ALFAXAN MULTIDOSE: Product Information (Page 4 of 4)

STORAGE INFORMATION

Store at controlled room temperature 20°C — 25°C (68° to 77°F) with excursions between 15° and 30°C (59° and 86°F). ALFAXAN MULTIDOSE contains preservatives. The product can be used for 56 days after broaching the vial. Any unused ALFAXAN MULTIDOSE remaining after 56 days should be discarded.

HOW SUPPLIED

ALFAXAN MULTIDOSE is supplied in 10 and 20 mL multiple-dose vials containing 10 mg alfaxalone per mL.

ALFAXAN is a registered trademark of Jurox Pty Ltd.
Approved by FDA under NADA # 141-342
Manufactured in Australia by Jurox Pty Ltd.
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007
Revised: April 2023471610

PRINCIPAL DISPLAY PANEL — 10 mL Carton

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

471615

PRINCIPAL DISPLAY PANEL — 20 mL Carton

20 mL Carton
(click image for full-size original)

471630

ALFAXAN MULTIDOSE alfaxalone injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-6696
Route of Administration INTRAVENOUS DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALFAXALONE (ALFAXALONE) ALFAXALONE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYLBETADEX (0.58-0.68 MS) 80 mg in 1 mL
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
ALCOHOL 150 mg in 1 mL
BENZETHONIUM CHLORIDE 0.2 mg in 1 mL
CHLOROCRESOL 1 mg in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-6696-1 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 10 mL in 1 VIAL, GLASS This package is contained within the CARTON (54771-6696-1)
2 NDC:54771-6696-2 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
2 20 mL in 1 VIAL, GLASS This package is contained within the CARTON (54771-6696-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141342 07/12/2018
Labeler — Zoetis Inc. (828851555)

Revised: 05/2023 Zoetis Inc.

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