Valsts: Indonēzija
Valoda: indonēziešu
Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
METHYLPREDNISOLONE SODIUM SUCCINATE
PFIZER INDONESIA - Indonesia
METHYLPREDNISOLONE SODIUM SUCCINATE
500 MG
SERBUK INJEKSI
DUS, 1 VIAL 500 MG + VIAL PELARUT 7,8 ML
PFIZER MANUFACTURING BELGIUM NV - Belgium
2015-03-26
Generic Name: Methylprednisolone Sodium Succinate Trade Name: SOLU-MEDROL ® CDS Effective Date: October 15, 2020 Supersedes: January 03, 2018 Approved by BPOM: Page 1 of 23 2020-0060428; 2020-0063308 PT PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Methylprednisolone Sodium Succinate Trade Name: SOLU-MEDROL ® CDS Effective Date: October 15, 2020 Supersedes: January 03, 2018 FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION SOLU-MEDROL 125 mg: each vial contains methylprednisolone sodium succinate equivalent to methylprednisolone 125 mg SOLU-MEDROL 500 mg: each vial contains methylprednisolone sodium succinate equivalent to methylprednisolone 500 mg DESCRIPTION SOLU-MEDROL Sterile Powder contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, occurs as a white or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20- dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α,11β), and the molecular weight is 496.53. The structural formula is represented below: Methylprednisolone sodium succinate is so extremely soluble in water that it may be administered in a small volume of diluent and is especially well suited for intravenous use in situations in which high blood levels of methylprednisolone are required rapidly. DISETUJUI OLEH BPOM: 27/10/2021 EREG10024112100016 EREG10024112100017 Generic Name: Methylprednisolone Sodium Succinate Trade Name: SOLU-MEDROL ® CDS Effective Date: October 15, 2020 Supersedes: January 03, 2018 Approved by BPOM: Page 2 of 23 2020-0060428; 2020-0063308 ACTIONS Methylprednisolone is a potent anti-inflammatory actions steroid synthesized in the Research Laboratories of Upjohn Company. It has a greater anti-inflammatory potency than prednisolone and even less tendency than prednisolone to induce sodium and w Izlasiet visu dokumentu