Country: United States
Language: English
Source: 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.
TRISODIUM CITRATE DIHYDRATE
Anhydrous Citric Acid 921 mg in 35 mL
INTRAVENOUS
PRESCRIPTION DRUG
New Drug Application
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) BLOOD-PACK UNITS IN PL 146 PLASTIC - ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION SOLUTION FENWAL, INC. ---------- ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION, USP (CPD) BLOOD- PACK™ UNIT 4R0012MC, 4R0837MC, 4R0112MC FENWAL BLOOD-PACK UNITS RX ONLY WITH INTEGRAL DONOR TUBE USING ACD OR CPD AND FENWAL HIGHFLO NEEDLE INSTRUCTIONS FOR USE COLLECTION PROCEDURE: USE ASEPTIC TECHNIQUE. PRECAUTION: DO NOT USE UNLESS SOLUTION IS CLEAR. 1. Identify Blood-Pack unit using appropriate donor identification system. Confirm that all numbered tubing of each Blood-Pack unit contains its own identical segment numbers. 2. Adjust donor scale to desired collection weight. 3. Position primary container from donor scale as far as possible below donor arm and clamp donor tubing. 4. Following blood center procedures, apply pressure to donor's arm and disinfect site of venipuncture. 5. Remove HighFlo needle cover per instructions below: a) Holding the hub and cover near the tamper-evident seal, twist cover and hub in opposite directions to break seal. b) Remove needle cover, being careful not to drag the cover across the needle point. Following blood center procedures, perform venipuncture, appropriately secure donor needle and/or tubing and release clamp. 6. MIX BLOOD AND ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION AND IMMEDIATELY AFTER COLLECTION. 7. Collect the appropriate volume based on Blood-Pack unit used. NOTE: The volume of anticoagulant is sufficient for the blood collection indicated on Blood-Pack unit ± 10%. 8. Apply clamp to donor tube. 9. As appropriate, release pressure on the donor's arm, collect donor samples following established procedures and withdraw donor needle. 10. WITHDRAWAL OF NEEDLE INTO NEEDLE GUARD. PRECAUTION: THE NEEDLE GUARD MUST BE HELD STATIONARY WHILE THE NEEDLE IS WITHDRAWN INTO IT. a) Hold sides of needle guard near the front, between the index finger and thumb. Pull the hub back smoothly until the needle is completely enclosed Read the complete document