Land: Canada
Sprog: engelsk
Kilde: Health Canada
POLYMYXIN B SULFATE; NEOMYCIN SULFATE; HYDROCORTISONE
ODAN LABORATORIES LTD
S02CA03
HYDROCORTISONE AND ANTIINFECTIVES
10000UNIT; 3.5MG; 10MG
SUSPENSION
POLYMYXIN B SULFATE 10000UNIT; NEOMYCIN SULFATE 3.5MG; HYDROCORTISONE 10MG
OTIC
10ML
Prescription
ANTIBACTERIALS
Active ingredient group (AIG) number: 0305646001; AHFS:
APPROVED
2015-10-21
PRESCRIBING INFORMATION INCLUDING PATIENT MEDICATION INFORMATION PR ODAN-SPOR-HC NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION, USP NEOMYCIN (AS NEOMYCIN SULFATE) 3.5 MG / ML POLYMYXIN B SULFATES 10 000 UNITS / ML HYDROCORTISONE 10 MG / ML ANTIBACTERIAL/ANTI-INFLAMMATORY ODAN LABORATORIES LTD. 325 Stillview Ave., Pointe-Claire, Québec H9R 2Y6 Control No: 226590 Date of Revision: June 5, 2019 www.odanlab.com 2 PRESCRIBING INFORMATION PR ODAN-SPOR-HC NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION, USP THERAPEUTIC CLASSIFICATION ANTIBACTERIAL/ANTI-INFLAMMATORY ACTION AND CLINICAL PHARMACOLOGY Corticoids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case. The anti-infective components in the combination are included to provide action against specific organisms susceptible to them. Polymyxin B sulfate and neomycin sulfate together are considered active against the following microorganisms: S. aureus, E. coli, H. influenzæ, Klebsiella-Enterobacter species, Neisseria species and P. æruginosa. This product does not provide adequate coverage against S. marcescens and Streptococci, including S. pneumoniæ. When used topically, polymyxin B and neomycin are rarely irritating and absorption from the intact skin or mucous membrane is insignificant. The incidence of skin sensitization to this combination has been shown to be low on normal skin. Since these antibiotics are seldom used systemically, the patient is spared sensitization to those antibiotics which might later be required systemically. The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle. INDICATIONS AND CLINICAL USE For the treatment of superficial bacterial infections of the external auditory canal caused by organi Læs hele dokumentet