Dextrose 10%

Manufacturer
Huaren Pharmaceutical Co., Ltd.
Effective date
2025-04-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:34:24

Label at a glance#

ProductDextrose 10%
Active ingredientANHYDROUS DEXTROSE
Label structure26 sections

Storage and handling

Sealed storage.

Label contents#

Full prescribing information#

GLUCOSE (Dextrose) INJECTION, USP BAG

SPL UNCLASSIFIED SECTION

Glucose (Dextrose) Injection Instructions

Please read the instructions carefully and use them under the guidance of a physician. Check carefully before use.

Do not use if leakage is found, the drug liquid is unclear, or there are visible particles.

INGREDIENTS

DESCRIPTION SECTION

This product is a sterilized aqueous solution of glucose.

Molecular formula: C6H12O6·H2O

Molecular weight: 198.17

Auxiliary material name: Dilute hydrochloric acid

CHARACTER

SPL UNCLASSIFIED SECTION

This product is colorless or almost colorless clear liquid.

INDICATIONS

INDICATIONS & USAGE SECTION

(1) Energy and fluid supplementation;It is used for underfeeding or massive fluid loss caused by various reasons (such as vomiting, diarrhea, etc.), total intravenous nutrition, and starvation ketosis.

(2) Drug diluents.

SPECIFICATION

DESCRIPTION SECTION

(1)50ml:2.5g(2)50ml:5g(3)100ml:5g(4)100ml:10g(5)250ml:12.5g(6)250ml:25g(7)500ml:25g(8)500ml:50g(9)1000ml:50g(10)1000ml:100g

DOSAGE AND USAGE

DOSAGE & ADMINISTRATION SECTION

Intravenous infusion, dosage according to the need of the disease.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

1.Eating less, long-term simple supply of glucose solution can appear hypokalemia, hyponatremia and other electrolyte disorders. 2.Excessive infusion of this product may cause palpitations, arrhythmia, dyspnea, and even acute left heart failure in patients with cardiac insufficiency.

3.Hypophosphatemia is easy to occur when combined with insulin without paying attention to phosphate supplement.

4.Phlebitis may occur at the injection site.

【Taboos】

1. Uncontrolled diabetic ketoacidosis;

2. Hyperglycemic nonketotic hyperosmolar state.

PRECAUTIONS

PRECAUTIONS SECTION

1. Periodic paralysis, hypokalemia patients should be used with caution;

2. Stress or glucocorticoid induced hyperglycemia should be used with caution; Patients with edema, cardiac and renal insufficiency and liver cirrhosis ascites are prone to water retention, and the infusion volume should be controlled. Drip velocity should be controlled especially in patients with cardiac insufficiency.

3. Should be carefully checked before use, such as found leakage, solution turbidity, foreign bodies, etc., discarded.

4. Should be used in sterile conditions.

MEDICATION IN PREGNANT WOMEN AND LACTATING WOMEN

PREGNANCY SECTION

Too much glucose injection during delivery may stimulate fetal insulin secretion, resulting in postpartum infant hypoglycemia.

MEDICATION IN CHILDREN

PEDIATRIC USE SECTION

Too fast and too much fluid infusion may cause palpitation, arrhythmia and even acute left heart failure.

MEDICATION IN THE ELDERLY

GERIATRIC USE SECTION

Too fast and too much fluid infusion may cause palpitation, arrhythmia and even acute left heart failure.

DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

The experiment was not performed and no reliable reference was available.

DRUG OVERDOSE

OVERDOSAGE SECTION

The experiment was not performed and no reliable reference was available.

PHARMACOLOGY AND TOXICOLOGY

CLINICAL PHARMACOLOGY SECTION

Glucose is an important nutrient component of the human body. Every 1 gram of glucose can produce 4 kilocalories of heat energy, so it is used to supplement heat.

PHARMACOKINETICS

PHARMACOKINETICS SECTION

It can be converted into glycogen and fat for storage. The ability of a normal human body to utilize glucose is 6mg/kg per minute.

PACKAGE

HOW SUPPLIED SECTION

1. Plastic infusion bag (non-PVC co-extrusion film, double hard pipe, easy to break apart, double valve and double plug). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 1000ml/ bag.

2. Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to break apart, double valve double plug, double layer sterile packaging). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 1000ml/ bag.

VALIDITY

SPL UNCLASSIFIED SECTION

(1) The validity period of 250ml and 500ml products is 36 months.

(2) The validity period of 50ml, 100ml and 1000ml products is 24 months.

STORAGE

STORAGE AND HANDLING SECTION

Sealed storage.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

【Executive standard】

Pharmacopoeia of the People's Republic of China (2020, Volume II)

【Pharmaceutical marketing authorization holder】

Name: Huaren Pharmaceutical Co., Ltd.

Registered Address: No. 187, Zhuzhou Road, Qingdao High-tech Park

【Manufacturer】

Enterprise Name: Huaren Pharmaceutical Co., Ltd.

Production Address:

No. 187, Zhuzhou Road, Qingdao High-tech Park

Zip code: 266101

Telephone number: 0532-67709071 0532-67709728

Fax number: 0532-88702625

HEALTH CARE PROVIDER LETTER pg.1

HEALTH CARE PROVIDER LETTER SECTION

HEALTH CARE PROVIDER LETTER pg.1HEALTH CARE PROVIDER LETTER pg.1

HEALTH CARE PROVIDER LETTER pg.2

HEALTH CARE PROVIDER LETTER SECTION

HEALTH CARE PROVIDER LETTER pg.2HEALTH CARE PROVIDER LETTER pg.2

HEALTH CARE PROVIDER LETTER pg.3

HEALTH CARE PROVIDER LETTER SECTION

HEALTH CARE PROVIDER LETTER pg.3HEALTH CARE PROVIDER LETTER pg.3

PACKAGE LABEL-Dextrose 10% 50 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dextrose 10% 50 mL Bag LabelDextrose 10% 50 mL Bag Label

PACKAGE LABEL-Dextrose 10% 100 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dextrose 10% 100 mL Bag LabelDextrose 10% 100 mL Bag Label

PACKAGE LABEL-Dextrose 10% 250 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dextrose 10% 250 mL Bag LabelDextrose 10% 250 mL Bag Label

PACKAGE LABEL-Dextrose 10% 500 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dextrose 10% 500 mL Bag LabelDextrose 10% 500 mL Bag Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

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NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ANHYDROUS DEXTROSE5SL0G7R0OKACTIB

Source Document#

Source XML

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
430669d7-9acf-9a04-e063-6394a90ababb338bdfb4-76ae-d2c3-e063-6394a90a0bcc2025-11-07Adverse reactionsExact identifier
spl set id: 338bdfb4-76ae-d2c3-e063-6394a90a0bcc

Reported adverse events (FAERS/openFDA)#

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