Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
CHLORAMPHENICOL
PHARMA STULLN INC.
S01AA01
CHLORAMPHENICOL
0.5%
SOLUTION
CHLORAMPHENICOL 0.5%
OPHTHALMIC
10ML/15ML
Prescription
ANTIBACTERIALS
Active ingredient group (AIG) number: 0151341006; AHFS:
APPROVED
2017-05-08
PRESCRIBING INFORMATION INCLUDING PATIENT MEDICATION INFORMATION CHLORAMPHENICOL CHLORAMPHENICOL OPHTHALMIC SOLUTION, USP 0.5% ANTIBIOTIC Eberth Pharmaceuticals Inc, 56 Eastview Ave., Pointe-Claire, Québec H9R 5N6 Control No # 215678 Date of Revision: May 22, 2019 2 PRESCRIBING INFORMATION CHLORAMPHENICOL CHLORAMPHENICOL OPHTHALMIC SOLUTION, USP 0.5% Antibiotic ACTION AND CLINICAL PHARMACOLOGY Chloramphenicol is a broad-spectrum antibiotic originally isolated from _Streptomyces venezuelae_. It is primarily bacteriostatic and acts by inhibition of protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to riboso mes. Development of resistance to chloramphenicol can be regarded as minimal for staphylococci and many other species of bacteria. NON-MEDICINAL INGREDIENTS CHLORAMPHENICOL SOLUTION CONTAINS boric acid, sodium borate, sodium chloride, sodium hydroxide (to adjust pH) and purified water. INDICATIONS This product is indicated for the treatment of superficial ocular infections involving the conjunctiva and/ or cornea caused by chloramphenicol-susceptible organisms. Bacteriological studies should be performed to determine the causative organisms and their sensitivity to chloramphenicol. _TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF _ _CHLORAMPHENICOL AND OTHER ANTIBACTERIAL DRUGS, CHLORAMPHENICOL SHOULD BE USED ONLY _ _TO TREAT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA._ CONTRAINDICATIONS This product is contraindicated in those persons who have shown hypersensitivity to any of its components. 3 WARNINGS Prolonged or frequent intermittent use of topical chloramphenicol should be avoided because of possibility of hypersensitivity reactions, including bone-marrow hypoplasia which may lead to aplastic anemia. Overuse of this product may produce increased redness of the eye. PRECAUTIONS Prolonged use of antibiotics may occasionally result in overgrowth of non-susceptible organisms, including fungi. If new Perskaitykite visą dokumentą