Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL)
LABORATORIOS GRIFOLS SA
EXTRACORPOREAL
PRESCRIPTION DRUG
Abbreviated New Drug Application
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 Läs hela dokumentet