Seresto 1.25 g + 0.56 g, collar for cats and dogs ≤ 8 kg
Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
21-08-2013
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Active ingredient:
flumethrin 0.56 g, imidacloprid 1.25 g
Available from:
Bayer Vital GmbH
ATC code:
QP53AC55
Pharmaceutical form:
Collar
Therapeutic group:
flumethrin, combinations
Therapeutic area:
Cats, Dogs
Authorization date:
2011-07-27
Summary of Product characteristics
[DE/V/0143/003/IB/001 – May 2013]
EU
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Seresto 1.25 g + 0.56 g, collar for cats and dogs ≤ 8 kg [AT, BE, CY, DE, DK, EL, ES, FI, FR, IE,
IS, IT, LU, NL, NO, PT, SE, UK]
Foresto 1.25 g + 0.56 g, collar for cats and dogs ≤ 8 kg [BG, CZ, EE, HU, LT, LV, PL, RO, SK, SI]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
One collar of 38 cm (12.5 g) contains 1.25 g imidacloprid and 0.56 g flumethrin as active substances.
EXCIPIENTS:
Titanium dioxide (E 171)
Iron oxide black (E 172)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Collar
Grey, odour free collar.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats, dogs (≤ 8 kg)
For dogs > 8 kg use Seresto 4.50 g + 2.03 g, collar for dogs > 8 kg (see section 4.9)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_CATS: _
For the treatment and prevention of flea (_Ctenocephalides felis_) infestation for 7 to 8 months. Efficacy
against fleas starts immediately after application of the collar.
Protects the animal’s immediate surroundings against flea larvae development for 10 weeks.
Seresto can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
The product has persistent acaricidal (killing) efficacy (_Ixodes ricinus, Rhipicephalus turanicus) _and
repellent (anti-feeding) efficacy against tick infestations (_Ixodes ricinus) _for 8 months. It is effective
against larvae, nymphs and adult ticks.
Ticks already on the cat prior to treatment may
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