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Vetflea 67 mg Spot-On Solution for Small Dogs
UK/V/0397/002/DC
Vetflea 134 mg Spot-On Solution for Medium Dogs
UK/V/0397/003/DC
Vetflea 268 mg Spot-On Solution for Large Dogs
UK/V/0397/004/DC
Vetflea 402 mg Spot-On Solution for Very Large Dogs
UK/V/0397/005/DC
Alfamed
Application for Decentralised
Publicly Available Assessment Report
1/16
UNITED KINGDOM
VETERINARY MEDICINES DIRECTORATE
WOODHAM LANE
NEW HAW
ADDLESTONE
SURREY KT15 3LS
MUTUAL RECOGNITION
PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY
MEDICINAL PRODUCT
VETFLEA 67 MG SPOT-ON SOLUTION FOR SMALL DOGS
VETFLEA 134 MG SPOT-ON SOLUTION FOR MEDIUM DOGS
VETFLEA 268 MG SPOT-ON SOLUTION FOR LARGE DOGS
VETFLEA 402 MG SPOT-ON SOLUTION FOR VERY LARGE DOGS
Vetflea 67 mg Spot-On Solution for Small Dogs
UK/V/0397/002/DC
Vetflea 134 mg Spot-On Solution for Medium Dogs
UK/V/0397/003/DC
Vetflea 268 mg Spot-On Solution for Large Dogs
UK/V/0397/004/DC
Vetflea 402 mg Spot-On Solution for Very Large Dogs
UK/V/0397/005/DC
Alfamed
Application for Decentralised
Publicly Available Assessment Report
2/16
MODULE 1
PRODUCT SUMMARY
EU Procedure number
UK/V/0397/002/DC
UK/V/0397/003/DC
UK/V/0397/004/DC
UK/V/0397/005/DC
Name, strength and
pharmaceutical form
Vetflea 67 mg Spot-On Solution for Small Dogs
UK/V/0397/002/DC
Vetflea 134 mg Spot-On Solution for Medium
Dogs
Vetflea 268 mg Spot-On Solution for Large
Dogs
Vetflea 402 mg Spot-On Solution for Very Large
Dogs
Applicant
ALFAMED
13ème Rue
– L.I.D.
06517 CARROS CEDEX
FRANCE
Active substance
Fipronil
ATC Vetcode
QP53AX15
Target species
Dogs
Indications
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제품 특성 요약
Issued: August 2012
AN: 00105/2011
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ALFAMED FIPRONIL (BE) / FIPROLINE (HU, RO) / VETFLEA (UK) 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.
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: 00105/2011
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
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