국가: 이스라엘
언어: 영어
출처: Ministry of Health
METHYLPREDNISOLONE AS SODIUM SUCCINATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
H02AB04
POWDER FOR SOLUTION FOR INJ/INF
METHYLPREDNISOLONE AS SODIUM SUCCINATE 125 MG/VIAL
I.M, I.V
Required
PFIZER INC, USA
METHYLPREDNISOLONE
METHYLPREDNISOLONE
Solu Medrol is indicated to treat any condition in which IM or IV corticosteroid treatment is required such as: endocrine disorders, rheumatic disorders, collagen diseases, immune complex diseases, dermatologic diseases, allergic states, ophthalmic diseases, gastrointestinal diseases, respiratory diseases, hematologic disorders, management of neoplastic diseases, edematous states, nervous system disorders and organ transplantation.
2022-03-31
Solu-Medrol LPD CC 240823 Page 1 of 27 2023-0083910, 2022-0082236 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT SOLU-MEDROL ® 40 mg SOLU-MEDROL ® 125 mg SOLU-MEDROL ® 500 mg SOLU-MEDROL ® 1000 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Solu-Medrol 40 mg: Methylprednisolone (as methylprednisolone sodium succinate) 40 mg/ Act-o-vial. Solu-Medrol 125 mg: Methylprednisolone (as methylprednisolone sodium succinate) 125 mg/ Act-o-vial. Solu-Medrol 500 mg: Methylprednisolone (as methylprednisolone sodium succinate) 500 mg/ vial. Excipient with known effect Solu-Medrol 500 mg contains 58.4 mg of sodium in each vial. Solu-Medrol 1000 mg: Methylprednisolone (as methylprednisolone sodium succinate) 1000 mg/ vial. Excipient with known effect Solu-Medrol 1 g contains 116.8 mg of sodium in each vial. For the full list of excipients, see section 6.1. Solu-Medrol 500 mg & 1000 mg diluent contain Benzyl alcohol (see Section 4.4 Special warnings and precautions for use) . 3. PHARMACEUTICAL FORM Powder for solution for injection or infusion 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Methylprednisolone sodium succinate is indicated in_ _the following conditions: ENDOCRINE DISORDERS • primary or secondary adrenocortical insufficiency (in conjunction with mineralocorticoids, where applicable) • acute adrenocortical insufficiency (mineralocorticoid supplementation may be necessary) Solu-Medrol LPD CC 240823 Page 2 of 27 2023-0083910, 2022-0082236 • shock secondary to adrenocortical insufficiency, or shock unresponsive to conventional therapy when adrenal cortical insufficiency may be present (when mineralocorticoid activity is undesirable)_ _ • preoperatively, or in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful • congenital adrenal hyperplasia • nonsuppurative thyroiditis • hypercalcemia associated with cancer. RHEUMATIC DISORDERS (as adjunctive therapy for short-term administration in the management of 전체 문서 읽기