Description
Release form
suspension for subcutaneous administration
Packaging
5 cartridges of 3 ml.
Pharmacological action
Humalog Mix – a hypoglycemic drug, a combination of fast and medium-duration insulin analogues. Humalog ® Mix 25 is a DNA recombinant analogue of human insulin and is a ready-made mixture consisting of lyspro insulin solution (a quick-acting analog of human insulin) and a suspension of lyspro protamine insulin (medium-duration human insulin analogue). The main action of insulin lyspro is the regulation of glucose metabolism. In addition, it has anabolic and anti-catabolic effects on various body tissues.
An increase in glycogen content occurs in muscle tissue. 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 the release of amino acids.
Lyspro insulin has been shown to be equimolar to human insulin, but its action is faster and lasts for a shorter time. The onset of the action of the drug is after about 15 minutes, which allows you to enter it immediately before meals (0-15 minutes before meals), compared with ordinary human insulin.
After sc injection of Humalog Mix 25, a rapid onset of action and an early peak in lyspro insulin activity are observed. The action profile of the insulin lysproprotamine is similar to the action profile of the usual insulin isophan with a duration of approximately 15 hours.
Indications
Diabetes mellitus requiring insulin therapy.
Contraindications
Hypoglycemia hypersensitivity to the drug.
Special instructions
Transfer of a patient to another type or brand of insulin with a different brand name must be carried out under strict medical supervision. Changes in activity, brand (manufacturer), type (e.g. Regular, NPH), species (animal, human, human insulin analogue) and / or production method (DNA recombinant insulin or insulin of animal origin) 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 different from those observed during administration of insulin of animal origin. With normalization of blood glucose levels, for example, as a result of intensive insulin therapy, all or some symptoms of the precursors of hypoglycemia may disappear, about which patients should be informed. Symptoms of the precursors of hypoglycemia may change or be less pronounced with a prolonged course of diabetes mellitus, diabetic neuropathy, or treatment with drugs such as beta-blockers.
Inadequate doses or discontinuation of treatment, especially in patients with insulin-dependent diabetes mellitus, can lead to hyperglycemia and diabetic ketoacidosis (conditions potentially life-threatening patient).
Insulin demand may decrease with adrenal gland, pituitary, or thyroid insufficiency, with kidney or liver failure. 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.
Composition of
1 ml of suspension contains: insulin lispro 100 IU is a mixture of: insulin solution lispro 25% suspension of insulin lyspro protamine 75%
Excipients: dibasic sodium phosphate, glycerol (glycerol), phenol liquid, metamnazole, phenol, methacresol oxide, water, water, hydrochloric acid (10% solution) and / or sodium hydroxide (10% solution) (to establish pH).
Dosing and Administration
The doctor determines the dose individually, depending on the level of glucose in the blood. The regimen of insulin administration is individual.
The drug should be administered sc.
In / in the introduction of the drug Humalog® Mix 25 is contraindicated.
The temperature of the administered drug should be at room temperature. SC should be administered to the shoulder, thigh, buttock or abdomen. The injection sites should be alternated so that the same place is used no more than 1 time per month.
When s / to the introduction of the drug Humalog®, care must be taken to avoid getting the drug into a blood vessel.
After injection, the injection site should not be massaged.
When installing a cartridge in an insulin injection device and attaching a needle before insulin administration, the instructions of the manufacturer of the insulin injection device must be strictly observed.
Side effects
Side effect associated with the main effect of the drug: most often hypoglycemia. Severe hypoglycemia can lead to loss of consciousness and, in exceptional cases, to 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 can be caused by reasons not related to insulin, for example, skin irritation by an antiseptic or improper injection ) systemic allergic reactions (occur less frequently, but are more serious) – generalized itching, shortness of breath, shortness of breath, decreased 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. A change of insulin may be required, or desensitization.
Local reactions: with prolonged use – development of lipodystrophy at the injection site is possible.
Drug interaction
Hypoglycemic effect of the drug Humalog Mix 25 decreases with the following drugs: oral contraceptives, corticosteroids, thyroid gonorrhiza, thyroid gynogen, thyroid gland, thyroid gynogen, thyroid gonorotin, salbutamol, terbutaline), thiazide diuretics, lithium preparations, chlorprotixen, diazoxide, isoniazid, nicotinic acid, phenothiazine derivatives.
The hypoglycemic effect of Humalog Mix 25 is enhanced by beta-blockers, ethanol and ethanol-containing drugs, anabolic steroids, fenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (e.g. acetylsalicylic acid), sulfonamides, sulfonamylamides, ACE inhibitors (captopril, enalapril), octreotide, angiotensin II receptor antagonists.
Beta-blockers, clonidine, reserpine can mask the manifestation of symptoms of hypoglycemia.
The interaction of Humalog Mix 25 with other insulin preparations has not been studied.
Overdose
Symptoms: hypoglycemia, accompanied by the following symptoms – lethargy, increased sweating, tachycardia, headache, vomiting, confusion. Under certain conditions, for example, with a long duration or with intensive monitoring of diabetes mellitus, the symptoms of the precursors of hypoglycemia can change.
Treatment: mild hypoglycemia is usually stopped by ingestion of glucose or other sugar, or by products containing sugar. A dose adjustment of insulin, diet, or physical activity may be required. Correction of moderately severe hypoglycemia can be carried out with the help of a / m or s / c administration of glucagon, followed by ingestion of carbohydrates. Severe hypoglycemia accompanied by coma convulsions or neurological disorders stop in / m or s / c by the introduction of glucagon or by / in the introduction of a solution of a concentrated solution of dextrose (glucose). After regaining consciousness, the patient must be given carbohydrate-rich foods to prevent the re-development of hypoglycemia. Further carbohydrate intake and patient monitoring may be required, as a relapse of hypoglycemia is possible.
Storage conditions
At 2 ° to 8 ° C
Term hodnosty
2 years
active substance
Insulin Lispro biphasic
Conditions of dispatch from
pharmacies Prescription
lekarstvennaja form
Solution for
