Metypred powder for solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

methylprednisolone (methylprednisolone sodium succinate)

Available from:

Orion Corporation

ATC code:

H02AB04

INN (International Name):

methylprednisolone (methylprednisolone sodium succinate)

Dosage:

250mg

Pharmaceutical form:

powder for solution for injection

Units in package:

glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-03-23

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Metypred 250 mg powder for solution for injection
Metypred 1000 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains methylprednisolone sodium succinate an amount
equivalent to 250 mg or 1000 mg of
methylprednisolone. The concentration of the reconstituted solution
after dissolving in water for injections
is 62,5 mg/ml.
Excipient with known effect:
sodium, see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection
_Powder for solution for injection_
: White or nearly white, amorphous solid.
_Reconstituted solution:_
Clear, with no visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glucocorticoids should only be considered as a purely symptomatic
treatment, unless in case of some
endocrine disorders, where they are used as substitution treatment.
ANTI-INFLAMMATORY TREATMENT
·
_Rheumatic disorders_
As adjunctive therapy for short-term administration (to tide the
patient over an acute episode or
exacerbation) in:
-
Post-traumatic osteoarthritis
-
Synovitis of osteoarthritis
-
Rheumatoid arthritis, including juvenile rheumatoid arthritis
(selected cases may require
low-dose maintenance therapy)
-
Acute and subacute bursitis
-
Epicondylitis
-
Acute nonspecific tenosynovitis
-
Acute gouty arthritis
-
Psoriatic arthritis
-
Ankylosing spondylitis
·
_Collagen diseases (immune complex diseases)_
During an exacerbation or as maintenance therapy in selected cases of:
-
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 dermatitis
-
Bullous dermatitis herpetiformis
-
Severe seborrheic dermatitis
-
Severe psoriasis
-
Mycosis fungoides
-
Urticaria
·
_Allergic states_
Control of severe or incapacitating allergi