Humalog Mix 50 suspension for subcutaneous injection 100IU/ml 3ml QuickPen syringe pen cartridges, 5pcs

Composition

1 ml of suspension for subcutaneous use contains:

Active ingredient:

two-phase insulin lispro 100 IU (a mixture of a solution of insulin lispro-50%; suspensions of insulin lispro protamine-50%)

auxiliary substances:

metacresol – 2.2 mg,

phenol liquid 1 mg,

glycerol (glycerin) – 16 mg

Protamine sulfate – 0.19 mg,

sodium hydrogen phosphate, heptahydrate – 3.78 mg,

zinc oxide – q. s. to obtain the Zn2+ 30.5 mcg,

water for injection up to 1 ml

of hydrochloric acid solution 10% and/or sodium hydroxide solution 10% – q. s. to pH 7.0-7.8.

Pharmacological action of

Humalog Mix 50 is a ready-mix solution of insulin lispro 50% (fast-acting human insulin analogue) and profenofos suspension of insulin lispro 50% (the analogue of human insulin of average duration of action).

The main action of insulin lispro is the regulation of glucose metabolism.

In addition, it has an anabolic and anti-catabolic effect on various body tissues. In muscle tissue, there is an increase in the content of glycogen, fatty acids, glycerol, increased protein synthesis and increased consumption of amino acids, but there is a decrease in glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid release.

It has been shown that insulin lispro is equimolar to human insulin, but its effect occurs faster and lasts less. After subcutaneous injection of Humalog Mix 50, a rapid onset of action and an early onset of peak activity of insulin lispro are observed. The onset of action of the drug is approximately 15 minutes, which allows the drug to be administered immediately before a meal (0-15 minutes before a meal), compared to normal human insulin. After subcutaneous injection of Humalog Mix 50, a rapid onset of action and an early onset of peak activity of insulin lispro are observed. The action profile of insulin lispro protamine is similar to that of conventional insulin isophane with a duration of action of approximately 15 hours

PHARMACOKINETICS

The completeness of absorption and the onset of the effect of insulin depends on the site of use (abdomen, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the drug, etc. It is distributed unevenly through the tissues; it does not penetrate through 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 requiring insulin therapy.

Use during pregnancy and lactation

Sufficient and well-controlled studies have not been conducted in pregnant women. Patients suffering from diabetes are advised to inform the doctor about the upcoming or planned pregnancy. During pregnancy, it is especially important to monitor the condition of patients receiving insulin therapy.

The need for insulin usually decreases during the first trimester and increases during the second and third trimesters. During labor and immediately after it, the need for insulin may decrease dramatically.

Women with diabetes may need to adjust their insulin dose, diet, or both during breast-feeding.

Contraindications

Hypoglycemia; hypersensitivity to insulin or to one of the components of the drug.

The safety and efficacy of Humalog Mix 50 in patients under 18 years of age has not been studied.

Side effects

Hypoglycemia is the most common side effect that occurs with the use of all insulin preparations, including Humalog ® Mix 50. Severe hypoglycemia can lead to unconsciousness and, in exceptional cases, death.

Allergic reactions: patients may experience local allergic reactions in the form of redness, swelling or itching at the injection site. These minor reactions usually disappear within a few days or weeks. In some cases, these reactions may be caused by non-insulin-related causes, such as skin irritation with a cleansing agent or improper injection.

Systemic allergic reactions caused by insulin occur less frequently, but are more serious. They can manifest as generalized itching, difficulty breathing, shortness of breath, decreased blood pressure, increased pulse rate, and increased sweating. Severe cases of systemic allergic reactions can be life-threatening. In rare cases of severe allergy to Humalog Mix 50, immediate treatment is required. You may need to change your insulin, or perform desensitization.

With prolonged use, lipodystrophy may develop at the injection site.

Interaction

The hypoglycemic effect of Humalog Mix 50 is reduced when co-administered with the following medications: oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, danazol, beta-2-adrenomimetics (for example, ritodrin, salbutamol, terbutaline), thiazide diuretics, Chlorprothixen, diazoxide, isoniazid, nicotinic acid, phenothiazine derivatives.

Hypoglycemic effect of the drug Humalog Mix 50 reinforce: beta-blockers, ethanol and etanolsodergaszczye drugs, anabolic steroids, fenfluramine, guanetidin, tetracyclines, oral hypoglycemic drugs, salicylates (eg, aspirin), sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors), ACE inhibitors (captopril, enapril), octreotide, antagonists of angiotensin II receptors.

Beta-blockers, clonidine, reserpine may mask the symptoms of hypoglycemia.

The interaction of Humalog Mix 50 with other insulin preparations has not been studied.

How to take, course of use and dosage

Subcutaneously. The dose of Humalog Mix 50 is determined by the doctor individually, depending on the concentration of blood glucose. The mode of use of insulin is individual.

The drug should only be administered subcutaneously. Intravenous use of Humalog Mix 50 is unacceptable.

The temperature of the administered drug should correspond to room temperature. Subcutaneous injections should be given in the shoulder, thigh, buttock or abdomen. Injection sites should be alternated so that the same site is used no more than about once a month. When injecting Humalog Mix 50 subcutaneously, care should be taken to avoid getting the drug into the lumen of blood vessels. After the injection, do not massage the injection site.

For instructions on how to insert the cartridge into the Humalog Mix 50 injection device and attach the needle to it before injecting the drug, read the instructions of the manufacturer of the device for injecting insulin. Strictly follow the instructions you read.

Preparing for the introduction

Immediately before use, the Humalog Mix 50 cartridge should be rolled ten times between the palms of your hands and swung, turning 180° also ten times to resuspend the insulin until it looks like a homogeneous, cloudy liquid. Do not shake vigorously, as this can lead to foam formation, which can interfere with the correct dose set. To facilitate mixing, a small glass ball is placed inside the cartridge.

Do not use Humalog Mix 50 if it contains flakes after mixing.

Dose use

1. Wash your hands.

2. Select the injection site.

3. Prepare the skin at the injection site as recommended by your doctor.

4. Remove the outer protective cap from the needle.

5. Fix the skin by it into a large fold.

6. Insert the needle subcutaneously into the collected fold and inject according to the instructions for using the pen.

7. Remove the needle and gently press the injection site with a cotton swab for a few seconds. Do not rub the injection site.

8. Using the outer needle protection cap, unscrew the needle and dispose of it.

9. Put the cap on the pen.

For Humalog Mix 50 in the Quickpen pen

Before injecting insulin, you should read the Quickpen Pen Instructions.

Overdose

An overdose of insulin causes hypoglycemia, accompanied by the following symptoms: lethargy, excessive sweating, tachycardia, pallor of the skin, headache, trembling, vomiting, confusion. Under certain conditions, for example, with a long duration of the disease or with intensive control of diabetes mellitus, the symptoms-harbingers of hypoglycemia may change.

Mild conditions of hypoglycemia can usually be relieved by ingesting glucose or sugar. You may need to adjust your insulin dose, diet, or physical activity. Correction of moderate hypoglycemia can be performed by intramuscular or subcutaneous use of glucagon, followed by ingestion of carbohydrates. Severe hypoglycaemic states, accompanied by coma, convulsions or neurological disorders, are stopped by intramuscular / subcutaneous use of glucagon or intravenous use of a concentrated dextrose (glucose) solution.

After regaining consciousness, the patient should be given food rich in carbohydrates, in order to avoid the re-development of hypoglycemia.

Further carbohydrate intake and subsequent monitoring of the patient may be required, as a recurrence of hypoglycemia may occur.

Special instructions

The transfer of the patient to another type of insulin or a drug with a different trade name should be carried out under strict medical supervision. Changes in the concentration of insulin, brand (manufacturer), type (Regular, NPH, etc.), species (animal, human, human insulin analog), and/or production method (DNA recombinant insulin or animal-derived insulin) may require dose adjustment.

For some patients, when switching from animal-derived insulin to human-derived insulin, it may be necessary to adjust the dose. This may occur as early as the first use of a human insulin preparation, or gradually over several weeks or months after the transfer. Symptoms-harbingers of hypoglycemia with the introduction of human insulin in some patients may be less pronounced or differ from those that were observed in them against the background of the introduction of insulin of animal origin. When the blood glucose concentration is normalized, for example, as a result of intensive insulin therapy, all or some of the symptoms that are harbingers of hypoglycemia may disappear, and patients should be informed about this. Warning signs of hypoglycemia may change or be less pronounced with prolonged diabetes, diabetic neuropathy, or treatment with medications such as beta-blockers.

The use of inadequate doses or discontinuation of treatment, especially in patients with type 1 diabetes, can lead to hyperglycemia and diabetic ketoacidosis (potentially life-threatening conditions). The need for insulin may decrease if the function of the adrenal glands, pituitary gland or thyroid gland is insufficient, with renal or hepatic insufficiency. With certain diseases or emotional stress, the need for insulin may increase. You may also need to adjust your insulin dose if you increase your physical activity or change your regular diet.

Influence on the ability to drive motor vehicles and manage mechanisms

During hypoglycemia, the patient’s concentration and speed of psychomotor reactions may decrease. This can be dangerous in situations where these abilities are particularly needed (such as driving motor vehicles or operating machinery). Patients should be advised to take precautions to avoid hypoglycemia when driving motor vehicles and operating machinery. This is especially important for patients with mild or no symptoms-harbingers of hypoglycemia or with frequent development of hypoglycemia. In such cases, the doctor should evaluate whether the patient should drive a car and operate mechanisms.

Form of production

Suspension for subcutaneous use

Storage conditions

At a temperature of 2-8°C. Protect from direct sunlight and heat. Avoid freezing. The used drug in the cartridge / syringe pen should be stored at a temperature of no more than 30°C for no more than 28 days.

Shelf

life is 2 years.

Active ingredient

Insulin lispro biphasic

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Type 2 Diabetes, Type 1 Diabetes