Riik: Armeenia
keel: inglise
Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
methylprednisolone (methylprednisolone sodium succinate)
Orion Corporation
H02AB04
methylprednisolone (methylprednisolone sodium succinate)
1000mg
powder for solution for injection
glass vial
Prescription
Registered
2022-03-23
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 Lugege kogu dokumenti