Fypryst 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs
Country: Romania
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
07-03-2013
Summary of Product characteristics
(SPC)
07-03-2013
Active ingredient:
fipronil 2.5 mg/ml
Available from:
Krka d.d.
ATC code:
QP53AX15
Pharmaceutical form:
Cutaneous spray, solution
Therapeutic group:
fipronil
Therapeutic area:
Cats, Dogs
Authorization date:
2012-07-25
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
FYPRYST 2.5 MG/ML CUTANEOUS SPRAY SOLUTION FOR CATS AND DOGS
Fypryst 2.5 mg/ml Cutaneous Spray Solution for Cats and Dogs
UK/V/0407/001/DC
Krka Dd
Application for Decentralised Procedure
Publicly Available Assessment Report
2/10
MODULE 1
PRODUCT SUMMARY
EU Procedure number
UK/V/0407/001/DC
Name, strength and
pharmaceutical form
Fypryst 2.5 mg/ml Cutaneous Spray Solution for
Cats and Dogs
Applicant
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Active substance
Fipronil
ATC Vetcode
QP53AX15
Target species
Cats and Dogs
Indication for use
The treatment and prevention of flea and tick
infestations in cats and dogs, and as part of a
treatment strategy for Flea Allergy Dermatitis in
cats and dogs.
The product is active against _Ixodes_ spp.
including _Ixodes ricinus_, important as the vector
of Lyme disease. The product controls
infestations with _Trichodectes canis _biting lice
on dogs, and _Felicola subrostratus_ biting lice on
cats.
The product is active for up to 3 months against
fleas in dogs, and up to 2 months in cats,
depending on the environmental challenge. It is
effective against tick infestations for up to one
month in dogs and cats, depending on the level
of environmental challenge.
Fypryst 2.5 mg/ml Cutaneous Spray Solution for Cats and Dogs
UK/V/0407/001/DC
Krka Dd
Application for Decentralised Procedure
Publicly Available Assessment Report
3/10
MODULE 2
The Summary of Product
Read the complete document
Summary of Product characteristics
Issued: November 2012
AN. 00628/2011
Page 1 of 6
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fypryst 2.5 mg/ml cutaneous spray, solution for cats and dogs
Fipronil
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
The treatment and prevention of flea and tick infestations in cats and dogs, and as
part of a treatment strategy for Flea Allergy Dermatitis in cats and dogs.
The product is active against _Ixodes_ spp. including _Ixodes ricinus_, important as the
vector of Lyme disease. The product controls infestations with _Trichodectes canis _
biting lice on dogs, and _Felicola subrostratus_ biting lice on cats.
The product is active for up to 3 months against fleas in dogs, and up to 2 months in
cats, depending on the environmental challenge. It is effective against tick
infestations for up to one month in dogs and cats, depending on the level of
environmental challenge.
4.3
CONTRAINDICATIONS
Do not use on sick (systemic diseases, fever) or convalescent animals
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 excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not exceed the recommended dosage.
Issued: November 2012
AN. 00
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