MEDESEDAN 10 MG/ML, SOLUTION FOR INJECTION FOR HORSES AND CATTLE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DETOMIDINE HYDROCHLORIDE

Available from:

CP-Pharma Handelsgesellschaft mbH

ATC code:

QN05CM90

INN (International Name):

DETOMIDINE HYDROCHLORIDE

Dosage:

10.0 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

VPO-Vet.Practitioner Only

Therapeutic group:

Bovine, Equine - Food

Therapeutic area:

Detomidine

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2008-02-15

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Medesedan 10 mg/ml, Solution for Injection for Horses and Cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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. endoscopy, 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.
See section 4.5 before use.
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. dehydrated animals).
Do not use in combination with butorphanol in horses suffering from colic.
Do not use in the last trimester of pregnancy.
See also section 4.7. and 4.8.
1 ml solution for injection contains:
ACTIVE SUBSTANCE:
QUANTITY:
Detomidine hydrochloride
10.0
mg
(equivalent to 8.36 mg detomidine)
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218)
1.0
mg
For a full list of excipients, see section 6.1.
IRISH MEDICINES BOARD
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_Date Printed 14/11/2011_
_CRN 7011058_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUT