Solu-Medrol powder lyophilized for solution for i/m and i/v injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

methylprednisolone (methylprednisolone sodium succinate)

Available from:

Pfizer Manufacturing Belgium N.V.

ATC code:

H02AB04

INN (International Name):

methylprednisolone (methylprednisolone sodium succinate)

Dosage:

1000mg

Pharmaceutical form:

powder lyophilized for solution for i/m and i/v injection

Units in package:

(1) glass vial with powder and (1) glass vial with solvent 15,6ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-10-18

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
SOLU-MEDROL
METHYLPREDNISOLONE SODIUM SUCCINATE
2
1.
NAME OF THE MEDICINAL PRODUCT
SOLU-MEDROL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active _ingredient — _methylprednisolone (in the form of
methylprednisolone sodium succinate)
40 mg, 125 mg, 250 mg, 500 mg, 1000 mg.
Excipients see section 6.1
3.
PHARMACEUTICAL FORM
Sterile powder for injection.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Solu-Medrol is indicated in_ _the following conditions:
ENDOCRINE DISORDERS
1

primary or secondary adrenocortical insufficiency (in conjunction with
mineralocorticoids,
where applicable)

acute adrenocortical insufficiency (mineralocorticoid supplementation
may be necessary)

shock secondary to adrenocortical insufficiency, or shock unresponsive
to conventional
therapy when adrenal cortical insufficiency may be present (when
mineralocorticoid activity
is undesirable)
1,2
_ _

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
1,2
(as adjunctive therapy for short-term administration in the management
of an acute episode or exacerbation)_ _

post-traumatic osteoarthritis

synovitis of osteoarthritis

rheumatoid arthritis, including juvenile rheumatoid arthritis

acute and subacute bursitis

epicondylitis

acute nonspecific tenosynovitis

acute gouty arthritis
3

psoriatic arthritis

ankylosing spondylitis.
COLLAGEN DISEASES AND IMMUNE COMPLEX DISEASES_ _(during an
exacerbation or as maintenance
therapy in selected cases)

systemic lupus erythematosus (and lupus nephritis)

acute rheumatic carditis

systemic dermatomyositis (polymyositis)

polyarteritis nodosa

Goodpasture's syndrome.
DERMATOLOGIC DISEASES_ _

pemphigus

severe erythema multiforme (Stevens-Johnson syndrome)

exfoliative dermati