Laferon-FarmBiotek

Laferon-FarmBiotek is a preparation of recombinant interferon, identical to natural human interferon, with antiviral and immunomodulatory effects.

Release form and composition

Laferon-FarmBiotek release in the following dosage forms:

• Lyophilized powder for the preparation of nasal drops: a highly soluble, amorphous white powder in water; when diluted, a clear, odorless solution is formed (in bottles with a sterile dropper with a cap in a protective casing, 1 bottle in a carton box);
• Suppositories for rectal use: a uniform consistency, a cylindrical shape with a pointed end, from light yellow to white (5 pieces in a contour cell pack, 2 packs in a carton box);
• Lyophilisate for preparation of solution for injections: highly soluble amorphous white powder in water with a moisture content of not more than 5%. The resulting solution is clear, sterile, non-opaque, with a pH of 6.0-7.5 (1, 3, 5 million IU (International Units): in bottles of 10 pieces in plastic cartridges, 1 cartridge in a carton box; 1 , 3, 5 million IU: in ampoules or bottles of 5 pieces in plastic cartridges, 1 cartridge in a cardboard box with a solvent (water for injection 1 or 2 ml); 3, 5, 6, 9, 18 million ME: in ampoules or bottles of 1 pc in plastic cartridges, 1 cartridge in a carton box together with the solvent (water for injection - 1 or 2 ml).

The composition of 1 bottle of lyophilized powder for the preparation of nasal drops includes:

• Active substance: human interferon alpha-2b - 1 million IU. After filling the bottle, 1 ml of the prepared drops contains about 200 thousand IU of interferon;
• Auxiliary components: dextran-70, sodium chloride, disodium hydrogen phosphate anhydrous, potassium dihydrogen phosphate anhydrous.

The structure of 1 suppository for rectal use includes:

• Active substance: human alpha-2b interferon - 500 thousand, 1 or 3 million IU;
• Auxiliary components: ascorbic acid, solid fat, Polysorbate-80.

The composition of 1 bottle with a lyophilisate for solution for injection includes:

• Active substance: human alpha-2b interferon - 1, 3, 5, 6, 9 or 18 million IU;
• Auxiliary components: potassium dihydrophosphate dextran-70, sodium chloride, sodium hydrophosphate anhydrous.

Indications for use

Laferon-FarmBiotek nasal is prescribed for the treatment and prevention of viral-bacterial and acute respiratory viral infections in adults and children, including newborns. For treatment, the drug should be used as early as possible - when the first signs of the disease appear. For prophylaxis, drops are used when there is a threat of infection (upon contact with a patient, during an epidemic period).

Laferon-FarmBiotek in the form of suppositories can be used in adults and children as monotherapy or simultaneously with other drugs in the treatment of various viral-bacterial and viral infections. The drug is indicated for viral hepatitis, pediatric viral infectious diseases, sepsis, infectious and inflammatory diseases of the urogenital and respiratory tracts, cervical dysplasia, meningitis, intrauterine infections, as well as for the rehabilitation of frequently ill children.

Laferon-FarmBiotek in the form of a lyophilisate for preparing a solution for injection is prescribed to children and adults in the complex therapy of the following diseases:

• Viral hepatitis B and C;
• Damages of the nervous system with poly-and monoradicular pain syndromes;
• Acute and chronic septic diseases of a bacterial and viral nature, including acute and chroniosepsis in dissiminated forms;
• Acute viral, bacterial and mixed infections, including in newborns;
• Chronic urogenital chlamydia;
• Herpetic infections of various localization: acute herpetic stomatitis in children, herpes zoster, genital herpetic infection, multiple skin herpetic eruptions, herpetic keratouveitis and keratoconjunctivitis, etc .;
• Multiple sclerosis;
• Laryngeal papillomatosis;
• Hemoblastosis: hairy cell leukemia, chronic myeloid leukemia, non-Hodgkin's lymphoma;
• Malignant tumors: Kaposi's sarcoma, melanoma of the skin and eyes, bladder, kidney, breast cancer, ovarian cancer, myeloma.

Contraindications

Laferon-FarmBiotek is contraindicated in case of hypersensitivity to the drug components.

The use of the drug in the form of suppositories in pregnant women is acceptable after 28 weeks, provided that the benefits of therapy for women are higher than the possible risk to the fetus. Injection solution during pregnancy should not be used.

Dosing and Administration

Lyophilized powder for the preparation of nasal drops

Before using the vial with dry powder Laferon-FarmBiotek nasal should be opened and filled with boiled water at room temperature to a level below 1 cm hole in the bottle. The bottle should be closed with a rubber stopper and gently shake until the powder is completely dissolved, after which the rubber stopper should be replaced with a dropper cap.

When treating flu and other respiratory viral infections, drops should be instilled into the nose every 2 hours. Single dose is determined by age:

• Infants - 2 drops;
• Children 1-7 years old - 4-6 drops;
• Children from 7 years old - 8 drops each;
• Adults - 10-12 drops each.

Usually the duration of the treatment course is 3-5 days.

A single dose of Laferon-FarmBiotek for prevention - 4 drops, the frequency of use - 4 times a day.

Suppositories for rectal use

The following treatment courses apply:

• Combined therapy of infectious and inflammatory diseases in infants (meningitis, pneumonia, intrauterine infections, sepsis, acute respiratory viral infection (ARVI)): 2 times a day, 250 thousand IU each. Course duration - 5 days. If necessary, after 5 days the course can be repeated;
• Combined therapy of viral and bacterial infections in children 1-7 years old: 2 times a day, 250 thousand IU each. Course duration - 10 days. In the future, according to an individual scheme, it is possible to conduct maintenance treatment for 1-12 months;
• Therapy for SARS and flu in children: 2 times a day; children 1-7 years old - 250 thousand IU each, over 7 years old - 500 thousand IU each. Course duration - 5 days. In severe illness, a single dose is doubled;
• Treatment of mumps, rubella, measles, chicken pox: 2 times a day; children 1-7 years old - 250 thousand IU each, over 7 years old - 500 thousand IU each. Course duration - 5 days;
• Combined therapy of chronic viral hepatitis in children: 2 times a day; daily dose - 3 million IU / m2 of body surface. Course duration - 10 days. In the future, for from 6 to 12 months, the drug is used 3 times a week;
• Comprehensive treatment in adults of chronic inflammatory diseases of the urogenital tract: 1 million IU 1 time per day. Course duration - 10 days. Treatment should be given to both sexual partners;
• Comprehensive treatment of cervical dysplasia: single dose - 3 million IU. Course duration - 10 days. Treatment should be carried out before the instrumental destruction of the altered dysplastic epithelium. If necessary, in the rehabilitation period, Laferon-FarmBiotek is used in the same dose.

In the treatment of rotavirus infection in children is usually prescribed:

• Up to 1 year - 250 thousand IU once a day;
• 1-3 years - 500 thousand IU once a day;
• 3-7 years - 500 thousand IU 2 times a day.

Course duration - 5 days.

When carrying out rehabilitation therapy for children 1-7 years old, who are prone to frequent diseases of recurrent viral-bacterial infections of the upper respiratory tract, the respiratory tract and recurrent herpes of the 1st type Laferon-FarmBiotek by 250 thousand IU are used for a total of 2 months according to the following scheme:

• Within 10 days: daily, 2 times a day;
• Within 14 days: 3 times a week, 2 times a day;
• Within 14 days: 2 times a week, 2 times a day;
• Within 14 days: 2 times a week, 1 time per day;
• Within 14 days: once a week once a day.

Children 7-14 years old, treatment is carried out according to the same scheme, using a therapeutic dose of 500 thousand IU.

In case of long-term current diseases, the use of Laferon-FarmBiotek is established individually, taking into account the dynamics and clinical picture.

Lyophilisate for solution for injection

The solution of Laferon-FarmBiotek can be administered subcutaneously, intramuscularly, endolymphly, intravenously, intravesically, intraperitoneally, parabulbally, intranasally or rectally. If the contents of the vial are dissolved in a volume of 1 ml, water for injection should be used for dissolution, and if saline is used in a larger volume.

The treatment regimen is determined by the disease:

• Acute viral hepatitis B: 2 times a day, 1 million IU intramuscularly (in severe cases, the dose can be doubled). Course duration - 10 days. Depending on the clinical picture, the course can be prolonged up to 14-21 days or continued using the same single dose 2 times a week for several weeks;
• Chronic viral hepatitis B: 3 times a week, 3-4 million IU intramuscularly. Course duration - 60 days;
• Chronic viral hepatitis C: 3 times a week for 3 million IU intramuscularly. Duration of the course is 6 months (as monotherapy or in combination with nucleoside analogues);
• Recurrent and acute pneumonia of viral-bacterial and viral etiology: 1 million IU intramuscularly. Duration of the course is 5-7 days (as part of a comprehensive anti-bacterial, detoxification and anti-inflammatory treatment);
• Acute intestinal infections with hypocoagulation in young children: 10 thousand IU / kg rectal each, 3 procedures with a break of 48 hours;
• Acute diarrhea syndrome in newborns: 100 thousand IU each rectally in the form of microclysters. Course duration - 3-7 days;
• Peritonitis, purulent-septic diseases, multiple abdominal abscesses: 1 time per day, 2-4 million IU intravenously; total dose per course - 12-16 million IU. Perhaps the simultaneous endolymphal introduction of Laferon-FarmBiotek in the same dose;
• Laryngeal papillomatosis: 100-150 thousand IU / kg body weight intramuscularly (if possible, perifocal introduction to the larynx area is shown). Course duration - 20-25 days. Courses are recommended to be repeated for six months with a break of 1-1.5 months, and then for the next six months in 2-3 months. The use of Laferon-FarmBiotek is advisable to combine with A-vitamin therapy;
• Affections of the nervous system with poly-and monoradicular pain syndromes: 1 million IU intramuscularly. Duration of the course is 5-10 days (simultaneously with other drugs);
• Multiple sclerosis: 2-3 million IU intramuscularly 2-3 times a day. Course duration - 10-15 days. In the future, over half a year, 1 million IU is administered once a week.

When treating acute respiratory viral infections in children, including newborns, Laferon-FarmBiotek is administered intranasally with 2-3 drops in each nasal passage 3-6 times a day. Course duration - 3-5 days. The dose is determined by age:

• Newborns - 20-50 thousand IU / ml;
• Older children - 100 thousand IU / ml.

Alternately, the introduction of 10-15 minutes in the nasal passages soaked in a solution of cotton wool.

Laferon-FarmBiotek in the treatment of acute respiratory viral infections in adults can be used:

• Intramuscular: 3 days for 1-3 million IU (since the first days of the disease);
• Intranasal: 6-8 times a day in each nasal passage 4-6 drops of a solution of 100 thousand IU / ml (before use, the solution should be heated to body temperature in a syringe without a needle, the rest of the solution should be stored in a refrigerator).

Treatment of malignant tumors is carried out according to the following schemes:

• Uveal melanoma: 1 million IU parabulbarno. Course duration - 10 days. The course is repeated 2 times with a break of 20 days. General course - 30 million IU. Perhaps repeated courses after 45 days. Laferon-FarmBiotek is used simultaneously with beta-application and photodegradation of the tumor;
• Melanoma of the skin: 3 million IU intramuscularly. Course duration - 10 days. For six months, with breaks of 45 days, the course will be repeated. It is also possible the endolymphal introduction of 3 million IU of Laferon-FarmBiotek 4 times with a break of 48 hours, followed by monthly lymphotropic injection of the solution for four days, 1 million IU;
• Bladder cancer: 5-10 million IU in the form of intravesical instillations 3-6 times. General course - 30 million IU. Repeated courses are carried out for 1-2 years with breaks of 2-3 months;
• Kidney cancer: 3 million IU intramuscularly. Course duration - 10 days. General course - 30 million IU. Repeated courses are carried out for six months with a break of 3-5 weeks, then for a year with intervals of 1.5-2 months;
• Breast cancer: 3 million IU intramuscularly. Course duration - 10 days. Repeated courses are held during the year with a break of 1.5-2 months, then in 2-3 months. It is advisable to alternate courses of Laferon-FarmBiotek with courses of chemotherapy or radiation therapy;
• Ovarian cancer: 5 million IU during surgery intraperitoneally and in the drainage for the next 5 days. In the future, Laferon-FarmBiotek administered 3 million IU intramuscularly. Course duration - 10 days (between the course of chemotherapy). General course - 90 million IU. Subsequent courses are carried out for 1-1.5 years with a break of 2-3 months according to the following scheme: 10 days, 3 million IU;
• Myeloma: 3 million IU intramuscularly. Course duration - 10 days. Repeated courses are held 1 time in 1.5-3 months (4-6 times a year);
• Kaposi's sarcoma: 3 million IU intramuscularly. Course duration - 10 days. Therapy is combined with monochemotherapy with prospidin; repeated courses are carried out for half a year once a month.

Treatment of herpetic infections:

• Herpes zoster: 1 million IU intramuscularly daily. Simultaneously, 2 million IU of Laferon-FarmBiotek, diluted in 5 ml of saline, is injected subcutaneously at several points around the rash zone. Course duration - 5-7 days;
• Skin herpetic eruptions: 2 million IU intramuscularly or subcutaneously (around the outbreak) daily; treatment can be combined with applications for herpetic papules;
• Herpetic keratoconjunctivitis: 1 million IU Laferon-FarmBiotek, diluted in 5 ml of saline, make 2-3 drops under the conjunctiva of the eye every 2 hours. Course duration - 7-10 days. With improvement, the interval between the use of the drug is increased to 4 hours;
• Genital herpetic infection: 2 million IU intramuscularly simultaneously with the local use of Laferon-FarmBiotek in the form of applications in the area of ​​lesions;
• Acute herpetic stomatitis in children: 4 times a day, 250 thousand IU each in the form of applications simultaneously with intranasal administration. 1 million IU Laferona-FarmBiotek diluted in 4 ml of water for injection. Use 1 ml of the solution for intranasal administration and one application: 2 drops are injected intranasally, the rest - after hygienic treatment of the mucous membrane of the oral cavity, applied topically in the form of applications. Course duration - 7-10 days.

Treatment of patients with chronic urogenital chlamydiosis is carried out in two stages:

• Preparatory, including the use of enterosorbent and multivitamin preparations for 14 days in therapeutic doses. Starting from the tenth day, 10 mg of thymalin (an immunotropic drug) is administered intramuscularly in the evening every other day (5 injections per course);
• The main one, including basic therapy with antibacterial drugs according to this scheme: during 5 days the first antibiotic; after a seven-day break, another antibiotic is prescribed for 10 days. Laferon-FarmBiotek is used during a break and after the end of the course of antibacterial treatment intramuscularly with 1 million IU once a day in the evening (10 injections per course). Also, while taking antibacterial drugs, antifungal drugs (diflucan, nystatin, nizoral, clotrimazole) and hepatoprotectors (Kars) should be used in therapeutic doses.

In the treatment of hemoblastosis, Laferon-FarmBiotek is used according to the following schemes:

• Hairy cell leukemia: 3 million IU intramuscularly 3 times a week. Course duration - 4-6 weeks. For maintenance therapy when reaching remission, Laferon-FarmBiotek should be administered every other day for 3 million IU for 12 months;
• Chronic myeloid leukemia: 5 million IU intramuscularly daily. The drug can be used as monotherapy or simultaneously with hydroxyurea (40 mg / m2 daily) and small doses of cytosar (every 10 days of the current month, 20 mg / m2 per day). Course duration - 6 months. For maintenance therapy, when remission is reached, Laferon-FarmBiotek is administered daily with 5 million IU for 10-12 months;
• Non-Hodgkin's malignant lymphoma: 3 million IU intramuscularly 3 times a week. Duration of the course is 12-18 months (as a supportive treatment for achieving remission due to the use of chemotherapy). During the period of partial remission, other chemotherapy protocols should be used with further intramuscular use of Laferon-FarmBiotek, 3 million IU 3 times a week for 18 months.

Side effects

Short courses of treatment Laferon-FarmBiotek in the form of drops of nasal side effects do not cause.

Side effects during basic courses of therapy with Laferon-FarmBiotek suppositories at the recommended doses are not observed. In the first days of treatment, in some cases, flu-like symptoms may develop, which subsequently decrease and disappear. To reduce their severity, you can use drugs of paracetamol in age doses.

Prolonged use of high doses of interferon can lead to changes in the blood (thrombocytopenia, leukopenia, anemia), increased levels of alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, as well as sleep disturbances and fluctuations in blood pressure. Such effects are dose-dependent and usually decrease with a decrease in dose.

Injecting Laferona-FarmBiotek in most cases is accompanied by the development of flu-like syndrome characterized by chills, fever, muscle, joint and headache, lethargy. As a rule, such side effects develop only in the first days of treatment and are dose-dependent. They can be stopped by using paracetamol at a dose of 0.5-1 g 30-40 minutes before the injection.

Sometimes with prolonged courses, leuko- and thrombocytopenia can develop, which is eliminated by reducing the doses.

special instructions

To preserve the immunobiological activity of Laferon-PharmBiotek nasal, only cooled to room temperature water should be used to dissolve the lyophilized powder.

It is possible to use Laferon-FarmBiotek in suppositories in infants, including premature. To obtain a single dose of 250 thousand IU, a suppository with an activity of 500 thousand IU should be divided in half.

Drug interaction

The drug is compatible with cytostatics, hormones and antibiotics, which are used in the treatment of neoplastic, viral and bacterial, viral and autoimmune diseases.

Terms and conditions of storage

The drug should be stored out of reach of children at a temperature of 2-8 ° C.

Shelf life is:

• Lyophilized powder for the preparation of nasal drops - 3 years. After opening the bottle with the drug and preparing the solution, the drug should be used for 5 days if it is stored in the refrigerator or 2 days at room temperature (15-25 ° C) in a place protected from direct sunlight;
• Suppositories for rectal use - 1 year;
• Lyophilisate for preparation of solution for injections - 3 years. The prepared solution for injection should be used immediately, for intranasal use - within 24 hours provided it is stored at a temperature of 2-8 ° C.