Instructions for Overin injection solution 250 mg/2 ml ampoule 2 ml blister No. 5
Composition
active ingredient: sodium oxodihydroacridinyl acetate;
1 ml of solution contains sodium oxodihydroacridinyl acetate 125 mg;
Excipients: sodium citrate; citric acid, monohydrate; water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear liquid of greenish-yellow color.
Pharmacotherapeutic group
Antineoplastic and immunomodulatory agents. Other immunostimulants.
ATX code L03A X.
Pharmacological properties
Pharmacodynamics
The drug has antiviral activity against DNA and RNA-genomic viruses and is used for the treatment and prevention of viral infections. It also has a pronounced antichlamydial effect. The activity of the drug is associated with its ability to cause an increase in the concentration of endogenous interferons, especially interferon alpha. An injection of 250 mg of Overin® in terms of serum interferon titers is equivalent to the administration of 6-9 million IU of recombinant interferon alpha. Overin® activates bone marrow stem cells, T-lymphocytes and macrophages. Overin® exhibits immunomodulatory activity, normalizes the balance between subpopulations of T-helper and T-suppressor cells. In a number of diseases, Overin® is able to reduce the production of tumor necrosis factor in the body (HIV infection, sepsis) and activate natural killer cells (in tumor diseases). It has a pronounced stimulating effect on the activity of the polymorphonuclear leukocyte system.
The peak of interferon activity in the blood and tissues is observed several hours after intramuscular administration of Overin® and is maintained for 16-20 hours after administration. Overin® is excreted from the body unchanged in the urine.
Pharmacokinetics
When administered intramuscularly, the bioavailability of the drug Overin® is over 90%. After administration of 100-500 mg of the drug Overin®, the maximum plasma concentration is reached after 15-30 minutes and is 8.3 μg/ml. After 5 hours, only a small amount of the drug Overin® is detected, and after 6 hours, Overin® is not detected in the blood plasma.
The drug is excreted from the body unchanged by the kidneys, without being metabolized, with a half-life of 1 hour.
15-30 minutes after administration of Overin®, serum interferon titers begin to increase in plasma. Two peaks of interferon content in plasma were detected: 70 IU/ml after 1.5-2 hours and 110 IU/ml after 8-10 hours, after which the content begins to decrease. After 24 hours, the serum interferon concentration remains quite high, and returns to the initial values 46-48 hours after administration.
Indication
Treatment (as part of combination therapy):
influenza and other acute respiratory viral diseases, including those caused by immunodeficiency states; infections caused by the Herpes simplex virus, Varicella zooster, Herpes simplex genitalis, including in people with impaired immune systems; cytomegalovirus infection in people with immunodeficiency; radiation immunodeficiency; HIV infection; encephalitis and encephalomyelitis of viral etiology; acute and chronic hepatitis B and C; urethritis, epididymitis, prostatitis, cervicitis and salpingitis of chlamydial etiology; venereal lymphogranuloma; oncological diseases; multiple sclerosis; candidal lesions of the skin and mucous membranes; papillomavirus infection.
Prevention of influenza and other acute respiratory viral diseases.
Contraindication
Hypersensitivity to the drug.
Autoimmune diseases. Pregnancy and breastfeeding. Children. Renal impairment (CC <30 ml/min).
Interaction with other medicinal products and other types of interactions
During clinical studies and use in clinical practice, no cases of incompatibility or potentiation of the drug's action when interacting with other drugs were recorded.
Application features
The drug should be used with caution in the treatment of elderly patients, as well as individuals undergoing immunosuppressive therapy.
Long-term use of the drug Overin® did not reveal any negative effects on the functions of the cardiovascular, nervous, respiratory, hematopoietic systems, gastrointestinal tract, excretory system and other systems of the human body. Studies conducted on animals and human tissue cultures did not reveal any data on the presence of teratogenic, mutagenic and carcinogenic properties of the drug.
In case of poor tolerance or prolonged local pain, it is recommended to administer Overin® together with a local anesthetic solution.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no information on the effect of the drug on the reaction speed when driving vehicles or during other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy and breastfeeding.
Method of administration and doses
Overin® is administered intramuscularly to adults at a dose of 250 mg (1 ampoule) or 4-6 mg/kg body weight. If necessary, a single dose of Overin® can be increased to 500 mg.
The course of treatment consists of 5-7 injections of the drug Overin® at a dose of 250 mg with an interval of 48 hours, the course dose depends on the clinical situation and the course of the disease. The duration of the course of treatment is 8-12 days.
The prophylactic dose is 250 mg (1 ampoule). With long-term use (from 3 to 12 months), the recommended interval between administrations of the drug Overin® is 3-7 days.
In HIV infection, the solution of the drug Overin® is used in combination with specific antiviral drugs. The course of treatment consists of 10 injections of 250 mg with an interval between injections of 48 hours. After the course of treatment, a break of 2 months is taken. Repeated courses are possible according to indications.
Children
The drug is not prescribed to children (under 18 years of age).
Overdose
There is no information regarding overdose of the drug.
Adverse reactions
Local pain at the injection site is possible, which quickly resolves. Subfebrile temperature and allergic reactions (including anaphylactic reactions) may occur.
In rare cases, an allergic reaction in the form of skin rashes may occur.
Expiration date
2 years.
Storage conditions
Store in the original packaging, out of the reach of children, protected from moisture and light, at a temperature not exceeding 25 °C.
Do not use after the expiry date stated on the packaging.
Packaging
2 ml of solution (250 mg/2 ml) in light-resistant glass ampoules, 5 ampoules in a contour blister pack made of polyvinyl chloride film. 1 contour blister pack in a cardboard pack.
Vacation category
According to the recipe.
Producer
PJSC "Lekhim-Kharkiv".
Location of the manufacturer and its business address
Ukraine, 61115, Kharkiv, Severyn Pototskoho St., 36.
