trenbolone acetate 100
The bioavailability of human hepatitis B immunoglobulin infusion at 100%. The distribution between plasma and extravascular fluid happens quickly, and after 3-5 days an equilibrium is reached between the intravascular and extravascular spaces. The trenbolone acetate 100 half-life Neogepatekta averages 24 days. Immunoglobulin G and IgG complexes are utilized by cells of the reticuloendothelial system.
Additional Information
When using medicines from human blood or plasma as a result of transmission of infectious agents infecting the latter can not be completely excluded. This also applies to pathogens of hitherto unknown nature. To reduce the risk of transmission of pathogens, according to strict criteria performed donor selection, tested and selected donor plasma and controlled plasma pool.
The production process includes the stage of elimination and / or inactivation of pathogens.
Used only plasma of healthy donors, which were not found to manufacture Neogepatekta antibodies to HIV type 1 and 2, hepatitis C virus and the surface antigen of hepatitis B virus
addition to the individual testing of individual donors monitoring plasma is first subjected minipuly (PCR tests for HIV, hepatitis viruses a, B and C, parvovirus B19) and then the production of the plasma pool is processed at Neogepatekt (repeat antibody testing for HIV -1.2, hepatitis B and C, as well as PCR for HIV, hepatitis viruses B and C).
In the production of the plasma pool is used only for negative test results.
Neogepatekt produced by fractionation with ethanol in the cold. To inactivate viruses and possible elimination processing is carried out with tri-n-butyl phosphate / Tween 80 and octanoic acid precipitation.
Envisaged virusinaktivatsii methods, using a validated model viruses are effective agents against AIDS, and hepatitis B and C.
Indications
- Prevention of hepatitis B in infants born to mothers-carriers of the surface antigen of hepatitis B virus
- Prevention of hepatitis B in:
- adults and children over two years old, not vaccinated against hepatitis B, or having the documentary confirmation of vaccination and subjected to the risk of infection with hepatitis B due to contact with the material in respect of which there were suspicions on its infection (for example, in the case of violation of the integrity of the skin prick with a needle injection, or direct contact with the mucous membrane).
In such cases, the introduction of Neogepatekta recommended to be carried out simultaneously with hepatitis B vaccine (simultaneous active and passive immunization). Launched thus vaccination should be continued in accordance with the instructions for use of the vaccine.
Introduction Neogepatekta not shown if affected by the risk of infection with hepatitis patient was vaccinated with the full scheme and has formed a sufficient trenbolone acetate 100 number of antibodies (at least 10 IU / mL serum). If the number of anti-HBs-antigen can not be detected within 24 hours after contact with contaminated material, in any case, need to combine prevention (vaccines and immunoglobulins). - individuals with antibody content after 6 months after vaccination, is less than 10 IU / l. Such patients simultaneously with the introduction of Neogepatekta should appoint additional vaccination against hepatitis B.
The use Neogepatekta shown persons with a tendency to bleeding that requires immediate prevention of hepatitis B, since the introduction of intramuscular preparations may lead to local hemorrhages.
- adults and children over two years old, not vaccinated against hepatitis B, or having the documentary confirmation of vaccination and subjected to the risk of infection with hepatitis B due to contact with the material in respect of which there were suspicions on its infection (for example, in the case of violation of the integrity of the skin prick with a needle injection, or direct contact with the mucous membrane).
- Use in patients with an increased risk of infection with hepatitis B prior to or simultaneously with vaccination against hepatitis B (pre-operations, re-transfusion, hemodialysis, etc.).
- Prevention of liver transplant patients infected with hepatitis B surface antigen B.
Contraindications
: Hypersensitivity to human immunoglobulin and other blood products, particularly in the rare cases of immunoglobulin in blood deficiency Class A (IgA) and the presence of antibodies against IgA.Hypersensitivity to the other ingredients.
Cautions Pregnancy and lactation No risk of the use of this drug during pregnancy in controlled clinical trials has not been studied, so during pregnancy and lactation should be used with caution, though long experience medical use of immunoglobulins does not allow to expect any harmful effect on pregnancy and on the fetus and newborn. Introduced immunoglobulins are excreted in breast milk and may contribute to the transfer of protective antibodies to the newborn.
Dosing and Administration The method of administration Prior to administration Neogepatekta necessary to visually check the contents of the vial. The solution should be clear or slightly opalescent.Opaque or containing pellet was prohibited to use. Before the introduction of the drug should be warmed to room temperature and body temperature. Neogepatekt for intravenous infusion. The preparation is not subject to a preliminary breeding. The initial infusion rate should be 0.1 ml / kg body / weight per hour. With good tolerability of the drug in 10 minutes after initiation of the speed can be gradually increased to 1 ml / kg body weight / hour. The patients belonging to risk groups, particularly the elderly, patients with impaired kidney function Neogepatekt be administered at a minimum speed. Clinical experience with Neogepatekta in infants born to mothers carrier-HBs-antigen showed that the drug at a dose of 2 ml injected within 5-15 minutes, a well-tolerated. it is not allowed to mix Neogepatekt with other drugs. You can not add any other agents to the solution Neogepatekta. Opened vials should be used immediately. Because of the risk of bacterial contamination trenbolone acetate 100 of the unused balance of the drug must not be stored. The recommended dosage of the drug : If not set anything else, we recommend the following: For the prevention of hepatitis B in newborns who are infected with hepatitis B virus mother-in immediately after birth once administered 20 – 50 ME Neogepatekta per kg of body weight, but not less than 100 ME (2 mL). Recommended emergency vaccination against hepatitis B. The first administration of the vaccine can be carried out on the same day as the administration Neogepatekta, only in different areas of the body. After contact with material suspected of containing Hepatitis B: immediately, no later than 72 hours once administered 8-10 ME (from 0.16 to 0.20 ml) Neogepatekta per kg body weight. for preventing at high risk of infection with hepatitis B (e.g., hemodialysis) administered once 7 ME (0,14 ml) at Neogepatekta kg body weight, but not less than 10 ml, and determining the HBsAg and anti-HBs. If a month (including monitoring conducted simultaneously active immunization) antibody titer to HBsAg will be greater than 10 IU / l, the immediate introduction Neogepatekta not required and it is performed at 2 months. Introduction immunoglobulin existing contaminating repeated if necessary at intervals of 1 month at monthly monitoring antibody titer to HBsAg. After an active formation of antibodies to HBsAg. Passive administration of antibodies is no longer required. For the prevention of infection in liver transplant HBsAg-positive recipient is administered intravenously during surgery after removal of the liver and liver to transplant new 10.000 ME (200ml) Neogepatekta. After surgery, the drug is administered at least 7 days at a daily dose of 2.000 ME (40 mL). When long-term therapy in serum levels must be maintained for at least 100 IU / L (monthly monitoring). The duration of therapy should be at least 6 months. Recommended dosages are based on the results of clinical trials.
Side effects
are possible, such side effects like fever, headache, fever, nausea, vomiting, allergic reactions, aches in the joints and easy back pain.
In rare cases there may be a sudden drop in blood pressure and in rare cases – anaphylactic shock, even if the patient under the previous administration did not show excessive sensitivity.
with the introduction of human immunoglobulin have been cases of the appearance of symptoms of aseptic meningitis and in rare cases, haemolytic anemia / haemolysis, transient skin reactions (rash or redness), which completely disappeared after discontinuation of therapy.
in addition, there was an increase of serum creatinine and / or acute renal failure.
It is noted isolated cases of thromboembolic reactions in elderly patients with signs of cerebral or cardiac ischemia, as well as in patients with overweight or severe hypovolemia.
In the case of reactions indicative of intolerance to the drug, it is necessary either to reduce the speed introduction or suspend infusion until the symptoms disappear. Selection of appropriate measures to prevent any side effects depend on the type and severity of side effects. In the case of negative effects on kidney function immunoglobulin therapy should be discontinued.
In the event of a shock, it is necessary to follow the current guidelines for the anti-shock therapy.
Precautions for the use of
Certain side effects may be due to the high rate of drug administration. It is necessary to strictly observe the rate of administration recommended in the section “Dosage and administration”, since the frequency of the possible symptoms of side effects increases with the infusion rate.
The patient during the whole infusion and for at least 20 minutes after its completion should be under medical supervision to monitor . with the possible appearance of the symptoms of side effects
Certain side effects may occur more often:
- introducing at high speed,
- in patients with complete or partial deficiency of immunoglobulins in the presence or absence of IgA-deficiency
- in patients receiving the first human immunoglobulin, or in rare cases when another immunoglobulin preparation or if treatment is conducted long immunoglobulins.
Hypersensitivity reactions occur in a pure form in very rare cases in which there is no blood immunoglobulin A (IgA) and formed antibodies against IgA.
In most cases, you can avoid possible complications if
- ensure that the patient has no allergic reactions when administered immunoglobulin slowly (0.1 ml / kg body weight / hour)
- carefully observe the patient during the entire time of administration and monitor signs of undesirable actions. Especially should be observed carefully during the whole infusion and for at least 1 hour after its completion for patients never previously treated with human immunoglobulins or receiving other immunoglobulins or immunoglobulins that were introduced a long time ago. All other patients should be observed for at least 20 minutes after administration.
With the introduction of intravenous immunoglobulins described isolated cases of acute renal failure in patients with additional risk factors: impaired renal function, diabetes, low blood volume, overweight, medications that have nephrotoxicity, age over 65 years.
In the treatment of immunoglobulin for all groups of patients should:
- sufficient fluid intake trenbolone acetate 100 before the infusion of immunoglobulin;
- monitoring of urine output;
- control of the content of the serum creatinine (kidney function display);
- exclude concomitant use of diuretics.
In the case of negative effects on renal function should consider discontinuing administration of immunoglobulin.
The most common renal dysfunction and acute renal failure associated with the use of immunoglobulin preparations containing sucrose as a stabilizer. Therefore, patients with any risk factor recommended immunoglobulins that do not contain sucrose. Neogepatekt does not contain sucrose. In addition, the drug should be administered with a minimum speed.
Vehicle and mechanisms management
There are no indications that immunoglobulins can affect the ability to drive or maintain mechanisms.
Overdose
An overdose of the drug in patients belonging to a risk group, especially in the elderly and in patients with impaired renal function, may lead to fluid overload and increase blood viscosity.
The interaction with other drugs
is impossible to add any other drugs Neogepatekta solution since changes in electrolyte concentration or pH can result in precipitation or denaturation of the protein. Live, attenuated (weakened) vaccine : 6 weeks minimum and up to 3 months after administration of immunoglobulins are reduce the efficacy of live attenuated vaccines for viral diseases such as measles, rubella, mumps and chicken pox.vaccination against these diseases should be carried out not earlier than after 3 months after administration Neogepatekta. The interval between administration of immunoglobulin and measles vaccine can be increased up to 1 year. In this regard, patients who need to be vaccinated against measles, it is first necessary to examine for the presence of specific antibodies.
Laboratory investigations
After administration of immunoglobulin may temporarily increase the titer of various passive administration of antibodies that can lead to false positive results of the analysis with serological studies.
Passively administered antibody against the erythrocyte antigens (e.g., A, B, D) may affect the individual serological parameters such as alloantibodies to red blood cells (eg, Coombs’ test), reticulocyte count and haptoglobin. clebol