Calcijex (Page 3 of 3)

HOW SUPPLIED

Calcijex (calcitriol injection) is supplied as follows:

List Container Concentration Fill
8110 Ampul 1 mcg/mL 1 mL

Protect from light.
Store at 20° — 25°C (68° — 77°F); excursions permitted to 15° — 30°C (59° — 86°F) [see USP Controlled Room Temperature]

Mfd. by:

Hospira, Inc.

Lake Forest, IL 60045 USA

For:

Abbott Laboratories

North Chicago, IL 60064 USA

©Abbott 2012

Printed in USA

Revised: 03/2012

NDC 0074–8110–31

1 mL Single-dose 5 Ampuls

CALCIJEX®

Calcitriol Injection (1 mcg/mL)

For I.V. use. Protect from light. Keep ampuls in package until time of use.

Each mL contains calcitriol, 1 mcg; polysorbate 20, 4 mg; sodium ascorbate 2.5 mg added. May contain hydrochloric acid and /or sodium hydroxide for pH adjustment. pH is 6.5 (5.9 to 7.0). Contains no more than 1 mcg/mL of aluminum. Usual dosage: See insert. Store at controlled room temperature 15° to 30° C (59° to 86° F).

Rx only

© Abbott 2004 Printed in USA

Mfd. by: Hospira, Inc., Lake Forest, IL 60045 USA

For: Abbott Laboratories, North Chicago, IL 60064 USA

Calcijex 1 mcg/mL
(click image for full-size original)

CALCIJEX
calcitriol injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-8110
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCITRIOL (CALCITRIOL) CALCITRIOL 1 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 20
SODIUM ASCORBATE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-8110-31 5 AMPULE in 1 CARTON contains a AMPULE
1 1 mL in 1 AMPULE This package is contained within the CARTON (0074-8110-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018874 06/01/2010
Labeler — Abbott Laboratories (001307602)

Revised: 08/2012 Abbott Laboratories

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