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:

http://medlibrary.org/lib/images-rx/calcium-gluconate-1/image2.jpg

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.

Product repackaged by: Henry Schein, Inc., Bastian, VA 24314
From Original Manufacturer/Distributor’s NDC and Unit of SaleTo Henry Schein Repackaged Product NDC and Unit of SaleTotal 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

//medlibrary.org/lib/images-rx/calcium-gluconate-1/label1-300x300.jpg
(click image for full-size original)

//medlibrary.org/lib/images-rx/calcium-gluconate-1/label2-300x284.jpg
(click image for full-size original)
CALCIUM GLUCONATE
calcium gluconate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-9831(NDC:63323-360)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM GLUCONATE MONOHYDRATE (CALCIUM CATION) CALCIUM GLUCONATE MONOHYDRATE 98 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CALCIUM SACCHARATE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0404-9831-50 1 VIAL, PLASTIC in 1 BAG contains a VIAL, PLASTIC
1 50 mL in 1 VIAL, PLASTIC This package is contained within the BAG (0404-9831-50)
2 NDC:0404-9831-10 1 VIAL, PLASTIC in 1 BAG contains a VIAL, PLASTIC
2 10 mL in 1 VIAL, PLASTIC This package is contained within the BAG (0404-9831-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208418 01/09/2022
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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