Neohepatect solution for infusion 50IU/ml vials, 2ml

Composition

1 ml – anti-HBs antibodies * 50 IU * human plasma proteins 50 mg, of which immunoglobulin G is not less than 96%, immunoglobulin A is not more than 2 mg.

Auxiliary substances:  

glycine 300 mmol,

water d/i up to 1 ml

Pharmacological action

Pharmacotherapeutic group: Human immunoglobulin against hepatitis B.

ATX Code J06BB04

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Neohepatect is an immunoglobulin preparation that is made from the plasma of donors with a high titer of antibodies against hepatitis B. The distribution of immunoglobulin G subclasses corresponds to the distribution in the plasma of healthy donors.

Pharmacokinetics

The bioavailability of human immunoglobulin against hepatitis B by infusion is 100%. The distribution between plasma and extravascular fluid occurs fairly quickly, and after 3-5 days, the balance between intravascular and extravascular space is reached. The elimination half-life of Neohepatect is on average 24 days. Immunoglobulin G and IgG complexes are utilized by cells of the reticuloendothelial system.

Additional information

When using drugs from human blood or plasma due to the transmission of pathogens of infectious diseases, infection with the latter cannot be completely excluded. This also applies to pathogens of a hitherto unknown nature. To reduce the risk of transmission of pathogens, donors are selected according to strict criteria, donor plasma is tested and selected, and the plasma pool is monitored.

The production process includes stages of elimination and/or inactivation of pathogens.

For the production of Neohepathect, only plasma from healthy donors is used, in which no antibodies to HIV type 1 and 2, to the hepatitis C virus, and surface antigen of the hepatitis B virus were detected.

In addition to individual testing of individual donors ‘ plasma, minipuls are monitored first (PCR testing for HIV, hepatitis A, B and C viruses, parvovirus B19), and then a production pool of plasma processed for Neohepathect (repeated testing for antibodies to HIV -1.2, hepatitis B and C, as well as PCR for HIV, hepatitis B and C viruses).

In production, a plasma pool is used only if the test results are negative.

Neohepatect is made by cold ethanol fractionation. To inactivate and eliminate possible viruses, tri-n-butyl phosphate/tween 80 treatment and octanoic acid precipitation are performed.

The proposed methods of virus inactivation, validated using model viruses, are effective against the causative agents of AIDS and hepatitis B and C.

Indications

Contraindications

Hypersensitivity to human immunoglobulin and other blood products, especially in rare cases of class A immunoglobulin (IgA) deficiency in the blood and the presence of anti-IgA antibodies. Hypersensitivity to other components of the drug.

Side effects

Possible side effects include chills, headache, fever, nausea, vomiting, allergic reactions, aching joints and mild back pain. In rare cases, an unexpected drop in blood pressure is possible and in isolated cases-anaphylactic shock, even if the patient did not show excessive sensitivity during the previous use. When human immunoglobulins were administered, there were cases of signs of aseptic meningitis and, in rare cases, hemolytic anemia/hemolysis, a transient skin reaction (rash or hyperemia), which completely disappeared after discontinuation of therapy. In addition, there was an increase in serum creatinine and / or acute renal failure. There have been isolated cases of thromboembolic reactions in elderly patients with signs of cerebral or cardiological ischemia, as well as in patients with overweight or severe hypovolemia. In case of reactions that indicate intolerance to the drug, it is necessary either to reduce the rate of use, or to suspend the infusion until the symptoms disappear. The choice of appropriate measures to prevent the occurrence of side effects depends on the type and severity of the side effect. In case of adverse effects on renal function, immunoglobulin therapy should be discontinued. In case of shock, it is necessary to follow the current recommendations for anti-shock therapy.

Interaction

Do not add any other drugs to the Neohepatect solution, as changes in the electrolyte concentration or pH value may lead to precipitation or denaturation of the protein.

Live attenuated (attenuated) vaccines: For a minimum of 6 weeks and up to 3 months after use, immunoglobulins may reduce the effectiveness of live attenuated vaccines against viral diseases such as measles, rubella, mumps and chickenpox.

Vaccination against these diseases should be carried out no earlier than 3 months after the introduction of Neohepatect. The interval between use of immunoglobulin and measles vaccine can be extended to 1 year. In this regard, patients who need to be vaccinated against measles should first be examined for the presence of specific antibodies.

Laboratory tests

After the introduction of immunoglobulin, a temporary increase in the titer of various passively administered antibodies is possible, which can lead to false positive test results in serological studies.

Passively administered antibodies against red blood cell antigens (for example, A, B, D) can affect individual serological parameters, such as allo-antibodies to red blood cells (for example, Coombs reaction), reticulocyte count, and haptoglobin.

How to take, course of use and dosage

Method of use Before use of Neohepathect, it is necessary to visually check the contents of the vial. The solution should be clear or slightly opalescent. It is forbidden to use an opaque or sedimentary solution. Before use, the drug should be heated to room temperature or body temperature. Neohepatect is intended for intravenous infusion. The drug is not subject to preliminary dilution. The initial infusion rate should be 0.1 ml / kg of body weight / hour. If the drug is well tolerated,10 minutes after the start of use, the rate can be gradually increased to 1 ml / kg of body weight/hour. Neohepatect should be administered at a minimum rate in patients at risk, especially the elderly and patients with impaired renal function. Clinical experience with the use of Neohepatect in newborns born to mothers carrying the HBs antigen showed that the drug in a dose of 2 ml, administered for 5-15 minutes, is well tolerated. It is not allowed to mix Neohepatect with other medicines. Do not add any other drugs to the Neohepatect solution. The opened bottle should be used immediately. Due to the risk of bacterial contamination, the unused remainder of the product cannot be stored. Recommended dosage of the drug: Unless otherwise specified, the following is recommended: : For the prevention of hepatitis B in newborns whose mothers are infected with the hepatitis B virus, immediately after birth,20-50 IU of Neohepatect is administered once per kg of body weight, but not less than 100 IU (2 ml). Urgent vaccination against hepatitis B is recommended. The first use of the vaccine can be carried out on the same day as the introduction of Neohepatect, only in different parts of the body. After contact with material suspected of containing hepatitis B virus: immediately, no later than 72 hours,8-10 IU (from 0.16 to 0.20 ml)is administered once Neohepathectasis per kg of body weight.For prevention at a high risk of hepatitis B infection (for example, in hemodialysis departments): 7IU (0.14 ml) of Neohepatect per kg of body weight, but not less than 10 ml, is administered once after determining HBsAg and antibodies to HBs. If the antibody titer to HBsAg is more than 10 IU / l in a month (including for monitoring the simultaneous active immunization), then immediate use of Neohepatect is not required and it is carried out after 2 months. The introduction of immunoglobulin at the existing risk of infection is repeated, if necessary, at intervals of 1 month with monthly monitoring of the antibody titer to HBsAg. After active formation of antibodies to HBsAg. passive antibody use is no longer necessary. To prevent liver graft infection in an HBsAg-positive recipient,10,000 IU (200 ml)is administered intravenously during surgery after liver removal and before new liver transplantation Neohepathect. After surgery, the drug is administered for at least 7 days daily at a dose of 2,000 IU (40 ml). During long-term therapy, the blood serum level should be maintained 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.

Overdose

Overdose of the drug in patients at risk, especially in the elderly, as well as in patients with impaired renal function, can lead to hypervolemia and increased blood viscosity.

Special instructions

Pregnancy and lactation The absence of the risk of using this drug during pregnancy in controlled clinical studies has not been studied, so during pregnancy and lactation it should be used with caution, although long-term experience with the medical use of immunoglobulins does not allow us to expect any harmful effects on the course of pregnancy, as well as on the fetus and newborn. Administered immunoglobulins are excreted in the mother’s milk and can promote the transmission of protective antibodies to newborns.

Storage conditions

The drug is transported at a temperature of 2 to 8°C. Do not freeze!The drug is stored at a temperature of 2 to 8°C in a dry place protected from light. Do not freeze!Keep out of reach of children.

Shelf

life is 2 years. The drug with an expired shelf life is not subject to use.

Active ingredient

Human immunoglobulin against hepatitis B

Conditions of release from pharmacies

By prescription

Dosage form

infusion solution