Product Details

Fleming 457 mg/5 mL Powder for Oral Suspension**

Amoxicillin (Amoxicillin Trihydrate); Clavulanic Acid (Potassium Clavulanate)
400 mg/5 mL; 57 mg/5 mL
Powder for suspension

ROA

Oral

Applicant Name

Sanofi-Aventis Nigeria Limited

NRN

A4-1667

Status

Active


Composition

Each 5 mL after reconstitution contains: Amoxicillin trihydrate BP equivalent to Amoxicillin 400 mg & Potassium Clavulanate BP as diluted Potassium Clavulanate BP equivalent to Clavulanic acid 57 mg. Excipients with known effect: Aspartame Fleming 457 mg Powder for oral suspension contains 17 mg aspartame in each 5 mL which is equivalent to 17 mg/5mL. Which is a source of phenylalanine. This may be harmful for children born with a condition called ’phenylketonuria’. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age  

ATC Code

J01CR02  

Product Category

Drugs

Marketing Category

Prescription-only Medicine (POM)  

Packsize

70 mL (in clear glass bottle)  

Product Description

Powder for oral suspension. Off-white dry powder. When reconstituted, an off-white suspension is formed. An off-white free flowing powder which on reconstitution becomes an off-white suspension having a characteristic odour

Manufacturer Name

Medreich Limited

Manufacturer Country

INDIA  

Approval Date

2021-03-01  

Expiry Date

2026-02-28