Riik: Kanada
keel: inglise
Allikas: Health Canada
POLYMYXIN B (POLYMYXIN B SULFATE); BACITRACIN (BACITRACIN ZINC); NEOMYCIN (NEOMYCIN SULFATE)
GLAXOSMITHKLINE INC
D06AX04
NEOMYCIN
5000UNIT; 400UNIT; 3.5MG
OINTMENT
POLYMYXIN B (POLYMYXIN B SULFATE) 5000UNIT; BACITRACIN (BACITRACIN ZINC) 400UNIT; NEOMYCIN (NEOMYCIN SULFATE) 3.5MG
TOPICAL
15G
Prescription
ANTIBIOTICS
Active ingredient group (AIG) number: 0331357001; AHFS:
CANCELLED POST MARKET
2016-06-07
_ 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 Lugege kogu dokumenti