INDICATIONS
CONTRA-INDICATIONS
DOSAGE
SIDE-EFFECTS
PREGNANCY
OVERDOSE
IDENTIFICATION
PATIENT INFORMATION
MINIMS* CHLORAMPHENICOL 0,5% Eye Drops
SCHEDULING STATUS:
Schedule 4
PROPRIETARY NAME
(and dosage form)
MINIMS* CHLORAMPHENICOL 0,5% Eye Drops
COMPOSITION:
(per dispensing unit of 0,5 mL)
Chloramphenicol 2,5 mg.
PHARMACOLOGICAL CLASSIFICATION:
A 15.1 Ophthalmic preparations with antibiotics and/or sulphonamides.
PHARMACOLOGICAL ACTION:
Chloramphenicol is a broad spectrum antibiotic with primarily bacteriostatic activity, and is effective in vitro against a wide range of Gram-positive and Gram-negative organisms.
INDICATIONS:
Chloramphenicol is used for the local treatment of acute eye infections caused by susceptible organisms.
CONTRA-INDICATIONS:
Chloramphenicol should not be used for minor infections or prophylactically, or as a long term treatment for dry eye syndrome.
WARNINGS:
Caution should be exercised on administration of chloramphenicol to newborn infants, and when treating anaemic patients. Chloramphenicol should not be used with other drugs which may suppress bone marrow function.
DOSAGE AND DIRECTIONS FOR USE:
Adults and children: To be used as directed by the ophthalmologist.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Local hypersensitivity reactions may occur. Treatment with chloramphenicol should be discontinued immediately.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Not applicable.
IDENTIFICATION:
Clear, colourless solution.
PRESENTATION:
Sterile, single-dose, disposable eye drops in cartons of 10 units, each containing approximately 0,5 mL.
STORAGE INSTRUCTIONS:
Minims Chloramphenicol must be stored under refrigeration at 5°C. DO NOT FREEZE.
If stored at room temperature, the product has a maximum shelf life of 1 month.
Keep out of reach of children.
REGISTRATION NUMBER:
E/15.1/223
NAME AND BUSINESS ADDRESS OF APPLICANT:
S & N Pharmaceuticals (Pty) Ltd
30 Gillitts Road
Pinetown 3610
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 10, 1974
* Trademark
9/67U SNP 27/2
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