Biosulin N, 100 me/ml suspension 3 ml Biomaticpen syringe pen cartridges 5 pcs

Pharmgroup:

Hypoglycemic agent – insulin of medium duration of action.

Pharmic action:

Biosulin® H is human insulin produced using recombinant DNA technology. It is a medium-acting insulin preparation. 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., dose, route and site 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 in 1-2 hours, maximum effect between 6 and 12 hours, duration of action 18-24 hours.

Pharmacokinetics:

The completeness of absorption and onset of effect of insulin depends on the place of administration (stomach, thigh, buttocks), dose (volume of injected insulin), the concentration of insulin in the drug, etc.

Distributes irregularly in tissues; does not penetrate through the placental barrier and into breast milk. It is broken down by insulinase mainly in the liver and kidneys. It is excreted by the kidneys (30-80%).

Indications

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.

Composition

1 ml of Biosulin H contains:

– human genetically engineered insulin – 100 ME;

Auxiliary substances:

Zinc oxide,

Sodium hydrophosphate,

Protamine sulfate,

p> methacresol,

crystalline phenol,

glycerol,

water for injection.

Note.

To adjust the pH, 10 % sodium hydroxide solution or 10 % hydrochloric acid solution is used.

How to take, the dosage

Biosulin® H is intended for subcutaneous administration. The dose of the drug is determined by the doctor individually in each case based on the blood glucose level. The average daily dose of the drug ranges from 0.5 to 1 IU/kg of body weight (depends on the individual characteristics of the patient and the blood glucose level).

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

Biosulin® H is usually injected subcutaneously in the thigh. It can also be injected into the anterior abdominal wall, gluteus, or deltoid region of the upper arm.

It is necessary to change injection sites within the anatomical area to prevent the development of lipodystrophy.

Biosulin® H can be given alone or in combination with short-acting insulin (Biosulin® P).

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.

. 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. Under the influence of reserpine and salicylates both weakening and enhancement of the drug action is possible.

Special Instructions

Biosulin® H should not be used if after shaking the suspension does not become white and uniformly turbid.
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 physical activity or changes their diet.

Concomitant 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, 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 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 that require increased attention and speed of mental and motor reactions.

Injection technique when using 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. Verify that your insulin dose is correct.

Inject immediately.
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.

Fill the syringe with the appropriate amount of air for the turbid insulin dose. 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 mix.
Always draw insulin in the same sequence as described above.

Injection technique for insulin cartridges:
The Biosulin® H cartridge is for use with the Biomatic Pen® or Biosulin® Pen syringe pen. The patient should be cautioned to carefully follow the instructions in the insulin syringe pen instructions.

Before use, make sure that the Biosulin® H 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.

Before inserting the cartridge into the syringe pen, turn the cartridge up and down so that the glass bead moves from end to end of the cartridge. This procedure should be repeated at least 10 times until all the liquid is white and uniformly turbid. Immediately thereafter, the injection should be made.

If the cartridge is already inside the syringe pen, the pen with the cartridge inside should be turned up and down at least 10 times. This needs to be repeated before each injection.

After injection, the needle should stay under the skin for at least 6 seconds. Holding the button depressed 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® H cartridge is for individual use only and must not be refilled.

Injection procedure
With two fingers take the skin fold, insert the needle into the base of the fold at an angle of about 45 ° and inject insulin under the skin.
After injection, the needle should remain 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 removing the needle, press the injection site lightly with your finger.
It is necessary to change the injection sites.

Contraindications

Individual hypersensitivity to insulin or any of the drug components
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: rare – 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.