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Registration Number R ¹ 002916/02
Trade Name
Derinat
International nonproprietary name
Derinat
Chemical name
Natrium deoxyribonucleat
Pharmaceutical dosage form
Solution for outward and local application
Composition
Active ingredient: natrium deoxyribonucleat 2.5 g
Auxiliary ingredients: natrium chloride 0,1 g, water for injection – 1000 ml
Description
Transparent colorless liquid without any inclusions.
Pharmacotherapeutic Group: immunomodulating drug,
regenerant, reparant
ATCh Code: LO3, VO3AX.
Pharmacological characteristics:
The drug activates the processes of cellular and humoral immunities. It optimizes specific responses to fungal, viral, and bacterial infections. The drug stimulates reparative and regenerative processes, normalizes tissues and organs condition at vascular dystrophies. Derinat contributes to the recovery of trophic ulcers of various aetiologies. It also contributes to quick recovery of full-thickness burns. Under Derinat action, no mucousa scars are generated during an ulcer recovery. The drug has neither teratogenic nor carcinogenic action.
Pharmacokinetics
When applied locally, Derinat is absorbed fast and distributed within organs and tissues via endolymphatic transportation way. At the stage of the drug intensive admission into blood, plasma and blood corpuscles are redistributed simultaneously with metabolism and excretion. Derinat is metabolized in organism. It is excreted from organism (as metabolites) by biexponential dependence, mainly with urine and partially with faeces.
Indications
- ARD (acute respiratory disease) – monotherapy;
- ARVI (acute respiratory viral infection) – monotherapy;
- rhinitis;
- sinuitis, antritis, frontal sinusitis;
- obliterating leg diseases;
- trophic ulcers;
- chronic nonhealing and infected wounds (including diabetic ones)
- gangrene;
- burns;
- chilblains;
- oral, eye, nasal, vaginal and rectal inflammatory diseases;
- haemorrhoids.
Contraindications
Individual intolerance.
Dosage and mode of administration
Nasal drops are prescribed to children from the very first day of life and to adults. For ARVI prophylaxis, 2 drops are injected into each nasal passage 2-4 times a day during 1-2 weeks. When catarrhal diseases signs are evidenced, the drug is injected into nose every 1-1.5 hrs within 24 hrs, and then 2-3 drops of the drug are injected into each nasal passage 3-4 times a day, with the treatment course duration of 2 weeks. For the treatment of nasal and paranasal sinuses inflammatory diseases, either 3-5 drops of the drug are injected into each nasal passage or a cotton plug with drug is inserted into each nasal passage 3-6 times a day, with the treatment course duration of 1 month.
For the treatment of oral diseases, the drug gargle is prescribed 4-6 times a day (1 bottle for 2-3 gargles), with the treatment course duration of 5-10 days.
In gynaecological practice, for the treatment of chronic inflammatory diseases and of fungal, bacterial and other mucous infections daily intrauterine lavement and drug endovaginal plugging are prescribed during 5-7 days. For haemorrhoids treatment, the drug is prescribed with rectal microclysters (15-40 ml), with the treatment course duration of 4-10 days.
For the treatment of serious ophthalmologic inflammatory and dystrophic diseases, 1-2 drops of Derinat are injected into eyes 2-3 times a day, during 14-45 days.
For the treatment of obliterating leg diseases, 1-2 drops of the drug are injected into each nosal passage 6 times a day, with the treatment duration course up to 6 months.
For the treatment of postradiation skin and mucous necrosis, cronic nonhealing wounds, burns, chilblains, trophic ulcers of various aetiology and gangrene, dressings of double-layer gauze with the drug on it are applied onto the damaged site 3-4 times during 24 hrs, and at the same time 1-2 drops of the drug are injected into nose 6 times a day, with the treatment duration course of 1-3 months.
Side-effects
The drug can effect on spontaneous sloughing at diseased areas during sphacelism treatment. Analgesic effect is evidenced during the treatment of open wounds and burns.
Overdose
No overdosing is evidenced.
Interaction with other drugs
When applied locally, incompatible with fat-based ointment.
Product form
0.25% solution for outward and local application. Package No.1 contains 10 ml, 20 ml, 50 ml, and 100 ml glass bottles, and 10 ml dropper bottle.
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 away from children at a temperature range from +4°Ñ to +18ºÑ. Opened bottle contents should be used within 2 weeks after opening.
Pharmacy purchasing terms
Nonprescription
Registration Number: R ¹ 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
ATCh Code: LO3, VO3AX, B03XA.
Pharmacological action:
The drug activates the processes of cellular and humoral immunities. Immunomodulating effect is caused by B-lymphocytes stimulation and T-helpers activation. Derinat activates non-specific body resistance by optimizing inflammatory responses and immune responses to bacterial, viral and fungal antigens. The drug stimulates reparative and regenerative processes. It increases body resistance to infections, regulates hemapoiesis by contributing to the normalization of leucocytes, granulocytes, phagocytes and platelets concentration. Demonstrating expressed lymphotropic effect, Derinat stimulates 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 endolymphatic transportation way. The drug is high-tropic in respect to hematopoietic system organs, and it actively participates in cellular metabolism processes by embedding into cell structures. At the stage of the drug intensive admission into blood, plasma and blood corpuscles 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. Semiexcretion time (Ò ½) at intramuscular introduction is 72.3 hrs. Derinat is distributed fast throughout a body, and during everyday course application it can be cumulated in organs and tissues, with maximum accumulation in bone marrow, lymph nodes, spleen and thymus, and with less accumulation in liver, cerebrum, stomach, and in small and large intestine. 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 drug introduction.
Metabolism and excretion
Derinat is metabolized in organism. It is excreted from organism (as metabolites) by biexponential dependence, mainly with urine and partially with faeces.
Indications
- radiation injuries;
- hemapoiesis derangement;
- cancer myelodepression and resistance to cytostatics developed due to cytostatic and/or radiation therapy (hemapoiesis stabilization, chemical cardio- and myelotoxicity decrease);
- stomatitis, induced by cytostatic therapy;
- stomach and peptic ulcer disease, erosive gastroduodenitis;
- ischemic heart disease;
- obliterating leg vessels diseases, 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.
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 is evidenced at rapid intramuscular introduction of the drug, which does not require any medication.
In some cases, 1.5 – 3 hrs after intramuscular injections simple continued fever can be evidenced with body temperature increase up to 38°Ñ in average, which is stopped with symptomatic drugs prescription (e.g. analgin and diphenhydramine hydrochloride). Hypoglycemic action is evidenced for diabetic patients, which must be taken into consideration by blood glucose monitoring.
Overdose
No negative consequences of overdosing are evidenced.
Interaction with other drugs
Derinat application in complex therapy increases the efficiency of the treatment and reduces its terms, given the significant decrease of antibiotics and antiviral drugs dosage.
Derinat increases the efficiency of antitumor antibiotics of anthracyclines type and cytostatics.
The drug potentiates the therapeutic effect of basic therapy of stomach and peptic ulcer disease. Derinat reduces iatrogenicity of basic drugs for rheumatoid arthritis treatment, achieving 50% and 70% improvement of a range of complex indicators of the disease activity.
For surgical sepsis cases, Derinat inclusion into complex therapy causes intoxication level decrease, immunity activation, hematosis normalization and better functioning of the organs responsible for detoxication processes within internal organism environment.
Special instructions
In order to make the injection less painful, Derinat is slowly introduced intramuscularly within 1-2 minutes. Immediately prior to the introduction, it is recommended to warm the bottle with hands up to body temperature.
Product form
1.5% solution for intramuscular introduction. Carton box package contains blister trays with 2 ml or 5 ml bottles made of import glass with injection infusion plugs.
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 away from children at a temperature range from +4°Ñ to +20ºÑ.
Pharmacy purchasing terms
Available on prescription only.
