Dilaterol 25 micrograms/ml syrup for horses

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Clenbuterol hydrochloride

Dostępny od:

Le Vet Beheer B.V.

Kod ATC:

QR03CC13

INN (International Nazwa):

Clenbuterol hydrochloride

Dawkowanie:

25 microgram(s)/millilitre

Forma farmaceutyczna:

Syrup

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupa terapeutyczna:

Horses

Dziedzina terapeutyczna:

clenbuterol

Wskazania:

Respiratory Tract preparations

Status autoryzacji:

Authorised

Data autoryzacji:

2012-11-16

Charakterystyka produktu

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dilaterol 25 micrograms/ml syrup for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Clenbuterol hydrochloride 25 micrograms
(corresponding to 22 micrograms 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)
2.02 mg
Propyl parahydroxybenzoate
0.26 mg
Carbomer 974P
Sucrose
Macrogol 400
Glycerol (85%)
Ethanol (96%)
Sodium hydroxide
Water, purified
Clear colourless syrup
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
2
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 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
veterinary 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 prod