LAFEROBION

I N S T R U C T I O N for medical use of the medicinal product LAFEROBION

Composition:

Active substance: interferon alfa-2b;

1 ml of the preparation contains 100,000 IU of recombinant human interferon alfa-2b;

Excipients: tromethamine, tromethamine hydrochloride, hypromellose, disodium edetate, lysine hydrochloride, potassium chloride, methylparahydroxybenzoate (E 218), water for injections.

Pharmaceutical form. Nasal drops.

Main physico-chemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Immunostimulants. Interferons. Interferon alfa-2b. ATC code L03A B05.

Pharmacological Properties

Pharmacodynamics

LAFFEROBIAN is an antiviral, antimicrobial, anti-inflammatory, immunomodulatory, and antiproliferative agent. The biological activity of interferon is characterized by the following effects:

• Antiviral – inhibits replication of viruses (including adenoviruses, influenza viruses, etc.) by suppressing transcription and translation processes;
• Antiproliferative – suppresses proliferation of cells (particularly those infected with DNA- and RNA-containing viruses);
• Immunomodulation – enhances phagocytic activity of macrophages and specific cytotoxicity of lymphocytes against target cells.

Interferon induces the synthesis of a specific enzyme—protein kinase—which interferes with translation by phosphorylating one of the initiation factors of this process. It also activates a specific ribonuclease that damages viral mRNA. Additional effects of interferon include stimulation of other cytokine production and induction of specific enzymes.

Pharmacokinetics

Not studied.

Clinical characteristics.

Indications.

Prevention and treatment of acute respiratory viral infections (ARVI):

• in patients who frequently and persistently suffer from upper respiratory tract diseases;
• upon contact with ARVI patients;
• during hypothermia;
• during seasonal increase in morbidity.

Contraindications. Hypersensitivity to alpha-2b interferon and other components of the medicinal product; severe forms of allergic diseases in medical history; thyroid dysfunction; presence of severe visceral disorders in patients with Kaposi's sarcoma; severe cardiovascular diseases; psoriasis; pronounced impairment of liver and/or kidney function; epilepsy and other central nervous system disorders (including functional ones); chronic hepatitis on the background of progressive or decompensated liver cirrhosis; chronic hepatitis in patients receiving or recently treated with immunosuppressants (except for a short course of corticosteroid therapy); autoimmune hepatitis or other autoimmune diseases in medical history. Myeloid hematopoiesis suppression. Pregnancy and breastfeeding.

Interaction with other medicinal products and other types of interactions. If you are taking any other medicinal products, you must inform your physician; if you are self-medicating, consult your doctor regarding the possibility of using this drug.

Concomitant use of intranasal vasoconstrictive agents is not recommended, as they may contribute to nasal mucosa dryness.

Special precautions for use.

The medicinal product contains methyl parahydroxybenzoate, which may cause allergic reactions, including delayed reactions, and in rare cases bronchospasm.

The medicinal product should not be used if the packaging integrity or labelling is compromised, if there are changes in physical properties (colour or clarity of the solution), or after the expiry date.

To prevent the spread of infection, individual use of the bottle is recommended.

Avoid contact of the medicinal product with the mucous membrane of the eyes.

Use during pregnancy or breastfeeding. Use is contraindicated.

Ability to influence reaction speed when driving or operating machinery. No effect.

Method of Administration and Dosage

The medication is administered into each nostril.

Before using the medication, it is recommended to lie down on your back or sit with your head slightly tilted backward and turned toward the side of the nostril into which the drops will be instilled. Without touching the inner walls of the nose with the dropper tip, instill the medication. Immediately after instillation, it is recommended to massage the outer nasal wings with fingers for several minutes to ensure even distribution of the medication over the nasal mucosa.

At the first signs of respiratory viral infection (for 5 days)

Adults – 3 drops into each nostril 5–6 times daily (single dose – 24,000 IU, daily dose – 120,000 – 144,000 IU).

Children. Newborns and children under 1 year of age – 1 drop into each nostril 5 times daily (single dose – 8,000 IU, daily dose – 40,000 IU).

Children aged 1 to 3 years – 2 drops into each nostril 3–4 times daily (single dose – 16,000 IU, daily dose – 48,000 – 64,000 IU).

Children aged 3 to 14 years – 2 drops into each nostril 4–5 times daily (single dose – 16,000 IU, daily dose – 64,000 – 80,000 IU).

Children aged 14 to 18 years – 3 drops into each nostril 5–6 times daily (single dose – 24,000 IU, daily dose – 120,000 – 144,000 IU).

For prevention of respiratory viral infections in adults

Upon contact with an infected person or after exposure to cold – 3 drops twice daily for 5–7 days. If necessary, preventive courses may be repeated. In case of single exposure, a single application is sufficient.

During seasonal increases in infection rates – single morning application every 1–2 days.

Instructions for using nasal drops in a bottle sealed with a micropump dropper:

1. Remove the protective cap from the bottle.
2. Before the first use, turn the bottle with the nozzle downward and press the pump dispenser several times to prime.
3. Insert the nozzle tip into each nostril alternately and press the pump dispenser the required number of times according to the prescribed dosage.
4. After use, replace the cap on the bottle.

Children. The medicinal product can be used in children from birth at the first signs of respiratory viral infection.

Overdose. There is no data available regarding overdose of this medicinal product.

Side effects.

General disorders: common – dose-dependent flu-like syndrome (chills, fever, headache, muscle and joint pain, fatigue, malaise, sweating); rare – nausea, vomiting, dizziness, flushing. Electrolyte imbalance. Hypersensitivity reactions to the drug may occur, including anaphylactic shock, angioedema (Quincke's edema).

Skin and subcutaneous tissue disorders: skin rash (in isolated cases), including herpetic rash, pruritus, hyperemia, skin swelling, urticaria, dry skin, alopecia.

Endocrine system disorders: thyroid gland dysfunction.

Eye disorders: visual disturbances, conjunctival hyperemia.

Gastrointestinal disorders: loss of appetite, increased levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase.

Hepatobiliary disorders: liver function abnormalities.

Renal and urinary disorders: kidney function abnormalities.

Blood and lymphatic system disorders: leukopenia, thrombocytopenia, anemia, epistaxis.

Cardiovascular disorders: arterial hypertension and hypotension, tachycardia.

Nervous system disorders: dizziness, sleep disturbances, ataxia, paresthesia, confusion, anxiety and depressive states, increased excitability, somnolence.

Respiratory, thoracic and mediastinal disorders: cough, dyspnea.

If adverse reactions occur, consult a physician.

Shelf life. 2 years. The shelf life after opening the vial, under storage conditions at 2 to 8 °C, is 10 days.

Storage conditions. Store in the original packaging to protect from light at a temperature of 2 to 8 °C.

Keep out of reach of children.

Packaging. 5 ml in a vial stoppered with a micropipette-dropper; 1 vial per cardboard pack.

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

Manufacturer. LLC "FZ "STADA", Ukraine.

Manufacturer's location and address of business activity.

37, Kyivska St., Bila Tserkva, Kyiv region, 09100, Ukraine.