Recombinant human granulocyte macrophage stimulating factor for injection

1 Pharmacological action: Recombinant human granulocyte macrophage colony stimulating factor (rhGM-CSF) acts on hematopoietic progenitor cells to promote their proliferation and differentiation. Its important role is to stimulate the maturation of granulocytes and mononuclear macrophages, promote the release of mature cells into the peripheral blood, and promote the various functions of macrophages and eosinophils. 2 Toxicological action: 1) Acute toxicity: The results showed that the LD50 could not be calculated when the maximum concentration was injected intravenously and subcutaneously into mice. The maximum tolerated dose is 5000 μg/kg, which is 500 to 1000 times the clinical dose for humans (5 to 10 μg/kg). After 14 days of observation, no obvious effects were observed in animals by both subcutaneous and intraperitoneal routes of administration.

Main ingredients: recombinant human granulocyte macrophage colony stimulating factor

This product is white or milky white loose body.

1. Prevent and treat leukopenia caused by tumor radiotherapy or chemotherapy. 2. Treat bone marrow hematopoietic dysfunction and myelodysplastic syndrome. 3. Prevent potential infectious complications during leukopenia. 4. Accelerate the recovery of neutrophil counts caused by infection.

1. After radiotherapy and chemotherapy for tumors: This product can be used 24 to 48 hours after radiotherapy and chemotherapy are stopped. Dissolve this product with 1 ml of sterile water for injection (do not shake it), and inject it subcutaneously in the abdomen, outer thigh or deltoid muscle of the upper arm (the local skin should bulge about 1cm2 after injection to allow the drug to be slowly absorbed). 3 to 10μg/kg per body weight, once a day, for 5 to 7 days. The maintenance dose is determined based on the recovery speed and level of white blood cells. The next course of radiotherapy and chemotherapy can be carried out at least 48 hours after stopping this product. 2. Bone marrow transplantation: 5 to 10μg/kg per body weight, intravenous drip for 4 to 6 hours, once a day, and continue to be used until the absolute number of neutrophils is ≥1000/μl for 3 consecutive days. 3. Myelodysplastic syndrome/aplastic anemia: 3 μg/kg per day, subcutaneously. It takes 2 to 4 days to observe the initial effect of leukocytosis. Thereafter, adjust the dose to maintain the white blood cell count at the desired level, usually <10,000/μl.

The safety of this product is related to the dose and route of administration. Most adverse reactions are mild to moderate, and severe reactions are rare. The most common adverse reactions are fever, chills, nausea, dyspnea, and diarrhea, which can be relieved by general symptomatic treatment; followed by rash, chest pain, bone pain, and diarrhea. According to foreign reports, hypotension and hypoxia syndrome may occur at the first dose, but not in subsequent doses. Adverse reactions are more common with intravenous push and rapid drip, and doses greater than 32μg/kg/day.

1. Patients with a history of allergy to rhGM-CSF or any other component of the preparation. 2. Patients with autoimmune thrombocytopenic purpura.

Precautions for children: Use with caution. Precautions for pregnancy and lactation: The safety of this product for pregnant and lactating women has not been established and should be used with caution. Precautions for the elderly: Observe the patient's condition, pay attention to the dosage and interval, and administer the drug with caution.

1. This product can increase bone marrow toxicity when used with chemotherapy drugs. Therefore, it should not be used with chemotherapy drugs at the same time. It should be used 24 to 48 hours after the end of chemotherapy. 2. This product can cause a decrease in plasma albumin. Therefore, when using drugs with high plasma albumin binding at the same time, you should pay attention to adjusting the dosage of the drug. 3. For those who have injected immunoglobulin, they should wait for more than 1 month before inoculating this product.

Store at 2～8℃ away from light

100μg/vial

24 months

Xiamen Amoytop Biotech Co., Ltd.

• Founded in:

  1996-08-07

• Address:

  No. 330, Wengjiao Road, Xinyang Industrial Zone, Haicang, Xiamen

• Tax NO.:

  913502002600603688

• Registered Funds:

  406.8 million yuan

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