Recombinant human erythropoietin injection (CHO cells)

1 Pharmacology: Erythropoietin is an active glycoprotein secreted by the kidneys. It acts on erythroid hematopoietic progenitor cells in the bone marrow and can promote their proliferation and differentiation. This product can induce a significant effect of stimulating colony formation through late mother erythroid progenitor cells (CFUE). At high concentrations, this product can also stimulate early mother erythroid progenitor cells (BFUE) to induce colony formation; 2 Toxicology: 2.1 Acute toxicity: The LD50 of intravenous injection to mice, rats and dogs and the LD50 of injection to rat pups 4 days after birth are all above 20,000 IU/kg. 2.2 Subacute and chronic toxicity: (1) The results of subacute and chronic toxicity experiments on male and female rats were conducted by intravenous or intraperitoneal injection of this product for 4 weeks, 13 weeks and 52 weeks respectively. The results showed that when this product was administered at a dose of 80 IU/kg/day, more than 20 IU/kg/day and more than 10 IU/kg/day for 4 weeks, 13 weeks and 52 weeks respectively, it caused polycythemia mainly due to excessive pharmacological effects of this product, and long-term administration of this product resulted in the occurrence of bone marrow fibrosis. (2) The results of subacute and chronic toxicity studies conducted on female and male dogs by intravenous injection at 4 weeks, 13 weeks and 52 weeks respectively showed that when the drug was administered at a dose of 200 IU/kg/day, 100 IU/kg/day or more, and 20 IU/kg/day or more at a dose of 4 weeks, 13 weeks and 52 weeks respectively, polycythemia was caused mainly due to excessive pharmacological effects of the drug, and long-term administration resulted in bone marrow fibrosis and structural changes in the kidneys.

Main ingredients: Recombinant human erythropoietin.

This product is a colorless and clear liquid with a pH of 6.9±0.5.

1. Anemia caused by renal insufficiency, including dialysis and non-dialysis patients. 2. Red blood cell mobilization during perioperative period of surgery. 3. Anemia caused by chemotherapy in the treatment of non-bone malignant tumors. It is not used to treat anemia caused by other factors (such as iron or folate deficiency, hemolysis or gastrointestinal bleeding) in cancer patients.

1. Renal anemia: This product should be used under the guidance of a doctor. It can be injected subcutaneously or intravenously, and is administered 2 to 3 times a week. The dosage needs to be adjusted according to the patient's anemia degree, age and other relevant factors. The following scheme is for reference: Treatment period: The recommended dose for hemodialysis patients is 100 to 150 IU/kg body weight per week, and for non-dialysis patients it is 75 to 100 IU/kg body weight per week. If the hematocrit increases by less than 0.5 vol% per week, the dose can be increased by 15 to 30 IU/kg body weight after 4 weeks, but the maximum increase should not exceed 30 IU/kg body weight/week. The hematocrit should be increased to 30 to 33 vol%, but should not exceed 36 vol%. Maintenance period: If the hematocrit reaches 30 to 33 vol% or the hemoglobin reaches 100 to 110 g/L, the maintenance treatment phase begins. It is recommended to adjust the dose to 2/3 of the treatment dose, and then check the hematocrit every 2 to 4 weeks to adjust the dose, avoid excessive red blood cell production, and maintain the hematocrit and hemoglobin at appropriate levels; 2 Surgical perioperative red blood cell mobilization is suitable for elective surgical patients (except cardiovascular surgery) with preoperative hemoglobin values of 100 to 130 g/L. The dosage is 150 IU/kg body weight, 3 times a week, subcutaneous injection, applied 10 days before surgery to 4 days after surgery, which can reduce intraoperative and postoperative anemia, reduce the need for allogeneic blood transfusion, and accelerate the recovery of postoperative anemia tendency. To prevent iron deficiency during medication, iron supplements can be taken at the same time; 3 Anemia caused by tumor chemotherapy When the patient's overall serum erythropoietin level is 200 mu/ml, this product is not recommended for treatment. Clinical data show that patients with low basal erythropoietin levels have better efficacy than those with high basal levels. The starting dose is 150 IU/kg/time, subcutaneous injection, three times a week. If after 8 weeks of treatment, the need for blood transfusions or increase in hematocrit cannot be effectively reduced, the dose can be increased to 200 IU/kg/time, subcutaneously injected, three times a week. If the hematocrit is 40%, the dose of this product should be reduced until the hematocrit drops to 36%. When treatment is restarted or the dose is adjusted to maintain the required hematocrit, the dose of this product should be reduced by 25%. If the initial treatment dose achieves a very rapid increase in hematocrit (e.g., an increase of 4% within any 2 weeks), the dose of this product should also be reduced; 4. Usage: Use aseptic technique, open the medicine bottle, connect the sterile needle to the sterile syringe, inhale an appropriate amount of liquid medicine, and inject intravenously or subcutaneously.

1 General reactions: A small number of patients may experience headache, low fever, fatigue, etc. in the early stage of medication. Some patients may experience myalgia, joint pain, etc. Most adverse reactions can be improved after symptomatic treatment and will not affect continued medication. In very rare cases, if the above symptoms persist, you should consider stopping the medication; 2 Allergic reactions: A very small number of patients may experience allergic reactions such as rash or urticaria after medication, including anaphylactic shock. Therefore, when using this product for the first time or reusing this product, it is recommended to use a small amount first, and after confirming that there are no abnormal reactions, inject the full amount. If any abnormality is found, the drug should be stopped immediately and properly handled; 3 Cardiovascular and cerebrovascular system: increased blood pressure, worsening of existing hypertension, and headaches, impaired consciousness, and convulsions due to hypertensive encephalopathy, and may even cause cerebral hemorrhage. Therefore, during the injection of erythropoietin

1. Patients with uncontrolled severe hypertension; 2. Patients who are allergic to this product and other mammalian cell derivatives, and those who are allergic to human serum albumin; 3. Patients with concurrent infections should use this product only after the infection is controlled.

Not yet clear.

Store at 2-8℃ away from light.

1000IU/ml/bottle

Chengdu DIAO Jiuhong Pharmaceutical Factory

• Founded in:

  1996-11-27

• Address:

  No. 16, Gaopeng East Road, Chengdu Hi-tech Zone

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  91510100202172097P

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  10 million yuan

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