DERINAT 1,5% SOLUTION FOR INJECTION - immunomodulator based on DNA

IMMUNOMODULATOR DERINAT is an immunomodulator that selectively stimulates Toll-like receptors 9 (TLR9). TLR9 are located on macrophages, dendritic cells of any localization, B-lymphocytes. The study of the nucleotide composition of the terminal sections of the DNA fragments that are part of the preparation DERINAT® showed that the fragments end in an unmethylated CpG dinucleotide motif. Unmethylated CpG DNA motifs are specific ligands for TLR9.

DERINAT® is an immunomodulating agent, hematopoiesis stimulator, regenerant, reparant.

DERINAT® (sodium salt of deoxyribonucleic acid) is a polydeoxynucleotide (PDRN) of eukaryotic origin with a molecular weight of up to 500 kDa, obtained from salmon milk.
Considering that the mass of one nucleotide is about 345 Daltons, the number of nucleotides in the molecule of the starting substance is estimated at 1500, that is, the Derinat® molecule consists of an average of 750 base pairs.
Available literature suggests that the mechanism of action of Derinat® on immunocompetent cells may be mediated by Toll-like TLR 9 receptors.
DERINAT® predominantly includes a short and medium strand of DNA, ending on average in at least 50% of the CPG nucleotide motifs.

DERINAT 15mg/ml is a modern, effective and safe preparation, a unique feature of which is a combination of immunomodulatory, reparative, regenerative and anti-inflammatory properties.

Due to the complex effect on the body, Derinat 15 mg / ml is widely and with high efficiency used to treat various diseases in gynecology, urology, dermatovenereology, therapy, surgery, oncology and other fields of medicine.

Chemical name: Natrium deoxyribonucleat

Pharmaceutical dosage form: Solution for outward and local application

Composition:

Active ingredient: sodium deoxyribonucleate - 75 mg.

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

Pharmacotherapeutic Group: immunomodulating preparation, regenerant, reparant

Pharmacodynamics:

The preparation activates the processes of cellular and humoral immunity. The immunomodulatory effect is due to the stimulation of B-lymphocytes, the activation of T-helpers. 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 to normalize the number of leukocytes, lymphocytes, granulocytes, phagocytes, platelets). Possessing a 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 preparations and radiation therapy. The preparation does not have embryotoxic, teratogenic and carcinogenic effects.

Pharmacokinetics:

Suction and distribution

The preparation is rapidly absorbed and distributed in organs and tissues with the participation of the endolymphatic pathway of transport. It has a high tropism for the organs of the hematopoietic system, takes an active part in cellular metabolism, integrating into cellular structures. In the phase of intensive intake of the preparation 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 the concentration of the preparation in the studied organs and tissues are characterized by a fast phase of increase and a fast phase of decrease in concentration in the time interval of 5-24 hours. The half-life (T ½ ) when administered intramuscularly is 72.3 hours. Derinat is rapidly distributed throughout the body, in the course of 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 the administration of the preparation. The preparation crosses the blood-brain barrier. The maximum concentration of the preparation 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) partly with feces, and, to a greater extent, with urine according to a biexponential dependence.

Indications for use:

• radiation damage;
• violation of hematopoiesis;
• myelodepression 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 preparations);
• 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 stage;
• trophic ulcers, long-term non-healing wounds;
• odontogenic sepsis, purulent-septic complications;
• rheumatoid arthritis;
• burn disease;
• preoperative and postoperative periods (in surgical practice);
• endometritis, salpinogo-oophoritis, endometriosis, fibroids;
• chlamydia, ureaplasmosis, mycoplasmosis;
• prostatitis, benign prostatic hyperplasia;
• chronic obstructive pulmonary disease;
• pulmonary tuberculosis, inflammatory diseases of the respiratory tract.

Benefits of Derinat: TRIPLE ANTI-VIRAL PROTECTION.

1. Derinat acts directly at the site of infection. Derinat fights viruses, bacteria. Suppresses the ability of infection to develop and spread throughout the body.
2. Derinat activates natural immunity, improves the functioning of the body's own defenses in case of their weakening.
3. Derinat prevents the penetration of infection. Restores and improves the protective properties of one of the main barriers of the body - the mucous membrane of the nasopharynx.

Contraindications:

Individual intolerance.

Use during pregnancy and during breastfeeding

A doctor's consultation is required. If it is necessary to prescribe the preparation during pregnancy, the expected benefit to the mother and the potential risk to the fetus should be assessed. During breastfeeding, use strictly according to the doctor's prescription.

Dosage and administration:

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

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

With peptic ulcer of the stomach and 12 duodenal ulcer - 5 injections with an interval of 48 hours.

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

In gynecology (endometritis, chlamydia, ureaplasmosis, mycoplasmosis, salpino-oophoritis, 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.

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

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

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

For children, the preparation is prescribed intramuscularly in the same way as for adults. For children under the age of 2 years, the preparation 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 preparation per year of life.
From the age of 10, a single dose is 5 ml of a solution, a course dose is up to 5 injections of the preparation.

Side effect:

In diabetic patients, a hypoglycemic effect is noted, which should be taken into account when controlling blood sugar levels.

Overdose:

Negative effects from an overdose have not been identified.

Interaction with other preparations:

The use of DERINAT in complex therapy improves the effectiveness and reduces the duration of treatment, with a significant reduction in doses of antibiotics and antiviral agents with an increase in remission periods.

Derinat increases the effectiveness of antitumor antibiotics of the anthracycline series, cytostatics.

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

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

Influence on the ability to drive vehicles and other mechanisms:

The use of the preparation Derinat does not affect the ability to perform potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions (including driving, working with moving mechanisms).

Release form:

Solution for intramuscular injection 15 mg/ml. 5 ml bottles of colorless or brown glass, hermetically sealed with rubber stoppers and rolled in aluminum caps with a tear-off plastic lining. 5 bottles are placed in a plastic contour package (pallet), which, together with instructions for use, is placed in a cardboard pack.

Storage conditions:

Store in a place protected from light, at a temperature of + 4°С to + 20°С. Keep out of the reach of children.

Best before date:

5 years. Do not use after the expiry date stated on the packaging. Do not use unclaimed contents of opened vials.

Individual intolerance: use during pregnancy and during breastfeeding

A doctor's consultation is required. If it is necessary to prescribe the preparation during pregnancy, the expected benefit to the mother and the potential risk to the fetus should be assessed. During breastfeeding, use strictly according to the doctor's prescription.

Guaranteed authenticity and quality:

100% Original from PHARM PACK (Russian Federation)

Development and production:

PHARM PACK (Russian Federation)

In 1994, for the development, production and sale of new generation medicines based on the main component of a living cell, the DNA molecule, a specialized enterprise was established - CJSC "FP" Technomedservice ", which later laid the foundation for the group of companies of research and production campaigns Farmpack and Immunnolex. Our Holding , one of the few in Russia that carries out scientific development, a full production cycle from substances to finished preparations and their distribution.Raw materials for the production of the substance are purchased in Russia, and all packaging materials are purchased from the factories of leading European manufacturers.

Promotion and distribution of preparations are provided by the company "PharmPack", established in 2005. Effective promotion of products requires close cooperation between of the Holding Company " PharmPack " with federal and regional research institutions, scientific medical community in the person of the main medical experts of the Russian Federation, Ministry of Health, and the regional Department of Health. Among them: N.V. Sklifosovsky Research Institute of Emergency Medicine, D.I. Ivanovsky Institute of Virology Russian Academy of Medical Sciences, N.N. Blokhin Russian Cancer Research Center, S. Fyodorov Eye Microsurgery Federal State Institution, S.M. Kirov Military Medical Academy, North-Western State Medical University named after I.I. Mechnikov, Voronezh State Medical University named after N.N. Burdenko, N.P.Ogarev Mordovia State University, Nizhny Novgorod, Tver, Samara, Chelyabinsk State Medical Academy and others.

Our Research and Production Holding annually increases production of the preparation: in 10 years of existence the company relise of finished product increased 150 times. The advent of a separate companies "PharmPack ", which engaged in promotion of products, had result of many times increase the effectiveness of sales. Recently growing interest to the product of the Holding Company evinces other countries the distributors. Holding Drugs are registered in Kazakhstan, Ukraine, Belarus, Georgia. The interest in promoting Derinat to market their countries evinces pharmaceutical companies from Slovakia, Yugoslavia, Czech Republic, Bulgaria, and India.

Products of our Holding were repeatedly awarded prestigious diplomas and prizes. In 1997, the Derinat preparation was declared the "medicine of Year" by Russian Biographical Institute. In 2000 the company became a laureate of the contest "Enterprise of the 21st century". The company is an official partner of the Kremlin providers Guild has grateful to the President of the Russian Federation, for his great contribution to the establishment of the domestic economy. One of the latest awards is International Prize "Profession - Life", for achievements in the field of medical production.