タイトルまたは説明

Product Name: Dextrose Injection 5% ,Glucose Injection 5%,Dextrose infusion 5%,Glucose infusion 5%

Product  Description  :A clear, colourless or almost colourless liquid,taste sweet.

Strength:5g/**0ml,*2.5g/**0ml,*5g/**0ml

INN or Generic Name:Hydrous Dextrose
Pharmaceutical Dosage Form:  injection

Port:Any port (depends on requests)       Certificate:GMP
Exporting Region:Areas which GMP is applicable

Therapeutic indications
Intravenous solutions containing Dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.

Posology and method of administration

The dose is dependent upon the age, weight and clinical condition of the patient.

As reported in the literature, the dosage and constant infusion rate of intravenous Dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

Contraindications:

5% Dextrose Injection, USP without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

Special warning and precautions for use:

Interaction with other medicinal products and other forms of Interactions

Pregnancy:
Teratogenic effects
Pregnancy Category C. Animal reproduction studies have not been conducted with Dextrose. It is also not known whether Dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
Caution should be exercised when 5% Dextrose Injection, USP is administered to a nursing mother.
Pediatric Use:
The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
Frequent monitoring of serum glucose concentrations is required when Dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.
In very low birth weight infants, excessive or rapid administration of Dextrose injection may result in increased serum osmolarity and possible intracerebral hemorrhage.
Geriatric Use:
An evaluation of current literature revealed no clinical experience identifying differences in response between 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..
Effects on ability to drive and use machine
Not applicable.
Undesirable effects
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Overdose and special antidotes

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.