Riik: Singapur
keel: inglise
Allikas: HSA (Health Sciences Authority)
Infliximab
CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED
L04AB02
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Infliximab 100mg/vial
INTRAVENOUS
Prescription Only
Mustafa Nevzat Ilac Sanayii A.S.
ACTIVE
2016-03-28
PRODUCT NAME REMSIMA ® 100 mg/vial powder for concentrate for solution for infusion. DOSAGE FORMS AND STRENGTHS Each vial of REMSIMA ® contains 100 mg of infliximab a chimeric lgG1 monoclonal antibody manufactured from a recombinant cell line cultured by continuous perfusion. Upon reconstitution each ml contains 10 mg of infliximab. For excipients, see List of Excipients . Powder for concentrate for solution for infusion. The powder is a freeze-dried white pellet. CLINICAL INFORMATION INDICATIONS RHEUMATOID ARTHRITIS REMSIMA ® , 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 REMSIMA ® 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). PAEDIATRIC CROHN’S DISEASE REMSIMA ® is indicated for: Treatment of severe, active Crohn’s disease, in paediatric 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. REMSIMA ® has been studied only in combination with conventional immunosuppr Lugege kogu dokumenti