Alfamed Fipronil 2.5 mg/ml Cutaneous Spray Solution for Cats & Dogs
Country: Romania
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
27-10-2012
Summary of Product characteristics
(SPC)
27-10-2012
Active ingredient:
fipronil 0.25 %
Available from:
Alfamed
ATC code:
QP53AX15
Pharmaceutical form:
Cutaneous spray, solution
Therapeutic group:
fipronil
Therapeutic area:
Cats, Dogs
Authorization date:
2012-03-21
Patient Information leaflet
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UNITED KINGDOM
VETERINARY MEDICINES DIRECTORATE
WOODHAM LANE
NEW HAW
ADDLESTONE
SURREY KT15 3LS
DECENTRALISED PROCEDURE
PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY
MEDICINAL PRODUCT
VETFLEA 2.5 MG/ML CUTANEOUS SPRAY, SOLUTION FOR CATS AND DOGS
Vetflea 2.5 mg/ml cutaneous spray, Solution for cats and dogs
UK/V/0397/006/DC
Alfamed
Application for Decentralised Procedure
Publicly Available Assessment Report
2/9
MODULE 1
PRODUCT SUMMARY
EU Procedure number
UK/V/0397/006/DC
Name, strength and
pharmaceutical form
Vetflea 2.5 mg/ml cutaneous spray, Solution for
cats and dogs
Applicant
Alfamed
13ème rue
– L.I.D.
06517 Carros Cedex
France
Active substance(s)
Fipronil
ATC Vetcode
QP53AX15
Target species
Cats and dogs
Indication for use
Treatment of flea infestation (_Ctenocephalides_
spp.) in dogs and cats.
Treatment of tick infestation (_Ixodes ricinus, _
_Rhipicephalus sanguineous_) in dogs and cats.
Treatment of biting lice infestation in dogs
(_Trichodectes _
_canis_)
and
cats
(_Felicola _
_subrostratus_).
The product can be used as part of a treatment
strategy for the control of Flea Allergy
Dermatitis (FAD).
Insecticidal efficacy against new infestations
with adult fleas persists for up to 6 weeks in
cats and up to 3 months in dogs, depending on
environmental challenge.
The product has a persistent acaricidal efficacy
for up to 4 weeks against ticks, depending on
the level of environmental challenge.
Vetflea 2.5 mg/ml cutaneous spray, Solution for cats and dogs
UK/V/0397/006/DC
Alfamed
Application for Decentralised Procedure
Publicly Available Assessm
Read the complete document
Summary of Product characteristics
Issued: May 2012
AN: 00106/2011
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ALFAMED FIPRONIL (BE) / FIPROLINE (HU, RO) / VETFLEA (UK)
2.5 mg/ml
cutaneous spray, Solution for cats and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains
ACTIVE SUBSTANCE:
Fipronil
2.5 mg
EXCIPIENT:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous spray, solution.
Clear, colourless to yellow solution.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea infestation (_Ctenocephalides_ spp.) in dogs and cats.
Treatment of tick infestation (_Ixodes ricinus, Rhipicephalus sanguineus_) in dogs and
cats.
Treatment of biting lice infestations in dogs (_Trichodectes canis_) and cats (_Felicola _
_subrostratus_).
The product can be used as part of a treatment strategy for the control of Flea Allergy
Dermatitis (FAD).
Insecticidal efficacy against new infestations with adult fleas persists for up to 6 weeks
in cats and up to 3 months in dogs, depending on environmental challenge.
The product has a persistent acaricidal efficacy for up to 4 weeks against ticks,
depending on the level of environmental challenge.
4.3 CONTRAINDICATIONS
Do not
use on sick (systemic diseases, fever…) or convalescent animals.
Issued: May 2012
AN: 00106/2011
Page 2 of 7
Do not use in rabbits, as adverse reactions and even death could occur.
Do not use in cases of hypersensitivity to the active substance or to any of excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET
Read the complete document
