Neovir 250 mg/2 ml solution for intramuscular injection ampoules 5 pcs.

As monotherapy or as part of combination therapy:

• influenza and other acute respiratory viral infections, including in the context of immunodeficiency states;

• infections caused by Herpes simplex virus, Varicella zoster, Herpes simplex genitalis, including in individuals with immune system disorders;

• cytomegalovirus infection in immunocompromised individuals;

• radiation-induced immunodeficiency;

• HIV infection;

• viral etiology encephalitides and encephalomyelitis;

• acute and chronic hepatitis B and C;

• urethritis, epididymitis, prostatitis, cervicitis, and salpingitis of chlamydial etiology;

• venereal lymphogranuloma;

• oncological diseases;

• multiple sclerosis;

• candidiasis of the skin and mucous membranes;

• papillomavirus infection.
Prevention of influenza and other acute respiratory viral infections.

The injection solution is administered intramuscularly, with a single therapeutic dose of 250 mg (1 ampoule) or 4-6 mg per kg of the patient's body weight. If necessary, the single dose of Neovir® may be increased to 500 mg.
The treatment course, unless otherwise specified, consists of 5-7 intramuscular injections of Neovir® at a dose of 250 mg with an interval of 48 hours; the total dose depends on the clinical picture. The duration of the course is 8-12 days. The single prophylactic dose is 250 mg (1 ampoule) or 4-6 mg per kg of body weight. For long-term use, the recommended interval between Neovir® administrations is 3-7 days.
In the case of HIV infection, the Neovir® injection solution is used in combination with specific antiviral medications. The treatment course consists of 10 injections of 250 mg with an interval of 48 hours between injections. After the course, a break of 2 months is taken. Repeated courses may be applied as indicated.

1 ml of solution contains:
active ingredient: sodium oxodihydroacridinylacetate (Neovir®) 125 mg;
excipients: sodium citrate 2.5 mg, citric acid monohydrate 0.5-1.5 mg (up to pH 7.5-8.3), water for injections up to 1 ml.

A clear liquid of greenish-yellow color.

• Individual intolerance to the drug;

• Severe renal insufficiency (creatinine clearance less than 30 ml/min);

• Autoimmune diseases;

• Pregnancy and lactation;

• Children under 18 years of age.

Caution:
Use with caution in elderly patients.
Use during pregnancy and lactation:
The safety of Neovir® during pregnancy and lactation has not been studied; therefore, the drug is contraindicated for use during pregnancy and lactation.

Effect on the ability to drive vehicles and operate machinery:
There is no information regarding the potential negative impact of the drug on the performance of potentially hazardous activities that require special attention and quick reactions (driving a car and other vehicles, working with moving machinery, dispatcher and operator work, etc.).

In rare cases, an allergic reaction may occur in the form of skin rashes. Subfebrile temperature and localized, quickly passing pain at the injection site may occur. In case of poor tolerance or pain at the injection site, it is recommended to administer Neovir® together with a local anesthetic solution (2 ml of 0.25-0.5% procaine solution).

No cases of Neovir® overdose have been reported.

No physicochemical incompatibility or other types of undesirable interactions have been identified.

The drug has antiviral activity against DNA and RNA genomic viruses. It exhibits pronounced anti-chlamydial action.
Neovir® induces a rapid increase in the titers of endogenous interferons α, β, and γ, particularly interferon α. Administration of 250 mg of Neovir® intramuscularly corresponds to the serum concentrations of interferon equivalent to the administration of 6-9 million ME of recombinant interferon α. The peak activity of interferons in the blood is observed 1.5-2 hours after administration and persists for 16-20 hours following the administration of Neovir®. As a result, a cascade of immune reactions is induced in the body aimed at destroying and eliminating pathogens and the cells affected by them. Interferon-producing cells acquire the ability to enhance interferon production in response to repeated induction caused by the pathogenic agent. This property remains for a long time after the discontinuation of the drug.
The immunomodulatory effect is due to Neovir®'s ability to activate hematopoietic stem cells, normalize the balance of T-lymphocyte subpopulations, and stimulate the effector components of the immune system. Neovir® has a pronounced stimulating effect on the functional activity of macrophages and polymorphonuclear leukocytes, enhancing their migration and phagocytic activity.
Neovir® corrects tissue growth: it activates NK cells, enhances all forms of cytotoxicity, positively influences the restoration of cell adhesion, and inhibits their proliferative and metastatic activity.

When administered intramuscularly, the bioavailability of Neovir® exceeds 90%. After the administration of 100-500 mg of Neovir®, the maximum concentration in plasma is reached within 15-30 minutes and is 8.3 mcg/ml. After 5 hours, only minor amounts of Neovir® are detected, and after 6 hours, Neovir® is not found in the blood plasma.

Neovir® is excreted from the body unchanged by the kidneys, without undergoing metabolism, with a half-life of 1 hour.

15-30 minutes after the administration of Neovir®, the titers of endogenous interferons begin to rise in the plasma, particularly early interferon ?. Two peaks of interferon α concentration in the plasma have been identified: 70 IU/ml at 1.5-2 hours and 110 IU/ml at 8-10 hours, after which the concentration of interferon α starts to decrease. After 24 hours, the concentration of endogenous interferons remains sufficiently high, returning to baseline values after 46-48 hours post-administration.

Cloudiness of the Neovir® solution to a milky-white color indicates a violation of storage conditions and unsuitability for use.