Haemonetics Anticoagulant Sodium Citrate

Haemonetics Anticoagulant Sodium Citrate

Drug Labeling and Warnings

Drug Details

k">

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

Label

label 2

label 3

HAEMONETICS ANTICOAGULANT SODIUM CITRATE  
trisodium citrate dihydrate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 57826-420
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 57826-420-02250 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDABN98012301/10/2013
Labeler - Haemonetics Corporation (057827420)

Revised: 12/2019
 
Haemonetics Corporation


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.