Oviren

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT OVERYN® (OVERIN®)

Composition:

Active substance: sodium oxodihydroacridinylacetate;

1 ml of solution contains sodium oxodihydroacridinylacetate 125 mg;

Excipients: sodium citrate; citric acid, monohydrate; water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: transparent greenish-yellow liquid.

Pharmacotherapeutic group.

Antineoplastic and immunomodulating agents. Other immunostimulants.

ATC code L03AX.

Pharmacological Properties.

Pharmacodynamics. The medicinal product has antiviral activity against both DNA and RNA genome viruses and is used for the treatment and prevention of viral infections. It also has pronounced anti-chlamydial activity. The drug's activity is associated with its ability to induce an increase in the concentration of endogenous interferons, particularly alpha interferon. An injection of 250 mg of the medicinal product Oferin® corresponds, in serum interferon titers, to the administration of 6–9 million IU of recombinant alpha interferon. Oferin® activates bone marrow stem cells, T-lymphocytes, and macrophages. It exhibits immunomodulatory activity and normalizes the balance between T-helper and T-suppressor cell subpopulations. In certain diseases, Oferin® is capable of reducing the production of tumor necrosis factor in the body (HIV infection, sepsis) and activating natural killer cells (in tumor diseases). It has a pronounced stimulatory effect on the activity of the polymorphonuclear leukocyte system.

The peak activity of interferons in blood and tissues occurs several hours after intramuscular administration of Oferin® and is maintained for 16–20 hours after administration. Oferin® is excreted from the body unchanged in urine.

Pharmacokinetics. After intramuscular administration, the bioavailability of the medicinal product Oferin® exceeds 90%. After administration of 100–500 mg of Oferin®, maximum plasma concentration is reached within 15–30 minutes and amounts to 8.3 µg/mL. Only a negligible amount of Oferin® is detectable at 5 hours, and by 6 hours post-administration, Oferin® is no longer detectable in blood plasma.

The drug is excreted unchanged by the kidneys without undergoing metabolism, with a half-life of 1 hour.

Fifteen to thirty minutes after administration of Oferin®, serum interferon titers begin to rise in plasma. Two peaks of interferon levels in plasma have been observed: 70 IU/mL at 1.5–2 hours and 110 IU/mL at 8–10 hours, after which levels gradually decline. Twenty-four hours after administration, serum interferon concentrations remain relatively high, returning to baseline values within 46–48 hours after injection.

Clinical characteristics.

Indications.

Treatment (as part of combination therapy):

• Influenza and other acute respiratory viral infections, including in patients with immunodeficiency states;
• Infections caused by Herpes simplex, Varicella zoster, Herpes simplex genitalis, including in patients with immune system disorders;
• Cytomegalovirus infection in immunocompromised individuals;
• Radiation-induced immunodeficiency;
• HIV infection;
• Viral etiology encephalitis and encephalomyelitis;
• Acute and chronic hepatitis B and C;
• Urethritis, epididymitis, prostatitis, cervicitis, and salpingitis of chlamydial etiology;
• Lymphogranuloma venereum;
• Oncological diseases;
• Multiple sclerosis;
• Candidal lesions of skin and mucous membranes;
• Papillomavirus infection.

Prevention of influenza and other acute respiratory viral infections.

Contraindications.

Hypersensitivity to the drug.

Autoimmune diseases. Pregnancy and lactation. Pediatric age. Renal function impairment (creatinine clearance < 30 mL/min).

Interaction with other medicinal products and other forms of interactions.

During clinical studies and clinical use, no cases of incompatibility or potentiation of the drug's effect have been reported when used concomitantly with other medicinal products.

Special precautions.

Overen® should be used with caution in elderly patients and in individuals receiving immunosuppressive therapy.

Long-term use of the medicinal product Overen® has shown no negative effects on the functions of the cardiovascular, nervous, respiratory, hematopoietic, gastrointestinal, excretory, and other human body systems. Studies conducted in animals and human tissue cultures have not provided evidence of teratogenic, mutagenic, or carcinogenic properties of the drug.

In cases of poor tolerance or prolonged local pain, it is recommended to administer Overen® together with a solution of a local anesthetic.

This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e., it is practically sodium-free.

Do not use after the expiry date stated on the packaging.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy and breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

There is no information available regarding the effect of the drug on reaction speed when driving vehicles or during other potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

Method of Administration and Dosage

Oferin® is administered intramuscularly to adults at a dose of 250 mg (1 ampoule) or 4–6 mg/kg body weight. If necessary, the single dose of Oferin® may be increased up to 500 mg.

The treatment course consists of 5–7 injections of Oferin® at a dose of 250 mg given at 48-hour intervals. The total course dose depends on the clinical situation and disease progression. The duration of treatment course is 8–12 days.

The prophylactic dose is 250 mg (1 ampoule). With prolonged use (from 3 to 12 months), the recommended interval between Oferin® administrations is 3–7 days.

In HIV infection, the Oferin® solution is used in combination with specific antiviral drugs. The treatment course consists of 10 injections of 250 mg each, administered at 48-hour intervals. After completing the course, a 2-month break is required. Repeated courses may be administered when clinically indicated.

Children

The drug is not prescribed for children (under 18 years of age).

Overdose

There is no information available regarding overdose with this medicinal product.

Side effects.

Local pain at the injection site, which quickly subsides, is possible. Subfebrile temperature and allergic reactions (including anaphylactic reactions) may occur.

In isolated cases, allergic skin rashes may appear.

Shelf life.

2 years.

Storage conditions.

In the original packaging, at a temperature not exceeding 25 °C, in a place inaccessible to children.

Incompatibility.

Ovarin® must not be administered in the same syringe with other medicinal products.

Packaging.

2 ml of solution (250 mg / 2 ml) in ampoules made of light-protective glass, 5 ampoules per contour cell pack made of polyvinyl chloride film. 1 contour cell pack per cardboard box.

Prescription status.

By prescription only.

Manufacturer.

JSC "Lekhim-Kharkiv".

Manufacturer's address and location of its business activity.

36 Severina Pototskogo Street, Kharkiv, 61115, Ukraine.

Marketing authorization holder: LLC "Geolik Farm Marketing Group".

Address of the marketing authorization holder:

1 Magnitogorska Street, Kyiv, 02094, Ukraine.