Protafan NM penfill suspension d / n / c injection 100 IU / ml, 3 ml No. 5

• Type I diabetes mellitus,

• type II diabetes mellitus (with resistance to sulfonylurea derivatives, intercurrent diseases, operations and in the postoperative period, during pregnancy).

ProtafanЃ HM

ProtafanЃ HM PenfillЃ

PC. The drug is intended for subcutaneous administration. Insulin suspensions should not be administered intravenously.

The dose of the drug is selected individually, taking into account the needs of the patient. Typically, the need for insulin is between 0.3 and 1 IU / kg / day. The daily insulin requirement may 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.

ProtafanЃ NM can be used both in monotherapy and in combination with fast or short acting insulin.

ProtafanЃ NM is usually injected subcutaneously into the thigh area. If convenient, injections can also be made in the anterior abdominal wall, in the gluteal region, or in the deltoid muscle of the shoulder. When the drug is injected into the thigh area, there is a slower absorption than when administered to other areas. If the injection is made into a retracted skin fold, the risk of accidental intramuscular injection of the drug is minimized.

The needle must remain under the skin for at least 6 seconds to ensure complete dose administration. It is necessary to constantly change injection sites within the anatomical region to prevent the development of lipodystrophies.

ProtafanЃ NM PenfillЃ is designed for use with Novo Nordisk insulin injection systems and NovoFineЃ or NovoTvistЃ needles. Detailed recommendations for the use and administration of the drug should be followed.

Dose adjustment

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, dysfunction of the adrenal glands, pituitary gland or thyroid gland. The need for dose adjustment may also arise when the physical activity or the patient's usual diet is changed. A dose adjustment may be required when a patient is switched from one type of insulin to another.

Suspension for subcutaneous administration of white color, stratifies upon standing, forming a white precipitate and a colorless or almost colorless supernatant liquid; with stirring, the precipitate should be resuspended.

1 ml

insulin isophane (human genetically engineered) 100 IU *

Excipients: zinc chloride - 33 ?g, glycerol - 16 mg, metacresol - 1.5 mg, phenol - 0.65 mg, sodium hydrogen phosphate dihydrate - 2.4 mg, protamine sulfate - about 0.35 mg, sodium hydroxide - about 0.4 mg and / or hydrochloric acid - about 1.7 mg (to adjust the pH), water d / i - up to 1 ml.

• Increased sensitivity to insulin;

• hypoglycemia.

pharmachologic effect

Human insulin of medium duration, obtained using recombinant DNA technology. Interacts with a specific receptor of the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, incl. synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthetase). A decrease in blood glucose is due to an increase in its intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis, glycogenesis, and a decrease in the rate of glucose production by the liver.

The duration of action of insulin preparations is mainly determined by the rate of absorption, which depends on several factors (for example, on the dose, route and site of administration), and therefore the profile of insulin action is subject to significant fluctuations, both in different people and in the same person.

On average, after subcutaneous administration, this insulin begins to act in 1.5 hours, the maximum effect develops between 4 hours and 12 hours, the duration of action is up to 24 hours.

Pharmacokinetics

The completeness of absorption and the onset of the effect of insulin depends on the injection site (abdomen, thigh, buttocks), dose, and concentration of insulin in the preparation.

It is distributed unevenly over the tissues; does not penetrate the placental barrier and into breast milk. It is metabolized in the liver and kidneys by the action of the enzyme insulinase. It is excreted by the kidneys (30-80%).

Side effect

Side effect due to the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitations, tremors, hunger, agitation, paresthesia of the oral mucosa, headache, dizziness, decreased visual acuity). Severe hypoglycemia can lead to the development of hypoglycemic coma.

Allergic reactions: skin rash, Quincke's edema, anaphylactic shock.

Local reactions: hyperemia, edema and itching at the injection site, with prolonged use - lipodystrophy at the injection site.

Others: edema, transient decrease in visual acuity (usually at the beginning of therapy).

Application during pregnancy and lactation

There are no restrictions on the treatment of diabetes mellitus with insulin during pregnancy. insulin does not cross the placental barrier. When planning pregnancy and during it, it is necessary to intensify the treatment of diabetes mellitus. The need for insulin usually decreases in the first trimester of pregnancy and gradually increases in the second and third trimesters.

During and immediately after childbirth, the need for insulin can drop dramatically. Soon after childbirth, the need for insulin quickly returns to pre-pregnancy levels.

Application for violations of liver function

It should be used with caution in patients with impaired liver function. Dose adjustment is required.

Application for impaired renal function

It should be used with caution in patients with impaired renal function. Dose adjustment is required.

Use in elderly patients

Caution should be given to elderly patients. Dose adjustment is required.

special instructions

Against the background of insulin therapy, constant monitoring of the concentration of glucose in the blood is necessary.

In addition to insulin overdose, the causes of hypoglycemia can be: drug replacement, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (liver and kidney dysfunction, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), change of the injection site, as well as interaction with other drugs.

Incorrect dosing or interruptions in insulin administration, especially in patients with type 1 diabetes mellitus, can lead to hyperglycemia. Usually, the first symptoms of hyperglycemia develop gradually over several hours or days. These include thirst, increased urination, nausea, vomiting, dizziness, redness and dryness of the skin, dry mouth, loss of appetite, and acetone odor in exhaled air. If left untreated, hyperglycemia in type 1 diabetes can lead to life-threatening diabetic ketoacidosis.

The insulin dose must be adjusted in case of thyroid dysfunction, Addison's disease, hypopituitarism, liver and kidney dysfunctions, and diabetes mellitus in patients over 65 years of age.

Due to the increased risk of cardiac and cerebral complications of hypoglycemia, the insulin preparation should be used with caution in patients with severe stenosis of the coronary and cerebral arteries.

With caution in patients with proliferative retinopathy, especially those not receiving photocoagulation (laser coagulation) treatment due to the risk of amaurosis (complete blindness).

If the patient increases the intensity of physical activity or changes the habitual diet, the dose of insulin may need to be adjusted.

Comorbidities, especially infections and conditions with fever, increase the need for insulin.

The transfer of a patient to a new type of insulin or insulin preparation from another manufacturer must be carried out under the supervision of a physician.

When using insulin preparations in combination with drugs of the thiazolidinedione group in patients with type 2 diabetes mellitus, fluid retention in the body may occur, as a result of which the risk of the development and progression of chronic heart failure increases, especially in patients with diseases of the cardiovascular system and the presence of risk factors for chronic heart failure. Patients receiving this therapy should be monitored regularly for signs of heart failure. If heart failure occurs, therapy should be carried out in accordance with current treatment standards.

Drug interactions

The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, nonselective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibazylamide, ketoconazole preparations containing ethanol.

The hypoglycemic effect of insulin is weakened by glucagon, somatropin, estrogens, oral contraceptives, corticosteroids, iodine-containing thyroid hormones, thiazide diuretics, 'loop' diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol blockers, epinephrine-1-channel blockers, H-blockers , diazoxide, morphine, phenytoin, nicotine.

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

Reduces ethanol tolerance.