ANTICOAGULANT SODIUM CITRATE- trisodium citrate dihydrate solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL)

Disponible depuis:

LABORATORIOS GRIFOLS SA

Mode d'administration:

EXTRACORPOREAL

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ANTICOAGULANT SODIUM CITRATE- TRISODIUM CITRATE DIHYDRATE SOLUTION
LABORATORIOS GRIFOLS SA
----------
ANTICOAGULANT SODIUM CITRATE
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)
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°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.
Laboratorios Grifols, S. A.
SPAIN
Revision: 10/2019
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�