Product Details

Silmen-5

Meningococcal ACWYX conjugate vaccine (MenACWYX)
0.5 mL
Powder for injection

ROA

Intramuscular

Applicant Name

Fidson Healthcare PLC

NRN

A6-100157

Status

Active


Composition

Meningococcal (A,C,Y,W,X) Polysaccharide Conjugate Vaccine (Freeze-Dried). Each dose (0.5 mL) contains: 5 µg of each Meningococcal A, C, Y, W, and X polysaccharide individually conjugated to a carrier protein. The serogroup A and X polysaccharides are conjugated to purified tetanus toxoid (TT) and the serogroup C, W, and Y polysaccharides are conjugated to recombinant CRM197 (cross-reactive material 197, a nontoxic mutant of diphtheria toxin) protein  

ATC Code/ATCvet Code

J07AH  

Product Category

Vaccines and Biologics

Marketing Category

Prescription-only Medicine (POM)  

Packsize

0.5 mL x 1's (in vial)  

Product Description

Freeze-dried formulated vaccine available in two presentations viz. 5-dose vial and single-dose vial. The freeze-dried vaccine is to be reconstituted with provided diluent i.e. 0.9% sodium chloride prior to the administration. 5-dose vial: The 5-dose vaccine vial is reconstituted with 2.5 mL of provided diluent i.e. 0.9% sodium chloride. Single-dose vial: The single-dose vaccine vial is reconstituted with 0.5 mL of provided diluent i.e. 0.9% sodium chloride Neither the vaccine nor the diluent contains any preservative

Manufacturer Name

Serum Institute of India Pvt. Ltd

Manufacturer Country

INDIA  

Approval Date

2024-07-31  

Expiry Date

2029-07-30