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CYSTARAN- cysteamine hydrochloride solution


Patient Information

17.1 Storage of Bottles

1.
Patients should be advised to store bottles in the freezer in the original carton.
2.
Each week, one new bottle should be removed from the freezer.
3.
Patients should be advised to allow the bottle to thaw completely (approximately 24 hours) prior to use.
4.
After the bottle is completely thawed, the patient should record the discard date on the bottle label. The discard date is seven (7) days from the day the bottle is thawed.
5.
Patients should be advised to store thawed bottle at 2 C to 25 C (36 F to 77 F) for up to 1 week. The thawed bottles should not be refrozen.
6.
At the end of 1 week (7 days), patients should discard the bottle. There may be medication left in the bottle; however, the bottle must be discarded by the patient because the medication is only stable for 1 week after thawing.

17.2 Risk of Contamination

Patients should be advised not to touch the eyelid or surrounding areas with the dropper tip of the bottle. The cap should remain on the bottle when not in use.

17.3 Use with Contact Lenses

Patients should be advised that contact lenses should be removed prior to application of CYSTARAN. Contact lenses may be reinserted 15 minutes following CYSTARAN administration.

17.4 Topical Ophthalmic Use Only

Patients should be advised that CYSTARAN is for topical ophthalmic use only.

Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878.

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cyspi-7-ht 05/2018



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