Domosedan Gel 7.6 mg/ml Oromucosal Gel

País: Reino Unido

Idioma: inglés

Fuente: VMD (Veterinary Medicines Directorate)

Ingredientes activos:

Detomidine Hydrochloride

Disponible desde:

Orion Corporation

Código ATC:

QN05CM90

Designación común internacional (DCI):

Detomidine Hydrochloride

formulario farmacéutico:

Oromucosal gel

tipo de receta:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapéutico:

Horses

Área terapéutica:

Neurological Agent sedative

Estado de Autorización:

Authorized

Fecha de autorización:

2009-02-06

Ficha técnica

AN: 01099/2013 & 1720/2012
Revised: December 2013
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DOMOSEDAN GEL 7.6 mg/ml oromucosal gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Detomidine
6.4 mg/ml
(equivalent to detomidine hydrochloride 7.6 mg/ml)
EXCIPIENT:
Brilliant Blue FCF (E133)
0.032 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal gel
Even, translucent, blue gel
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horse
4.2
INDICATIONS FOR USE
Sedation to facilitate restraint for non-invasive veterinary
procedures (e.g. passage of
naso-gastric tube, radiography, rasping teeth) and minor husbandry
procedures (e.g.
clipping, shoeing).
4.3
CONTRAINDICATIONS
Do not use in seriously ill animals with heart failure or impaired
liver or kidney
function.
Do not use in conjunction with intravenous potentiated sulphonamides.
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS
Unlike most other oral veterinary products, this product is not meant
to be swallowed.
Instead, it must be placed under the tongue of the horse. When the
product is
administered, the animal should be allowed to rest in a quiet place.
Before any
AN: 01099/2013 & 1720/2012
Revised: December 2013
Page 2 of 6
procedure is initiated, sedation should be allowed to fully develop
(approximately 30
min).
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Horses approaching or in endotoxic or traumatic shock, or horses
suffering from
cardiac diseases, advanced lung disease, or fever should only be
treated according
to the benefit risk assessment by the responsible veterinarian.
Protect treated horses
from extreme temperatures. Some horses, although apparently deeply
sedated, may
still respond to external stimuli.
Food and water should be withheld until the sedative effect of the
product has worn
off.
Special precautions to be taken by the person administering the
veterinary medici