CALCIUM GLUCONATE injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

CALCIUM GLUCONATE MONOHYDRATE (UNII: CZN0MI5R31) (CALCIUM CATION - UNII:2M83C4R6ZB)

Disponibil de la:

Medical Purchasing Solutions, LLC

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Calcium Gluconate Injection is 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. Calcium Gluconate Injection is contraindicated in: - Hypercalcemia - Neonates (28 days of age or younger) receiving ceftriaxone [see Warnings and Precautions ( 5.2)] Risk summary Limited available data with Calcium Gluconate Injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see Clinical Considerations] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recogniz

Rezumat produs:

Calcium Gluconate Injection 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.

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

CALCIUM GLUCONATE- CALCIUM GLUCONATE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCIUM GLUCONATE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CALCIUM GLUCONATE
INJECTION.
CALCIUM GLUCONATE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1941
INDICATIONS AND USAGE
Calcium Gluconate Injection is a form of calcium indicated for
pediatric and adult patients for the
treatment of acute symptomatic hypocalcemia. ( 1)
Limitations of Use: The safety of Calcium Gluconate Injection for long
term use has not been
established. ( 1)
DOSAGE AND ADMINISTRATION
Contains 100 mg of calcium gluconate per mL which contains 9.3 mg
(0.465 mEq) of elemental calcium
( 2.1)
Administer intravenously (bolus or continuous infusion) via a secure
intravenous line ( 2.1)
See Full Prescribing Information (FPI) for dilution instructions,
administration rates, and appropriate
monitoring ( 2.1)
Individualize the dose within the recommended range in adults and
pediatric patients depending on the
severity of symptoms of hypocalcemia, the serum calcium level, and the
acuity of onset of
hypocalcemia. See Table 1 in the FPI for dosing recommendations in mg
of calcium gluconate for
neonates, pediatric and adult patients. ( 2.2)
Measure serum calcium during intermittent infusions every 4 to 6 hours
and during continuous infusion
every 1 to 4 hours. ( 2.3)
Calcium Gluconate Injection is not physically compatible with fluids
containing phosphate or
bicarbonate. Precipitation may result if mixed. See FPI for all drug
incompatibilities. (2.5)
Supplied in a single-dose vial or pharmacy bulk package (PBP). For
PBP, dispense single doses to many
patients in a pharmacy admixture program; use within 4 hours of
puncture ( 2.6)
DOSAGE FORMS AND STRENGTHS
Injection: ( 3)
Single-dose vial: 1,000 mg per 10 mL (100 mg per mL)
Single-dose vial: 5,000 mg per 50 mL (100 mg per mL)
Pharmacy bulk package: 10,000 mg per