Humalog Mix 50, 100 me/ml suspension 3 ml quikpen syringe pen cartridges 5 pcs

Humalog Mix 50 is a pre-mix consisting of a 50% insulin lispro solution (a fast-acting human insulin analog) and a 50% pro-tamine suspension of insulin lispro (a medium-acting human insulin analog).

The primary action of insulin lispro is to regulate glucose metabolism.

In addition, it has anabolic and anti-catabolic effects on various tissues of the body. In muscle tissue there is an increase of glycogen, fatty acids, glycerol content, increased protein synthesis and increased amino acid consumption, but there is a decrease of 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 is faster and lasts less. After a subcutaneous injection of Humalog Mix 50, there is a rapid onset of action and an early onset of peak insulin lispro activity. The onset of action of the drug is about 15 minutes later, allowing the drug to be injected immediately before a meal (0-15 minutes before the meal), compared to regular human insulin. After subcutaneous injection of Humalog Mix 50 there is a rapid onset of action and early onset of peak insulin lispro activity. The action profile of insulin lispro protamine is similar to that of regular isophan insulin with a duration of action of approximately 15 hours

PHARMACOKINETICS

The completeness of absorption and onset of effect of insulin depends on the place of administration (stomach, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the drug, etc. Distributed irregularly in tissues; does not penetrate through 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

Diabetes mellitus requiring insulin therapy.

Pharmacological effect

Humalog Mix 50 is a ready-made mixture consisting of a solution of insulin lispro 50% (a fast-acting analogue of human insulin) and a protamine suspension of insulin lispro 50% (an analogue of human insulin with an average duration of action).

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

In addition, it has anabolic and anti-catabolic effects on various tissues of the body. In muscle tissue, there is an increase in the content of glycogen, fatty acids, glycerol, increased protein synthesis and an increase in amino acid consumption, but at the same time 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 is 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 meals (0-15 minutes before meals), compared to regular 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 regular isophane insulin 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 injection site (abdomen, thigh, buttocks), dose (volume of insulin administered), insulin concentration in the drug, etc. It is unevenly distributed throughout the tissues; does not penetrate the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and kidneys. Excreted by the kidneys (30-80%).

Special instructions

Transferring a patient to another type or insulin preparation with a different trade name should occur under strict medical supervision. Changes in insulin concentration, brand (manufacturer), type (Regular, NPH, etc.), species (animal, human, analogue of human insulin) and/or production method (DNA recombinant insulin or insulin of animal origin) may require dose adjustment.

For some patients, when switching from animal insulin to human insulin, it may be necessary to adjust the dose. This may occur as early as the first injection of human insulin or gradually over several weeks or months after the transfer. Symptoms that are precursors of hypoglycemia during the administration of human insulin in some patients may be less pronounced or different from those observed during the administration of animal insulin. When blood glucose concentrations are normalized, for example, as a result of intensive insulin therapy, all or some of the symptoms that are precursors of hypoglycemia may disappear, of which patients should be informed. Warning symptoms of hypoglycemia may change or be less severe with long-term diabetes mellitus, diabetic neuropathy, or treatment with drugs such as beta-blockers.

The use of inappropriate doses or discontinuation of treatment, especially in patients with type 1 diabetes, can lead to hyperglycemia and diabetic ketoacidosis (conditions that are potentially life-threatening for the patient). The need for insulin may be reduced if there is insufficiency of the adrenal glands, pituitary gland or thyroid gland, or with renal or liver failure. With some illnesses or emotional stress, the need for insulin may increase. Insulin dosage adjustments may also be necessary if you increase your physical activity or change your usual diet.

Impact on the ability to drive vehicles and operate machinery

During hypoglycemia, the patient’s concentration and speed of psychomotor reactions may decrease. This may pose a hazard in situations where these abilities are particularly needed (for example, driving a vehicle or operating machinery). Patients should be advised to take precautions to avoid hypoglycemia while driving vehicles and operating machinery. This is especially important for patients with mild or absent warning signs of hypoglycemia or those with frequent hypoglycemia. In such cases, the doctor must evaluate the appropriateness of the patient driving a car and operating machinery.

Active ingredient

Insulin lispro biphasic

Composition

1 ml of suspension for subcutaneous administration contains:

active ingredient:

insulin lispro biphasic 100 IU (mixture of insulin lispro solution – 50%; insulin lispro protamine suspension – 50%)

excipients:

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 Zn2+ 30.5 μg,

water for injection – up to 1 ml;

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

Pregnancy

There are no sufficient and well-controlled studies in pregnant women. Patients suffering from diabetes are advised to inform their doctor about an existing or planned pregnancy. During pregnancy, it is especially important to monitor the condition of patients receiving insulin therapy.

Insulin requirements usually decrease during the 1st trimester and increase during the 2nd and 3rd trimesters. During and immediately after childbirth, the need for insulin may decrease dramatically.

In patients with diabetes mellitus, adjustments in insulin dosage, diet, or both may be necessary during breastfeeding.

Contraindications

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

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

Side Effects

Hypoglycemia is the most common side effect that occurs with the administration of all insulin preparations, including Humalog® Mix 50. Severe hypoglycemia can lead to loss of consciousness 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 due to causes unrelated to insulin, such as skin irritation from the cleansing agent or improper injection administration.

Systemic allergic reactions caused by insulin occur less frequently but are more severe. They can manifest as generalized itching, difficulty breathing, shortness of breath, decreased blood pressure, increased heart 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 undergo desensitization.

With long-term use, lipodystrophy may develop at the injection site.

Interaction

The hypoglycemic effect of Humalog Mix 50 is reduced when co-administered with the following drugs: oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, danazol, beta2-adrenergic agonists (for example, ritodrine, salbutamol, terbutaline), thiazide diuretics, chlorprothixene, diazoxide, isoniazid, nicotinic acid, phenothiazine derivatives.

The hypoglycemic effect of Humalog Mix 50 is enhanced by: beta-blockers, ethanol and ethanol-containing drugs, anabolic steroids, fenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (for example, acetylsalicylic acid), sulfonamide antibiotics, some antidepressants (inhibitors monoamine oxidase), ACE inhibitors (captopril, enapril), octreotide, angiotensin II receptor antagonists.

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

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

Overdose

An overdose of insulin causes hypoglycemia, accompanied by the following symptoms: lethargy, increased sweating, tachycardia, pale 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 warning symptoms of hypoglycemia may change.

Mild hypoglycemia can usually be treated with oral glucose or sugar. Adjustments to your insulin dose, diet, or physical activity may be necessary. Correction of moderate hypoglycemia can be carried out using intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrates. Severe conditions of hypoglycemia, accompanied by coma, convulsions or neurological disorders, are treated with intramuscular/subcutaneous administration of glucagon or intravenous administration of a concentrated solution of dextrose (glucose).

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

Continued carbohydrate intake and subsequent monitoring of the patient may be necessary as relapse of hypoglycemia may occur.

Storage conditions

At a temperature of 2-8°C. Protect from direct sunlight and heat.

Shelf life

2 years.

Manufacturer

Lilly France, France