ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC) (anticoagulant citrate phosphate dextrose- cpd solution and adsol preservation solution kit

ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) by

Drug Labeling and Warnings

ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) by is a Prescription medication manufactured, distributed, or labeled by Fenwal, Inc., Fenwal International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Instructions for Blood Collection Using CPD OPTIPAC™ Unit with an Integrally Attached Container of ADSOL™ Red Cell Preservation Solution

Rx Only

Opti-System

Use aseptic technique

Caution: Do not use unless the solutions are clear.

1. Identify BLOOD-PACK™ OPTIPAC™ unit using appropriate donor identification system.

2. Adjust donor scale to desired collection weight/volume.

3. Suspend primary container from donor scale as far as possible below donor arm and clamp donor tubing with hemostat.

4. Apply pressure to donor’s arm and disinfect site of venipuncture.

5. If blood pressure cuff is used, inflate to approximately 60 mm Hg, or use tourniquet as applicable.

6. Remove needle cover per instructions below:

a) 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).

b) Remove needle cover (Figure 3), be careful not to drag cover across the needle point (Figure 4).

7. Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.

8. Mix blood and anticoagulant at several intervals during collection and immediately after collection.

9. Collect labeled volume of blood. Anticoagulant volume is sufficient for labeled volume ± 10%.

10. Apply hemostat to donor tubing.

11. If it is necessary, obtain whole anticoagulated blood samples for typing or crossmatching by returning donor tubing blood to the primary bag, mixing and allowing tubing to refill. Repeat once. Seal donor tubing at the desired intervals in order to obtain the desired total blood samples.

12. Centrifuge primary and secondary bags in order to prepare CPD Red Blood Cells.

13. Refer to the OPTIPRESS™ Blood Components Automated Extractor User Manual, in order to prepare the components.

14. After separation, seal transfer tubing in three places near the primary bag and cut middle seal taking care to avoid fluid splatter.
NOTE: In OPTIPAC Quadruple BLOOD-PACK unit, the empty transfer unit may be used for preparation of other components.

15. Fill empty tubing of OPTIPAC AS-1 for red blood cells by stripping the tubing and mixing the AS-1 containter, twice, in order to ensure that the tubing is correctly filled. Seal on "X" marks on tubing in order to obtain red blood cells samples.

16. Mix Adsol Solution and red cells thoroughly.

17. Store suspended Red Blood Cells between 1 and 6 °C.

For further processing, use standard techniques for component processing.

Sterile, non-pyrogenic fluid path. Sterilized by steam. Single use only. Dispose of container appropriately.

Store at Controlled Room Temperature
USP Definition of “Controlled Room Temperature”
United States Pharmacopeia, General Notices.
United States Pharmacopeial Convention, Inc.
12601 Twinbrook Parkway, Rockville, MD

logo Manufactured by:
Fenwal International, Inc.
Road 357, Km. 0.8
Maricao, PR 00606

Made in USA

07-19-05-015 REV: A
07/2010

Imported and distributed in Indonesia by:
PT.Medquest Jaya Global
Menara Salemba 6th Floor
Jl.Salemba Raya Kav 5-5A
Jakarta-Indonesia 10440
Reg. No.: DEPKES RI AKL 20209902359

Imported and distributed in Thailand by:
Fenwal (Thailand) Ltd.
17th Fl. Thanapoom Tower
1550 New Petchburi Rd., Makasan
Rajthevi, Bangkok 10400
Thailand
Reg. No.:

Imported and distributed in Philippines by:
Medlink Marketing
Unit 404 Vicar’s Building,
No.31 Visayas Ave.,
Vasra, Quezon City 1100
Philippines
Reg. No.: DVR-5805

logo – Manufacturer

FENWAL, ADSOL, BLOOD-PACK, OPTIPAC and OPTIPRESS are trademarks of Fenwal, Inc.

PACKAGE/LABEL DISPLAY PANEL

Code A4R7703

5 Units

Fenwal™

Quadruple BLOOD-PACK™ OPTIPAC™ Unit CPD/ADSOL™ OPTI-SYSTEM™

Rx only

Quadruple BLOOD-PACK OPTIPAC unit consisting of a primary pack containing 63 mL of CPD anticoagulant solution for collection of 450 mL of blood, one TRANSFER-PACK containing 100 mL of ADSOL solution and two TRANSFER-PACK containers without solution. 16 gauge needle.

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

Each 100 mL of ADSOL solution contains: 2.20 g Dextrose (monohydrate), USP - 900 mg Sodium Chloride (monohydrate,) USP - 750 mg Mannitol, USP - 27.0 mg Adenine, USP. Water for injection USP to 100 mL.

See instructions for use. Sterile, non-pyrogenic fluid path. Steam sterilized. Single use only. Do not vent. Do not use if there is visible evidence of deterioration. Dispose of container properly.

Store at Controlled Room Temperature
(refer to direction insert).

Unused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture.

Direct handling of product surfaces prior to extended storage in the foil pouch may result in mold growth.

Units removed from the foil pouch must be used within 4 days (96 hours). Units out of the foil pouch for longer than 4 days must be discarded.

logo Manufactured by:
Fenwal International, Inc.
Road 357, Km. 0.8
Maricao, PR 00606

Made in USA

Imported and distributed in Thailand by:
Fenwal (Thailand) Ltd.
17th Fl. Thanapoom Tower
1550 New Petchburi Rd., Makasan
Rajthevi, Bangkok 10400
Thailand

Imported and distributed in Indonesia by:
PT.Medquest Jaya Global
Menara Salemba 6th Floor
Jl.Salemba Raya Kav 5-5A
Jakarta-Indonesia 10440
Reg. No.: DEPKES RI AKL 20209902359

FENWAL, BLOOD-PACK, ADSOL, OPTIPAC and OPTI-SYSTEM are trademarks of Fenwal, Inc.

07-28-05-406 REV: A

Lot No.:

Exp. Date:

Quadruple BLOOD-PACK™ OPTIPAC™ Unit CPD/ADSOL™ OPTI-SYSTEM™ label

INGREDIENTS AND APPEARANCE

ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)
anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0942-6502

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0942-6502-04	1 in 1 KIT

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BAG	63 mL
Part 2	1 BAG	100 mL

Part 1 of 2

CPD
citrate phosphate dextrose solution

Product Information
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL)	Anhydrous Citric Acid	1.66 g in 63 mL
Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	Dextrose Monohydrate	1.61 g in 63 mL
Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL)	Anhydrous Citric Acid	188 mg in 63 mL
Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)	Sodium Phosphate, Monobasic, Monohydrate	140 mg in 63 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		63 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	BN811104	01/11/2011

Part 2 of 2

ADSOL RED CELL PRESERVATION SOLUTION SYSTEM
adsol red cell preservation solution solution

Product Information
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	Dextrose Monohydrate	2.2 g in 100 mL
Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	Sodium Chloride	900 mg in 100 mL
Mannitol (UNII: 3OWL53L36A) (Mannitol - UNII:3OWL53L36A)	Mannitol	750 mg in 100 mL
Adenine (UNII: JAC85A2161) (Adenine - UNII:JAC85A2161)	Adenine	27 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		100 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	BN811104	01/11/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	BN811104	01/11/2011

Labeler - Fenwal, Inc. (794519020)

Name	Address	ID/FEI	Business Operations
Establishment
Fenwal International, Inc.		091164590	MANUFACTURE(0942-6502)