DEXAMETHASONE OMEGA UNIDOSE SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

DEXAMETHASONE PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)

Saatavilla:

OMEGA LABORATORIES LIMITED

ATC-koodi:

H02AB02

INN (Kansainvälinen yleisnimi):

DEXAMETHASONE

Annos:

10MG

Lääkemuoto:

SOLUTION

Koostumus:

DEXAMETHASONE PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) 10MG

Antoreitti:

INTRAMUSCULAR

Kpl paketissa:

10X1ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ADRENALS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

MARKETED

Valtuutus päivämäärä:

2013-05-08

Valmisteyhteenveto

Dexamethasone Omega Unidose 10 mg/1 mL
(Dexamethasone Sodium Phosphate Injection USP)
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PRESCRIBING INFORMATION
PR
DEXAMETHASONE OMEGA UNIDOSE
(DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP)
(10 MG/ML)
STERILE
CORTICOSTEROID
Omega Laboratories Limited
11,177 Hamon
Montreal, Quebec, Canada
H3M 3E4
Date of preparation:
June 12, 2012
Control Number: 154533
Dexamethasone Omega Unidose 10 mg/1 mL
(Dexamethasone Sodium Phosphate Injection USP)
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of
12
PR
D
EXAMETHASONE
O
MEGA
U
NIDOSE
(DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP) 10 MG/ML
STERILE
CORTICOSTEROID
ACTION AND PHARMACOLOGY
Dexamethasone is a synthetic glucocorticoid used principally as an
anti-inflammatory or
immunosuppressant drug. After administration of the injection,
dexamethasone sodium
phosphate is rapidly converted into dexamethasone. Dexamethasone is a
synthetic
glucocorticoid which has 7 times the anti-inflammatory potency of
prednisolone. Like
other
glucocorticoids,
dexamethasone
also
has
antiallergic,
antitoxic,
antishock,
antipyretic and immunosuppressive properties. Dexamethasone has
practically no water
and salt-retaining properties and is, therefore, particularly suitable
for use in patients with
cardiac decompensation or hypertension. Because of the long biological
half-life (36 to
54
hours),
dexamethasone
is
especially
suitable
in
conditions
where
a
continuous
glucocorticoid action is desired.
INDICATIONS AND CLINICAL USE
D
EXAMETHASONE
O
MEGA
U
NIDOSE
may be given by IV or IM 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
glucocorticoids may be used
in conjunction with a 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
glucocorticoids are use