DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

DEXAMETHASONE PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)

Disponibil de la:

STRIDES PHARMA CANADA INC

Codul ATC:

H02AB02

INN (nume internaţional):

DEXAMETHASONE

Dozare:

10MG

Forma farmaceutică:

SOLUTION

Compoziție:

DEXAMETHASONE PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) 10MG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

10ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ADRENALS

Rezumat produs:

Active ingredient group (AIG) number: 0106305005; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-07-30

Caracteristicilor produsului

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