Human immunoglobulin normal | Intratekt solution for infusion 50 mg / ml vials of 200 ml

Release form

solution for infusion

Packing

Bottle 200 ml.

Pharmacological action

Intratect - immunomodulatory.

Pharmacodynamics

Intratect contains predominantly IgG with a wide range of antibodies against various pathogens. Intratect is produced from a plasma pool of more than 1000 donors, the distribution of IgG subclasses corresponds to that in human plasma. The immunological properties of Intratect allow to bring a pathologically low concentration of Ig to a normal level. The mechanism of action for other indications, except for substitution therapy in patients with immunodeficiency, is completely unclear, and, apparently, lies in the immunomodulating effect.

Pharmacokinetics

The bioavailability of Ig with iv administration is 100%.

Distributed between plasma and extravascular fluid fairly quickly, and after 3-5 days, an equilibrium state between the intravascular and extravascular spaces is reached.

T1 / 2 Intratect in patients with primary immunodeficiency is approximately 27 days. T1 / 2 may vary in different patients, especially in the case of primary immunodeficiencies. IgG and its complexes are utilized by the cells of the reticuloendothelial system.

Indications

replacement therapy: congenital immunodeficiency (complete or selective immunodeficiency, general variable immunodeficiency, severe combined immunodeficiency, Wiskott-Aldrich syndrome)

chronic lymphocytic leukemia and myeloma with severe secondary selective immunodeficiency, as well as recurrent bacterial infections

children with AIDS, as well as recurrent bacterial infections.

immunomodulation: idiopathic thrombocytopenic purpura in adults and children with a high risk of bleeding before surgery (to adjust platelet count)

allogeneic bone marrow transplantation

Guillain-Barré syndrome krdasa kavasaki syndrome.

Contraindications

Hypersensitivity to any component of the drug, hypersensitivity to human Ig, especially in rare cases of blood deficiency of IgA and the presence of antibodies against IgA.

Composition

Active ingredient: human plasma proteins 50 mg

Excipients: glycine - 300 μmol water for injection - up to 1 ml

Side effects

Possible side effects such as chills, headache, fever, nausea, vomiting, allergic reactions, joint aches and mild back pain.

In rare cases, Ig can cause a sudden drop in blood pressure and, in rare cases, anaphylactic shock, even if the patient did not show hypersensitivity during the previous administration of the drug.

In connection with the administration of human Ig, there were cases of signs of aseptic meningitis and, in rare cases, hemolytic anemia / hemolysis, as well as transient skin reaction (rash or hyperemia), which completely disappeared after discontinuation of therapy. An increase in serum creatinine and / or acute renal failure has also been observed.

In isolated cases in elderly patients, patients with signs of cerebral or cardiac ischemia (impaired blood supply to the brain or heart), as well as patients with overweight or severe hypovolemia, thromboembolic complications were noted.

Drug Interactions

Live Viral Vaccines: Ig administration can adversely affect live vaccines against viral diseases such as measles, rubella, mumps and chickenpox for 6 weeks and up to 3 months. Vaccination with an appropriate live vaccine should be given no earlier than 3 months after the introduction of Intratect. In the case of measles vaccination, this effect of Ig can last up to 1 year. Before the expiration of this period, measles vaccination should be carried out after determining if the patient has the appropriate antibodies.

Serological laboratory tests: after administration of Ig, a temporary increase in the titer of various passively introduced antibodies is possible, which can lead to false positive analysis results in a serological test.

Passively introduced antibodies against red blood cell antigens (e.g. A, B, D) can affect serological parameters such as the level of red blood cell alloantibodies (e.g. Coombs reaction) and the number of reticulocytes, haptoglobin test.

Storage conditions

In a dark place at a temperature not exceeding 25 РC (do not freeze).

Expiration

2 years

Deystvuyuschee substances

immunoglobulin man Normal

dosage form

solution infusion