Alfamed Fipronil 268 mgSpot-On Solution for Large Dogs
Country: Romania
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
27-10-2012
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Active ingredient:
fipronil 10 %
Available from:
Alfamed
ATC code:
QP53AX15
Pharmaceutical form:
Spot-on solution
Therapeutic group:
fipronil
Therapeutic area:
Dogs
Authorization date:
2012-03-21
Summary of Product characteristics
Issued: August 2012
AN: 00104/2011
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ALFAMED FIPRONIL (BE) / FIPROLINE (HU, RO) / VETFLEA (UK) 268 mg Spot-on
solution for large dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 2.68 ml pipette contains :
ACTIVE SUBSTANCE:
Fipronil
268 mg
EXCIPIENTS:
Butyhydroxyanisole E320 0.536 mg
Butylhydroxytoluene E321 0.268 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.
The product can be used as part of a treatment strategy for the control of Flea Allergy
Dermatitis (FAD) where this has been previously diagnosed by a veterinary surgeon._ _
Issued: August 2012
AN: 00104/2011
Page 2 of 7
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.
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