MENQUADFI SOLUTION FOR INJECTION [SIN16454P]
Active ingredients: MENQUADFI SOLUTION FOR INJECTION
Product Info
MENQUADFI SOLUTION FOR INJECTION
[SIN16454P]
Product information
Active Ingredient and Strength | MENINGOCOCCAL POLYSACCHARIDE, SEROGROUP A (MONOVALENT CONJUGATE) - 10 MCG/0.5 ML |
Dosage Form | INJECTION, SOLUTION |
Manufacturer and Country | SANOFI PASTEUR, INC. - UNITED STATES |
Registration Number | SIN16454P |
Licence Holder | SANOFI-AVENTIS SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J07AH08 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
Therapeutic indications
MenQuadfi is indicated for active immunisation of individuals from the age of 6 weeks 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.
Dosing
Posology and method of administration
Posology
Primary vaccination:
Infants from 6 weeks of age: Three doses (each of 0.5 mL) should be administered with an interval of at least 2 months.
Individuals 6 months of age and older: One single dose (0.5 mL).
Booster vaccination:
After completion of the primary immunisation series prior to 12 months of age, a booster dose should be given in the second year of life (from 12 months of age) at least 2 months after the last dose (see section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
A single 0.5 mL dose of MenQuadfi may be used to boost individuals 12 months of age and older 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).
Other paediatric population
The safety and immunogenicity of MenQuadfi in individuals under 6 Weeks of age have not yet been established.
Special Populations
Pediatric individuals
Safety and effectiveness of MenQuadfi were established in individuals from 6 weeks through 17 years of age.
Data from MET41, MET42 and MET58 indicate that MenQuadfi can be given to infants with a history of preterm birth. The safety of MenQuadfi was evaluated in 237 infants with a history of preterm birth and no differences in adverse reactions following MenQuadfi were found between these infants and those who were born full term (see Section 9 Adverse Reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Additionally, the immune responses to MenQuadfi evaluated in 61–71 infants with a history of preterm birth (MET42) were comparable to those infants who were born full term (see Section 14 Clinical Efficacy/ Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Infants with a history of preterm birth whose clinical condition is satisfactory should be immunized with full doses of vaccine at same chronological age and according to the same schedule as full-term infants, regardless of birth weight.
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.
Contraindications
Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information or after previous administration of the vaccine or a vaccine containing the same components.
