Humalog solution for injection 100IU / ml, 3 ml No. 5 cartridge

Diabetes mellitus in adults and children, requiring insulin therapy to maintain normal blood glucose levels.

The dose of the drug HumalogЃ is determined by the doctor individually, depending on the concentration of glucose in the blood. The mode of insulin administration is individual.

HumalogЃ can be administered shortly before a meal. If necessary, HumalogЃ can be administered immediately after a meal.

The temperature of the injected drug should be at room temperature.

HumalogЃ should be administered by subcutaneous injection or extended subcutaneous infusion using an insulin pump. If necessary (ketoacidosis, acute diseases, the period between operations or the postoperative period), HumalogЃ can also be administered intravenously.

It should be injected subcutaneously into the shoulder, thigh, buttocks, or abdomen. The injection sites should be alternated so that the same site is used no more than about 1 time per month.

With subcutaneous administration of the drug HumalogЃ, care must be taken to avoid getting the drug into the blood vessel. After injection, do not massage the injection site. The patient must be trained in the correct injection technique.

Instructions for the administration of the drug HumalogЃ
Preparation for administration
The solution of the drug HumalogЃ should be transparent and colorless. Do not use a solution of the HumalogЃ drug if it turns out to be cloudy, thickened, weakly colored, or solid particles are visually detected.

When installing the cartridge in the pen, attaching the needle and injecting insulin, you must follow the manufacturer's instructions that come with each pen.

Dose administration
1. Wash your hands.
2. Select an injection site.
3. Prepare the skin at the injection site as recommended by your doctor.
4. Remove the outer protective cap from the needle.
5. Fix the skin.
6. Insert the needle subcutaneously and inject according to the instructions for use of the pen.
7. Remove the needle and gently press the injection site with a cotton swab for a few seconds. Do not rub the injection site.
8. Using the outer needle shield, unscrew the needle and discard.
9. Place the cap on the pen.

For the drug HumalogЃ in the QuickPen Щ syringe pen.
Before injecting insulin, you must read the QuickPen Щ Syringe Pen Guidelines.

Intravenous administration of insulin
Intravenous injections of HumalogЃ should be performed in accordance with normal clinical practice for intravenous injection, for example, intravenous bolus administration or using an infusion system. This requires frequent monitoring of the concentration of glucose in the blood.

Infusion systems with concentrations from 0.1 IU / ml to 1.0 IU / ml insulin lispro in 0.9% sodium chloride solution or 5% dextrose solution are stable at room temperature for 48 hours.

Subcutaneous insulin infusion using an insulin pump
For the infusion of HumalogЃ, you can use pumps - systems for continuous subcutaneous insulin administration with CE marking. Before administering insulin lispro, you should make sure that your pump is suitable. The instructions supplied with the pump must be strictly followed. Use a suitable reservoir and pump catheter. The infusion set should be changed according to the instructions supplied with the infusion set. If a hypoglycemic reaction develops, the infusion is stopped until the episode resolves. If there is a very low concentration of glucose in the blood, then it is necessary to inform the doctor and provide for a decrease or termination of the insulin infusion. A malfunctioning pump or blockage in the infusion system can lead to a rapid rise in blood glucose levels. In case of suspicion of a violation of insulin supply,you must follow the instructions and, if necessary, inform the doctor. When using a pump, HumalogЃ should not be mixed with other insulins.

1 ml contains:
active substance: insulin lispro 100 IU;
excipients: glycerol (glycerin) 16 mg, metacresol 3.15 mg, zinc oxide qs to a Zn ++ content of 0.0197 mg, sodium hydrogen phosphate heptahydrate 1.88 mg, hydrochloric acid solution 10% and / or sodium hydroxide solution 10% qs to pH 7 , 0 - 8.0. water for injection qs up to 1 ml.

• Hypersensitivity to insulin lispro or to any excipient;

• Hypoglycemia.

Pharmacological properties

HumalogЃ is a DNA recombinant analog of human insulin. It differs from human insulin in the reverse amino acid sequence at positions 28 and 29 of the insulin B chain.

Pharmacodynamics
The main action 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, an increase in protein synthesis and an increase in the consumption of amino acids, but at the same time there is a decrease in glycogenolysis, gluconeogenesis, ketogenesis, and lipolysis. protein catabolism and amino acid release.

Insulin lispro has been shown to be equimolar to human insulin, but its effect occurs faster and lasts less. Insulin lispro is characterized by a rapid onset of action (about 15 minutes), since it has a high absorption rate, and this allows it to be administered immediately before a meal (0-15 minutes before a meal), unlike ordinary short-acting insulin (30-45 minutes before meals). Insulin lispro is fast acting and has a shorter duration of action (2 to 5 hours) compared to normal human insulin.

In patients with type 1 and type 2 diabetes mellitus, when using insulin lispro, the hyperglycemia that occurs after eating is reduced more significantly compared to soluble human insulin.

As with all insulin preparations, the duration of action of insulin lispro can vary from patient to patient or from time to time in the same patient and depends on dose, injection site, blood supply, body temperature, and physical activity.

The pharmacodynamic characteristics of insulin lispro in children and adolescents are similar to that. which is observed in adults.

The use of insulin lispro in patients with type 1 and type 2 diabetes mellitus is accompanied by a decrease in the frequency of nocturnal hypoglycemic reactions in comparison with soluble human insulin.

The glucodynamic response to insulin lispro is independent of liver or kidney function.

Pharmacokinetics
After subcutaneous administration, insulin lispro is rapidly absorbed and reaches its maximum concentration in the blood after 30-70 minutes.

When administered subcutaneously, the half-life of insulin lispro is about 1 hour.

With the introduction of insulin lispro, there is a faster absorption compared to soluble human insulin in patients with renal failure. In patients with type 2 diabetes mellitus, pharmacokinetic differences are noted between insulin lispro and soluble human insulin, regardless of renal function. With the introduction of insulin lispro, there is a faster absorption and faster elimination compared to soluble human insulin in patients with hepatic insufficiency.

Application during pregnancy and breastfeeding

Numerous data on the use of insulin lispro during pregnancy indicate the absence of an undesirable effect of the drug on pregnancy or the condition of the fetus and newborn.

Maintaining good glycemic control in diabetic patients receiving insulin treatment is essential during pregnancy. Insulin requirements usually decrease during the first trimester and increase during the second and third trimesters. During and immediately after childbirth, the need for insulin can drop dramatically. Patients with diabetes mellitus should consult a doctor in case of pregnancy or planning. In the case of pregnancy in patients with diabetes mellitus, careful control of glucose as well as overall health is essential.

For patients with diabetes mellitus during breastfeeding, it may be necessary to adjust the dose of insulin, diet, or both.

Side effect

Hypoglycemia is the most common adverse event in insulin therapy in patients with diabetes mellitus. Severe hypoglycemia can lead to loss of consciousness (hypoglycemic coma) and, in exceptional cases, death.

Patients may experience local allergic reactions such as redness, swelling or itching at the injection site. These symptoms usually disappear within a few days or weeks. In some cases, these reactions can be caused by reasons not related to insulin, for example, skin irritation with a cleansing agent or improper injection.

More rarely, generalized allergic reactions occur, in which itching may occur throughout the body, urticaria, angioedema, fever, shortness of breath, decreased blood pressure, tachycardia, increased sweating. Severe cases of generalized allergic reactions can be life threatening.

Lipodystrophy may develop at the injection site.

Spontaneous reports:
Cases of edema have been identified, mainly with a rapid normalization of blood glucose levels against the background of intensive insulin therapy with initially unsatisfactory glycemic control.

Overdose

Overdose is accompanied by the development of symptoms of hypoglycemia: lethargy, increased sweating, hunger, tremors, tachycardia, headache, dizziness, blurred vision, vomiting, confusion.

Mild hypoglycemic episodes are controlled by ingestion of glucose or foods containing sugar. Correction of moderately severe hypoglycemia can be carried out with the help of intramuscular or subcutaneous administration of glucagon, followed by ingestion of carbohydrates after stabilization of the patient's condition. Patients who do not respond to glucagon are given a solution of glucose intravenously.

If the patient is in a coma, then glucagon should be administered intramuscularly or subcutaneously. In the absence of glucagon or if there is no reaction to its administration, dextrose solution must be injected intravenously. Immediately after recovery of consciousness, the patient should be given food rich in carbohydrates.

Further supportive carbohydrate intake and patient monitoring may be required, as recurrence of hypoglycemia may occur.

It is necessary to inform the attending physician about the transferred hypoglycemia.

Interaction with other medicinal products

The severity of the hypoglycemic action is reduced when administered together with the following drugs: oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, danazol, beta2-adrenergic agonists (for example, regodrin, salbutamol, terbutaline), isotonic diuretics, diuretic acid, chloroprotein phenothiazine.

The severity of the hypoglycemic action increases when administered together with the following drugs: beta-blockers, ethanol and ethanol-containing drugs, anabolic steroids, fenfluramine. guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (eg, acetylsalicylic acid), sulfa antibiotics. some antidepressants (monoamine oxidase inhibitors, serotonin reuptake inhibitors), angiotensin-converting enzyme inhibitors (captopril, enapril), octreotide, angiotensin II receptor antagonists.

If you need to use other drugs in addition to insulin, you should consult your doctor.

special instructions

The transfer of the patient to another type or preparation of insulin should be carried out under strict medical supervision. Changes in activity, brand (manufacturer), type (Regular, NPH, etc.), species (animal, human, analog of human insulin) and / or method of production (DNA recombinant insulin or insulin of animal origin) can lead to the need for dose adjustment.

In patients with hypoglycemic reactions after switching from animal insulin to human insulin, the early symptoms of hypoglycemia may be less pronounced or different from those experienced with their previous insulin treatment. Uncorrected hypo- and hyperglycemic conditions can lead to loss of consciousness, coma, or death.

It should be borne in mind that a consequence of the pharmacodynamics of fast-acting human insulin analogs is that if hypoglycemia develops, it can develop after injection of a fast-acting human insulin analog earlier than in the case of the use of soluble human insulin.

For patients receiving short-acting and basal insulins, it is necessary to adjust the dose of both insulins in order to achieve optimal blood glucose concentration during the day, especially at night or on an empty stomach.

Symptoms that predict hypoglycemia may change and be less pronounced with prolonged diabetes mellitus, diabetic neuropathy, or treatment with drugs such as beta-blockers.

The use of inadequate doses or discontinuation of treatment, especially in patients with type 1 diabetes mellitus, can lead to hyperglycemia and diabetic ketoacidosis, potentially life-threatening conditions for the patient.

The need for insulin may decrease in the case of renal insufficiency, as well as in patients with hepatic insufficiency as a result of decreased gluconeogenesis and insulin metabolism. However, in patients with chronic liver failure, increased insulin resistance can lead to an increased need for insulin.

The need for insulin may increase with certain diseases or emotional stress.

Insulin dose adjustment may be required when patients increase their physical activity or when changing their usual diet. Exercise can increase the risk of hypoglycemia.

When using insulin preparations in combination with drugs of the thiazolidinedione group, the risk of edema and chronic heart failure increases, especially in patients with diseases of the cardiovascular system and the presence of risk factors for chronic heart failure.

The use of HumalogЃ in children instead of soluble human insulin is preferable in cases where a rapid onset of insulin action is required (for example, insulin administration just before a meal).

To avoid possible transmission of infectious disease, each cartridge / syringe pen should only be used by one patient, even if the needle is replaced.

HumalogЃ cartridges must be used with CE marked syringe pens in accordance with the device manufacturer's instructions.

Influence on the ability to drive vehicles and use mechanisms

During hypoglycemia, a person's concentration of attention and the speed of psychomotor reactions may decrease. This can be dangerous in situations where these abilities are especially needed (for example, driving a motor vehicle or operating machinery).

Patients should be advised to take precautions to prevent hypoglycemic reactions while driving and operating machinery. This is especially important for patients with mild or absent symptoms, precursors of hypoglycemia, or with frequent development of hypoglycemia. In such cases, the doctor should assess the appropriateness of the patient driving vehicles and operating machinery.