Calcium Gluconate (Page 3 of 3)
NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of Calcium Gluconate Injection. Calcium gluconate was not mutagenic with or without metabolic activation in the Ames test with Salmonella typhimurium (strains TA-1535, TA-1537, and TA-1538) or Saccharomyces cerevisiae (Strain D4). Fertility studies in animals have not been conducted with calcium gluconate administered by the intravenous route.
HOW SUPPLIED/STORAGE AND HANDLING
Calcium Gluconate Injection, USP is a clear, colorless to slightly yellow solution supplied as follows:
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze.
Preservative Free. Discard any unused portion in the single-dose vial immediately or the Pharmacy Bulk Package vial within 4 hours after initial closure puncture.
Each dose dispensed from the Pharmacy Bulk Package vial must be used immediately.
The diluted solution must be used immediately.
NOTE: Supersaturated solutions are prone to precipitation. The precipitate, if present, may be dissolved by warming the vial to 60° to 80°C, with occasional agitation, until the solution becomes clear. Shake vigorously. Allow to cool to room temperature before dispensing. Use injection only if clear immediately prior to use.
From Original Manufacturer/Distributor’s NDC and Unit of Sale | To Henry Schein Repackaged Product NDC and Unit of Sale | Total Strength/Total Volume (Concentration) per unit |
NDC 63323-360-19 25 x 10 mL single dose vials | NDC 0404-9831-10 1 10 mL single dose vial in a bag (Vial bears NDC 63323-360-01) | 1,000 mg calcium gluconate per 10 mL (100 mg per mL) |
NDC 63323-360-59 25 x 50 mL single dose vials | NDC 0404-9831-50 1 50 mL single dose vial in a bag (Vial bears NDC 63323-360-03) | 5,000 mg calcium gluconate per 50 mL (100 mg per mL) |
PATIENT COUNSELING INFORMATION
- Advise the patient that the risks associated with infusion including local tissue inflammation, local necrosis and calcinosis. [see Warnings and Precautions ( 5.3)] .
Lake Zurich, IL 60047
www.fresenius-kabi.com/us
451463B
Revised: July 2018
Sample Package Label
CALCIUM GLUCONATE calcium gluconate injection, solution | |||||||||||||||||||||||||
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Labeler — Henry Schein, Inc. (012430880) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Henry Schein, Inc. | 830995189 | relabel (0404-9831) |
Revised: 10/2023 Henry Schein, Inc.
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