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  5. Label Information: Dextrose 10%

FDA Label for Dextrose 10%

View Indications, Usage & Precautions

Table of Contents

    1. GLUCOSE (DEXTROSE) INJECTION, USP BAG
    2. INGREDIENTS
    3. CHARACTER
    4. INDICATIONS
    5. SPECIFICATION
    6. DOSAGE AND USAGE
    7. ADVERSE REACTIONS
    8. PRECAUTIONS
    9. MEDICATION IN PREGNANT WOMEN AND LACTATING WOMEN
    10. MEDICATION IN CHILDREN
    11. MEDICATION IN THE ELDERLY
    12. DRUG INTERACTIONS
    13. DRUG OVERDOSE
    14. PHARMACOLOGY AND TOXICOLOGY
    15. PHARMACOKINETICS
    16. PACKAGE
    17. VALIDITY
    18. STORAGE
    19. OTHER INFORMATION
    20. HEALTH CARE PROVIDER LETTER PG.1
    21. HEALTH CARE PROVIDER LETTER PG.2
    22. HEALTH CARE PROVIDER LETTER PG.3
    23. PACKAGE LABEL-DEXTROSE 10% 50 ML BAG LABEL
    24. PACKAGE LABEL-DEXTROSE 10% 100 ML BAG LABEL
    25. PACKAGE LABEL-DEXTROSE 10% 250 ML BAG LABEL
    26. PACKAGE LABEL-DEXTROSE 10% 500 ML BAG LABEL

Dextrose 10% Product Label

The following document was submitted to the FDA by the labeler of this product Huaren Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Glucose (Dextrose) Injection, Usp Bag



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



This product is a sterilized aqueous solution of glucose.

Molecular formula: C6H12O6·H2O

Molecular weight: 198.17

Auxiliary material name: Dilute hydrochloric acid


Indications



(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



（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



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


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.


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



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


Medication In Children



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


Medication In The Elderly



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


Drug Overdose



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


Pharmacology And Toxicology



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



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



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



(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.


* Please review the disclaimer below.