国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL), Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL), Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)
Fenwal, Inc.
PRESCRIPTION DRUG
New Drug Application
ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)- ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION SOLUTION FENWAL, INC. ---------- TRIPLE BLOOD-PACK™ UNIT CPD/ADSOL™ INSTRUCTIONS FOR BLOOD COLLECTION USING (CPD) BLOOD-PACK™ UNIT WITH AN INTEGRALLY ATTACHED CONTAINER OF ADSOL™ RED CELL PRESERVATION SOLUTION. RX ONLY BLOOD-PACK™ unit for the collection, processing and/or storage of blood or blood components. Contains Y-Sampling Site Use aseptic technique. CPD FORMULA: Each 63 mL of CPD solution contains: 1.66 g Sodium citrate (dihydrate) USP; 1.61 g Dextrose (monohydrate) USP; 188 mg Citric acid (anhydrous) USP; 140 mg Monobasic sodium phosphate (monohydrate) USP; Water for Injection USP to 63 mL ADSOL™ FORMULA: Each 100 mL of ADSOL solution contains: 900 mg Sodium chloride USP; 2.20 g Dextrose monohydrate USP; 27.0 mg Adenine USP; 750 mg Mannitol USP; Water for Injection USP to 100 mL. CAUTION: Do not use unless the solutions are clear. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. PRECAUTION: DO NOT PROCEED WITH THE REMAINING STEPS UNTIL THE ENTIRE WHOLE BLOOD UNIT IS COLLECTED. 11. Identify BLOOD-PACK unit using appropriate donor identification system. Adjust donor scale to desired collection weight/volume. Suspend primary container from donor scale as far as possible below donor arm and clamp donor tubing with hemostat. Apply pressure to donor’s arm and disinfect site of venipuncture. If blood pressure cuff is used, inflate to approximately 60 mm Hg. Remove needle cover per instructions below: a) b) Hold the needle hub upwards. With the other hand, grasp the base of the needle cover (Figure 1), twist approximately 1/4 turn to break tamper evident seal (Figure 2). Remove needle cover (Figure 3), be careful not to drag cover across the needle point (Figure 4). Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat. MIX BLOOD AND ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION AND IMMEDIATELY AFTER COLLECTION. C 阅读完整的文件