KENALOG IN ORABASE 0.1% PASTE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

TRIAMCINOLONE ACETONIDE

Saatavilla:

BRISTOL-MYERS SQUIBB CANADA

ATC-koodi:

A01AC01

INN (Kansainvälinen yleisnimi):

TRIAMCINOLONE

Annos:

1MG

Lääkemuoto:

PASTE

Koostumus:

TRIAMCINOLONE ACETONIDE 1MG

Antoreitti:

DENTAL

Kpl paketissa:

7.5G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTI-INFLAMMATORY AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0106310002; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2008-09-04

Valmisteyhteenveto

PRESCRIBING INFORMATION
PR
KENALOG IN ORABASE
(TRIAMCINOLONE DENTAL PASTE))
DENTAL CORTICOSTEROID
Bristol-Myers Squibb Canada
2365 Côte-de-Liesse
Date of Preparation:
Montreal, Canada H4N 2M7
November 19, 2004
*
TM of Bristol-Myers Squibb Canada
Date of Revision:
Control No.: 095318
1
PRESCRIBING INFORMATION
PR
KENALOG IN ORABASE
(TRIAMCINOLONE DENTAL PASTE)
THERAPEUTIC CLASSIFICATION
Dental Corticosteroid
ACTION AND CLINICAL PHARMACOLOGY
Triamcinolone is a synthetic corticosteroid which possesses
anti-inflammatory, antipruritic, and
antiallergic action. The emollient dental paste acts as an adhesive
vehicle for applying the active
medication to the oral tissues. The vehicle provides a protective
covering which may serve to
temporarily reduce the pain associated with oral irritation.
INDICATIONS AND CLINICAL USE
Adjunctive treatment and temporary relief of symptoms associated with
oral inflammatory lesions
and ulcerative lesions resulting from trauma.
CONTRAINDICATIONS
Fungal, viral or bacterial infections of the mouth or throat.
Hypersensitivity to any of the
components.
PRECAUTIONS
Pregnancy: Safe use of this preparation during pregnancy has not been
established with respect
to possible adverse reactions upon fetal development; therefore, it
should not be used in women
of childbearing potential and particularly during early pregnancy
unless the potential benefits
outweigh the possible hazards.
Patients with tuberculosis, peptic ulcer or diabetes mellitus should
not be treated with any
corticosteroid preparation without the advice of the patient's
physician. It should be borne in mind
that the normal defensive reponses of the oral tissues are depressed
in patients receiving topical
corticosteroid therapy. Virulent strains of oral microorganisms may
multiply without producing the
usual symptoms of oral infections.
The small amount of steroid released when the preparation is used as
recommended makes
systemic effects very unlikely; however, they are a possibility when
topical corticosteroid
preparations are used