Fipralone 402 mg Spot-on Solution for Very Large Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Fipronil

Available from:

Alfamed

ATC code:

QP53AX15

INN (International Name):

Fipronil

Pharmaceutical form:

Spot-on solution

Prescription type:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Therapeutic group:

Dogs

Therapeutic area:

Ectoparasiticide

Authorization status:

Authorized

Authorization date:

2013-06-13

Summary of Product characteristics

Revised: April 2018
AN: 01991/2017
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fipralone 402 mg Spot-on solution for very large dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 4.02 ml pipette contains:
ACTIVE SUBSTANCE:
Fipronil
402 mg
EXCIPIENTS:
Butyhydroxyanisole E320
0.804 mg
Butylhydroxytoluene E321
0.402 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear, colourless to yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE
Treatment
of
flea
(_Ctenocephalides_
spp.)
and
tick
(_Dermacentor_
_reticulatus_)
infestations.
Insecticidal efficacy against new infestations with adult fleas
persists for up to 8
weeks.
The product has a persistent acaricidal efficacy for up to 4 weeks
against ticks
(_Rhipicephalus sanguineus_, _Ixodes ricinus_, _Dermacentor
reticulatus_). If ticks of some
species (_Rhipicephalus sanguineus_ and _Ixodes_ _ricinus_) are
present when the product
is applied, all the ticks may not be killed within the first 48 hours
but they may be
killed within a week.
4.3
CONTRAINDICATIONS
Do not use on puppies less than 2 months old and /or weighing less
than 2kg in the
absence of available data.
Do not use on sick (e.g. systemic diseases, fever…) or convalescent
animals.
Do not use in rabbits, due to a risk of adverse drug reactions or even
death.
This product is specifically developed for dogs. Do not use in cats,
as this could lead
to overdosing.
Revised: April 2018
AN: 01991/2017
Page 2 of 7
Do not use in known cases of hypersensitivity to the active substance
or to any of
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Shampooing an hour prior to treatment does not affect the efficacy of
the product
against fleas.
Bathing/immersion in water within two days after application of the
product should be
avoided. _ _Weekly immersion in water for one minute reduces the
period of persistent
insecticidal efficacy against fleas by one week.
The product does not preve