מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
letermovir, Quantity: 240 mg
Merck Sharp & Dohme (Australia) Pty Ltd
Injection, concentrated
Excipient Ingredients: water for injections; hydroxypropylbetadex; sodium chloride; sodium hydroxide
Intravenous Infusion
1 vial
(S4) Prescription Only Medicine
PREVYMIS is indicated for the prophylaxis of cytomegalovirus (CMV) infection or disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
Visual Identification: Clear, colourless liquid, essentially free of visible particulates; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2018-06-22
PREVYMIS ® P R E V Y M I S ® 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. ▼ Please report side effects. See the full CMI for further details. 1. WHY AM I USING PREVYMIS? PREVYMIS contains the active ingredient letermovir. PREVYMIS is used to help keep you from getting sick from CMV (cytomegalovirus) in adults who have recently had a bone marrow transplant. PREVYMIS works by preventing the body from making more CMV. For more information, see Section 1. Why am I using PREVYMIS? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE PREVYMIS? Do not use if you have ever had an allergic reaction to letermovir or any of the ingredients listed at the end of the CMI. Do not use PREVYMIS if you are taking pimozide or ergot alkaloids. Do not use pitavastatin or simvastatin if you are taking PREVYMIS with ciclosporin. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR 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 PREVYMIS? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with PREVYMIS and affect how it works. PREVYMIS may affect the way other medicines work. 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 PREVYMIS? IF YOU TAKE THE TABLETS: • Take 1 tablet once a day. • Swallow the tablet whole. Do not break, crush, or chew the tablet. Take it with or without food. • Take PREVYMIS at about the same time each day. • Your doctor will tell you when to take your tablets. IF YOU RECEIVE PREVYMIS THROUGH AN IV (INTRAVENOUSLY): • You will receive PREVYMIS once a day and it will take about 1 hour. More instructions can be found in Section 4. How do I use PREVYMIS? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PREVYMIS? THINGS YOU SHOULD DO • T קרא את המסמך השלם
1 This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems AUSTRALIAN PRODUCT INFORMATION - PREVYMIS ® (LETERMOVIR) 1 NAME OF THE MEDICINE letermovir 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PREVYMIS tablets and concentrated injection for infusion contain letermovir. FILM COATED TABLET Each film-coated tablet contains 240 mg or 480 mg of letermovir. Excipients with known effect Each 240 mg film-coated tablet contains 3.96 mg of lactose (as monohydrate) and 1.90 mg (or 0.08 mmol) of sodium. Each 480 mg film-coated tablet contains 6.38 mg of lactose (as monohydrate) and 3.80 mg (or 0.17 mmol) of sodium. For the full list of excipients, see section 6.1, LIST OF EXCIPIENTS. CONCENTRATED INJECTION FOR INFUSION Each single-dose vial contains 240 mg (12 mL per vial) or 480 mg (24 mL per vial) of letermovir. Excipient with known effect Each 240 mg vial contains 22.91 mg (or 1.00 mmol) sodium. Each 480 mg vial contains 45.82 mg (or 1.99 mmol) sodium. For the full list of excipients, see section 6.1, LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM FILM COATED TABLET PREVYMIS 240 mg tablet is a yellow oval tablet. Each tablet is debossed with “591” on one side and MSD logo on the other side. PREVYMIS 480 mg tablet is a pink oval, bi-convex tablet. Each tablet is debossed with “595” on one side and MSD logo on the other side. CONCENTRATED INJECTION FOR INFUSION PREVYMIS 240 mg/12 mL (20 mg/mL) concentrated injection for infusion is supplied as a clear solution and may contain a few small translucent or white particles in a single-dose vial. PREVYMIS 480 mg/24 mL (20 mg/mL) concentrated injection for infusion is supplied as a clear solution and may contain a few small translucent or white particles in a single-dose vial. ▼ 2 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PREVYMIS is indicated for the prophylaxis of קרא את המסמך השלם