ZINC SULFATE injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)

थमां उपलब्ध:

Gland Pharma Limited

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Zinc Sulfate Injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Zinc Sulfate Injection is contraindicated in patients with known hypersensitivity to zinc [see Warnings and Precautions (5.6)] . Risk Summary Administration of the approved recommended dose of Zinc Sulfate Injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with intravenous zinc sulfate.  The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Consid

उत्पाद समीक्षा:

Zinc Sulfate Injection, USP is a clear, colorless solution supplied as: Vial closure is not made with natural rubber latex.  Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] .  For storage of admixed solution see Dosage and Administration (2.3) .

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

ZINC SULFATE - ZINC SULFATE INJECTION, SOLUTION
GLAND PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZINC
SULFATE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZINC
SULFATE INJECTION.
ZINC SULFATE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1957
RECENT MAJOR CHANGES
Dosage and Administration
Preparation Instructions for Admixing Using a Parenteral Nutrition
Container (2.3) 10/2020
Recommended Dosage and Monitoring in Adult and Pediatric Patients
(2.5) 10/2020
INDICATIONS AND USAGE
Zinc Sulfate Injection is a trace element indicated in adult and
pediatric patients as a source of zinc for
parenteral nutrition when oral or enteral nutrition is not possible,
insufficient, or contraindicated. (1)
DOSAGE AND ADMINISTRATION
• _Pharmacy Bulk Package. Not for direct intravenous infusion.
(2.1)_
• See full prescribing information for information on preparation,
administration, and general dosing
considerations. (2.1, 2.2, 2.3, 2.4)
Recommended Dosage and Monitoring (2.5)
Zinc Sulfate Injection provides 1 mg/mL, 3 mg/mL, or 5 mg/mL of zinc.
Zinc Sulfate Injection in a concentration of 1 mg/mL is recommended
for use in pediatric patients,
particularly those weighing less than 12 kg.
Individualize the dosage based upon the patient’s clinical
condition, nutritional requirements, and the
contribution of oral or enteral zinc intake.
_Adults:_ The recommended adult dosage is 3 mg/day for metabolically
stable patients, with potential
need for a higher daily dosage in monitored patients with small bowel
fluid loss or excess stool or
ileostomy output.
_Pediatrics:_ The recommended dosage in pediatric patients is shown by
age and estimated weight.
The dosages in the table are general recommendations intended for most
pediatric patients.
However, based on clinical requirements, some patients may require a
higher dosage.
POPULATION
ESTIMATED WEIGHT FOR AGE
RECOMMENDED DAILY DOSAGE
Pediatric Patients
10 kg and abov