Subestin 25 microgram/ml Oral Solution for Horses

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Clenbuterol Hydrochloride

Available from:

Floris Holding B.V.

ATC code:

QR03CC13

INN (International Name):

Clenbuterol Hydrochloride

Pharmaceutical form:

Oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Horses

Therapeutic area:

Respiratory expectorant

Authorization status:

Authorized

Authorization date:

2022-08-25

Summary of Product characteristics

Revised: November 2023
AN: 01419/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Subestin 25 microgram/ml oral solution for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains:
ACTIVE SUBSTANCE:
Clenbuterol Hydrochloride
25 microgram
(equivalent to 22 microgram clenbuterol)
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)
1.8 mg
Propyl parahydroxybenzoate
0.2 mg
Carbomer (974P)
Sucrose
Macrogol 400
Glycerol (E422)
Ethanol 96%
Trolamine (for pH adjustment)
Water, purified
Oral solution
Slightly viscous, colourless to slightly yellow solution.
Revised: November 2023
AN: 01419/2023
Page 2 of 6
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Horses.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of respiratory disease in horses where it is considered that
airway
obstruction due to bronchospasm and/or accumulation of mucus is a
contributing
factor, and improved mucociliary clearance is desirable.
To be used alone or as adjuvant therapy.
3.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance
or any of the
excipients.
Do not use in horses with known cardiac disease.
For use during pregnancy or lactation see section 3.7.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
In cases accompanied by bacterial infection the administration of
antimicrobial
agents is recommended.
In case of glaucoma the veterinary medicinal product must only be used
after a
careful benefit-risk assessment by the attending veterinarian.
Special precautions should be taken in case of halothane anaesthesia,
since the
heart function can show increased sensitivity to catecholamines.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
This veterinary me