Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
INFLIXIMAB
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
L04AB02
100 mg/vial
INJECTION, POWDER, FOR SOLUTION
INFLIXIMAB 100 mg/vial
INTRAVENOUS
Prescription Only
Patheon Italia S.p.A.
ACTIVE
2002-11-11
1 1. NAME OF THE MEDICINAL PRODUCT Remicade 100 mg powder for concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Remicade contains 100 mg of infliximab, a chimeric IgG1 monoclonal antibody manufactured from a recombinant cell line cultured by continuous perfusion. Upon reconstitution each ml contains 10 mg of infliximab. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. The powder is a freeze-dried white pellet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid arthritis: Remicade, in combination with methotrexate, is indicated for: The reduction of signs and symptoms as well as the improvement in physical function in • patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate. • patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by x-ray, has been demonstrated (see section 5.1). Crohn’s disease Remicade is indicated for: • Treatment of moderately to severely, active Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. • Treatment of fistulising Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with conve Przeczytaj cały dokument
1 PRODUCT NAME REMICADE ® (infliximab) 100 mg powder for concentrate for solution for infusion. DOSAGE FORMS AND STRENGTHS REMICADE ® is available as a powder for concentrate for solution for infusion. The powder is a freeze-dried white pellet. Each vial of REMICADE ® contains 100 mg of infliximab, a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology. Upon reconstitution, each ml contains 10 mg of infliximab. For excipients, see _List of Excipients_ . CLINICAL INFORMATION INDICATIONS RHEUMATOID ARTHRITIS REMICADE ® , in combination with methotrexate (MTX), is indicated for: The reduction of signs and symptoms as well as the improvement in physical function in • patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate. • patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by x-ray, has been demonstrated (see _Pharmacodynamic Properties_ ). CROHN’S DISEASE REMICADE ® is indicated for: • Treatment of moderately to severely, active Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. • Treatment of fistulising Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). PEDIATRIC CROHN’S DISEASE REMICADE ® is indicated for: Treatment of severe, active Crohn’s disease, in pediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. REMICADE ® has b Przeczytaj cały dokument