TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)

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Overview

What is TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)?

11.   DESCRIPTION

11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and a 250 mL (nominal capacity 300 mL) collection bag containing 35 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant.

11.2.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer).

11.3.   The blood bag has no components made of natural rubber latex.

11.4.   Tubing internal diameter (ID) nominal 3.0 mm.

11.5.   Tubing outer diameter (OD) nominal 4.4 mm.

11.6.   Donor tubing line maximum 12 segments available.

What does TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) look like?

What are the available doses of TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)?

3. DOSAGE FORMS AND STRENGTHS

3.1. 35 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant USP for collection of 250 mL Whole Blood. Each 35 mL contains 105mg Citric Acid (anhydrous) USP, 921mg Sodium Citrate (dihydrate) USP, 77.7mg Monobasic Sodium Phosphate (monohydrate) USP, 1.12g Dextrose (monohydrate) USP and 9.63mg Adenine USP.

What should I talk to my health care provider before I take TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)?

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How should I use TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)?

For the collection of 250 mL of Whole Blood

Revised 2015-12 N-BB-A 3

FULL PRESCRIBING INFORMATION*

1.   INDICATIONS AND USAGE

NOTE

2.   DOSAGE AND ADMINISTRATION

2.1.     To open blister package, peel cover film back 4/5 of its length.

2.2.     Prepare the blood bag following your institution's standard operating procedures.

2.3.     Make a loose knot in the donor tubing approximately 10 cm or 4 inches from the needle unless alternate methods are used to seal the tubing at the end of collection.

2.4.     Temporarily clamp donor tubing.

2.5.     Suspend the collection bag as far as possible below the donor's arm.

2.6.     Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy according to institutional standard operating procedures. If blood pressure cuff is used, inflate to approximately 60 mmHg.

2.7.     Remove the needle cover and perform phlebotomy.

    2.7.1.   :   Do not touch the needle after removing the needle cover.

2.8.     Remove the temporary clamp on the donor tubing to permit blood flow into the collection bag.

2.9.    Secure donor tubing to donor's arm.

2.10. Mix blood with anticoagulant in the collection bag and continue to mix at several intervals during collection and immediately after collection. If using an automated mixer, follow manufacturer's instructions.

2.11.   Collect labeled volume of blood 250 mL ±10%.

2.12. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in Step 2.3. Temporarily clamp between the knot and needle. Sever donor tubing between knot and clamp. Alternate methods may be used to seal tubing. Collect blood samples using careful attention to aseptic technique and following your institution's standard operating procedures.

2.12.1. : Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.

2.13. Reapply clamp to donor tubing; release pressure on donor's arm and remove needle. If using a needle safety device, follow manufacturer's instructions.

2.13.1. : Discard phlebotomy needle/donor tubing according to institutional standard operating procedures.

2.14.   Immediately after collection, invert collection bag several times to assure blood and anticoagulant are well mixed.

2.15. Strip blood from donor tubing into collection bag, mix well, and allow tubing to refill; repeat once. To prevent the blood from clotting in the tubing, work quickly as possible. Make an appropriate number of segments of anticoagulated blood for testing by sealing on or near the X marks. Leave segments attached to Whole Blood unit.

2.16.   Store CPDA-1 Whole Blood (or Red Blood Cells) between 1 – 6 ° C for up to 35 days.

2.17.   For further preparation and processing of other components, use standard processing and storage techniques following approved regulations and standards.

    2.17.1.   : Production of Platelets and Plasma is not intended with this product.

What interacts with TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)?

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What are the warnings of TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)?

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What are the precautions of TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)?

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What are the side effects of TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)?

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What should I look out for while using TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)?

What might happen if I take too much TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)?

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How should I store and handle TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)?

Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Protect from light. Keep bottles tightly closed to protect from moisture.16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC. 16. HOW SUPPLIED/STORAGE AND HANDLING16.1. Single use only.16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product.16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F).16.5. Avoid excessive heat and direct sunlight. Protect from freezing.16.6. To open blister package, peel cover film back 4/5 of its length.16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions.16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging.16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.16.10. Dispose of the AGELESS packet with the blister tray.16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.16.12. The Single blood bag set, Code ＊, is supplied 90/case.MANUFACTURED BY: 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN（R）: Registered Trademark ©TERUMO CORPORATION December, 2015AGELESS is a registered trademark of MITSUBISHI GAS CHEMICAL CO., INC.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology

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5.   WARNINGS AND PRECAUTIONS

5.1. Rx ONLY.

5.2. Do not use unless solutions are clear and free from particulates.

5.3.   Always inspect the blood bag set for leaks before use.

5.4.   Avoid excessive heat and direct sunlight. Protect from freezing.

5.5.   Recommended storage conditions: Room Temperature (15-30°C/59-86°F).

5.6.   It is normal to have condensation in the blister packaging. If the amount of moisture is greater than expected, check for leaks from the fluid-filled components of the blood bag set.

5.7.   Use aseptic techniques.

5.8. Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.

5.9.   Do not touch needle after removing the needle cover.

5.10. Discard phlebotomy needle/donor tubing according to institutional standard operating procedures.

5.11. The AGELESS® (oxygen absorber packet, Mitsubishi Gas Chemical) contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.

5.12. Dispose of the AGELESS packet with the blister tray.

5.13. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials.

5.14. Due to possible exposure to infectious agents in the handling of blood, take adequate precautions at all times to prevent exposure to and transmission of such agents. Follow your institution's standard operating procedures.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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