Instruction for use: Actrapid HM Penfill

ATX Code A10AB Short-acting insulins and their analogs for injection

Active substance Insulin soluble [human biosynthetic]

Pharmacological group

Hypoglycemic agent - short-acting insulin [Insulins]

Nosological classification (ICD-10)

E10 Insulin-dependent diabetes mellitus

Decompensation of carbohydrate metabolism, Diabetes mellitus, Diabetes insulin sugar, Diabetes mellitus type 1, Diabetic ketoacidosis, Insulin-dependent diabetes, Insulin-dependent diabetes mellitus, Coma hyperosmolar non-ketoacidotic, Labile form of diabetes mellitus, Violation of carbohydrate metabolism, Type 1 diabetes mellitus, Type I diabetes mellitus, Insulin-dependent diabetes mellitus, Type 1 diabetes mellitus

E11 Non-insulin-dependent diabetes mellitus

Acetonuric diabetes, Decompensation of carbohydrate metabolism, Diabetes insulin-independent sugar, Diabetes sugar type 2, Type 2 Diabetes, Non-insulin-dependent diabetes, Non-insulin dependent diabetes mellitus, Non-insulin-dependent diabetes mellitus, Insulin resistance, Insulin resistant diabetes mellitus, Coma lactobacillus diabetic, Violation of carbohydrate metabolism, Type 2 diabetes mellitus, Diabetes mellitus type II, Diabetes mellitus in adulthood, Diabetes mellitus in old age, Diabetes insulin-independent, Diabetes mellitus type 2, Sugar insulin-independent diabetes type II

Composition

Solution for injection 1 ml

active substance:

Insulin soluble (human genetically engineered) 100 IU (3.5 mg)

(1 MU corresponds to 0.035 mg of anhydrous human insulin)

Auxiliary substances: zinc chloride; Glycerin (glycerol); Meta-cresol; Sodium hydroxide and / or hydrochloric acid (for pH adjustment); water for injections

Characteristic

Neutral human monocomponent insulin of short action.

pharmachologic effect

Pharmacological action - hypoglycemic.

Interacts with a specific receptor of the plasma membrane and penetrates into the cell, which activates the phosphorylation of cellular proteins, stimulates glycogen synthase, pyruvate dehydrogenase, hexokinase, inhibits fat lipase and lipoprotein lipase. In combination with a specific receptor facilitates the penetration of glucose into cells, enhances its assimilation by tissues and promotes conversion into glycogen. Increases the glycogen reserve in muscles, stimulates the synthesis of peptides.

Clinical Pharmacology

The effect develops 30 minutes after the SC administration, reaches a maximum after 1-3 hours and lasts 8 hours.

Indications

Diabetes mellitus type I and II.

Contraindications

Hypoglycemia, insulinoma.

Side effects

Hypoglycemia, refractive disorders (usually at the beginning of therapy), allergic reactions.

Interaction

MAO inhibitors, non-selective beta-blockers, ACE inhibitors, salicylates, anabolic steroids, alcohol - increase, oral contraceptives, corticosteroids, thyroid hormones, thiazide diuretics, sympathomimetics - weaken the hypoglycemic effect.

Dosing and Administration

P / to, in / in.

The dose of the drug is selected individually, taking into account the needs of the patient.

Usually the need for insulin is 0.3 to 1 IU / kg / day. The daily requirement for insulin can be higher in patients with insulin resistance (for example, during puberty, as well as in obese patients), and lower in patients with residual endogenous insulin production.

The drug is administered 30 minutes before a meal or a light snack containing carbohydrates.

Actrapid® HM is a short-acting insulin and can be used in combination with long-acting insulins.

Actrapid® HM is usually administered sc, to the area of the anterior abdominal wall. If it is convenient, then injections can be done also in the thigh area, in the gluteal region or in the deltoid muscle region of the shoulder. When the drug is injected into the anterior abdominal wall, a faster absorption is achieved than when injected into other areas. If the injection is made into a stretched skin fold, the risk of accidental intramuscular injection of the drug is minimized. The needle should remain under the skin for at least 6 seconds, which guarantees a full dose. It is necessary to constantly change the injection site within the anatomical area to reduce the risk of developing lipodystrophy.

In / m injections are also possible, but only for the doctor's prescription.

Actrapid® HM is also possible to administer IV, and such procedures can only be performed by a medical professional.

Intravenous introduction of the drug Actrapid® HM Penfill® from the cartridge is allowed only as an exception in the absence of vials. In this case, you should dial the drug into an insulin syringe without a set of air or infusion with a system for infusions. This procedure should only be performed by a doctor. Actrapid® HM Penfill® is designed for use with Novo Nordisk insulin injection systems and NovoFine® or NovoTvist® needles. Detailed recommendations for the use and administration of the drug should be observed.

Correction of the dose

Concomitant diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin. Correction of the dose of the drug may also be required if the patient has concomitant diseases of the kidneys, liver, adrenal, pituitary or thyroid gland disorders.

The need for dose adjustment can also arise when the physical load or the patient's normal diet changes. Dose adjustment may be required when transferring a patient from one type of insulin to another

Overdose

Symptoms: development of hypoglycemia (cold sweat, palpitation, tremor, hunger, excitement, irritability, pallor, headache, drowsiness, movement uncertainty, speech and vision impairment, depression). Severe hypoglycemia can lead to temporary or permanent impairment of brain function, coma and death.

Treatment: sugar or glucose solution inside (if the patient is conscious), sc, v / m, or / in - glucagon or IV glucose.

Precautionary measures

It should be borne in mind that the ability to drive after the transfer of patients to human insulin may temporarily decrease. The drug can be used if it is completely transparent and colorless. If you use two types of insulin preparations in Penfill cartridges, you need a syringe pen for each type of insulin.

Form of issue

Solution for injection, 100 IU / ml. In the Penfill® glass cartridges, 3 ml; In the blister 5 cartridges; In a pack of cardboard 1 blister.

Terms of leave from pharmacies

On prescription.

Storage conditions

In the refrigerator, at a temperature of 2-8 ° C (do not freeze). The opened cartridge - at a temperature of no higher than 30 ° C for 6 weeks; Do not store in the refrigerator. The drug should be protected from heat and sunlight.

Keep out of the reach of children.

Shelf life

30 months

Do not use after the expiry date printed on the package.