Biosulin R, 100 me/ml 10 ml

Biosulin P, a short-acting insulin, is human insulin produced using recombinant DNA technology.

It interacts with specific receptor of outer cytoplasmic cell membrane and forms insulin-receptor complex, stimulating intracellular processes, including synthesis of several key enzymes (hexokinase, pyruvate kinase, glycogen synthetase).

The decrease of glucose in blood is caused by the increase of its intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis and glycogenogenesis and decreased rate of glucose production by liver.

The duration of action of Biosulin P is mainly due to the rate of absorption, which depends on several factors (e.g., dose, route and site of administration), so the action profile of insulin is subject to significant fluctuations, both in different people and in the same person. After subcutaneous administration, the onset of action of Biosulin P is observed after approximately 30 minutes, with maximum effect between 2 and 4 hours, and duration of action of 6-8 hours.

Pharmacokinetics

Absorption

The completeness of absorption and onset of effect of insulin depends on the route of administration (i.e., injection or injection) and the site of administration (abdomen, thigh, buttocks), the dose (amount of insulin administered), and the concentration of insulin in the drug.

Distribution

Distribution in tissues is uneven. It does not penetrate the placental barrier and is not excreted with the breast milk.

Metabolism

It is broken down by insulinase mainly in the liver and kidneys.

Elimination

The T1/2 is a few minutes. Excreted with the urine is 30-80%.

Indications

Type 2 diabetes, Type 1 diabetes

• Type 1 diabetes mellitus (insulin-dependent);
• Type 2 diabetes mellitus (insulin-independent): stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (when combined therapy), intercurrent diseases;
• uncomplicated conditions in diabetic patients accompanied by decompensation of carbohydrate metabolism.

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Composition

1 ml of injectable solution contains:

the active ingredient:

Human isophane insulin 100 units;

auxiliary substances:

Glycerol;

Methacresol;

Injection water

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How to take, the dosage

Subcutaneously, intramuscularly, intravenously, 30 minutes before a meal or snack containing carbohydrates.

The dose of the drug is determined by the doctor individually, in each case on the basis of blood glucose levels.

The average daily dose is 0.5 to 1 IU/kg body weight (it depends on the individual patient and the blood glucose level).

The temperature of the administered insulin should be at room temperature.

In monotherapy the frequency of administration is 3 times a day (if necessary – 5-6 times a day). If the daily dose exceeds 0.6 IU/kg, it is necessary to administer as 2 or more injections in different areas of the body.

Biosulin R is usually injected subcutaneously into the anterior abdominal wall. It can also be injected into the thigh, buttock, or deltoid region of the upper arm. It is necessary to change the injection sites within the anatomical area to prevent the development of lipodystrophy.

Biosulin R should only be given intramuscularly and intravenously under a physician’s supervision.

Biosulin P is short-acting insulin and is usually used in combination with a medium-acting insulin (Biosulin H).

Injection technique when using insulin in vials

If the patient uses only one type of insulin

1. The rubber membrane on the vial must be disinfected.
2. Puff the syringe with the amount of air that corresponds to the correct dose of insulin. Introduce air into the insulin bottle.
3. Turn the bottle with the syringe upside down and draw the desired dose of insulin into the syringe. Take the needle out of the bottle and remove the air from the syringe. Check that the dose of insulin is correct.
4. Inject immediately.

If the patient needs to mix two types of insulin

1. Make sure the rubber membranes on the vials are disinfected.
2. Just prior to dispensing, swirl the vial of long-acting (“cloudy”) insulin between the palms of the hands until the insulin is uniformly white and cloudy. Add air to the vial of “turbid” insulin and remove the needle from the vial (“turbid” insulin should not be taken at this stage yet).
3. Puff the syringe with air in the amount corresponding to the dose of short-acting insulin (“transparent”). Introduce air into the vial of “clear” insulin. Turn the bottle with the syringe upside down and draw the desired dose of “clear” insulin. Take out the needle and remove the air from the syringe. Check to see if the dose is correct.
4. Place the needle in the vial of turbid insulin, turn the bottle with the syringe upside down and draw out the desired dose of insulin. Remove the air from the syringe and check the correct dose. Immediately inject the selected insulin mixture.
5. Insulins should always be injected in the same sequence, described above.

Injection technique for insulin cartridges

The Biosulin P cartridge is for use with the Biosulin Pen only. The patient should be cautioned to carefully follow the instructions in the insulin pen instructions for use.

Before use, make sure that the Biosulin P cartridge is not damaged in any way (e.g., cracked). Do not use the cartridge if there is any visible damage. Once the cartridge is inserted into the syringe pen, the colored stripe should be visible through the window of the cartridge holder.

After injection, the needle must remain under the skin for at least 6 seconds. The button must be held in until the needle is completely withdrawn from under the skin, this ensures the correct dose is delivered and limits the potential for blood or lymphatic leakage into the needle or insulin cartridge.

The Biosulin P cartridge is for individual use only and must not be refilled.

Injection Procedure

1. With two fingers, gather the skin fold, then insert the needle at the base of the fold at about a 45° angle and inject the insulin under the skin.
2. After injection, the needle should remain under the skin for at least 6 seconds to make sure that the insulin is fully injected.
3. If there is blood on the injection site after removing the needle, press the injection site with your finger.
4. The injection site should be changed.

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Interaction

There are a number of drugs that affect the need for insulin.

. Hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbohydrate inhibitors, non-selective beta-adrenoblockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, cyclophosphamide, phenfluramine, lithium preparations; Drugs containing ethanol.

The hypoglycemic effects of insulin are impaired by oral contraceptives, GCS, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, BKK, diazoxide, morphine, phenytoin, nicotine.

The effects of reserpine and salicylates may both weaken and enhance the effect of the drug.

Special Instructions

Biosulin P should not be used if the solution has become cloudy, stained, or solid particles are detected.

With insulin therapy, blood glucose levels should be monitored constantly.

The causes of hypoglycemia, in addition to insulin overdose, may be: changing the drug, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (liver and kidney function disorders, hypofunction of the adrenal gland, pituitary or thyroid), change of injection site, and interaction with other drugs.

Inappropriate dosing regimens or interruptions of insulin administration, especially in patients with type 1 diabetes, may lead to hyperglycemia. Usually the first symptoms of hyperglycemia develop gradually over a few hours or days (increased thirst, frequent urination, nausea, vomiting, dizziness, redness and dry skin, dry mouth, loss of appetite, smell of acetone in exhaled air). If left untreated, hyperglycemia in type 1 diabetes can lead to life-threatening diabetic ketoacidosis.

The dose of the drug should be adjusted if there is significant physical activity, infectious diseases, fever, thyroid dysfunction, Addison’s disease, hypopituitarism, hepatic and/or renal dysfunction, diabetes in persons over 65, increased intensity of physical activity, or changes in habitual diet.

Concomitant diseases (especially infectious) and conditions accompanied with fever increase the need for insulin.

Transition from one type of insulin to another should be done under control of blood glucose levels.

The drug reduces alcohol tolerance.

Due to the possibility of precipitation in some catheters, use of the drug in insulin pumps is not recommended.

Impact on driving and operating machinery

In connection with the initial prescription of insulin, a change in its type, or significant physical or mental stress on the body, the ability to drive or operate various mechanisms, as well as to engage in other potentially dangerous activities requiring increased attention and rapid psychomotor reactions may decrease.

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Contraindications

Individual hypersensitivity to insulin or other drug components; hypoglycemia.

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Side effects

Metabolic disorders: hypoglycemic states (pale skin, increased sweating, palpitations, tremors, hunger, agitation, paresthesias in the mouth, headache). Severe hypoglycemia may lead to hypoglycemic coma.

Local reactions: hyperemia, swelling and itching at the injection site, with long-term use – lipodystrophy at the injection site.

Allergic reactions: rarely – skin rash, Quincke’s edema; in single cases – anaphylactic shock.

Others: edema, transient refractive disorders (usually at the beginning of therapy).

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Overdose

Symptoms: hypoglycemia may occur.

Treatment: mild hypoglycemia can be managed by the patient himself by ingesting sugar or carbohydrate-rich foods. Therefore, it is recommended that diabetics carry sugar, sweet fruit juice, or other sweets with them at all times.

In severe cases, if the patient loses consciousness, 40% dextrose solution is administered intravenously; intramuscularly, subcutaneously, intravenously – glucagon. After recovery of consciousness, the patient is advised to take a meal rich in carbohydrates to prevent the recurrence of hypoglycemia.

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Pregnancy use

There are no data on the use of the drug in pregnancy and during breast-feeding.

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