Domidine 10 mg/ml solution for injection, for horses and cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Detomindine hydrochloride

Available from:

Eurovet Animal Health B.V.

ATC code:

QN05CM90

INN (International Name):

Detomindine hydrochloride

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Horses

Therapeutic area:

detomidine

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2006-09-27

Summary of Product characteristics

Health Products Regulatory Authority
25 June 2019
CRN0094HY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Domidine 10 mg/ml solution for injection, for horses and cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
ACTIVE SUBSTANCES:
Detomidine hydrochloride 10.0 mg
this corresponds to 8.36 mg detomidine base
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218)
1.0 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horse, cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the sedation and slight analgesia of horses and cattle, to
facilitate physical examinations and treatments, such as minor
surgical interventions.
Detomidine can be used for:

Examinations (e.g. endoscopia, rectal and gynaecological examinations,
X-rays).

Minor surgical procedures (e.g. treatment of wounds, dental treatment,
tendon treatment, excision of skin tumours,
teat treatment).

Before treatment and medication (e.g. stomach tube, horse shoeing).
For premedication prior to administration of injection or inhalation
anaesthetics.
4.3 CONTRAINDICATIONS
Do not use in animals with cardiac abnormalities or respiratory
diseases.
Do not use in animals with liver insufficiency or renal failure.
Do not use in animals with general health problems (e.g. diabetes
mellitus, dehydrated animals, shock or any other
extraordinary stress conditions).
Do not use in combination with butorphanol in horses suffering from
colic.
See also section 4.7 and 4.8.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Health Products Regulatory Authority
25 June 2019
CRN0094HY
Page 2 of 5
As sedation begins, especially horses may start to sway and lower the
head rapidly while they remain standing. Cattle and
especially young cattle will try to lie down. To prevent injuries the
location sho