ARBIVIR-ZDOROVYA FORTE

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

Composition:

Active substance: umifenovir;

1 capsule contains umifenovir hydrochloride 200 mg;

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

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules of white color. The capsule contents is a mixture containing granules and powder ranging in color from white to white with a greenish-yellow or yellowish tint. The presence of powder particle agglomerates is acceptable. The 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 A and B viruses, including highly pathogenic subtypes A (H1N1) pdm09 and A (H5N1). According to its antiviral mechanism of action, it belongs to fusion (fusiogenic) 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 adverse effects 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 the 50 mg dose and within 1.5 hours after administration of the 100 mg dose. Elimination half-life ranges from 17 to 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 observed when the drug is used in combination with other medicinal products.

Special precautions for use.

Use with caution:

• in elderly patients (since the 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).

There are no data on long-term use of the medicinal product.

Use during pregnancy or breastfeeding.

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

Ability to influence reaction rate while driving or operating machinery.

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

Method of Administration and Dosage

For adult use only. 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 treatment of influenza: 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 medication has not been reported.

If any adverse reactions occur, consult a physician.

Treatment is symptomatic.

Adverse reactions.

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

Gastrointestinal disorders: including heartburn, epigastric fullness, 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. Over-the-counter.

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

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