Depo-Medrol

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Methylprednisolone acetate 40 mg/mL

Tersedia dari:

Pharmacia Limited Company trading as Pharmacia

INN (Nama Internasional):

Methylprednisolone acetate 40 mg/mL

Dosis:

40 mg/mL

Bentuk farmasi:

Injection (depot)

Komposisi:

Active: Methylprednisolone acetate 40 mg/mL

Unit dalam paket:

Syringe, Pre-filled 1 x 2 mL, 2 mL

Kelas:

Prescription

Jenis Resep:

Prescription

Diproduksi oleh:

Pharmacia & Upjohn Company LLC

Ringkasan produk:

Package - Contents - Shelf Life: Syringe, Pre-filled 1 x 2 mL - 2 mL - 60 months from date of manufacture stored at or below 30°C

Tanggal Otorisasi:

1987-12-01

Karakteristik produk

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