LAFEROBION

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LAFEROBION (LAFEROBIONUM)

Composition:

Active substance: interferon alfa-2b;

1 vial contains 100,000 IU of recombinant human interferon alfa-2b;

Excipients: sodium chloride, dextran-70, potassium dihydrogen phosphate, disodium phosphate dodecahydrate, polysorbate-80.

Pharmaceutical form. Nasal powder.

Main physicochemical characteristics: lyophilized powder or porous white mass. Hygroscopic. The reconstituted preparation is a clear, slightly colored liquid.

Pharmacotherapeutic group. Immunostimulants. Interferons. Interferon alfa-2b.

ATC code L03A B05.

Pharmacological properties.

Pharmacodynamics.

Laferobion 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 (adenoviruses, influenza viruses, etc.) by suppressing transcription and translation processes;
Antiproliferative — suppresses cell proliferation (of most DNA- and RNA-containing viruses);
Immunomodulation — enhances phagocytic activity of macrophages and specific cytotoxicity of lymphocytes against target cells.
Interferon induces 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 messenger RNA (mRNA). Additional effects of interferon include stimulation of production of other cytokines and induction of specific enzymes.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Prevention and treatment of influenza, as well as other acute respiratory viral infections (ARVI) and viral-bacterial infections in adults and children, including newborns.

Contraindications.

Hypersensitivity to interferon alfa-2b 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); chronic hepatitis on the background of progressive or decompensated cirrhosis of the liver; chronic hepatitis in patients receiving or who recently received immunosuppressive therapy (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 promote dryness of the nasal mucosa.

Instructions for Use

The Laferobion solution should be used within 1 day when stored at a temperature between 2 and 8 °C.

The medicinal product should be administered into each nasal passage.

Before using the medication, lie on your back or sit down, slightly tilt your head backward, and turn it toward the side of the nasal passage into which the drops will be instilled. Without touching the inner walls of the nose with the dropper pipette, administer the medication. Immediately after instillation, to ensure even distribution of the medicinal product over the nasal mucosa, it is recommended to gently massage the nostrils externally with fingers for several minutes.

Administration of the drops to children should be performed under adult supervision.

Do not use the medication if the packaging or its labeling is damaged, or after the expiration date has passed.

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

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to affect reaction rate while driving or operating machinery.

Does not affect.

Administration and Dosage

Drug Dilution

Immediately before use, open the vial and add sterile distilled or boiled water cooled to room temperature.

To obtain a solution with an activity of 100,000 IU/mL, add 1 mL of water to the vial. Then gently shake the vial until the contents are completely dissolved.

Laferobion is administered by pipette drops.

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).

Prophylaxis of Respiratory Viral Infections in Adults

Upon contact with an infected person or after chilling – 3 drops twice daily for 5–7 days. Prophylactic courses may be repeated if necessary. In case of single exposure, a single administration is sufficient.

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

Children

Used in pediatric practice (see section "Administration and Dosage").

Children should use the drops under adult supervision.

Overdose

There is no data regarding overdose with 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, flushing. Electrolyte imbalance. Hypersensitivity reactions to the drug may occur, including anaphylactic shock, Quincke's edema.

Skin and subcutaneous tissue disorders: skin rash (including herpetic), 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 system 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; frequency unknown – pulmonary arterial hypertension.

Pulmonary arterial hypertension

Cases of pulmonary arterial hypertension (PAH) have been reported with the use of interferon alpha medicinal products, particularly in patients with risk factors for PAH (such as portal hypertension, HIV infection, cirrhosis). Such reports occurred at various times, usually several months after initiation of interferon alpha therapy.

If adverse reactions occur, consult a physician.

Shelf life. 3 years.

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. Nasal powder, 100,000 IU per vial. 5 vials in a blister made of PVC film coated with aluminum foil. 2 blisters per cardboard box.

Availability category. Over-the-counter.

Manufacturer. LLC "FZ “STADA”, Ukraine.

Manufacturer's address and place of business.

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