Prescription Drug Information: Sodium Citrate

SODIUM CITRATE- sodium citrate solution
Haemonetics Manufacturing Inc

DESCRIPTION

Re-Order Product Code: 798-60

250 mL volume. Single use container.

Sterile, nonpyrogenic fluid path. Sterilized by steam.

Store at room temperature.

INDICATIONS AND USAGE

For use with automated plasmapheresis equipment only. Use according to equipment manufacturer’s instructions. This unit should be used for plasmapheresis only.

CONTRAINDICATIONS

Not for direct intravenous infusion.

WARNINGS

Avoid excessive heat. Protect from freezing. Do NOT vent.

PRECAUTIONS

Do not use unless solution is clear and no leaks detected.

General

Rx only. Discard unused portion.

Recommended Storage: Store at room temperature (25°C / 77°F).

HOW SUPPLIED

250 mL volume bag.

Each 250 ml contains:

10.0 g sodium citrate (dihydrate), USP

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Bag Label

798-60 Bag Label
(click image for full-size original)

Envelope Label

798-60 Envelope Label798-60 Bag Label798-60 Envelope Label

References

HAEMONETICS and THE Blood Management Company are trademarks of Haemonetics Corporation.

Manufactured for:

Haemonetics Corporation

400 Wood Road

Braintree, MA 02184, USA

By: Haemonetics Manufacturing Inc.

1630 Industrial Park Street

Covina, CA 91722, USA

SODIUM CITRATE
anticoagulant sodium citrate solution solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53157-798
Route of Administration INTRAVENOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CITRATE (ANHYDROUS CITRIC ACID) SODIUM CITRATE 10.0 g in 250 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53157-798-60 36 BAG in 1 CARTON contains a BAG
1 250 mL in 1 BAG This package is contained within the CARTON (53157-798-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA760305 06/30/1978
Labeler — Haemonetics Manufacturing Inc (078598396)
Registrant — Haemonetics Manufacturing Inc (078598396)
Establishment
Name Address ID/FEI Operations
Haemonetics Manufacturing Inc 078598396 MANUFACTURE (53157-798), STERILIZE (53157-798), LABEL (53157-798)

Revised: 02/2015 Haemonetics Manufacturing Inc

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