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