Sileo gel oromucosal

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

dexmedetomidine (dexmedetomidine hydrochloride)

Disponible desde:

Orion Corporation

Código ATC:

QN05CM18

Designación común internacional (DCI):

dexmedetomidine (dexmedetomidine hydrochloride)

Dosis:

0,1mg/ml

formulario farmacéutico:

gel oromucosal

Unidades en paquete:

(1) pre-filled syringe 3ml

tipo de receta:

OTC

Estado de Autorización:

Registered

Fecha de autorización:

2021-07-05

Ficha técnica

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sileo 0.1 mg/ml oromucosal gel for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the oromucosal gel contains:
ACTIVE SUBSTANCE:
Dexmedetomidine hydrochloride
0.1 mg
(equivalent to 0.09 mg dexmedetomidine).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal gel.
Translucent, green gel.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alleviation of acute anxiety and fear associated with noise in dogs.
4.3
CONTRAINDICATIONS
Do not use in dogs with severe cardiovascular disorders.
Do not use in dogs with severe systemic disease (graded as ASA III-IV)
e.g. end stage renal or liver
failure.
Do not use in known cases of hypersensitivity to the active substance
or to any of the excipients.
Do not use in dogs obviously sedated from previous dosing.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
If the oromucosal gel is swallowed it will become ineffective.
Therefore feeding the dog or giving it
treats within 15 minutes after administration of the gel should be
avoided. In case the gel is swallowed
the dog can be given another dose if necessary 2 hours after the
previous dose.
In extremely nervous, excited or agitated animals, the levels of
endogenous catecholamines are often
high. The pharmacological response elicited by alpha-2 agonists (e.g.
dexmedetomidine) in such
animals may be reduced.
3
The safety of administering dexmedetomidine to puppies younger than 16
weeks and dogs over 17
years of age has not been studied.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
In case of accidental ingestion or prolonged mucosal contact, seek
medical advice immediately and
show the package leaflet or the label to the physician. Do not drive
as sedation and changes in blood
pressure may occur.
Avoid skin, eye or mu