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FDA Drug information

Anticoagulant Sodium Citrate

Read time: 1 mins
Marketing start date: 18 Nov 2024
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Summary of product characteristics


Warnings

CAUTION Not for direct intravenous infusion. The pouch is a moisture barrier. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion.

Effective Time

20230911

Version

5

Spl Product Data Elements

Anticoagulant Sodium Citrate Trisodium Citrate Dihydrate Trisodium Citrate Dihydrate Anhydrous Citric Acid Water Citric Acid Monohydrate carton-76297-006-03.jpg container-76297-006-02.jpg

Application Number

BA125697

Brand Name

Anticoagulant Sodium Citrate

Generic Name

Trisodium Citrate Dihydrate

Product Ndc

76297-006

Product Type

HUMAN PRESCRIPTION DRUG

Route

EXTRACORPOREAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 76297-006-03 Anticoagulant Sodium Citrate 4% w/v Solution, USP 250 mL Rx Only Intended for use only with automated apheresis devices. Not for direct intravenous infusion. RECOMMENDED STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. LOT XXXXXX EXP YYYY-MM 30 x 250 mL Num.: GRIFOLS Laboratorios Grifols, S. A. SPAIN LOT: XXXXXX EXP: YYYY-MM NDC 76297-006-02 Anticoagulant Sodium Citrate 4% w/v Solution, USP 250 mL Rx Only Intended for use only with automated apheresis devices Each 100 mL contains: Sodium Citrate (Dihydrate), USP 4.0 g (pH adjusted with Citric Acid, Monohydrate, USP) Caution: Not for direct intravenous infusion. The pouch is a moisture barrier. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion. STERILE, nonpyrogenic fluid path. RECOMMENDED STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Laboratorios Grifols, S. A. SPAIN GRIFOLS

Spl Unclassified Section

ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION USP Rx only 250 mL Intended for use only with automated apheresis devices. Each 100 mL contains: Sodium Citrate (Dihydrate), USP 4.0 g (pH adjusted with Citric Acid, Monohydrate, USP)

Storage And Handling

RECOMMENDED STORAGE: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing.

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