Pharmacological properties

Pharmacodynamics. interferon alpha 2b recombinant the person — high cleaning soluble protein in water with a molecular weight of 19,300 yes.

Laferon-FarmBiotek, like natural leukocytic interferon, possesses three main types of biological activity: immunomodulatory, antiviral and antineoplastic.

action Mechanism Laferona-FarmBiotek is based by

that interferon, contacting the corresponding receptors of cages of an organism, induces a complex of the intracellular mechanisms leading to emergence of enzymes which prevent replication of viruses increase phagocytal activity of macrophages, specific cytotoxicity of lymphocytes to target cells, inhibit proliferation of the metastasizing cages.

Pharmacokinetics. Data are absent.

Indication

Laferon-pharmbiotek is applied in complex therapy at:

• an acute and chronic viral hepatitis In (medium-weight and severe forms);
• chronic hepatitis C;
• sharp virus, bacterial and multi-infections (at a SARS at children, including at newborns, a sharp diarrheal syndrome at newborn, sharp intestinal infections at children of early age with the hypocoagulation phenomena);
• sharp and chronic septic diseases of the virus and bacterial nature, including disseminate forms sharp and a hroniosepsisa;
• herpes infections of various localization: shingles, multiple skin herpetic rashes;
• a genital herpes infection; a herpetic keratoconjunctivitis and a keratouveita, sharp herpetic stomatitis at children;
• chronic urogenital clamidiosis;
• damages of nervous system with mono - and polyradicular pain syndromes;
• multiple sclerosis;
• throat papillomatosis;
• to a melanoma of skin and eye; cancer of a kidney, bladder, ovary, mammary gland; to Kaposi sarcoma, multiple myeloma; chronic myeloid leukemia, hairy cell leukemia, non-Hodgkin's malignant lymphomas, bazalnokletochny carcinoma; To the T-cellular lymphoma of skin (fungoid mycosis).

Use

Solution laferona-pharmbiotek enter in oil, p / to, in/in, endolimfatichesk, intraperitoneally, vnutripuzyrno, rektalno, parabulbarno, intranazalno.

• Acute viral hepatitis In: enter in oil 1 million ME (in hard cases — on 2 million ME) 2 times a day within 10 days. The similar course can be prolonged up to 2–3 weeks depending on the clinical status of the patient or is continued on 1 million ME 2 times a week within several weeks.
• Chronic viral hepatitis In: enter 3 times, in oil on 3–4 million ME, a week within 2 months
• Chronic viral hepatitis With: enter 3 times, in oil on 3 million ME, a week within 6 months in the form of monotherapy or into combinations with analogs of nucleosides.

to use Drug within 3–4 months then to carry out HCV RNA definition; farther to continue treatment only if by HCV RNA it is not revealed; at monotherapy a course of treatment — 12–18 months, in combination with ribaviriny — 6 months; at a genotype 1 and the high content of RNA of a virus in the beginnings of therapy in case of absence in HCV RNA blood plasma by the end of 6 months of treatment it is possible to continue combination therapy 6 more months, however to take such negative factors as age into account 40 years, a male, the progressing fibrosis are more senior.

• a SARS at children, including at newborns: enter intranazalno 2–3 drops into each nasal course of 3-6 times a day within 3–5 days; the medicine dose for newborns — 20–50 thousand ME/ml, for children is aged more senior than 6 months — 100 thousand ME/ml. Introduction to the nasal courses (serially) cotton turundas moistened Laferonom-FarmBiotek for 10–15 min. is admissible.
• a SARS (including flu) at adults:
• is entered in oil on 1–3 million ME, since 1-2nd day of a disease within 3 days;
• intranazalno on 4–6 drops of Laferona-FarmBiotek solution (100 thousand ME/ml) in each nasal course of 6-8 times a day (before application the entered dose Laferona-FarmBiotek should be warmed up in the syringe (to use the syringe without needle) to body temperature to store other solution in the fridge, protecting from bacterial pollution).
• Acute and recurrent pneumonia of a virus and virus and bacterial etiology: Laferon-FarmBiotek enter in oil on 1 million ME within 5–7 days together with complex treatment (antibacterial, disintoxication, anti-inflammatory, etc.).
• Sharp diarrheal syndrome at newborns: rektalno in the form of the daily mikroklizmochek containing 100 thousand ME Laferona-FarmBiotek within 3–7 days.
• Acute intestinal infections at children of early age with the hypocoagulation phenomena: rektalno in a dose of 10 thousand ME/kg of body weight 3 times with an interval of 48 h
Are purulent
• - septic diseases, peritonitis, multiple abscesses of an abdominal cavity: in/in on 2–4 million ME of 1 times a day; the general dose of 12-16 million ME on a course; the expediency of simultaneous endolymphatic administration of medicine in the same dose is not excluded: 2–4 million ME of 1 times a day.

Herpes infections

Shingles: daily 1 million ME in oil + 2 million ME in 5 ml of physiological solution p / to in several points around a rash zone. Treatment duration — 5–7 days.

Skin herpetic rashes: daily in oil or p / to (around the center) introduction of medicine in a dose of 2 million ME; treatment can be combined with topical administration of medicine (appliques) on herpetic papules; duration of treatment is determined by the doctor.

Genital herpes infection: daily introduction in oil in a dose of 2 million ME in combination with local use of medicine in the form of appliques to the area of rashes; duration of treatment is determined by the doctor.

Herpetic keratoconjunctivitis: introduction of Laferona-FarmBiotek solution in a dose of 1 million ME in 5 ml of physiological solution under an eye conjunctiva on 2–3 drops each 2 h within 7–10 days; in process of disappearance of symptoms of a disease medicine it is possible to drip less often — each 4 h; duration of treatment is determined by the doctor.

Acute herpetic stomatitis at children: on 250 thousand ME on reception 4 times a day in the form of appliques in combination with intranasal introduction. Laferon-FarmBiotek to part 1 million ME in 4 ml of water for injections, to apply on 1 ml of solution on 1 applique and intranasal introduction — 2 drops, the rest — after hygienic processing of a mucous membrane of an oral cavity to put locally in the form of appliques. A course of treatment — 7–10 days.

Chronic urogenital clamidiosis

Treatment of patients with urogenital clamidiosis is carried out by

in 2 steps:

1st stage — preparatory which includes reception of an enterosorbent, polyvitaminic medicines in therapeutic doses for 2 weeks. From the 10th day, immunotropny medicine Thymalinum on 10 mg in oil in the evening every other day, is appointed to a course — 5 injections;

2nd stage — the main during which basic therapy by antibacterial agents according to such scheme is carried out: the first antibiotic for 5 days; after a 7-day break the patient appoint other antibiotic for 10 days. During a break and after the termination of a course of antibacterial therapy Laferon-FarmBiotek on 1 million ME in oil 1 times a day in the evening, only 10 injections is appointed to a course.

during intake of antibacterial agents needs to take the antifungal medicaments (nystatin, flukonazol, Clotrimazolum) and gepatoprotektor (Silymarinum) in therapeutic doses.

• Damage of nervous system with mono - and a polyradicular pain syndrome: in oil 1 million ME in a dose, a course of 5-10 days at complex treatment.
• throat Papillomatosis: in oil (and whenever possible — perifokalno to the area of a throat) introduction Laferona-FarmBiotek in a dose of 100-150 thousand ME/kg of body weight daily within 20–25 days. Similar courses are recommended to be repeated with an interval of 1-1.5 months within half a year, and then — in 2–3 months within the next half-year. Laferonom-FarmBiotek it is reasonable to combine therapy with use of vitamin A (retinoids).
• Multiple sclerosis: 2–3 times, in oil on 1 million ME, a day within 10–15 days with the subsequent introduction on 1 million ME once a week within half a year.

skin Melanoma: in addition to surgical treatment and for induction of remission in/in on 20 million ME/m ² (infusion within 20 min.) 5 times a week during 4 weeks, maintenance therapy — p / to on 10 million ME/m ² 3 times a week (every other day) during 48 weeks

At development of heavy side effects, namely — at decrease in quantity of granulocytes (500/mm ³ ), increase in AlAT/AsAT (exceeding the upper bound of norm by 5 times) use of medicine to stop before normalization of indicators. To restore treatment in a half dose. If the intolerance remains, and the quantity of granulocytes decreases to 250/mm ³ or activity of AlAT and/or AsAT raises (exceeds the upper bound of norm by 10 times), medicine should be cancelled.

Uveal melanoma: parabulbarno daily on 1 million ME within 10 days; repeated 10-day introductions carry out in 20 days twice; the general course Laferona-FarmBiotek makes 30 million ME. Need of repeated courses in 45 days is not excluded; treatment Laferonom-FarmBiotek is combined with photodestruction of a tumor and beta applique.

kidney Cancer: as induction therapy on 10 million ME/m ² (up to 18 million ME/m ² / days) in oil or p / to; the specified doses to reach by increase each 3 days of the previous dose on 3 million ME/m ² (the first 3 days — on 3 million ME/m ² , the second 3 days — on 6 million ME/m ² , the third 3 days — on 9 million ME/m ² , etc. up to 18 million ME/m ² ); to adjust doses taking into account tolerance of medicine. At good tolerance the maximum dose — 36 million ME/m ² . Duration of induction therapy — 3 months then it is necessary to resolve an issue of medicament withdrawal or continuation of treatment in the presence of remission or stabilization of a state. At the supporting treatment to administer the medicament in the same doses on 3 times a week not less than 6 months

bladder Cancer: vnutripuzyrno 30–50 million ME weekly during 8–12 weeks at a carcinoma in situ, on 60–100 million ME — instillation weekly during 12 weeks. Before administration of medicine the patient has to abstain from intake of liquid during 8 h. Before medicine introduction the bubble should be emptied. To administer the medicament the sterile syringe through a catheter in a bladder cavity where it has to be during 2 h, at the same time each 15 min. the patient has to change position of a body (for the best interaction of medicine with a mucous membrane of a bladder). In 2 h the bladder should be emptied.

ovary Cancer: intraperitoneally during surgical intervention and in the next 5 days — in a drainage — on 5 million ME; further introduction Laferona-FarmBiotek — 3 million ME in oil within 10 days between chemotherapy courses; the general dose Laferona-FarmBiotek makes 90 million ME. The following courses can be appointed with an interval of 2-3 months within 1-1.5 years: 3 million ME daily 10 days.

Breast cancer: in oil, daily within 10 days on 3 million ME on an injection. Repeated courses are conducted during 1 year with an interval of 1.5-2 months, and then 2–3 months (depending on the clinical status); it is reasonable to alternate therapy courses Laferonom-FarmBiotek to chemotherapy courses (or radiation therapy).

Kaposi sarcoma. The following schemes of treatment are possible:

• in oil daily within 10 days of 3 million ME on an injection; treatment is combined with monochemotherapy Prospidinum; repeated courses — once a month within 6 months;
• in/in by drop infusion within 30 min. 50 million ME (30 million ME/m ² ) daily within 5 days or with an interval of 1 day then the 9-day break prior to the beginning of a new 5-day course is necessary a minimum; duration of treatment is determined by the doctor.

Multiple myeloma: in oil, daily within 10 days on 3 million ME on an injection, repeated courses — 1 time in 1.5-3 months (4–6 times within a year).

Chronic myeloid leukemia: p / to on 3 million ME/m ² / days daily or 1 time in 2 days, gradually raising a dose to 5 million ME/m ² / days daily or 1 time in 2 days under observation of the doctor to achievement of full hematologic remission (quantity of leukocytes in peripheral blood no more than 10·10 ⁹ / l) or during 18 months

Hairy cell leukemia: 3 times, in oil on 3 million ME, a week (every other day) during 4–6 weeks. At achievement of remission the maintenance therapy is carried out: 3 million ME every other day up to 12 months

Non-Hodgkin's malignant lymphomas: 3 times, in oil on 3 million ME, a week within 12–18 months as maintenance therapy at achievement of the remission received owing to application of chemotherapy. During partial remission use of other protocols of chemotherapy with the subsequent therapy Laferon-FarmBiotek on 3 million ME in oil 3 times a week within 18 months

is shown to

Bazalnokletochnaya a carcinoma: on 10 million ME (dissolved in 1 ml of water for injections) — in the basis and in a tumor (by means of the 1 ml syringe) if a zone of defeat of 2 cm ² to enter 0.15 ml of medicine (1,500,000 ME) 3 times a week (every other day) during 3 weeks. The total dose should not exceed 13,500,000 ME. If the area of defeat of 2-10 cm ² , the dose has to make 1,500,000 ME/cm ² (but not less than 15 million ME in the first injection). To enter 3 times a week during 3 weeks. In one stage to carry out treatment of one site of defeat. In the absence of positive dynamics (the outward, the amount of defeat, extent of reddening given to a biopsy) after 2–3 months of treatment to consider a question of surgical treatment of a disease.

T-cellular lymphoma (fungoid mycosis) in an ulceration stage: intradermalno (in a derma blanket, spots or ulcers are lower) on 1–2 million ME (dissolved in 0.5 ml of water for injections) the site of defeat to process 3 times a week during 4 weeks before introduction a cotton plug with alcohol. To enter solution of medicine a fine needle (30th caliber), using the 1 ml syringe. At introduction the needle has to be in almost parallel situation to a body surface. It is necessary to avoid deep — p / to introduction.

medicine solution Preparation. Solution of medicine is prepared just before its application. As solvent to use water for injections (if solution is prepared for p / to, boiled and smoked or introductions in oil). For solution preparation the contents of a bottle are dissolved in 1 ml of water for injections.

If solution of medicine to prepare

for intra belly or intravesical introduction, as solvent to use 0.9% chloride sodium solution (whom to take from calculation that concentration Laferona-FarmBiotek made not less than 300,000 ME/ml).

Preparation and carrying out in/in medicine infusion. In 30 min. prior to infusion Laferona-FarmBiotek to begin infusion 0.9 solutions of sodium of chloride (with a speed of 200 ml/h) and to finish it just before medicine introduction. For preparation of infusional Laferon-FarmBiotek solution at first to dissolve in water for injections (at the rate of 1 ml of water for injections on a dose of the administered drug), then the necessary amount of medicine to select and add 0.9% of solution of sodium of chloride to 50 ml. To enter the prepared solution in/in by drop infusion within 30 min. After completion of introduction Laferona-FarmBiotek it is necessary to continue infusion of 0.9% of solution of sodium of chloride with a speed of 200 ml/h within 10 min.

medicine Solution to apply to injections immediately. For intranasal application solution is used during 1 days on condition of storage at a temperature of 2-8 °C.

Contraindication

• Hypersensitivity to interferon alpha 2b or to other components of medicine; a serious illness of a cardiovascular system (including heart failure in decompensation stages, recently postponed myocardial infarction, heavy arrhythmia); heavy dysfunction of kidneys or liver; epilepsy and/or dysfunction of central nervous system (including functional); chronic hepatitis with dekompensirovanny cirrhosis; chronic hepatitis at patients who pass or recently received medical treatment for immunosuppressive medicines, except a short course of corticosteroids; autoimmune hepatitis or an autoimmune disease in the anamnesis; presence at the patient of dysfunction of a thyroid gland; presence of heavy visceral violations at patients with Kaposi sarcoma; psoriasis; pregnancy period (failure threat).

Side effects

Injection introduction laferona-pharmbiotek, as well as all other medicines of interferon the alpha, in most cases is followed by the grippopodobny syndrome which is characterized by fervescence, a fever, head and muscular pain, a joint pain, slackness. these side effects of a dozozavisima also, as a rule, are noted only in the first days of treatment, then weaken and disappear. these symptoms can be stopped or are considerably reduced by prescribing of paracetamol in a dose of 0.5-1 g in 30–40 min. prior to an injection. vomiting, dizziness, inflows can seldom be observed.

from a cardiovascular system: hypo - or hypertensia, tachycardia.

from skin and hypodermic cellulose: alopecia.

Allergic reactions: rash (including herpetic), an itch, hyperaemia, urticaria, an acute anaphylaxis.

from an endocrine system: dysfunction of a thyroid gland.

development of disorders of vision, electrolytic balance, function of a liver and kidneys Is possible

.

can be observed by

At long courses leucio- and thrombocytopenia which are eliminated with a medicine dose decline, nasal bleedings.

Mental violations: confusion of consciousness, alarming and depressions, hyperexcitability, drowsiness.

Disturbance from the central and peripheral nervous system: ataxy, paresthesias.

Disturbance from a respiratory system: cough.

Special instructions

Laferon-pharmbiotek should be applied under observation of the doctor. patients should be informed on advantages of this therapy and possible side reactions.

If side effect does not weaken or amplifies, the dose is reduced to 50% or treatment is stopped. Depending on individual sensitivity and the appointed medicine dose at patients the slowed-down speed of psychomotor reactions — drowsiness, weakness, increased fatigue can be observed.

alcohol intake has to be excluded by

At medicament treatment.

Before prescribing of medicine it is long in doses of 3 million ME and above the research of function of a thyroid gland is recommended. Drug can begin to be used provided that the level of thyroid stimulating hormone (TSH) is in norm limits. If changes of the TSH level are revealed, it is necessary to carry out the corresponding therapy and to begin treatment Laferonom-FarmBiotek provided that the TSH level manages to be supported at the normal level. In the course of treatment it is also reasonable to control the TSH level.

function of a thyroid gland which is increased as a result of administration of medicine is not restored by

After the therapy termination.

to All patients before the beginning and regularly during treatment needs to carry out by

developed analysis of peripheral blood with an obligatory qualitative and quantitative research of indicators of blood and also biochemical analysis of blood, including determination of content of electrolytes, calcium, liver enzymes and creatinine.

periodic control of function of kidneys is necessary for

In a multiple myeloma.

At all patients receiving medicine needs to control carefully albumine level in blood plasma and a prothrombin time.

At patients after organ transplantation or marrow the medicamentous immunosuppression can be less effective as interferona make the stimulating impact on the immune system.

should appoint by

With care medicine in the presence in the anamnesis of such diseases as diabetes with episodes of ketoacidosis and chronic obstructive diseases of lungs, at violations of blood clotting expressed to myelosuppression.

needs to provide to

At medicament treatment adequate hydration of an organism; at manifestations of fever it is necessary to exclude other reasons of its emergence.

recommends to use

medicine against the background of antihistaminic and febrifugal therapy.

Instruction on direct cardiotoxicity of interferon are absent, however there is a probability that existence of a hyperthermia and fever which often accompany treatment can cause exacerbation of the available heart diseases. In the presence in the anamnesis of chronic heart failure, myocardial infarction and/or the previous or existing arrhythmias the treatment by interferon alpha 2b should be carried out under stringent control of the doctor.

When performing combination therapy with ribaviriny needs to consider precautionary measures for a ribavirin.

Use of medicine during pregnancy is justified by

only if the advantage of the carried-out therapy exceeds possible risk for a fruit.

At development of reaction of immediate hypersensitivity (urticaria, a Quincke's disease, a bronchospasm, an anaphylaxis) medicine should cancel and take the appropriate measures immediately.

Use of medicine to stop

in cases of lengthening of a blood clotting time (at patients with chronic hepatitis), manifestations of a pulmonary syndrome and radiological identification of infiltrate, appearance or increase in severity of disorders of vision, dysfunction of a thyroid gland (TSH aberration), decrease in level of albumine in serum of blood and a prothrombin time.

Means does not contain preservatives therefore in order to avoid bacterial pollution it is recommended to apply solution to parenteral administration immediately.

Use during pregnancy and feeding by a breast. During pregnancy and feeding by a breast use of medicine is contraindicated.

Children. It is applied in pediatric practice at a SARS at children, including at newborns, a sharp diarrheal syndrome at newborn, sharp intestinal infections at children of early age with the hypocoagulation phenomena, sharp herpetic stomatitis at children (see USE).

Ability to influence speed of response at control of vehicles or other mechanisms. Depending on a dose, the scheme and individual sensitivity to interferon the alpha treatment can be followed by drowsiness, weakness, increased fatigue and to lead to reduction in the rate of psychomotor reactions.

As interferon the alpha changes

Interaction

cellular metabolism, there is potentiality of modification of effect of other medicines. oxidizing metabolic processes can change, it should be considered at co-administration of medicines which are metabolized in this way (Cimetidinum, Phenytoinum, warfarin, theophylline, Aminophyllinum, diazepam, propranolol). concentration of theophylline in blood plasma needs to be controlled and if necessary to adjust the dosing mode.

With care should use medicament along with the opioid medicines, analgetics, hypnotic medicaments and sedative medicines (which are potentially causing myelosuppressive effect).

At use of medicine in a combination with chemotherapeutic medicines (Cytarabinum, doxorubicine, tenipozid, cyclophosphamide) risk of development of life-threatening toxic effects (their weights and duration) increases.

Synergism of side effects (concerning quantity of leukocytes) is described by

at the combined prescribing of interferon an alpha and a zidovudine. At the patients who received these medicines at the same time the frequency of development of a neutropenia was higher, than at treated only by a zidovudine.

by

Overdose

did not describe overdose cases laferona-pharmbiotek So far. however as well as at overdose of any medicine are recommended symptomatic therapy with observation of functions of vitals and monitoring of a condition of the patient.

Storage conditions

At a temperature of 2-8 °C.