Recombinant human erythropoietin-β injection

1. The amino acid and carbohydrate composition of recombinant human erythropoietin-β is consistent with that of erythropoietin isolated from the urine of anemic patients. 2. Erythropoietin is a glycoprotein that promotes erythropoiesis by stimulating stem cell precursors and acts as a mitogenic stimulator and differentiation hormone. 3. The biological effects of recombinant human erythropoietin-β have been confirmed after intravenous and subcutaneous injection. After administration of recombinant human erythropoietin-β in various carrier animal models (normal and uremic rats, polycythemia mice, dogs), total iron binding rate, red blood cell number, hemoglobin level and reticulocyte count increased. In the mouse spleen cell culture carrier experiment, it was found that after incubation with recombinant human erythropoietin-β, the 3H-thymidine incorporation rate of nucleated erythrocytes in the spleen increased. Investigations of human bone marrow cell culture showed that injection of recombinant human erythropoietin-β only stimulated erythropoiesis without affecting leukocytes. No toxic effects of recombinant human erythropoietin-β on human bone marrow or skin cells have been found, nor have any preclinical or clinical studies shown that recombinant human erythropoietin-β has an effect on tumor progression. 4. A single dose of recombinant human erythropoietin-β had no effect on the behavior and movement of mice, nor on the respiration and circulation of dogs.

Recombinant human erythropoietin epoetinbeta; (rhEPO)

Clear liquid

Rocoman is suitable for dialysis patients with anemia caused by chronic renal failure. Rocoman is suitable for the treatment of pathological renal anemia in patients with non-dialysis renal insufficiency.

The freeze-dried powder can be injected subcutaneously or intravenously after dissolution. ① Dosage (each time and weekly dose) The treatment goal is to increase the hematocrit between 30-35%, with an average weekly increase of at least 0.5%, and the highest level cannot exceed 35%. If there is hypertension or cardiovascular disease, cerebrovascular or peripheral vascular disease, etc., the weekly increase and target level should be determined according to individual conditions. For some patients, the ideal level may be lower than 30%. The hematopoietic treatment program is divided into two steps: a. Treatment period: subcutaneous injection: The initial treatment dose is 3×20IU/kg body weight per week. If it is found that the hematocrit increase is not ideal (less than 0.5vol% per week), the dose can be increased by 33×20IU/kg body weight/week after every 4 weeks. At the same time, the weekly dose can also be divided into daily doses. Intravenous injection: The initial treatment dose is 33×40IU/kg body weight per week. If the increase in blood cells is not ideal (less than 0.5 vol% per week), the dose can be increased to 3 × 80 IU/kg body weight/week after 4 weeks. Thereafter, the dose can be increased by 3 × 20 IU/kg body weight/week every month. For the above two routes of administration, the maximum dose should not exceed 720 IU/kg body weight per week. b. Maintenance period: To maintain the hematocrit between 30 vol% and 35 vol%, first reduce the dose to half of the treatment dose, and then adjust the dose every week or every two weeks. Clinical observations on children show that, on average, the younger the patient, the higher the maintenance dose of hematopoietic hormone. However, due to the different reactions of individual patients, it is difficult to estimate, so this drug should be used according to the recommended dose. ② Treatment course Hematopoietic hormone is generally used for long-term treatment, but if necessary, the course of treatment can be terminated at any time. ③ Usage Hematopoietic hormone should be used under the careful monitoring and guidance of medical personnel. Since cases of allergic reactions have been found, it is recommended that the first administration should be carried out under the supervision of medical personnel. Hematopoietin is supplied as a lyophilized powder in a vial. When used, dissolve hematopoietin in the accompanying solvent, but it should be used immediately (within 2 hours). Before use, make sure that the solution is colorless and particle-free, transparent or slightly milky before use. Leftover medicine should be discarded. This drug solution can be used for subcutaneous injection or intravenous injection. Intravenous injection should be completed within about 2 minutes. For example, it is injected through an arteriovenous fistula at the end of the dialysis process. Non-dialysis patients should use subcutaneous injection to avoid puncturing peripheral veins. ④Important contraindications for coordination Pay attention to the following tips to avoid incompatibility or affecting activity; - Do not use other solvents! - Do not mix with other drugs! - Do not use glass injection utensils, use plastic products!

Cardiovascular system: The most common adverse reactions during treatment are increased blood pressure or worsening of hypertension, which can be treated with appropriate medications. If the increase in blood pressure cannot be controlled by medication, hematopoietic hormone must be temporarily discontinued. In addition to regular blood pressure testing, patients should also be monitored between appropriate analyses (especially in the early stages of treatment). Hypertensive crisis accompanied by encephalopathy-like symptoms (such as headache, mental confusion, sensory and/or motor center disorders, such as speech disorders, gait disorders and clonic seizures, etc.) may occur in patients with normal blood pressure or hypotension. Such patients should be closely monitored immediately, especially those with acute needle-like migraine. Blood: Hematopoietic hormone may cause a slight increase in platelets within the normal range, especially after intravenous injection. The situation generally disappears with continued treatment, although

Rocoman is contraindicated in patients with uncontrolled hypertension.

Precautions for children: No relevant studies have been conducted in children. Precautions for pregnancy and lactation: There is currently no clinical research data on recombinant human erythropoietin-β for pregnant women. Animal studies have shown that there are no direct or indirect harmful effects during pregnancy, embryo/fetal development, delivery or postpartum development. The drug should be used with caution in pregnant women. Precautions for the elderly: No relevant studies have been conducted in elderly patients.

1. So far, clinical results have not shown that this product interacts with other drugs. 2. Animal experiments have shown that recombinant human erythropoietin-β does not increase the bone marrow toxicity of cell growth inhibitory drugs such as etoposide, cisplatin, cyclophosphamide, and fluorouracil.

Store at 2-8℃. If the refrigeration temperature is interrupted during transportation, the time should not exceed 5 days and the temperature should not exceed 25℃.

4000IU/0.3ml/vial

24 months