Humalog Mix 25, 100me/ml cartridges, 3ml in Quickpen syringe pen, 5

Composition

>1 ml of suspension contains: insulin lispro 100 meusmedical substances: metacresol – 1.76 mg, phenol liquid – 0.8 mg (calculated as 89% phenol 0.715 mg), glycerol (glycerin) – 16 mg Protamine sulfate – 0.28 mg, sodium hydrogen phosphate – 3.78 mg, zinc oxide – q. s. to obtain the Zn2+ no more than 25 mcg of hydrochloric acid solution 10% and/or sodium hydroxide solution 10% – q. s. to establish a pH of 7.0-7.8, water d/and – up to 1 ml.

Pharmacological action

Hypoglycemic drug, a combination of fast-acting and medium-acting insulin analogues. Humalog ® Mix 25 is a DNA-recombinant analog of human insulin and is a ready-made mixture consisting of a solution of insulin lispro (a fast-acting analog of human insulin) and a suspension of insulin lispro protamine (an analog of human insulin of medium duration).

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 action develops faster and lasts for a shorter time. The onset of action of the drug is approximately 15 minutes, which allows it to be administered immediately before a meal (0-15 minutes before a meal), compared to normal human insulin. After subcutaneous injection of Humalog Mix 25, a rapid onset of action and an early peak of insulin lispro activity 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.

Indications

Diabetes mellitus requiring insulin therapy.

Contraindications

Hypoglycemia; hypersensitivity to the components of the drug.

Side effects

Side effect associated with the main action of the drug:  most often – hypoglycemia. Severe hypoglycemia can lead to unconsciousness and, in exceptional cases, death.

Allergic reactions:  local allergic reactions are possible – redness, swelling or itching at the injection site (usually disappear within a few days or weeks; in some cases, these reactions can be caused by non-insulin reasons, for example, skin irritation with an antiseptic or improper injection); systemic allergic reactions (occur less often, but are more serious) – generalized itching, difficulty breathing, shortness of breath, decreased blood pressure, tachycardia, increased sweating. Severe cases of systemic allergic reactions can be life-threatening.

In rare cases of severe allergy to Humalog Mix 25, immediate treatment is required. You may need to change your insulin or desensitize it.

Local reactions:  with prolonged use, lipodystrophy may develop at the injection site.

Interaction

The hypoglycemic effect of Humalog Mix 25 decreases when administered concomitantly with the following medications: oral contraceptives, corticosteroids, thyroid hormone preparations, danazol, beta-2-adrenomimetics (including ritodrin, salbutamol, terbutaline), thiazide diuretics, lithium preparations, Chlorprothixen, diazoxide, isoniazid, nicotinic acid, phenothiazine derivatives. The hypoglycemic effect of Humalog Mix 25 is enhanced by beta-blockers, ethanol and ethanol-containing drugs, anabolic steroids, fenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (for example, acetylsalicylic acid), sulfonamides, MAO inhibitors, ACE inhibitors (captopril, enalapril), octreotide, receptor antagonists angiotensin II. Beta-blockers, clonidine, and reserpine may mask the symptoms of hypoglycemia. The interaction of Humalog Mix 25 with other insulin preparations has not been studied.

How to take, course of use and dosage

The doctor determines the dose individually, depending on the level of glucose in the blood. The mode of use of insulin is individual. The drug should be administered subcutaneously. Intravenous use of Humalog ® Mix 25 is contraindicated. The temperature of the administered drug should correspond to room temperature. The subcutaneous injection should be applied to the shoulder, hip, buttock, or abdomen. Injection sites should be alternated so that the same place is used no more than once a month. Caution should be exercised when administering Humalog subcutaneously to avoid the drug entering the blood vessel. After the injection, do not massage the injection site. When inserting the cartridge into the insulin injection device and attaching the needle before injecting insulin, you must strictly follow the instructions of the manufacturer of the insulin injection device.

Overdose

Symptoms: hypoglycemia, accompanied by the following symptoms: lethargy, increased sweating, tachycardia, headache, vomiting, confusion. Under certain conditions, for example, with a long duration or with intensive control of diabetes mellitus, the symptoms-harbingers of hypoglycemia may change. Treatment: Mild conditions of hypoglycemia are usually relieved by ingestion of glucose or other sugar, or by foods containing sugar. You may need to adjust your insulin dose, diet, or physical activity. Correction of moderately severe hypoglycemia can be carried out with the help of intravenous or subcutaneous use of glucagon, followed by ingestion of carbohydrates. Severe conditions of hypoglycemia, accompanied by coma, convulsions or neurological disorders are stopped by intravenous or subcutaneous use of glucagon or intravenous use of a solution of concentrated dextrose (glucose) solution. After regaining consciousness, the patient should be given a carbohydrate-rich diet to avoid recurrent hypoglycemia. It may be necessary to continue taking carbohydrates and monitor the patient, as a relapse of hypoglycemia may occur.

Special instructions

The transfer of a patient to a different type of insulin or a drug with a different trade name should be carried out under strict medical supervision. A change in the activity, brand (manufacturer), type (e. g., Regular, NPH), species (animal, human, human insulin analog), and/or method of production (DNA recombinant insulin or animal-derived insulin) may lead to the need for dose adjustment. For some patients, when switching from animal-derived insulin to human-derived insulin, a dose adjustment may be necessary. 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 during the use of human insulin in some patients may be less pronounced or differ from those observed in them during the use of animal-derived insulin. When blood glucose levels normalize, 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 insulin-dependent diabetes mellitus, 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.

Storage conditions

List B. The drug should be stored out of the reach of children at a temperature of 2° to 8°C; do not freeze, protect from direct sunlight and heat.

The used drug in the cartridge should be stored at a temperature not exceeding 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