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Golimumab Injection.

Function and indication:
Rheumatoid arthritis: This product is used in combination with methotrexate (MTX) to treat adult patients with moderate to severe active rheumatoid arthritis who have not responded well to disease-modifying antirheumatic drugs (DMARDs) including MTX. This product combined with MTX has been shown to reduce the incidence of progressive joint damage (detected by X-ray) and improve physical function. Ankylosing spondylitis: This product is used to treat adult patients with active ankylosing spondylitis.
Usage and Dosage:
1. Intravenous drip, rheumatoid arthritis, 2 mg/kg, intravenous drip over 30 minutes at week 0 and 4, and then once every 8 weeks. This product needs to be combined with methotrexate. Other non-biological DMARDS, corticosteroids, NSAIDs and (or) analgesics can continue to be used during treatment with this product. The effectiveness and safety of switching between subcutaneous and intravenous administration have not been established. 2. Instructions for intravenous drip administration of this product: (1) At a dose of 2 mg/kg, calculate the required amount of medicine according to the patient’s weight. Each 4 ml contains 50 mg of this product. (2) The solution may contain a small amount of translucent fine particles because this product is a protein. If the solution is opaque, discolored or contains other particles, it should be discarded. (3) Dilute the total amount of this product with 0.9% sodium chloride injection to a final volume of 100 ml. Draw out an equal volume of 0.9% sodium chloride injection from the 100 ml infusion bag and bottle and slowly add this product to a total of 100 ml. Mix gently and discard the unused portion in the bottle. (4) Check the dilution of this product for insoluble particles and discoloration before infusion. If so, discard it. (5) Use an infusion line equipped with a sterile, non-pyrogenic, low protein binding filter device (pore size ≤0.22m) for infusion. (6) Do not use the same infusion line with other drugs for infusion. (7) The diluted solution of this product should be intravenously infused over 30 minutes. (8) Once this product is diluted, the diluted solution should not be stored at room temperature for more than 4 hours. 3. Subcutaneous injection: (1) RA patients: 50 mg, subcutaneous injection, once a month; must be used in combination with methotrexate. (2) PsA and AS patients: 50 mg, subcutaneous injection, once a month, can be used in combination with methotrexate or other DMARDS. (3) Moderate to severe active ulcerative colitis: 200 mg, subcutaneous injection in week 0, 100 mg in week 2; maintenance treatment: 100 mg, once every 4 weeks. 4. Instructions for subcutaneous injection: (1) Before subcutaneous administration, remove the prefilled syringe and auto-injector of this product from the original box and place at room temperature for 30 minutes before subcutaneous administration. Do not heat in any way. (2) Before administration, visually inspect the solution through the observation window for particles or discoloration. If there is discoloration, turbidity or particles, discard it. Any unused part of the prefilled syringe or pre-filled auto-injector should be discarded. (3) Patients who are allergic to latex should not touch the needle cap of the prefilled syringe or the needle cap of the prefilled syringe in the cap of the automatic syringe, because it contains dry natural rubber (a derivative of latex). (4) When administering, if multiple injections are required, administer the medicine to different parts of the body. (5) Rotate the injection site and do not inject into areas of tenderness, bruises, redness or nodules on the skin.
Adverse reactions:
1. In clinical trials, the most common adverse reaction leading to drug discontinuation was sepsis (0.2%). 2. Common infections include mycobacterial infections, invasive fungal infections, bacteria, viruses and other opportunistic pathogens. During and after the use of this product,


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