Infliximab

【Product name】REMICADE, Remicade

[English common name]Infliximab

[Chinese common name]Infliximab

[English name]

[Chinese other name]

[indications]
Rheumatoid Arthritis
This product is a disease-control anti-rheumatic drug. For patients with moderate to severe active rheumatoid arthritis, this product can be used in combination with methotrexate:
· Reduce symptoms and signs;
· Improve physical function and prevent disability in patients.
Crohn's disease
For patients with moderate to severe active Crohn's disease who are not well received by traditional treatment, this product can be used for:
· Reduce symptoms and signs;
· Achieve and maintain clinical efficacy;
· Promote mucosal healing;
· Improve the quality of life;
· Reduce the amount of corticosteroids or stop using corticosteroids.
Tracheal Crohn's disease
For patients with fistile Crohn's disease, this product can be used for:
Reduce the number of intestinal-cutaneous fistulas and rectal-vaginal fistulas to promote and maintain fistula healing;
· Reduce symptoms and signs;
· Improve the quality of life.
Ankylosing spondylitis
For patients with active ankylosing spondylitis, this product can be used for:
· Alleviate symptoms and signs, including increasing the range of activity;
· Improve physical function;
· Improve the quality of life.
psoriasis
For patients with psoriasis, this product can be used for:
Adult patients with chronic severe plaque psoriasis who require systemic treatment and are ineffective, contraindicated or tolerant to other systems such as cyclosporine, methotrexate or photochemotherapy. This product is intended for use only in patients who are treated under close supervision by a physician and regularly followed up by a physician.

【Dosage】
Usage: intravenous infusion.
Rheumatoid Arthritis
The product was administered 3 mg/kg for the first time, and then the same dose was administered once every 8 weeks after the second week and the sixth week after the first administration and thereafter. This product should be combined with methotrexate. For patients with poor efficacy, consider adjusting the dose to 10 mg/kg and/or adjusting the medication interval to 4 weeks.
Moderate and severe active Crohn's disease, fistula Crohn's disease
The product was administered 5 mg/kg for the first time, and then the same dose was administered once every 8 weeks after the second week and the sixth week after the first administration and thereafter. For patients with poor efficacy, consider adjusting the dose to 10 mg/kg.
Ankylosing spondylitis
The product was administered 5 mg/kg for the first time, and then the same dose was administered once every 6 weeks after the second week and the sixth week after the first administration and thereafter.
User guides
Sterility should be performed.
1. Calculate the dosage and determine the number of bottles used in this product: This product contains 100mg of infliximab per bottle, and calculate the total amount of the solution to be prepared.
2. Dissolve each bottle of medicine with 10 ml of sterile water for injection using a syringe equipped with a 21 gauge (0.8 mm) or smaller needle: remove the flip of the vial, wipe the top of the vial with a medical alcohol swab, and insert the syringe needle into the vial Cover, inject sterile water for injection. If the vacuum in the vial has been destroyed, the bottle cannot be used. Gently rotate the vial to dissolve the powder. Avoid shaking for a long time or with force. Do not oscillate. Foam may appear during the dissolution of the drug. After 5 minutes of storage, the solution should be colorless or light yellow, and the milk is white. Since infliximab is a protein, there may be some translucent particles in the solution. If opaque particles, discoloration or other substances appear in the solution, they cannot be used any more.
3. Dilute the sterile aqueous solution of this product to 250 ml with 0.9% sodium chloride injection: withdraw the same amount of liquid from the 250 ml 0.9% sodium chloride injection bottle or bag as the sterile injectable aqueous solution of this product. The sterile aqueous solution for injection of this product is completely injected into the infusion bottle or bag and gently mixed.
4. The infusion time should not be less than 2 hours: the infusion set should be equipped with a built-in, sterile, pyrogen-free, low protein binding filter (pore size ≤ 1.2 μm). Unused infusions should not be stored for further use.
5. The physical and biochemical compatibility studies of this product in combination with other drugs have not been carried out, and this product should not be infused simultaneously with other drugs.
Products administered parenterally should be visually inspected for the presence of particulate matter or discoloration prior to administration. If opaque particles, discoloration, or other foreign matter are found, the drug may not be used.
Plaque psoriasis
The product was administered 5 mg/kg for the first time, and then the same dose was administered once every 8 weeks after the second week and the sixth week after the first administration and thereafter. If the patient does not respond after week 14 (ie, after 4 doses), the product should not be treated.
Psoriasis patients re-administered
Patients with psoriasis have limited experience with a single administration after 20 weeks, suggesting a reduction in the effectiveness of the product compared to the initial induction therapy and an increase in mild to moderate infusion response.
After relapse of the disease, limited experience with repeated induction therapy showed an increase in infusion response (including severe reactions) compared to 8-week maintenance therapy.
If treatment interruption is maintained, it is not recommended to initiate induction therapy again and should be re-administered according to maintenance therapy.

[Storage]Store at 2-8 °C in the dark.

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