국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
vedolizumab, Quantity: 119 mg
Takeda Pharmaceuticals Australia Pty Ltd
Injection, solution
Excipient Ingredients: citric acid monohydrate; sodium citrate dihydrate; histidine; histidine hydrochloride monohydrate; arginine hydrochloride; polysorbate 80; water for injections
Subcutaneous
6 pre-filled syringe, 2 pre-filled syringe, 1 pre-filled syringe
(S4) Prescription Only Medicine
Treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNF-alpha) antagonist.,Treatment of adult patients with moderate to severe Crohn's disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNF-alpha) antagonist.
Visual Identification: Colourless to yellow solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-05-12
ENTYVIO ® PRE-FILLED SYRINGE E N T Y V I O ® P R E - F I L L E D S Y R I N G E C M I V 2 . 0 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING ENTYVIO? Entyvio pre-filled syringe for subcutaneous injection contains the active ingredient vedolizumab. Entyvio is used to treat the signs and symptoms of moderate to severe ulcerative colitis or moderate to severe Crohn’s disease in adults who have not responded well enough or are intolerant to other treatments. For more information, see Section 1. Why am I using Entyvio? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ENTYVIO? Do not use if you have ever had an allergic reaction to vedolizumab or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING OR PLAN TO BREASTFEED. For more information, see Section 2. What should I know before I use Entyvio? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Entyvio and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ENTYVIO PRE-FILLED SYRINGE? • Entyvio solution for injection is given by injection just under the skin (subcutaneous injection). More instructions can be found in Section 4. How do I use Entyvio? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ENTYVIO? THINGS YOU SHOULD DO • Read this leaflet carefully before you start using this medicine. It contains important information for you. • Keep this leaflet. You may need to read it again. • Your doctor or nurse will also give you a Patient Alert Card when you first start treatment with Entyvio. Keep it with you at all times. • If you have any questions, ask your doctor, pharmacist or nurse. THINGS YOU SHOULD NOT DO • Do not stop using Entyv 전체 문서 읽기
ENTYVIO ® PI V7.0 (CCDS v6.0) _ _ 1 AUSTRALIAN PRODUCT INFORMATION ENTYVIO ® (VEDOLIZUMAB) 1 NAME OF THE MEDICINE Vedolizumab 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Intravenous infusion: Each vial of ENTYVIO contains 300 mg of vedolizumab. The powder is intended to be reconstituted with 4.8 mL of sterile water for injections. After reconstitution, each mL contains 60 mg of vedolizumab and the pH is approximately 6.3. Five (5) mL of the reconstituted solution is to be diluted into 250 mL sterile 0.9% sodium chloride solution or 250 mL of sterile Lactated Ringer’s solution prior to use. Subcutaneous injection: Each ENTYVIO pre-filled syringe or pre-filled pen contains 108 mg of vedolizumab in 0.68 mL. ENTYVIO 108 mg is supplied as a sterile, clear, colourless to yellow, preservative free solution for subcutaneous administration with a pH of 6.5. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Intravenous infusion: ENTYVIO 300 mg powder for injection for intravenous infusion is supplied as a white to off-white lyophilised cake or powder for injection, in a single-use vial. Subcutaneous injection: ENTYVIO 108 mg solution for injection is supplied as single-dose pre-filled syringe with needle safety device or single-dose pre-filled pen. The solution is colourless to yellow. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist. Treatment of adult patients with moderate to severe Crohn’s disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist. 4.2 DOSE AND METHOD OF ADMINISTRATION ENTYVIO treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative co 전체 문서 읽기