Ectoline 67 mg Spot-On Solution for Small Dogs
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
10-05-2013
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Active ingredient:
fipronil 100 mg
Available from:
Alfamed
ATC code:
QP53AX15
Pharmaceutical form:
Spot-on solution
Therapeutic group:
fipronil
Therapeutic area:
Dogs
Authorization date:
2012-01-31
Summary of Product characteristics
Revised: January 2012
AN: 01618/2011
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ALFAMED 268 mg spot-on solution for large dogs
(DE: FIPROLINE, FR: TICK-PUSS, IT: PROCARE FICONTROL, UK: ECTOLINE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 2.68 ml pipette contains :
ACTIVE SUBSTANCE:
Fipronil
268 mg
EXCIPIENTS:
Butyhydroxyanisole E320 0.536 mg/pipette
Butylhydroxytoluene E321 0.268 mg/pipette
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._ _
Revised: January 2012
AN: 01618/2011
Page 2 of 7
4.3 CONTRAINDICATIONS
Do not use on puppies less than 2 months old and /or weighing le
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