Страна: Израел
Език: английски
Източник: Ministry of Health
VEDOLIZUMAB
TAKEDA ISRAEL LTD
L04AA33
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
VEDOLIZUMAB 300 MG/VIAL
I.V
Required
TAKEDA PHARMA A/S, DENMARK
VEDOLIZUMAB
Ulcerative Colitis:Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist.Crohn’s Disease:Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist.
2020-02-29
1 File Name Entyvio300mg-solution for injection-PIL-ENG-D25 Product Entyvio IV Job No. 230000806 Language English Artwork Patient Leaflet Document History Ver. Date Change description By 18-Dec-23 13:47 Last save _Our Expertise. Your Success._ 2 Patient leaflet in accordance with the Pharmacists’ Regulations (Preparations) - 1986 This medicine is dispensed with a doctor’s prescription only ENTYVIO I.V . Powder for concentrate for solution for infusion Active ingredient Each vial contains 300 mg of vedolizumab. Inactive ingredients and allergens: See section 6, “Additional information”. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult with your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. What is this medicine intended for? Ulcerative colitis Entyvio I.V. is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have shown an inadequate response with or lost response to, or were intolerant to either conventional therapy or to a tumor necrosis factor-alpha (TNFα) antagonist. Crohn’s disease Entyvio I.V. is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have shown an inadequate response with or lost response to or were intolerant to either conventional therapy or to a tumor necrosis factor-alpha (TNFα) antagonist. Therapeutic group: Selective immunosuppressants. Entyvio contains the active ingredient vedolizumab. Vedolizumab belongs to a group of biological medicines called monoclonal antibodies (MAbs). Entyvio works by blocking a protein on the surface of white blood cells that cause the inflammation in ulcerative colitis and in Crohn’s disease. This reduces the severity of the inflammation. 2. Before using this medicine Do no Прочетете целия документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Entyvio ® I.V. Powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 300 mg of vedolizumab. After reconstitution, each mL contains 60 mg of vedolizumab. Vedolizumab is a humanised IgG 1 monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white lyophilised cake or powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Ulcerative colitis Entyvio I.V. is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist. Crohn’s disease Entyvio I.V. is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist. 4.2 Posology and method of administration Treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis or Crohn’s disease see section 4.4. Patients should be given the package leaflet. 2 Posology _Ulcerative colitis _ The recommended dose regimen of intravenous vedolizumab is 300 mg administered by intravenous infusion at 0, 2 and 6 weeks and then every 8 weeks thereafter. Therapy for patients with ulcerative colitis should be discontinued if no evidence of therapeutic benefit is observed by week 10 (see section 5.1). Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to intravenous vedolizumab 300 mg every 4 weeks. In patients who have responded to treatmen Прочетете целия документ