Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METHYLPREDNISOLONE
PHARMAFORTE (MALAYSIA) SDN. BHD.
METHYLPREDNISOLONE
100Tablet Tablets
PT DEXA MEDICA
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ MEDIXON TABLET Methylprednisolone (4 mg) 1 WHAT IS IN THIS LEAFLET: 1. What Medixon is used for 2. How Medixon works 3. Before you use Medixon 4. How to use Medixon 5. While you are taking it 6. Side effects 7. Storage and disposal of Medixon 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT MEDIXON IS USED FOR Medixon is used in the treatment of various conditions such as allergy or inflammation. HOW MEDIXON WORKS Medixon contains a corticosteroid. It decreases the body’s immune response to certain diseases and reduces symptoms such as swelling and redness. BEFORE YOU USE MEDIXON _-When you must not take it _ Do not take Medixon if: − You have allergies to methylprednisolone or any other steroid medicine or any of the ingredients in Medixon. An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath. − You have recently had any vaccination. − You have any fungal infection. − You have bowel or stomach ulcer, osteoporosis, history of psychosis, and herpes virus infection, especially when you take Medixon for long-term treatment. If you get a rash or symptom of an infection, tell your doctor immediately. _-Before you start to take it _ Talk to your doctor or pharmacist before taking Medixon if you have any of the diseases or conditions below: − You are about to have any vaccination. − You have tuberculosis or you have suffered tuberculosis in the past. − You have an under-active thyroid or liver scarring. − You have infection including viral eye infection. _-Taking other medicines _ Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This could affect the way Medixon or the other medicine works. Inform your doctor if you are taking: - Prednisolone or anti- inflammatory medicines such as NSAID or aspirin. - Anti-diabetic medicines. - Ciclosporin: used to prevent Přečtěte si celý dokument
SpecPacGen001814/7 Author(s): 29.10.2021, Helen Fransiska Manurung, Artwork Management Officer - BTR, Reviewed by: Approved by: Effective date : 02.11.2021 02.11.2021, Riski Amanda Tambunan, Supervisor Packaging Design, 02.11.2021, RA Officer 03, Regulatory Affairs Officer, Specification Packaging Material E-67052-04, LEAFLET MEDIXON TABLET MALAYSIA CONFIDENTIAL _DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_ SpecPacGen001814/7 Approved :RA Officer 03, Regulatory Affairs Officer, Effective date: 02.11.2021 CONFIDENTIAL _DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_ SpecPacGen001814/7 Approved :RA Officer 03, Regulatory Affairs Officer, Effective date: 02.11.2021 CONFIDENTIAL _DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_ NO. PARAMETERS SPECIFICATION 1. Material HVS (Lihat CoA / _See CoA_) 2. Gramatur / _Grammature_ 54 – 66 gsm 3. Dimensi panjang / _Length dimension_ 149 – 151 mm 4. Dimensi lebar / _Width dimension_ 99 – 101 mm 5. Arah serat / _Fiber direction_ Horisontal / _Horizontal_ 6. Warna / _Colour_ Lihat proof print / _See proof print_ 7. Redaksional / _Redactional_ Lihat proof print / _See proof print_ SpecPacGen001814/7 Approved :RA Officer 03, Regulatory Affairs Officer, Effective date: 02.11.2021 CONFIDENTIAL _DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_ HISTORY REVISION NO. REVISION DATE DETAILS REASON 00 - - Dokumen baru menggantikan SPM-E-67052-01 - Perubahan NIE Malaysia CC001976 01 15-Jul-16 Penambahan keterangan tanggal revisi terakhir dan perubahan distributor Email RA 15 Juli 2016 02 22-Jul-16 Penambahan tanggal revisi terakhir Approval Distributor 21 Juli 2016 03 29-Jan-18 - Perubahan redaksional TD Medixon 09.01.2018 - Penghilangan ® setelah nama brand Email Marketing OBU 22.03.2018 - Perubahan dimensi Mengikuti Drawing Leaflet Cartoning IMA - Penambahan parameter warna dan redaksional pada spesifikasi MoM Packdev-TS 29.08.2017 04 07 Mei 2019 - Perubahan dokumen menjadi general use - Penambahan approval site CC004303 05 22 Jun 2020 - Revisi item number menjadi E-67052- 04 - Přečtěte si celý dokument