INDICATIONS
CONTRA-INDICATIONS
DOSAGE
SIDE-EFFECTS
PREGNANCY
OVERDOSE
IDENTIFICATION
PATIENT INFORMATION
MINIMS PREDNISOLONE SODIUM PHOSPHATE 0,5%
SCHEDULING STATUS:
Schedule 4
PROPRIETARY NAME
(and dosage form):
MINIMS PREDNISOLONE SODIUM PHOSPHATE 0,5%
Eye drops
COMPOSITION:
(per dispensing unit of 0,5 mL)
Prednisolone sodium phosphate 2,5 mg
PHARMACOLOGICAL CLASSIFICATION:
A 15.2 Ophthalmic preparations with corticosteroids
PHARMACOLOGICAL ACTION:
Prednisolone is a synthetic corticosteroid with anti-inflammatory effects.
INDICATIONS:
Prednisolone is administered locally for non-infected inflammatory conditions of the outer eye and anterior segment.
CONTRA-INDICATIONS:
Prednisolone is contra-indicated in viral, fungal, tuberculous and other bacterial infections, or in ulcerated eyes. The drug should not be used in patients with glaucoma as prolonged use can cause intra-ocular pressure to rise.
DOSAGE AND DIRECTIONS FOR USE:
Adults: one or two drops to be instilled as required.
Children: at the discretion of the ophthalmologist.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Because prolonged use of ophthalmic steroids has caused increased intra-ocular pressure, corneal ulcers, and reduced visual function, as well as increased susceptibility to all kinds of infection, prednisolone should not be used for more than one week except under strict supervision.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Not applicable.
CONDITIONS OF REGISTRATION:
Advertising to the professions only.
IDENTIFICATION:
Clear, colourless solution.
PRESENTATION:
Sterile, single-dose, disposable eye drops in cartons of 10 units, each containing approximately 0,5 mL.
STORAGE INSTRUCTIONS:
Store in the refrigerator protected from strong light. DO NOT FREEZE.
Keep out of reach of children.
REGISTRATION NUMBER:
P/15.2/212
NAME AND BUSINESS ADDRESS OF APPLICANT:
S & N Pharmaceuticals (Pty) Ltd.
30 Gillitts Road,
Pinetown
3610
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
December 3, 1982
9/67S SNP 40/1
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