Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Infliximab (PF-06438179)
PFIZER PRIVATE LIMITED
L04AB02
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Infliximab (PF-06438179) 100mg / vial
INTRAVENOUS
Prescription Only
Pfizer Manufacturing Belgium NV
ACTIVE
2020-06-03
IXIFI™ Infliximab 1. NAME OF THE MEDICINAL PRODUCT IXIFI Powder for Concentrate for Solution for Infusion 100 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single dose vial contains 100 mg of infliximab in a 15 mL vial. After reconstitution with 10 mL of Sterile Water for Injection, each mL contains 10 mg of infliximab. Infliximab, the active ingredient in IXIFI, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions) specific for human tumor necrosis factor-alpha (TNFα), with an identical amino acid sequence for the variable and constant regions and identical primary structure with Remicade (infliximab), the reference product. It has a molecular weight of approximately 149 kilodaltons. The manufacturing process for infliximab drug substance uses a recombinant Chinese hamster ovary (CHO) cell line that contains the DNA encoding the sequence for infliximab and is grown in suspension culture using chemically-defined (CD), animal-derived component-free (ACF) media. 3. PHARMACEUTICAL FORM White, lyophilized powder for intravenous (IV) infusion. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS RHEUMATOID ARTHRITIS (RA) IXIFI, in combination with methotrexate (MTX), is indicated for: The reduction of signs and symptoms as well as the improvement in physical function in • adult patients with active disease when the response to disease-modifying drugs, including MTX, has been inadequate. • adult patients with severe, active and progressive disease not previously treated with MTX or other disease-modifying anti-rheumatic drugs (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 IXIFI is indicated for: • Treatment of moderately to severely, active Crohn’s disease, in adult 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 medi Read the complete document
Page 1 of 46 IXIFI™ Infliximab 1. NAME OF THE MEDICINAL PRODUCT IXIFI Powder for Concentrate for Solution for Infusion 100 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single dose vial contains 100 mg of infliximab in a 15 mL vial. After reconstitution with 10 mL of Sterile Water for Injection, each mL contains 10 mg of infliximab. Infliximab, the active ingredient in IXIFI, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions) specific for human tumor necrosis factor-alpha (TNFα), with an identical amino acid sequence for the variable and constant regions and identical primary structure with Remicade (infliximab), the reference product. It has a molecular weight of approximately 149 kilodaltons. The manufacturing process for infliximab drug substance uses a recombinant Chinese hamster ovary (CHO) cell line that contains the DNA encoding the sequence for infliximab and is grown in suspension culture using chemically-defined (CD), animal-derived component-free (ACF) media. 3. PHARMACEUTICAL FORM White, lyophilized powder for intravenous (IV) infusion. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS RHEUMATOID ARTHRITIS (RA) IXIFI, in combination with methotrexate (MTX), is indicated for: The reduction of signs and symptoms as well as the improvement in physical function in • adult patients with active disease when the response to disease-modifying drugs, including MTX, has been inadequate. • adult patients with severe, active and progressive disease not previously treated with MTX or other disease-modifying anti-rheumatic drugs (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 IXIFI is indicated for: • Treatment of moderately to severely, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or who are intolerant to Read the complete document