Composition: Infliximab 100mg.
Presentation: Powder for concentrate for solution for infusion.
Storage and stability: Store at 2-8C. Do not freeze.
Action: Inhibits functional activity of tumour necrosis factor a (TNF-a). Chimeric human-murine monoclonal antibody with high affinity to both soluble and transmembrane forms of TNF-a.
Indications: Severe, active Crohn's disease or fistulising Crohn's disease in patients who are unresponsive to full and adequate corticosteroid and/or immunosuppressant therapy.
Contraindications: Patients with sepsis, clinically manifested infections and/or abscesses. History of hypersensitivity to infliximab, other murine proteins or to any of the excipients.
Dosage and administration: Adults: severe, active Crohn's disease, 5mg/kg as an intravenous infusion over a two-hour period. Fistulising Crohn's disease, an initial 5mg/kg infusion given over a two-hour period followed by additional 5mg/kg infusion doses at two and six weeks after the first infusion.
Children, not recommended under 17 years of age.
Retreatment, if signs and symptoms re-occur, readminister within 14 weeks following the last infusion.
Pregnancy, not recommended.
See SPC for details on reconstitution.
Overdosage: Single doses of up to 20mg/kg have been administered without toxic effects. No clinical experience of overdose.
Precautions: Infliximab has been associated with acute infusion effects and a delayed hypersensitivity reaction. See SPC for further details.
Drug interactions: No specific studies on interactions with other medicinal products conducted.
Side effects: See SPC.
Net price: 1 vial £451.20.
Supplier: Schering-Plough Ltd, Schering-Plough House, Shire Park, Welwyn Garden City, Hertfordshire AL7 1TW. Tel 01707 363636.
Legal class: POM.