HAEMONETICS ANTICOAGULANT SODIUM CITRATE- trisodium citrate dihydrate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

Available from:

Haemonetics Corporation

INN (International Name):

TRISODIUM CITRATE DIHYDRATE

Composition:

ANHYDROUS CITRIC ACID 40 mg in 1 mL

Administration route:

EXTRACORPOREAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

HAEMONETICS ANTICOAGULANT SODIUM CITRATE- TRISODIUM CITRATE
DIHYDRATE SOLUTION
HAEMONETICS CORPORATION
----------
HAEMONETICS ANTICOAGULANT SODIUM CITRATE
HAEMONETICS 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 4.0g
(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:
Room temperature (25°C/77°F). Avoid excess heat. Protect from
freezing.
PRODUCT CODE
Product Code 420A
117881-00, Rev. AA-XXX
Haemonetics Corporation
400 Wood Road
Braintree, MA 02184 USA
PRODUCT LABELING
HAEMONETICS ANTICOAGULANT SODIUM CITRATE
trisodium citrate dihydrate solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:578 26 -420
ROUTE OF ADMINISTRATION
EXTRACORPOREAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K) (ANHYDROUS CITRIC
ACID -
UNII:XF417D3PSL)
ANHYDROUS CITRIC
ACID
40 mg
in 1 mL
INACTIVE INGREDIENTS
Haemonetics Corporation
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:578 26 -420 -0 2
250 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
NDA
BN9 8 0 123
0 1/10 /20 13
LABELER -
Haemonetics Corporation (057827420)
Revised: 2/2021