Laferon-Pharmbiotek

Laferon-Pharmbiotek – medicine with anti-virus, immunomodulatory and antineoplastic activity.

Form of release and structure

Laferon-Pharmbiotek is issued in three dosage forms:

• Suppositories rectal: from light yellow till white color, cylindrical with the pointed end, a homogeneous consistence (in blister strip packagings on 5 pieces, on 2 packagings in a cardboard pack);
• Lyophilisate for preparation of solution for injections: amorphous, well soluble powder of white color in water with residual humidity to 5%; the received solution – not opalescent, transparent, sterile, рН 6-7,5 (in bottles, on 1, 5, 10 bottles in plastic cartridges, on 1 cartridge in a cardboard pack complete with solvent or without it);
• The lyophilized powder for preparation of drops nasal (in bottles, on 1 bottle in a cardboard pack).

Is a part of 1 suppository:

• Active agent: interferon of the person alpha 2b – 0,5, 1, 3 million IU (International Units);
• Auxiliary components: polysorbate-80, ascorbic acid, solid fat.

For preparation of solution for injections is a part of 1 bottle of lyophilisate:

• Active agent: interferon alpha 2b recombinant the person – 1, 3, 5, 6, 9, 18 million ME;
• Auxiliary components: sodium chloride – 9 mg, a dextran-70 – 5 mg.

For preparation of drops nasal is a part of 1 bottle of the lyophilized powder:

• Active agent: interferon of the person alpha 2b – 1 million ME (after dissolution of powder 1 ml of drops contains about 0,2 million ME of interferon);
• Auxiliary components: sodium chloride – 9 mg, a dextran-70 – 5 mg, anhydrous hydrophosphate of dinatrium – 0,144 mg, anhydrous dihydropotassium phosphate – 0,025 mg.

Indications to use

Injection solution Laferon-Pharmbiotek is applied as monotherapy and as a part of complex treatment of various virus and bacterial and viral infections:

• Viral hepatitis In and With;
• Virus, bacterial and multi-infections (an acute current), including at newborns;
• Septic diseases of a bacterial and virus etiology (acute and chronic current), including sepsis in the disseminated forms;
• Multiple sclerosis;
• The infections of various localization caused by a herpes simplex virus: herpetic keratouveita and keratoconjunctivites, genital herpes, shingles, multiple herpetic skin rashes;
• Throat papillomatosis;
• Urogenital clamidiosis (chronic current);
• The disturbances of a nervous system which are followed by poly-and monoradicular pain syndromes;
• Malignant new growths: multiple myeloma, Kaposha's sarcoma, melanoma of skin and eye, cancer of kidneys, ovaries, bladder, mammary gland;
• Hemoblastoses: chronic myeloid leukemia, hairy cell leukemia, nekhodzhkinsky malignant lymphoma.

Laferon-Pharmbiotek in the form of suppositories rectal appoint for treatment of infectious and inflammatory diseases of urogenital and respiratory paths, pre-natal infections, a dysplasia of a neck of uterus, a viral hepatitis, sepsis, meningitis, children's viral infectious diseases (as monotherapy or along with other medicines). Also drug is shown for rehabilitation of children who often are ill.

Laferon-Pharmbiotek nasal appoint at treatment and prevention of acute respiratory virus and bacterial and viral infections at patients of all age, including newborn children. Also drug is used for prevention at threat of infection (at contact with patients, during the epidemic period).

Contraindications

Laferon-Pharmbiotek in all dosage forms do not appoint at hypersensitivity to drug components.

Pregnant women should not use drug in the form of injection solution, in the form of suppositories its use is possible after the 28th week of pregnancy after ratio assessment advantage/risk.

Route of administration and dosage

Solution for injections
Laferon-Pharmbiotek depending on indications enter intravenously, intramusculary, intraperitoneally, subcutaneously, endolimfalno, vnutripuzyrno, rektalno, intranazalno or parabulbarno.

For dissolution of lyophilisate of 1 ml it is necessary to use water for injections, in need of obtaining bigger volume – normal saline solution.

Schemes of use is defined by indications:

• Viral hepatitis In (an acute current): intramusculary, 2 times a day on 1 million ME (at a heavy current increase in a single dose is possible twice), a course – 10 days. In the presence of indications increase in duration of a course up to 14-21 days or use of 1 million ME 2 times in 7 days for several weeks is possible;
• Viral hepatitis In (a chronic current): intramusculary, 3 times a week on 3-4 million ME, a course – 60 days;
• Viral hepatitis With (a chronic current): intramusculary 3 times a week on 3 million ME, a course – 6 months (as monotherapy or along with analogs of nucleosides);
• Acute respiratory viral infection at children, including newborns: intranazalno, 3-6 times a day on 2-3 drops in each nasal course, a course – 3-5 days. Also drug can be used, serially entering into the nasal courses the wadded turundas moistened in solution (duration of procedures – 10-15 minutes). A dosage for newborns – 0,02-0,05 million ME/ml, for other children – 0,1 million ME/ml;
• Acute respiratory viral infection (including flu) at adults: intramusculary on 1-3 million ME, a course – 3 days (therapy begin from the first or second day of a disease). Also it is intranazalno possible to use drug – 6-8 times a day on 4-6 drops (0,1 million ME/ml) in each nasal course (before use solution should be warmed up to body temperature);
• The pneumonia having a virus and bacterial and virus etiology (an acute and recurrent current): intramusculary on 1 million ME, a course – from 5 to 7 days (along with performing antibacterial, disintoxication and antiinflammatory therapy);
• Diarrheal syndrome (acute current) at newborns: rektalno, daily, as mikroklizmochka with the maintenance of 0,1 million ME of drug, a course – 3-7 days;
• The intestinal infections (acute current) at children of early age which are followed by blood coagulation delay: rektalno, 3 times with an interval of 48 hours on 0,01 million ME/kg of body weight;
• Multiple abscesses of an abdominal cavity, it is purulent - septic diseases, peritonitis: intravenously, once a day on 2-4 million ME, a course dose – 12-16 million ME. Laferon-Pharmbiotek in the same dose it is endolimfalno possible to enter at the same time;
• Shingles: intramusculary, daily on 1 million ME along with hypodermic introduction around a rash zone (in several points) 2 million ME in 5 ml of normal saline solution, a course – from 5 to 7 days;
• Skin herpetic rashes: subcutaneously (around the center) or intramusculary, daily on 2 million ME (therapy can be combined with applications on the area affected with herpes);
• The genital infections caused by a herpes simplex virus: intramusculary, daily on 2 million ME along with applications on the struck area;
• The keratoconjunctivites caused by a herpes simplex virus: solution introduction (1 million ME in 5 ml of normal saline solution) under an eye conjunctiva, each 2 hours on 2-3 drops, a course – from 7 to 10 days. In process of improvement of a state frequency rate of use of drug is reduced (each 4 hours);
• Herpetic stomatitis (acute current) at children: applications along with intranasal introduction, 4 times a day on 0,25 million ME (1 million ME should be parted in 4 ml of water for injections, on 1 ml of solution use for 1 application and intranasal introduction: 2 drops intranazalno, apply other solution locally in the form of applications after preliminary carrying out processing of a mucous membrane of an oral cavity), a course – from 7 to 10 days;
• The defeats of a nervous system which are followed by radicular pains: intramusculary on 1 million ME, a course – from 5 to 10 days (complex therapy);
• Throat papillomatosis: intramusculary (it is preferable – perifokalno to the area of a throat), on 0,1-0,15 million ME/kg daily, a course – 20-25 days. Repetition of courses with a break 1-1,5 months for 6 months, then for the next 6 months – in 2-3 months is recommended. Laferon-Pharmbiotek it is reasonable to apply along with performing A-vitamin therapy;
• Multiple sclerosis: intramusculary, 2-3 times a day on 1 million ME, a course – 10-15 days. Further within 6 months the drug is administered on 1 million ME once a week;
• Skin melanoma: intramusculary on 3 million ME a day, a course – 10 days. Further for half a year with a break 1,5 months repeat a course. Use of other scheme is also possible: endolimfalny introduction 4 times with a break of 48 hours on 3 million ME of solution with the subsequent lymphotropic administration of drug monthly for 4 days on 1 million ME;
• Uveal melanoma: parabulbarno, on 1 million ME daily, a course – 10 days. It is necessary to repeat a course 2 times with a break of 20 days, a course dose – 30 million ME. If necessary with a break 1,5 months conduct repeated medical courses;
• Cancer of kidneys: intramusculary, on 3 million ME daily, a course – 10 days. Repeatedly courses are conducted for 6 months with breaks from 3 to 5 weeks, further within a year – with breaks 1,5-2 months;
• Bladder cancer: intravesical instillations on 5-10 million ME on 1 instillation, a course – 3-6 procedures, a course dose – 30 million ME. Repeatedly courses of therapy are conducted by each 2-3 months for 1-2 years;
• Ovary cancer: intraperitoneally during surgical intervention and for the next 5 days – on 5 million ME in a drainage. Further Laferon-Pharmbiotek enter intramusculary 3 million ME, a course – 10 days (between carrying out courses of chemotherapy), a course dose – 90 million ME. Further courses (daily on 3 million ME within 10 days) appoint for 1-1,5 bucketed years 2-3 months;
• Breast cancer: intramusculary, on 3 million ME daily, a course – 10 days. Within a year conduct repeated courses with a break 1,5-2 months, then – in 2-3 months (according to indications). Alternation of courses of use Laferona-Pharmbiotek with himio-or radiation therapy is reasonable;
• Kaposha's sarcoma: intramusculary, daily on 3 million ME, a course – 10 days (along with use of Prospidinum as monochemotherapy). Repeatedly courses are conducted for 6 months (once a month);
• Multiple myeloma: intramusculary, daily on 3 million ME, a course – 10 days. Repeatedly courses are conducted by 4-6 times a year (1 time in 1,5-3 months);
• Chronic myeloid leukemia: intramusculary, on 5 million ME daily, a course – 6 months (as monotherapy or along with small doses of Cytosarum and hydroxurea). After achievement of remission use Laferona-Pharmbiotek is continued as the supporting treatment: on 5 million ME daily, a course – from 10 to 12 months;
• Hairy cell leukemia: intramusculary, 3 times a week (every other day) on 3 million ME, a course – from 4 to 6 weeks. After achievement of remission carry out a maintenance therapy: every other day on 3 million ME, a course – up to 12 months;
• Nekhodzhkinsky malignant lymphoma: intramusculary, 3 times a week on 3 million ME, a course – 12-18 months (as a maintenance therapy after achievement of remission owing to use of chemotherapy). At partial remission other protocols of chemotherapy with further use Laferona-Pharmbiotek are shown: intramusculary, 3 times a week on 3 million ME, a course – 18 months.

Treatment of chronic urogenital clamidiosis is carried out in two steps. During the preparatory period for 14 days in therapeutic doses apply enterosorbents and polyvitaminic drugs. Since tenth day appoint immunotropny medicine – Thymalinum (intramusculary, every other day on 10 mg in the evening, a course – 5 injections).

At the second stage carry out basic antibacterial therapy as follows: 5 days the first antibiotic, after a seven-day break appoint other antibiotic drug to 10 days. Laferon-Pharmbiotek apply during breaks and after end of an antibacterial course (intramusculary, once a day in the evening 1 million ME, a course – 10 injections). During use of antibiotic medicines in therapeutic doses appoint gepatoprotektor (karsit) also antifungal drugs (nizorat, Diflucan, nystatin, Clotrimazolum).

Suppositories rectal
Laferona-Pharmbiotek the doctor establishes the scheme of use individually on the basis of a clinical picture and dynamics.

As a rule, drug is appointed as follows:

• Infectious and inflammatory diseases at babies, including meningitis, sepsis, pneumonia, pre-natal infections, acute respiratory viral infections (complex treatment): 2 times a day on 0,25 million ME, a course – 5 days. If necessary with a break of 5 days courses can be repeated;
• Virus and bacterial infections (complex treatment): 2 times a day; children of 1-7 years – on 0,25 million ME, children of 7 years and adults – on 0,5 million ME; a course – 10 days. Further performing the supporting treatment according to the individual scheme for 1-12 months is possible;
• Flu and acute respiratory viral infections: 2 times a day; children of 1-7 years – 0,25 million ME, children of 7 years – 0,5 million ME; a course – 5 days. At heavy disease the single dose of drug can be increased twice;
• Epidemic parotitis, measles, rubella, chicken pox: 2 times a day; children of 1-7 years – 0,25 million ME, children of 7 years – 0,5 million ME; a course – 5 days;
• Rotavirusny infection: children till 1 year – once a day on 0,25 million ME; children of 1-3 years – once a day on 0,5 million ME; children of 3-7 years – 2 times a day on 0,5 million ME; a course – 5 days;
• Chronic viral hepatitis at children (complex treatment): daily on 1,5 million ME/m ² body surfaces 2 times a day, a course – 10 days; further – for 6-12 months 3 times a week;
• Chronic infectious and inflammatory diseases of an urogenital path at adults (complex treatment): once a day on 1 million ME, a course – 10 days. Therapy should be carried out to both sexual partners;
• Dysplasia of a neck of uterus (complex treatment): daily on 3 million ME, a course – 10 days.

Rehabilitation therapy to children who are subject to frequent diseases of virus and bacterial recurrent infections of ENT organs, a respiratory path, recurrent herpes of the 1st type is carried out step by step (a single dose for children of 1-7 years – 0,25 million ME; children of 7-14 years – 0,5 million ME):

• 1-10 day: 2 times a day;
• 11-24 day: 3 times a week 2 times a day;
• 25-38 day: 2 times a week 2 times a day;
• 39-52 day: 2 times a week once a day for the night;
• 53-66 day: once a week once a day for the night.

The general duration of a course – 2 months.

Drops are nasal
Laferon-Pharmbiotek at treatment of flu and other respiratory viral infections appoint in the following doses:

• Babies: 8 times a day on 2 drops;
• Children of 1-7 years: 8 times a day on 4-6 drops;
• Children of 7 years: 8 times a day on 8 drops;
• Adults: 8-10 times a day till 10-12 drops.

As a rule, duration of therapy varies from 3 to 5 days.

With the preventive purpose drug is used by 4 times a day on 4 drops.

Before use the bottle with dry powder is filled with the boiled water cooled to the room temperature (15-25 °C). The top level of liquid has to be 10 mm lower than a bottle opening. After full dissolution of powder the rubber bung needs to be replaced with a cover dropper.

Side effects

Solution for injections
As a rule, injection administration of drug is followed by emergence of a grippopodobny syndrome of which are characteristic fervescence, a fever, head, muscular and joint pains, slackness. These disturbances are dozozavisimy, and are usually observed only in the first days of therapy, then they weaken and take place. To stop or considerably it is possible to reduce expressiveness of these side effects purpose of 0,5-1 g of paracetamol in 30-40 minutes prior to an injection.

At long use of drug development leucio-and thrombocytopenia is sometimes noted (the dose decline is necessary).

Suppositories rectal
At observance of the recommended scheme of use Laferona-Pharmbiotek side effects, as a rule, are not observed. For stopping or decrease in expressiveness of development of grippopodobny symptoms use of age doses of paracetamol is possible.

Laferona-Pharmbiotek in high doses can lead prolonged use to change of composition of blood (development of thrombocytopenia, a leukopenia, anemia), increase in levels of aspartate aminotransferase, alaninaminotranspherase, an alkaline phosphatase, a sleep disorder, fluctuation of arterial pressure. These disturbances are dozozavisimy and take place at reduction of a dose.

Drops are nasal
At use of short medical courses side effects, as a rule, do not develop.

Special instructions

Laferon-Pharmbiotek in the form of suppositories babies can appoint, including premature.

For receiving a single dose of 0,25 million ME suppository with activity of 0,5 million ME needs to be divided into 2 equal parts.

Medicinal interaction

Laferon-Pharmbiotek it is possible to apply along with antibiotic, hormonal, cytostatic drugs which are used for therapy of virus and bacterial, viral, autoimmune and tumoral diseases.

Terms and storage conditions

To store in protected from light, the place, unavailable to children, at a temperature of 2-8 °C.

Period of validity:

• Suppositories rectal – 1 year;
• Lyophilisate for preparation of solution for injections and drops nasal – 3 years.

After preparation injection solution needs to be used at once; solution for intranasal use keeps the properties within 1 day at observance of temperature condition (at a temperature of 2-8 °C).

Nasal it is possible to store drops 5 days in the refrigerator, at the room temperature in the place protected from direct sunshine – 2 days.