SUBESTIN 25 microgram/ml oral solution for horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clenbuterol hydrochloride

Available from:

Floris Holding BV

ATC code:

QR03CC13

INN (International Name):

Clenbuterol hydrochloride

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

clenbuterol

Authorization date:

2022-08-19

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Subestin 25 microgram/ml oral solution for horses
SUBESTIN SOLUTION BUVABLE POUR CHEVAUX
Subestin 25 microgrammi/ml soluzione orale per cavalli
SUBESTIN 25 microgram/ml orale oplossing voor paarden
PULMISTIN 25 Mikrogramm/ml Lösung zum Eingeben für Pferde
PULMISTIN Vet 25 mikrogram/ml oral lösning för häst
PULMISTIN Vet 25 mikrogram/ml oral opløsning
Subestin 25 Mikrogramm/ml Lösung zum Eingeben für Pferde
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 PRODUC
t
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.
2
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 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