INDICATIONS
CONTRA-INDICATIONS
DOSAGE
SIDE-EFFECTS
PREGNANCY
OVERDOSE
IDENTIFICATION
PATIENT INFORMATION
CELLUFRESH Eye Drops
SCHEDULING STATUS:
Schedule 0
PROPRIETARY NAME
(and dosage form):
CELLUFRESH Eye Drops
COMPOSITION
CELLUFRESH is an isotonic formulation and contains carboxymethylcellulose sodium 5 mg/mL, sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, magnesium chloride and purified water.
PHARMACOLOGICAL CLASSIFICATION
A. 15.4 Ophthalmic preparations. Other.
PHARMACOLOGICAL ACTION
CELLUFRESH Eye Drops are an isotonic, lubricating, non-preserved formulation similar to normal tears.
INDICATIONS
CELLUFRESH Eye Drops are indicated as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.
CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients.
WARNINGS
If irritation increases or persists for more than 24 hours, discontinue use and consult a medical practitioner.
DOSAGE AND DIRECTIONS FOR USE
Ensure that the container is intact before use. To open, completely twist off the tab. Apply one or two drops in each eye as needed, or as directed. There is no special dosage schedule for the elderly or for children. Use immediately after opening. Do not store opened container. Discard after use.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Irritation on instillation is the most frequently reported side-effect. Transient blurring may also be experienced.
To avoid contamination, do not touch the tip of the container to any surface and avoid direct contact with the eye. Do not use if the solution is cloudy or discoloured
IDENTIFICATION
Clear, colourless to slightly straw coloured solution in low density polyethylene single-use containers.
PRESENTATION
Cardboard cartons containing 30 sterile single-use vials per carton. Each single-use container contains 0,4 mL CELLUFRESH.
STORAGE INSTRUCTIONS
Store unopened container in a cool place (below 25ºC). Do not store opened single-use container. Discard any unused portion. KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER
32/15.4/0477
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Allergan Pharmaceuticals (Pty.) Ltd
30 New Road (entrance of Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
South Africa
DATE OF PUBLICATION OF THIS PACKAGE INSERT
24 April 1998
Updated on this site: July 2008
Source: Pharmaceutical Industry
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