CHLORAMPHENICOL SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CHLORAMPHENICOL

Disponibil de la:

PHARMA STULLN INC.

Codul ATC:

S01AA01

INN (nume internaţional):

CHLORAMPHENICOL

Dozare:

0.5%

Forma farmaceutică:

SOLUTION

Compoziție:

CHLORAMPHENICOL 0.5%

Calea de administrare:

OPHTHALMIC

Unități în pachet:

10ML/15ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTIBACTERIALS

Rezumat produs:

Active ingredient group (AIG) number: 0151341006; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2017-05-08

Caracteristicilor produsului

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.
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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