REMICADE POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Manufacturer
CILAG AG(SWITZERLAND)

Registraction Number
MAL20041199AZ

Content:

• Active Ingredient: Infliximab (100 mg per vial)
• Other Ingredients: The powder contains a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology. After reconstitution, each mL contains 10 mg of infliximab.

• Rheumatoid Arthritis: Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active disease.
• Crohn's Disease: Reducing signs and symptoms, inducing and maintaining clinical remission, and closing fistulas in adult and pediatric patients.
• Ulcerative Colitis: Reducing signs and symptoms, inducing and maintaining clinical remission, and mucosal healing in adult and pediatric patients.
• Ankylosing Spondylitis: Reducing signs and symptoms in patients with active disease.
• Psoriatic Arthritis: Reducing signs and symptoms of active arthritis and improving physical function.
• Plaque Psoriasis: Reducing signs and symptoms in adult patients with moderate to severe plaque psoriasis.

1. Reconstitution: Reconstitute the powder with sterile water for injection as per the manufacturer's instructions.
2. Dosage: The recommended dose for adults is 5 mg/kg given as an intravenous infusion. For pediatric patients, the dose is also 5 mg/kg.
3. Administration: Administer the infusion over a period of at least 2 hours. Infusions should be given under the supervision of a healthcare professional experienced in the diagnosis and treatment of the relevant condition.
4. Maintenance Dosing: After the initial doses, maintenance infusions are typically given every 8 weeks.
5. Storage: Store the powder in a refrigerator at 2°C to 8°C. Reconstituted solution should be used within 24 hours if stored at room temperature or within 7 days if refrigerated.