Expiration date: 12/2026

The composition and form of issue:

Suspension for subcutaneous injection. 1 ml contains:

insulin lispro* 100 IU

is a mixture of: 

a solution of insulin lispro* — 25% suspension insulin lispro* Protamine 75% 

excipients: sodium phosphate dibasic, glycerol (glycerin), phenol, metacresol, Protamine sulfate, zinc oxide, water d/and, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% — to create the necessary pH level 

in cartridges 3 ml in packages contour cell for 5 cartridges in cardboard pack 1 pack.

* — international nonproprietary name recommended by the who in the Russian Federation adopted the spelling of international names — insulin lispro.

Description pharmaceutical form:

Suspension for p/to the introduction white color, flaking with the formation of a white precipitate and a clear, colorless or almost colorless supernatant liquid, the precipitate is easily resuspendiruetsa with mild shaking.

Feature:

Hypoglycemic agents, insulin analogues combination of quick and medium duration of action.

Pharmacokinetics:

Absorption and distribution. The fullness of the suction and the beginning of the effect of insulin depends upon the site of injection (abdomen, thigh, buttocks), dose (amount of insulin), insulin concentrations of the drug. Unevenly distributed in the tissues. Does not penetrate through the placental barrier and in breast milk.

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

Description pharmacological action:

Humalog™ Mix 25 is the DNA recombinant analog of human insulin and is a ready mixture consisting of a solution of insulin lispro (fast-acting analog of human insulin) and a suspension of insulin lispro Protamine (an analogue of human insulin average duration).

The main action of insulin lispro is the regulation of glucose metabolism. In addition, it has an anabolic and anti-catabolic effects on different tissues of the body. In muscle tissue there is an increase in glycogen content, 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 release of amino acids.

It is shown that the equimolar insulin lispro human insulin, but its action develops more quickly and lasts for a shorter time. The beginning of drug action of approximately 15 minutes, allowing you to enter it immediately before the meal (15 min before the meal) compared to human insulin. After p/to the injections of Humalog™ Mix 25 there is a rapid onset of action and early peak of activity of insulin lispro. The action profile of insulin lispro Protamine is similar to the action profile of regular insulin isophane with a duration of approximately 15 h.

Indications:

Diabetes mellitus, requiring insulin.

Contraindications:

• hypersensitivity to the drug
  
• hypoglycemia.
  

Application of pregnancy and breast-feeding:

To date not revealed any unwanted actions of insulin lispro on pregnancy or the fetus and newborn.

The goal of insulin therapy during pregnancy is to maintain adequate glucose control. The need for insulin usually decreases in the first trimester and increases in II and III trimestrah pregnancy. During childbirth and immediately after their need for insulin can dramatically decrease.

Women of childbearing age with diabetes should inform the doctor about current or planned pregnancy.

In patients with diabetes mellitus in the period of breast-feeding may require dose adjustment of insulin and/or diet.

Application for violations of liver and kidney. Insulin requirements may be reduced in hepatic or renal failure.

Side effects:

A side effect that is associated with the main action of the drug: the most common being hypoglycemia. Severe hypoglycemia can lead to unconsciousness and, in extreme cases, death.

Allergic reactions: there local allergic reactions — redness, swelling or itching at the injection site (usually disappear within several days or weeks in some cases, these reactions can be caused by causes not related to insulin, such as skin irritation with antiseptic or improper injection) systemic allergic reactions (occur less frequently but are more serious) — generalized itching, shortness of breath, reducing AD, tachycardia, excessive sweating. Severe cases of systemic allergic reactions can be life threatening.

In rare cases, a severe Allergy to Humalog™ Mix 25 requires immediate treatment. May be necessary to change insulin or the conduct of desensitization.

Other: with prolonged use may develop lipodystrophy at the injection site.

Drug interactions:

Hypoglycemic effect of Humalog™ Mix 25 is reduced with concomitant administration with the following drugs: oral contraceptives, corticosteroids, preparations for thyroid hormones, danazol, &beta2-agonists (including ritodrine, salbutamol, terbutaline), thiazide diuretics, lithium preparations, chlorprothixene, diazoxide, isoniazid, Niacin, phenothiazines.

Hypoglycemic effect of Humalog™ Mix 25 increase &beta-adrenoblokatora, ethanol and etanolsodergaszczye products, anabolic steroids, fenfluramine, guanetidin, tetracyclines, oral gipoglikemicakie preparations, salicylates (e.g. acetylsalicylic acid), sulfonamides, MAO inhibitors, ACE inhibitors (captopril, enalapril), oktreotid, antagonists of angiotensin II receptors.

&beta-blockers, clonidine, and reserpine may mask the symptoms of hypoglycemia.

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

Method of application and dose:

N/a, in the shoulder, thighs, buttocks or abdomen. Injection sites should be alternated so that one and the same place to use no more than 1 time per month. When s/to the introduction of Humalog™ Mix 25 need to exercise caution to avoid getting the drug into the blood vessel. After the injection you should not massage the injection site.

The temperature of the injected preparation should correspond to the room.

Dose doctor determines individually, depending on the level of glucose in the blood. Mode of insulin individual.

In/with the introduction of Humalog™ Mix 25 is contraindicated.

When installing the cartridge into the device for insulin administration and the accession of the needle before the introduction of insulin should strictly observe the instructions of the manufacturer of the device for insulin.

Rules of administration Humalog™ Mix 25

Prepare for the introduction.Just before using the cartridge, Humalog™ Mix 25 should be rolled between the palms 10 times and shake, turning it 180° 10 times to resuspension of insulin, until it reaches the form of a homogeneous turbid liquid or milk. You should not shake vigorously, as this may cause foam, which may prevent the correct set of dose. To facilitate the mixing cartridge contains a small glass ball. The drug should not be used if it has after mixing the cereal.

Introduction

1. To wash my hands.

2. Choose an injection site.

3. Processing antiseptic skin at the injection site (if self-injection is in accordance with the recommendations of the doctor).

4. Remove the outer protective needle cap.

5. To fix the skin, pulling it or taking a big fold.

6. Insert the needle s/C and to perform the injection in accordance with the instructions for using the pen.

7. Remove the needle and gently press the injection site for several seconds. Do not RUB the injection site.

8. Using the outer protective cap of the needle, Unscrew needle and destroy her.

9. Put a cap on the pen.

Overdose:

Symptoms: hypoglycemia, accompanied by the following symptoms: lethargy, sweating, tachycardia, headache, vomiting, confusion. Under certain conditions, such as long duration or intense control of diabetes, symptoms-signs of hypoglycaemia may change.

Treatment: light condition of hypoglycemia usually cropped ingestion of glucose or other sugar or products containing sugar. You may need to adjust insulin dose, diet or physical activity.

Correction of moderately severe hypoglycaemia can be accomplished by using the/m or p/to the introduction of glucagon with subsequent ingestion of carbohydrate.

Heavy state of hypoglycemia, accompanied by coma, convulsions or neurological disorders cropped in/m or p/to the introduction glukagona or in/with the introduction of concentrated solution of dextrose (glucose). After regaining consciousness, the patient should give food, rich in carbohydrates, to avoid a recurrence of hypoglycemia.

You may need to continue the intake of carbohydrates and observation of the patient, as may occur recurrence of hypoglycemia.

Special instructions:

Transfer the patient to another type or insulin product with a different trade name should be under strict medical supervision. The change in the activity of, trade mark (manufacturer), type (e.g. Regular, NPH), species (animal, human, human insulin analogue) and/or method of production (DNA-recombinant insulin or the insulin of animal origin) can lead to the need for dose adjustment.

For some patients when switching from animal insulin to human insulin may need dose adjustment. This may occur already at the first administration of the drug is human insulin or gradually over several weeks or months after the transfer.

Symptoms-signs of hypoglycemia on the background of the introduction of human insulin some patients may be less pronounced or different from those they have observed on the background of insulin of animal origin. With the normalization of blood glucose levels through intensive insulin therapy, can disappear all or some of the symptoms-signs of hypoglycemia, what patients need to be informed. Symptoms-signs of hypoglycaemia may change or be less pronounced with prolonged duration of diabetes, diabetic neuropathy, or treatment with drugs such as beta-blockers.

The use of inadequate doses or discontinuation of treatment, especially in patients with insulin-dependent diabetes, may lead to hyperglycaemia and diabetic ketoacidosis (condition, potentially life-threatening patient).

Insulin requirements may be reduced in case of insufficient function of the adrenal, pituitary or thyroid glands, when kidney or liver failure. In some diseases or emotional stress insulin requirements may increase. Correction doses of insulin may also be required in increasing physical activity or changing diets.

Effects on ability to drive vehicles and management mechanisms

During hypoglycemia, the patient may reduce the concentration of attention and speed of psychomotor reactions. This may present a risk in situations where these abilities are especially needed (e.g. driving a car or operating machinery).

Patients should be advised to take precautions to avoid hypoglycemia while driving vehicles and management mechanisms. This is especially important for patients with mild or absent symptoms-signs of hypoglycemia or if you frequently develop hypoglycemia. In such cases, the physician should evaluate the appropriateness of the patient driving a car and management mechanisms.

Storage conditions:

Do not freeze.