Nutricel Additive System – CP2D (Page 2 of 2)

WHEN USING SYSTEMS WITH A PRE-ATTACHED SAMPLOK VACUUM TUBE HOLDER

1. To collect blood samples, open lid from SampLok vacuum tube holder.

2. Open snap-open closure between sample diversion pouch and SampLok vacuum tube holder.

3. Position the sample diversion pouch downwards so that the air rises to the top of the pouch and away from the SampLok vacuum tube holder. Note: Drawing air into the vacuum tube may cause hemolysis.

4. Collect blood samples from the sample diversion pouch into vacuum tubes within approximately four minutes to avoid possible clot formation.

5. Ensure the vacuum tubes are centered within the SampLok vacuum tube holder during sample collection.

6. Maintain forward pressure on the vacuum tubes during sample collection.

7. The lid may be closed on the SampLok vacuum tube holder after sample collection.

8. Return to “Blood Collection Instruction for Systems Containing a Sample Diversion Pouch with or without a Pre-attached SampLok Vacuum Tube Holder”, Step 17. Note: When collection of unit is complete, and the donor needle is engaged in the DCNG, open the lid of the SampLok vacuum tube holder and insert the DCNG into the holder. Twist until it locks into place. An audible click will confirm that it is locked.

PROCESSING INSTRUCTIONS

1. Process whole blood within 72 hours of collection.

2. Mix whole blood/anticoagulant thoroughly.

3. Load whole blood and satellite bags into centrifuge cup, ensuring that the tubing stays in the top half of the cup.

4. Centrifuge at appropriate conditions to produce desired components.

5. Carefully remove the unit from the centrifuge and place the red cell storage bag in the plasma expressor.

6. Clamp tubing to extra satellite bags, if present.

7. Gently apply expressor pressure.

8. Open snap-open closure to satellite bag and express plasma.

9. After plasma is expressed, clamp tubing between red cell storage bag and Y connector, and release expressor pressure.

10. Clamp tubing between the Y connector and plasma bag.

11. Hang AS-3 bag above red cell storage bag and remove clamp from tubing to the red cell storage bag.

12. Open snap-open closure on the bag containing the AS-3 additive solution and transfer to the bag containing the red cells. Note: AS-3 solution should be added to the packed red blood cells immediately after removal of plasma. Transfer AS-3 solution under one of the following processing conditions:

a. within 8 hours of collection if whole blood is held at room temperature.

b. within 72 hours of collection if whole blood is refrigerated.

13. Seal tubing and detach the bag containing packed red cells, and set aside plasma for further processing.*

14. Gently mix packed red cells and AS-3 solution.

15. Store CP2D/AS-3 preserved red blood cells at 1—6 °C for up to 42 days and use as indicated. Note: If AS-3 is not used, whole blood or red blood cells in CP2D alone may be stored at 1—6 °C for up to 21 days.

HOW SUPPLIED

Each shipping case contains 8 foil envelopes. Within each foil envelope resides 3 clear pouches containing an individual collection system. Each collection system consists of CP2D/AS-3 500 ml, Double Blood Bag Collection System with Nutricel Additive Solution and Sample Diversion Pouch.

PRINCIPAL DISPLAY PANEL

CP2D 500 ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION

AS-3 RED BLOOD CELLS, ADENINE — SALINE ADDED, 16.5 mEq sodium added.

From 500 ml CP2D Whole Blood. Store at 1—6 °C.

70 ml Anticoagulant Citrate Phosphate Double Dextrose Solution for collection of 500 ml of blood. Each 70 ml of CP2D solution contains 3.57 g dextrose (monohydrate), USP; 1.84 g sodium citrate (dihydrate), USP; 0.229 g citric acid (monohydrate), USP; and 0.155 g monobasic sodium phosphate (monohydrate), USP. Use only if solution is clear.

See circular of information for indications, contraindications, cautions and methods of infusion. VOLUNTEER DONOR. This product may transmit infectious agents. Rx only. PROPERLY IDENTIFY INTENDED RECIPIENT.

FigA
(click image for full-size original)

CP2D 500

See circular of information for indications, contraindications, cautions and methods of infusion. VOLUNTEER DONOR. This product may transmit infectious agents. Rx only.

PROPERLY IDENTIFY INTENDED RECIPIENT.

FigB
(click image for full-size original)

Double 500ml CP2D/AS-3

BLOOD COLLECTION SYSTEM with Nutricel Additive Solution

CP2D/AS-3 Double with Sample Diversion Pouch

For collection of 500 ml of blood and preparation of red blood cells and plasma.

Each unit consists of a collection bag with 70 ml of CP2D solution, an additive bag with 110 ml of AS-3 solution, and one empty bag. Each 70 ml of CP2D solution contains 3.57 g dextrose (monohydrate), USP; 1.84 g sodium citrate (dihydrate), USP; 0.229 g citric acid (monohydrate), USP; and 0.155 g monobasic sodium phosphate (monohydrate), USP. Each 110 ml of AS-3 solution contains 1.21 g dextrose (monohydrate), USP; 0.647 g sodium citrate (dihydrate), USP; 0.451 g sodium chloride, USP; 0.304 g monobasic sodium phosphate (monohydrate), USP; 0.046 g citric acid (monohydrate), USP; and 0.033 g adenine, USP.

Sterile, nonpyrogenic fluid path. Sterilized by steam. See accompanying directions for use. Rx only. Store at room temperature. Unused bags in opened pouches may be kept 30 days by folding and SECURING open end of pouch to prevent possible loss of moisture.

3 Units Code 120-92

FigC
(click image for full-size original)

REFERENCES

HAEMONETICS, THE Blood Management Company and Nutricel are registered trademarks of Haemonetics Corporation. DonorCare and SampLok are registered trademarks of ITL Corporation, Canberra, Australia.

MANUFACTURER

Manufactured for: Haemonetics Corporation

400 Wood Road

Braintree, MA 02184, USA

By: Haemonetics Manufacturing Inc

1630 Industrial Park Street

Covina, CA 91722, USA

Visit us at www.haemonetics.com

Phone: 888.489.5938

NUTRICEL ADDITIVE SYSTEM — CP2D
cp2d/as-3 anticoagulant and additive system solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53157-120
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE (DEXTROSE) DEXTROSE 3.57 g in 70 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
SODIUM CITRATE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
WATER
Product Characteristics
Color yellow (yellowish solution) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53157-120-BO 8 POUCH (POUCH) in 1 BOX contains a POUCH (53157-120-PO)
1 NDC:53157-120-PO 3 BAG (BAG) in 1 POUCH This package is contained within the BOX (53157-120-BO) and contains a BAG (53157-120-92)
1 NDC:53157-120-92 70 mL in 1 BAG This package is contained within a POUCH (53157-120-PO) and a BOX (53157-120-BO)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA820915 08/05/2013
NUTRICEL ADDITIVE SYSTEM — AS3
cp2d/as-3 anticoagulant and additive system solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53157-AS3
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADENINE (ADENINE) ADENINE 0.033 g in 110 mL
DEXTROSE (DEXTROSE) DEXTROSE 1.21 g in 110 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
SODIUM CHLORIDE
SODIUM CITRATE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
WATER
Product Characteristics
Color yellow (yellowish solution) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53157-AS3-BO 8 POUCH (POUCH) in 1 BOX contains a POUCH (53157-AS3-PO)
1 NDC:53157-AS3-PO 3 BAG (BAG) in 1 POUCH This package is contained within the BOX (53157-AS3-BO) and contains a BAG (53157-AS3-BG)
1 NDC:53157-AS3-BG 110 mL in 1 BAG This package is contained within a POUCH (53157-AS3-PO) and a BOX (53157-AS3-BO)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA820915 08/05/2013
Labeler — Haemonetics Manufacturing Inc (078598396)
Registrant — Haemonetics Manufacturing Inc (078598396)
Establishment
Name Address ID/FEI Operations
Haemonetics Manufacturing Inc 078598396 manufacture (53157-120)

Revised: 08/2013 Haemonetics Manufacturing Inc

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