TERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRE

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Trisodium Citrate Dihydrate (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), Sodium Phosphate, Monobasic, Unspecified Form (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37), Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), Anhydrous Citric Acid (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

Available from:

Terumo Corporation

INN (International Name):

Trisodium Citrate Dihydrate

Composition:

Trisodium Citrate Dihydrate 26.3 g in 1000 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Issued 8/96 TERUFLEX® BLOOD BAG SYSTEM With Blood Sampling Arm® CPD/OPTISOL® SOLUTION Read these instructions carefully before use. INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic technique Materials Needed: VENOJECT® ll Tube Holder (code P-1316R) VENOJECT® ll Multi-Sample Luer Adapter (code MN *2000) VENOJECT® ll Plastic Blood Collection Tubes (or equivalent glass or plastic evacuated blood collection tube) 1. Confirm that all numbered tubing of each blood bag unit contains segment numbers. 2. Make a loose knot in donor tubing below "Y" unless alternate methods are used to seal tubing. 3. Clamp donor tubing. 4. Suspend primary bag as far as possible below the donor's arm. 5. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate cuff to approximately 60 mmHg. 6. Remove needle protector and perform phlebotomy. Remove clamp to permit blood flow into primary bag. CAUTION Do not touch needle aft

Authorization status:

New Drug Application

Summary of Product characteristics

TERUFLEX BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL
PRESERVATIVE - ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5
RED CELL PRESERVATIVE
TERUMO CORPORATION
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TERUFLEX® BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM® CPD/OPTISOL®
SOLUTION
Issued 8/96
TERUFLEX® BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM® CPD/OPTISOL®
SOLUTION
READ THESE INSTRUCTIONS CAREFULLY BEFORE USE.
INSTRUCTIONS FOR BLOOD COLLECTION: USE ASEPTIC TECHNIQUE
Materials Needed:
VENOJECT® ll Tube Holder (code P-1316R)
VENOJECT® ll Multi-Sample Luer Adapter (code MN *2000)
VENOJECT® ll Plastic Blood Collection Tubes (or equivalent glass or
plastic evacuated blood
collection tube)
1. Confirm that all numbered tubing of each blood bag unit contains
segment numbers.
2. Make a loose knot in donor tubing below "Y" unless alternate
methods are used to seal tubing.
3. Clamp donor tubing.
4. Suspend primary bag as far as possible below the donor's arm.
5. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect
site of phlebotomy. If blood
pressure cuff is used, inflate cuff to approximately 60 mmHg.
6. Remove needle protector and perform phlebotomy. Remove clamp to
permit blood flow into primary
bag.
CAUTION Do not touch needle after removing the needle protector.
7. Appropriately secure donor tubing to donor's arm.
8. MIX BLOOD WITH ANTICOAGULANT AT SEVERAL INTERVALS DURING
COLLECTION.
9. Collect labeled volume of blood (+/–10%).
10. Tighten knot firmly after collection. Clamp between knot and "Y".
Sever donor tubing between the
knot and clamp. Alternate methods may be used to seal tubing.
CAUTION Do not use the dielectric tube sealer while the needle is
connected to the donor's body.
Anytime before Step #13 below, sever donor tubing between the two
seals.
Collect blood samples as follows:
a) Connect VENOJECT II Multi-Sample Luer Adapter to VENOJECT II Tube
Holder (Fig. 1).
b) Remove covers and connect multi-sample luer adapter to female luer
at end of don