Label: DEXTROSE 5% injection, solution
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NDC Code(s):
85268-803-02,
85268-803-03,
85268-803-04,
85268-803-05, view more85268-803-06, 85268-803-07, 85268-803-08, 85268-803-09, 85268-803-10, 85268-803-11
- Packager: Huaren Pharmaceutical Co., Ltd.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 24, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- GLUCOSE (Dextrose) INJECTION, USP BAG
- INGREDIENTS
- CHARACTER
- INDICATIONS
- SPECIFICATION
- USAGE AND DOSAGE
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ADVERSE REACTIONS
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.
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PRECAUTIONS
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
- MEDICATION IN CHILDREN
- MEDICATION IN THE ELDERLY
- DRUG INTERACTIONS
- DRUG OVERDOSE
- PHARMACOLOGY AND TOXICOLOGY
- PHARMACOKINETICS
- STORAGE
- VALIDITY
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PACKAGE
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.
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OTHER INFORMATION
【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 pg.2
- HEALTH CARE PROVIDER LETTER pg.3
- PACKAGE LABEL– Dextrose 5% 50 mL Bag Label
- PACKAGE LABEL– Dextrose 5% 100 mL Bag Label
- PACKAGE LABEL-Dextrose 5% 500 mL Bag Label
- PACKAGE LABEL-Dextrose 5% 250 mL Bag Label
- PACKAGE LABEL-Dextrose 5% 1000 mL Bag Label
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INGREDIENTS AND APPEARANCE
DEXTROSE 5%
dextrose 5% injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:85268-803 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) ANHYDROUS DEXTROSE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:85268-803-03 60 in 1 CASE 03/07/2025 1 NDC:85268-803-02 50 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC:85268-803-05 50 in 1 CASE 03/07/2025 2 NDC:85268-803-04 100 mL in 1 BAG; Type 0: Not a Combination Product 3 NDC:85268-803-07 30 in 1 CASE 03/07/2025 3 NDC:85268-803-06 250 mL in 1 BAG; Type 0: Not a Combination Product 4 NDC:85268-803-09 20 in 1 CASE 03/07/2025 4 NDC:85268-803-08 500 mL in 1 BAG; Type 0: Not a Combination Product 5 NDC:85268-803-11 10 in 1 CASE 03/07/2025 5 NDC:85268-803-10 1000 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/07/2025 Labeler - Huaren Pharmaceutical Co., Ltd. (547602854)








