Medrol

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Methylprednisolone 4mg; Methylprednisolone 4mg

Disponible depuis:

Pfizer New Zealand Limited

DCI (Dénomination commune internationale):

Methylprednisolone 4 mg

Dosage:

4 mg

forme pharmaceutique:

Tablet

Composition:

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

Unités en paquet:

Blister pack, PVC, 100 tablets

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Pharmacia & Upjohn Company LLC

indications thérapeutiques:

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

Descriptif du produit:

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

Date de l'autorisation:

1969-12-31

Résumé des caractéristiques du produit

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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):
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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