LAFEBIYON

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: trometamol, trometamol hydrochloride, hypromellose, disodium edetate, lysine hydrochloride, potassium chloride, methylparaben (E 218), water for injections.

Pharmaceutical form. Nasal spray.

Main physicochemical characteristics: clear, colorless liquid.

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

Pharmacological Properties

Pharmacodynamics

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

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

Interferon induces the synthesis of a specific enzyme – protein kinase – which inhibits translation by phosphorylating one of the initiation factors of this process. It also activates a specific ribonuclease that degrades viral messenger RNA (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 patients suffering from ARVI;
• 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 who are receiving or have recently received immunosuppressive therapy (except for a short course of corticosteroid therapy); autoimmune hepatitis or other autoimmune diseases in medical history. Myeloid bone marrow suppression. Pregnancy and breastfeeding.

Interaction with other medicinal products and other forms of interaction. 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 the drug.

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

Special precautions for use.

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

The 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 vial is recommended.

Use during pregnancy or breastfeeding. Contraindicated.

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

Method of Administration and Dosage

The medication is administered into each nostril.

1 spray-dose = 1 short press of the dispenser.

Instructions for nasal spray administration:

1. Remove the protective cap from the bottle.
2. Prime the micro-dispenser atomizer by pressing (initial priming spray).
3. While in an upright position, insert the tip of the nozzle into one nostril and press the pump dispenser. Repeat administration in the other nostril.
4. After use, cover the bottle with the cap.

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

Adults: 3 spray-doses into each nostril 5–6 times daily (single dose — 30,000 IU, daily dose — 150,000 – 180,000 IU).

Children.
Children aged 1 to 3 years: 2 spray-doses into each nostril 3–4 times daily (single dose — 20,000 IU, daily dose — 60,000 – 80,000 IU).
Children aged 3 to 14 years: 2 spray-doses into each nostril 4–5 times daily (single dose — 20,000 IU, daily dose — 80,000 – 100,000 IU).
Children aged 14 to 18 years: 3 spray-doses into each nostril 5–6 times daily (single dose — 30,000 IU, daily dose — 150,000 – 180,000 IU).

For prevention of respiratory viral infections in adults

Upon contact with an infected person or after exposure to cold: 3 spray-doses twice daily for 5–7 days. Prophylactic courses may be repeated as needed. For single exposure, a single application is sufficient.

During seasonal increases in respiratory infections: single morning application every 1–2 days.

Children.

To be used in children aged 1 year and older at the first signs of respiratory viral infection.

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

Side effects.

General disorders: common – dose-dependent influenza-like syndrome (chills, fever, headache, muscle pain, joint pain, fatigue, malaise, sweating); rare – nausea, vomiting, dizziness, flushes. Electrolyte imbalance. Hypersensitivity reactions to the drug may occur, including anaphylactic shock, 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 function disorders.

Eye disorders: visual disturbances, conjunctival hyperemia.

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

Hepatobiliary disorders: liver function disorders.

Renal and urinary disorders: kidney function disorders.

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

Cardiovascular system 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. 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 sealed with a microdosing spray pump; 1 vial per cardboard box.

Prescription status. Over-the-counter.

Manufacturer. FZ "STADA" LLC, Ukraine.

Manufacturer's address and location of business operations.

37 Kyivska Street, Bila Tserkva, Kyiv Oblast, 09100, Ukraine.