TRICITRASOL (TRISODIUM CITRATE DIHYDRATE) SOLUTION [CITRA LABS LLC]

TRICITRASOL (TRISODIUM CITRATE DIHYDRATE) SOLUTION [CITRA LABS LLC]
PDF | XML

NDC 23731-6030-1, 23731-6030-2, 23731-6030-3
Set ID 64e7652c-1437-43bd-8ea2-3cafab447b8c
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Citra Labs LLC
Generic Name
Product Class Anti-coagulant
Product Number
Application Number BN010409
  • SPL UNCLASSIFIED SECTION

    ANTICOAGULANT SODIUM CITRATE CONCENTRATE – 46.7% Trisodium Citrate
    PN 6030, 30 mL
    NDC 23731-6030-3

  • DESCRIPTION

    triCitrasol® Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is a sterile, non-pyrogenic solution of Trisodium Citrate (Dihydrate), USP.

    Each 30 mL of concentrate contains:

    Trisodium Citrate, dihydrate, USP14.0 grams
    Water for Injection, USPq.s.

    pH adjusted with Citric Acid

    pH: 6.3 – 6.6

    Chemical StructureSingle patient use only, on a single occasion.

  • CLINICAL PHARMACOLOGY

    A sodium citrate solution acts as an anticoagulant by the action of the citrate ion chelating free ionized calcium; thus, the calcium ion is unavailable to the coagulation system 1.

  • INDICATIONS AND USAGE

    triCitrasol® Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is an anticoagulant used in granulocytapheresis procedures (granulocyte collection by apheresis). Just prior to performing granulocytapheresis, aseptically add 30 mL of triCitrasol® to 500 mL of the 6% solution of Hydroxyethyl Starch (HES), e.g. Hespan ® 2-8. Agitate the resultant solution for 1 minute to assure a uniform concentration of anticoagulant. The resultant solution of triCitrasol® and 6% solution of HES contains the following concentration depending upon the volume used:

    Volume of triCitrasol®Volume of HESTotal VolumeFinal Concentration of triCitrasol®
    30 mL500 mL (measured from HES bag)530 mL2.6%
    30 mL558 mL (injected directly into HES bag)588 mL2.4%

    The triCitrasol®/HES solution is stable for up to 24 hours at room temperature after mixing.

    Refer to the manufacturer's Operator's Manual of the apheresis medical device for the directions to perform the granulocytapheresis procedure.

  • CONTRAINDICATIONS

    NOT FOR DIRECT INTRAVENOUS INFUSION.

  • WARNINGS

    CONCENTRATED ANTICOAGULANT – DILUTE PRIOR TO USE.

  • PRECAUTIONS

    General

    Aseptic technique must be maintained at all times.

    triCitrasol® Anticoagulant Sodium Citrate Concentrate is a clear/colorless solution. If the product shows any cloudiness or turbidity, the concentrate should be discarded.

    The cap/stopper system provides a biological barrier and should be intact – discard product if system is comprised.

    Information for Patients

    None.

    Laboratory Tests

    There are no laboratory tests for the drug product at this time.

    Drug Interactions

    There are no adverse reactions for the addition of the product to the rouleaux agent.

    Carcinogenesis, mutagenesis, impairment of fertility

    Long-term studies in animals have not been performed to evaluate the carcinogenic potential of triCitrasol®.

    Pregnancy

    Long-term studies in animals have not been performed to evaluate the effects of triCitrasol® on pregnant women.

    Pediatric Use

    The safety and effectiveness of triCitrasol® in children have not been established.

  • ADVERSE REACTIONS

    Citrate reactions or toxicity may occur with the infusion of blood products containing citrate anticoagulant 1. 9 11. The recipient of the citrated blood product should be monitored for the signs and symptoms of citrate toxicity 1. 9 11. The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by chills, stomach cramps, or pressure in the chest, followed by more severe reactions that are characterized by hypotension and possible cardiac arrhythmia 1. 9 11. Citrate toxicity may occur more frequently in patients that are hypothermic 10, have impaired liver or renal function 10, or have low calcium levels because of an underlying disease 9.

  • OVERDOSAGE

    Since the bottle of triCitrasol® contains only 30mL of the product, it is impossible to overdose the addition of the product to the 6% solution of HES. However, in the event of a reaction to the infusion of citrated blood products, evaluate the patient and institute appropriate corrective actions 1, 9.

  • DOSAGE AND ADMINISTRATION

    The apheresis system will control the amount of the citrate/6% solution of HES that is added to the whole blood and the method of administration of the solution. Refer to the Operator's Manual of the apheresis medical device.

  • HOW SUPPLIED

    triCitrasol® Anticoagulant Sodium Citrate Concentrate 46.7% Trisodium Citrate

    REFSIZECASE
    PN 6030-2530 mL Vial25 Vials/Case
    PN 6030-1030 mL Vial10 Vials/Case

    It is recommended that the product be stored at ambient room temperature, 24°C (75°F); however, the product can be stored between 15°C (59°F) and 30°C (86°F). Protect from freezing and exposure to excessive heat should be minimized.

  • SPL UNCLASSIFIED SECTION

    Rx ONLY

    triCitrasol® is a registered trademark of Citra Labs, LLC, Braintree, MA.

    Hespan ® is a registered trademark of B. Braun Medical, Inc., Irvine, CA.

  • REFERENCES

    1. Grindon, A. J., "Adverse Reactions to Whole Blood Donation and Plasmapheresis", CRC Crit. Rev Clin. Lab. Sci., 17:51-75, 1982.
    2. Rock, G., and McCombie, N., "Alternate Dosage Regimens for High-Molecular-Weight Hydroxyethyl Starch", Transfusion, 25:417-419, 1985.
    3. Strauss, R. G., Hester, J. P., Vogler, W.R., Higby, D. J., Snikeris, A. C., Imig, K. M., Greazel, C., Mallard, G., Burnett, D., Gupta, S., and Hulse, J.D., "A Multicenter Trial to Document the Efficacy and Safety of a Rapidly Excreted Analog of Hydroxyethyl Starch for Leukapheresis with a Note on Steroid Stimulation of Granulocyte Donors", Transfusion, 26:258-264, 1986.
    4. Strauss, R.G., Rohret, P.A., Randels, M. J., and Wihegarden, D. C., "Granulocyte Collection", J. of Clin. Apheresis, 6:241-243, 1991.
    5. Lee, J.H., and Klein, H. G., "The Effect of Donor Red Cell Sedimentation Rate on Efficiency of Granulocyte Collection by Centrifugal Leukapheresis", Transfusion, 35:384-388, 1995.
    6. Adkins, D., Ali., S. Despotis, G., Dynis, M. and Goodnough, L. T., "Granulocyte Collection Efficiency and Yield are Enhanced by the Use of a Higher Interface Offset During Apheresis of Donors Given Granulocyte-Colony-Stimulating Factor", Transfusion, 38:557-564, 1998.
    7. Jendiroba, D. B., Lichtiger, B., Anaissie, E., Reddy, V., O'Brien, S., Kantarjian, H., and Freireich, E. J., "Evaluation and Comparison of Three Mobilization Methods for the Collection of Granulocytes". Transfusion, 38:722-728, 1998.
    8. Leavey P. J., Thurman, G., and Anbruso, D. R., "Functional Characteristics of Neutrophils Collected and Stored After Administration of G-CSF", Transfusion. 40:414-419, 2000.
    9. AABB Technical Manual, 14 th Edition, page 590, 2001.
    10. Denlinger, J.V., Nahrwold, M. L., Gibbs, P.S., and Lecky, J.H., "Hypocalcemia During Rapid Blood Transfusion in Anaesthetized Man", Br. J. Anaesth., 48-995-1000, 1976.
    11. Stack, G., Judge, J.V., and Snyder, E.L., "Febrile and Nonimmune Transfusion Reactions", in Principles of Transfusion Medicine, pp. 780-781, editors Rossi, E.C., Simon, T.L., Moss, G.S., and Gould, S.A., Williams & Wilkins, Baltimore, MD, 2 nd ed., 1996.
  • SPL UNCLASSIFIED SECTION

    Manufactured & Distributed by: Citra Labs, LLC, 55 Messina Drive, Braintree, MA 02184 • 1-800-299-3411 or 1-781-848-2174 Fax: 1-781-848-6781

    FL6030 04/13
    Printed in USA

  • PRINCIPAL DISPLAY PANEL - 10 Vial Case Label

    triCitrasol®

    ANTICOAGULANT SODIUM CITRATE CONCENTRATE
    46.7% Trisodium Citrate
    PN 6030 - 30 mL
    WARNING: CONCENTRATED ANTICOAGULANT
    Dilute prior to use
    NOT FOR DIRECT INTRAVENOUS INFUSION

    THIS CARTON CONTAINS
    10 Sterile Units - 30 mL each

    Used with 6% Hydroxyethyl Starch 500 mL (diluent) for the Collection of
    Granulocytes by Apheresis. Do not use for other anticoagulant purposes.
    See package insert for directions for use.

    Manufactured & Distributed by:
    Citra Labs™
    55 Messina Drive, Braintree, MA 02184 • USA
    Phone Number: 1-800-299-3411
    Fax Number: 781-848-6781

    Sterile ■ Non-Pyrogenic

    Composition per 30 mL of Concentrate:
    Trisodium Citrate (Dihydrate), USP      14.0 g
    (pH adjusted with Citric Acid)

    CAUTION: Single Procedure Use - Discard Unused Portion
    Do Not Use Unless Solution is Clear and Seal is intact
    Store Between 15°C - 30° C (59° F - 86° F)

    Rx only

    Exp:

    Lot:

    LA6030-10B 5/15

    PRINCIPAL DISPLAY PANEL - 10 Vial Case Label
  • INGREDIENTS AND APPEARANCE
    TRICITRASOL 
    trisodium citrate dihydrate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:23731-6030
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID14 g  in 30 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23731-6030-110 in 1 CASE
    1NDC:23731-6030-330 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:23731-6030-225 in 1 CASE
    2NDC:23731-6030-330 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN01040907/10/2003
    Labeler - Citra Labs LLC (962863838)
    Establishment
    NameAddressID/FEIBusiness Operations
    Citra Labs, LLC962863838manufacture(23731-6030)