ODAN-SPOR-HC SUSPENSION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

POLYMYXIN B SULFATE; NEOMYCIN SULFATE; HYDROCORTISONE

Dostupné s:

ODAN LABORATORIES LTD

ATC kód:

S02CA03

INN (Mezinárodní Name):

HYDROCORTISONE AND ANTIINFECTIVES

Dávkování:

10000UNIT; 3.5MG; 10MG

Léková forma:

SUSPENSION

Složení:

POLYMYXIN B SULFATE 10000UNIT; NEOMYCIN SULFATE 3.5MG; HYDROCORTISONE 10MG

Podání:

OTIC

Jednotky v balení:

10ML

Druh předpisu:

Prescription

Terapeutické oblasti:

ANTIBACTERIALS

Přehled produktů:

Active ingredient group (AIG) number: 0305646001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2015-10-21

Charakteristika produktu

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