Humodar B 100 (Suspension) Instructions for Use

Marketing Authorization Holder

Indar Private Joint Stock Company for Insulin Production (Ukraine)

ATC Code

A10AC01 (Insulin human)

Active Substance

Insulin human (Rec.INN registered by WHO)

Dosage Form

Humodar B 100

Subcutaneous injection suspension 100 U/ml: 3 ml cartridge 3 or 5 pcs., 10 ml vials 1 pc.

Dosage Form, Packaging, and Composition

3 ml – cartridges (5) – carton packs.
3 ml – cartridges (3) – carton packs.
10 ml – vials (1) – carton packs.

Clinical-Pharmacological Group

Intermediate-acting human insulin

Pharmacotherapeutic Group

Intermediate-acting insulin

Pharmacological Action

Humodar B 100 is a human semi-synthetic insulin preparation of intermediate duration of action. It interacts with a specific receptor on the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, etc.). The decrease in blood glucose is due to increased intracellular transport, enhanced uptake and utilization by tissues, stimulation of lipogenesis, glycogenesis, decreased rate of glucose production by the liver, etc.

The duration of action of insulin preparations is mainly determined by the rate of absorption, which depends on several factors (e.g., dose, route and site of administration), and therefore the insulin action profile is subject to significant variations, both among different people and in the same person.

On average, the onset of action of the drug after subcutaneous administration occurs within 60 minutes, the maximum effect is between 4 and 6 hours, and the duration of action is 12-20 hours.

Pharmacokinetics

The completeness of absorption and the onset of the effect of insulin depend on the method of administration (subcutaneous, intramuscular), the site of administration (abdomen, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the preparation, etc.

It is distributed unevenly in tissues; does not cross the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and kidneys. It is excreted by the kidneys (30-80%).

Indications

• Diabetes mellitus in adults.

ICD codes

Dosage Regimen

The drug is intended for subcutaneous administration. The dose and time of administration of the drug are determined by the doctor individually in each specific 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. The drug is usually administered subcutaneously into the thigh. Injections can also be made into the anterior abdominal wall, buttock, or the area of the deltoid muscle of the shoulder. It is necessary to change injection sites within the anatomical area to prevent the development of lipodystrophies.

Humodar B 100 can be administered either alone or in combination with short-acting insulin (Humodar R 100).

Instructions to be given to the patient

Injection technique when using insulin in vials

If the patient uses only one type of insulin

1. Disinfect the rubber membrane on the vial
2. Draw air into the syringe in an amount corresponding to the required dose of insulin. Inject the air into the insulin vial.
3. Turn the vial with the syringe upside down and draw the required dose of insulin into the syringe. Remove the needle from the vial and remove air from the syringe. Check the correctness of the insulin dose drawn
4. Immediately make the injection.

If the patient needs to mix two types of insulin

1. Disinfect the rubber membranes on the vials.
2. Immediately before drawing, roll the vial with long-acting insulin (“cloudy”) between your palms until the insulin becomes uniformly white and cloudy.
3. Draw air into the syringe in an amount corresponding to the dose of “cloudy” insulin. Inject the air into the vial with “cloudy” insulin and remove the needle from the vial.
4. Draw air into the syringe in an amount corresponding to the dose of short-acting insulin (“clear”). Inject the air into the vial with “clear” insulin. Turn the vial with the syringe upside down and draw the required dose of “clear” insulin. Remove the needle and remove air from the syringe. Check the correctness of the drawn dose.
5. Insert the needle into the vial with “cloudy” insulin, turn the vial with the syringe upside down and draw the required dose of insulin. Remove air from the syringe and check the correctness of the drawn dose. Immediately make an injection of the drawn insulin mixture.
6. Always draw insulins in the same sequence described above.

Injection technique when using insulin in cartridges

The cartridge with Humodar B 100 is intended for use in pen injectors only. It is necessary to carefully follow the instructions in the manual for the pen injector for insulin administration.

Before use, make sure that the cartridge with Humodar B 100 has no damage (e.g., cracks). Do not use the cartridge if there are any visible damages. After the cartridge is inserted into the pen injector, the colored stripe should be visible through the cartridge holder window. Before placing the cartridge into the pen injector, turn the cartridge up and down so that the glass ball moves from one end of the cartridge to the other. This procedure should be repeated at least 10 times until the entire liquid becomes white and uniformly cloudy. Immediately after this, an injection should be made.

If the cartridge is already inside the pen injector, turn it with the cartridge inside up and down at least 10 times. This procedure must be repeated before each injection.

After the injection, the needle should remain under the skin for at least 6 seconds. Hold the button pressed until the needle is completely removed from under the skin, thus ensuring correct administration of the dose and limiting the possibility of blood or lymph entering the needle or the insulin cartridge.

The cartridge with Humodar B 100 is intended for individual use only and is not refillable.

Injection procedure

1. With two fingers, take a fold of skin, insert the needle into the base of the fold at an angle of about 45°C (113°F) and inject the insulin under the skin.

2. After the injection, the needle should remain under the skin for at least 6 seconds to ensure that the insulin is completely injected.

3. If blood appears at the injection site after removing the needle, press the injection site lightly with your finger.

4. It is necessary to change injection sites.

Adverse Reactions

Due to the effect on carbohydrate metabolism hypoglycemic conditions (pallor of the skin, increased sweating, palpitations, tremor, feeling of hunger, agitation, paresthesia in the mouth area, headache). Severe hypoglycemia can lead to the development of hypoglycemic coma.

Allergic reactions rarely – skin rash, angioedema; extremely rarely – anaphylactic shock.

Local reactions hyperemia, swelling and itching at the injection site, with prolonged use – lipodystrophy at the injection site.

Other edema, transient refraction disorders (usually at the beginning of therapy).

Contraindications

• Hypoglycemia;
• Hypersensitivity to insulin or other components of the drug.

Use in Pregnancy and Lactation

There are no restrictions on the treatment of diabetes mellitus with insulin during pregnancy, since insulin does not cross the placental barrier. When planning pregnancy and during it, it is necessary to intensify the treatment of diabetes mellitus. The need for insulin usually decreases in the first trimester of pregnancy and gradually increases in the second and third trimesters. During childbirth and immediately after them, the need for insulin may decrease sharply. Soon after childbirth, the need for insulin quickly returns to the level that was before pregnancy.

There are no restrictions on the treatment of diabetes mellitus with insulin during lactation. However, a reduction in the insulin dose may be required, so careful monitoring is necessary until the insulin requirement stabilizes.

Use in Hepatic Impairment

The insulin dose must be adjusted in case of impaired liver function.

Use in Renal Impairment

The insulin dose must be adjusted in case of impaired renal function.

Geriatric Use

The insulin dose must be adjusted in patients over 65 years of age.

Special Precautions

During insulin therapy, constant monitoring of blood glucose levels is necessary. Causes of hypoglycemia, in addition to insulin overdose, may include: changing the drug, skipping a meal, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (impaired liver and kidney function, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), changing the injection site, as well as interaction with other drugs.

Incorrect dosing or interruptions in insulin administration can lead to hyperglycemia. Usually, the first symptoms of hyperglycemia develop gradually, over several hours or days. They include the appearance of thirst, frequent urination, nausea, vomiting, dizziness, redness and dryness of the skin, dry mouth, loss of appetite.

The insulin dose must be adjusted in case of thyroid dysfunction, Addison’s disease, hypopituitarism, impaired liver and kidney function, and diabetes mellitus in persons over 65 years of age.

Do not use the drug if, after shaking, the suspension does not become white or uniformly cloudy.

Adjustment of the insulin dose may also be required if the patient increases the intensity of physical activity or changes the usual diet. Concomitant diseases, especially infections and conditions accompanied by fever, increase the need for insulin.

Switching from one type of insulin to another should be carried out under the control of blood glucose levels.

The drug reduces tolerance to alcohol.

Effect on the ability to drive vehicles and mechanisms

Due to the initial prescription of insulin, changing its type, or in the presence of significant physical or mental stress, the ability to drive a car or operate various mechanisms, as well as engage in other potentially hazardous activities that require increased attention and speed of mental and motor reactions, may be reduced.

Overdose

Symptoms development of hypoglycemia is possible.

Treatment mild hypoglycemia can be eliminated by the patient himself by taking sugar or carbohydrate-rich foods orally. Therefore, patients with diabetes are recommended to always carry sugar, sweets, cookies or sweet fruit juice with them.

In severe cases, when the patient loses consciousness, 40% dextrose (glucose) solution is administered intravenously; glucagon is administered intramuscularly, subcutaneously, or intravenously. After regaining consciousness, the patient is recommended to take food rich in carbohydrates to prevent the re-development of hypoglycemia.

Drug Interactions

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

The hypoglycemic effect of Humodar B 100 is enhanced by oral hypoglycemic drugs, 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, quinidine, quinine, chloroquine, preparations containing ethanol.

The hypoglycemic effect of the drug is weakened by oral contraceptives, corticosteroids, thyroid hormones, glucagon, somatotropin, estrogens, loop and thiazide diuretics, sulfinpyrazone, marijuana, epinephrine, histamine H1-receptor blockers, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Under the influence of reserpine and salicylates, both weakening and enhancement of the drug’s effect is possible.

Pentamidine can both enhance and weaken the hypoglycemic effect of insulin.

While taking alcohol, the need for insulin decreases, which requires adjustment of the drug dose.

Storage Conditions

The drug should be stored at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Do not allow freezing.

An insulin vial that is in use can be stored for 6 weeks, and an insulin cartridge for 3 weeks at room temperature (not higher than 25°C (77°F)), provided it is protected from direct exposure to heat and light. Keep out of reach of children.

Shelf Life

Shelf life – 2 years. Do not use after the expiration date indicated on the package.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.