Sileo 0.1 mg/mL Oromucosal Gel for Dogs

国家: 新西兰

语言: 英文

来源: Ministry for Primary Industries

有效成分:

dexmedetomidine hydrochloride

可用日期:

Mavlab Animal Health Limited

组成:

dexmedetomidine hydrochloride 0.1 g/kg

治疗领域:

Behaviour modifier

授权日期:

2022-09-02

产品特点

TEXT LABEL: Sileo 0.1 mg/mL Oromucosal Gel for Dogs
Immediate Container Label: Syringe – Main Panel
Text appearing above the Header and below the Footer lines is not
included in the label
8 June 2023
Draft text label
Page 1 of 24
FOR ANIMAL TREATMENT ONLY
SILEO® 0.1 MG/ML
OROMUCOSAL GEL FOR DOGS
0.1 MG/ML DEXMEDETOMIDINE HYDROCHLORIDE
(EQ. TO 0.09 MG/ML DEXMEDETOMIDINE)
3 mL
Mavlab Animal Health
EXP:
BN:
TEXT LABEL: Sileo 0.1 mg/mL Oromucosal Gel for Dogs
Individual Carton Label: Main Panel
Text appearing above the Header and below the Footer lines is not
included in the label
8 June 2023
Draft text label
Page 2 of 24
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
SILEO® 0.1 MG/ML
OROMUCOSAL GEL FOR DOGS
0.1 MG/ML DEXMEDETOMIDINE HYDROCHLORIDE
(EQUIVALENT TO 0.09 MG/ML DEXMEDETOMIDINE)
Sileo is indicated for the alleviation of acute anxiety and fear
associated with noise in dogs.
1 x 3 mL pre-filled syringe
1.
PUSH TO BREAK THE SEALS
2.
PUSH THE BUTTON AND PULL TO OPEN
Make sure that the package is closed correctly so that it remains
child-resistant. When closing, the
Sileo logo must be on the same side on both the inner and the outer
carton so that the yellow button
becomes visible.
TEXT LABEL: Sileo 0.1 mg/mL Oromucosal Gel for Dogs
Individual Carton Label: Ancillary Panels
Text appearing above the Header and below the Footer lines is not
included in the label
8 June 2023
Draft text label
Page 3 of 24
READ THE ENCLOSED LEAFLET FOR FULL INSTRUCTIONS.
USE AS DIRECTED BY PRESCRIBING VETERINARIAN.
DIRECTIONS FOR USE
DOSAGE AND ADMINISTRATION:
For oromucosal use in dogs only. Not intended for ingestion.
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 enclosed
leaflet for dosing table and
complete directions for use.
SAFETY DIRECTIONS
Avoid contact with eyes and skin. Do not touch or rub ey