Altevir

General characteristics. Structure:

Active agent: 1, 3, 5, 10 million ME of interferon alpha 2b human recombinant.

Excipients: sodium acetate of 0,00164 g, sodium chloride of 0,005844 g, dinatrium of an edetat a dihydrate of 0,000075 g, polysorbate - 80 0,0001 g, a dextran the 40th solution for infusions of 10% 0,05 g, water for injections to 1,0 ml.

Pharmacological properties:

Альтевир®, solution for injections, represents interferon alpha 2b the human recombinant, received from cells Escherichia coli which genetic device the gene of human interferon alpha 2b is built in. The peptide sequence of a molecule, biological activity and the main pharmacological properties of recombinant protein and human interferon alpha 2b are identical.

Альтевирâ renders antiviral, immunomodulatory, anti-proliferative and antineoplastic action. Interferon alpha 2b, interacting with specific receptors on a cell surface, initiates the difficult chain of changes in a cell including induction of synthesis of a number of specific cytokines and enzymes breaks synthesis of virus RNA (RNA) and proteins of a virus in a cell. The nonspecific antiviral and anti-proliferative activity connected with prevention of replication of a virus in a cell, braking of proliferation of cells and immunomodulatory effect of interferon is result of these changes. Interferon alpha 2b stimulates process of the presentation of antigen to immunocompetent cells, has ability to stimulate phagocytal activity of macrophages, and also cytotoxic activity of the T-cells and "natural killers" participating in virus-induced immunity. Prevents proliferation of cells, especially tumoral. Exerts the oppressing impact on synthesis of some oncogenes leading to inhibition of tumoral growth.

Pharmacokinetics. At п / to or administration of interferon in oil alpha 2b bioavailability makes it from 80% to 100%. Time of achievement of Cmax makes 4-12 h, T1/2 is 2-6 h respectively. After introduction recombinant interferon in blood serum is not defined by 16 - 24 h. Metabolism is carried out in a liver. Interferona an alpha can break oxidizing metabolic processes, reducing activity of "hepatic" microsomal enzymes of system of P450 cytochrome. Are removed generally by kidneys by glomerular filtering.

Indications to use:

Альтевирâ it is applied in complex therapy at adults:
- at a chronic viral hepatitis In without symptoms of cirrhosis;
- at a chronic viral hepatitis With in lack of symptoms of a liver failure (monotherapy or a combination therapy with ribaviriny);
- at a throat papillomatosis, sharp-pointed condylomas;
- at a hairy cell leukosis, a myelosis, a nekhodzhkinsky lymphoma, a melanoma, a multiple myeloma, Kaposha's sarcoma at patients with AIDS, the progressing kidney cancer.

Route of administration and doses:

Depending on indications to use the drug Altevir® is administered subcutaneously, intramusculary and intravenously. Treatment has to be begun by the doctor. Further with the permission of the doctor can enter a maintenance dose of the patient to itself independently (in cases when drug is appointed subcutaneously or intramusculary).

Chronic hepatitis C: Альтевирâ enter п / to or in oil 3 million ME in a dose 3 times a week within 24-48 weeks. At patients with a recurrent current is a disease and the patients who were earlier not receiving treatment of an interferonama alpha 2b, efficiency of treatment increases when using a combination therapy with ribaviriny. Duration of a combination therapy is not less than 24 weeks. Patients with the 1st genotype of a virus of chronic hepatitis C and high virus loading at which by the end of the first 24 weeks of treatment in blood serum hepatitis C virus RNA is not defined therapy of Альтевиромâ should spend 48 weeks.

Chronic hepatitis B: Альтевирâ enter п / to or in oil 5-10 million ME in a dose 3 times a week within 16-24 weeks. In the absence of positive dynamics (according to hepatitis B virus DNA definition) after 3-4 months of use treatment is stopped.

Throat papillomatosis: Альтевирâ enter п / to in a dose of 3 million ME/sq.m 3 times a week. Treatment there begin after surgical (or laser) removals of tumoral fabric. The dose is selected taking into account portability of drug. Achievement of affirmative answer can demand performing treatment within 6 months.

Sharp-pointed condylomas: Альтевирâ enter п / to in a dose of 3 million ME/sq.m 3 times a week. Treatment is begun after surgical or laser removal of condylomas. Achievement of affirmative answer can demand performing treatment within 6 months.

Hairy cell leukosis: the recommended dose of Альтевираâ for п / to introduction to patients after a splenectomy or without it makes 2 million ME/sq.m 3 times a week. In most cases normalization of one and more hematologic indicators occurs in 1-2 months of treatment. It is necessary to adhere to this mode of dosing constantly if at the same time there is no bystry progressing of a disease or emergence of symptoms of heavy intolerance of drug.

Myelosis: the recommended dose of Альтевираâ as monotherapy - 4-5 million ME/sq.m a day п / to daily. If treatment allows to achieve control of number of leukocytes, then for maintenance of hematologic remission drug should be used in the maximum tolerable dose (4-5 million ME/sq.m daily). If therapy in 8-12 weeks did not lead to partial hematologic remission or clinically significant decrease in number of leukocytes, drug needs to be cancelled.

Nekhodzhkinsky lymphoma: Альтевирâ use as adjuvant therapy in a combination with standard schemes of chemotherapy п / to in a dose of 5 million ME/sq.m 3 times a week within 2-3 months. The dose needs to be adjusted depending on portability of drug.

Melanoma: Альтевирâ apply as adjuvant therapy at the available high risk of a recurrence after an oncotomy in a dose 15 million ME/sq.m intravenously 5 weekly within 4 weeks, then п / to in a dose of 10 million ME/sq.m 3 times a week during

48 weeks. The dose needs to be adjusted depending on portability of drug.

Preparation of solution for in/in introductions: gain the Альтевираâ solution volume necessary for preparation of a required dose, add sterile 0,9% of solution of sodium of chloride to 100 ml and enter within 20 min. Solution is prepared just before implementation of the procedure of intravenous administration, this solution is not subject to storage.

Multiple myeloma: Альтевирâ appoint during achievement of steady remission in a dose 3 million ME/sq.m 3 times a week п / to.

Kaposha's sarcoma at patients with AIDS: the optimum dose is not established. It is possible to use drug in doses 10-12 million ME/sq.m a day п / to or in oil. In case of stabilization of a disease or positive dynamics, therapy is continued until there is a regress of a tumor or drug withdrawal will not be required.

Kidney cancer. The optimum dose and the scheme of use are not established. It is recommended to apply п / to in doses from 3 to 10 million ME/sq.m 3 times a week.

Features of use:

In case of side effects during treatment of Альтевиромâ the dose of drug should be lowered by 50% or to temporarily cancel drug before their disappearance. If side effects remain or arise after a dose decline again, or progressing of a disease is observed, then treatment of Альтевиромâ should be stopped.

At decrease in level of thrombocytes below 50×109/л or the level of granulocytes below 0,75×109/л reduction of a dose of Альтевираâ twice with performing blood test in 1 week is recommended. If the specified changes remain, Altevir® should be cancelled.

At decrease in level of thrombocytes below 25×109/л or the level of granulocytes below 0,5×109/л drug withdrawal with control of blood test in 1 week is recommended.

Prior to treatment of Альтевиромâ of a chronic viral hepatitis In and With it is recommended to carry out a liver biopsy to estimate a liver damage rate (signs of active inflammatory process and/or fibrosis). Efficiency of treatment of chronic hepatitis C increases at a combination therapy of Альтевиромâ and ribaviriny. Use of Альтевираâ is not effective at development of dekompensirovanny cirrhosis or a hepatic coma.

The patients receiving drugs of interferon alpha 2b in blood serum can have antibodies neutralizing its antiviral activity. Practically in all cases antiserum capacities are low, their emergence does not lead to decrease in efficiency of treatment or emergence of autoimmune disorders.

In case of the admission of a dose of an injection continue, observing an interval of introduction and not increasing the subsequent dose.

INFLUENCE ON ABILITY TO MANAGE VEHICLES AND MECHANISMS
Альтевир® exerts insignificant impact on ability to driving of vehicles and work with cars and mechanisms. When developing dizziness, drowsiness, confusion of consciousness and weakness it is necessary to refuse driving of the vehicle or work with cars and mechanisms.

Side effects:

Grippopodobny symptoms
Most often at the beginning of use of the drug Альтевирâ the grippopodobny syndrome, characteristic of interferon (fever, a fever, a headache, muscular and/or joint pains, weakness, nausea) can be observed. These manifestations are usually moderately expressed, are observed in an initiation of treatment and decrease at treatment continuation.

Reactions from the alimentary system
Vomiting, dryness in a mouth, change of taste, an abdominal pain, dyspepsia, appetite loss, decrease in body weight are seldom noted.

Reactions from a nervous system
Irritability, nervousness, dizziness, sleeplessness, depression, suicide thoughts and attempts, adynamy, drowsiness, indisposition, uneasiness are seldom noted.

Reactions from cardiovascular system.
The lowering of arterial pressure, tachycardia are seldom noted.

Reactions from skin and hypodermic cellulose
Seldom at prolonged use of drug Altevir development of an alopecia, the increased sweating, skin rash, a skin itch is possible.

Reactions from a musculoskeletal system
Arthralgias are very seldom noted.

Reactions from endocrine system
Interferona can exert impact on function of a thyroid gland, very seldom causing development of an autoimmune thyroiditis. Against the background of prolonged use of drug Altevir it is necessary to control once in 6 months indicators of hormones of a thyroid gland.

Deviations of laboratory indicators
Changes of laboratory indicators can seldom be observed: leukopenia, granulocytopenia, decrease in hemoglobin, thrombocytopenia, increase in activity of liver enzymes. These changes are dozozavisimy and reversible and disappear within 72 hours after a break in treatment or its terminations.

Interaction with other medicines:

Interaction of Altevira® with other medicines is completely not studied. With care it is necessary to apply Altevir® at the same time with the hypnotic drugs and sedatives, narcotic analgetics and drugs rendering myelosuppressive effect.

At simultaneous use of Altevira® and theophylline it is necessary to control concentration of the last in blood serum and if necessary to change the mode of its dosing.

At use of Altevira® in a combination with chemotherapeutic drugs (Cytarabinum, cyclophosphamide, doxorubicine, тенипозид) the risk of development of toxic effects increases.

Contraindications:

Hypersensitivity to recombinant interferon alpha 2b or to any of drug components. A serious cardiovascular illness in the anamnesis (uncontrollable chronic heart failure, the myocardial infarction postponed within the last 6 months, the expressed disturbances of a cordial rhythm). A heavy renal and/or liver failure, including, caused by existence of metastasises. The epilepsy and other heavy disturbances of functions of the central nervous system which are especially expressed a depression, suicide thoughts and attempts (including, in the anamnesis). Chronic hepatitis with dekompensirovanny cirrhosis.

The treatment which is carried out or carried out within the last 6 months immunodepressive medicines, apart from a complete short-term course of treatment glucocorticosteroids.

Autoimmune hepatitis or other autoimmune disease, the disease of a thyroid gland which is not giving in to control by the standard therapeutic methods.

Dekompensirovanny diseases of lungs, including, a chronic obstructive pulmonary disease, a dekompensirovanny diabetes mellitus, hypercoagulation, including, at thrombophlebitis, a thromboembolism of a pulmonary artery.

The expressed miyelosupressiya.

Pregnancy and period of breastfeeding.

Children's age up to 18 years.

PREGNANCY AND PERIOD OF FEEDING BY THE BREAST
The drug Альтевирâ is not used during pregnancy and breastfeeding.

Overdose:

In clinical trials cases of inadvertent overdose were not registered. In case of exceeding of a dose, including increase in one-time volume or frequency of inclusion in week, immediately tell the doctor. In case of overdose the patient has to be hospitalized for observation and carrying out in need of a maintenance therapy.

Storage conditions:

To store according to the joint venture 3.3.2-1248-03, at a temperature from 2 to 8 °C, in the place, unavailable to children. Not to freeze. Short-term storage within 10 days at a temperature not above 25 °C is allowed.

Transportation at a temperature from 2 to 8 °C. Not to freeze. Short-term transportation within 10 days at a temperature not above 25 °C is allowed.

Issue conditions:

According to the recipe

Packaging:

Solution for injections 1, 3, 5, 10 million ME/ml.

In hermetically soldered colourless glass ampoules on 1 ml containing 1, 3, 5, 10 million ME/ml. On 5 ampoules in a blister strip packaging; 1 blister strip packaging in a cardboard pack.

In sterile glass syringes injection with the pasted needle and a protective cap from polypropylene with an insert from rubber on 1 ml containing 3 million ME/ml. On 1 filled syringe in a blister strip packaging, 1 blister strip packaging in a cardboard pack.

In each pack of a vklozhen application instruction.