SILEO GEL

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DEXMEDETOMIDINE HYDROCHLORIDE

Available from:

ORION CORPORATION

Dosage:

0.1MG

Pharmaceutical form:

GEL

Composition:

DEXMEDETOMIDINE HYDROCHLORIDE 0.1MG

Administration route:

BUCCAL

Units in package:

100

Prescription type:

Prescription

Therapeutic group:

DOGS

Product summary:

Active ingredient group (AIG) number: 0152657002

Authorization status:

APPROVED

Authorization date:

2022-09-02

Patient Information leaflet

29 August 2022
SYRINGE LABEL (PROPOSED BILINGUAL*) – 3 ML
DIN ########
SILEO
®
DEXMEDETOMIDINE HYDROCHLORIDE GEL 0.1 MG/ML
OROMUCOSAL GEL FOR DOGS
GEL ORO-MUQUEUX POUR CHIENS
S
ee Package Insert for complete product information.
Voir la notice pour l’information complète sur le produit
3 mL
Orion Corporation
LOT
EXP.:
29 August 2022
CARTON LABEL (BILINGUAL) – 3 ML
MAIN PANEL:
DIN ########
VETERINARY USE ONLY/USAGE VÉTÉRINAIRE SEULEMENT
SILEO
®
DEXMEDETOMIDINE HYDROCHLORIDE GEL 0.1 MG/ML
GEL DE CHLORHYDRATE DE DEXMÉDÉTOMIDINE 0,1 MG/ML
OROMUCOSAL GEL FOR DOGS
GEL ORO-MUQUEUX POUR CHIENS
WARNINGS: Keep out of reach of children. See Package Insert for
complete Warnings.
MISES EN GARDE : Garder hors de la portée des enfants. Consulter la
notice pour toutes les
mises en garde.
3 mL
_ _
Orion Corporation
Turku, Finland
Imported and distributed by/Importé et distribué par : Virbac
Canada, Inc., 231 Shearson
Crescent, Suite 209, Cambridge, ON, Canada, N1T 1J5. 1-800-338-3659
_ _
SIDE PANEL-ENGLISH:
ACTIVE INGREDIENT: Dexmedetomidine HCl, USP, 0.1 mg/mL
INDICATIONS: For the alleviation of acute anxiety and fear associated
with noise in dogs.
DOSAGE AND ADMINISTRATION: SILEO is administered onto the oral mucosa
between the dog’s
cheek and gum at 125 µg/m
2
. The dosing syringe delivers the product in 0.25 mL increments.
Each increment is shown as one dot on the plunger. See the Package
Insert for dosing table
and complete directions for use.
_READ PACKAGE INSERT BEFORE USING THIS PRODUCT. _
CAUTIONS: For oromucosal use in dogs only. See Package Insert for
complete Cautions.
CONTRAINDICATIONS: Do not use SILEO in dogs with severe
cardiovascular, respiratory, liver or
kidney disease, or in conditions of shock, severe debilitation, or
stress due to extreme heat, cold
or fatigue. Do not use in case of hypersensitivity to the active
substance or to any of the
excipients. Do not use in dogs obviously sedated from previous dosing.
See Package Insert for
complete Contraindications.
WARNINGS: Keep out of reach of