Instructions Glycosteril F5 solution for infusions bottle 200 ml
Composition
active ingredients: sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, fructose;
100 ml of solution contain: sodium chloride – 0.8 g; potassium chloride – 0.0298 g; calcium chloride dihydrate – 0.0242 g; magnesium chloride hexahydrate – 0.0254 g; fructose – 5 g;
ionic composition per 1000 ml of solution: Na+– 136.89 mmol; K+– 4 mmol; Ca++– 1.65 mmol;
Mg++ – 1.25 mmol; Cl¯– 146.69 mmol;
excipient: water for injections.
Dosage form
Solution for infusion.
Main physicochemical properties: transparent colorless or slightly yellowish liquid; theoretical osmolarity – 568 mosmol/l; pH 3.0 – 6.0.
Pharmacotherapeutic group
Solutions for correction of electrolyte balance disorders. Electrolytes with carbohydrates. ATX code B05B B02.
Pharmacological properties
Plasma-replacing isotonic saline solution containing a balanced composition of ions and fructose necessary for the body. The drug compensates for the loss of fluid, electrolytes and partly energy, restores water-salt balance. Fructose stimulates the formation of glucose and glycogen in the liver, improves the supply of glucose to cells. Fructose metabolism is carried out independently of insulin, when it is used, the blood glucose level does not increase, which is important in the treatment of patients with diabetes. Fructose exhibits a pronounced antiketogenic effect, has a slight diuretic effect, and has a specific effect on protein metabolism, which is manifested in the saving of amino acids due to their lower use in gluconeogenesis.
Incompatibility: The drug cannot be mixed with phosphate- and carbonate-containing solutions.
Indication
For primary plasma replacement in case of blood loss and burns; iso- and hypotonic dehydration due to uncontrollable vomiting, profuse diarrhea, intestinal obstruction, peritonitis; for partial compensation of the need for carbohydrates, including as part of complex therapy in patients with diabetes mellitus and other disorders of glucose utilization, provided that the acid-base balance of the blood is normal or its shifts to the alkaline side.
Contraindication
Edema, hypervolemia, hypersensitivity to fructose and/or other components of the drug, methanol intoxication, hyperlactatemia, hypertensive dehydration, metabolic acidosis.
Interaction with other medicinal products and other types of interactions
The drug cannot be mixed with phosphate- and carbonate-containing solutions.
Application features
Use the drug with caution in renal and/or hepatic insufficiency. Treatment should be carried out under the control of water balance.
Since each 100 ml of the drug contains 5 g of fructose, use with caution in patients with diabetes.
Long-term use (more than 5 days) of Glycosteryl F5 is inappropriate, as it may cause fructose-induced hyperglycemia and hypertriglyceridemia due to lipid metabolism disorders and a decrease in the number of glucose transporters on the outer surfaces of cell membranes.
Use during pregnancy or breastfeeding
The drug should be used during pregnancy or breastfeeding only for vital indications in cases where the expected benefit of treatment for the mother outweighs the possible risk to the fetus/child.
Ability to influence reaction speed when driving vehicles or other mechanisms
Data are missing due to the use of the drug exclusively in a hospital setting.
Method of administration and doses
Administer intravenously to adults.
Administer intravenously by drip at a rate of 3 ml/kg/hour, i.e. 210 ml/hour for a body weight of 70 kg. Maximum dose is 30 ml/kg/day (1.5 g fructose/kg/day), but not more than 2000 ml/day. Maximum infusion rate is 5 ml/kg/hour, i.e. 350 ml/hour for a body weight of 70 kg.
To quickly obtain the target catalytic fructose concentration, it is necessary to perform a jet infusion of 100-120 ml of Glycosteril F5.
Maintenance of the target fructose concentration is achieved by infusion of Glycosteril F5 at 120 to 150 ml/hour for 12-24 hours.
To prepare patients before urgent operations, Glycosteryl F5 should be used in a dose of 800-1200 ml in combination with colloidal and crystalloid solutions.
Children
Do not use in pediatrics due to lack of clinical trials.
Overdose
If the recommended rate of administration is exceeded, tachycardia, increased blood pressure, shortness of breath, headache, chest pain, abdominal pain may develop. These symptoms quickly disappear on their own after stopping or significantly reducing the rate of administration of the solution.
Adverse reactions
On the part of the immune system: allergic reactions, including skin and systemic manifestations, hyperthermia.
From the cardiovascular system: blood pressure fluctuations, edema, tachycardia.
Disturbances of water and electrolyte balance: during massive infusion therapy, electrolyte metabolism disorders (potassium, calcium, sodium, chlorine), lactic acidosis, and hyperhydration may occur.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
200 ml or 250 ml, or 400 ml, or 500 ml in bottles.
Vacation category
According to the recipe.
Producer
Closed Joint-Stock Company "Infusion", Ukraine.
Location of the manufacturer and its business address
Vinnytsia, A. Ivanova St., bldg. 55.
Applicant
Closed Joint-Stock Company "Infusion", Ukraine.
Location of the applicant and/or applicant's representative
Kyiv, Moskovsky Avenue, building 21-A.
