Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Letermovir
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
Letermovir
28 Tablets
MSD International GmbH T/A MSD Ireland (Ballydine)
PREVYMIS ® FILM- COATED TABLET 1 Letermovir ( 240mg and 480mg ) Consumer Medication Information Leaflet (RiMUP) WHAT IS IN THIS LEAFLET 1. What PREVYMIS is used for 2. How PREVYMIS works 3. Before you take PREVYMIS 4. How to take PREVYMIS 5. While you are taking PREVYMIS 6. Side effects 7. Storage and Disposal of PREVYMIS 8. Product Description 9. Manufacturer, Packer and Product Registration Holder 10. Date of revision Please read this information carefully before you start to take your medicine, even if you have just refilled your prescription. Some of the information may have changed. Remember that your doctor has prescribed this medicine only for you. Never give it t o anyone else. WHAT PREVYMIS IS USED FOR PREVYMIS is a prescription medicine for adults who have recently had a stem cell (bone marrow) transplant. The medicine helps stop you from getting ill from CMV (‘cytomegalovirus’). CMV is a virus that a lot of people have without knowing. Normally, CMV just stays in their body and it does not hurt them. However, if your immune system is weak afte r you get a stem cell transplant, you may be at high risk of becoming ill from CMV . HOW PREVYMIS WORKS PREVYMIS is an antiviral medicine that contains the active substance letermovir. BEFORE YOU TAKE PREVYMIS When you must not use it Do not take PREVYMIS if: • you are allergic to letermovir or any of the other ingredients of this medicine (listed in section Product Description) . • You take either of these medicines: o Pimozide – used for Tourette’s syndrome o Ergot alkaloids (such as ergotamine and dihydroergotamine) - used for migraine headaches Do not take PREVYMIS if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking PREVYMIS. IF YOU ARE TAKING PREVYMIS WITH CYCLOSPORINE , DO NOT TAKE THE FOLLOWING MEDICINES : o Dabigatran – used for blood clots o Atorvastatin, simvastati n, rosuvastatin, pitavastatin , lovastatin – for high cholesterol Before you start to use it WARNINGS AND PRECAUTIO Soma hati kamili
PREVYMIS ® (LETERMOVIR) LPC-MK8228-MF-112022a TABLET AND CONCENTRATE FOR SOLUTION FOR INFUSION 1. NAME OF THE MEDICINAL PRODUCT PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets PREVYMIS 240 mg concentrate for solution for infusion PREVYMIS 480 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PREVYMIS 240 mg film-coated tablets Each film-coated tablet contains 240 mg of letermovir. PREVYMIS 480 mg film-coated tablets Each film-coated tablet contains 480 mg of letermovir. PREVYMIS 240 mg concentrate for solution for infusion Each vial contains 240 mg (12 mL per vial) of letermovir. Each mL contains 20 mg of letermovir. PREVYMIS 480 mg concentrate for solution for infusion Each vial contains 480 mg (24 mL per vial) of letermovir. Each mL contains 20 mg of letermovir. Excipient with known effect Each 240 mg film-coated tablet contains 4 mg of lactose (as monohydrate). Each 480 mg film-coated tablet contains 6.4 mg of lactose (as monohydrate). Each 240 mg film-coated tablet contains less than 1 mmol sodium (23 mg). Each 480 mg film-coated tablet contains less than 1 mmol sodium (23 mg). For the full list of excipients, see section 6.1. This medicinal product contains 23 mg (1.0 mmol) sodium per 240 mg vial, equivalent to 1.15% of the WHO recommended maximum daily intake of 2 g sodium for an adult. This medicinal product contains 46 mg (2.0 mmol) sodium per 480 mg vial, equivalent to 2.30% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Each 240 mg dose (12 mL vial) of this medicinal product contains 1800 mg hydroxypropylbetadex (cyclodextrin). Each 480 mg dose (24 mL vial) of this medicinal product contains 3600 mg hydroxypropylbetadex (cyclodextrin). For additional information, see section 4.2. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 3.1 FILM-COATED TABLET (TABLET) PREVYMIS 240 mg film-coated tablets Yellow oval tablet of dimensions 16.5 mm x 8.5 mm, debossed with “591” on one side and corporate lo Soma hati kamili