Z-Itch 40 mg/ml pour-on solution

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Permethrin (80:20) technical

Disponible desde:

Floris Holding BV

Código ATC:

QP53AC04

Designación común internacional (DCI):

Permethrin (80:20) technical

Dosis:

40 milligram(s)/millilitre

formulario farmacéutico:

Pour-on solution

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapéutica:

permethrin

Estado de Autorización:

Authorised

Fecha de autorización:

2013-06-21

Ficha técnica

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BE, DE, IE, IT, PT, UK (NI): Z-Itch 40 mg/ml pour-on solution
DK, SE: Zitch Vet 40 mg/ml Pour-on Solution
PL: Zetronil 40 mg/ml Pour-on Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Permethrin (80:20) 40 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Butyl dioxitol
A clear, colourless to pale yellow, non-aqueous pour-on solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Horses and donkeys.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For use as an aid in the control of sweet itch due to its repellent
effect on the biting insect
_Culicoides_
spp.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in equids suffering from hepatic disease.
Do not use in cats.
3.4
SPECIAL WARNINGS
Sweet itch is believed to be caused by hypersensitivity to the bites
of flying insects e.g.
_Culicoides_
species. In addition to treatment, other measures should be taken to
reduce exposure to such insects
where practicable. It may be appropriate for owners to seek veterinary
advice on management of
horses with sweet itch. It is also recommended that owners seek
veterinary advice in severe cases of
sweet itch and in cases of sweet itch which do not respond to
treatment.
Washing or exposure to rain after application of the veterinary
medicinal product may affect
protection.
Unnecessary use of antiparasitics or use deviating from the
instructions given in the SPC may increase
the resistance selection pressure and lead to reduced efficacy. The
decision to use the product should
be based on confirmation of the parasitic species and burden, or of
the risk of infestation based on its
epidemiological features, for each individual animal.
2
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
For