DEXTROSE injection, solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Hospira, Inc.

INN (আন্তর্জাতিক নাম):

DEXTROSE MONOHYDRATE

রচনা:

DEXTROSE MONOHYDRATE 70 g in 100 mL

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. The use of Dextrose Injection is contraindicated in patients: Risk Summary There are no data with Dextrose Injection in pregnant women. In addition, animal reproduction studies have not been conducted with dextrose. 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 Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Consider parenteral nutrition in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, including preterm delivery, low birth weight, intrauterine growth

পণ্য সারাংশ:

Dextrose Injection, 20%, 30%, 40%, 50%, and 70% USP are sterile hypertonic solutions of dextrose supplied in single-dose, partial-fill flexible containers (see Tables 1 and 2) for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)] . Do not remove container from the overwrap until intended for use. Strength Fill Volume NDC# 20% (0.2 grams/mL) 500 mL 0409-7935-19 30% (0.3 grams/mL) 500 mL 0409-8004-15 40% (0.4 grams/mL) 500 mL 0409-7937-19 50% (0.5 grams/mL) 500 mL 0409-7936-19 1000 mL 0409-7936-29 70% (0.7 grams/mL) 500 mL 0409-7918-19 Use the product immediately after mixing and the introduction of additives. Store between 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Do not freeze.

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

DEXTROSE- DEXTROSE INJECTION, SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXTROSE INJECTION 20%, 30%, 40%,
50% AND 70% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR DEXTROSE INJECTION 20%, 30%,
40%, 50% AND 70%.
DEXTROSE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1940
INDICATIONS AND USAGE
Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids
or other compatible intravenous fluids, is
indicated as a source of calories for patients requiring parenteral
nutrition when oral or enteral nutrition is not possible,
insufficient or contraindicated (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: Single-dose, partial-fill, flexible containers with (3):
500 mL fill volume in 1000 mL flexible container:
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1000 mL fill volume in 2000 mL flexible container:
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Must be diluted with compatible intravenous fluids or used as
admixture, prior to administration. NOT FOR DIRECT
INTRAVENOUS INFUSION. (2.1)
Only for slow intravenous infusion only into a: (2.1)
o
o
Central vein, if final dextrose concentration is greater than 5% or
osmolality is greater than 900 mOsm/L
Peripheral vein, if final dextrose concentration 5% or less and
osmolality is less than 900 mOsm/L
Individualize dosage based on the patient's clinical condition, body
weight, nutritional/fluid requirements, as well as
additional energy given orally/enterally (2.2)
Discontinue infusion of concentrated dextrose solutions slowly and/or
administer 5% dextrose (2.3)
20% (0.2 grams/mL): 20 grams of dextrose hydrous per 100 mL
30% (0.3 grams/mL): 30 grams of dextrose hydrous per 100 mL
40% (0.4 grams/mL): 40 grams of dextrose hydrous per 100 mL
50% (0.5 grams/mL): 50 grams of dextrose hydrous per 100 mL
70% (0.7 grams/mL): 70 grams of dextrose hydrous per 100 mL
50% (0.5 grams/mL): 50 grams of dextrose hydrous p