Dilaterol 25 microgr/ml oral syrup for horses
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
19-06-2013
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Active ingredient:
clenbuterol hydrochloride 25 mg/ml
Available from:
Le Vet B.V
ATC code:
QR03CC13
Pharmaceutical form:
Oral liquid
Therapeutic group:
Clenbuterol
Therapeutic area:
Horses
Authorization date:
2012-09-26
Summary of Product characteristics
AN: 01218/2011
Issued: March 2013
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Dilaterol 25 micrograms/ml syrup for horses. (AT, BE, CZ, ES, HU, IE, IT, LU, PL, PT,
RO, SK, UK)
Dilaterol vet. 25 micrograms/ml syrup for horses. (FI, IS, NO, SE)
Dilaterol vet. (DK)
Dilaterol 22 micrograms/ml syrup for horses (FR)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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
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.
AN: 01218/2011
Issued: March 2013
Page 2 of 5
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
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In cases accompanied by bacterial infection the administration of antimicrobial age
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