Humalog Mix 25, 100 me/ml suspension 3 ml cartridges 5 pcs

Humalog Mix 25 is a DNA recombinant human insulin analog and is a pre-mix consisting of a solution of insulin lispro (a fast-acting human insulin analog) and an insulin lispro protamine suspension (a medium-acting human insulin analog).

The main action of lispro insulin is to regulate glucose metabolism. In addition, it has anabolic and anti-catabolic effects on various tissues of the body. In muscle tissue there is an increase of glycogen, fatty acids, glycerol, increased protein synthesis and increased consumption of amino acids, but there is a decrease of glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and release of amino acids.

Lispro insulin has been shown to be equimolar to human insulin, but its action is faster and lasts for a shorter time. It has an onset of action of about 15 minutes, allowing it to be injected immediately before a meal (up to 15 minutes before a meal), compared to regular human insulin. After a subcutaneous injection of Humalog Mix 25, there is a rapid onset of action and an early peak of activity of insulin lispro. The action profile of insulin lispro protamine is similar to that of regular isophan insulin with a duration of action of approximately 15 hours.

Pharmacokinetics

Absorption and distribution. Completeness of absorption and onset of effect of insulin depends on the place of administration (stomach, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the drug. Distributed in tissues irregularly. It does not penetrate through the placental barrier and into the breast milk.

Metabolism and excretion. Is broken down by insulinase mainly in the liver and kidneys. Excreted by the kidneys – 30-80%.

Indications

Diabetes mellitus requiring insulin therapy.

Active ingredient

Composition

1 ml of suspension for subcutaneous administration contains:

the active ingredient:

insulin lispro biphasic 100 IU (mixture of insulin lispro solution – 25%; insulin lispro protamine suspension – 75%)

excipients:

bicarbonate sodium phosphate,

glycerol (glycerin),

phenol,

methacresol,

protamine sulfate,

Zinc oxide,

water for injection,

Hydrochloric acid solution of 10% and/or sodium hydroxide solution of 10% – until the required pH level is reached.

How to take, the dosage

Subcutaneously, in the shoulder, thigh, buttock or abdomen area. The injection sites should be alternated so that the same site is not used more than once a month. When injecting Humalog Mix 25 subcutaneously, care should be taken to avoid getting the drug into a blood vessel. After injection, the injection site should not be massaged.

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

The doctor determines the dose individually, depending on the blood glucose level. The mode of administration of insulin is individual.

Intravenous administration of Humalog Mix 25 is contraindicated.

When inserting the cartridge into the insulin injection device and attaching the needle before insulin injection, the instructions of the insulin injection device manufacturer must be strictly followed.

Principles for Humalog™ Mix 25 administration

Preparing for administration: Immediately before use, the Humalog Mix 25 cartridge should be palm-tapped 10 times and rocked upside down, 180°, 10 times to resuspend the insulin until it looks like a homogenous cloudy fluid or milk. Do not shake vigorously as this may cause foam to form which may interfere with proper dosing. The cartridge contains a small glass bead to facilitate stirring. The product should not be used if it has flakes in it after mixing.

Injection

Interaction

The hypoglycemic effect of Humalog Mix 25 is decreased when the following drugs are administered simultaneously: oral contraceptives, GCS, thyroid hormones, danazol, β2-adrenomimetics (incl.Ritodrine, salbutamol, terbutaline), thiazide diuretics, lithium preparations, chlorprotixene, diazoxide, isoniazid, nicotinic acid, phenothiazine derivatives.

The hypoglycemic effect of Humalog Mix 25 is increased by β-adrenoblockers, ethanol and ethanol-containing drugs, anabolic steroids, phenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (e.g. acetylsalicylic acid), sulfonamides, MAO inhibitors, ACE inhibitors (captopril, enalapril), octreotide, angiotensin II receptor antagonists.

β-adrenoblockers, clopheline, reserpine may mask the symptoms of hypoglycemia.

The interaction of Humalog Mix 25 with other insulin drugs has not been studied.

Special Instructions

Transfer of a patient to another type or preparation of insulin with a different brand name must take place under strict medical supervision. Changes in activity, brand name (manufacturer), type (e.g., Regular, NPH), species (animal, human, human insulin analogues), and/or method of production (DNA recombinant or animal insulin) may require dose adjustments.

For some patients, a dose adjustment may be necessary when switching from animal insulin to human insulin. This may occur as early as the first administration of human insulin or gradually over a period of weeks or months after transfer.

The precursor symptoms of hypoglycemia with human insulin in some patients may be less severe or different from those seen with human insulin. When blood glucose levels normalize, e.g. as a result of intensive insulin therapy, all or some of the precursor symptoms of hypoglycemia may disappear, and patients should be informed about it. Hypoglycemic precursor symptoms may change or be less pronounced with a long-term course of diabetes mellitus, diabetic neuropathy, or treatment with drugs such as β-adrenoblockers.

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

The need for insulin may decrease in adrenal, pituitary, or thyroid insufficiency with renal or hepatic insufficiency. Some medical conditions or emotional stress may increase the need for insulin. Adjustment of insulin dosage may also be necessary when physical activity increases or when there is a change in your normal diet.

Impact on the ability to drive and operate machinery

At the time of hypoglycemia, the patient may have reduced concentration and speed of psychomotor reactions. This may be dangerous in situations in which these abilities are particularly necessary (e.g., driving or operating machinery).

Patients should be advised to take precautions to avoid hypoglycemia while driving and operating machinery. This is especially important for patients with mild or absent precursor symptoms of hypoglycemia or with frequent development of hypoglycemia. In such cases, the physician should evaluate the appropriateness of the patient’s driving and operating machinery.

Contraindications

Hypersensitivity to the drug components; hypoglycemia.

Side effects

A side effect associated with the main effect of the drug: the most common is 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 may be caused by causes unrelated 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, BP decrease, tachycardia, increased sweating. Severe cases of systemic allergic reactions may be life-threatening.

In rare cases of severe allergy to Humalog Mix 25, immediate treatment is required. A change of insulin or desensitization may be necessary.

Others: prolonged use may cause lipodystrophy at the injection site.

Overdose

Symptoms: hypoglycemia accompanied by the following symptoms: lethargy, increased sweating, tachycardia, headache, vomiting, confusion. Under certain conditions, such as long duration or intensive control of diabetes mellitus, the precursor symptoms of hypoglycemia may change.

Treatment: Mild states of hypoglycemia are usually controlled by ingestion of glucose or other sugar, or by foods containing sugar. Adjustment of insulin dose, diet, or physical activity may be necessary.

Correction of moderately severe hypoglycemia may be done with intramuscular or subcutaneous injection of glucagon followed by oral carbohydrate intake.

Severe states of hypoglycemia accompanied by coma, seizures or neurological disorders are controlled by intramuscular or subcutaneous administration of glucagon or intravenous infusion of concentrated dextrose (glucose) solution. After recovery of consciousness, the patient should be given food rich in carbohydrates, in order to avoid the recurrence of hypoglycemia.

Further carbohydrate intake and monitoring of the patient may be necessary, as a recurrence of hypoglycemia may occur.

Pregnancy use

To date, no adverse effects of insulin lispro on pregnancy or on the fetus and newborn have been identified.

The goal of insulin therapy in pregnancy is to maintain adequate glucose control. The need for insulin usually decreases in the first trimester and increases in the second and third trimesters of pregnancy. During and immediately after delivery, the need for insulin may decrease dramatically.

Women of childbearing age with diabetes should inform their physician of an existing or planned pregnancy.

In diabetic patients during breastfeeding, it may be necessary to adjust the insulin dose and/or diet.

The use in patients with hepatic and renal dysfunction. The need for insulin may decrease in hepatic or renal impairment.

Similarities