Fiproclear 67 mg Spot-On Solution for Small Dogs

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Fipronil

Inapatikana kutoka:

Norbrook Laboratories (Ireland) Limited

ATC kanuni:

QP53AX15

INN (Jina la Kimataifa):

Fipronil

Kipimo:

67 mg/pipette

Dawa fomu:

Spot-on solution

Dawa ya aina:

POM: Prescription Only Medicine as defined in relevant national legislation

Eneo la matibabu:

fipronil

Idhini hali ya:

Authorised

Idhini ya tarehe:

2013-05-17

Tabia za bidhaa

Health Products Regulatory Authority
27 February 2019
CRN008TR3
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fiproclear 67 mg Spot-On Solution for Small Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One 0.67 ml pipette contains:
Active Substance:
Fipronil
67
mg
Excipients:
Butylhydroxyanisole (E320)
0.134
mg
Butylhydroxytoluene (E321)
0.067
mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution.
A clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infestations by fleas (_Ctenocephalides felis_).
The product shows immediate insecticidal effect and persistent
insecticidal activity against new infestations by adult fleas for up
to 8 weeks.
The product has a persistent acaricidal efficacy against _Ixodes
ricinus _for up to 2 weeks, _Rhipicephalus sanguineus _for up to 3
weeks and _Dermacentor reticulatus _for up to 4 weeks. If ticks of
these species are present when the product is applied, all ticks
will not be killed within the first 48 hours but they may be killed
within a week.
The product can be used as part of a treatment programme for Flea
Allergy Dermatitis where this has been previously
diagnosed by a Veterinary Surgeon.
4.3 CONTRAINDICATIONS
Do not use in dogs weighing less than 2 kg.
In the absence of available data, the product should not be used in
puppies less than 8 weeks old.
Do not use in sick (systemic diseases, fever…) or convalescent
animals.
Do not use in rabbits, as adverse reactions and even death could
occur.
This product is specifically developed for dogs. Do not use in cats,
as this could lead to overdosing.
Do not use in cases of known hypersensitivity to fipronil or to any of
the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The product does not prevent ticks from attaching to the animals, but
ticks may be killed in the first 24-48 hours after
attachment prior to full engorgement and