SOLU MEDROL

Valsts: Indonēzija

Valoda: indonēziešu

Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktīvā sastāvdaļa:

METHYLPREDNISOLONE SODIUM SUCCINATE

Pieejams no:

PFIZER INDONESIA - Indonesia

SNN (starptautisko nepatentēto nosaukumu):

METHYLPREDNISOLONE SODIUM SUCCINATE

Zāļu forma:

SERBUK INJEKSI + PELARUT

Vienības iepakojumā:

DUS, 1 VIAL @ 125 MG + VIAL PELARUT @ 2 ML

Ražojis:

PFIZER MANUFACTURING BELGIUM NV - Belgium

Autorizācija datums:

2020-02-01

Produkta apraksts

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