Dexmethsone

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Dexamethasone sodium phosphate 4.4 mg equivalent to dexamethasone phosphate 4.0 mg
Available from:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
INN (International Name):
Dexamethasone sodium phosphate 4.4 mg (equivalent to dexamethasone phosphate 4.0 mg)
Dosage:
4 mg/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Dexamethasone sodium phosphate 4.4 mg equivalent to dexamethasone phosphate 4.0 mg Excipient: Creatinine Sodium citrate Water for injection
Prescription type:
Prescription
Manufactured by:
Sanofi Chimie
Therapeutic indications:
Replacement Therapy Adrenocortical Insufficiency Dexamethasone has predominantly glucocorticoid activity and, therefore, is not a complete replacement therapy in cases of adrenocortical insufficiency. Dexamethasone should be supplemented with salt and/or a mineralocorticoid, such as deoxycorticosterone. When so supplemented, dexamethasone is indicated in the following: · Acute adrenocortical insufficiency · Addison's disease · Bilateral adrenalectomy · Relative adrenocortical insufficiency · Primary and secondary adrenocortical insufficiency Prolonged administration of adrenocortical steroids can produce dormancy of the adrenal cortex. The reduced secretory capacity gives rise to a state of relative adrenocortical insufficiency which persists for a varying length of time after therapy is discontinued. Should a patient be subjected to a sudden stress during this period of reduced secretion (for up to two years after therapy has ceased) the steroid output may not be adequate. Steroid therapy should
Product summary:
Package - Contents - Shelf Life: Vial, glass, single dose, 5 x 1 ml type I, amber vial with grey chlorobutyl stopper - 5 mL - 12 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, single dose, 5 x 2 ml type I, amber vial with grey chlorobutyl stopper - 10 mL - 12 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, single dose, 10 x 1 ml type I, amber vial with grey chlorobutyl stopper - 10 mL - 12 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, single dose, 10 x 2 ml type I, amber vial with grey chlorobutyl stopper - 20 mL - 12 months from date of manufacture stored at or below 25°C protect from light
Authorization number:
TT50-7558/3
Authorization date:
2013-04-02

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