NDC # | Total Amount | Fill Volume | Concentration | Container Type | Pack Size | Shelf Life | Package Insert | Barcodes |
---|---|---|---|---|---|---|---|---|
44567-622-24 |
1,000 mg | 100 mL | 10 mg/mL | 100 mL Premix Bag | 24 | 24 months | Bag Carton | |
44567-620-24 | 1,000 mg | 50 mL | 20 mg/mL | 100 mL Premix Bag | 24 | 36 months | Bag Carton | |
44567-621-24 | 2,000 mg | 100 mL | 20 mg/mL | 100 mL Premix Bag | 24 | 36 months | Bag Carton |
INDICATIONS AND USAGE: Calcium Gluconate in Sodium Chloride Injection is a form of calcium indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use: The safety of Calcium Gluconate Injection for long term use has not been established. IMPORTANT SAFETY INFORMATION: Contraindicated in hypercalcemia and in neonates receiving ceftriaxone. Warnings and Precautions: cardiac arrhythmias may occur with concomitant cardiac glycoside use; use caution when administering with ceftriaxone as a precipitate may form in the IV line; tissue necrosis and calcinosis may occur with or without extravasation; hypotension, bradycardia and cardiac arrhythmias may occur with rapid administration; contains aluminum which may cause toxicity. The most common adverse events are local soft tissue inflammation and necrosis; calcinosis cutis and calcification related to extravasation; vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmia, syncope and cardiac arrest. See package insert for complete prescribing information. |
References:
U.S. Patent Numbers: 10, 130, 646 and 10,342,813