Land: Kanada
Tungumál: enska
Heimild: Health Canada
DIBUCAINE HYDROCHLORIDE; ESCULIN; HYDROCORTISONE; FRAMYCETIN SULFATE
ODAN LABORATORIES LTD
C05AA51
HYDROCORTISONE, COMBINATIONS
5MG; 10MG; 5MG; 10MG
SUPPOSITORY
DIBUCAINE HYDROCHLORIDE 5MG; ESCULIN 10MG; HYDROCORTISONE 5MG; FRAMYCETIN SULFATE 10MG
RECTAL
12/24
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0404592002; AHFS:
CANCELLED POST MARKET
2021-10-07
PRESCRIBING INFORMATION INCLUDING PATIENT MEDICATION INFORMATION PR ODAN PROCTOMYXIN HC Hydrocortisone, Framycetin Sulfate, Cinchocaine Hydrochloride and Esculin Ointment 5 mg, 10 mg, 5 mg and 10 mg PR ODAN PROCTOMYXIN HC SUPPOSITORIES Hydrocortisone, Framycetin Sulfate, Cinchocaine Hydrochloride and Esculin Suppositories 5 mg, 10 mg, 5 mg and 10 mg Antibacterial – Corticosteroid – Anorectal Therapy Odan Laboratories Ltd. 325 Stillview ave. Pointe Claire, QC H9R 2Y6 Date of Revision June 17, 2021 www.odanlab.com Submission Control Number: 251272 _Odan Proctomyxin HC and Odan Proctomyxin HC Suppositories _ _Page 2 of 11 _ PRESCRIBING INFORMATION PR ODAN PROCTOMYXIN HC PR ODAN PROCTOMYXIN HC SUPPOSITORIES Hydrocortisone, Framycetin Sulfate, Cinchocaine Hydrochloride and Esculin Ointment and Hydrocortisone, Framycetin Sulfate, Cinchocaine Hydrochloride and Esculin Suppositories THERAPEUTIC CLASSIFICATION Antibacterial – Corticosteroid – Anorectal Therapy ACTIONS AND CLINICAL PHARMACOLOGY Framycetin sulfate, also known as neomycin B, is an aminoglycoside antibiotic which forms the major component of neomycin sulfate and has similar actions and uses. Aminoglycosides are taken up into sensitive bacterial cells by an active transport process which is inhibited in anærobic, acidic, or hyperosmolar environments. Within the cell, they bind to the 30S and to some extent to the 50S subunits of the bacterial ribosome, inhibiting protein synthesis and generating errors in the transcription of the genetic code. The manner in which cell death is brought about is imperfectly understood, and other mechanisms may contribute, including effects on membrane permeability. In general, neomycin is active against many ærobic gram-negative bacteria and some aerobic gram-positive bacteria. Bacterial strains susceptible to neomycin include: _Escherichia coli_, _Hæmophilus influenzæ,_ _Moraxella lacunata_, indole-positive and indole-negative _Proteus_, _Staphylococcus aureus_,_ S. epidermidis_ and _Serratia_. Neomycin is only mini Lestu allt skjalið