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medicalmeds.eu Medicines Means for clinical nutrition. Carbohydrates. Glucose

Glucose

Препарат Глюкоза. АО "Биннофарм" Россия


Producer: JSC Binnofarm Russia

Code of automatic telephone exchange: B05BA03

Release form: Liquid dosage forms. Solution for infusions.

Indications to use: Parenteral food. Hypoglycemia. Disturbance of carbohydrate metabolism.


General characteristics. Structure:

Active ingredient: 50 g or 100 g of glucose (dextrose monohydrate).

Excipients: sodium chloride, Acidum hydrochloricum 0,1M, water for injections.




Pharmacological properties:

Pharmacodynamics. Glucose strengthens oxidation-reduction processes in an organism, improves anti-toxic function of a liver, strengthens sokratitelny activity of a myocardium, is a source of digestible carbohydrates.

Pharmakodinamichesky properties of 5% and 10% of solutions of a dextrose are similar to properties of glucose – the main source of energy of cellular metabolism.

5% solution of a dextrose isotonic solution with osmolarity represents about 278 ¼Äß¼/l. The consumed caloric content of 5% of solution of a dextrose makes 200 kcal/l. 10% solution of a dextrose hypertonic salt solution with osmolarity represents about 555 ¼Äß¼/l. The consumed caloric content of 10% of solution of a dextrose makes 400 kcal/l.

Within parenteral food of 5% and 10% solutions of a dextrose enter as a source of carbohydrates (separately or as a part of parenteral food if necessary). 5% and 10% solutions of a dextrose allow to fill insufficiency of liquid without simultaneous introduction of ions. A dextrose, coming to fabrics, it is phosphorylated, turning into glyukozo-6-phosphate which actively joins in many links of a metabolism of an organism.

At use of solutions of a dextrose for cultivation and dissolution of the medicines administered parenterally, pharmakodinamichesky properties of solution will depend on the added substance.

Pharmacokinetics. Glucose is metabolized in two various ways: anaerobic and aerobic.

Dextrose, breaking up to pyruvic or lactic acid (anaerobic glycolysis), it is metabolized to carbon dioxide and water with energy release.

At use of solution of a dextrose for cultivation and dissolution of the medicines administered parenterally, pharmacokinetic properties of solution will depend on the added substance.


Indications to use:

  • 5% glucose solution:

- as a source of carbohydrates (separately or as a part of parenteral food if necessary);
- for a regidratation in case of liquid loss, especially at patients with the high need for carbohydrates;
- for cultivation and dissolution of the medicines administered parenterally.

  • 10% glucose solution:

- as a source of carbohydrates (separately or as a part of parenteral food if necessary);
- for a regidratation in case of liquid loss, especially at patients with the high need for carbohydrates;
- for cultivation and dissolution of the medicines administered parenterally;
- for prevention and treatment of a hypoglycemia.


Route of administration and doses:

Dextrose solution for infusions is entered intravenously (kapelno). The drug is usually administered in a peripheral or central vein. Concentration and a dose of the entered solution depend on age, body weight and a clinical condition of the patient. Use of drug should be carried out under regular medical observation. It is necessary to control carefully clinical and biochemical parameters, in particular concentration of glucose in blood, and also water-salt balance.

The recommended dose as a source of carbohydrates (separately or as a part of perenteralny food if necessary):

For adult and elderly people: the recommended doses provided below serve as a reference point for use for adults with body weight about 70 kg.

As a source of carbohydrates (separately or as a part of parenteral food if necessary), Prevention and treatment of a hypoglycemia and regidratation in case of loss of liquid and at dehydration at patients with the high need for carbohydrates the initial daily dose makes: 500-3000 ml a day (7-40 ml/kg a day). The maximum recommended speed of infusion should not exceed a threshold of utilization of glucose in the patient's organism as it can lead to a hyperglycemia: 5 mg/kg/min. (3 ml/kg/h). Duration of treatment depends on a clinical condition of the patient.

For cultivation and dissolution of the medicines administered parenterally use 50-250 ml on one dose of the administered medicine. Speed of infusion and duration of treatment depend on the divorced medicine.

* - the maximum volumes within the recommended doses should be entered within 24 hours to avoid hemodilution.

Children and teenagers: speed and volume of infusion depend on age, body weight, a clinical condition and metabolism of the patient, and also on the accompanying therapy. At children the attending physician having experience of use of intravenous drugs for this category of patients has to define them.

The recommended doses in table 2 serve as a reference point for use for children and teenagers and depend on the body weight and age.

Recommendations about dosing at children and teenagers. As a source of carbohydrates (separately or as a part of parenteral food if necessary), Prevention and treatment of a hypoglycemia and regidratation in case of loss of liquid and at dehydration at patients with the high need for carbohydrates the initial daily dose for children makes: weighing 0-10 kg – 100 ml / кК / days; Weighing from 10 to 20 kg – 1000 ml + additional 50 ml on each kg of body weight over 10 kg/days; Weighing more than 20 kg – 1500 ml + additional 20 ml on each kg of body weight over 20 kg/days.

Rate of administering to babies and children of early age (1-23 months) - 5-11 ml/kg/h (9-18 mg/kg/min.); children are 2-11 years old - 4-8 ml/kg/h (7-14 mg/kg/min.); to teenagers (12-16 years) - From 4 ml/kg/h (7-8,5 mg/kg/min.).

For cultivation and dissolution of the medicines administered parenterally an initial dose: from 50 to 100 ml on one dose of the administered medicine. Irrespective of age. Infusion speed: depending on the divorced medicine. Irrespective of age.

* Speed, volume of infusion and duration of treatment depend on age, body weight, a clinical condition and metabolism of the patient, and also on the accompanying therapy. The attending physician having experience of use of intravenous drugs for children has to define them.

Note: the maximum volumes within the recommended doses should be entered within 24 hours to avoid hemodilution.

The maximum speed of infusion should not exceed a threshold of utilization of glucose in the patient's organism as it can lead to a hyperglycemia therefore the maximum dose of a dextrose varies from 5 mg/kg/min. for adults and 10-18 mg/kg/min. for newborns and children depending on age and the lump of a body.

Depending on a clinical condition of the patient rate of administering can be lowered for reduction of risk of developing of an osmotic diuresis.

At use of drug for cultivation and dissolution of medicines for infusional introduction necessary volume is determined on the basis of the application instruction of the added medicines.


Features of use:

Glucose solutions during pregnancy and a lactation can be used only on condition of control from the doctor. 5% solution of glucose can be used according to indications at pregnancy and during feeding by a breast.

During pregnancy most often use 5% glucose solution as transport of other medicines – usually oxytocin. About emergence of undesirable action on a fruit during pregnancy, there are no childbirth and a lactation of data.

10% glucose solution during pregnancy and a lactation can be used only on condition of control from the doctor of balance of liquid in an organism and electrolytic balance which have to be in physiological limits. When using solution as transport of other medicines it is necessary to estimate influence of these additional resources at pregnancy and a lactation.

As at patients with a diabetes mellitus, a renal failure or being in an acute critical state, portability of glucose (dextrose) can be broken, it is necessary to control especially carefully their kliniko-biological parameters, in particular concentration of electrolytes in a blood plasma, including magnesium or phosphorus, concentration of glucose in blood. In the presence of a hyperglycemia it is necessary to correct rate of administering of drug or to appoint insulin of short action.

Usually glucose is completely acquired by an organism (normal by kidneys it is not removed) therefore emergence of glucose in urine can be a pathological sign.

In case of long introduction or use of a dextrose in high doses it is necessary to control potassium concentration in a blood plasma and if necessary to enter potassium in addition to avoid a hypopotassemia.

At episodes of intracranial hypertensia careful control of concentration of glucose in blood is necessary.

Use of solutions of a dextrose can lead to a hyperglycemia. Therefore they are not recommended to enter after an acute ischemic stroke as the hyperglycemia is accompanied by strengthening of ischemic injury of a brain and interferes with recovery.

Especially careful clinical monitoring is required at the beginning of intravenous administration of drug.

Solutions of carbohydrates should be applied to rehydration therapy in a combination with solutions of electrolytes in order to avoid disturbance of electrolytic balance (a hyponatremia, a hypopotassemia).

It is necessary to control concentration of glucose and content of electrolytes in blood, a water balance, and also an acid-base condition of an organism.

Before use solution should be examined. To apply only transparent solution without visible inclusions and at absence of damage of packaging. To enter directly after connection to infusional system.

Solution should be entered using the sterile equipment with observance of rules of an asepsis and antiseptics.

In order to avoid an air embolism it is necessary to remove air from infusional system by means of solution.

Not to connect containers consistently in order to avoid an air embolism which can arise because of suction of air from the first container before completion of administration of solution from the second container. Supply of the intravenous solutions which are contained in soft plastic containers under supertension for the purpose of increase in a flow rate can lead to an air embolism if before introduction the minimal air in a container is removed not completely. Use of system for intravenous administration with the gas outlet can lead to an air embolism at the open gas outlet. Soft plastic containers with such systems should not be used.

The added substances can be entered before infusion or during infusion through the place of input (in the presence of special port for input of drugs). Addition in solution of other medicines or disturbance of the technology of introduction can cause fever owing to possible hit in an organism of pyrogens. At development of undesirable reactions infusion should be stopped immediately.

At addition of other medicines before parenteral administration it is necessary to check isotonicity of the received solution. Full and careful hashing in aseptic conditions is obligatory. The solutions containing additional substances should be applied immediately, their storage is forbidden. At administration of additional nutrients it is necessary to define osmolarity of the received mix prior to infusion. The received mix needs to be entered through the central or peripheral venous catheter depending on final osmolarity. Compatibility of in addition entered medicines needs to be estimated before their addition at solution (similar to use of other parenteral solutions). Assessment of compatibility of in addition entered medicines with drug enters competence of the doctor. It is necessary to check the received solution for discoloration and/or emergence of a deposit, insoluble complexes or crystals. It is necessary to study the application instruction of the added medicines.

From the microbiological point of view divorced drug should be used immediately. The exception is made by the cultivations prepared in controlled and aseptic conditions. Otherwise after solution preparation terms and conditions of its storage before introduction are responsibility of the user.

Children. At newborns, especially at premature or been born with low body weight, the risk of development hypo - or a hyperglycemia therefore during intravenous administration of solutions of a dextrose careful control of concentration of glucose in blood in order to avoid the remote undesirable effects is necessary is increased.

The hypoglycemia at newborns can lead to long spasms, a coma and injury of a brain. The hyperglycemia is connected with an intraventricular hemorrhage, the delayed bacterial and fungus infectious diseases, a retinopathy premature, a necrotic coloenteritis, a bronchopulmonary dysplasia, long hospitalization and mortality. In order to avoid potentially lethal overdose of intravenous drugs at newborns special attention needs to be paid to a route of administration.

When using for intravenous administration of drugs by the newborn of the spray pump it is impossible to leave a container with solution attached to the syringe. When using the infusional pump before removal of system from the pump or its shutdown it is necessary to close all clips of system, irrespective of existence in system of the device interfering free to liquid current. Devices for intravenous infusion and the other equipment for administration of drugs should be controlled regularly.

If drug contains the dextrose received from corn, use of drug is contraindicated to patients with the known intolerance of corn or products from corn since the following manifestations of hypersensitivity are possible: anaphylactic reactions, fever and fever.

For drugs in containers: it is necessary to utilize containers after single use. It is necessary to utilize each unused dose. Not to connect repeatedly partially used containers.

Does not influence control of vehicles and mechanisms in connection with drug use only in a hospital.


Side effects:

The Undesirable Reactions (UR) are grouped in systems and bodies according to the MedDRA dictionary and classification of frequency of development of NR WHO:

Very often (1/10), it is frequent (1/100 to <1/10), is not frequent (1/1000 to <1/100), is rare (1/10000 to <1/1000), is very rare (<1/10000), frequency is unknown – (frequency cannot be determined on the basis of the available data).

From immune system: frequency is unknown – anaphylactic reactions, hypersensitivity.

From a metabolism and food: frequency is unknown – disturbance of water and electrolytic balance (a hypopotassemia, a hypomagnesiemia, a hypophosphatemia), a hyperglycemia, hemodilution, a hypervolemia, dehydration.

From vessels: frequency is unknown – venous thrombosis, phlebitis.

From skin and hypodermic fabrics: frequency is unknown – the increased sweating.

From kidneys and urinary tract: frequency is unknown – a polyuria.

The general disturbances and frustration in an injection site: frequency is unknown – a fever, fever, an infection in the place of an injection, irritation in the place of an injection, an ekstravazation, morbidity in the place of an injection.

Laboratory and tool data: frequency is unknown – a glucosuria.

Undesirable reactions can be also connected with drug which was added to solution. The probability of other undesirable reactions depends on properties of the specific added medicine.

At emergence of undesirable reactions administration of solution should be stopped.


Interaction with other medicines:

Combined use of catecholamines and steroids reduces assimilation of a dextrose (glucose).

When mixing with other medicines it is necessary to control visually them on incompatibility.

For cultivation or dissolution of other medicines drug should be used only in the presence of instructions on cultivation by dextrose solution in the application instruction on this medicine.

In the absence of information on compatibility of drug it is not necessary to mix with other medicines.

Before addition of any medicine it is necessary to be convinced that it растворимо also is stable in water in the range рН drug.

After addition the received solution should be entered into drug of compatible medicine immediately.

Medicines with the known incompatibility cannot be used.

At administration of solutions of a dextrose through the same infusional system, as for a hemotransfusion, the risk of hemolysis and thrombosis is possible.


Contraindications:

Dekompensirovanny diabetes mellitus and not diabetes mellitus; giperosmolyarny coma; hemodilution and extracellular overhydratation, hypervolemia; hyperglycemia and giperlaktatemiya; a heavy renal failure (with an oliguria or an anury); dekompensirovanny heart failure; generalized hypostases (including a fluid lungs and a brain) and cirrhosis with ascites; other known forms of intolerance of glucose (for example, metabolic stress); hypersensitivity to drug components; administration of solution during the first 24 h after a head injury; use of the same infusional system, as for a hemotransfusion, because of risk of hemolysis and thrombosis; patients with the known intolerance of corn or products from corn (when receiving a dextrose from corn); contraindications to any drugs added to glucose solution.


Overdose:

Symptoms: long infusional administration of drug can lead to a hyperglycemia, a glucosuria, hyper osmolarity, an osmotic diuresis and dehydration. Bystry infusion can create accumulation of liquid in an organism with hemodilution and a hypervolemia, and at exceeding of ability of an organism to oxidize glucose bystry introduction can cause a hyperglycemia. Also decrease in content of potassium and inorganic phosphate in a blood plasma can take place.

At use of solution of a dextrose for infusions for cultivation and dissolution of other medicines for intravenous administration, clinical signs and symptoms of overdose can be connected with properties of the used medicines.

Treatment: at emergence of symptoms of overdose it is necessary to suspend administration of solution, to estimate the patient's condition, to enter insulin of short action, if necessary to carry out the supporting symptomatic therapy.


Storage conditions:

To store at a temperature from +5 °C to +30 °C. Drug freezing (is allowed when transporting) on condition of storage of integrity and tightness of primary packaging and is not a contraindication to its use. Bottles with the frozen solution maintain at the room temperature before thawing and mix stirring. To store in the place, unavailable to children! 3 years. Not to use after the expiry date specified on packaging.


Issue conditions:

According to the recipe


Packaging:

Solution for infusions of 5%, 10%. On 200 ml, 250 ml, 400 ml, 500 ml in plastic bottles with the soldered mouth from polyethylene of low density allowed for use in the Russian Federation with the protective cap from polyethylene or polypropylene having an insert from thermoplastic elastomer and an aluminum protective foil and a ring holder at the bottom of a plastic bottle or without it. On 200 ml, 400 ml, 500 ml in bottles glass for infusion solutions, corked by rubber bungs and pressed out by aluminum klopachka. Each bottle is placed in an individual cardboard pack together with the application instruction. On 15 or 20 bottles glass or plastic on 400 ml or 500 ml, on 28 or 36 bottles glass on 200 ml or bottles plastic on 200 ml or 250 ml place in a cardboard box with cells together with the application instruction (for hospitals).



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