Recombinant human interferon α2b injection (Pseudomonas)

1. Pharmacology: This product is produced by recombinant Pseudomonas carrying the human leukocyte interferon α2b gene plasmid. It has broad-spectrum antiviral, anti-tumor, cell proliferation inhibition and immune function enhancement effects. Interferon binds to cell surface receptors, induces cells to produce a variety of antiviral proteins, and inhibits viral reproduction in cells; interferon has a direct inhibitory effect on tumor cells, can regulate the host's anti-tumor immune response, and change the relationship between the host and tumor cells by inhibiting and decomposing factors required for tumor cell growth; interferon improves immune function, including enhancing the phagocytic function of macrophages, enhancing the cytotoxicity of lymphocytes to target cells and the function of natural killer cells. 2. Toxicology: (1) Acute toxicology test: Mice were injected intraperitoneally and intravenously with this product, and the dosage was 150,000 international units per kilogram and 150,000 international units per kilogram, respectively, which is 105 times and 104 times the therapeutic dose for humans. No acute poisoning symptoms occurred, and no animals died. (2) Long-term toxicity test: Rats were injected intramuscularly with this product at a dose of 15 million international units per kilogram, 1.5 million international units per kilogram, and 150,000 international units per kilogram, 5 times a week for a total of 6 months. There were no abnormalities in the general condition, weight, and behavior of the rats. The above test was repeated in rabbits, and no toxic reactions were observed for three months. The pathological tissue examination of the rabbits' internal organs did not show any changes caused by the toxicity of this product. (3) Reproductive toxicity: Literature shows that interferon may damage fertility. In primate studies, it was observed that animals using interferon had abnormal menstrual cycles. It is reported that women treated with human leukocyte interferon had reduced serum estradiol and progesterone concentrations. Therefore, women of childbearing age should not use this product unless effective contraceptive measures are used during medication. Literature data from foreign studies using rhesus monkeys show that this product has an abortion effect at a dose of 90-180 times the recommended dose for intramuscular or subcutaneous injection for humans (2MIU/m2). Although abortion occurred in all dose groups (7.5 MIU, 15 MIU and 30 MIU/kg), it was statistically significant only in the medium and high doses (equivalent to 90-180 times the recommended human dose of 2 MIU/m2 for intramuscular or subcutaneous injection) compared with the control group. High doses of other types of interferon α or β are known to cause dose-related ovulation arrest and abortion in rhesus monkeys. The above toxic doses are generally not easily reached clinically for this product.

Recombinant human interferon alpha; 2b, human serum albumin.

This product is a colorless, transparent liquid with no insoluble matter visible to the naked eye.

1. Used to treat certain viral diseases, such as acute and chronic viral hepatitis, herpes zoster, and condyloma acuminatum. 2. Used to treat certain tumors, such as hairy cell leukemia, chronic myeloid leukemia, multiple myeloma, non-Hodgkin's lymphoma, malignant melanoma, renal cell carcinoma, laryngeal papilloma, Kaposi's sarcoma, ovarian cancer, basal cell carcinoma, superficial bladder cancer, etc.

1. Chronic hepatitis B: subcutaneous or intramuscular injection, 3-6106IU/day, change to 3 times/week after four weeks, and continue for more than 16 weeks. 2. Acute and chronic hepatitis C: subcutaneous or intramuscular injection, 3-6106IU/day, change to 3 times/week after four weeks, and continue for more than 16 weeks. 3. Hepatitis D: subcutaneous or intramuscular injection, 4-5106IU/day, change to 3 times/week after four weeks, and continue for more than 16 weeks. 4. Herpes zoster: intramuscular injection, 1106IU/day, for 6 days, and oral acyclovir. 5. Genital warts: can be used alone, intramuscular injection, 1-3106IU/day, for four weeks. It can also be used in combination with laser or electrocautery, generally injected at the base of the wart, 1106IU/time. 6. Hairy cell leukemia: 2-8106IU/m2/day, continuous use for at least 3 months. 7. Chronic myeloid leukemia: 3-5106IU/m2/day, intramuscular injection. Can be used in combination with chemotherapy drugs such as hydroxyurea and Ara-c. 8. Multiple myeloma: as induction or maintenance therapy, 3-5106IU/m2, intramuscular injection, 3 times/week, and combined with chemotherapy regimens such as VMCP. 9. Non-Hodgkin's lymphoma: as induction or maintenance therapy, 3-5106IU/m2, intramuscular injection, 3 times/week, and combined with chemotherapy regimens such as CHVP. 10. Malignant melanoma: 6106IU, intramuscular injection, 3 times/week, combined with chemotherapy drugs. 11. Renal cell carcinoma: 6106IU, intramuscular injection, 3 times/week, combined with chemotherapy drugs. 12. Laryngeal papilloma: 3106IU/m2, intramuscular injection or subcutaneous injection, 3 times a week (once every other day). 13. Kaposi's sarcoma: 50106IU/m2/day, for 5 consecutive days, intravenous drip for 30 minutes each time. At least 9 days interval before the next 5-day treatment period. 14. Basal cell carcinoma: 5106IU, intratumoral injection, 3 times/week, 3 weeks. 15. Ovarian cancer: 5-8106IU, intramuscular injection, 3 times/week, combined with chemotherapy drugs.

Common symptoms of this product include fever, headache, chills, fatigue, myalgia, and joint pain, which often occur in the first week of medication. Adverse reactions usually disappear 48 hours after injection. In case of serious adverse reactions, the treatment plan must be modified or the medication must be stopped. If an allergic reaction occurs, the medication should be stopped immediately. A small number of patients may experience abnormal blood counts such as leukopenia and thrombocytopenia, which can return to normal after stopping the medication. Occasionally, adverse reactions such as anorexia, nausea, diarrhea, vomiting, hair loss, increased or decreased blood pressure, and nervous system dysfunction are seen.

1. Those who have a history of allergy to recombinant human interferon α2b or any of the ingredients of this preparation. 2. Those with severe heart disease. 3. Those with severe liver, kidney or bone marrow dysfunction. 4. Those with epilepsy and central nervous system damage. 5. Those with other serious diseases who cannot tolerate this product should not use it.

Precautions for children: There is still limited experience in the use of this drug in children. For such cases, the drug should be used in accordance with the doctor's advice after carefully weighing the pros and cons. Precautions for pregnancy and lactation: 1. Precautions for pregnant women are limited, and the safe use of this product in pregnant women has not yet been established. Therefore, when the condition of a pregnant woman seriously requires the use of this product, it should be carefully considered by the clinician, and it can only be used when the benefits of the drug to the mother outweigh the potential risks to the fetus. 2. There is no data showing whether interferon is secreted through breast milk after the use of this product. When breastfeeding women need to use the drug, they should consider the importance of this product to the mother to decide whether to terminate breastfeeding or stop taking the drug. Precautions for the elderly: For elderly patients with heart disease and advanced cancer, an electrocardiogram should be performed before and during treatment with this product, and the use of this product should be adjusted or stopped according to the doctor's advice.

Interferon may change the activity of some enzymes, especially reduce the activity of cytochrome P450, thus affecting the metabolism of drugs such as cimetidine, warfarin, theophylline, diazepam, propranolol, etc. When used in combination with drugs with central nervous system effects, interactions may occur.

Store at 2-8℃ away from light.

1ml: 3 million international units

24 months

Tianjin Sinobioway Biomedicine Co., Ltd.

• Founded in:

  1992-10-27

• Address:

  No. 203, Huanghai Road, Tianjin Economic and Technological Development Zone

• Tax NO.:

  91120116600600595N

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  228.23410473 yuan

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