Immunoglobulin is usually used in combination with other immunosuppressive drugs (methyl Prednisolone, prednisolone, azathioprine, cyclosporine A) to inhibit the body's immune mechanisms after organ transplantation and thus prevent their rejection by the body in the following cases: in post-operative prophylaxis immediately after organ transplantation (in combination with glucocorticoids, azathioprine and / or ciclosporin A) to enhance the immunosuppressive effect; in the treatment of acute rejection, when the attempt to treat methylprednisolone does not give the expected therapeutic result.
Composition:
1 ml of the product contains 20 mg of rabbit immunoglobulin against human T lymphocytes.
Action:
Immunosuppressive immunoglobulin, containing high titre antibodies against human T lymphocytes. The polyclonal antibodies present in the preparation bind to antigens on the surface of T lymphocytes, destroying them in the opsonization and disintegration mechanism via complement activation. This leads to a reduction in the number of T lymphocytes in the blood. The preparation is essentially free of antibodies that cross-react with red blood cells, human plasma proteins and basal glomerular membranes. In the body, the drug undergoes changes appropriate to the proteins of its own system. T0,5 in the case of a standard dosage is 14 days.
Contraindications:
Hypersensitivity to rabbit protein. Thrombocytopenia with platelet count <50,000 platelets / μl. Bacterial, viral or fungal infections that are not under therapeutic control. Pregnancy or its suspicion (the drug may cross the placental barrier - the decision to use the therapy should be made after risk assessment and possible benefits).
Precautions:
In the case of hypersensitivity reactions or anaphylactic shock after administration of the preparation, it is necessary to follow the accepted medical standards. If the hypersensitivity reactions are mild, administration of the immunoglobulin may be continued using additional adjuvant therapy if necessary. If the symptoms are very severe and pose a risk to the patient, treatment should be discontinued and anti-shock therapy initiated. During treatment, the patient should be observed for signs of infection; in case of infection, use appropriate drugs (antibiotics, antiviral, antifungal, immunoglobulins). Despite the use of inactivation methods of infectious agents, the transfer of known and unknown pathogens can not be completely ruled out. Measures taken to prevent infections are considered effective against enveloped viruses such as HIV, HBV and HCV; may have limited efficacy against non-enveloped viruses such as HAV and parvovirus B19.
Pregnancy and lactation:
The safety of the medicine during pregnancy and breastfeeding has not been established - the benefits and risks should be carefully evaluated taking into account the patient's condition.
Side effects:
The most common: nausea, fever and dizziness. Fever ≥40st.C and chills are rare and usually disappear in the first days of treatment. After 8-14 days of administration, symptoms of serum sickness may appear. Anaphylactic reactions may occur - immediately after the start, during or shortly after the infusion: increased temperature, general redness of the skin (erythema), swelling, breathing disorders, wheezing and a drop in blood pressure. Rare: thrombocytopenia or granulocytopenia.
Dosage:
Intravenously, infusion. Prophylaxis after organ transplantation: 2-5 mg / kg (the daily dose is usually 3-4 mg / kg), usually for 5-14 days, starting on the day of the transplant. Treatment of acute rejection of steroid-resistant grafts: 3-5 mg / kg (the daily dose is usually 3-4 mg / kg), usually for 5-14 days from the day of the rejection symptoms. The drug should be diluted in 250-500 ml of physiological saline before use, followed by intravenous infusion for at least 4 hours. When administering the drug to a peripheral vein, choose a vessel with a wide light.Systemic and topical tolerance of the preparation is better if corticosteroids and / or antihistamines are administered before the infusion. Sodium Heparin should not be added to the infusion solution, nor should it be administered by the same route, Glucose, blood, blood products, solutions containing lipids, because of pharmaceutical incompatibilities with the immunoglobulin.
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