Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED triCitrasol ® Anticoagulant Sodium Citrate Concentrate 46.7% Trisodium Citrate REF SIZE CASE PN 6030-25 30 mL Vial 25 Vials/Case PN 6030-10 30 mL Vial 10 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.; 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 ™ A Biomet Inc. Company. 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; PRINCIPAL DISPLAY PANEL - 25 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 25 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 ™ A Biomet Inc. Company. 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: LA6030-25B 5/15 PRINCIPAL DISPLAY PANEL - 25 Vial Case Label
- HOW SUPPLIED triCitrasol ® Anticoagulant Sodium Citrate Concentrate 46.7% Trisodium Citrate REF SIZE CASE PN 6030-25 30 mL Vial 25 Vials/Case PN 6030-10 30 mL Vial 10 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.
- 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 ™ A Biomet Inc. Company. 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
- PRINCIPAL DISPLAY PANEL - 25 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 25 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 ™ A Biomet Inc. Company. 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: LA6030-25B 5/15 PRINCIPAL DISPLAY PANEL - 25 Vial Case Label
Overview
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, USP 14.0 grams Water for Injection, USP q.s. pH adjusted with Citric Acid pH: 6.3 – 6.6 Single patient use only, on a single occasion. Chemical Structure
Indications & 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 HES Total Volume Final Concentration of triCitrasol ® 30 mL 500 mL (measured from HES bag) 530 mL 2.6% 30 mL 558 mL (injected directly into HES bag) 588 mL 2.4% 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.
Dosage & 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.
Warnings & Precautions
WARNINGS CONCENTRATED ANTICOAGULANT – DILUTE PRIOR TO USE.
Contraindications
NOT FOR DIRECT INTRAVENOUS INFUSION.
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 .
Drug Interactions
There are no adverse reactions for the addition of the product to the rouleaux agent.
Storage & Handling
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.
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