DEXTROSE AND SODIUM CHLORIDE- dextrose monohydrate, sodium chloride injection, solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)

Dostupné s:

Fresenius Kabi USA, LLC

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

2.5% Dextrose and 0.45% Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. 2.5% Dextrose and 0.45% Sodium Chloride Injection is contraindicated in patients with: - known hypersensitivity to dextrose and/or sodium chloride [see Warnings and Precautions 5.1)] - clinically significant hyperglycemia [see Warnings and Precautions (5.2)] Risk Summary Appropriate administration of 2.5% Dextrose and 0.45% Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with 2.5% Dextrose and 0.45% Sodium Chloride Injection. The estimated background risk of major birth defects and miscarriage for the indicated population 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

Přehled produktů:

2.5% Dextrose and 0.45% Sodium Chloride is a clear solution in 1000 mL single-dose, flexible containers available as follows: Storage: Avoid excessive heat. Store at 20° to 25°C (68° to 77°F) [ see USP Controlled Room Temperature]; brief exposure up to 40°C/104°F does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

DEXTROSE AND SODIUM CHLORIDE- DEXTROSE MONOHYDRATE, SODIUM
CHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXTROSE AND SODIUM
CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR DEXTROSE
AND SODIUM CHLORIDE INJECTION.
DEXTROSE AND SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1970
RECENT MAJOR CHANGES
Contraindications (4)
08/2019
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7)
08/2019
INDICATIONS AND USAGE
2.5% Dextrose and 0.45% Sodium Chloride Injection is indicated as a
source of water, electrolytes and
calories. (1)
DOSAGE AND ADMINISTRATION
Only for intravenous infusion. (2.1)
See full prescribing information for information on preparation,
administration, dosing considerations
and instructions for use. (2.1, 2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
2.5% Dextrose and 0.45% Sodium Chloride Injection is a clear solution
in 1000 mL single dose, flexible
containers. (3)
CONTRAINDICATIONS
Known hypersensitivity to dextrose, or sodium chloride (4, 5.1)
Clinically significant hyperglycemia (4, 5.2)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Monitor for signs and symptoms and
discontinue infusion if reactions occur.
(5.1)
Hyperglycemia or Hyperosmolar Hyper glycemic State: Monitor blood
glucose and administer insulin as
needed. (5.2, 8.4)
Hyponatremia, Hypokalemia, Hypernatremia and Hyperchloremia: Avoid in
patients with or at risk for
hypo-/hypernatremia and hypokalemia. If use cannot be avoided, monitor
serum sodium and
potassium concentrations. (5.3, 5.4, 5.5, 8.4)
Fluid Overload: Avoid in patients with or at risk for fluid and/or
solute overloading. If use cannot be
avoided, monitor daily fluid balance and electrolyte, concentrations
and acid-base balance, as needed
and especially during prolonged use. (5.6)
Refeeding Syndrome: Monitor severely undernourished patients and
slowly increase nutrient intake.
(5.7)
ADVERSE REAC