DOMOSEDAN GEL 7.6 mg/ml oromucosal gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Detomidine hydrochloride

Available from:

Orion Corporation

ATC code:

QN05CM90

INN (International Name):

Detomidine hydrochloride

Dosage:

7.6 milligram(s)/millilitre

Pharmaceutical form:

Oromucosal gel

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Horses

Therapeutic area:

detomidine

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2009-02-27

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
DOMOSEDAN GEL 7.6 mg/ml oromucosal gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oromucosal gel
Even, translucent, blue gel
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horse
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 FOR EACH TARGET SPECIES
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 procedure is initiated, sedation should be allowed to fully
develop (approximately 30 min).
ACTIVE SUBSTANCE:
Detomidine
6.4
mg/ml
(equivalent to detomidine hydrochloride
7.6
mg/ml)
EXCIPIENTS:
Brilliant Blue FCF (E133)
0.032 mg/ml
For a full list of excipients, see section 6.1
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