HUMALOG MIX 25

Active material: Insulin lispro
When ATH: A10AD04
CCF: Čelovečeskiij insulin average duration with rapid onset of action
ICD-10 codes (testimony): E10, E11
When CSF: 15.01.01.03
Manufacturer: LILLY FRANCE S.A.S. (France)

Pharmaceutical form, composition and packaging

Suspension for s / c administration white, which exfoliated, forming white residue and transparent colorless or nearly colorless liquid nadosadocnuu; easily reached with resuspendiruetsa light shaking.

Excipients: sodium phosphate dibasic, glycerol (glycerol), phenol, liquid, cresol, protamine sulfate, Zinc oxide, water d / and, hydrochloric acid (solution 10%) and/or sodium hydroxide (solution 10%) (to adjust the pH).

3 ml – cartridges (5) – blisters (1) – packs cardboard.

* – international non-proprietary name, recommended by the WHO – Insulin lispro.

Pharmacological action

Hypoglycemic agents, the combination of insulin analogs fast and average duration. Humalog^® Mix 25 is DNA – recombinant human insulin analogue and represents a ready mix, consisting of a solution of insulin lizpro (fast-acting human insulin analog) and suspension lizpro insulin protamine (human insulin analog average duration).

The main action of insulin lizpro is the regulation of glucose metabolism. Besides, It has anabolic and some anticatabolic effect on various body tissues. The muscle tissue is increased glycogen content, fatty acids, glycerol, Increased protein synthesis and increased consumption of amino acids, but there is a decrease glycogenolysis, gluconeogenesis, ketogeneza, lipolysis, protein catabolism and amino acid release.

Displaying, Insulin lispro equimolar human insulin, but it develops faster and lasts for a shorter time. The onset of action of the drug – approximately 15 m, that allows you to enter it immediately before the meal (for 0-15 minutes before eating), in comparison with human insulin. After p/to the injections Humaloga^® Mix 25 There has been a rapid onset of action and early achievement of peak insulin activity lizpro. Action profile of insulin lizpro protamine is similar to conventional insulin action izofana profile with duration of approximately 15 no.

Pharmacokinetics

Absorption and distribution

Completeness of suction and the beginning of the effect of insulin is dependent on site of injection (life, hip, buttocks), dose (volume of insulin), Insulin concentration in the formulation. Unevenly distributed in the tissues. Not penetrates through the placental barrier, and in breast milk.

Metabolism and excretion

It destroyed insulinase mainly in the liver and kidneys. Report the news – 30-80%.

Testimony

- Diabetes, requiring insulin therapy.

Dosage regimen

The dose is determined individually by the physician, Depending on the level of glucose in the blood. The introduction of insulin individual.

The drug should enter n/a.

In/in the introduction of the drug Humalog^® Mix 25 contraindicated.

The temperature of the injected drug must comply room.

P / to be administered to the shoulder, hips, buttock or abdomen. Injection sites should be alternated so, to the same place to use no more 1 once a month. When s / to a Humalog product^® caution must be exercised, to avoid contact with the drug in the blood vessel. After injection should not be massaged injection site.

When you install the cartridge into the device for insulin needles and accessions before the introduction of insulin should strictly observe the instructions of the manufacturer of the device for insulin.

Terms of Humalog injection^® Mix 25

Preparations for the introduction of

Just before using the drug Humalog cartridge^® Mix 25 should laminate between your hands ten times and push, Turning to 180° ten times for resuspension of insulin, until it becomes kind of a homogeneous turbid liquid or milk. Should not vigorously shaking, tk. This can cause foam, which may interfere with the correct set of dose. To facilitate the mixing cartridge contains a small glass ball. The drug cannot be used, If after mixing are flakes.

Introduction

1.Wash hands.

2. Choose an injection site.

3. Process antiseptic skin at the injection site (When self injection – in accordance with the doctor's recommendations).

4. Remove the outer protective cap from the needle.

5. Secure skin, pulling it or fold greater zaschepit.

6. Introduce the needle s/c and perform the injection in accordance with the instructions for using spric-rucki.

7. Remove the needle and gently squeeze the injection site for a few seconds. Do not rub the injection site.

8. Take the outer protective cap needles, unscrew the needle and destroy it.

9. To put the cap on the syringe pen.

Side effect

Side effect, associated with the main action of the drug: common – gipoglikemiâ. Severe hypoglycemia can cause loss of consciousness and, in exceptional cases, death.

Allergic reactions: possible local allergic reaction – 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 factors, not associated with insulin, eg, irritation of the skin antiseptic or improper conduct of the injection); systemic allergic reactions (occur less frequently, but are more serious) – generalized itching, difficulty breathing, breathlessness, decrease in blood pressure, tachycardia, increased perspiration. Severe cases of systemic allergic reactions may be life threatening.

In rare cases, severe allergies to Humalog^® Mix 25 need immediate treatment. You may need to change insulin, or that desensitization.

Local reactions: prolonged use – may develop lipodystrophy at the site of injection.

Contraindications

- Gipoglikemiâ;

- Hypersensitivity to the drug.

Pregnancy and lactation

So far not revealed any unwanted actions of insulin lizpro for pregnancy or fetal and newborn.

The purpose of insulin therapy during pregnancy is to maintain adequate glucose control. Insulin requirements usually reduced in the I trimester and increases in the II and III trimester of pregnancy. During childbirth and immediately after their need for insulin can dramatically decrease.

Women of childbearing age, diabetics, You must inform the doctor about the ensuing or planned pregnancy.

Diabetic patients during breast-feeding may require dose adjustment of insulin and / or diet.

Cautions

Transfer the patient to another type or drug insulin with other trade name should be under strict medical supervision. Change of activity, brand (Manufacturer), type (eg, Regular, NPH), specific accessory (animal, human, human insulin analog) and / or method of manufacture (DNA recombinant insulin or animal insulin,) can lead to the need for dose adjustment.

For some patients in the transition from animal to human insulin insulin may need dose adjustment. This could occur as early as the first introduction of the drug human insulin or gradually over several weeks or months after the transfer of.

Symptoms-harbingers of hypoglycemia on the background of introduction of human insulin in some patients may be less pronounced or differ from those, they have seen on the background of introduction of animal insulin. When the normalization of blood glucose levels, eg, as a result of intensive insulin therapy, may disappear some or all symptoms-harbingers of hypoglycemia, what patients need to be informed. Symptoms-harbingers of Hypoglycemia may change or be less pronounced with a long course of diabetes mellitus, diabetic neuropathy or treatment of such drugs, like beta-adrenoblokatora.

The use of inadequate dose or discontinuation of treatment, especially in patients with insulinzawisimam diabetes, It may lead to hyperglycemia and diabetic ketoacidosis (states, potentially life-threatening patient).

The need for insulin may drop with insufficient adrenal function, pituitary or thyroid, with kidney or liver failure. In certain diseases, or when the emotional stress the need for insulin may increase. Correction dose of insulin may also be required when increasing physical exertion or when changing the normal diet.

Effects on ability to drive vehicles and management mechanisms

During hypoglycemia patient may reduce concentration and psychomotor speed reactions. This can be dangerous in situations, where these abilities are especially needed (eg, driving or controlling mechanisms).

Patients should be encouraged to take precautions to avoid hypoglycemia during driving vehicles and management mechanisms. This is especially important for patients with poorly expressed or absent symptoms-a precursor of hypoglycemia or if you frequently develop hypoglycemia. In such cases, the physician should assess the feasibility of driving patient car and management mechanisms.

Overdose

Symptoms: gipoglikemiâ, accompanied by the following symptoms – slackness, increased perspiration, tachycardia, headache, vomiting, confusion. Under certain conditions, eg, at the big duration or with intensive diabetes control, symptoms gipoglikemii may change harbingers.

Treatment: light condition of hypoglycemia usually cropped ingestion of glucose or other sugar, or products, Sugarless. May require insulin dose adjustment, diet or physical activity.

Correction of moderately severe hypoglycemia can be performed using in/m or m/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 m/to the introduction glukagona or in/with the introduction of a solution of concentrated solution of dextrose (Glucose). After regaining consciousness, the patient should give food, rich in carbohydrates, in order to avoid a recurrence of hypoglycemia.

You may need to accept further carbohydrates and monitor the patient, tk. you may experience a relapse of hypoglycaemia.

Drug Interactions

Hypoglycemic effect of the drug Humalog^® Mix 25 decreases together with: oral contraceptives, GCS, thyroid hormone drugs, danazol, beta₂-adrenomimetiki (incl. ritodrin, salbutamol, terbutaline), thiazide diuretics, lithium preparations, chlorprothixene, diazoksid, Isoniazid, a nicotinic acid, phenothiazines.

Hypoglycemic effect of the drug Humalog^® Mix 25 increase beta-blockers, ethanol etanolsoderzhaschie drugs, anabolic steroid, fenfluramin, guanethidine, tetracikliny, oral hypoglycemic drugs, salicilaty (eg, acetylsalicylic acid), sulfonamides, MAO inhibitors, ACE inhibitors (captopril, Enalapril), Octreotide, angiotensin II receptor antagonists.

Beta-blockers, clonidine, rezerpin may mask symptoms gipoglikemii.

Interaction Humaloga^® Mix 25 with other insulin was not investigated.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children at a temperature of 2 ° to 8 ° C; Do not freeze, Protect from direct sunlight and heating. Shelf life – 2 year.

Located in the use the drug in the cartridge should be stored at a temperature of no higher than 30° c not more than 28 days.