Instructions Laferobion suppositories 500,000 IU No. 10
Composition
active ingredient: interferon alfa-2b
1 suppository contains: recombinant human interferon alpha-2b – 150,000 IU or 500,000 IU;
excipients: refined sunflower oil, tocopherol acetate, sodium ascorbate, ascorbic acid, solid fat.
Dosage form
Suppositories.
Main physicochemical properties: spherical suppositories of yellowish-white color with a homogeneous consistency.
Pharmacotherapeutic group
Immunostimulants. Interferons. Interferon alpha-2b.
ATX code L03A B05.
Pharmacological properties
Pharmacodynamics
Interferon alpha-2b recombinant has a pronounced antiviral, antiproliferative and immunomodulatory effect. The active substance of the drug Laferobion® - interferon alpha-2b recombinant - has an immunomodulatory effect on T- and B-lymphocytes, normalizes the content of immunoglobulin E, has antiviral activity. Antibodies that neutralize the antiviral activity of interferon alpha-2b recombinant are not formed, even when used for 2 years, the functioning of the endogenous system is normalized.
Pharmacokinetics
The pharmacokinetic properties for recombinant interferon alfa-2b have been poorly studied.
Indication
For children: in the complex therapy of acute respiratory viral infections (ARVI).
Contraindication
Hypersensitivity to the components of the drug; the presence of thyroid dysfunction in the patient; the presence of severe visceral disorders in patients with Kaposi's sarcoma; severe cardiovascular diseases; psoriasis; severe liver and/or kidney dysfunction; epilepsy and other CNS diseases (including functional); chronic hepatitis against the background of progressive or decompensated liver cirrhosis; chronic hepatitis in patients receiving or recently receiving immunosuppressant therapy (except for a short course of corticosteroid therapy); autoimmune hepatitis or other autoimmune diseases in history. Suppression of the myeloid germ of hematopoiesis.
Interaction with other medicinal products and other types of interactions
The drug should be used with caution simultaneously with opioid drugs, analgesics, hypnotics and sedatives (potentially causing a myelosuppressive effect).
When used simultaneously with drugs that are metabolized by oxidation (including xanthine derivatives - aminophylline and theophylline), the possibility of the effect of Laferobion® on oxidative metabolic processes should be taken into account. The concentration of theophylline in the blood serum should be monitored and, if necessary, the dosage regimen should be adjusted.
When using the drug in combination with chemotherapeutic drugs (cytarabine, doxorubicin, teniposide, cyclophosphamide), the risk of developing life-threatening toxic effects (their severity and duration) increases.
When used simultaneously with zidovudine, the risk of neutropenia increases.
Application features
Treatment with Laferobion® should be carried out under the supervision of a physician.
With prolonged use of the drug, a complete blood count, liver, kidney and thyroid function tests are monitored.
All patients are recommended to undergo a comprehensive peripheral blood test before starting and regularly during treatment, with mandatory qualitative and quantitative blood tests, as well as a biochemical blood test, including determination of electrolytes, calcium, liver enzymes, and creatinine.
It is recommended that serum albumin levels and prothrombin time be carefully monitored in all patients receiving the drug.
The drug should be prescribed with caution in patients with a history of diseases such as diabetes mellitus with episodes of ketoacidosis and chronic obstructive pulmonary disease, with blood clotting disorders (including pulmonary artery thrombophlebitis), and with severe myelosuppression.
During treatment with the drug, it is necessary to ensure adequate hydration of the body; in case of fever, other causes of its occurrence should be excluded.
It is recommended to use the drug against the background of antihistamine and antipyretic therapy.
The development of severe and moderate side effects requires dose adjustment, and in some cases, discontinuation of treatment with the drug.
Discontinue use of the drug in cases of: prolonged blood clotting time (in patients with chronic hepatitis), manifestations of pulmonary syndrome and radiological detection of infiltrate or impaired lung function, appearance or increase in visual impairment, thyroid dysfunction (deviation from the normal level of TSH), decreased serum albumin levels and decreased prothrombin time.
If an immediate-type hypersensitivity reaction develops (urticaria, angioedema, bronchospasm, anaphylaxis), the drug should be immediately discontinued and appropriate measures taken.
The drug is not allowed to be used after the expiration date. The drug is not subject to repeated quality control and extension of the expiration date after its expiration.
This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially sodium-free.
Use during pregnancy or breastfeeding
There are no data on the use of the drug during pregnancy and breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Some adverse CNS effects caused by the use of the drug may affect patients' ability to drive vehicles and operate potentially dangerous machinery.
Method of administration and doses
For children in the complex therapy of acute respiratory viral infections, the recommended doses are:
Newborns and premature babies should be given the drug rectally at 150,000 IU, 2 suppositories per day with a 12-hour break. Treatment courses and breaks between courses are 5 days.
Premature newborns with a gestational age of less than 34 weeks should be given the drug rectally at 150,000 IU 3 times a day (every 8 hours). The course is 5 days.
Children aged 1 to 14 years - 500,000 IU 2 times a day for 5 days.
Children
Used in pediatric practice (see section "Method of administration and dosage").
Overdose
No cases of overdose with Laferobion® have been described to date. However, as with any drug overdose, symptomatic therapy with monitoring of vital organ functions and careful observation of the patient's condition is recommended.
Adverse reactions
All adverse reactions associated with the use of Laferobion® are minor or moderate in severity. They usually disappear after the end of treatment.
Rectal administration of the drug is not accompanied by severe adverse reactions, which are usually observed with parenteral administration of interferon drugs. In some cases, in the first days of treatment, flu-like symptoms may occur, which subsequently decrease and disappear. To prevent them, paracetamol preparations can be used in doses according to the patient's age.
General disorders. When administering Laferobion®, flu-like symptoms are possible: chills, fever, fatigue, lethargy, as well as headache, muscle and joint pain, sweating; rarely - vomiting, dizziness, hot flashes. Hypersensitivity reactions to the drug are possible.
From the side of the hematopoietic system: with prolonged use, leukopenia, thrombocytopenia, anemia, and nosebleeds are possible.
Gastrointestinal tract, liver: increased ALT and AST levels, increased LF levels, loss of appetite. Liver function disorders.
Endocrine disorders: thyroid dysfunction.
From the side of the central and peripheral nervous system: with prolonged use, dizziness, sleep disturbances, confusion, anxiety and depressive states, increased excitability, drowsiness, ataxia, paresthesias are possible.
From the cardiovascular system: possible arterial hypertension or hypotension; rarely - tachycardia.
Skin and subcutaneous tissue disorders: allergic reactions, including rashes (including herpetic), itching, hyperemia, urticaria, anaphylactic shock.
Respiratory system: cough.
Other: changes at the injection site, visual disturbances, renal dysfunction, electrolyte imbalance.
Expiration date
2 years.
Storage conditions
Store in the original packaging to protect from light at a temperature of 2 to 8 ºС.
Keep out of reach of children.
Packaging
3 or 5 suppositories in a contour blister pack. 1 contour blister pack with 3 or 5 suppositories or 2 contour blister packs with 5 suppositories in a cardboard box.
Vacation category
Without a prescription.
Producer
LLC "FZ "BIOPHARMA", Ukraine.
Location of the manufacturer and address of its place of business
Ukraine, 09100, Kyiv region, Bila Tserkva, Kyivska st., 37.
