DILATEROL 25 MICROGRAMS/ML SYRUP FOR HORSES

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLENBUTEROL-HYDROCHLORIDE PH. EUR. (CORRESPONDING TO CLENBUTEROL)

Available from:

Le Vet Beheer B.V.

ATC code:

QR03CC13

INN (International Name):

CLENBUTEROL-HYDROCHLORIDE PH. EUR. (CORRESPONDING TO CLENBUTEROL)

Dosage:

25 Microgram/ML

Pharmaceutical form:

Oral Gel

Prescription type:

POM

Therapeutic group:

Equine - Food

Therapeutic area:

Clenbuterol

Therapeutic indications:

Respiratory Tract Preparations

Authorization status:

Authorised

Authorization date:

2012-11-16

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dilaterol 25 micrograms/ml syrup for horses.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Syrup.
Clear colourless syrup.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE 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.
4.3 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 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Each ml contains:
Active substance:
Clenbuterol hydrochloride
25
micrograms
(corresponding to 22 micrograms clenbuterol)
Preservatives:
Methyl parahydroxybenzoate (E218)
2.02 mg
Propyl parahydroxybenzoate
0.26 mg
For a full list of excipients, see section 6.1
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/11/2012_
_CRN 7011560_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In cases accompanied by bacterial infection the administration of antimicrobial agents is recommended.
In case of glaucoma the product must only be used after a careful risk-benefit assessment.
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 MEDICINAL PRODUCT TO ANIMALS
This product contains clenbuterol h