SOLU MEDROL 500 MG

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

METHYLPREDNISOLONE AS SODIUM SUCCINATE

Dostupné s:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC kód:

H02AB04

Léková forma:

POWDER FOR SOLUTION FOR INJ/INF

Složení:

METHYLPREDNISOLONE AS SODIUM SUCCINATE 62.5 MG/ML

Podání:

I.M, I.V

Druh předpisu:

Required

Výrobce:

PFIZER MANUFACTURING BELGIUM NV/SA

Terapeutické skupiny:

METHYLPREDNISOLONE

Terapeutické oblasti:

METHYLPREDNISOLONE

Terapeutické indikace:

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.

Datum autorizace:

2014-05-31

Charakteristika produktu

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