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

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Fipronil

Inapatikana kutoka:

Beaphar B.V.

ATC kanuni:

QP53AX15

INN (Jina la Kimataifa):

Fipronil

Dawa fomu:

Cutaneous spray, solution

Dawa ya aina:

NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person

Kundi la matibabu:

Cats, Dogs

Eneo la matibabu:

Ectoparasiticide

Idhini hali ya:

Authorized

Idhini ya tarehe:

2017-10-18

Tabia za bidhaa

Issued October 2017
AN: 00456/2016
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fiprotec Spray 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
ACTIVE SUBSTANCE:
Fipronil
2.5 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous Spray, Solution
Clear, colourless liquid
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats and Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and prevention of flea (_Ctenocephalides _spp.) and tick
(_Ixodes _spp.,
including _Ixodes ricinus_) infestations in cats and dogs.
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 one month
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.
Issued October 2017
AN: 00456/2016
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not exceed the recommended dosage.
Avoid contact with the animal’s eyes. In the case of accidental eye
contact
immediately and thoroughly flush the eyes with water.
Do not spray directly onto areas of broken skin.
Allow treated animals to dry in a well ventilated room (see also
section 4.5).
Do not confine animals in an enclosed space or pet carrier until the
coat is totally dry.
In the absence of specific tolerance and efficacy data, the product is
not
recommended for the treatment of species other than cats and dogs.
For optimum efficacy, it is not recommended to bathe or shampoo