Amflee 2.5 mg/ml cutaneous spray, solution for cats and dogs
Country: United Kingdom
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
21-08-2013
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Active ingredient:
fipronil 2.5 mg/ml
Available from:
Miklich Laboratorios S.L
ATC code:
QP53AX15
Pharmaceutical form:
Cutaneous spray, solution
Therapeutic group:
fipronil
Therapeutic area:
Cats Non Food, Dogs Non Food
Authorization date:
2012-07-25
Summary of Product characteristics
Issued: January 2013
AN: 00744/2011
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amflee 2.5 mg/ml cutaneous spray, solution for cats and dogs
Amflee vet 2.5 mg/ml cutaneous spray, solution for cats and dogs
Fipronil Krka 2.5 mg/ml cutaneous spray, solution for cats and dogs
Amflee 2.5 mg/ml cutaneous spray, solution for cats and dogs (United Kingdom,
Austria, Belgium, Germany, Spain, France, Greece, Ireland, Italy, Luxembourg,
Netherlands, Portuguese)
Amflee vet 2.5 mg/ml cutaneous spray, solution for cats and dogs (Finland, Swedish,
Denmark)
Fipronil Krka 2.5 mg/ml cutaneous spray, solution for cats and dogs (Norwegian)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains
ACTIVE SUBSTANCE:
Fipronil 2.5 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous spray, solution
Clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats and dogs.
4.2
INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES
Treatment of flea (_Ctenocephalides_ spp.) and tick (_Ixodes ricinus_, _Rhipicephalus _
_sanguineus_) infestations 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 2
months in cats and up to 3 months in dogs, depending on environmental challenge.
Issued: January 2013
AN: 00744/2011
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