NEOSPORIN OINTMENT

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

POLYMYXIN B (POLYMYXIN B SULFATE); BACITRACIN (BACITRACIN ZINC); NEOMYCIN (NEOMYCIN SULFATE)

Disponibil de la:

GLAXOSMITHKLINE INC

Codul ATC:

D06AX04

INN (nume internaţional):

NEOMYCIN

Dozare:

5000UNIT; 400UNIT; 3.5MG

Forma farmaceutică:

OINTMENT

Compoziție:

POLYMYXIN B (POLYMYXIN B SULFATE) 5000UNIT; BACITRACIN (BACITRACIN ZINC) 400UNIT; NEOMYCIN (NEOMYCIN SULFATE) 3.5MG

Calea de administrare:

TOPICAL

Unități în pachet:

15G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTIBIOTICS

Rezumat produs:

Active ingredient group (AIG) number: 0331357001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2016-06-07

Caracteristicilor produsului

_ April 9, 2015 _
_ _
_Page 1 of 15_
PRESCRIBING INFORMATION
PR
NEOSPORIN
®
OINTMENT
(Polymyxin B and Neomycin Sulfates, and Bacitracin zinc)
ANTIBACTERIAL
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga, Ontario
L5N 6L4
Date of Revision :
April 9, 2015
Control No.: 182707
_©_
_ 2015 GlaxoSmithKline Inc. All Rights Reserved _
_ _
_NEOSPORIN is a registered trademark of the GSK group of companies _
_ April 9, 2015 _
_ _
_Page 2 of 15_
PRESCRIBING INFORMATION
PR
NEOSPORIN
®
Ointment
(Polymyxin B and Neomycin Sulfates, and Bacitracin zinc)
ANTIBACTERIAL
CLINICAL PHARMACOLOGY
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: _Staphylococcus aureus, Escherichia coli, Haemophilus
_
_influenzae, Klebsiella-Enterobacter_ species, _Neisseria_ species and
_Pseudomonas aeruginosa_. Bacitracin is active against most
Gram-positive
bacteria, pathogenic _Neisseria spp_ and _Haemophilus influenzae_.
INDICATIONS AND CLINICAL USE
NEOSPORIN
®
(Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc)
Ointment is indicated for all lesions which are infected or likely to
become
infected by bacteria.
_ April 9, 2015 _
_ _
_Page 3 of 15_
CONTRAINDICATIONS
GENERAL
The use of NEOSPORIN
®
is contraindicated in patients who have demonstrated
allergic hypersensitivity to any of the components of the preparation
or to cross-
sensitizing substances such as aminoglycosides and other related
antibiotics.
Due to the known ototoxic and nephrotoxic potential of neomycin
sulfate, the use
of NEOSPORIN
®
in large quantities or on large areas for prolonged periods of
time is not recommended in circumstances where significant systemic
absorption
may occur.
A possibility of increased absorption exists in very young children,
thus
NEOSPORIN
®
is not recommended for use in neonates and infants (<2 years). In
neonates and infants, absorption by immature