Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)
Gland Pharma Limited
INTRAVENOUS
PRESCRIPTION DRUG
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
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) .
Abbreviated New Drug Application
ZINC SULFATE - ZINC SULFATE INJECTION, SOLUTION GLAND PHARMA LIMITED ---------- 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 Les hele dokumentet