Recombinant human interleukin-2 (Ⅰ) for injection

This product has shown biological activity of human natural interleukin-2 (IL-2), including increasing lymphocyte mitosis, which can proliferate cytotoxic T cells, natural killer cells and lymphokine-activated killer cells (LAK), and enhance their killing activity. When the dosage of this product in the human body reaches a certain level, it will produce immune effects and can induce the production of some cytokines such as tumor necrosis factor, IL-1 and gamma-interferon. This product has antiviral, anti-tumor and immune enhancement effects.

The main ingredient is recombinant human interleukin-2 (I), and the auxiliary ingredients are mannitol, disodium hydrogen phosphate, sodium dihydrogen phosphate and sodium dodecyl sulfate.

This product is white or slightly yellow loose, easily soluble in water, and becomes a clear liquid after dissolution.

Used for the treatment of congenital or acquired immunodeficiency, improving the patient's cellular immune function and anti-infection ability. Treatment of various autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, etc. It has a certain therapeutic effect on certain viral, bacillary diseases, and intracellular parasitic infectious diseases, such as hepatitis B, leprosy, tuberculosis, and Candida albicans infection. Used in combination with chemotherapy and radiotherapy to enhance the therapeutic effect and improve immunity. Used for anti-recurrence and anti-metastasis treatment after surgery, chemotherapy and radiotherapy of malignant tumors, and at the same time enhance immunity. Treat malignant pleural, abdominal and pericardial effusions. Used for biological immunotherapy of tumors that are not suitable for surgery, chemotherapy and radiotherapy.

Dissolve with sterile water for injection or saline before injection. The specific usage varies according to the disease. Generally, the following methods are used or follow the doctor's advice. 1. Systemic administration: Subcutaneous injection: 600,000 to 1 million IU/m2/time, dissolved with 2 ml of dissolving solution, subcutaneous injection 3 times a week, 6 weeks as a course of treatment. Intravenous injection: 400,000 to 800,000 IU/m2/time, dissolved in 500 ml of saline, drip for 2 to 4 hours, 3 times a week, 4 to 6 weeks as a course of treatment. 2. Regional or local administration: Pleural injection: used for cancerous pleural effusion, 1 million to 2 million IU/m2/time, try to remove the effusion in the cavity, 1 to 2 times a week, 2 to 4 weeks (or the effusion disappears) as a course of treatment. Local administration of tumor lesions: The dosage is determined according to the size of the tumor, once every other day, and each lesion is injected with no less than 100,000 units each time, 4 to 6 weeks as a course of treatment.

Common adverse reactions include fever, chills, and muscle aches, which are related to the dosage. There may also be chills and high fever. Some patients may experience nausea and vomiting. A few patients may have rashes and local swelling at the injection site. All adverse reactions can be recovered after stopping the drug. When this product is used in large doses, foreign reports have shown that it may cause capillary leakage syndrome, which manifests as low blood pressure, peripheral edema, temporary renal insufficiency, etc. It should be discontinued immediately and symptomatic treatment should be actively carried out.

It is contraindicated for patients who are allergic to the ingredients of this product, have severe heart and kidney dysfunction, severe hypotension, or high fever.

Precautions for children: Precautions for pregnancy and lactation: Not yet clear. Precautions for the elderly:

This product affects the function of the central nervous system. Therefore, interactions may occur when this product is used together with psychotropic drugs (such as anesthetics, analgesics, antiemetics, sedatives, tranquilizers). If this product is co-administered with drugs that are harmful to the kidneys (such as aminoglycosides, analgesics and anti-inflammatory drugs), drugs that are toxic to the bone marrow (such as cytotoxic chemotherapy), drugs that are toxic to the heart (such as doxorubicin) or hepatotoxic drugs (such as methotrexate, asparaginase), it will enhance the toxic effects on these organ systems. The safety and efficacy of this product co-administered with any anti-tumor have not been confirmed. In addition, the decline in liver and kidney function caused by the use of this product will delay the clearance of concomitant drugs, thereby increasing the risk of adverse reactions to these drugs. Allergic reactions have been reported when this product is co-administered to patients at high doses in combination with anti-tumor agents, especially anti-tumor agents such as methylthiazide, cisplatin and alpha-interferon. These reactions include erythema, pruritus, and hypotension, and occur within hours of chemotherapy. Some patients may require treatment for these conditions. When alpha-interferon is given to patients, it can increase the incidence of myocardial damage, including myocardial infarction, myocarditis, ventricular hypokinesia, and severe rhabdomyomas. When alpha-interferon is given to patients concurrently with alpha-interferon, patients have been observed to have worsened or developed some autoimmune and inflammatory conditions, including crescent-shaped IgA glomerulonephritis, myasthenia gravis, inflammatory arthritis, thyroiditis, and bullous pemphigoid. Although glucocorticoids have been shown to reduce the adverse reactions caused by alpha-interferon, including fever, renal insufficiency, hyperbilirubinemia, and dyspnea, their co-administration with alpha-interferon may reduce the anti-tumor efficacy of alpha-interferon and should be avoided. Beta-blockers and other antihypertensive drugs may cause hypotension when used with alpha-interferon.

Store and transport at 2-8℃ away from light.

3 million IU/vial

Beijing Shougang Gas Company Limited

• Founded in:

  1997-11-14

• Address:

  No. 200, Renli Road, Liqiao Town, Shunyi District, Beijing

• Tax NO.:

  91110107102284454Q

• Registered Funds:

  75.462 million yuan

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