Recombinant human interferon α1b for injection

This product has broad-spectrum antiviral, anti-tumor and immunomodulatory functions. Interferon binds to cell surface receptors, inducing cells to produce a variety of antiviral proteins, thereby inhibiting the replication of viruses in cells; it can enhance the specific cytotoxic effect of macrophages and lymphocytes on target cells by regulating immune function, effectively curbing the occurrence of viral invasion and infection; enhancing the activity of natural killer cells, inhibiting the growth of tumor cells, and clearing early malignant cells. Acute toxicity test: mice were injected with 3 times the human dose (calculated by body weight) of this product through the tail vein, and there was no acute toxic reaction. Long-term toxicity test: dogs were injected with 5.6 times and 28 times the human dose; rats were injected with 5.6 times, 28 times and 140 times the human dose (all calculated by body weight), and the injections were continued for 3 months and 6 months respectively. All animals survived and no toxic reactions were observed. No pathological changes of toxicological significance were found in blood and bone marrow smears and organ pathological sections.

The main ingredient of this product is recombinant human interferon α1b, which is made from Escherichia coli containing highly efficient expression of human interferon α1b gene, which is fermented, separated and highly purified before freeze-drying. Excipients: human serum albumin, sodium chloride

This product is a white, thin, loose shell. After adding 1 ml of sterile water for injection, it will quickly dissolve into a clear liquid.

This product is suitable for the treatment of viral diseases and certain malignant tumors. It has been approved for the treatment of chronic hepatitis B, hepatitis C and hairy cell leukemia. Clinical trial results and literature reports have shown that it is effective in treating viral diseases such as herpes zoster, condyloma acuminatum, epidemic hemorrhagic fever and respiratory syncytial virus pneumonia in children. It can be used to treat malignant tumors such as chronic myeloid leukemia, melanoma, lymphoma, etc.

Dissolve each vial in 1ml of sterile water for injection and inject intramuscularly or subcutaneously. The dosage and course of treatment are as follows: Chronic hepatitis B: 30~50μg of this product once, once every other day, subcutaneously or intramuscularly, for a course of 4~6 months, which can be extended to 1 year depending on the condition. Induction therapy can be performed, that is, at the beginning of treatment, take the drug once a day, and change to once every other day after 0.5~1 month until the end of the course of treatment. Chronic hepatitis C: 30~50μg of this product once, once every other day, subcutaneously or intramuscularly. Treat for 4~6 months, and discontinue if ineffective. Those who are effective can continue treatment for up to 12 months. It can be extended to 18 months depending on the condition. In the first month of treatment, take it once a day. Follow up for 6~12 months after the end of the course of treatment. Acute hepatitis C should be treated with this product early to reduce chronicity. Chronic myeloid leukemia: 30~50μg of this product once a day, subcutaneously or intramuscularly, for more than 6 months. It can be adjusted appropriately according to the condition, and can be changed to injection every other day after remission. Hairy cell leukemia: 30~50μg of this product once a day, subcutaneously or intramuscularly, for more than 6 months. It can be adjusted appropriately according to the condition, and can be changed to injection every other day after remission. Genital warts: 10~30μg of this product once a day, subcutaneously or intramuscularly, or 10μg once a time, local injection under the wart, once every other day, for 3 consecutive weeks as a course of treatment. The course of treatment can be extended or repeated according to the condition. Tumor: 30~50μg of this product once a day or once every other day, subcutaneously or intramuscularly, for more than 6 months. The course of treatment can be extended depending on the condition. If the patient does not experience rapid deterioration of the condition or serious adverse reactions, the medication should be continued at an appropriate dose.

The adverse reactions of this product are mild, the most common of which are fever, fatigue, etc., which often appear in the early stage of medication and are mostly one-time and reversible reactions; other possible adverse reactions include headache, myalgia, joint pain, loss of appetite, nausea and hair loss; a few patients may experience abnormal blood counts such as leukopenia and thrombocytopenia, which can be restored after stopping the drug. If the above-mentioned serious adverse reactions that the patient cannot tolerate occur, the dosage should be reduced or the drug should be stopped, and necessary symptomatic treatment should be given.

1. Those who are known to be allergic to interferon products. 2. Those with a history of angina pectoris, myocardial infarction, and other serious cardiovascular diseases. 3. Those with other serious diseases who cannot tolerate the side effects of this product. 4. Those with epilepsy and other central nervous system disorders.

Precautions for children: This product is feasible for treating viral diseases in children, and no toxic or side effects have been found. However, there is not much experience so far. When using it, it should be under the close observation of a pediatrician, and the dosage should be appropriately controlled to accumulate more experience. Precautions for pregnancy and lactation: There is not much experience in the use of this product in pregnant and lactating women, so it should be used with caution. It should be used under the guidance of a doctor when the condition is very necessary. Precautions for the elderly: This product can be used in elderly patients, except for those with contraindications. It should be used with great caution for those who are old and weak and cannot tolerate the possible adverse reactions, and should be used under the close observation of a physician. It should be used with caution when using a larger dose. If necessary, a small dose can be used first, and gradually increasing the dose can reduce adverse reactions.

Sleeping pills and sedatives should be used with caution when using this product.

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

50 micrograms/vial

30 months

Shenzhen Kexing Pharmaceutical Co., Ltd.

• Founded in:

  2018-03-23

• Address:

  Room B1601, Chuangyi Technology Building, Kejizhong 1st Road, Maling Community, Yuehai Subdistrict, Nanshan District, Shenzhen

• Tax NO.:

  91440300MA5F1UL356

• Registered Funds:

  230 million yuan

• Email:

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