OPTIMYXIN PLUS SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

POLYMYXIN B (POLYMYXIN B SULFATE); NEOMYCIN (NEOMYCIN SULFATE); GRAMICIDIN

Tilgængelig fra:

EURO-PHARM INTERNATIONAL CANADA INC

ATC-kode:

S03AA30

INN (International Name):

ANTIINFECTIVES, COMBINATIONS

Dosering:

10000UNIT; 1.75MG; 0.025MG

Lægemiddelform:

SOLUTION

Sammensætning:

POLYMYXIN B (POLYMYXIN B SULFATE) 10000UNIT; NEOMYCIN (NEOMYCIN SULFATE) 1.75MG; GRAMICIDIN 0.025MG

Indgivelsesvej:

OPHTHALMIC

Enheder i pakken:

10ML

Recept type:

Prescription

Terapeutisk område:

ANTIBACTERIALS

Produkt oversigt:

Active ingredient group (AIG) number: 0331392001; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2022-03-21

Produktets egenskaber

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
OPTIMYXIN PLUS
GRAMICIDIN, NEOMYCIN AND POLYMYXIN B SULFATE
EACH ML OF SOLUTION CONTAINS GRAMICIDIN 0.025 MG
NEOMYCIN 1.75 MG (AS NEOMYCIN SULFATE) AND
POLYMYXIN B SULFATE 10 000 UNITS
OPHTHALMIC/OTIC
USP
ANTIBIOTIC
Sandoz Canada Inc.
Date of Preparation: July 1989
110 Rue de Lauzon
Date of Revision: March 12, 2019
Boucherville, QC, Canada
J4B 1E6
Submission Control Number: 217599
Page 2 of 8
OPTIMYXIN PLUS
EYE/EAR SOLUTION
(NEOMYCIN AND POLYMYXIN B SULFATE AND GRAMICIDIN OPHTHALMIC SOLUTION
USP)
ANTIBIOTIC
INDICATIONS
Optimyxin Plus is used for the prophylaxis and treatment of eye and
ear infections.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
OPTIMYXIN PLUS and other antibacterial drugs, OPTIMYXIN PLUS should be
used only
to treat infections that are proven or strongly suspected to be caused
by bacteria.
CONTRAINDICATIONS
Hypersensitivity to any of the components.
The presence of preexisting nerve deafness is a contraindication to
the use of any topical
aminoglycoside in circumstances where significant systemic absorption
could occur.
WARNINGS AND PRECAUTIONS
The manifestations of sensitization to neomycin are usually itching,
reddening and edema of
the conjunctiva and eyelid. It may be manifest simply as a failure to
heal. During long-term
use of neomycin-containing products, periodic examination for such
signs is advisable, and
the patient should be told to discontinue the product if they are
observed. These symptoms
subside quickly on withdrawing the medication. Neomycin-containing
applications should
be avoided for the patient thereafter.
SUSCEPTIBILITY/RESISTANCE
DEVELOPMENT OF DRUG RESISTANT BACTERIA
Prescribing OPTIMYXIN PLUS in the absence of a proven or strongly
suspected bacterial
infection is unlikely to provide benefit to the patient and risks the
development of drug-
resistant bacteria.
Page 3 of 8
POTENTIAL FOR MICROBIAL OVERGROWTH
The use of OPTIMYXIN PLUS may promote the selection of non-s