Algeron – the drug with the immunostimulating, antiviral action applied at treatment of primary chronic active hepatitis C.
Algeron release in the form of solution for hypodermic introduction: transparent, from light yellow color to colourless (in sterile ternary syringes from neutral colourless glass on 0,4, 0,5, 0,6, 0,8 or 1 ml, on 1 syringe in blister strip packagings from a polymeric film, on 1 or 4 packagings in a cardboard pack; in colourless glass bottles on 1 ml, on 1 or 4 bottles in blister strip packagings, on 1 packaging in a cardboard pack).
Structure of 1 ml of solution:
Algeron appoint the adult in combination with ribaviriny for treatment of primary chronic active hepatitis C from positive HCV RNA in cases of lack of signs of a decompensation of a disease of a liver.
Relative (Algeron appoint with care in the presence of the following diseases / states):
Algeron enter subcutaneously, into the area of a hip or a front abdominal wall. Intravenously it is impossible to administer the drug. Places for an injection are recommended to be alternated.
Has to appoint drug and to control its further use the doctor with experience of therapy of patients with hepatitis C.
The recommended mode of dosing of Algeron (0,0015 mg/kg once a week) in combination with ribaviriny (the minimum volume of the syringe/weight / a one-time dose/volume of solution):
The syringe on 0,4 ml:
The syringe on 0,5 ml:
The syringe on 0,6 ml:
The syringe on 0,8 ml:
The syringe on 1 ml:
Each bottle / syringe with solution is intended only for single use. To mix the solution which is contained in the bottle/syringe or it is not necessary to enter it in parallel with other medicines.
Administration of solution in painful points, areas with small knots and consolidations or the reddened, decoloured sites of skin is not recommended.
It is impossible to apply a double dose of Algeron.
Without consultation with the doctor it is not necessary to cancel therapy.
Ribavirin accept inside, along with meal, daily. The daily dose is defined by body weight (a single dose morning/evening):
Duration of a therapeutic course is defined by a virus genotype:
In cases of development of the undesirable phenomena or deviations of laboratory indicators of moderate severity it is necessary to lower Algeron's doses or a ribavirin or to suspend therapy. The question of increase in a dose, up to initial, can be considered after normalization of a state or laboratory indicators.
Correction of the mode of dosing is required at development of hematologic disturbances.
About 600 mg at decrease in hemoglobin to level less than 100 g/l are recommended to lower a daily dose of a ribavirin. At decrease in this indicator less than 85 g/l Algeron and рибавирин cancel. Extra care is demanded by patients with diseases of cardiovascular system.
At increase in concentration of free bilirubin up to 85,5 µmol/l about 600 mg are recommended to lower a daily dose of a ribavirin.
Algeron and рибавирин cancel at the progressing increase in activity of alaninaminotranspherase or aspartate aminotransferase more than twice from a reference value or it is more, than by 10 times from the upper bound of norm.
In cases of developing of a moderately severe depression Algeron's dose is reduced. Therapy is cancelled at development of a heavy depression, and also emergence of suicide thoughts.
At a slight renal failure (clearance of creatinine> of 50 ml/min.) when carrying out a combination therapy concerning development of anemia it is necessary to be careful.
Side effects when performing the combined therapy of 0,0015 mg/kg a week of Algeron with ribaviriny in most cases had the easy or moderately expressed character and the terminations of treatment did not demand.
Possible side reactions (it is very frequent (≥1/10), it is frequent (≥1/100; <1/10), infrequently (≥1/1000; <1/100), it is rare (≥1/10 000; <1/1000), it is very rare (<1/10 000)):
At Algeron's use in a dose of 0,002 mg/kg a week in addition to the disturbances described above the following side effects were also recorded: pains in heart, a menorrhagia, disturbances in injection sites in the form of cyanosis, dot hemorrhage, a furuncle.
The disturbances observed at a combination therapy of similar drugs of peginterferon an alpha - 2b with ribaviriny:
The profile of safety of Algeron (monotherapy or in combination with ribaviriny) for patients is younger than 18 years, and also patients after transplantation of a liver or other bodies is not studied.
Algeron's appointment to patients with heavy mental disturbances (including the patients having instructions on such disturbances in the anamnesis) is possible only after carrying out careful individual inspection and the corresponding treatment of a mental disorder.
With a depression in the anamnesis it is necessary to watch a condition of patients regarding emergence of symptoms of a depression during therapy and for half a year after its termination. At increase or preservation of symptoms, in particular a depression, an agressive behavior or suicide intentions, it is necessary to cancel Algeron and to provide timely survey by the psychiatrist.
At heart troubles before the beginning and during treatment carrying out an ECG is recommended. The anemia caused by reception of a ribavirin can aggravate the course of cardiovascular diseases. At an aggravation of symptoms therapy is cancelled.
In case of a bronchospasm, a small tortoiseshell, anaphylactic reactions, a Quincke's disease it is necessary to cancel immediately Algeron and to immediately appoint the corresponding treatment. At passing rash cancellation of therapy is not required.
At reduced function of kidneys, and also patients aged from 50 years at Algeron's use with ribaviriny need to trace carefully a state concerning possible development of anemia.
Prior to therapy carrying out a research of function of kidneys is recommended to all patients. Less than 50 ml/min. do not appoint a combination therapy at clearance of creatinine.
In case of development of a liver failure treatment is cancelled.
Also during therapy it is necessary to consider development of the following disturbances / states:
Algeron's use can be followed by development of ulcer and hemorrhagic and/or ischemic colitis within 12 weeks from the moment of an initiation of treatment. Typical signs of manifestation of colitis: availability of blood in Calais, abdominal pains, fever. At emergence of similar complaints Algeron cancel at once.
If during performing therapy development of dizziness, weakness, confusion of consciousness, drowsiness is observed, control of motor transport and works with mechanisms and cars it is necessary to refuse.
At the combined use of Algeron with some substances / medicines development of the following effects is possible:
The combination of a ribavirin with didanoziny is not recommended (possibly development of peripheral neuropathy, fatal liver failure, a symptomatic lactacidemia and pancreatitis).
To store in protected from light, the place, unavailable to children, at a temperature of 2-8 °C, not to freeze.
Period of validity – 2 years.
The most rare disease – a disease the Kura. Only representatives of the tribe Faure in New Guinea are ill it. The patient dies of laughter. It is considered that eating of a human brain is an origin of a disease.
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