HESPAN (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCEL® Containers packaged 12 per case.

NDC REF Volume
0264-1965-10 L6511 500 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing.

Store at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

Rx only

EXCEL and HESPAN are registered trademarks of B. Braun Medical Inc.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y36-002-949 LD-233-4

PRINCIPAL DISPLAY PANEL — 500 mL

6% hetastarch in
0.9% sodium chloride injection

HESPAN®

NDC 0264-1965-10

500 mL
EXCEL® CONTAINER

For intravenous use only.

Each 100 mL contains: Hetastarch 6 g
Sodium Chloride USP 0.9 g in Water for Injection, USP
pH adjusted with Sodium Hydroxide, NF

Electrolytes (mEq/L): Sodium 154 Chloride 154

If administration is by pressure infusion, all air should be withdrawn
or expelled from the bag through the medication port prior to infusion.

Sterile. Single dose container. Discard unused solution.

Recommended Storage: Store at room temperature, 25°C (77°F). Avoid
excessive heat. Protect from freezing. Usual Dosage: See package insert for
complete information.

Do not remove overwrap until ready for use. If leaks are found, discard solution as
sterility may be impaired. DO NOT INTRODUCE ADDITIVES OTHER THAN CITRATE INTO BAG.

REF L6511

Not made with natural rubber latex, PVC or DEHP.

Rx only

Recycle symbol
B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862www.bbraun.com

Y94-003-305 LD-152-7

EXP LOT

500 mL Container Label L6511
(click image for full-size original)

6% hetastarch in
0.9% sodium chloride
injection
HESPAN®

Y94-003-184 LD-427-1

L6511 Overwrap
(click image for full-size original)

HESPAN hetastarch in sodium chloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-1965
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HETASTARCH (HETASTARCH) HETASTARCH 6 g in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 0.9 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0264-1965-10 12 CONTAINER in 1 CASE contains a CONTAINER
1 500 mL in 1 CONTAINER This package is contained within the CASE (0264-1965-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA BN890105 04/04/1991
Labeler — B. Braun Medical Inc. (002397347)
Establishment
Name Address ID/FEI Operations
B. Braun Medical Inc. 037425308 LABEL (0264-1965), MANUFACTURE (0264-1965), PACK (0264-1965)

Revised: 05/2018 B. Braun Medical Inc.

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