HOW SUPPLIED
OptiMARK™ Injection is a clear, colorless to slightly yellow solution containing 330.9 mg/mL, 0.5 mmol/mL of gadoversetamide. OptiMARK™ Injection is supplied in 50 mL glass bottles containing 50 mL of solution. Each bottle is rubber stoppered with an aluminum seal and the contents are sterile. Bottles are contained in shipping cartons with the following configurations:
50 mL in glass bottles in cartons of 5 bottles (NDC Code 0019-1177-50)
Storage
OptiMARK™ Injection should be stored at 20°C to 25°C (68°F to 77°F)[ see USP Controlled Room Temperature] and protected from light and freezing. OptiMARK™ Injection may be stored at 37°C for up to one month in a contrast media warmer utilizing circulating warm air. For periods longer than one month, store at 20°C to 25°C (68°F to 77°F).
This product is covered by U.S. Patent No. 5130120, 5137711, 5508388. The use of this product is covered by U.S. Patent No. 5130120 and 5137711.
OptiMARK is a trademark of Mallinckrodt Inc. Omniscan is a registered trademark of GE Healthcare AS Magnevist is a registered trademark of Berlex Laboratories, Inc. MultiHance is a registered trademark of Bracco International B.V. ProHance is a registered trademark of Bracco Diagnostics Inc.
Copyright 1998, Mallinckrodt Inc. All rights reserved
Manufactured and Distributed by: Mallinckrodt Inc. St. Louis, MO 63042 U.S.A.
Printed in U.S.A.
tyco Healthcare
MALLINCKRODT
Mallinckrodt Inc. St. Louis, MO 63042 U.S.A. www.Mallinckrodt.com
MKR 11PB0908 Revised 09/08 Printed in U.S.A.
|