Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Alcon Laboratories UK, Ltd., Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
Prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults and children aged 2 years and older.
One drop instilled into the conjunctival sac(s) every 4 to 6 hours while the patient is awake. During the initial 24 to 48 hours, the dosage may be increased to one drop every two hours while the patient is awake. Dosing should continue for 14 days not to exceed a maximum of 24 days. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
Clinical studies have indicated dosage modifications are not required for use in the elderly.
TOBRADEX may be used in children 2 years of age and older at the same dose as in adults. Currently available data is described in section 5.1.
The safety and efficacy in children younger than 2 years of age have not been established, and no data is available.
Shake the bottle well before use. To prevent contamination of the dropper tip and suspension, care should be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. After cap is removed, if tamper evident snap collar is loose, remove before using product.
In case of concomitant therapy with other topical ophthalmic medicinal products, an interval of 5 minutes should be allowed between successive applications.
Eye ointments should be administered last.
Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, or in the event of accidental ingestion of the contents of one bottle or tube.
A topical overdose of TOBRADEX may be flushed from the eye(s) with lukewarm tap water.
2 years.
After the first opening of the container, the sterile ophthalmic suspension should not be used longer than four weeks.
No special precautions for storage.
5ml dropper container (LDPE) and screw cap (polypropylene).
Pack size: 1 × 5ml.
No special requirements.
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