Presedine 10 mg/ml Solution for Injection for Horses and Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Detomidine Hydrochloride

Available from:

Alfasan Nederland B.V.

ATC code:

QN05CM90

INN (International Name):

Detomidine Hydrochloride

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Horses

Therapeutic area:

Neurological Agent sedative

Authorization status:

Authorized

Authorization date:

2023-08-30

Summary of Product characteristics

Issued August 2023
AN: 00129/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Presedine 10 mg/ml solution for injection for horses and cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains :
ACTIVE SUBSTANCE:
Detomidine hydrochloride
10.0 mg
(equivalent to 8.36 mg detomidine)
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt
Methyl parahydroxybenzoate (E218)
1.0 mg
Sodium chloride
Hydrochloric acid, dilute (for pH-
adjustment)
Sodium hydroxide (for pH-adjustment)
Water for injection
Clear and colourless solution for injection
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Horses and cattle
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
A sedative intended for use in horses and cattle in:
-
Examinations for diagnostic purposes, such as endoscopy and X-rays;
-
Treatment of wounds, horse shoeing and change of bandages;
-
Minor surgical procedures, such as castration and excision of tumours.
3.3
CONTRAINDICATIONS
Do not use in animals with disorders of the circulatory system.
Do not use in horses with pre-existing AV blocks or in animals with
severe cardiac
insufficiency, respiratory disease or renal failure.
Do not use in conjunction with sympathomimetic amines or with
intravenous
potentiated sulphonamides.
Issued August 2023
AN: 00129/2022
Page 2 of 7
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in mares during the last trimester of pregnancy.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Horses in shock or in danger of being in shock, horses suffering from
cardiac disease
or horses that have fever, should only be treated according to the
benefit/risk
assessment by the responsible veterinary surgeon.
Protect treated horses from extreme temperatures.
After treatment, animals should recover in