Zilretta

Name: Zilretta

How Supplied/Storage and Handling

Description NDC Presentation/How Supplied
Zilretta NDC 70801-003-01 Zilretta (triamcinolone acetonide extended-release injectable suspension) single-dose kit.
Kit Contents
Zilretta microsphere powder NDC 70801-001-01 5 mL single-dose vial to deliver 32 mg of triamcinolone acetonide supplied as a sterile, white to off-white powder in a cerium glass (clear) vial with a rubber stopper and an aluminum seal with a gray plastic cap.
Diluent NDC 70801-002-01 5 mL single-dose vial supplied as a sterile, clear liquid solution of 0.9% w/w sodium chloride (normal saline) containing 0.5% w/w sodium carboxymethylcellulose, and 0.1% w/w polysorbate-80 in a glass vial with a rubber stopper, aluminum seal and white plastic cap.
Sterile vial adapter

STORAGE

To maintain expiry period, refrigerate the Zilretta single-dose kit (36°-46°F; 2°-8°C) before use.

If refrigeration is unavailable, store the Zilretta single-dose kit in the sealed, unopened kit at temperatures not exceeding 77°F (25°C) for up to six weeks and then discard. Do not expose the Zilretta single-dose kit to temperatures above 77°F (25°C).

Do not freeze. Store vials in carton.

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