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HSA Approval

MENQUADFI SOLUTION FOR INJECTION

SIN16454P

MENQUADFI SOLUTION FOR INJECTION

MENQUADFI SOLUTION FOR INJECTION

March 29, 2022

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantSANOFI-AVENTIS SINGAPORE PTE. LTD.
Licence HolderSANOFI-AVENTIS SINGAPORE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SOLUTION

**Posology and method of administration** Posology Primary vaccination: - Individuals 12 months of age and older: One single dose (0.5 mL). Booster vaccination: - A single 0.5 mL dose of MenQuadfi may be used to boost subjects who have previously received a meningococcal vaccine containing the same serogroups (see section Pharmacodynamic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Long-term antibody persistence data following vaccination with MenQuadfi are available up to 7 years after vaccination (see sections Special warnings and precautions for use and Pharmacodynamic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - There are no data available to indicate the need for or timing of a booster dose of MenQuadfi (see section Pharmacodynamic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Other paediatric population_ The safety and immunogenicity of MenQuadfi in individuals under 12 months of age have not yet been established. Method of administration For intramuscular injection only, preferably in the deltoid region or anterolateral thigh depending on the recipient's age and muscle mass. For instructions on handling of the vaccine before administration, see section Special precautions for disposal and other handling – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.

INTRAMUSCULAR

Medical Information

**Therapeutic indications** MenQuadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by _Neisseria meningitidis_ serogroups A, C, W, and Y. The use of this vaccine should be in accordance with available official recommendations.

**Contraindications** Hypersensitivity to the active substances or to any of the excipients listed in section List of excipients or after previous administration of the vaccine or a vaccine containing the same components – _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

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Sanofi Pasteur, Inc.

Active Ingredients

Tetanus Toxoid, Filtered Concentrate (Carrier Protein)

55 mcg/ 0.5 mL

Meningococcal Polysaccharide, Serogroup C (Monovalent Conjugate)

10 mcg/ 0.5 mL

Meningococcal Polysaccharide, Serogroup Y (Monovalent Conjugate)

10 mcg/ 0.5 mL

Meningococcal Polysaccharide, Serogroup A (Monovalent Conjugate)

10 mcg/ 0.5 mL

Meningococcal Polysaccharide, Serogroup W-135 (Monovalent Conjugate)

10 mcg / 0.5mL

Documents

Package Inserts

MenQuadfi Injection PI.pdf

Approved: November 21, 2022

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