Vectra 3D
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
21-02-2022
Karatteristiċi tal-prodott
(SPC)
21-02-2022
Rapport ta 'Valutazzjoni Pubblika
(PAR)
20-06-2019
Ingredjent attiv:
dinotefuran, pyriproxyfen, permethrin
Disponibbli minn:
Ceva Sante Animale
Kodiċi ATC:
QP53AC54
INN (Isem Internazzjonali):
dinotefuran, permethrin, and pyriproxyfen
Grupp terapewtiku:
Dogs
Żona terapewtika:
permethrin, combinations
Indikazzjonijiet terapewtiċi:
Treatment and prevention of flea infestation (Ctenocephalides felis and Ctenocephalides canis).Treatment and prevention of tick infestation (Rhipicephalus sanguineus, Dermacentor reticulatus, Ixodes ricinus).Prevention of biting from sand flies (Phlebotomus perniciosus), mosquitoes (Culex pipiens, Aedes aegypti) and stable flies (Stomoxys calcitrans).Treatment of mosquito (Aedes aegypti) and stable fly (Stomoxys calcitrans) infestation.
Sommarju tal-prodott:
Revision: 7
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2013-12-04
Fuljett ta 'informazzjoni
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET:
VECTRA 3D SPOT-ON SOLUTION FOR DOGS 1.5–4 KG
VECTRA 3D SPOT-ON SOLUTION FOR DOGS > 4–10 KG
VECTRA 3D SPOT-ON SOLUTION FOR DOGS > 10–25 KG
VECTRA 3D SPOT-ON SOLUTION FOR DOGS > 25–40 KG
VECTRA 3D SPOT-ON SOLUTION FOR DOGS > 40 KG
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 3D spot-on solution for dogs 1.5–4 kg
Vectra 3D spot-on solution for dogs > 4
–
10 kg
Vectra 3D spot-on solution for dogs > 10
–
25 kg
Vectra 3D spot-on solution for dogs > 25
–
40 kg
Vectra 3D spot-on solution for dogs > 40 kg
dinotefuran / pyriproxyfen / permethrin
3.
STATEMENT OF THE ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS
Each ml contains 54 mg dinotefuran, 4.84 mg pyriproxyfen and 397 mg
permethrin.
Each spot-on applicator delivers:
Weight of dog (kg)
Colour of
applicator cap
Volume
(ml)
Dinotefuran
(mg)
Pyriproxyfen
(mg)
Permethrin
(mg)
for dogs 1.5
–
4 kg
Yellow
0.8
44
3.9
317
for dogs > 4
–
10 kg
Teal
1.6
87
7.7
635
for dogs > 10
–
25 kg
Blue
3.6
196
17.4
1,429
for dogs > 25
–
40 kg
Purple
4.7
256
22.7
1,865
for dogs > 40 kg
Red
8.0
436
38.7
3,175
The veterinary medicine is a pale-yellow spot-on solution, packaged in
single dose spot-on
applicators.
4.
INDICATION(S)
Fleas:
This veterinary medicine kills fleas on infested animals and prevents
further infestations for one
month. It is effective against the following fleas found on dogs
_(Ctenocephalides canis _
and
20
_Ctenocephalides felis_
). This veterinary medicine also prevents the multiplication of fleas
for two
months after use by inhibiting flea egg hatching (ovicidal activity)
and by inhibiting t
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vectra 3D spot-on solution for dogs 1.5–4 kg
Vectra 3D spot-on solution for dogs > 4–10 kg
Vectra 3D spot-on solution for dogs > 10–25 kg
Vectra 3D spot-on solution for dogs > 25–40 kg
Vectra 3D spot-on solution for dogs > 40 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Each ml contains 54 mg dinotefuran, 4.84 mg pyriproxyfen and 397 mg
permethrin.
Each spot-on applicator delivers:
Weight of dog (kg)
Colour of
applicator cap
Volume
(ml)
Dinotefuran
(mg)
Pyriproxyfen
(mg)
Permethrin
(mg)
for dogs 1.5–4 kg
Yellow
0.8
44
3.9
317
for dogs > 4–10 kg
Teal
1.6
87
7.7
635
for dogs > 10–25 kg
Blue
3.6
196
17.4
1,429
for dogs > 25–40 kg
Purple
4.7
256
22.7
1,865
for dogs > 40 kg
Red
8.0
436
38.7
3,175
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Pale-yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Fleas:
Treatment and prevention of flea infestation (
_Ctenocephalides felis_
and
_Ctenocephalides canis_
). The
treatment prevents flea infestation for one month. It also prevents
multiplication of fleas for two
months after application by inhibiting egg hatching (ovicidal
activity) and by inhibiting the emergence
of adults from eggs laid by adult fleas (larvicidal activity).
Ticks:
The veterinary medicinal product has persistent acaricidal and
repellent efficacy against tick
infestations (
_Rhipicephalus sanguineus_
and
_Ixodes ricinus_
for one month, and
_Dermacentor _
_reticulatus_
for up to three weeks)
_. _
3
If ticks are present when the veterinary medicinal product is applied,
the ticks may not all be killed
within the first 48 hours, but they may be killed within a week. To
remove ticks, it is recommended to
use an appropriate tick removal device.
Sand flies, mosquitoes and stable flies:
The treatment provides persistent repellent (anti-feeding) activity.
It prevents biting from
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