Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
METHYLPREDNISOLONE AS HEMISUCCINATE
GENMEDIX , ISRAEL
H02AB04
LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION OR INFUSION
METHYLPREDNISOLONE AS HEMISUCCINATE 1 G/VIAL
I.V
Required
VIATRIS SANTE, FRANCE
METHYLPREDNISOLONE
METHYLPREDNISOLONE
Methylprednisolone Mylan is indicated to treat any condition in which 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.
2017-08-31
Page 1 of 26 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT METHYLPREDNISOLONE VIATRIS 500 MG METHYLPREDNISOLONE VIATRIS 1 G 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Methylprednisolone Viatris 500 mg: Methylprednisolone hemisuccinate: 633.50 mg Quantity equivalent to methylprednisolone base: 500.00 mg Per vial Excipient with known effect Methylprednisolone Viatris 500 mg contains 1.0 mmol (or 41 mg) sodium per dose. Methylprednisolone Viatris 1 g: Methylprednisolone hemisuccinate: 1267.00 mg Quantity equivalent to methylprednisolone base: 1000.00 mg Per vial Excipient with known effect Methylprednisolone Viatris 1 g contains 2.0 mmol (or 81 mg) sodium per dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilized powder for solution for injection or infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Methylprednisolone Viatris is indicated to treat any condition in which 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The first administration must be done in a hospital. 5 mg of prednisone is equivalent in terms of anti-inflammatory potency to 4 mg of methylprednisolone. This proprietary medicinal product is not suitable for inhalation using a nebulizer. This drug is reserved for cases requiring high dose corticosteroid therapy. Page 2 of 26 Dosage: • acute symptoms of rheumatoid arthritis, extra-renal symptoms of certain systemic diseases, certain cases of systemic necrotizing vasculitis, initial treatment for certain cases of glomerulopathy: 500 mg to 1 g per day, • organ transplantation, graft rejection: 10 to 15 mg/kg/day, • graft versus host reaction: 10 to 20 mg/kg/day and up t Prečítajte si celý dokument