Product Details

Tractocile Injection+++

Atosiban
37.5 mg/5 mL
Injection

ROA

Intravenous

Applicant Name

Swan Medico Limited

NRN

B4-6503

Status

Active


Composition

Each mL of solution contains 7.5 mg Atosiban Each vial of 5 mL solution contains 37.5 mg Atosiban (as acetate) After dilution, the concentration of Atosiban is 0.75 mg/mL Excipients: Mannitol, Hydrochloric acid 1m, Water for Injections  

ATC Code

G02CX01  

Product Category

Drugs

Marketing Category

Prescription-only Medicine (POM)  

Packsize

5 mL (in vial)  

Product Description

Concentrate for solution for infusion (sterile concentrate) Clear, colorless solution without particles 93 RNW-PP-226179 TRACTOCILE INJECTION ATOSIBAN 37.5 mg/ 5 ml Atosiban 37.5mg/5ml Mannitol 250mg Hydrochloric Acid q.s Water for Injection to 5ml B4-6503 Drugs Imported Products 5ml Prescription Only Medicine (POM) 12/29/2021 SWAN MEDICO LIMITED, PLOT B4, PLOT 602, ZUMA MALL, NDOLA SQUARE ZONE 5 ABUJA FCT 80339067 yaksky123@yahoo.com FERRING GmbH, Wittland 11 24109 Kiel Germany , Germany

Manufacturer Name

Ferring GmbH

Manufacturer Country

GERMANY  

Approval Date

2023-12-21  

Expiry Date

2028-12-20