Instructions for medical use of the drug Derinat

Registration number: P N002916/01

Trade name of the drug: Derinat®.

International nonproprietary or generic name : Sodium deoxyribonucleate

Dosage form: Solution for intramuscular administration.

Composition: Active ingredient: sodium deoxyribonucleate – 75 mg.

Excipients: sodium chloride – 45 mg, water for injection – up to 5 ml

Description: transparent colorless liquid.

Pharmacotherapeutic group: immunomodulatory agent, hematopoiesis stimulator, regenerant, reparant.

ATX code: L03, V03AX, B03XA.

Pharmacological properties

Pharmacodynamics

The drug activates the processes of cellular and humoral immunity. The immunomodulatory effect is due to stimulation of B lymphocytes and activation of T helper cells. Derinat activates the body's nonspecific resistance, optimizing inflammatory reactions and the immune response to bacterial, viral and fungal antigens. Stimulates reparative and regenerative processes. Increases the body's resistance to infections, regulates hematopoiesis (helps normalize the number of leukocytes, lymphocytes, granulocytes, phagocytes, platelets). Possessing pronounced lymphotropism, Derinat stimulates the drainage and detoxification function of the lymphatic system. Derinat significantly reduces the sensitivity of cells to the damaging effects of chemotherapy drugs and radiation therapy. The drug does not have embryotoxic, teratogenic or carcinogenic effects.

Pharmacokinetics

Suction and distribution

The drug is quickly absorbed and distributed in organs and tissues via the endolymphatic transport pathway. It has a high affinity for the organs of the hematopoietic system, takes an active part in cellular metabolism, integrating into cellular structures. During the phase of intensive entry of the drug into the blood, redistribution occurs between plasma and blood cells, in parallel with metabolism and excretion. After a single injection, all pharmacokinetic curves describing the change in drug concentration in the studied organs and tissues are characterized by a rapid phase of increase and a rapid phase of decrease in concentration in the time interval of 5–24 hours. The half-life (T ½) for intramuscular administration is 72.3 hours. Derinat is quickly distributed throughout the body, during daily course use it accumulates in organs and tissues: maximum: – in the bone marrow, lymph nodes, spleen, thymus; to a lesser extent - in the liver, brain, stomach, small and large intestines. The maximum concentration in the bone marrow is determined 5 hours after administration of the drug. The drug crosses the blood-brain barrier. The maximum concentration of the drug in the brain is achieved after 30 minutes.

Metabolism and excretion.

Derinat is metabolized in the body. It is excreted from the body (in the form of metabolites) partially with feces, and, to a greater extent, with urine according to a biexponential dependence.

Derinat 1.5% 5ml 5 pcs. solution for intramuscular injection ampoule

pharmachologic effect

Immunomodulatory, wound healing, reparative, regenerating, stimulating hematopoiesis.

Composition and release form Derinat 1.5% 5ml 5 pcs. solution for intramuscular injection ampoule

Solution for intramuscular administration - 100 ml:

• active substance: sodium deoxyribonucleate - 1.5 g;
• excipients: sodium chloride - 0.9 g; water for injection - up to 100 ml.

Solution for intramuscular administration, 15 mg/ml. In bottles made of imported glass with injection infusion stoppers of 2 or 5 ml. In blister trays of 5 (5 ml) or 10 (2 ml) bottles. There is 1 blister tray in a cardboard pack.

Description of the dosage form

Transparent colorless liquid.

Directions for use and doses

V/m.

Adults. 5 ml of a 15 mg/ml solution (75 mg) is administered over 1–2 minutes, with an interval of 24–72 hours.

For acute inflammatory diseases - 3-5 injections with an interval of 24-72 hours.

For chronic inflammatory diseases - 5 injections with an interval of 24 hours, then - 5 injections with an interval of 72 hours.

In gynecology (endometritis, chlamydia, ureaplasmosis, mycoplasmosis, salpingoophoritis, fibroids, endometriosis) - 10 injections with an interval of 24–48 hours.

In urology and andrology (prostatitis, benign prostatic hyperplasia) - 10 injections with an interval of 24–48 hours.

For coronary artery disease - 10 injections with an interval of 48–72 hours.

For gastric and duodenal ulcers - 5 injections with an interval of 48 hours.

For oncological diseases - 3-10 injections with an interval of 24-72 hours.

For pulmonary tuberculosis - 10-15 injections with an interval of 24-48 hours.

For children, the drug is prescribed intramuscularly according to the same regimen as for adults. For children under 2 years of age, the drug is prescribed in a single dose of 7.5 mg (0.5 ml). In children aged 2 to 10 years, a single dose is determined at the rate of 0.5 ml of the drug per year of life. From the age of 10, a single dose is 5 ml of a 15 mg/ml solution, a course dose is up to 5 injections of the drug.

Pharmacodynamics

The drug has a modulating effect on the cellular and humoral components of the immune system and nonspecific resistance of the body, which leads to optimization of the inflammatory reaction and specific immune response to bacterial, viral and fungal antigens. The immunomodulatory effect of Derinat® is due to its ability to stimulate B-lymphocytes, activate T-helper cells and cells of the monocyte-macrophage system. The drug accelerates energy metabolism inside the cell, RNA and DNA synthesis. Activation of cellular immunity by Derinat® increases the ability of natural killer cells to act on cells affected by viruses, chlamydia, Staphylococcus aureus, Escherichia coli, Helicobacter, etc. Derinat® stimulates reparative and regenerative processes. The drug has anti-inflammatory, antitumor, antiallergic and detoxifying effects, as well as antioxidant and membrane-stabilizing properties. Derinat® normalizes the condition of the body in case of dystrophies of vascular origin and has a weak anticoagulant effect.

Derinat® helps remove free radicals from the body and reduces the sensitivity of cells to the damaging effects of chemotherapy drugs.

In the body, the drug accumulates mainly in the organs of the immune system and hematopoiesis - bone marrow, spleen, lymph nodes, as well as in the intestinal epithelium.

Increases the body's resistance to infections. Stimulates hematopoiesis (normalizing the number of leukocytes, lymphocytes, granulocytes, phagocytes, platelets).

Possessing pronounced lymphotropism, Derinat® stimulates the drainage and detoxification function of the lymphatic system. Derinat® significantly reduces the sensitivity of cells to the damaging effects of chemotherapy drugs and radiation therapy.

It has cardioprotective, anti-ischemic and cytoprotective effects. When Derinat® is included in the complex therapy of patients with coronary artery disease, the contractile function of the myocardium improves, the death of cardiomyocytes is prevented, and exercise tolerance increases.

In case of gastric and duodenal ulcers, the drug has a reparative effect, restoration of the mucous membrane and a pronounced immunomodulatory effect aimed at eliminating the infectious factor Helicobacter pylori.

The drug does not have embryotoxic, teratogenic or carcinogenic effects.

Pharmacokinetics

Suction and distribution

The drug is quickly absorbed and distributed in organs and tissues via the endolymphatic transport pathway. It has a high affinity for the organs of the hematopoietic system, takes an active part in cellular metabolism, integrating into cellular structures. During the phase of intensive entry of the drug into the blood, redistribution occurs between plasma and blood cells, in parallel with metabolism and excretion. After a single injection, all pharmacokinetic curves describing changes in the concentration of the drug in the studied organs and tissues are characterized by a rapid phase of increasing and a rapid phase of decreasing concentration in the time interval of 5–24 hours. T1/2 with intramuscular administration is 72.3 hours. Derinat ® is quickly distributed throughout the body, during daily course use it accumulates in organs and tissues: maximum - in the bone marrow, lymph nodes, spleen, thymus; to a lesser extent - in the liver, brain, stomach, small and large intestines. Cmax in the bone marrow is determined 5 hours after drug administration. The drug crosses the BBB. Cmax of the drug in the brain is reached after 30 minutes.

Metabolism and excretion

Derinat® is metabolized in the body. It is excreted from the body (in the form of metabolites) partially with feces and to a greater extent with urine, according to a biexponential dependence.

Indications for use Derinat 1.5% 5ml 5 pcs. solution for intramuscular injection ampoule

• as part of complex therapy for chronic recurrent inflammatory diseases of various etiologies that are not amenable to standard therapy;
• severe influenza, ARVI and their complications (pneumonia, bronchitis, bronchial asthma);
• chronic obstructive pulmonary diseases;
• as part of complex therapy of bacterial and viral infections;
• allergic diseases (allergic rhinitis, bronchial asthma, atopic dermatitis, hay fever);
• to activate regenerative processes;
• peptic ulcer of the stomach and duodenum, erosive gastroduodenitis;
• urogenital infections (chlamydia, ureaplasmosis, mycoplasmosis, including combined virus-associated infections);
• endometritis, salpingoophoritis, endometriosis, fibroids;
• prostatitis, benign prostatic hyperplasia;
• preoperative and postoperative periods (in surgical practice);
• cardiac ischemia;
• trophic ulcers, long-term non-healing wounds;
• obliterating diseases of the vessels of the lower extremities, chronic ischemic disease of the lower extremities of stages II and III;
• burn disease;
• rheumatoid arthritis, incl. complicated acute respiratory infection or acute respiratory viral infection;
• stomatitis induced by cytostatic therapy;
• odontogenic sepsis, purulent-septic complications;
• myelosuppression and resistance to cytostatics in cancer patients, which developed against the background of cytostatic and/or radiation therapy (stabilization of hematopoiesis, reduction of cardio- and myelotoxicity of chemotherapy drugs);
• hematopoiesis disorders;
• treatment of radiation injuries;
• pulmonary tuberculosis, inflammatory diseases of the respiratory tract;
• secondary immunodeficiency states of various etiologies.

Contraindications

Individual intolerance.

Application Derinat 1.5% 5ml 5 pcs. solution for intramuscular administration of an ampoule during pregnancy and breastfeeding

A doctor's consultation is required. If it is necessary to prescribe the drug during pregnancy, the expected benefit to the mother and the potential risk to the fetus should be assessed. During lactation, use strictly as prescribed by a doctor.

special instructions

The drug can be administered subcutaneously.

IV administration of the drug is not allowed.

Overdose

No negative effects from overdose were identified.

Side effects Derinat 1.5% 5ml 5 pcs. solution for intramuscular injection ampoule

In patients with diabetes mellitus, a hypoglycemic effect is observed, which should be taken into account when monitoring blood sugar levels.

Drug interactions

The use of Derinat® in complex therapy makes it possible to increase the effectiveness and shorten the duration of treatment, with a significant reduction in doses of antibiotics and antivirals with an increase in periods of remission.

Derinat® increases the effectiveness of antitumor anthracycline antibiotics and cytostatics.

The drug potentiates the therapeutic effect of basic therapy for gastric and duodenal ulcers. Derinat® reduces the iatrogenicity of basic drugs in the treatment of rheumatoid arthritis, achieving 50 and 70% improvement in a number of complex indicators of disease activity.

In case of surgical sepsis, the introduction of the drug Derinat® as part of complex therapy causes a decrease in the level of intoxication, activation of the immune system, normalization of hematopoiesis, and improves the functioning of organs responsible for the processes of detoxification of the internal environment of the body (including lymph nodes, spleen).

Indications for use

• radiation injuries;
• hematopoiesis disorder;
• myelosuppression and resistance to cytostatics in cancer patients, which developed against the background of cytostatic and/or radiation therapy (stabilization of hematopoiesis, reduction of cardio- and myelotoxicity of chemotherapy drugs);
• stomatitis induced by cytostatic therapy;
• peptic ulcer of the stomach and duodenum, erosive gastroduodenitis;
• cardiac ischemia;
• obliterating diseases of the vessels of the lower extremities, chronic ischemic disease of the lower extremities II – III stages;
• trophic ulcers, long-term non-healing wounds;
• odontogenic sepsis, purulent-septic complications;
• rheumatoid arthritis;
• burn disease;
• preoperative and postoperative periods (in surgical practice);
• endometritis, salpinoophoritis, endometriosis, fibroids;
• chlamydia, ureaplasmosis, mycoplasmosis;
• prostatitis, benign prostatic hyperplasia;
• chronic obstructive pulmonary diseases;
• pulmonary tuberculosis, inflammatory diseases of the respiratory tract.

Indications

Due to its immunomodulatory properties, all forms of the drug are in demand for the treatment of various pathologies. Safety and a wide spectrum of action make Derinat injections, solution and nasal drops unique medicines. They can be used as a single agent or in complex therapy of various diseases. In the first case, the drug is used most often for the prevention and treatment of acute respiratory viral infections. In addition, the drops work effectively in the treatment of ophthalmic diseases. They help reduce dystrophic and purulent-inflammatory processes. Also, derinat, the instructions emphasize this, is used to eliminate inflammation in the oral mucosa.

When combined with other drugs, the drug is used to treat the following pathologies:

• Chronic diseases characterized by inflammatory processes of various etiologies.
• Diseases of the upper respiratory tract in acute and chronic form: sinusitis, rhinitis,
• Obliterating diseases of the lower extremities (OLD), which are characterized by dystrophic changes in the neurovascular endings.
• Non-healing wounds and ulcers due to diabetes and other conditions.

Derinat is indicated, the instructions for use provide for this, in the treatment of gangrene, frostbite and burns. Its use increases the effectiveness of treatment of hemorrhoids, and also reduces the risk of necrosis of the skin and mucous membranes during radiation therapy.

Derinat injections, the instructions indicate this, are administered intramuscularly if necessary to stimulate the hematopoietic function. This form of immunomodulatory agent has shown high effectiveness in the treatment of radiation injuries during the treatment of tumor processes.

Injections are indicated for the following pathologies:

• Stomatitis caused by antitumor therapy;
• Stomach and duodenal ulcers.
• Rheumatoid arthritis.
• Trophic ulcers.
• Prostate.
• Endomerite.

There are many other indications for intramuscular administration of the drug. But it should be understood that decisions about treatment should always be made by a doctor.

Directions for use and doses

For adults:

5 ml of solution intramuscularly over 1-2 minutes, with an interval of 24-72 hours.

For coronary heart disease - 10 injections with an interval of 48-72 hours.

For gastric and duodenal ulcers – 5 injections with an interval of 48 hours.

For cancer - 3-10 injections with an interval of 24-72 hours.

In gynecology (endometritis, chlamydia, ureaplasmosis, mycoplasmosis, salpinoophoritis, fibroids, endometriosis) - 10 injections with an interval of 24-48 hours.

In andrology (prostatitis, benign prostatic hyperplasia) – 10 injections with an interval of 24-48 hours.

For pulmonary tuberculosis - 10-15 injections with an interval of 24-48 hours.

For acute inflammatory diseases - 3-5 injections with an interval of 24-72 hours.

For chronic inflammatory diseases - 5 injections with an interval of 24 hours, then - 5 injections with an interval of 72 hours.

When using a 1.5% solution of 2 ml, intramuscular injections should be carried out daily, recalculating, until the course dose of 375-750 mg is reached.

For children:

the drug is prescribed intramuscularly according to the same regimen as for adults. For children under 2 years of age, the drug is prescribed in a single dose of 7.5 mg (0.5 ml). In children aged 2 to 10 years, a single dose is determined at the rate of 0.5 ml of the drug per year of life.

From the age of 10, a single dose is 5 ml of solution, a course dose is up to 5 injections of the drug.

Interaction with other drugs

The use of Derinat in complex therapy makes it possible to increase the effectiveness and reduce the duration of treatment, with a significant reduction in doses of antibiotics and antiviral agents with an increase in periods of remission.

Derinat increases the effectiveness of antitumor anthracycline antibiotics and cytostatics.

The drug potentiates the therapeutic effect of basic therapy for gastric and duodenal ulcers. Derinat reduces the iatrogenicity of basic drugs in the treatment of rheumatoid arthritis, achieving 50% and 70% improvement in a number of complex indicators of disease activity.

In case of surgical sepsis, the introduction of Derinat into complex therapy causes a decrease in the level of intoxication, activation of the immune system, normalization of hematopoiesis, and improves the functioning of the organs responsible for the processes of detoxification of the internal environment of the body (lymph nodes, spleen, etc.).