DOMOSEDAN 10 MG/ML SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-01-2017
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Active ingredient:
DETOMIDINE HYDROCHLORIDE
Available from:
Orion Corporation
ATC code:
QN05CM90
INN (International Name):
DETOMIDINE HYDROCHLORIDE
Dosage:
10 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
VPO-Vet.Practitioner Only
Therapeutic group:
Equine - Food
Therapeutic area:
Detomidine
Therapeutic indications:
Neurological Preparations
Authorization status:
Authorised
Authorization date:
2010-03-12
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Domosedan 10 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Detomidine hydrochloride
10 mg/ml
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218)
1 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Domosedan is a sedative with analgesic properties used to facilitate handling of horses for examination, minor surgical
interventions and other manipulations.
Domosedan can be used in combination with butorphanol_._
The product is also indicated for use with ketamine for short duration general anaesthesia to carry out surgical
procedures such as castration.
4.3 CONTRAINDICATIONS
Do not administer to horses during pregnancy.
Do not use in conjunction with sympathomimetic amines or with intravenous potentiated sulphonamides.
Do not use in horses with pre-existing atrio-ventricular heart blocks, with severe cardiac insufficiency, respiratory
disease or chronic renal failure.
Do not use the butorphanol combination in horses suffering from colic.
Domosedan/butorphanol combination should not be used in horses with a history of liver disease or cardiac
irregularities.
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
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 23/12/2016_
_CRN 7024043_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Careful consideration should be given prior to
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