Balanced Salt SODIUM CHLORIDE POTASSIUM CHLORIDE CALCIUM CHLORIDE MAGNESIUM CHLORIDE SODIUM ACETATE AND SODIUM CITRATE B. BRAUN MEDICAL INC. FDA Approved Balanced Salt Solution Sterile Irrigating Solution is a sterile balanced salt solution in 500 mL single-dose EXCEL ® flexible containers. Each mL contains sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl 2 ·2H 2 O) 0.048%, magnesium chloride hexahydrate (MgCl 2 ·6H 2 O) 0.03%, sodium acetate trihydrate (C 2 H 3 NaO 2 ·3H 2 O) 0.39%, sodium citrate dihydrate (C 6 H 5 Na 3 O 7 ·2H 2 O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.0. The osmolality is approximately 300 mOsm/Kg. The EXCEL ® plastic container is made from a multilayered film. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.
FunFoxMeds bottle
Substance Calcium Chloride
Route
IRRIGATION
Applications
ANDA091387
Package NDC

Drug Facts

Composition & Profile

Strengths
500 ml
Quantities
500 ml
Treats Conditions
Indications And Usage For Use As An Extraocular And Intraocular Irrigating Solution During Ocular Surgical Procedure Involving Perfusion Of The Eye With An Expected Maximum Duration Of Less Than 60 Minutes

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
M4I0D6VV5M 02F3473H9O 660YQ98I10 4550K0SC9B 451W47IQ8X 1Q73Q2JULR
Packaging

HOW SUPPLIED Balanced Salt Solution Sterile Irrigating Solution is supplied in sterile and nonpyrogenic 500 mL single-dose EXCEL ® flexible containers with clear overwrap, 24 per case. Not made with natural rubber latex, PVC or DEHP. NDC REF Size Balanced Salt Solution Sterile Irrigating Solution 0264-1945-10 L2514 500 mL; PRINCIPAL DISPLAY PANEL - 500 mL Label Balanced Salt Solution Sterile Irrigating Solution NOT FOR INTRAVENOUS USE SINGLE USE ONLY REF L2514 NDC 0264-1945-10 500 mL EXCEL® CONTAINER Each mL contains sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl 2 ·2H 2 O) 0.048%, magnesium chloride hexahydrate (MgCl 2 ·6H 2 O) 0.03%, sodium acetate trihydrate (C 2 H 3 NaO 2 · 3H 2 O) 0.39%, sodium citrate dihydrate (C 6 H 5 Na 3 O 7 ·2H 2 O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. pH: approximately 7.0; Osmolality: approximately 300 mOsm/Kg WARNINGS: NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless overwrap is intact, product is clear, seal is intact, and container is undamaged. Do not use if product is discolored or contains a precipitate. Discard unused contents. Do not use this container for more than one patient. See package insert. Storage: Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from freezing. Not made with natural rubber latex, PVC or DEHP. Rx only Y94-003-436 LD-720-1 EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-436 Y94-003-436

Package Descriptions
  • HOW SUPPLIED Balanced Salt Solution Sterile Irrigating Solution is supplied in sterile and nonpyrogenic 500 mL single-dose EXCEL ® flexible containers with clear overwrap, 24 per case. Not made with natural rubber latex, PVC or DEHP. NDC REF Size Balanced Salt Solution Sterile Irrigating Solution 0264-1945-10 L2514 500 mL
  • PRINCIPAL DISPLAY PANEL - 500 mL Label Balanced Salt Solution Sterile Irrigating Solution NOT FOR INTRAVENOUS USE SINGLE USE ONLY REF L2514 NDC 0264-1945-10 500 mL EXCEL® CONTAINER Each mL contains sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl 2 ·2H 2 O) 0.048%, magnesium chloride hexahydrate (MgCl 2 ·6H 2 O) 0.03%, sodium acetate trihydrate (C 2 H 3 NaO 2 · 3H 2 O) 0.39%, sodium citrate dihydrate (C 6 H 5 Na 3 O 7 ·2H 2 O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. pH: approximately 7.0; Osmolality: approximately 300 mOsm/Kg WARNINGS: NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless overwrap is intact, product is clear, seal is intact, and container is undamaged. Do not use if product is discolored or contains a precipitate. Discard unused contents. Do not use this container for more than one patient. See package insert. Storage: Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from freezing. Not made with natural rubber latex, PVC or DEHP. Rx only Y94-003-436 LD-720-1 EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-436 Y94-003-436

Overview

Balanced Salt Solution Sterile Irrigating Solution is a sterile balanced salt solution in 500 mL single-dose EXCEL ® flexible containers. Each mL contains sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl 2 ·2H 2 O) 0.048%, magnesium chloride hexahydrate (MgCl 2 ·6H 2 O) 0.03%, sodium acetate trihydrate (C 2 H 3 NaO 2 ·3H 2 O) 0.39%, sodium citrate dihydrate (C 6 H 5 Na 3 O 7 ·2H 2 O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.0. The osmolality is approximately 300 mOsm/Kg. The EXCEL ® plastic container is made from a multilayered film. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

Indications & Usage

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

Dosage & Administration

The irrigating solution should be used according to standard format for each surgical procedure. Follow directions of the particular administration set to be used. Allow the fluid to flow and remove air from the tubing before irrigation begins.

Warnings & Precautions
WARNINGS NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless overwrap is intact, product is clear, seal is intact, and container is undamaged. Do not use if product is discolored or contains a precipitate. SINGLE patient use only. The contents of this container should not be used in more than one patient. This solution contains no preservative, unused contents should be discarded.
Adverse Reactions

Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy. Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

Storage & Handling

STORAGE Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: August 2021 EXCEL ® is a registered trademark of B. Braun Medical Inc.


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