Название документа
  • Laferobion liof. for solution for infection. 3 million ME fl. No. 10

Pharmacological properties

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

Has anti-proliferative effect on tumor cells and also has antiviral and immunomodulatory effects. Effect of interferon alpha 2b is shown by its linking with specific receptors on a superficial membrane of cell and initiation of a complex of the consecutive intracellular reactions connected with induction of a number of enzymes and implementation of cellular functions namely: with suppression of replication of a virus in the infected cell and decrease in proliferation of tumor cells; with implementation of immunomodulatory processes (strengthening of phagocytal activity of macrophages, increase in specific cytotoxicity of lymphocytes to target cells).

Indication

Drug is used in complex therapy at adults and children at:

  • an acute and chronic viral hepatitis In (medium-weight and severe forms);
  • chronic hepatitis C;
  • sharp and chronic septic diseases of the virus nature;
  • sharp virus, bacterial and multi-infections, including at newborns;
  • sharp and chronic septic diseases of a virus and bacterial etiology, including dessiminirovanny forms sharp and a hroniosepsisa;
  • a herpes infection of various localization (shingles, multiple skin herpetic rashes, genital herpes, a herpetic keratoconjunctivitis also keratouveit);
  • throat papillomatosis;
  • multiple sclerosis;
  • to a malignant melanoma, a uveal melanoma, a nephrocellular carcinoma, superficially localized bladder cancer, cancer of an ovary and mammary gland, Kaposi sarcoma against the background of HIV infection, a myelosis, a hairy cell leukosis, non-Hodgkin's lymphomas, a bazalnokletochny carcinoma, the T-cellular lymphoma of skin (fungoid mycosis).

Use

Drug is used in the form of solution. solution of a laferobion is entered in/in (by drop infusion), in oil, p / to, vnutrikozhno, intraperitoneally, vnutripuzyrno, rektalno, intranazalno, subkonjyunktivalno.

Laferobion of 100,000 ME for intranasal application

a SARS at children, including at newborns

Intranazalno's

on 4–6 drops in each nasal course of 3-6 times a day within 3–5 days; a medicine dosage for newborns — 20 000–50 000 ME/ml, for other children — 100,000 ME/ml. Introduction to the nasal courses (serially) cotton turundas moistened with Laferobiona solution for 10–15 min.

is admissible

a SARS at adults

Intranazalno's

on 0.25 ml of Laferobiona solution (100,000 ME/ml) in each nasal course of 6-8 times a day. Before application the entered Laferobiona solution should be warmed up in the syringe (to use the syringe without needle) to body temperature, to store residue of solution in the fridge, protecting from bacterial pollution.

Sharp diarrheal syndrome at newborns

Rektalno's

in the form of the daily microclysters containing 100,000 ME Laferobiona within 3–7 days.

Acute intestinal infections at children of early age with the hypocoagulation phenomena

Rektalno's

in a dose of 10,000 ME/kg 3-multiply with an interval of 48 h

It is purulent - septic diseases, peritonitis, multiple abscesses of an abdominal cavity

In/in on 2–4 million ME of 1 times in day; a total dose on a course — 12–16 million ME; reasonablly simultaneous endolymphatic introduction of medicine in the same dose — 2–4 million ME of 1 times a day.

Herpetic keratoconjunctivitis: burying on 2–3 drops of Laferobiona solution (1 million ME in 5 ml of isotonic solution) each 2 h within 7–10 days; in process of disappearance of symptoms of a disease, medicament can be used less often.

Laferobion for parenteral application

Acute viral hepatitis In

In oil introduction on 1 million ME (in hard cases — on 2 million ME) 2 times a day for 10 days. Further depending on the clinical status of the patient the course of treatment can be prolonged up to 2–3 weeks according to this scheme or be carried out in a dose of 1 million ME 2 times a week within several weeks.

Chronic viral hepatitis In

In oil introduction on 3–4 million ME 3 times a week within 2 months

Chronic viral hepatitis of C

P / to introduction on 3 million ME 3 times a week are (every other day) combined by

with ribaviriny or as monotherapy (in the presence of contraindications or at intolerance of a ribavirin). A course of treatment — 3–4 months then carry out HCV RNA definition. Therapy is continued in case of negative take (HCV RNA is not revealed).

At monotherapy the course of treatment by Laferobion makes 12–18 months, in a combination with ribaviriny — 6 months; at a genotype of 1 virus and high level of virus DNA in blood serum prior to therapy in case of absence in HCV RNA blood serum by the end of 6 months of treatment it is possible to continue combination therapy 6 more months, in view of such burdening factors as age 40 years, a male, the progressing fibrosis are more senior.

Herpes infections

Shingles: daily 1 million ME in oil + 2 million ME in 5 ml of isotonic solution of sodium of chloride 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 (appliques) on herpetic papules.

Genital herpes: daily introduction in oil in a dose of 2 million ME in combination with topical administration of medicine in the form of appliques on area of rashes.

throat Papillomatosis: p / to on 3 million ME/m 2 3 times a week (every other day) within 6 months and more.

Dose is korrigirut taking into account tolerance of medicine, treatment is begun after removal surgical (by means of the laser) by tumoral fabric.

Multiple sclerosis

In oil on 1 million ME 2–3 times a day within 10–15 days with the subsequent introduction on 1 million ME once a week within half a year.

Malignant melanoma: as addition to surgical treatment and for induction of remission enter in/in 20 million ME/m 2 in day (infusionally within 20 min.), 5 times a week during 4 weeks. Maintenance therapy — p / to on 10 million ME/m 2 3 times a week during 48 weeks

At development of heavy side effects, namely: at a granulocytopenia (granulocytes of 500/mm 3 ), increase in levels of AlAT/AsAT in blood serum (is 5 times higher than the upper bound of norm) — use of medicine stop before normalization of indicators. Treatment is resumed in a half dose. During the maintaining intolerance of medicine and decrease in quantity of granulocytes to 250/mm 3 or increase in activity of AlAT and/or AsAT in blood serum (is 10 times higher than the upper bound of norm) cancel medicine.

Uveal melanoma: (at treatment by Laferobion in combination with photodestruction of a tumor and beta applique) — parabulbarno daily on 1 million ME medicine (divorced in 1 ml of water for injections) within 10 days; repeated 10-day introductions are carried out in 20 days twice; the general course of treatment — 48 weeks. Need of carrying out repeated courses in 45 days is not excluded.

Nephrocellular carcinoma: in oil on 3 million ME, daily within 10 days; the total dose on a course of treatment makes 30 million ME; repeated courses are conducted with an interval of 3-5 weeks within half a year, and then with an interval of 1.5-2 months within a year.

as induction therapy are entered in oil or p / to on 10 million ME/m 2 (up to 18 million ME/m 2 / by days). These doses are reached by increase in the previous dose every 3 day 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 next 3 days — on 9 million ME/m 2 and further to achievement of a dose of 18 million ME/m 2 ). Dose adjustment is carried out taking into account tolerance of medicine. At good tolerance the maximum dose makes 36 million ME/m 2 , duration of induction therapy — 3 months then resolve an issue of medicament withdrawal or continuation of treatment in the presence of remission or stabilization of a state. At maintenance therapy the medicament is administered in the same doses by 3 times a week not less than 6 months

Superficial localized bladder cancer: intravesical instillations in a dose of 30-50 million ME weekly during 8–12 weeks. In a carcinoma in situ enter 60–100 million ME on instillation weekly during 12 weeks. Before administration of medicine the patient has to abstain from intake of liquid during 8 h; before introduction of medicine it is necessary to empty a bladder. Laferobion enter the sterile syringe through a catheter into a bladder cavity where it has to be during 2 h, at the same time each 15 min. the patient should change position of a body (for the best soprikasayemost of medicine with a mucous membrane of a bladder), in 2 h the bladder needs to be emptied.

ovary Cancer: intraperitoneally during surgical intervention and in the next 5 days in a drainage — on 5 million ME; further introduction of Laferobion — in oil on 3 million ME within 10 days between chemotherapy courses; the total course dose of Laferobion makes 90 million ME. It is possible to appoint the subsequent courses at an interval of 2–3 months for 1-1.5 years: 3 million ME daily within 10 days.

Breast cancer: in oil daily within 10 days on 3 million ME. Repeated courses are conducted within a year with intervals of 1.5-2 months, and then — 2–3 months (depending on the clinical status); it is reasonable to alternate courses of therapy by Laferobion to courses khimio- or radiation therapy.

Kaposi sarcoma against the background of HIV infection: enter in oil daily within 10 days on 3 million ME; treatment is combined with chemotherapy Prospidinum; repeated courses — once a month within half a year or in/in by drop infusion within 30 min. — on 50 million ME (30 million ME/m 2 ) daily within 5 days in a row or at an interval of 1 day then it is necessary to take a break not less than 9 days prior to the beginning of the following 5-day course. This mode of introduction can last the unlimited period, except for cases of fast progressing of a disease or the expressed intolerance of medicine.

Myelosis: enter p / to 5 million ME/m 2 in day daily to achievement of full hematologic remission (quantity of leukocytes in peripheral blood — no more than 10·10 9 / l) or during 18 months; at achievement of full hematologic remission the therapy is continued before full cytogenetic remission (at some patients it is reached only in 1-2 years after the beginning of therapy). Treatment needs to be begun as soon as possible. At quantity of leukocytes it is higher than 50·10 9 / l treatment can be begun with hydroxurea in a standard dose, and then to pass to Laferobion's application.

Hairy cell leukosis: in oil or p / to on 2–3 million ME/m 2 before achievement of a condition of remission, further — 3 times a week every other day. Treatment duration — on average 12 months. The dose is korrigirut taking into account tolerance of medicine.

Non-Hodgkin's lymphomas: enter in oil or p / to 5 million ME/m 2 3 times in a week (in addition to chemotherapy) or on 3 million ME 3 times in a week for 12–18 months (as maintenance therapy at achievement of remission owing to the carried-out chemotherapy).

Bazalnokletochnaya carcinoma: on 10 million ME (dissolved in 1 ml of water for injections) — in the basis and in depth of a tumor (by means of the 1 ml syringe).

If the area of tumoral defeat is less than 2 cm 2 of

— 3 times a week (every other day) during 3 weeks enter 0.15 ml of solution of medicine (1.5 million ME); the total dose should not exceed 13.5 million ME.

At the area of defeat of 2-10 cm 2 — the dose of medicine makes 0.5 million ME/cm 2 (the first injection not less than 1.5 million ME), enter 3 times a week (every other day) during 3 weeks; treatment of one site of defeat is in one stage carried out; in the absence of positive dynamics (assessment of outward, the amount of defeat, degree of hyperaemia, data of a biopsy) after 2–3 months of treatment consider a question of surgical treatment of a disease.

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

medicine solution Preparation

for

Solution is prepared just before its introduction. As solvent use water for injections (in case solution is prepared for p / to, intracutaneous or introduction in oil), at the same time take water for injections at the rate of 1 ml on the entered medicine dose (that provides isotonicity of the entered solution).

If solution of medicine is prepared for intra belly or intravesical introduction as solvent use 0.9% isotonic solution of sodium of chloride (which take at the rate of obtaining necessary concentration of Laferobion in solution not less than 0.3 million ME/ml).

Preparation and carrying out

In 30 min. prior to infusional introduction of Laferobion carry out by

infusion of 0.9% of isotonic solution of sodium of chloride in to medicine infusions (with a speed of 200 ml/h) and finish it just before medicine introduction.

For preparation of infusional Laferobion solution is dissolved in water for injections in the beginning (at the rate of 1 ml of water on the entered medicine dose), then the required amount of medicine (a dose in 1 ml of water solution) is selected and add 0.9% of isotonic solution of sodium of chloride to 50 ml. The prepared solution is entered in/in by drop infusion within 30 min. After the end of introduction Laferobiona it is necessary to continue infusional introduction of 0.9% of isotonic solution of sodium of chloride (with a speed of 200 ml/h) within 10 min.

Contraindication

Hypersensitivity to medicine components, the period of pregnancy and feeding by a breast, dysfunction of a thyroid gland, heavy visceral violations at patients with Kaposi sarcoma; a serious cardiovascular illness, psoriasis, a sarcoidosis, the expressed abnormal liver functions and/or kidneys, epilepsy and other diseases of central nervous system (including functional), chronic hepatitis against the background of the progressing or dekompensirovany cirrhosis, chronic hepatitis at the patients who are receiving or recently receiving therapy by immunodepressants (except for a short course of corticosteroid therapy), autoimmune hepatitis or others autoimmune a disease in the anamnesis.

Side effects

At use of medicine the development of a dose-dependent grippopodobny syndrome (fever, fervescence, a headache, muscle and joints pain, feeling of fatigue) is most often possible

.

Possible side effects: dysfunction of a thyroid gland, disorder of vision, functions of a liver, kidneys, electrolytic balance.

At long courses of therapy the development leucio-is possible

and thrombocytopenia, can note AG and hypotension, vomiting, an arthralgia, confusion of consciousness, dizziness, an ataxy, parasthesias, alarming and depressions, hyperexcitability, drowsiness, an alopecia, skin rash, the naggers, inflows, tachycardia, cough, nasal bleedings, herpetic defeats.

to

Special instructions

to

Before prescribing of medicine and in the course of treatment needs a research of function of a thyroid gland. medicine is begun or continues to be applied only on condition of the TSH normal level in blood plasma. after the therapy termination the function of a thyroid gland broken as a result of administration of medicine is not restored.

to All patients before the beginning and during therapy needs to conduct researches regularly: the developed analysis of peripheral blood with obligatory high-quality and quantitative definition of indicators of white blood, biochemical analysis of blood, including determination of level of electrolytes, calcium, enzymes of a liver 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 serum and a prothrombin time.

by

With care appoint medicine in the presence in the anamnesis of the following diseases: diabetes with episodes of ketoacidosis, HOBL, violation of blood clotting (including a pulmonary embolism), the expressed myelosuppression.

needs to provide to

At administration of medicament adequate hydration of an organism, at development of fever it is necessary to exclude other reasons of its emergence.

At development of hypersensitivity reaction of immediate type (urticaria, a Quincke's disease, a bronchospasm, an anaphylaxis) medicine needs to cancel and hold the relevant therapeutic activities immediately.

dose adjustment, in certain cases — medicament withdrawal is necessary for

At development of average degree and heavy side effects.

Use of medicine is stopped in such cases: lengthening of the period of fibrillation (at patients with chronic hepatitis), emergence of a legechny syndrome and radiological identification of infiltrate or dysfunction of lungs, emergence or increase in disorders of vision, dysfunctions of a thyroid gland (TSH level aberration), decrease in level of albumine and indicators of a prothrombin time in blood serum.

Use during pregnancy and feeding by a breast. Use of medicine is contraindicated during this period.

Ability to steer vehicles can decrease owing to development of weakness, drowsiness, violations of consciousness at use of medicine.

Interaction

With care use medicament along with opioid medicines, analgetics, hypnotic medicaments and sedative medicines (potentially show myelosuppressive effect).

At simultaneous application with the medicines which are metabolized by oxidation (including with xanthine derivatives — Aminophyllinum and theophylline), it is necessary to consider a possibility of influence of Laferobion on oxidizing metabolic processes. It is necessary to control theophylline level in blood serum, if necessary to korrigirovat the dosing mode.

by

At use of medicine it is combined with chemotherapeutic medicines (Cytarabinum, doxorubicine, tenipozid, cyclophosphamide) risk of development of the toxic effects (degrees of their weight and duration) menacing for life increases.

At simultaneous application with a zidovudine the risk of development of a neutropenia increases.

Storage conditions

B the dry, protected from light place at a temperature of 2-8 °C.

Characteristics
Active ingredients Interferon alpha 2b
Amount of active ingredient 3,000,000 ME
Applicant Biopharma
Code of automatic telephone exchange L03AB05 Interferon alpha 2b
Interaction with food It doesn't matter
Light sensitivity Sensitive
Market status The branded generic
Origin Biological
Prescription status According to the prescription
Primary packing bottle
Producer BIOFARM OF THE FEDERAL LAW OF LTD COMPANY
Quantity in packing 10 pieces.
Release form powder for injections
Route of administration Intramuscular
Sign Domestic
Storage temperature from 2 °C to 8 °C
Trade name Laferobion

Reviews Laferobion liof. for solution for infection. 3 million ME fl. No. 10

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Laferobion liof. for solution for infection. 3 million ME fl. No. 10

  • Product Code: 176195
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  • $64.87


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