Evicto

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

selamectin

Beschikbaar vanaf:

Virbac S.A.

ATC-code:

QP54AA05

INN (Algemene Internationale Benaming):

selamectin

Therapeutische categorie:

Cats; Dogs

Therapeutisch gebied:

Endectocides

therapeutische indicaties:

Treatment and prevention of flea infestations caused by Ctenocephalides spp. for one month following a single administration. This is as a result of the adulticidal, larvicidal and ovicidal properties of the product. The product is ovicidal for 3 weeks after administration. Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven week of age. The product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations in area to which the animal has access.Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration. The product may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with the product. It is also recommended that dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when the product has been administered monthly. This product is not effective against adult D. immitis.Treatment of ear mites (Otodectes cynotis).Cats:Treatment of biting lice infestations (Felicola subrostratus)Treatment of adult roundworms (Toxocara cati)Treatment of adult intestinal hookworms (Ancylostoma tubaeforme).Dogs:Treatment of biting lice infestations (Trichodectes canis)Treatment of sarcoptic mange (caused by Sarcoptes scabiei)Treatment of adult intestinal roundworms (Toxocara canis).

Product samenvatting:

Revision: 1

Autorisatie-status:

Authorised

Autorisatie datum:

2019-07-19

Bijsluiter

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET:
EVICTO SPOT-ON SOLUTION
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch
release:
_ _
VIRBAC
1ère avenue – 2065m – LID
06516 Carros
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Evicto 15 mg spot-on solution for cats and dogs ≤ 2.5 kg
Evicto 30 mg spot-on solution for dogs 2.6–5.0 kg
Evicto 45 mg spot-on solution for cats 2.6–7.5 kg
Evicto 60 mg spot-on solution for cats 7.6–10.0 kg
Evicto 60 mg spot-on solution for dogs 5.1–10.0 kg
Evicto 120 mg spot-on solution for dogs 10.1–20.0 kg
Evicto 240 mg spot-on solution for dogs 20.1–40.0 kg
Evicto 360 mg spot-on solution for dogs 40.1–60.0 kg
selamectin
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each single-dose (pipette) delivers:
Evicto 15 mg for cats and dogs
60 mg/ml solution
Selamectin
15 mg
Evicto 30 mg for dogs
120 mg/ml solution
Selamectin
30 mg
Evicto 45 mg for cats
60 mg/ml solution
Selamectin
45 mg
Evicto 60 mg for cats
60 mg/ml solution
Selamectin
60 mg
Evicto 60 mg for dogs
120 mg/ml solution
Selamectin
60 mg
Evicto 120 mg for dogs
120 mg/ml solution
Selamectin
120 mg
Evicto 240 mg for dogs
120 mg/ml solution
Selamectin
240 mg
Evicto 360 mg for dogs
120 mg/ml solution
Selamectin
360 mg
EXCIPIENTS:
Butylated hydroxytoluene
0.8 mg/ml.
Colourless to yellow solution.
4.
INDICATION(S)
CATS AND DOGS:

TREATMENT AND PREVENTION OF FLEA INFESTATIONS
caused by
_Ctenocephalides_
spp. for one month
following a single administration. This is as a result of the
adulticidal, larvicidal and ovicidal
properties of the product. The product is ovicidal for 3 weeks after
administration. Through a
26
reduction in the flea population, monthly treatment of pregnant and
lactating animals will also
aid in the prevention of flea infestations in the litter up to seven
weeks of age.
The product can
be used as part of a treatm

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
EVICTO 15 mg spot on solution for cats and dogs ≤ 2.5 kg
EVICTO 30 mg spot on solution for dogs 2.6 – 5.0 kg
EVICTO 45 mg spot on solution for cats 2.6 – 7.5 kg
EVICTO 60 mg spot on solution for cats 7.6 – 10.0 kg
EVICTO 60 mg spot on solution for dogs 5.1 – 10.0 kg
EVICTO 120 mg spot on solution for dogs 10.1 – 20.0 kg
EVICTO 240 mg spot on solution for dogs 20.1 – 40.0 kg
EVICTO 360 mg spot on solution for dogs 40.1 – 60.0 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose (pipette) delivers:
ACTIVE SUBSTANCE:
EVICTO 15 mg for cats and dogs
60 mg/ml solution
Selamectin
15 mg
EVICTO 30 mg for dogs
120 mg/ml solution
Selamectin
30 mg
EVICTO 45 mg for cats
60 mg/ml solution
Selamectin
45 mg
EVICTO 60 mg for cats
60 mg/ml solution
Selamectin
60 mg
EVICTO 60 mg for dogs
120 mg/ml solution
Selamectin
60 mg
EVICTO 120 mg for dogs
120 mg/ml solution
Selamectin
120 mg
EVICTO 240 mg for dogs
120 mg/ml solution
Selamectin
240 mg
EVICTO 360 mg for dogs
120 mg/ml solution
Selamectin
360 mg
EXCIPIENT:
Butylhydroxytoluene
0.8 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Colourless to yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATS AND DOGS:
•
TREATMENT AND PREVENTION OF FLEA INFESTATIONS
caused by
_Ctenocephalides _
spp. for one month
following a single administration. This is as a result of the
adulticidal, larvicidal and ovicidal
properties of the product. The product is ovicidal for 3 weeks after
administration. Through a
reduction in the flea population, monthly treatment of pregnant and
lactating animals will also
aid in the prevention of flea infestations in the litter up to seven
week of age. The product can
be used as part of a treatment strategy for flea allergy dermatitis
and through its ovicidal and
3
larvicidal action may aid in the control of existing envir