Land: Kanada
Sprache: Englisch
Quelle: Health Canada
POLYMYXIN B (POLYMYXIN B SULFATE); NEOMYCIN (NEOMYCIN SULFATE); GRAMICIDIN
EURO-PHARM INTERNATIONAL CANADA INC
S03AA30
ANTIINFECTIVES, COMBINATIONS
10000UNIT; 1.75MG; 0.025MG
SOLUTION
POLYMYXIN B (POLYMYXIN B SULFATE) 10000UNIT; NEOMYCIN (NEOMYCIN SULFATE) 1.75MG; GRAMICIDIN 0.025MG
OPHTHALMIC
10ML
Prescription
ANTIBACTERIALS
Active ingredient group (AIG) number: 0331392001; AHFS:
CANCELLED POST MARKET
2022-03-21
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 Lesen Sie das vollständige Dokument