ts.
Re-administration for ulcerative colitis
The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Re-administration for ankylosing spondylitis
The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Re-administration for psoriatic arthritis
The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Re-administration for psoriasis
Limited experience from re-treatment with one single Remicade dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1).
Limited experience from re-treatment following disease flare by a re-induction regimen suggests a higher incidence of infusion reactions, including serious ones, when compared to 8-weekly maintenance treatment (see section 4.8).
Re-administration across indications
In case maintenance therapy is interrupted, and there is a need to restart treatment, use of a re-induction regimen is not recommended (see section 4.8). In this situation, Remicade should be re-initiated as a single dose followed by the maintenance dose recommendations described above.
Elderly patients ( 65 years)
Specific studies of Remicade in elderly patients have not been conducted. No major age-related differences in clearance or volume of distribution were observed in clinical studies. No dose adjustment is required (see section 5.2). For more information about the safety of Remicade in elderly patients see sections 4.4 and 4.8.
Impaired renal and/or hepatic function
Remicade has not been studied in these patient populations. No dose recommendations can be made (see section 5.2).
Paediatric population
Crohn's disease (6 to 17 years)
5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient. Available data do not support further infliximab treatment in children and adolescents not responding within the first 10 weeks of treatment (see section 5.1).
Remicade has not been studied in patients with Crohn's disease below the age of 6 years.
Ulcerative Colitis
The safety and efficacy of Remicade in children and adolescents younger than 18 years in the indication ulcerative colitis have not been established. No data are available.
Psoriasis
The safety and efficacy of Remicade in children and adolescents younger than 18 years in the indication psoriasis have not been established. No data are available.
Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis
The safety and efficacy of Remicade in children and adolescents younger than 18 years in the indications juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established. No data are available.
Juvenile rheumatoid arthritis
The safety and efficacy of Remicade in children and adolescents younger than 18 years in the indication juvenile rheumatoid arthritis have not been established. Currently available data are described in section 4.8 but no recommendation on a posology can be made. |
