Dilaterol 25 micrograms/ml Syrup for Horses

País: Regne Unit

Idioma: anglès

Font: VMD (Veterinary Medicines Directorate)

ingredients actius:

Clenbuterol Hydrochloride

Disponible des:

Le Vet Beheer B.V.

Codi ATC:

QR03CC13

Designació comuna internacional (DCI):

Clenbuterol Hydrochloride

formulario farmacéutico:

Syrup

tipo de receta:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapéutico:

Horses

Área terapéutica:

Respiratory expectorant

Estat d'Autorització:

Authorized

Data d'autorització:

2013-03-07

Fitxa tècnica

Revised: May 2018
AN: 00963/2017
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dilaterol 25 micrograms/ml syrup for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Clenbuterol hydrochloride 25 micrograms
(corresponding to 22 micrograms clenbuterol)
EXCIPIENTS:
Methyl parahydroxybenzoate (E218) 2.02 mg
Propyl parahydroxybenzoate 0.26 mg
For the 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.
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.
Revised: May 2018
AN: 00963/2017
Page 2 of 6
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 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 hydrochloride, a beta-agonist.
Wear gloves to avoid skin contact. In case of accidental skin contact,
wash affected area
thoroughly. If irritation occurs/persists seek medical advice. Wash
hands thoroughly after
using the product.
Take care to avoid eye contact. In the case of accidental eye contact,
flush thor