Recombinant interferon trenbolone acetate 100 alpha-2b is prepared from a clone of E. coli, which contains a genetically engineered hybrid plasmid encoding the interferon alpha-2b human leukocytes. Studies in vitro and in vivo indicate that the biological activity of interferon alpha is caused PegIntron-2b. Interferons cellular effects caused by binding to specific receptors on the cell surface. Studies of other interferons have demonstrated their species specificity. However, certain types of monkeys, such as rhesus monkeys, pharmacodynamic effects sensitive to human type 1 interferons.
By binding to cell membrane, interferon initiates a sequence of intracellular events that include the induction of certain enzymes. It is believed that this process, at least in part, mediate a variety of cellular effects of interferons, including inhibition of virus replication in infected cells, inhibition of cell proliferation and immunomodulatory properties, such as the phagocytic activity of macrophages and cytotoxicity of lymphocytes in specific target cells. Any or all of these effects may mediate therapeutic activity of interferon. Recombinant interferon alpha-2b also suppresses viral replication in vitro and in vivo.
Although the exact mechanism of the antiviral action of recombinant interferon alfa-2b is not known, however, it is believed that the drug alters the metabolism of the organism cells. This leads to the suppression of virus replication; if it does occur, then the virions produced can not exit the cell. pharmacodynamics trenbolone acetate 100 increasing doses studied after a single application in healthy volunteers, by examining changes in oral temperature, concentrations of effector proteins such as serum neopterin and 2’5′-oligoadenylate and the number of leukocytes and neutrophils. Patients treated with PegIntron, there was a slight dose-dependent increase in body temperature.After single dose administration PegIntron from 0.25 to 2.0 mg / kg / week observed a dose-dependent increase in serum neopterin.
Reducing the number of neutrophils and leukocytes to the end of the 4th week dose correlated with PegIntron. Pharmacokinetics. PegIntron is a well-studied pegylated (i.e., coupled to PEG) derivatives of interferon alpha-2b and is composed mainly of monopegilirovannyh molecules. PegIntron elimination half-life of plasma elimination half-life greater than non-pegylated interferon alfa-2b. PegIntron can depegilirovatsya with the release of interferon alfa-2b. The biological activity of the pegylated isomers is qualitatively similar to that of free interferon alfa-2b, but weaker. After subcutaneous administration the serum concentration reaches its peak after 15-44 hours and lasts for 48-72 hours. The C max and AUC increased proportionally to the dose of PegIntron. The apparent volume of distribution averaged 0.99 L / kg. With repeated use occurs accumulation of immunoreactive interferons. However, the biological activity increased slightly.PegIntron elimination half-life averages about 30.7 hours (from 27 to 33 hours), an explicit clearance – 22.0 ml / h / kg. Mechanisms of clearance of interferons is not fully described. . However, it is known that the proportion of renal clearance is about 30% of the total clearance of PegIntron For a single application in a dose of 1.0 mg / kg in patients with impaired renal function showed an increase in C max , AUC, and half-life – in proportion to the degree of renal failure. When used in the same dose (1.0 mg / kg) for 4 weeks (one injection per week) PegIntron clearance decreased by 17% in patients with moderate renal impairment (creatinine clearance of 30-49 ml / min) and 44% in patients with severe renal failure (creatinine clearance of 10-29 ml / min) compared with those with normal renal function.
The trenbolone acetate 100 in patients with severe hepatic impairment has not been studied. The pharmacokinetics of PegIntron with a single subcutaneous administration at a dose of 1 0 mg / kg did not depend on age, so changing the dose in the elderly is not required. The pharmacokinetics of PegIntron in patients under the age of 18 years has not been studied specifically. Neutralizing antibodies to interferon analyzed in serum samples of patients who received PegIntron in the clinical trial. These antibodies neutralize the antiviral activity of interferon. Frequency detection of neutralizing antibodies in patients treated with PegIntron 0.5 mg / kg was 1.1%.
- Chronic hepatitis B. Treatment of chronic hepatitis B patients between the ages of 18 years in the absence of decompensated liver disease.
- Chronic hepatitis C. Treatment of patients with chronic hepatitis C at the age of 18 years in the absence of decompensated liver disease, including patients with clinically stable HIV infection (coinfection).
The generally accepted optimal treatment for chronic hepatitis C is combination therapy drugs interferon alpha-2b (including peginterferon alfa-2b) and ribavirin. When combination therapy is necessary, also, to follow the instructions for medical use of ribavirin.
- Hypersensitivity to any component of the formulation.
- Hypersensitivity to any interferon.
- Autoimmune hepatitis or other autoimmune disease in history.
- Severe mental illness or severe mental disorders in history, particularly severe depression, suicidal thoughts or attempts.
- Severe disease of the cardiovascular system, uncontrolled or unstable during the previous 6 months.
- Impaired function of the thyroid gland, which can not be maintained at a normal level by drug therapy.
- Impaired renal function – creatinine clearance less than 50 mL / min (when used in combination with ribavirin).
- Decompensated liver disease.
- Cirrhosis of the liver with the presence of hepatic failure in patients with .
- Epilepsy and / or dysfunction of the central nervous system.
- Rare hereditary transmitted diseases – fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency (due to the presence of sucrose in the composition of the drug).
- Pregnancy; including a pregnant woman – male partner who is supposed treatment PegIntron in combination with ribavirin.
Dosing and Administration
Therapy PegIntron should be initiated by physicians with experience in the treatment of patients with hepatitis B, and in the future be carried out under its control. PegIntron is administered subcutaneously at a dose of 1.0 to 1.5 g / kg 1 time a week for 24 to 52 weeks. The dose should be selected individually based on the anticipated efficacy and safety of the drug. Patients with difficult to treat chronic hepatitis B virus called genotype C or D, in order to achieve a therapeutic effect may require higher doses and longer treatment. Recommended alternate location for injection. Chronic Hepatitis C Therapy PegIntron should be initiated by physicians with experience in treating patients with hepatitis C, and subsequently carried out under its control. Monotherapy PegIntron is administered subcutaneously at a dose of 0.5 or 1.0 mg / kg once week for at least 6 months. The dose is selected with regard to the intended efficiency and safety. If after the first 6 months of treatment, there is elimination of serum viral RNA, the treatment was continued for 6 months (i.e., generally within 1 year). If after 6 months of treatment there is no elimination of the RNA virus, the treatment is stopped. PegIntron monotherapy in HIV-infected patients with chronic hepatitis C has not been studied. It is recommended each time to choose a new site for subcutaneous injection..
When you save unwanted effects or reoccurs after changing the dose of PegIntron treatment is stopped. Use in impaired renal function “Recommendations for dose adjustment” ). Application for violations of liver function. Safety and efficacy of PegIntron therapy in patients with severe hepatic impairment has not been studied, therefore these patients should not use PegIntron. Use in elderly patients (65 years and older). Trenbolone acetate 100 of PegIntron of age is not revealed. The results of pharmacokinetic studies in elderly humans after a single subcutaneous injection of PegIntron indicate that the dose selection based on age is required. Use in patients under the age of 18 years. Experience in the use of PegIntron in patients under the age of 18 years is missing. It is recommended each time to choose a new site for subcutaneous injection. Combination therapy with ribavirin. In combination therapy with ribavirin PegIntron is administered as a subcutaneous injection in a dose of 1.5 mg per 1 kg of body weight one time per week. Ribavirin is taken orally on a daily basis. how much to inject for weight loss
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