DEXTROSE- dextrose monohydrate injection, solution, concentrate

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

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Aktivní složka:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)

Dostupné s:

ICU Medical Inc.

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

10% Dextrose Injection is indicated for admixture with amino acids or dilution with other compatible IV fluids to provide a 5% final dextrose concentration for intravenous infusion in patients whose condition requires parenteral nutrition. The use of 10% Dextrose Injection is contraindicated in patients with: - Clinically significant hyperglycemia [see Warnings and Precautions (5.1)] . - Known hypersensitivity to dextrose [see Warnings and Precautions (5.2)] . Risk Summary Appropriate administration of Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with injectable dextrose solutions. 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 to 4% and 15 to 20%, respectively Risk Summary There are no data on the presence of dextrose in human milk, the effects on a breastfed infant, or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Dextrose Injection to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Dextrose Injection and any potential adverse effects on the breastfed infant from Dextrose Injection or from the underlying maternal condition. The safety profile of Dextrose Injection in pediatric patients is similar to adults. Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo-or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects. Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)]. Because of immature renal function, preterm infants receiving prolonged treatment with Dextrose Injection, may be at risk aluminum toxicity [see Warnings and Precautions (5.6)] . Clinical studies of Dextrose Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)] . Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Přehled produktů:

10% Dextrose Injection, USP is supplied in single-dose, 500 mL volume in a 1000 mL partial-fill flexible container. See the following table. ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Stav Autorizace:

New Drug Application

Charakteristika produktu

                                DEXTROSE- DEXTROSE MONOHYDRATE INJECTION, SOLUTION, CONCENTRATE
ICU MEDICAL INC.
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10% DEXTROSE INJECTION, USP
CONCENTRATED DEXTROSE IN WATER
Concentrated source of carbohydrate calories for intravenous infusion.
NOTE: This solution is hypertonic − see _WARNINGS_ and
_PRECAUTIONS_.
Partial-Fill Flexible Plastic Container Rx only
_DESCRIPTION_
10% Dextrose Injection, USP (concentrated dextrose in water) is a
sterile, nonpyrogenic, hypertonic
solution of Dextrose, USP in water for injection for intravenous
administration after appropriate
admixture or dilution.
10% Dextrose Injection, USP is provided as a 500 mL volume in a 1000
mL partial-fill container. The
container is designed to facilitate admixture or dilution.
See table under _HOW SUPPLIED_ for summary of content and
characteristics of this concentrated
solution.
The solution contains no bacteriostat, antimicrobial agent or added
buffer and is intended only for use as
a single-dose injection following admixture or dilution.
The flexible plastic container is fabricated from a specially
formulated polyvinyl chloride. Water can
permeate from inside the container into the overwrap but not in
amounts sufficient to affect the solution
significantly. Solutions in contact with the plastic container may
leach out certain chemical components
from the plastic in very small amounts; however, biological testing
was supportive of the safety of the
plastic container materials. Exposure to temperatures above
25°C/77°F during transport and storage will
lead to minor losses in moisture content. Higher temperatures lead to
greater losses. It is unlikely that
these minor losses will lead to clinically significant changes within
the expiration period.
Dextrose Injection, USP is a parenteral fluid and nutrient
replenisher.
Dextrose Injection, USP is chemically designated D-glucose monohydrate
(C H O • H O), a hexose
sugar freely soluble in water. It has the following structural
formula:
Water for Injection, USP is chemically designated H O.
_CLINICAL PHARMACOLOGY_

                                
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