БЕТФЕР®-1b

General characteristics. Structure:

The ampoule or bottle operating veshchestva:1 contains 0.3 mg (9 600 000 ME) of recombinant interferon beta-1 b; 1 ml of solution contains 0.25 mg (8 000 000 ME) of recombinant interferon beta-1 b;

excipients:: glucose monohydrate, albumine of human 20%;

Main physical and chemical properties: powder from white till beige color, free from alien particles;

Pharmacological properties:

Has antiviral and immunomodulatory effect. Activity of interferon a beta – 1b is species-specific. Mechanisms of effect of interferon a beta – 1b at multiple sclerosis are not finalized. However it is known that the biological effect of Interferon a beta – 1b is caused by its interaction with the specific receptors revealed on a surface of cells of the person. Interferon binding the beta – 1b with these receptors induces an expression of a number of substances which are considered as mediators of biological effects of interferon a beta - 1b. Interferon a beta – 1bsnizhayet the connecting ability and an expression of receptors to interferon scale, strengthens their disintegration. Besides, interferon a beta – 1bpovyshayet suppressor activity of mononuclear cells of peripheral blood.

Use of drug at multiple sclerosis allows to detain further progressing of a disease and approach of disability, including heavy, for up to 12 months. This effect is observed at patients both with exacerbations of diseases, and without them, and also slyuby degree of an invalidism. Patients with assessment to 5.5 points on EDSS scale took part in researches. Both at remmitiruyushchy, and at repeatedly - the progressing multiple sclerosis, lecheniyepreparaty reduces frequency and disease tyazhestyobostreniye, gospitalizatsiya number потребностьв treatment by steroids, and also extends remission duration.

Indications to use:

Multiple sclerosis with a recurrent remmitiruyushchim current type which is characterized not less than two aggravations within 2 previous years and lack of signs of its continuous progressing current between a recurrence with full or incomplete updating of neurologic deficit. Secondary - the progressing multiple sclerosis with the active course of a disease which is characterized by an aggravation or considerable deterioration in neurologic functions for the last two years.

Route of administration and doses:

8 000 000 ME of interferon a beta – 1b (1mlprigotovlennogo solution) vvodyatpodkozhno, every other day. For receiving solution of drugs the ampoule or a bottle with Betferom®-1b are entered by 1,2 ml of solvent (0,54% r-rnatriyakhlorida). Powder has to be dissolved entirely without stirring; before use it is necessary to examine ready solution. In the presence of particles or discoloration solution cannot be applied.

Vdanny time remains unresolved a therapy duration question nterferony beta 1b. In controlled clinical trial the effect of treatment remained on протяжениевсех 3 years of observations.

Features of use:

Patients should be informed that side effects of interferon beta-1 b can be a depression and suicide thoughts with the advent of which it is necessary to see a doctor immediately. In rare instances these sostoyaniyamonut to lead to suicide attempts. In the presence of a depression and suicide thoughts it is necessary to stop treatment immediately.

At patients with a depression, at persons in whose anamnesis there is an instruction on a depression or spasms and also at patients who receive antiepileptic means, drug should be used with care.

Interferon beta 1b should be applied with care at patients with heart diseases, in particular, at patients with heart failure of a ІІІ-Ivfunktsionalny class on classification of NÝHA and ubolny with cardiomyopathies. If communication of a cardiomyopathy which developed in the course of treatment, using interferon beta 1b is supposed, drug should be cancelled.

To purpose of drug and against the background of treatment it is necessary to carry out regularly developed blood test, including definitions of a leukocytic formula, and also to define activity of nuclear heating plant, ATT and γ-glutamiltransferaza. In case of increase in activity of transaminases in blood serum it is necessary to make careful observation and inspection of the patient. Drug needs to be cancelled at substantial increase of activity of liver enzymes or emergence of symptoms of hepatitis. In the absence of clinical signs of injury of a liver, after normalization of activity of pechenochnykhferment it is possible to try to recover therapy under careful control of function of a liver. There are no clinical data on use of drug for patients with the broken function of a liver or kidneys.

In isolated cases the pancreatitis which is often caused by a gipertriglitseridemiya was observed.

In clinical trials at 41% of patients with remmitiruyushchy multiple sclerosis emergence of serumal neutralized antibodies to interferon beta 1b was noted (two consecutive caption ≥ 20). In a research at patients spovtorno emergence of neutralized antibodies is revealed by the progressing multiple sclerosis in 28% of cases. Influence of antibody formation on clinical performance of interferon beta 1b is studied at present. The available results are contradictory and do not allow to draw an unambiguous conclusion. Signs of negative influence of neutralized antibodies on disease at repeatedly - the progressing multiple sclerosis are not revealed.

In vitro is established that neutralized antibodies against recombinant interferon beta 1b interact also sprirodny interferon a beta, though to a lesser extent. In vivo this effect was not studied therefore clinical it znacheniyeneizvestno.

Data obolny which completed therapy by interferon beta 1b despite emergence of neutralized antibodies, are not numerous and unconvincing.

At patients who received interferon beta 1b necrosis cases in the place of an injection are described. With the advent of the multiple ilibolshy centers of a necrosis lecheniyesledut to stop before their full healing. In the presence of one center and otsutstviye of a big necrosis treatment can be continued.

To reduce risk of development of a necrosis in the place of an injection, to sleduyetstrogosoblyudat pravilaaseptik when performing injections, and also to constantly change places of an injection.

It is necessary to adhere to care at treatment at patients with a miyelosupressiya, anemia or thrombocytopenia. There are separate messages on development of a cardiomyopathy. If communication of a cardiomyopathy with drug is provided, treatment should be stopped. Use of cytokines for patients with a monoclonal gammapathy sometimes was followed by system increase in permeability of capillaries with shocklike symptoms and a lethal outcome.

It is unknown whether interferon is capable beta 1b to cause damage of a fruit at treatment of women впериод pregnancies or / ивлиять on reproductive function of the person. In controlled clinical trials at patients with a srasseyanny sclerosis misbirth cases were noted. At researches at macaques a Rhesus factor interferon beta-1 b had embriotoksichesky effect, and in higher doses increased the frequency of abortions. So, interferon beta-1 b, is contraindicated during pregnancy. Women of reproductive age at treatment by this drug should use reliable methods of contraception. In case of approach of pregnancy during treatment or pregnancy planning the woman следуетинформироватьо potential risk and to recommend the treatment termination. It is unknown whether interferon beta 1b is emitted to sg with ore milk. Considering potentiality of development of serious undesirable reactions to interferon beta 1b at children of chest age, it is necessary to stop feeding by a breast or to cancel drug.

Efficiency and safety of use of interferon beta 1b for children and teenagers up to 18 years were not studied, in this regard patients of this age group should not appoint drug.

Side effects:

The leukopenia, lymphopenia, neutropenia, anemia, thrombocytopenia are possible. In редкихслучаях the expressed thrombocytopenia, сообщалосьо development of a cardiomyopathy was noted; pain behind a breast, was takhikardiyait palpitation.

In rare instances against the background of treatment preparatomotmechatsya dysfunction of a thyroid gland (a hyperthyroidism, and also a hypothyroidism). Nausea and vomiting are possible. In isolated cases it was observed панкреатитчасто caused by a gipertriglitseridemiya. Grippopodobny symptoms (fever, a fever, mialgiya, a febricula, perspiration), an adynamy are frequent. There can be heavy reactions of hypersensitivity (in редкихслучаях such reactions as a bronchospasm, an anaphylaxis and urticaria are observed). When using drug in the recommended dose it can be observed povysheniyeaktivnost of nuclear heating plant, γ-glutamiltransferaza ALTI; cases of hepatitis of presumably medicinal etiology are described. At treatment drug in certain cases observed a hypocalcemia and a hyperuricemia, in редкихслучаях — a gipertriglitseridemiya, short wind, a depression, feeling of alarm, emotional lability, depersonalization, spasms, suicide tendencies and confusion of consciousness. Cases of increase in a muscle tone are known. Women who did not reach a menopause can have disturbances of a menstrual cycle. Separate cases of an asthma after drug injections are described. The alopecia is seldom observed. Local reactions in the form of a hyperemia, hypostases, discoloration of skin, an inflammation, pain, hypersensitivity, a necrosis, a lymphadenopathy. Over time at treatment continuation the frequency of reactions in a drug injection site usually decreases.

Interaction with other medicines:

Influence of drug in a dose of 8 000 000 ME every other day on metabolism of medicinal substances at patients with a srasseyanny sclerosis it is not studied. At treatment of exacerbations of a disease patients who received drug had a good portability of corticosteroids or AKTG which applied courses up to 28 days. Use of drug along with other immunomodulators, except corticosteroids or AKTG, was not studied.

Interferona reduce activity hepatic cytochrome, P450-dependent enzymes at the person and animals. It is necessary to adhere to care at purpose of drug in a combination with medical supplies which have a narrow therapeutic index which clearance substantially depends otpechenochny system of P450 cytochrome (for example, antiepileptic means). It is also necessary to adhere to care at simultaneous use with any drugs which influence system of a hemopoiesis.

Contraindications:

The pregnancy period, the feeding period a breast, reactions of hypersensitivity to natural or recombinant interferon - a beta or human albumine in the anamnesis, tyazhelyedepressivny states and / илисуицидальные attempts in the anamnesis, a liver disease in a decompensation phase, epilepsy which adequately is not controlled.

Overdose:

It is not established.

Storage conditions:

The extra available to children, dry, protected from light place, at a temperature from 2 °C to 8 °C. A period of storage of the prepared solution – till 3 o'clock at a temperature of 2 °C - 8 °C.

Issue conditions:

According to the recipe

Packaging:

Poroshokpo of 0.3 mg (9 600 000 ME) of antiviral activity in ampulakhil bottles No. 10 complete with solvent (sodium chloride of 0,54%) on 2 ml in ampoules or bottles No. 10 in a pack with a corrugated partition or a polymeric insert from a film polyvinyl chloride.