Derinat solution for intramuscular injection of 15 mg / ml, in vials of 5 ml, №5

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Registration Number: R № 002916/01

Drug Trade Name: Derinat

International nonproprietary name: Derinat.

Pharmaceutical dosage form: solution for intramuscular introduction.

Composition:
Active ingredient: natrium deoxyribonucleat 1.5 g
Auxiliary ingredients: natrium chloride 0.9 g, water for injection – 100 ml

Description: Transparent colorless liquid.

Pharmacotherapeutic Group: immunomodulating drug, hemapoiesis stimulator, regenerant, reparant

BATCh Code: LO3, VO3AX, B03XA.

Pharmacological action:

The drug activates the processes of innate and adaptive immunities. Immunomodulating effect is caused by stimulation B-lymphocytes and T-helpers activation. Derinat activated non-specific body resistance by optimizing inflammatory and immune responses to the bacterial, viral and fungal antigens. The drug stimulates reparative and regenerative processes. Drug increases body resistance to infections, regulates hematopoiesis by contributing to the normalization of leukocytes, granulocytes, phagocytes and concentration of platelets. Demonstrating expressed of the lymphotropic effect, Derinat stimulate drainage detoxification function of lymphatic system. Derinat significantly reduces cellular sensitivity to the damaging action of chemotherapeutic compounds and radiotherapy. The drug has neither teratogenic nor carcinogenic action.

Pharmacokinetics

Absorption and distribution

The drug is absorbed fast and distributed within organs and tissues via the way endolymphatic system. The drug has high-tropic to hematopoietic system organs, and that actively participates in cellular metabolism processes by interaction with cell structures. At the phase of the intensive drug absorption into blood, plasma and blood cells, the drug are redistributed simultaneously with metabolism and excretion. 5 – 24 hrs after a single injection, rapid phase of concentration increase and rapid phase of concentration decrease are typical for all pharmacokinetic curves describing the drug concentration changes in the analyzed organs and tissues. Time of half-life of drug (Т ½) at intramuscular introduction is 72.3 hrs. Derinat is distributed fast throughout a body, and during everyday application possible may be accumulate in organs and tissues, with maximum accumulation in bone marrow, lymph nodes, spleen and thymus, and with less accumulation in hepar, cerebrum, stomach, and in intestinal and colon. Maximum concentration in bone marrow is reached 5 hrs after the drug introduction. The drug can pass through hemato-encephalitic barrier. Maximum drug concentration in cerebrum is reached 30 min after the introduction.

Metabolism and excretion

Derinat is excreted from organism (as metabolites) mainly with urine and partially with faeces. Excretion of the drug from the body is described by a bi-exponential graph.

Indications

  • radiation injuries;
  • inhibition of hemopoiesis;
  • cancerous myelodysplastic syndrome and resistance to cytostatics under the cytostatic and/or radiation therapy (hemopoiesis stabilization, decrease of chemical cardio- and myelotoxicity );
  • stomatitis, induced by cytostatic therapy;
  • stomach and peptic ulcer disease, erosive gastroduodenitis;
  • ischemic heart disease;
  • obliterating diseases of vessels leg , chronic leg ischemia of II – III stage;
  • trophic ulcers, chronic nonhealing wounds;
  • odontogenic sepsis, suppurative-septic complications;
  • rheumatoid arthritis;
  • burn disease;
  • preoperative and postoperative periods (in surgery);
  • endometritis;
  • clamidiosis, ureaplasmosis, mycoplasmosis;
  • prostatitis;
  • chronic obstructive pulmonary disease;
  • pulmonary tuberculosis.

Contraindications

Individual intolerance, pregnancy, lactation period.

Use during pregnancy and lactation

The appointment of the drug during pregnancy should evaluate the expected benefit to the mother and the potential risk to the fetus. In lactating to apply is only on prescription.

Dosage and mode of administration

Adults: intramuscular introduction of 5 ml (75 mg) of 1,5% solution during 1-2 minutes, with 24-72 hrs interval.

For ischemic heart disease – 10 injections with 48-72 hrs interval.

For stomach and peptic ulcer disease – 5 injections with 48 hrs interval.

For oncological diseases – 3-10 injections with 24-72 hrs interval.

For gynaecological disorders (myoma, endometriosis, gestosis, salpingo-oophoritis).

For andrological disorders (prostatitis) – 10 injections with 24-48 hrs interval.

For pulmonary tuberculosis – 10-15 injections with 24-48 hrs interval.

For chronic inflammatory diseases – 5 injections with 24 hrs interval, then 5 more injections with 72 hrs interval.

When 2 ml of 1.5% solution is used, intramuscular injections should be made on a daily basis with dosage recalculation to the total course dose of 375-750 mg.

Children: drug is prescribed intramuscularly with the same scheme as the adult one. Single dose of 7.5 mg (0.5 ml of 1.5% solution) is prescribed to children under two years old.

For children ageing from 2 to 10, single dose is calculated using the ratio of 0.5 ml of the drug per every year of life. For children of ten years and upward, single dose equals to 5 ml of 1.5% solution, and treatment course dose can contain up to 5 injections of 1.5% drug.

Side-effects

Moderate painfulness at the injection site at the intramuscular introduction of the drug not requires any therapy.

Possible short-time fever (body temperature can increase up to 38°С), few hyperemia and painfulness at the injection site. Moderate hypoglycemic action is evidenced for diabetic patients; this must be taken into consideration by blood glucose monitoring.

Overdose

No negative consequences of overdosing are evidenced.

Interaction with other drugs

Derinat for applications in complex therapy is increases the efficiency of the treatment and reduces its terms, provides the significant decrease of antibiotics and antiviral drugs dosage. Derinat increases the efficiency of antitumor antibiotics of anthracyclines type and others cytostatics.

The drug potentiates the therapeutic effect of basic therapy of stomach and peptic ulcer disease. Derinat reduces iatrogenic side-effects of basic drugs for treatment of rheumatoid arthritis; create improvement in 50% to 70% indicators of the disease activity. For cases of surgical sepsis, inclusion of Derinat into complex therapy causes decrease of level intoxication, create of immunity activation, normalization of hemopoiesis and better functioning of the organs responsible for detoxication processes and homeostasis.

Special instructions

The drug may be administered subcutaneously.

Product form

The solution for intramuscular introduction 15 mg/ml, in neutral or dark glass bottles of 2 ml and 5 ml.

Original carton box package contains either 5 bottles 5 ml each, or 10 bottles 2 ml each on a blister tray, inside with Medication Guide.

Period of validity

5 years. Do not use after the expiration of validity period which is indicated on the package.

Keeping conditions

Keep in a shadowed place at a temperature range from +4°С to +20ºС. Save away from children.

Pharmacy purchasing terms

Available is on prescription only.

Official website: www.derinat.ru

Additional materials