Humalog mix 25 suspension 100m/ml 3 ml №5 cartridges

Active substance

Insulin lispro biphasic

Composition

1 ml of suspension for subcutaneous administration contains:
active ingredient: insulin lispro biphasic 100 IU (mixture of insulin lispro solution - 25%; insulin suspension lizpro-protamine - 75%)
excipients: sodium phosphate dibasic, glycerol (glycerin), phenol, metacresol, protamine sulfate, zinc oxide, water for injection, hydrochloric acid 10% solution and / or sodium hydroxide solution 10% - until the required pH is created.

Mechanism of action

Humalog Mix 25 is a DNA-recombinant analogue of human insulin and is a ready-made mixture consisting of a solution of insulin lispro (a fast-acting analogue of human insulin) and a suspension of insulin lizpro-protamine (an analogue of human insulin of average duration).

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 glycogen, fatty acids, glycerol, increased protein synthesis and increased amino acid intake, but there is a decrease in glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and release of amino acids.

It is shown that insulin lispro is equimolar to human insulin, but its action develops faster and continues for a shorter time. The beginning of the action of the drug - after about 15 minutes, which allows you to enter it immediately before a meal (up to 15 minutes before a meal), compared with normal human insulin. After subcutaneous injection of Humaloga Mix 25, a rapid onset of action and an early peak in lizpro insulin activity are observed. The action profile of insulin lisprotamine is similar to the action profile of regular insulin isophane with a duration of action of approximately 15 hours.

Pharmacokinetics

Suction and distribution. The completeness of absorption and the onset of the insulin effect depends on the injection site (abdomen, thigh, buttocks), dose (volume of insulin injected), and insulin concentration in the preparation. Distributed in tissues unevenly.Does not penetrate the placental barrier and into breast milk.

Metabolism and excretion. It is destroyed by insulinase mainly in the liver and kidneys. Excreted by the kidneys - 30-80%.

Indications

Diabetes mellitus requiring insulin therapy.

Contraindications

Hypersensitivity to the drug; hypoglycemia.

Side effects

The side effect associated with the main action of the drug: most often - hypoglycemia. Severe hypoglycemia can lead to loss of consciousness 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 may be caused by reasons not related to insulin, such as irritation of the skin with an antiseptic or inappropriate injection); systemic allergic reactions (occur less frequently, but are more serious) - generalized itching, shortness of breath, lowering 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. It may be necessary to change insulin, or desensitization.

Other: long-term use may develop lipodystrophy at the injection site.

Interaction

Hypoglycemic effect of the drug Humalog Mix 25 decreases with simultaneous administration with the following drugs: oral contraceptives, GCS, thyroid hormone drugs, danazol, β2-adrenomimetics (including ritodrin, Salbutamol, terbutaline), thiazide diuretics, lithium preparations, chlorprotix, diazoxide, isoniazid, nicotinic acid, phenothiazine derivatives.

The hypoglycemic effect of the drug Humalog Mix 25 is enhanced by β-blockers, ethanol and ethanol-containing drugs, anabolic steroids, fenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (for example, acetylsalicylic acid), sulfonamides, MAO inhibitors, forces, and other factors that are useful in the first place, which is used by the MAO, they can be used by women, they can be used by women, they can also be used by the MAO, they can be used by women, they can also be used by women, they can also be used by women, they can be used by women, they can be used by women, they can be used by the oral hypoglycemic drugs, salicylates (for example, acetylsalicylic acid), sulfonamides, MAO inhibitors, by the means of the source, they will be used by you, you will be able to use them;, angiotensin II receptor antagonists.

β-adrenergic blockers, clonidine, reserpine may mask the manifestation of symptoms of hypoglycemia.

The interaction of Humalog Mix 25 with other insulin preparations has not been studied.

How to take, the course of administration and dosage

Subcutaneously, in the shoulder, thigh, buttocks or abdomen. Injection sites should be alternated in such a way that the same place should not be used more than once a month. When subcutaneous administration of the drug Humalog Mix 25, care must be taken to avoid getting the drug in a blood vessel. After the injection should not massage the injection site.

The temperature of the drug should be at room temperature.

The doctor determines the dose individually, depending on the level of glucose in the blood. The mode of administration of insulin is individual.

Intravenous administration of the drug Humalog Mix 25 is contraindicated.

When installing the cartridge in the device for insulin administration and attaching the needle, before the introduction of insulin, you should strictly follow the instructions of the manufacturer of the device for insulin administration.

Rules of administration of the drug Humalog^Tm Mix 25

Preparation for the introduction. Immediately before using the cartridge with the drug Humalog Mix 25 should be rolled between the palms 10 times and shake, turning 180 ° and 10 times to resuspend insulin until it takes on the appearance of a homogeneous turbid liquid or milk. Do not shake vigorously, because this can lead to foam, which can interfere with the correct set of doses. To facilitate mixing, the cartridge contains a small glass bead. The drug is not to be used if it contains flakes after mixing.

Introduction

1. Wash the hands.
2. Choose a place for injection.
3. Treat the skin at the injection site with an antiseptic (for self-injection - in accordance with the recommendations of the doctor).
4. Remove outer protective cap from needle.
5. To fix the skin, pulling it or taking it in a large fold.
6. Introduce the needle subcutaneously and perform the injection in accordance with the instructions for using the syringe pen.
7. Remove the needle and gently press the injection site for a few seconds. Do not rub the injection site.
8. Using the outer protective cap of the needle, unscrew the needle and destroy it.
9. Put the cap on the pen.

Overdosage

Symptoms: hypoglycemia, accompanied by the following symptoms: lethargy, increased sweating, tachycardia, headache, vomiting, confusion. Under certain conditions, for example, with long duration or intensive control of diabetes mellitus, the symptoms of precursors of hypoglycemia may change.

Treatment: Mild conditions of hypoglycemia are usually stopped by ingestion of glucose or other sugar, or products containing sugar. You may need a dose adjustment of insulin, diet, or physical activity.

Correction of moderately severe hypoglycemia can be performed using intramuscular or subcutaneous administration of glucagon, followed by ingestion of carbohydrates.

Severe conditions of hypoglycemia, accompanied by coma, convulsions or neurological disorders, are stopped by intramuscular or subcutaneous administration of glucagon or by intravenous administration of a concentrated solution of dextrose (glucose). After the recovery of consciousness, the patient must be given food rich in carbohydrates in order to avoid the recurrence of hypoglycemia.

May require further carbohydrate intake and patient monitoring, as possible recurrence of hypoglycemia.

Special instructions

The transfer of a patient to another type or drug of insulin with a different trade name must take place under strict medical supervision. Changes in activity, brand (manufacturer), type (for example, Regular, NPH), species (animal, human, human insulin analogue) and / or method of production (DNA-recombinant insulin or insulin of animal origin) may necessitate dose adjustment.

For some patients, switching from animal insulin to human insulin may require a dose adjustment. This may occur already at the first injection of a human insulin preparation or gradually over several weeks or months after the transfer.

Symptoms are precursors of hypoglycemia in the presence of human insulin in some patients may be less pronounced or different from those observed in the presence of insulin of animal origin. With the normalization of blood glucose levels, for example, as a result of intensive insulin therapy, all or some of the symptoms, precursors of hypoglycemia, may disappear, about which patients should be informed. Symptoms precursors of hypoglycemia may change or be less pronounced with long-term diabetes mellitus, diabetic neuropathy, or treatment with drugs such as β-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 (conditions that are potentially life-threatening to the patient).

The need for insulin may be reduced if there is insufficient adrenal, pituitary, or thyroid function in renal or hepatic failure. For some illnesses or emotional overvoltages, the need for insulin may increase. Insulin dose adjustment may also be required with increasing physical exertion or with a change in the normal diet.

Influence on ability to drive motor transport and control mechanisms

During hypoglycemia in a patient, a decrease in concentration and speed of psychomotor reactions is possible. This can be dangerous in situations in which these abilities are particularly necessary (for example, driving a car or controlling machinery).

Patients should be advised to take precautions to avoid hypoglycemia while driving and operating machinery. This is especially important for patients with mild or absent symptoms that are precursors of hypoglycemia or with the frequent development of hypoglycemia. In such cases, the physician should assess the feasibility of driving a car and controlling machinery.

Suspension for subcutaneous administration

In a place protected from direct sunlight, at a temperature of 2-8 ° C