Laferon-farmbiotek® nasal

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Laferon-PharmBiotek® NASAL

Composition:

Active substance: recombinant human interferon alfa-2b;

1 vial contains 1 million IU of recombinant human interferon alfa-2b;

Excipients: sodium chloride, dextran 70, potassium dihydrogen phosphate, anhydrous sodium hydrogen phosphate.

Pharmaceutical form. Lyophilisate for preparation of nasal drops.

Main physicochemical characteristics: hygroscopic lyophilized powder or porous mass of white color.

Pharmacotherapeutic group.

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

Pharmacological Properties.

Pharmacodynamics.

Human recombinant interferon alfa-2b is a highly purified, water-soluble protein with a molecular weight of 19,300 daltons.

Laferon-FarmBiotech® NASAL exerts antiviral effects. Under the influence of interferon, replication of viruses (influenza, parainfluenza, adenoviruses, rhinoviruses, reoviruses, etc.) in infected cells is inhibited, and protective factors are produced, preventing infection of other cells. The drug's additional immunomodulatory effects include activation of phagocytosis, stimulation of antibody production, and lymphokine synthesis.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Laferon-FarmBiotech® NASAL is used:

• for the treatment and prevention of acute respiratory viral and viral-bacterial infections in adults and children (including newborns);
• for prophylaxis in case of risk of disease (during epidemic periods, upon contact with a patient with acute respiratory viral infection);
• as part of combination therapy for viral eye diseases, various forms of ophthalmic herpes (keratoconjunctivitis, keratouveitis).

Contraindications.

Individual hypersensitivity to interferon alpha-2b or other components of the drug; severe forms of allergic diseases in medical history; pregnancy or breastfeeding period; 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); chronic hepatitis on the background of progressive or decompensated liver cirrhosis; chronic hepatitis in patients receiving or who have recently received immunosuppressive therapy (except for a short course of corticosteroid therapy); autoimmune hepatitis or other autoimmune diseases in medical history; suppression of myeloid hematopoiesis.

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 this drug.

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

Special precautions for use.

To preserve the biological activity of the medicinal product, only liquid cooled to room temperature (15−25 °C) should be used for dissolving the powder.

For intranasal administration, boiled water cooled to room temperature should be used as the solvent.

For instillation of the medicinal product into the conjunctival sac of the affected eye, 0.9% sodium chloride physiological solution should be used as the solvent.

The medicinal product should not be used if the packaging integrity or labeling is compromised, or after the expiry date has passed.

To avoid the spread of infection, individual use of the vial is recommended.

Use during pregnancy or breastfeeding.

There is insufficient data regarding the use of the medicinal product during pregnancy or breastfeeding. Use is contraindicated.

Ability to influence reaction rate when driving or operating machinery.

Not studied.

Administration and Dosage

For therapeutic purposes, the drug should be used as early as possible – at the first signs of illness. The earlier treatment is initiated, the higher the efficacy of the drug.

Open the vial containing the dry powder and add cooled boiled water at room temperature (15–25 °C) (for intranasal use) or 0.9% sodium chloride physiological solution (for preparation of eye drops).

To prepare nasal and eye drops, add 5 mL of the appropriate diluent to the vial. Close the vial tightly with the dropper cap provided and gently shake until the powder is completely dissolved. The solution is now ready for use. After each use, close the dropper with the protective cap. Each 1 mL of the prepared solution contains approximately 200,000 IU of interferon.

For the treatment of influenza and other respiratory viral infections, Laferon-FarmBiotech® NASAL drops are administered into each nostril in the following doses:

• Infants, including premature babies: 1 drop, 4–5 times daily;
• Children aged 1 to 7 years: 2–3 drops, 4–5 times daily;
• Children over 7 years of age: 2–3 drops, 5–6 times daily;
• Adults: 4–5 drops, 6–8 times daily.

The usual course of antiviral treatment with Laferon-FarmBiotech® NASAL lasts 3–5 days.

For prophylaxis during contact with infected individuals or after exposure to cold, Laferon-FarmBiotech® NASAL is administered according to age-specific dosages, twice daily for 5–7 days. Prophylactic courses may be repeated if necessary. In case of single exposure, a single dose is sufficient. During seasonal increases in infection rates, a single morning dose every 1–2 days is recommended.

In complex therapy of viral eye diseases and various forms of ocular herpes (keratoconjunctivitis, keratouveitis), the solution of Laferon-FarmBiotech® NASAL – 1 million IU in 5 mL of physiological saline – is administered as 2–3 drops into the conjunctival sac of the affected eye every 2 hours for 7–10 days; after symptoms subside, the drug may be administered every 4 hours.

Children

Laferon-FarmBiotech® NASAL is used in pediatric practice, including in infants and premature babies. Children should use the drops under adult supervision.

Overdose

No cases of acute overdose have been reported.

Adverse Reactions

When used at recommended doses in basic treatment courses, no adverse effects were observed with Laferon-FarmBiotech® NASAL. Due to minimal systemic absorption, intranasal administration and instillation into the conjunctival sac of the affected eye with Laferon-FarmBiotech® NASAL is not associated with pronounced adverse reactions typically seen following parenteral administration of interferon-containing drugs.

General disorders: Dose-dependent influenza-like syndrome (chills, fever, headache, muscle pain, joint pain, fatigue, malaise, sweating); nausea, vomiting, dizziness, flushing; possible development of hypersensitivity reactions to the drug, including anaphylactic shock and Quincke's edema.

Metabolism and nutrition disorders: Electrolyte imbalance.

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 abnormalities.

Eye disorders: Visual disturbances, conjunctival hyperemia.

Gastrointestinal disorders: Loss of appetite.

Laboratory test abnormalities: 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 irritability, somnolence.

Respiratory, thoracic and mediastinal disorders: Cough, dyspnea.

If any adverse reactions occur, consult a physician.

Shelf Life

3 years.

Storage Conditions

Store in the original packaging at a temperature of 2 °C to 8 °C. Keep out of reach of children.

After opening the vial and preparing the solution, the drug may be stored for up to 5 days in the refrigerator or 2 days at room temperature (15−25 °C). The prepared solution should be protected from direct sunlight.

Packaging

1 vial of lyophilizate with dropper cap in a cardboard box.

Availability
Over-the-counter (without prescription).

Manufacturer
LLC "Scientific-Production Company "InterFarmBiotech".

Manufacturer's Address and Place of Business
150 Zabolotnoho Street, Kyiv, 03143, Ukraine.