Antisedan: Product Information (Page 3 of 3)

STORAGE INFORMATION

Store at room temperature 20° to 25°C (68-77°F), with excursions permitted to 15° to 30°C (59-86°F). Use within 90 days of first puncture.

HOW SUPPLIED

ANTISEDAN is supplied in 10-mL, multidose vials containing 5.0 mg of atipamezole hydrochloride per mL.

Approved by FDA under NADA # 141-033

Antisedan® , Dexdomitor® , and Domitor® are trademarks of Orion Corporation.

Figure
(click image for full-size original)

Revised: April 2019

Developed and manufactured by:
ORION
PHARMA
Orion Corporation
Espoo, Finland

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

Product of Finland

107237-8

PRINCIPAL DISPLAY PANEL — 10 mL Carton Label

10 mL Carton Label
(click image for full-size original)

ANTISEDAN
atipamezole hydrochloride injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-6293
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
atipamezole hydrochloride (atipamezole) atipamezole hydrochloride 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
methylparaben 1 mg in 1 mL
sodium chloride 8.5 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-6293-1 10 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141033 08/06/1966
Labeler — Zoetis Inc. (828851555)

Revised: 06/2020 Zoetis Inc.

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