Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Methylprednisolone 4mg; Methylprednisolone 4mg
Pfizer New Zealand Limited
Methylprednisolone 4 mg
4 mg
Tablet
Active: Methylprednisolone 4mg Excipient: Calcium stearate Lactose monohydrate Liquid paraffin Purified water Sucrose Active: Methylprednisolone 4mg Excipient: Calcium stearate Lactose monohydrate Maize starch Purified water Sucrose
Blister pack, PVC, 100 tablets
Prescription
Prescription
Pharmacia & Upjohn Company LLC
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). · Congenital adrenal hyperplasia. · Nonsuppurative thyroiditis · Hypercalcemia associated with cancer
Package - Contents - Shelf Life: Blister pack, PVC - 100 tablets - 60 months from date of manufacture stored at or below 25°C - Bottle, plastic, 60mL HDPE with cotton filller and PP child resistant cap - 100 tablets - 18 months from date of manufacture stored at or below 25°C
1969-12-31
Version: pfdmedrt11123 Supersedes: pfdmedrt10323 Page 1 of 22 NEW ZEALAND DATA SHEET 1. PRODUCT NAME MEDROL ® 4 mg tablets MEDROL ® 100 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MEDROL 4 mg tablets: Each 4 mg tablet contains 4 mg methylprednisolone. MEDROL 100 mg tablets: Each 100 mg tablet contains 100 mg methylprednisolone. EXCIPIENTS WITH KNOWN EFFECT MEDROL 4 mg tablets contain: • lactose monohydrate • sucrose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM MEDROL tablets 4 mg Tablet: White, flat, elliptical, coded "MEDROL 4" on one side, double scored on the reverse. The score line is not intended for breaking the tablet. MEDROL tablets 100 mg Tablet: Light blue, round, biconvex cross-scored, coded "Upjohn 3379". The score line is not intended for breaking the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MEDROL (methylprednisolone) is indicated in the following conditions: ENDOCRINE DISORDERS Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance): Version: pfdmedrt11123 Supersedes: pfdmedrt10323 Page 2 of 22 • Congenital adrenal hyperplasia • Nonsuppurative thyroiditis • Hypercalcaemia associated with cancer NON-ENDOCRINE DISORDERS _RHEUMATIC DISORDERS _ As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: • Psoriatic arthritis • Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) • Ankylosing spondylitis • Acute and subacute bursitis • Acute nonspecific tenosynovitis • Acute gouty arthritis • Post-traumatic osteoarthritis • Synovitis of osteoarthritis • Epicondylitis _COLLAGEN DISEASES _ During an exacerbation or as maintenance therapy in selected cases of: • Systemic lupus erythematosus • S Izlasiet visu dokumentu