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Infliximab for Injection

Effects and efficacy: This product is mainly used to treat rheumatoid arthritis, Crohn’s disease, fistulizing Crohn’s disease and ankylosing spondylitis. It is used in combination with methotrexate for moderate to severe active rheumatoid arthritis. It can be used for fistulizing Crohn’s disease and moderate to severe active Crohn’s disease that is not effective with traditional treatment. It can be used for active ankylosing spondylitis. It can be used for chronic severe plaque psoriasis that requires systemic treatment and is ineffective, contraindicated or intolerant to other systemic treatments such as cyclosporine, methotrexate or photochemotherapy. This product is only used for adult patients who can be treated under the close supervision of a physician and are regularly followed up by a physician. It is used for moderate to severe active ulcerative colitis that is not effective, intolerant or medically contraindicated to traditional conventional treatment.
Dosage and administration: For rheumatoid arthritis, the first dose of this product is 3 mg/kg, and then the same dose is given every 8 weeks in the second and sixth weeks after the first dose. This product should be used in combination with methotrexate. For patients with poor efficacy, the dose may be adjusted to 10 mg/kg, and/or the medication interval may be adjusted to 4 weeks. Please follow your doctor’s advice for details. For ankylosing spondylitis, the first dose of this product is 5 mg/kg, and then the same dose is given once in the 2nd and 6th weeks after the first dose and every 6 weeks thereafter. Please follow your doctor’s advice for details. For Crohn’s disease 1. For adults with moderate to severe active Crohn’s disease and fistulizing Crohn’s disease, the first dose of this product is 5 mg/kg, and then the same dose is given once in the 2nd and 6th weeks after the first dose and every 8 weeks thereafter. For patients with poor efficacy, the dose may be adjusted to 10 mg/kg. Please follow your doctor’s advice for details. 2. For children with moderate to severe active Crohn’s disease (6 years and above), the first dose of this product is 5 mg/kg, and then the same dose is given once in 0, 2, 6 weeks and every 8 weeks thereafter. Existing data do not support the continued use of this product in children and adolescents who have not responded within the first 10 weeks of treatment. Some patients may need a shorter dosing interval to maintain their clinical benefit, while for other patients, extending the dosing interval can also produce sufficient clinical benefit. The risk of adverse reactions in children who increase the dose to more than 5 mg/kg (once every 8 weeks) may increase. For patients who do not gain more therapeutic benefits after dose adjustment, careful consideration should be given to whether to continue treatment with the adjusted dose. Children’s medication must be carried out under the guidance of a doctor and adult supervision. For psoriasis 1. For plaque psoriasis, this product is first administered at 5 mg/kg, then once at 0, 2, and 6 weeks, and then the same dose is administered every 8 weeks. If the patient does not respond after the 14th week (i.e., after 4 doses), this product should not be continued for treatment and should be discontinued in time. Please follow the doctor’s advice for details. 2. There is limited experience in re-administering this product to patients with psoriasis after a single dose of 20 weeks. Compared with the initial induction treatment, the effectiveness of this product may be reduced, and mild to moderate infusion reactions increase, so vigilance should be increased. After disease relapse, limited experience with repeated induction therapy has shown that infusion reactions (including severe reactions) are increased compared with maintenance therapy once every 8 weeks. If maintenance therapy is interrupted, it is not recommended to restart induction therapy, and the drug should be re-administered as maintenance therapy. Please follow your doctor’s advice for details. For ulcerative colitis, for adult ulcerative colitis, 5 mg/kg of this product is given for the first time, and then the same dose is given once every 8 weeks in the 2nd and 6th weeks after the first dose and thereafter. Please follow your doctor’s advice for details.
Adverse reactions:
Upper respiratory tract infection is the most common adverse drug reaction of this product. Other adverse reactions are as follows: Infusion-related reactions About 20% of patients treated with this product will experience infusion reactions. Among all infusion reactions, 3% are accompanied by non-specific symptoms such as fever or chills, 1% are accompanied by cardiopulmonary reactions (mainly chest pain, hypotension, hypertension or dyspnea), and <1% are accompanied by itching, urticaria or itching and urticaria combined symptoms and cardiopulmonary reactions. <1% of patients may experience severe infusion reactions, including allergic reactions, such as laryngeal (pharyngeal) edema and severe bronchospasm and epileptic seizures, convulsions, erythematous rash and hypotension. Approximately 3% of patients discontinued the drug due to infusion reactions. Reaction after re-administration In clinical studies, it was found that after re-administration of infliximab, some patients experienced adverse reactions, with symptoms and signs such as fever and/or rash, myalgia and/or arthralgia. Some patients may also experience facial, hand or lip edema, as well as itching, dysphagia, urticaria, sore throat, headache, etc. The most frequent infections are respiratory tract infections (including rhinitis, laryngitis and bronchitis) and urinary tract infections. Severe infections include tuberculosis infection, pneumonia, cellulitis abscesses, skin ulcers and sepsis. Autoantibodies (lupus-like syndrome) In clinical trials, about half of patients with negative baseline antinuclear antibodies treated with infliximab developed positive antinuclear antibodies, and about 20% of patients treated with infliximab had newly detected anti-ds-DNA antibodies, but lupus and lupus-like syndrome may still occur. Malignant diseases: In controlled trials, patients treated with infliximab had a higher incidence of malignant diseases than those treated with placebo, the most common of which were lymphoma, breast cancer, colorectal cancer, and melanoma. Immunogenicity Antibodies to infliximab may appear after administration of this product. After 3 induction regimens, the incidence of anti-infliximab antibodies is about 10% after 1-2 years of maintenance dose treatment. Antibody-positive patients are more likely to have increased clearance, reduced effectiveness, and more infusion reactions than antibody-negative patients. The incidence of antibodies is lower in patients who are also receiving immunosuppressive drugs such as methotrexate (MTX). Hepatotoxicity Long-term carriers of hepatitis B virus (surface antigen positive) have experienced reactivation of hepatitis B in patients receiving infliximab. In clinical trials, patients receiving infliximab were observed to have more frequent elevations of aminotransferases (ALT more often than AST) than controls. Patients with elevated ALT and AST are generally asymptomatic, and these abnormalities decrease or disappear regardless of whether infliximab is continued or discontinued. Other systemic conditions: allergies, diaphragmatic hernia, edema, surgical sequelae, sepsis, serum sickness. Cardiovascular system: circulatory failure, hypotension, syncope, arrhythmia, bradycardia (tachycardia). Digestive system: constipation, gastrointestinal bleeding, small intestinal perforation, small intestinal stenosis, pancreatitis, peritonitis, anal hemorrhoids, bile duct pain, cholecystitis, cholelithiasis, hepatitis. Endocrine system: parathyroid disease. Blood and lymphatic system: pancytopenia, thrombocytopenia, hemolytic anemia, leukopenia, lymphadenopathy. Metabolic and nutritional diseases: dehydration. Musculoskeletal system: intervertebral disc herniation, tendon disease. Tumor formation: basal cell tumor. Nervous system: meningitis, neuritis, peripheral neuropathy, vertigo. Respiratory system: adult respiratory distress syndrome, lower respiratory tract infection (including pneumonia), pleural effusion, pleurisy, pulmonary edema, dyspnea. Skin and appendages: increased sweating, ulcers, cellulitis. Thrombosis: cerebral infarction, pulmonary embolism, thrombophlebitis, lower limb thrombosis. Urogenital system: kidney stones, renal failure, menstrual disorders. If you feel any discomfort during medication, please consult a doctor in time. Drug contraindications: Allergic to this product is prohibited. It is prohibited during pregnancy and lactation.

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