Pegylated recombinant human granulocyte-stimulating factor injection

The mechanism of action of pegylated recombinant human granulocyte-stimulating factor (PEG-rhG-CSF) is that granulocyte-stimulating factor binds to the surface receptors of hematopoietic cells and acts on hematopoietic cells, thereby stimulating proliferation, differentiation, typing and activation of mature cell functions. Compared with rhG-CSF, PEG-rhG-CSF can reduce plasma clearance rate and prolong half-life.

Active ingredient: PEGylated recombinant human granulocyte-stimulating factor (PEG-rhG-CSF), obtained by cross-linking recombinant human granulocyte-stimulating factor (rhG-CSF) with 20KD polyethylene glycol and purification. Excipients: sorbitol, polysorbate 80, acetic acid-sodium acetate buffer.

It is a clear liquid.

It is indicated for reducing the incidence of infections manifested by febrile neutropenia in patients with non-myeloid malignancies who are receiving myelosuppressive anticancer drugs that are prone to cause clinically significant febrile neutropenia.

Subcutaneous injection after the end of each chemotherapy cycle of anti-tumor drugs. The recommended dose is a fixed dose of 6 mg per injection. Xinruibai can also be individualized according to the patient's weight at 100μg/kg. Do not administer Xinruibai within 14 days before and 24 hours after chemotherapy using cytotoxic chemotherapy drugs. Before injection, check whether the Xinruibai solution is clear and transparent. If suspended matter is produced or discolored, it should not be used further. Note: Injection of 6mg or 100μg/kg dose is not recommended for infants, children and growing adolescents weighing less than 45kg.

According to the clinical trial results of Xinrebai, the main adverse reactions are as follows: 1. Musculoskeletal system: skeletal muscle pain; 2. Digestive system: constipation, nausea, vomiting, diarrhea, poor appetite; 3. Other systems: fatigue, fever, dizziness, insomnia, heart rate and rhythm disorders; 4. Immunogenicity: Like all therapeutic proteins, PEG-rhG-CSF has potential immunogenicity.

It is contraindicated for patients who are allergic to pegylated recombinant human granulocyte-stimulating factor, recombinant human granulocyte-stimulating factor, and other preparations expressed by E. coli. It is contraindicated for patients with severe liver, kidney, heart, and lung dysfunction.

Precautions during pregnancy and lactation: Use with caution in lactating women.

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

1ml:3mg*1/box (prefilled syringe)

24 months

Qilu Pharmaceutical Co., Ltd.

• Founded in:

  1992-08-21

• Address:

  No. 317, Xinluo Street, High-tech Zone, Jinan City, Shandong Province

• Tax NO.:

  91370000614073351Q

• Registered Funds:

  600 million yuan

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