TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION USP

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

TRIAMCINOLONE ACETONIDE

Disponível em:

SANDOZ CANADA INCORPORATED

Código ATC:

H02AB08

DCI (Denominação Comum Internacional):

TRIAMCINOLONE

Dosagem:

10MG

Forma farmacêutica:

SUSPENSION

Composição:

TRIAMCINOLONE ACETONIDE 10MG

Via de administração:

INTRA-ARTICULAR

Unidades em pacote:

1X5ML

Tipo de prescrição:

Prescription

Área terapêutica:

ADRENALS

Resumo do produto:

Active ingredient group (AIG) number: 0106310007; AHFS:

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2021-03-25

Características técnicas

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_Triamcinolone Acetonide Injectable Suspension USP _
_Page 1 of 13 _
PRESCRIBING INFORMATION
PR TRIAMCINOLONE ACETONIDE INJECTABLE
SUSPENSION USP
10 MG/ML
STERILE
CORTICOSTEROID - ANTI-INFLAMMATORY
Sandoz Canada Inc
Date of revision
145, Jules-Léger Street
May 28, 2018
Boucherville, QC, Canada
J4B 7K8
Submission Control Number: 210289
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_Triamcinolone Acetonide Injectable Suspension USP _
_Page 2 of 13 _
PR TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION USP
10 mg/mL
Sterile
THERAPEUTIC CLASSIFICATION
Corticosteroid - Anti-inflammatory
NOTE: Triamcinolone Acetonide Injectable Suspension USP is
triamcinolone acetonide, a synthetic
glucocorticoid corticosteroid with marked anti-inflammatory action, in
a sterile aqueous suspension
suitable for intradermal, intra-articular, and intrabursal injection
and for injection into tendon
sheaths. THIS FORMULATION IS NOT SUITABLE FOR INTRAVENOUS,
INTRAMUSCULAR, INTRAOCULAR, EPIDURAL
OR INTRATHECAL INJECTION.
ACTION AND CLINICAL PHARMACOLOGY
Naturally occurring glucocorticoids (e.g., hydrocortisone), which also
have salt-retaining properties,
are used as replacement therapy in adrenocortical deficiency states.
Synthetic analogs such as
triamcinolone are primarily used for their potent anti-inflammatory
effects in disorders of many
organ systems.
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify the body's
immune responses to diverse stimuli.
INDICATIONS AND CLINICAL USE
Intra-articular: For intra-articular or intrabursal administration,
and for injections into tendon
sheaths, as adjunctive therapy for short-term administration in the
following conditions: synovitis of
osteoarthritis, rheumatoid arthritis, acute and subacute bursitis,
acute gouty arthritis, epicondylitis,
acute nonspecific tenosynovitis, and post-traumatic osteoarthritis.
Intradermal: Intralesional administration is indicated for the
treatment of keloids, discoid lupus
erythematosus, necrobiosis lipoidica diabeticorum, alopecia areata,
and localized hypertrophic,
infiltra