Description
Release form
Suspension for subcutaneous administration
Pharmacological action
Humalog Mix 50 is a ready-made mixture consisting of lispro 50% insulin solution (a fast-acting analog of human insulin) and 50% lyspro insulin suspension (medium-duration human insulin analog).
The main action of insulin lyspro 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 there is a decrease in glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and the release of amino acids.
was shaken that lyspro insulin is equimolar to human insulin, but its effect is faster and lasts less. After a subcutaneous injection of Humalog Mix 50, a rapid onset of action and an early onset of peak activity of lyspro insulin are observed. The onset of the drug is approximately 15 minutes later, which allows you to administer the drug immediately before meals (0-15 minutes before meals), compared with ordinary human insulin. After a subcutaneous injection of Humalog Mix 50, a rapid onset of action and an early onset of peak activity of lyspro insulin are observed. The action profile of insulin lyspro protamine is similar to the action profile of conventional insulin-isophan with a duration of approximately 15 hours
PHARMACOKINETICS
The completeness of absorption and the onset of the effect of insulin depends on the injection site (stomach, thigh, buttocks), dose (volume of injected insulin), insulin concentration in the drug, etc. Distributed throughout the tissues unevenly does not penetrate the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and kidneys. It is excreted by the kidneys (30-80%).
Indications
Diabetes mellitus requiring insulin therapy.
Pregnancy and lactation
Sufficient and well-controlled studies in pregnant women have not been conducted. Patients with diabetes mellitus are advised to inform the doctor of an ongoing or planned pregnancy. During pregnancy, it is especially important to monitor the condition of patients receiving insulin therapy. Insulin demand usually decreases during the first trimester and increases during the second and third trimesters. During and immediately after birth, insulin requirements may decrease dramatically.
In patients with diabetes mellitus, a dose adjustment of insulin, diet, or both may be necessary.
Special instructions
Transfer of the patient to another type or insulin product with a different brand name must occur under strict medical supervision. Changes in insulin concentration, brand (manufacturer), type (Regular, NPH, etc.), species (animal, human, human insulin analogue) and / or production method (DNA recombinant insulin or animal insulin) may require dose adjustment.
For some patients, a dose adjustment may be necessary when switching from animal-derived insulin to human insulin. This can happen already at the first administration of the human insulin preparation or gradually within a few weeks or months after the transfer. Symptoms of the precursors of hypoglycemia during administration of human insulin in some patients may be less pronounced or differ from those that were observed during administration of animal insulin. With normalization of blood glucose concentration, for example, as a result of intensive insulin therapy, all or some of the symptoms that precursor to hypoglycemia may disappear, which patients should be informed about. Symptoms of the precursors of hypoglycemia may change or be less pronounced with a long course of diabetes, diabetic neuropathy or treatment with drugs such as beta-blockers.
Inadequate doses or discontinuation of treatment, especially in patients with type 1 diabetes, can lead to hyperglycemia and diabetic ketoacidosis (conditions that are potentially life-threatening to the patient). The need for insulin may decrease with insufficiency of the adrenal gland, pituitary or thyroid gland, with renal or hepatic insufficiency. With some diseases or with emotional stress, the need for insulin may increase. Correction of the dose of insulin may also be required with an increase in physical activity or with a change in the usual diet.
Influence on the ability to drive vehicles and control mechanisms
During a patient s hypoglycemia, the concentration of attention and the speed of psychomotor reactions may decrease. This can be dangerous in situations in which these abilities are especially necessary (for example, driving vehicles or operating machinery). Patients should be advised to take precautions to avoid hypoglycemia while driving vehicles 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 must evaluate the feasibility of the patient driving the car and controlling the mechanisms.
Composition
1 ml suspension for subcutaneous administration contains: active substance: lyspro insulin biphasic 100 IU (mixture of lyspro insulin solution – 50% suspension of lyspro protamine insulin – 50%)
excipients: metacresol – 2.2 mg, phenol liquid – 1 mg, glycerol (glycerin) – 16 mg, protamine sulfate – 0.19 mg, sodium hydrogen phosphate heptahydrate – 3.78 mg, zinc oxide – qs to obtain Zn2 ² ¹ ² ¹+ 30.5 Ñg, water for injection – up to 1 ml of hydrochloric acid, solution 10% and / or sodium hydroxide solution 10% – qs to pH 7.0-7.8.
Dosage and Administration
Subcutaneous. The dose of Humalog Mix 50 is determined by the doctor individually, depending on the concentration of blood glucose. The regimen of insulin administration is individual.
The drug should be administered only subcutaneously. Intravenous administration of the drug Humalog Mix 50 is unacceptable.
The temperature of the administered drug should be at room temperature. Subcutaneous injections should be given to the shoulder, thigh, buttock or abdomen. The injection sites must be alternated so that the same place is used no more than about once a month. With subcutaneous administration of Humalog Mix 50, care should be taken to avoid getting the drug into the lumen of blood vessels. After the injection, the injection site should not be massaged.
For recommendations on installing a cartridge in a Humalog Mix 50 administration device and attaching a needle to it before administering the drug, read the manufacturer’s instructions for the insulin administration device. Strictly follow the instructions you read.
Preparation for administration
Immediately before use, the Humalog Mix 50 cartridge should be rolled between the palms ten times and shaken, turning 180 ° also ten times to resuspend insulin until it becomes a uniform, turbid liquid. Do not shake vigorously, as this can lead to the appearance of foam, which can interfere with the correct dose. To facilitate mixing, a small glass ball is located inside the cartridge.
Do not use Humalog Mix 50 if it contains flakes after stirring.
Dosing
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 by folding it into a large fold.
6. Insert the needle subcutaneously into the collected fold and perform the injection in accordance with the instructions for using the syringe 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 protective cap of the needle, unscrew the needle and discard it.
9. Put the cap on the syringe pen.
For the HumalogMix 50 preparation in the Quick Pen syringe pen
Before administering insulin, it is necessary to read the Quick Quick Pen Syringe Handbook.
Side effects
Hypoglycemia is the most common side effect that occurs with the administration of all insulin preparations, including Humalog Mix 50. Severe hypoglycemia can lead to loss of consciousness and, in exceptional cases, death.
Allergic reactions: patients may experience local allergic reactions in the form of redness, swelling, or itching at the injection site. These minor reactions 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.
Systemic allergic reactions caused by insulin occur less frequently, but are more serious. They can manifest as generalized itching, shortness of breath, shortness of breath, decreased blood pressure, increased heart rate, and excessive sweating. Severe cases of systemic allergic reactions can be life threatening. In rare cases of severe allergy to Humalog Mix 50, immediate treatment is required. You may need a change of insulin, or desensitization.
With prolonged use, lipodystrophy may develop at the injection site.
Drug interactions
Hypoglycemic effect of the drug Humalog Mix 50 is reduced when used together with the following drugs: oral contraceptives, glucocorticosteroids, iodide-dimethamine, dimethodimeric-dimethredetin, terbutaline), thiazide diuretics, chlorprothixene, diazoxide, isoniazid, nicotinic acid, phenothiazine derivatives.
Hypoglycemic effect of Humalog Mix 50 is enhanced by: beta-blockers, ethanol and ethanol-containing drugs, anabolic steroids, phenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (e.g. acetylsalicylic acid), sulfanilines some antidepressants (monoamine oxidase inhibitors), ACE inhibitors (captopril, enapril), octreotide, angiotensin II receptor antagonists.
Beta-blockers, clonidine, reserpine can mask the manifestation of symptoms of hypoglycemia.
The interaction of Humalog Mix 50 with other insulin preparations has not been studied.
Overdose of
An overdose of insulin causes hypoglycemia, which is accompanied by the following symptoms: lethargy, excessive sweating, tachycardia, pallor of the skin, headache, trembling, vomiting, confusion. Under certain conditions, for example, with a long duration of the disease or with intensive monitoring of diabetes mellitus, the symptoms of harbingers of hypoglycemia can change.
Mild hypoglycemia can usually be stopped by ingesting glucose or sugar. A dose adjustment of insulin may be required, diet or physical activity. Correction of moderate hypoglycemia can be carried out 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 / subcutaneous administration of glucagon or intravenous administration of a concentrated solution of dextrose (glucose).
After regaining consciousness, the patient must be given carbohydrate-rich foods in order to avoid the re-development of hypoglycemia.
May require further intake of carbohydrates and subsequent monitoring of the patient, since a relapse of hypoglycemia may occur.
Storage Conditions
At 2-8 ° C. Protect from direct sunlight and heat. Do not allow freezing. Used drug in cartridge / syringe pen should be stored at a temperature not higher than 30 ° C for no more than 28 days. Keep out of the reach and sight of children.
Expiration
2 years.
active substance
Insulin Lispro biphasic
Terms leave through pharmacies
In retseptu
dosage form
solution for injection
