underlying conditions predisposing them to meningococcal infection due to anatomic or functional asplenia (such as sickle cell disease) may receive at least one dose of **Nimenrix™** (see sections 4.8 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Method of administration Immunization should be carried out by intramuscular injection only. In infants, the recommended injection site is the anterolateral aspect of the thigh. In individuals from 1 year of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle (see sections 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). For instructions on reconstitution of the medicinal product before administration, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.

INTRAMUSCULAR

Medical Information

**4.1. Indications** **Nimenrix™** is indicated for active immunization of individuals from 6 weeks of age against invasive meningococcal diseases caused by _Neisseria meningitidis_ groups A, C, W-135 and Y.

**4.3. Contraindications** **Nimenrix™** should not be administered to subjects with hypersensitivity to the active substances or to any of the excipients contained in the vaccine (see sections 2 and 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

J07AH08

meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated

Manufacturer Information

PFIZER PRIVATE LIMITED

Catalent Belgium S.A. (diluent in pre-filled syringe)

Pfizer Manufacturing Belgium NV (diluent in pre-filled syringe)

Pfizer Manufacturing Belgium NV

GlaxoSmithKline Biologicals SA

Active Ingredients

Neisseria meningitidis group A polysaccharide

5 micrograms

Neisseria meningitidis group W-135 polysaccharide

5 micrograms

Neisseria meningitidis group Y polysaccharide

5 micrograms

Neisseria meningitidis group C polysaccharide

5 micrograms

Tetanus toxoid carrier protein

~44 micrograms

Documents

Package Inserts

Nimenrix Injection PI.pdf

Approved: July 7, 2022

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