Mixtard^® 30 HM Penfill (Suspension) Instructions for Use

ATC Code

A10AD01 (Human insulin)

Active Substance

Biphasic isophane insulin injection

Clinical-Pharmacological Group

Intermediate-acting human insulin

Pharmacotherapeutic Group

Hypoglycemic agent – combination of short- and intermediate-acting insulins

Pharmacological Action

Insulin identical to human insulin with a rapid onset and intermediate duration of action. It lowers blood glucose levels, enhances its uptake by tissues, increases lipogenesis, glycogenesis, protein synthesis, and reduces the rate of glucose production by the liver.

The onset of action is within 30 minutes after administration, the maximum effect occurs between 2 and 8 hours, and the duration of action is 24 hours.

Indications

Type 1 diabetes mellitus (insulin-dependent).

Type 2 diabetes mellitus (non-insulin-dependent), including in cases of complete or partial resistance to oral hypoglycemic agents (combination therapy); during intercurrent illnesses, surgical interventions; during pregnancy (when diet therapy is ineffective).

ICD codes

Dosage Regimen

Determine the dosage individually for each patient based on blood glucose levels.

Administer the suspension subcutaneously. Do not administer intravenously or intramuscularly.

Inject twice daily, approximately 30 minutes before a meal.

Rotate injection sites systematically within the same anatomical region to prevent lipodystrophy.

Use the abdomen, thighs, buttocks, or the back of the upper arms as preferred injection areas.

Roll the Penfill vial ten times and tilt it ten times before each use to ensure a homogeneous, milky suspension.

Do not use the product if clumps or particles remain after mixing or if a solid white deposit sticks to the bottom of the vial.

Adjust the dosage during intercurrent illness, changes in physical activity, or meal patterns.

Monitor blood glucose closely when transferring a patient from other insulins to Mixtard^® 30 HM Penfill.

Reduce the risk of hypoglycemia by correctly timing the injection in relation to meals.

Be aware that the onset of action occurs within 30 minutes, the peak effect is between 2 and 8 hours, and the total duration of action is up to 24 hours.

Adverse Reactions

Side effects related to the effect on carbohydrate metabolism: hypoglycemic conditions (pallor, increased sweating, palpitations, sleep disorders, tremor).

Allergic reactions: rarely – skin rash; extremely rarely – angioedema.

Local reactions: rarely – redness and itching at the injection site; with prolonged use, rarely – lipodystrophy at the injection site.

Contraindications

Hypoglycemia, insulinoma, hypersensitivity to this insulin.

Use in Pregnancy and Lactation

The need for insulin changes during pregnancy and lactation, which should be taken into account to maintain adequate metabolic control.

Insulin does not cross the placental barrier.

Special Precautions

Switching from one type of insulin to another should be carried out under the control of blood glucose levels.

In case of insulin overdose, if the patient is conscious, it is necessary to administer glucose orally; if consciousness is lost, glucose is administered intravenously or glucagon is administered subcutaneously, intramuscularly, or intravenously.

Effect on the ability to drive vehicles and operate machinery

When transferring a patient to this insulin, a temporary decrease in the speed of psychomotor reactions is possible.

During the initial use of insulin, changing its type, or in the presence of significant physical or mental stress, a decrease in the speed of psychomotor reactions and the ability to concentrate may occur.

Drug Interactions

The hypoglycemic effect of insulin is enhanced by MAO inhibitors, non-selective beta-blockers, sulfonamides, anabolic steroids, tetracyclines, clofibrate, cyclophosphamide, fenfluramine; drugs containing ethanol.

The hypoglycemic effect of insulin is reduced by oral contraceptives, glucocorticoids, thyroid hormones, thiazide diuretics, heparin, lithium preparations, tricyclic antidepressants.

Under the influence of reserpine and salicylates, both weakening and enhancement of the action of insulin are possible.

Beta-blockers, clonidine, reserpine can mask the manifestation of hypoglycemia symptoms.

Ethanol and various disinfectants can reduce the biological activity of insulin.

When using insulin preparations in combination with drugs of the thiazolidinedione group in patients with type 2 diabetes, fluid retention in the body may occur, resulting in an increased risk of developing and progressing chronic heart failure, especially in patients with cardiovascular diseases and the presence of risk factors for chronic heart failure.

Patients receiving such therapy should be regularly examined to identify signs of heart failure. If heart failure occurs, therapy should be carried out in accordance with current treatment standards.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.