Fiproclear 50 mg Spot-On Solution for Cats

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Fipronil

متاح من:

Norbrook Laboratories (Ireland) Limited

ATC رمز:

QP53AX15

INN (الاسم الدولي):

Fipronil

جرعة:

50 mg/pipette

الشكل الصيدلاني:

Spot-on solution

نوع الوصفة الطبية :

POM: Prescription Only Medicine as defined in relevant national legislation

المجال العلاجي:

fipronil

الوضع إذن:

Authorised

تاريخ الترخيص:

2013-05-17

خصائص المنتج

Health Products Regulatory Authority
27 February 2019
CRN008TR3
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fiproclear 50 mg Spot-On Solution for Cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One 0.5 ml pipette contains:
Active Substance
Fipronil
50
mg
Excipients
Butylhydroxyanisole E320
0.1
mg
Butylhydroxytoluene E321
0.05
mg
For 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
Cats.
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 5 weeks.
The product shows acaricidal efficacy with killing effect against
ticks (_Ixodes ricinus_) within 48 hours.
The product has persistent acaricidal efficacy for up to 2 weeks
against ticks (_Dermacentor reticulatus_). If ticks of this 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
In the absence of available data, the product should not be used on
kittens less than 8 weeks old and/or weighing less than 1
kg.
Do not use on sick (systemic diseases, fever…) or convalescent
animals.
Do not use in rabbits, as adverse drug reactions and even death could
occur.
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. If
the animal has been treated prior to exposure to the ticks,
the ticks will start to be killed in the first 24-48 hours after
attachment. This will usually be prior to engorgement, minimising
bu