Vectra 3D solution spot-on

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

dinotefuran, pyriproxyfen, permethrin

Beschikbaar vanaf:

Ceva Sante Animale

ATC-code:

QP53AC54

INN (Algemene Internationale Benaming):

dinotefuran, pyriproxyfen, permethrin

Dosering:

54mg/ml+ 4.84mg/ml+ 397mg/ml

farmaceutische vorm:

solution spot-on

Eenheden in pakket:

(3) tube with applicator 0.8ml, 1.6ml, 3.6ml, 4.7ml, 8ml

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2016-12-06

Bijsluiter

SPOT-ON SOLUTION FOR DOGS
1.5-4 KG / 4-10 KG / 10-25 KG / 25-40 KG / > 40 KG
Marketing authorisation holder and manufacturer responsible for batch
release:
Ceva Santé Animale, 10 av. de La Ballastière, 33500 Libourne, France
Each spot-on applicator delivers:
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
Each ml contains 54 mg dinotefuran, 4.84 mg pyriproxyfen and 397 mg
permethrin.
The veterinary medicine is a pale yellow spot-on solution, packaged in
single dose
spot-on applicators.
INDICATIONS: 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
_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 the transformation
of immature fleas into adult fleas. The veterinary medicine can be
used
as part of a treatment strategy for flea allergy dermatitis (FAD), an
inflammation of the skin.
Ticks: This veterinary medicine kills and repels ticks (_Rhipicephalus
sanguineus_ and_ Ixodes ricinus_ ticks are controlled for one month;
_Dermacentor reticulatus_ ticks are
controlled for up to three weeks). If ticks are present when this
medicine is applied, the ticks may not all be killed within the first
48 hours after use, 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 veterinary medicine repels
(prevents biting) flying insects such as sand flies (_Phlebotomus
perniciosus_), mosquitoes (_Culex pipiens, Aedes aegypti_) and stable
flies (_Stomoxys calcitrans_) for one month after
use. It also kills mosq

Productkenmerken

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).
The veterinary medicinal product can be used as part of a treatment
strategy for flea allergy dermatitis
(FAD).
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