Country: New Zealand
Lingwa: Ingliż
Sors: Medsafe (Medicines Safety Authority)
Methylprednisolone acetate 20 mg/mL
Pharmacia Limited Company trading as Pharmacia
Methylprednisolone acetate 20 mg/mL
20 mg/mL
Injection (depot)
Active: Methylprednisolone acetate 20 mg/mL Excipient: Hydrochloric acid Macrogol 4000 Miripirium chloride Sodium chloride Sodium hydroxide Water for injection
Unknown, 1 mL
Prescription
Prescription
Pharmacia & Upjohn Company LLC
Package - Contents - Shelf Life: Unknown, - 1 mL - 60 months from date of manufacture stored at or below 30°C - Unknown, - 5 mL - 60 months from date of manufacture stored at or below 30°C
1976-06-16
Version: pfddepmi11123 Supersedes: pfddepmi10323 Page 1 of 25 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Depo-Medrol ® 40 mg/mL Suspension for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL vial contains 40 mg/mL methylprednisolone acetate. EXCIPIENTS WITH KNOWN EFFECTS: • Sodium • Macrogol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Depo-Medrol is a white, aqueous, sterile suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A. FOR INTRAMUSCULAR ADMINISTRATION When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of Depo-Medrol is indicated as follows: _ENDOCRINE DISORDERS _ • Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy; mineralocorticoid supplementation is of particular importance). • Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). • Congenital adrenal hyperplasia. • Hypercalcaemia associated with cancer. Version: pfddepmi11123 Supersedes: pfddepmi10323 Page 2 of 25 • Nonsuppurative thyroiditis. _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 _ During an exacerbation or as maintenance therapy in selected cases of: • Systemic lupus erythematosus • Systemic derm Aqra d-dokument sħiħ