Biosulin R 100 IU/ml solution for injection vial 10 ml 1 vial

— diabetes mellitus;
— emergency conditions in patients with diabetes mellitus accompanied by decompensation of carbohydrate metabolism.

The dosage of the medication is determined by the physician individually, in each specific case based on the blood glucose level.
The medication is intended for subcutaneous, intramuscular, or intravenous administration.
The average daily dose of the medication ranges from 0.5 to 1 IU/kg of body weight (depends on individual patient characteristics and blood glucose level).
The medication should be administered 30 minutes before meals or a light snack containing carbohydrates.
The temperature of the insulin to be administered should be at room temperature.
In monotherapy, the frequency of administration is 3 times (if necessary - 5-6 times). For a daily dose exceeding 0.6 IU/kg, it should be administered in 2 or more injections in different areas of the body.
Biosulin® R is usually administered subcutaneously in the anterior abdominal wall. Injections can also be made in the thigh, buttock, or deltoid area of the shoulder. It is necessary to rotate injection sites within the anatomical area to prevent the development of lipodystrophy.
Intramuscular and intravenous Biosulin® R can only be administered under medical supervision.
Biosulin® R is a short-acting insulin and is usually used in combination with intermediate-acting insulin (Biosulin® N).

1 ml
insulin, soluble (human recombinant) 100 IU
Excipients: glycerol, metacresol, hydrochloric acid or sodium hydroxide (10% solution, for pH adjustment), water for injection.

Injection solution is colorless or almost colorless, clear or almost clear.

— hypoglycemia;
— increased sensitivity to insulin or other components of the medication.

Do not use Biosulin® R if the solution has become cloudy, discolored, or if solid particles are present.
During insulin therapy, it is necessary to continuously monitor blood glucose levels.
Causes of hypoglycemia, aside from insulin overdose, may include: change of medication, missed meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (liver and kidney dysfunction, adrenal cortex hypofunction, pituitary or thyroid gland hypofunction), change of injection site, as well as interactions with other medications.
Incorrect dosing regimen or interruptions in insulin administration, especially in patients with type 1 diabetes, may lead to hyperglycemia. Typically, the first symptoms of hyperglycemia develop gradually over several hours or days (thirst, increased urination, nausea, vomiting, dizziness, redness and dryness of the skin, dry mouth, loss of appetite, acetone smell in exhaled air). If left untreated, hyperglycemia in type 1 diabetes can lead to life-threatening diabetic ketoacidosis.
The dosage of the medication should be adjusted in cases of thyroid dysfunction, Addison's disease, hypopituitarism, liver and/or kidney dysfunction, diabetes in individuals over 65 years of age, with increased physical activity, or changes in usual diet.
Comorbidities (especially infections) and conditions accompanied by fever increase the need for insulin.
Transitioning from one type of insulin to another should be done under blood glucose level monitoring.
The medication reduces alcohol tolerance.
Due to the possibility of precipitation in certain catheters, the use of the medication in insulin pumps is not recommended.
Effect on the ability to drive and operate machinery
Due to the initial administration of insulin, change in its type, or significant physical or psychological stress on the body, there may be a decrease in the ability to drive a vehicle or operate various mechanisms, as well as engage in other potentially dangerous activities that require increased attention and rapid psychomotor responses.

Metabolic side effects: hypoglycemic states (pallor of the skin, increased sweating, sensation of heartbeat, tremor, hunger, agitation, paresthesia in the mouth area, headache). Severe hypoglycemia may lead to the development of hypoglycemic coma.
Allergic reactions: rarely - skin rash, angioedema; in rare cases - anaphylactic shock.
Local reactions: hyperemia, swelling, and itching at the injection site; with prolonged use - lipodystrophy at the injection site.
Other: edema, transient refractive disturbances (usually at the beginning of therapy).

hypoglycemia may occur

There are a number of medications that affect the need for insulin.
The hypoglycemic effect of insulin is enhanced by oral hypoglycemic agents, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, and preparations containing ethanol.
The hypoglycemic effect of insulin is weakened by oral contraceptives, glucocorticoids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, and nicotine.
Under the influence of reserpine and salicylates, both weakening and enhancement of the drug's effect may occur.

Short-acting insulin. It is human insulin obtained using recombinant DNA technology.
It interacts with a specific receptor on the external cytoplasmic membrane of cells and forms an insulin-receptor complex, stimulating intracellular processes, including the synthesis of several key enzymes (including hexokinase, pyruvate kinase, glycogen synthase). The reduction of glucose levels in the blood is due to increased intracellular transport, enhanced absorption and utilization by tissues, stimulation of lipogenesis, glycogenogenesis, and decreased glucose production by the liver.
The duration of action of insulin preparations is mainly determined by the rate of absorption, which depends on several factors (for example, dose, method, and site of administration), resulting in significant variability in the insulin action profile, both among different individuals and within the same patient.
After subcutaneous administration, the onset of action is observed approximately 30 minutes after injection, with peak effect occurring between 2 and 4 hours, and duration of action lasting 6-8 hours.

Absorption
The completeness of absorption and the onset of insulin effect depend on the route of administration (subcutaneous or intramuscular) and the site of injection (abdomen, thigh, buttocks), the dose (volume of insulin administered), and the concentration of insulin in the preparation.
Distribution
Distributes unevenly in tissues. Does not cross the placental barrier and is not excreted in breast milk.
Metabolism
Degraded by insulinase primarily in the liver and kidneys.
Excretion
The half-life (T1/2) is several minutes. Excreted in urine - 30-80%.