Activyl Tick Plus
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
04-10-2022
Charakterystyka produktu
(SPC)
04-10-2022
Sprawozdanie z oceny publicznego
(PAR)
04-10-2022
Składnik aktywny:
indoxacarb, permethrin
Dostępny od:
Intervet International BV
Kod ATC:
QP53AC54
INN (International Nazwa):
indoxacarb, permethrin
Grupa terapeutyczna:
Dogs
Dziedzina terapeutyczna:
permethrin, combinations, Ectoparasiticides for topical use, incl. insecticides
Wskazania:
Treatment of flea infestations (Ctenocephalides felis); the product has persistent insecticidal efficacy for up to 4 weeks against Ctenocephalides felis. The product has persistent acaricidal efficacy for up to 5 weeks against Ixodes ricinus and up to 3 weeks against Rhipicephalus sanguineus. One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus perniciosus) for up to 3 weeks.,
Podsumowanie produktu:
Revision: 9
Status autoryzacji:
Withdrawn
Data autoryzacji:
2012-01-09
Ulotka dla pacjenta
18
B. PACKAGE LEAFLET
Medicinal product no longer authorised
19
PACKAGE LEAFLET:
ACTIVYL TICK PLUS SPOT-ON SOLUTION FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer responsible for batch release:
Intervet Productions SA
Rue de Lyons
27460 Igoville
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Activyl Tick Plus 75 mg + 240 mg spot-on solution for very small dogs
Activyl Tick Plus 150 mg + 480 mg spot-on solution for small dogs
Activyl Tick Plus 300 mg + 960 mg spot-on solution for medium dogs
Activyl Tick Plus 600 mg + 1920 mg spot-on solution for large dogs
Activyl Tick Plus 900 mg + 2880 mg spot-on solution for extra large
dogs
Indoxacarb + permethrin
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
ACTIVE SUBSTANCES:
One ml contains 150 mg indoxacarb and 480 mg permethrin.
One pipette delivers:
VOLUME
(ML)
INDOXACARB
(MG)
PERMETHRIN
(MG)
For very small dogs (1.2
–
5 kg)
0.5
75
240
For small dogs (5.1
–
10 kg)
1
150
480
For medium dogs (10.1
–
20 kg)
2
300
960
For large dogs (20.1
–
40 kg)
4
600
1920
For extra large dogs (40.1
–
60 kg)
6
900
2880
A clear, colourless to yellow or brown-coloured solution.
4.
INDICATION(S)
Treatment of flea infestations (
_Ctenocephalides felis_
); the product has persistent insecticidal efficacy for
up to 4 weeks against
_Ctenocephalides felis_
.
The product has persistent acaricidal efficacy for up to 5 weeks
against
_Ixodes ricinus _
and up to 3 weeks
against
_Rhipicephalus sanguineus_
. If ticks of these species are present when the product is applied,
all
the ticks may not be killed within the first 48 hours but they may be
killed within a week.
Developing stages of fleas in the dog’s immediate surroundings are
killed following contact with the
Medicinal product no longer authorised
20
treated dogs.
One treatment p
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Activyl Tick Plus 75 mg + 240 mg spot-on solution for very small dogs
Activyl Tick Plus 150 mg + 480 mg spot-on solution for small dogs
Activyl Tick Plus 300 mg + 960 mg spot-on solution for medium dogs
Activyl Tick Plus 600 mg + 1920 mg spot-on solution for large dogs
Activyl Tick Plus 900 mg + 2880 mg spot-on solution for extra large
dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
One ml contains 150 mg indoxacarb and 480 mg permethrin.
One unit dose pipette delivers:
VOLUME OF UNIT
DOSE
(ML)
INDOXACARB
(MG)
PERMETHRIN
(MG)
Very small dogs (1.2 - 5 kg)
0.5
75
240
Small dogs (5.1 - 10 kg)
1
150
480
Medium dogs (10.1 - 20 kg)
2
300
960
Large dogs (20.1 - 40 kg)
4
600
1920
Extra large dogs (40.1 - 60 kg)
6
900
2880
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
A clear, colourless to yellow or brown-coloured solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea infestations (
_Ctenocephalides felis_
); the product has persistent insecticidal efficacy for
up to 4 weeks against
_Ctenocephalides felis_
.
The product has persistent acaricidal efficacy for up to 5 weeks
against
_Ixodes ricinus _
and up to 3 weeks
against
_Rhipicephalus sanguineus_
. If ticks of these species are present when the product is applied,
all the
ticks may not be killed within the first 48 hours but they may be
killed within a week.
Developing stages of fleas in the dog’s immediate surroundings are
killed following contact with the
treated dogs.
One treatment provides repellent (anti-feeding) activity against sand
flies (
_Phlebotomus perniciosus_
) for
up to 3 weeks.
Medicinal product no longer authorised
3
4.3
CONTRAINDICATIONS
Do not use in cats as adverse reactions and even death can occur (see
also section 4.5 Special precautions
for use in animals).
Do not
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