Vectra Felis
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
07-02-2022
Charakterystyka produktu
(SPC)
07-02-2022
Sprawozdanie z oceny publicznego
(PAR)
19-11-2019
Składnik aktywny:
pyriproxyfen, dinotefuran
Dostępny od:
CEVA Santé Animale
Kod ATC:
QP53AX73
INN (International Nazwa):
pyriproxyfen, dinotefuran
Grupa terapeutyczna:
Cats
Dziedzina terapeutyczna:
Antiparasitic products, insecticides and repellents, Other ectoparasiticides for topical use, pyriproxyfen, combinations
Wskazania:
Treatment and prevention of flea infestations (Ctenocephalides felis) on cats.One application prevents flea infestation for one month. It also prevents the multiplication of fleas by inhibiting flea emergence in the environment of the cat for 3 months.
Podsumowanie produktu:
Revision: 5
Status autoryzacji:
Authorised
Data autoryzacji:
2014-06-06
Ulotka dla pacjenta
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
VECTRA FELIS 423 MG/42.3 MG SPOT-ON SOLUTION FOR CATS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Ceva Santé Animale, 10, av. de La Ballastière, 33500 Libourne,
France
Manufacturer responsible for batch release:
Ceva Santé Animale, 10, av. de La Ballastière, 33500 Libourne,
France
AB7 SANTE, Chemin des Monges, 31450 Deyme, France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vectra Felis 423 mg/42.3 mg spot-on solution for cats
dinotefuran/pyriproxyfen
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each 0.9 ml spot-on applicator delivers: 423 mg dinotefuran and 42.3
mg pyriproxyfen.
Colourless to pale yellow spot-on solution.
4.
INDICATION(S)
This veterinary medicine kills fleas (
_Ctenocephalides felis_
) on infested cats and prevents further
infestations for one month. It also prevents the multiplication of
fleas, by inhibiting immature flea
emergence in the cat’s environment, for 3 months.
5.
CONTRAINDICATIONS
Do not use in cats or kittens weighing less than 0.6 kg.
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
6.
ADVERSE REACTIONS
Slight scales, transient erythema and alopecia can be observed in rare
cases, which usually disappear
spontaneously without treatment.
Transient neurological signs such as muscle tremors or lethargy may
occur very rarely and in
particular after application site licking.
Transient cosmetic effects such as wet hair and a white dry residue
may occur at the application site
very rarely and may persist up to 7 days; however, these effects are
usually not noticeable after 48
hours. These changes do not affect the safety or the efficacy of the
veterinary medicinal product.
Other application site disorders such as erythema, pruritus, lesions
and inflammation may occur very
rarely.
Hyperactivity and tachypnoea may occur very rarely.
The frequency of a
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vectra Felis 423 mg/42.3 mg spot-on solution for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Each 0.9 ml spot-on applicator delivers:
Dinotefuran………………….. 423 mg
Pyriproxyfen…………………
42.3 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and prevention of flea infestations (
_Ctenocephalides felis_
) on cats.
One application prevents flea infestation for one month. It also
prevents the multiplication of fleas by
inhibiting flea emergence in the environment of the cat for 3 months.
4.3
CONTRAINDICATIONS
Do not use in cats or kittens weighing less than 0.6 kg.
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
All cats within the household should be treated. Dogs in the household
should only be treated with a
veterinary medicinal product authorised for use in that species.
Fleas can infest the cat’s basket, bedding and regular resting areas
such as carpets and soft furnishings.
In case of massive flea infestation and at the beginning of the
control measures, these areas should be
treated with a suitable insecticide and then vacuumed regularly.
The impact of shampooing on the efficacy of the veterinary medicinal
product has not been evaluated.
In case of suspicion of dermatitis (itch and skin irritation), seek
for veterinary advice.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The safety of the product has not been established in cats younger
than 7 weeks or weighing less than
0.6 kg (see section 4.3).
After accidental ingestion of the product, transient reactions such as
salivation, abnormal faeces and
emesis may occur, however these should resolve without treatment
wit
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