Biosulin P, 100 me/ml 3 ml 3 ml cartridges in Biomatikpen syringe pens 5 pcs

Pharmaceutical group:

Hypoglycemic agent – short-acting insulin.

Pharmic action:

Biosulin® P is human insulin produced using recombinant DNA technology. It is a preparation of short-acting insulin. It interacts with specific receptor of outer cytoplasmic cell membrane and forms insulin-receptor complex, which stimulates intracellular processes, including synthesis of several key enzymes (hexokinase, pyruvate kinase, glycogen synthetase and others). Decrease of glucose content in blood is caused by an increase of its intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis, glycogenogenesis, decrease of glucose production rate by liver, etc.

The duration of action of insulin drugs is mainly due to the speed of absorption, which depends on several factors (e.g. on the dose, route and place of administration), so the action profile of insulin is subject to significant variations both in different people and in the same person.

The profile of action when injected subcutaneously (approximate figures): onset of action after 30 minutes, maximum effect between 2 and 4 hours, duration of action — 6-8 hours.

Pharmacokinetics:

The completeness of absorption and onset of effect of insulin depends on the route of administration (subcutaneous, intramuscular), site of administration (stomach, thigh, buttocks), dose (volume of insulin administered), insulin concentration in the drug, etc.

The distribution in tissues is uneven: it does not penetrate through the placental barrier and into the breast milk. It is broken down by insulinase mainly in the liver and kidneys. The elimination half-life is a few minutes. It is excreted by the kidneys (30-80%).

Indications

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

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Composition

In 1 ml of the drug Biosulin R contains:

– human genetically engineered insulin – 100 IU;

Supplementary substances:

Methacresol,

Glycerol,

Water for injection.

Note:

Sodium hydroxide solution or 10% hydrochloric acid solution is used to adjust the pH.

How to take, the dosage

Biosulin® R is intended for subcutaneous, intramuscular and intravenous administration.

The dose and route of administration is determined by the physician individually in each case based on the blood glucose level.
On average the daily dose of the drug ranges from 0.5 to 1 IU/kg of body weight (depending on the individual patient and blood glucose level).

The drug is given 30 minutes before a meal or snack containing carbohydrates.

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

In monotherapy with the drug, the frequency of administration is 3 times a day (if necessary, 5-6 times a day). If the daily dose is greater than 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 may also be injected into the thigh, buttock, or deltoid region of the shoulder. It is necessary to change the injection sites within the anatomical area to prevent the development of lipodystrophy. Intramuscular and intravenous Biosulin® R should be administered only under the control of a physician.

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

Interaction

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

. The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, monoamine oxidase inhibitors, angiotensin-converting enzyme inhibitors, carboanhydrase inhibitors, non-selective beta-adrenoblockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, phenfluramine, lithium preparations, preparations containing ethanol.

. The hypoglycemic effect of insulin is weakened by oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Reserpine and salicylates may both weaken and enhance the effect of the drug.

Special Instructions

Biosulin® R should not be used if it has become turbid, stained, or if solid particles are detected.
During insulin therapy, continuous monitoring of blood glucose levels is necessary.

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 medications.

Inadequate dosing or intermittent insulin administration, especially in patients with type 1 diabetes, can lead to hyperglycemia. Usually the first symptoms of hyperglycemia develop gradually over a few hours or days. They include the appearance of thirst, increased urination, nausea, vomiting, dizziness, red and dry skin, dry mouth, loss of appetite, and the smell of acetone in the exhaled air. If left untreated, hyperglycemia in type 1 diabetes can lead to life-threatening diabetic ketoacidosis.

The insulin dose should be adjusted for thyroid dysfunction, Addison’s disease, hypopituitarism, hepatic and renal dysfunction, and diabetes mellitus in individuals over age 65.

The insulin dose may also need to be adjusted if the patient increases the intensity of physical activity or changes their diet.

Companion diseases, especially infections and conditions 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, the use of the drug in insulin pumps is not recommended.

Impact on the ability to drive and operate machinery
In connection with the initial prescription of insulin, change of its type or in the presence of significant physical or mental stress, it is possible to reduce the ability to drive or operate various mechanisms, as well as to engage in other potentially dangerous activities requiring increased attention and speed of mental and motor reactions.

Injection technique for insulin in vials

1. If the patient uses only one type of insulin
Disinfect the rubber membrane on the vial.
Draw air into the syringe in the amount corresponding to the desired dose of insulin. Insert air into the insulin bottle.
Turn the bottle with the syringe upside down and draw the desired dose of insulin into the syringe. Remove the needle from the vial and bleed the air from the syringe. Check that the insulin dose is correct.
Immediately give the injection.
2. If the patient needs to mix two types of insulin
Disinfect the rubber membranes on the vials.
Immediately prior to delivery, roll the vial of long-acting insulin (“turbid”) between your palms until the insulin is evenly white and turbid.

Push the amount of air into the syringe corresponding to the dose of the cloudy insulin. Insert the air into the vial of cloudy insulin and remove the needle from the vial (do not inject the cloudy insulin at this time).

Push the amount of air into the syringe that corresponds to the dose of the short-acting insulin (the clear insulin). Insert the air into the vial of clear insulin. Turn the syringe bottle upside down and draw in the desired dose of clear insulin. Remove the needle and bleed the syringe. Verify that the dose is correct.

Push the needle into the cloudy insulin bottle, turn the syringe bottle upside down, and draw in the correct dose of insulin. Remove any air from the syringe and make sure the dose is correct. Immediately inject the insulin mixture you have drawn.

Always inject insulin in the same sequence described above.

Injection technique when using insulin cartridges

The Biosulin® P cartridge is for use only with the Biomatik®Pen or Biosulin®Pen syringe pen. The patient must be cautioned to carefully follow the instructions in the insulin syringe pen instructions.

Before use, make sure that the Biosulin®P cartridge is free of any damage (e.g., cracks). The cartridge should not be used 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. Holding the button depressed until the needle is completely out of 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

With two fingers take the skin fold, insert the needle at the base of the fold at an angle of about 45° and inject the insulin under the skin.
After injection, the needle must stay under the skin for at least 6 seconds to make sure that the insulin is fully injected.

If there is blood on the injection site after the needle is removed, lightly press the injection site with your finger.
It is important to change the injection sites.

Contraindications

• Hypoglycemia.

Side effects

Associated effects on carbohydrate metabolism: hypoglycemic states (pale skin, increased sweating, palpitations, tremors, hunger, agitation, paresthesias in the mouth, headache). Severe hypoglycemia may lead to hypoglycemic coma.

Allergic reactions: rarely – skin rash, Quincke’s edema, very rare – anaphylactic shock.

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

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

Overdose

Hypoglycemia may occur in overdose.

Treatment: Mild hypoglycemia can be treated by the patient himself by taking sugar or carbohydrate-rich foods. Therefore, it is recommended that diabetics carry sugar, candy, cookies, or sweet fruit juice with them at all times.

In severe cases, if the patient loses consciousness, a 40% solution of dextrose 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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