Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
INFLIXIMAB
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
L04AB02
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
INFLIXIMAB 100 MG
I.V
Required
PFIZER MANUFACTURING BELGIUM NV, BELGIUM
INFLIXIMAB
Rheumatoid arthritis:IXIFI, in combination with methotrexate, 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 antirheumatic drugs (DMARDs),including methotrexate, has been inadequate.• adult 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.* Ankylosing spondylitis:IXIFI is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.* Psoriatic arthritis:IXIFI is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.* IXIFI should be administered:• in combination with methotrexate• or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease.* Psoriasis:IXIFI is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA)* Adult Crohn’s diseaseIXIFI 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/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.• treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).* Ulcerative colitis• IXIFI is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
2019-11-27
PP-IFX-ISR-0000 8 7 9 7 DURING TREATMENT WITH IXIFI ® • Tell your physician straight away if you get new or worsening signs of heart failure during treatment with IXIFI ® Signs include shortness of breath, swelling of the feet or changes in your heartbeat. || PREGNANCY AND VACCINATIONS || • If you received IXIFI ® during your pregnancy, your baby may have a higher risk for getting an infection. In case you have received this medicine while you were pregnant, it is important that you inform the medical staff about it before your baby receives any vaccine. Your baby must not receive a “live vaccine” within the first 6 months after birth, and BCG vaccine (intended to prevent tuberculosis) within the first 12 months after birth, unless your doctor recommends otherwise. In case of pregnancy, keep this card for at least 12 months after birth. At any visit to a healthcare professional, please make sure to bring a list of all other medicines that you are using. Keep this card with you for 4 months after receiving your last dose of IXIFI ® . Side effects may occur a long time after receiving your last dose. REPORTING OF SUSPECTED ADVERSE REACTIONS Adverse events can be reported directly to the Ministry of Health using the adverse events reporting portal which is available on the home page of the Ministry of Health website: www.health.gov.il or by this link: https://sideeffects. health.gov.il/ Side effects can also be reported to Pfizer by email: isr.aereporting@pfizer.com This card was approved according to the guidelines of the Ministry of Health on December 2022 IXIFI ® 100 MG INFLIXIMAB PATIENT SAFETY INFORMATION CARD SHOW THIS CARD TO ANY PHYSICIAN INVOLVED IN YOUR TREATMENT PFIZER PHARMACEUTICALS ISRAEL LTD. 9 Shenkar St., Herzliya Pituach, Israel. Tel: 09-9700500, Fax: 09-9700501 1 2 3 4 5 6 PATIENT SAFETY INFORMATION CARD IXIFI ® 100 MG (INFLIXIMAB) Show this card to any physician involved in your treatment This Patient Safety Information Card contains important safety information that you need to be Baca dokumen lengkap
IXIFI, LPD, Israel CC 14 Mar 2023 1 2022-0083057 1. NAME OF THE MEDICINAL PRODUCT Ixifi ® 100 mg powder for concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg of infliximab. Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. After reconstitution each ml contains 10 mg of infliximab. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion 4. CLINICAL PARTICULARS The marketing of Ixifi is subject to a risk management plan (RMP) including a 'Patient safety information card'. The 'Patient safety information card', emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment. 4.1 THERAPEUTIC INDICATIONS Rheumatoid arthritis: Ixifi ® , in combination with methotrexate, 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 antirheumatic drugs (DMARDs), including methotrexate, has been inadequate. adult 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. Ankylosing spondylitis: Ixifi ® is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy. Psoriatic arthritis: Ixifi ® is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. * Ixifi ® should be administered: in combination with methotrexate or alone in patients who show intolerance to methotrexate or for whom methotrexa Baca dokumen lengkap