BETAJECT SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BETAMETHASONE ACETATE; BETAMETHASONE (BETAMETHASONE 21-DISODIUM PHOSPHATE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

H02AB01

INN (International Name):

BETAMETHASONE

Dosage:

3MG; 3MG

Pharmaceutical form:

SUSPENSION

Composition:

BETAMETHASONE ACETATE 3MG; BETAMETHASONE (BETAMETHASONE 21-DISODIUM PHOSPHATE) 3MG

Administration route:

INTRA-ARTICULAR

Units in package:

1X5ML/10X1ML

Prescription type:

Prescription

Therapeutic area:

ADRENALS

Product summary:

Active ingredient group (AIG) number: 0206301001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-08-01

Summary of Product characteristics

_BETAJECT_
_Page 1 of 14_
PRESCRIBING INFORMATION
PR
BETAJECT
BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE INJECTABLE
SUSPENSION USP
(6MG/ML)
STERILE
GLUCOCORTICOID
Sandoz Canada Inc.
Date of Revision:
145 Jules-Léger
May 29, 2018
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 214913
_BETAJECT_
_Page 2 of 14_
_2018/05/29 _
PR
BETAJECT
BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE INJECTABLE
SUSPENSION USP
(6 MG/ML)
THERAPEUTIC CLASSIFICATION
Glucocorticoid
PHARMACOLOGY
Betamethasone sodium phosphate and betamethasone acetate injectable
suspension is a
combination of soluble and slightly soluble betamethasone esters that
provides potent anti-
inflammatory, antirheumatic and antiallergic effects in the treatment
of corticosteroid-responsive
disorders. Prompt therapeutic activity is achieved by betamethasone
sodium phosphate, which is
absorbed quickly after injection. Sustained activity is provided by
betamethasone acetate, which is
only slightly soluble and becomes a repository for slow absorption,
thereby controlling symptoms
over a prolonged period.
INDICATIONS AND CLINICAL USE
BETAJECT is indicated as follows:

IM injection in allergic, dermatologic, rheumatic, and other
conditions responsive to systemic
corticosteroids, including bursitis;

Local injection into the affected tissues in bursitis and associated
inflammatory disorders of
tendons such as tenosynovitis, and inflammatory disorders of muscle
such as fibrosis and
myositis

Intra-articular and periarticular injection in rheumatoid arthritis
and osteoarthritis;

Intralesional injection in various dermatologic conditions; and

Local injection in certain inflammatory and cystic disorders of the
foot.
CONTRAINDICATIONS
Betaject is contraindicated in patients:

who are hypersensitive to any components of this product (see DOSAGE
FORMS,
COMPOSITION AND PACKAGING).

with herpes simplex of the eye

with systemic fungal infections.

with vaccinia

with cerebral malaria

in idiopathic thrombocytopen