FLEANIL 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Fipronil

זמין מ:

Norbrook Laboratories (Ireland) Limited

קוד ATC:

QP53AX15

INN (שם בינלאומי):

Fipronil

כמות:

2.5 milligram(s)/millilitre

טופס פרצבטיות:

Cutaneous spray, solution

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

איזור תרפויטי:

fipronil

מצב אישור:

Authorised

תאריך אישור:

2014-08-22

מאפייני מוצר

Health Products Regulatory Authority
29 July 2019
CRN008RWX
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
FLEANIL 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains
​
​
ACTIVE SUBSTANCE:
​
​
Fipronil
2.5​ mg
​
EXCIPIENT:
​
​
For the full list of excipients,
see section 6.1 ​
3 PHARMACEUTICAL FORM
Cutaneous spray, solution.
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea (_Ctenocephalides_ spp.) and tick (_Ixodes ricinus_,
_Rhipicephalus sanguineus_) infestations in dogs and cats.
Treatment of biting lice infestations in dogs (_Trichodectes canis_)
and cats (_Felicola subrostratus_).
Insecticidal efficacy against new infestations with adult fleas
persists for up to 2 months in cats and up to 3 months in dogs,
depending on environmental challenge.
The product has a persistent acaricidal efficacy for up to 4 weeks
against ticks, depending on the level of environmental
challenge.
4.3 CONTRAINDICATIONS
Do not use on sick (systemic diseases, fever…) or convalescent
animals.
Do not use in rabbits, as adverse reactions and even death could
occur.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of bedding, carpets and soft furnishings with a suitable
insecticide will aid reduction in environmental challenge and
maximise the duration of protection against re-infestation provided by
the product.The product is not suitable for direct
treatment of the environment.
For optimum efficacy, it is not recommended to bathe or shampoo
animals in the two days prior to or following treatment with
the product. Bathing or shampooing up to four times in two months has
been shown to have no significant effect on the
residual efficacy of the product. Monthly treatment is recommended
when more frequent sh