Pays: Canada
Langue: anglais
Source: Health Canada
DEXAMETHASONE PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
STRIDES PHARMA CANADA INC
H02AB02
DEXAMETHASONE
10MG
SOLUTION
DEXAMETHASONE PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) 10MG
INTRAMUSCULAR
10ML
Prescription
ADRENALS
Active ingredient group (AIG) number: 0106305005; AHFS:
APPROVED
2020-07-30
1 PRESCRIBING INFORMATION PR DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP 4 MG/ML STERILE SOLUTION FOR INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, INTRALESIONAL, AND SOFT TISSUE INJECTION 10 MG/ML STERILE SOLUTION FOR INTRAVENOUS, INTRAMUSCULAR CORTICOSTEROID Strides Pharma Canada Inc. Date of revision 1565, Boul. Lionel-Boulet July 30, 2020 Varennes, Quebec J3X 1P7 Submission Control No.: 240776 2 PR DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP 4 MG/ML STERILE SOLUTION FOR INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, INTRALESIONAL, AND SOFT TISSUE INJECTION 10 MG/ML STERILE SOLUTION FOR INTRAVENOUS, INTRAMUSCULAR CORTICOSTEROID INDICATIONS Dexamethasone Sodium Phosphate Injection may be given by I.V. or I.M. injection when oral therapy is not feasible in the following conditions: ENDOCRINE DISORDERS: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoid 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). Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Congenital adrenal hyperplasia. Nonsupportive thyroiditis. SHOCK: The adjunctive treatment of shock where high (pharmacologic) doses of corticosteroids are needed: e.g., severe shock of hemorrhagic, traumatic, surgical, or septic origin. Treatment with Dexamethasone Sodium Phosphate Injection is an adjunct to, and not a substitute for, specific or supportive measures that the patient may require, e.g., restoration of circulating blood volume, correction of fluid and electrolyte balance, oxygen, surgical measures and antibiotics. RHEUMATIC DISORDERS: As adjunctive therapy for short-term administration (to support the patient Lire le document complet