Arbivir-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ARBIVIR-ZDOROVYE (ARBIVIR-ZDOROVYE)

Composition:

Active substance: umifenovir;

1 capsule contains umifenovir hydrochloride 100 mg;

Excipients: potato starch, povidone, microcrystalline cellulose, calcium stearate, anhydrous colloidal silicon dioxide; the capsule shell contains Yellow West FCF (E 110), titanium dioxide (E 171), gelatin.

Pharmaceutical form. Capsules.

Main physicochemical characteristics: hard gelatin capsules of orange color. The capsule contents are a mixture containing granules and powder ranging from white to white with a greenish-yellow or yellowish tint. The presence of powder particle agglomerates is permissible. A manufacturer's trademark – ZT – may be printed on the capsule.

Pharmacotherapeutic group. Antiviral agents for systemic use. Other antiviral agents. ATC code J05AX13.

Pharmacological properties.

Pharmacodynamics.

An antiviral agent that specifically inhibits influenza viruses A and B, including highly pathogenic subtypes A (H1N1) pdm09 and A (H5N1). By mechanism of antiviral action, it belongs to fusion inhibitors, interacting with viral hemagglutinin and preventing fusion of the viral lipid envelope with cellular membranes.

Therapeutic efficacy in influenza is manifested by reduction in duration and severity of the disease and its main symptoms, as well as by decreasing the frequency of influenza-related complications.

The medicinal product belongs to low-toxicity drugs and has no negative impact on the human body when used at recommended doses.

Pharmacokinetics.

The drug is rapidly absorbed in the gastrointestinal tract. Maximum concentration is reached within 1.2 hours after administration of a 50 mg dose, and within 1.5 hours after administration of a 100 mg dose. The elimination half-life is 17–21 hours. Approximately 40% of the drug is excreted unchanged in feces (38.9%) and urine (0.12%). About 90% of the administered dose is excreted within the first 24 hours.

Clinical characteristics.

Indications.

Prevention and treatment of influenza A and B.

Contraindications.

Hypersensitivity to the drug.

Interaction with other medicinal products and other forms of interaction.

No negative effects have been identified in interactions of the drug with other medicinal products.

Special precautions for use

Use with caution:

• in elderly patients (since safety and efficacy in elderly patients have not been sufficiently studied);
• in patients with impaired liver or kidney function (since the pharmacokinetics and safety of use in such patients have not been studied).

Data on long-term use of the medicinal product are lacking.

The medicinal product contains the colouring agent Sunset Yellow FCF (E 110), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

The use of this medicinal product during pregnancy is contraindicated. It is unknown whether the active substance or its metabolites are excreted in breast milk during lactation. If it is necessary to use the medicinal product, breastfeeding should be discontinued.

Ability to influence reaction rate while driving or operating machinery.

At recommended doses, the medicinal product does not affect the reaction rate while driving or operating machinery.

Method of Administration and Dosage

For use in adults. Take orally before meals. The single dose is 200 mg.

For prophylaxis:

During direct contact with influenza patients: 200 mg once daily for 10–14 days.

During influenza epidemic period: 200 mg twice weekly for 3 weeks.

For influenza treatment: 200 mg four times daily (every 6 hours) for 5 days.

The maximum daily dose is 800 mg.

Children.

Do not use in children.

Overdose.

Overdose of the drug has not been reported.

In case of any adverse events, consult a physician.

Treatment is symptomatic.

Side effects.

Immune system disorders: hypersensitivity reactions, including skin redness, itching sensation, rash, urticaria, angioedema.

Gastrointestinal disorders: including heartburn, feeling of epigastric heaviness, vomiting.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. Capsules, 10 in a blister pack per box.

Availability category. Over-the-counter (without prescription).

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's location and address of business activity. 22, Shevchenka Street, Kharkiv, Kharkiv Region, 61013, Ukraine.