Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
METHYLPREDNISOLONE HYDROGEN SUCCINATE PH. EUR.
Pharmacia Ireland
40 Base Milligrams
Pdr+Solv for Soln for Inj
2001-01-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solu-Medrone powder and solvent for solution for injection or concentrate for solution for infusion 40 mg/vial. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Act-O-Vial contains methylprednisolone sodium succinate equivalent to 40 mg of methylprednisolone (40 mg/ml following reconstitution). The powder also contains sodium and the solvent contains benzyl alcohol. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection or concentrate for solution for infusion. A white to off-white lyophilised powder, supplied with a clear, colourless solution for reconstitution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Solu -Medrone is indicated for any condition in which rapid and intense corticosteroid effect is required such as: 1. Allergic states, for example: bronchial asthma, severe seasonal and perennial rhinitis, angioneurotic oedema, anaphylaxis. 2. Dermatological conditions severe erythema multiforme (for example: Stevens -Johnson syndrome). 3. Acute adrenal insufficiency with supplemental salt and/or desoxycorticosterone. Solu-Medrone is not first line treatment for acute adrenal insufficiency because it does not possess sufficient mineralocorticoid properties. 4. Acute systemic lupus erythematosus. 5. Acute rheumatic carditis. 6. Suppression of graft rejection reactions following transplantation. 7. Cerebral oedema secondary to cerebral tumour. 8. The prevention of nausea and vomiting associated with cancer chemotherapy. 9. Ulcerative colitis. 10. Crohn's disease. 11. Aspiration of gastric contents. 12. Acute spinal cord injury. Treatment should begin within eight hours of injury. 13. The treatment of acute exacerbations of multiple sclerosis superimposed on either a relapsing-remitting Pročitajte cijeli dokument