Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D) (Page 2 of 2)

IV. Warnings and Cautions

Contraindications:
None known


Precautions for use:
• Solutions are NOT INTENDED FOR DIRECT INFUSION.
• Do not use if particulate matter is present or if the solution is cloudy
Note: Some opacity of the plastic container due to moisture absorbance by
the PVC during the sterilization process may be observed. This is normal and
does not affect the quality or the safety of the product. This white, hazy
appearance will diminish gradually over time. This advice only applies to the
plastic container. Do not use if the solution itself is cloudy or contains
particulate matter.
•Do not use if the container is damaged, leaking or if there is any visible sign
of deterioration.
Note: The over wrap serves as a moisture barrier. Upon removing the
solution bag, small droplets of condensation may be present in the
packaging. This is considered normal. After removing the over wrap gently
squeeze the inner bag which protects the sterility of the solution. Discard if
any leaks are observed or if an excessive amount of solution is noted within
the over wrap.
• Do not reuse solution. Discard any unused or partially used solutions.
• Protect from sharp objects.
• Verify that solutions have been appropriately connected to avoid leaks.
• The set should be loaded and primed for use within 8 hours of the start of the collection.
• Carry out the apheresis procedure in accordance with the detailed
instructions of the manufacturer of the apheresis device.

Adverse Reactions:

Donors being reinfused with citrated blood or blood components may experience
side effects due to the presence of citrate. Patients being transfused with the blood
components could also experience a reaction to the citrated blood components.
The major symptom experienced by donors is paraesthesia. Should this occur the
reinfusion should be stopped or the reinfusion rate decreased. In the event of
inadvertent bolus of the product administer calcium gluconate.

Drug Abuse / Dependence:

Both solutions are intended to be used only with automated apheresis devices for
collecting human blood and blood components. CP2D is used as an anticoagulant
solution and AS-3 is intended for use a nutrient solution. Neither solution is
intended for direct infusion; neither solution produces a pharmacological effect.

Overdosage:

Both solutions are intended to be used only with automated apheresis devices for
collecting human blood and blood components. CP2D is used as an anticoagulant
solution and AS-3 is intended for use a nutrient solution. Neither solution is
intended for direct infusion.

How Supplied:

250mL CP2D Anticoagulant Solution is supplied in flexible PVC containers with a
sterile, non-pyrogenic fluid path.
250mL and 300mL AS-3 Nutrient Solution is supplied in flexible PVC containers with
a sterile, non-pyrogenic fluid path.

Storage and Handling:

Room temperature (25°C/77°F). Avoid excessive heat. Protect from freezing.

113692-00(AB)

Package Label

HAEMONETICS®
ANTICOAGULANT CITRATE PHOSPHATE
DOUBLE DEXTROSE SOLUTION
(CP2D)


Intended for use only with automated red cell apheresis devices to collect
red blood cells and plasma (FFP and PF24). See the appropriate Operator’s
manual for additional information and complete usage instructions.


Each 100 mL contains:
Citric Acid (Monohydrate), USP 0.327 g
Sodium Citrate (Dihydrate), USP 2.630 g
Monobasic Sodium Phosphate (Monohydrate), USP 0.222 g
Dextrose (Anhydrous), USP 4.640 g


CAUTION: Not for direct intravenous infusion.
The pouch is a moisture barrier.
Do not use unless solution is clear and no leaks detected.
Single use container. Discard unused portion.
Sterile, nonpyrogenic fluid path.
Rx Only


RECOMENDED STORAGE: Room Temperature (25°C / 77°F)
Avoid excessive heat. Protect from freezing.


L065 DA Product code 455A
Haemonetics Corporation Lot No. Braintree, MA 02184 USA Exp Date

Product Label — Package

Label
(click image for full-size original)

HAEMONETICS ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D) citric acid monohydrate, trisodium citrate dihydrate, sodium phosphate, monobasic, monohydrate, anhydrous dextrose solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57826-455
Route of Administration EXTRACORPOREAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITRIC ACID MONOHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 32.7 mg in 1 mL
TRISODIUM CITRATE DIHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 263 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (PHOSPHATE ION) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 22.2 mg in 1 mL
ANHYDROUS DEXTROSE (ANHYDROUS DEXTROSE) ANHYDROUS DEXTROSE 464 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57826-455-02 250 mL in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA BN000127 01/10/2013
Labeler — Haemonetics Corporation (057827420)
Establishment
Name Address ID/FEI Operations
Haemonetics Manufacturing Inc. 078598396 manufacture (57826-455)
Establishment
Name Address ID/FEI Operations
Haemonetics Corporation 942344649 manufacture (57826-455)

Revised: 09/2020 Haemonetics Corporation

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