国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
nirmatrelvir; Ritonavir
PFIZER (MALAYSIA) SDN. BHD.
nirmatrelvir; Ritonavir
30 Tablets
Pfizer Manufacturing Deutschland GmbH.
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ PAXLOVID FILM COATED TABLET Nirmatrelvir 150 mg and Ritonavir 100 mg 1 WHAT IS IN THIS LEAFLET 1. What Paxlovid is used for 2. How Paxlovid works 3. Before you use Paxlovid 4. How to use Paxlovid 5. While you are using it 6. Side Effects 7. Storage and Disposal of Paxlovid 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT PAXLOVID IS USED FOR Paxlovid is an antiviral medicine used for treating mild-to-moderate COVID-19. COVID-19 is caused by a virus. Paxlovid is used in adults 18 years of age and older with mild-to-moderate COVID-19. It is only used in patients who are at high risk for progression to severe COVID-19, including hospitalisation or death. You must talk to a doctor if you do not feel better or if you feel worse while on treatment with Paxlovid. HOW PAXLOVID WORKS Paxlovid stops the virus multiplying in cells and this stops the virus multiplying in the body. This can help your body to overcome the virus infection, and may help you get better faster. BEFORE YOU USE PAXLOVID - _When you must not use it_ - if you are allergic to nirmatrelvir, ritonavir or any of the other ingredients of this medicine - if you have severe liver or kidney disease - if you are taking any of the following medicines. Taking Paxlovid with these medicines may cause serious or life- threatening side effects or affect how Paxlovid works: - alfuzosin (used to treat symptoms of an enlarged prostate) - pethidine, piroxicam, propoxyphene (used to relieve pain) - ranolazine (used to treat chronic chest pain [angina]) - dronedarone (used to correct irregular heartbeats) - colchicine (used to treat gout) - lurasidone (used to treat depression) - pimozide and clozapine (used to treat abnormal thoughts or feelings) - dihydroergotamine and ergotamine (used to treat migraine headaches) - methylergonovine (used to stop excessive bleeding that may occur following childbirth or an abortion) - cisapride (used to 阅读完整的文件
PFIZER (MALAYSIA) SDN BHD 197801003134 (40131-T) Level 10 & 11, Wisma Averis, Tower 2 Avenue 5, Bangsar South, No. 8 Jalan Kerinchi 59200 Kuala Lumpur, Malaysia Tel: 603.22816000 Fax: 603.22816388 30 September 2022 Dear Healthcare Professionals, CONDITIONAL REGISTRATION OF PAXLOVID (NIRMATRELVIR 150 MG FILM-COATED TABLETS AND RITONAVIR 100 MG FILM-COATED TABLETS) WITH UNITED KINGDOM LABEL ON PRODUCT CARTON AND PRINTED PATIENT INFORMATION LEAFLET (PIL) With regards to the matter above, Pfizer would like to inform that the label on the product carton and printed PIL is the label approved by the Medicines and Healthcare products Regulatory Agency (MHRA). The approved label by MHRA will be used by markets which reference to UK dossier including Malaysia. There will not be country-specific packs for Malaysia until commercial supply stage which has not been determined yet. QR code will be printed on the product carton where HCP may access to the latest approved version of country specific package insert from the Paxlovid global website, including the label approved by Malaysia National Pharmaceutical Regulatory Authority (NPRA). 2. The name and address for the Marketing Authorization Holder (MAH) in UK is reflected on the product carton, Pfizer Limited with the address of Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom. The manufacturer and batch releaser information will not be reflected on the product carton. 3. Enclosed are the product information approved in Malaysia for your reference. PRODUCT INFORMATION DETAILS PRODUCT NAME PAXLOVID (nirmatrelvir 150 mg film-coated tablets and ritonavir 100 mg film-coated tablets) LOI NO. 202201046462A (First source - Germany) 202202186938A (Second source - Ireland) STRENGTH OF ACTIVE INGREDIENTS Nirmatrelvir 150 mg film-coated tablets and ritonavir 100 mg film- coated tablets MANUFACTURER AND BATCH RELEASER (FOR MALAYSIA) Nirmatrelvir _Manufacturer and Batch Releaser _ Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee 1 79090 Freiburg, Germany P 阅读完整的文件