Translation of the instructions can be
GLUCOSE SOLUTION 10% for infusions solution for infusions 10%
Instruction
For medical use of the medicinal product
Glucose solution 10% for infusions
(Solutio glucosi 10% pro injectionibus)
Composition:
Active ingredient: glucose;
100 ml of solution contain 10 g of glucose (calculated as anhydrous glucose);
excipient: water for injections.
Dosage form.
Solution for infusion.
Main physicochemical properties: clear colorless or slightly yellowish liquid; theoretical osmolarity - 555 mosmol/l; pH 3.5 - 6.5.
Pharmacotherapeutic group.
Solutions for parenteral nutrition.
PBX code V06D C01.
Pharmacological properties.
Pharmacodynamics.
Glucose solution has a plasma-replacing, hydrating, metabolic and detoxifying effect. It maintains the volume of circulating blood and replenishes the volume of lost fluid. It is able to cause diuresis depending on the clinical condition of the patient.
Glucose undergoes complete metabolism, can reduce protein and nitrogen losses, supports glycogen storage, and reduces or prevents ketosis (excessive formation of ketone bodies) when administered in sufficient doses. During the metabolism of glucose in the tissues, a significant amount of energy is released, which is necessary for the vital activity of the body.
Pharmacokinetics.
The normal blood glucose level ranges from 45-85 mg/100 ml, which corresponds to a molar concentration of 3.0-5.6 mmol/l. To maintain these levels in an adult weighing 60-100 kg, its daily intake should be 100-200 g. The contribution of blood glucose to the total plasma osmolarity - 290 mOsm/l - is insignificant, only 5.6 mOsm/l. Thus, the infusion of glucose solutions does not have a noticeable effect on increasing plasma osmolarity, since glucose is rapidly utilized. In patients, glucose intake is limited only to intravenous infusions, the minimum daily requirement for the prevention of acidosis is 100 g of glucose (1000 ml of 10% glucose solution).
Glucose metabolism in the body ends with the formation of carbon dioxide (CO 2) and water; during aerobic glycolysis, 686 kcal or 4.1 kcal per 1 m 3 of glucose is released from one mole of glucose. Glucose is almost completely eliminated by metabolism. In healthy patients, glucose in the urine can be detected only in trace amounts, since after glomerular filtration it enters the primary urine - it is completely absorbed in the proximal tubules; this process continues until the blood glucose level increases to a level not lower than 200-240 mg / 100 ml.
Clinical characteristics.
Indication.
hypoglycemia; parenteral nutrition; disorders associated with increased protein breakdown due to hypoergosis.
Contraindication.
Glucose solution 10% for infusion is contraindicated in patients with:
intracranial and intraspinal hemorrhages, except for conditions associated with hypoglycemia and the need for parenteral nutrition; severe hypertensive dehydration; hypersensitivity to dextrose; diabetic coma with hyperglycemia; hyperosmolar coma; glucose-galactose malabsorption syndrome.
The drug should not be administered simultaneously with blood products.
Interaction with other drugs and other types of interactions.
When used simultaneously with thiazide diuretics and furosemide, their ability to affect serum glucose levels should be taken into account.
Insulin promotes the entry of glucose into peripheral tissues, stimulates the formation of glycogen, the synthesis of proteins and fatty acids. Glucose solution reduces the toxic effect of pyrazinamide on the liver. The introduction of a large volume of glucose solution contributes to the development of hypokalemia, which increases the toxicity of simultaneously used digitalis drugs.
Glucose is incompatible in solutions with aminophylline, soluble barbiturates, erythromycin, hydrocortisone, kanamycin, soluble sulfonamides, and cyanocobalamin.
Application features.
With prolonged intravenous use of the drug, blood sugar levels must be monitored.
When administering the drug, insulin should be administered subcutaneously at the rate of 1 U per 4-5 g of glucose.
Use during pregnancy or breastfeeding.
The drug can be used only when the expected benefit to the mother outweighs the potential risk to the fetus or child.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
Data are missing due to the exclusive use of the drug in a hospital setting.
Method of administration and doses.
The drug is administered intravenously drip. The dose for adults is up to 1500 ml per day. The maximum daily dose for adults is 2,000 ml. If necessary, the maximum rate of administration for adults is 150 drops per minute (500 ml / h).
Children.
For children, the dose depends on age, body weight, condition, and laboratory parameters.
Overdose.
Increased manifestations of adverse reactions: tachypnea, pulmonary edema.
Hyperglycemia and hyperhydration may develop. In case of overdose, symptomatic treatment should be prescribed and, if necessary, regular insulin should be administered.
Adverse reactions.
From the side of the central nervous system: very rarely - confusion or loss of consciousness;
From the endocrine system and metabolism: hyperglycemia; hypokalemia; hypophosphatemia; hypomagnesemia.
From the urinary system: polyuria; glycosuria.
General reactions of the body: hypervolemia; feeling of flushing and redness of the skin; allergic reactions (hyperthermia, skin rashes, angioedema, shock).
Adverse reactions at the injection site: pain at the injection site; vein irritation, phlebitis, venous thrombosis.
In case of adverse reactions, the administration of the solution should be stopped, the patient's condition should be assessed and appropriate assistance should be provided.
Expiration date.
5 years.
Storage conditions.
Store at a temperature not exceeding 25 °C in a place inaccessible to children. Freezing of the drug, provided that the bottle is kept airtight, is not a contraindication for use. Non-wetting of the inner surface of the bottle is not a contraindication for use of the drug.
Incompatibility.
Glucose is incompatible in solutions with aminophylline, soluble barbiturates, erythromycin, hydrocortisone, warfarin, kanamycin, soluble sulfonamides, and cyanocobalamin.
Do not use in the same system simultaneously either before or after blood transfusion due to the possibility of pseudoagglutination.
Packaging.
200 ml or 250 ml, or 400 ml, or 500 ml in bottles.
Vacation category.
According to the recipe.
Producer.
Private Joint Stock Company "Infusion".
Location of the manufacturer and address of its place of business.
Ukraine, 21034, Vinnytsia, Voloshkova St., 55 or Ukraine, 23219, Vinnytsia Oblast, Vinnytsia District, Vinnytsia Khutora Village, Nemyrivske Shose St., 84a.
Applicant.
Private Joint Stock Company "Infusion".
Location of the applicant.
Ukraine, 04073, Kyiv, Moskovsky Prospect, 21-a.
