ACD-A- anticoagulant citrate dextrose solution a solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

זמין מ:

Haemonetics Manufacturing Inc

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

For use with automated pheresis equipment only. Use according to equipment manufacturer’s instructions. This unit should be used for pheresis only. Not for direct intravenous infusion.

leaflet_short:

750 mL volume bag. Each 100 ml contains: 0.73 g citric acid (anhydrous), USP 2.20 g sodium citrate (dihydrate), USP 2.45 g dextrose (monohydrate), USP

מצב אישור:

New Drug Application

מאפייני מוצר

ACD-A- ANTICOAGULANT CITRATE DEXTROSE SOLUTION A SOLUTION
HAEMONETICS MANUFACTURING INC
----------
ANTICOAGULANT CITRATE DEXTROSE SOLUTION, USP (ACD), SOLUTION A
DESCRIPTION
Re-Order Product Code: 796-08
750 mL volume. Single use container.
Sterile, nonpyrogenic fluid path. Sterilized by steam.
Store at room temperature.
INDICATIONS AND USAGE
For use with automated pheresis equipment only. Use according to
equipment manufacturer’s
instructions. This unit should be used for pheresis only.
CONTRAINDICATIONS
Not for direct intravenous infusion.
WARNINGS
Avoid excessive heat. Protect from freezing.
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
750 mL volume bag.
Each 100 ml contains:
0.73 g citric acid (anhydrous), USP
2.20 g sodium citrate (dihydrate), USP
2.45 g dextrose (monohydrate), USP
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Hot Stamped Bag
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.
Haemonetics Manufacturing Inc
1630 Industrial Park Street
Covina, CA 91722, USA
ACD-A
anticoagulant citrate dextrose solution a solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:53157-79 6
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DEXTRO SE MO NO HYDRATE (UNII: LX22YL0 8 3G) (ANHYDROUS DEXTROSE -
UNII:5SL0 G7R0 OK)
DEXTROSE
MONOHYDRATE
2.45 g
in 10 0 mL
SO DIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID -
UNII:XF417D3PSL)
SODIUM CITRATE
2.20 g
in 10 0 mL
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP) (ANHYDROUS CITRIC
ACID -
UNII:XF417D3PSL)
ANHYDROUS CITRIC
ACID
0 .73 g
in 10 0 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:53157-79 6 -0 8
12 i