Felpreva
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
09-03-2022
Summary of Product characteristics
(SPC)
09-03-2022
Public Assessment Report
(PAR)
09-03-2022
Active ingredient:
emodepside, praziquantel, Tigolaner
Available from:
Vétoquinol SA
ATC code:
QP52AA51
INN (International Name):
emodepside, praziquantel, tigolaner
Therapeutic group:
Cats
Therapeutic area:
Anthelmintics,
Therapeutic indications:
For cats with, or at risk from, mixed parasitic infestations.The veterinary medicinal product is exclusively indicated when ectoparasites, cestodes and nematodes are targeted at the same time.
Authorization status:
Authorised
Authorization date:
2021-11-11
Patient Information leaflet
19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET:
Felpreva spot-on solution for small cats (1.0 - 2.5 kg)
Felpreva spot-on solution for medium cats (> 2.5 – 5.0 kg)
Felpreva spot-on solution for large cats (> 5.0 – 8.0 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 and manufacturer responsible for batch
release:
Vetoquinol S.A.
Magny-Vernois
70200 Lure
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Felpreva spot-on solution for small cats (1.0 - 2.5 kg)
Felpreva spot-on solution for medium cats (> 2.5 – 5.0 kg)
Felpreva spot-on solution for large cats (> 5.0 – 8.0 kg)
tigolaner/emodepside/praziquantel
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each spot-on applicator delivers:
FELPREVA SPOT-ON SOLUTION
VOLUME OF
UNIT DOSE [ML]
TIGOLANER
[MG]
EMODEPSIDE
[MG]
PRAZIQUANTEL
[MG]
for small cats (1.0 - 2.5 kg)
0.37
36.22
7.53
30.12
for medium cats
(> 2.5 – 5.0 kg)
0.74
72.45
15.06
60.24
for large cats (> 5.0 – 8.0 kg)
1.18
115.52
24.01
96.05
EXCIPIENTS: 2.63 mg/ml butylhydroxyanisole (E320) and 1.10 mg/ml
butylhydroxytoluene (E321) as
antioxidants.
Spot-on solution.
Clear yellow to red solution.
Change in colour may occur during storage. This phenomenon does not
affect product quality.
4.
INDICATION(S)
For cats with, or at risk from, mixed parasitic infections/
infestations. The veterinary medicinal
product is exclusively indicated when ectoparasites, cestodes and
nematodes are targeted at the same
time.
Ectoparasites
For the treatment of flea (_Ctenocephalides felis_) and tick (_Ixodes
ricinus, Ixodes holocyclus_)
infestations in cats providing immediate and persistent killing
activity for 13 weeks.
The veterinary medicinal product can be used as part of a treatment
strategy for the control of flea
allergy dermatitis (FAD).
For the treatment of mild to moderate cases of notoedric mange (caused
by _Notoedres cati_).
For the treatment of ear
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Felpreva spot-on solution for small cats (1.0 - 2.5 kg)
Felpreva spot-on solution for medium cats (> 2.5 – 5.0kg)
Felpreva spot-on solution for large cats (> 5.0 – 8.0 kg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Each spot-on applicator delivers:
VOLUME OF
UNIT DOSE [ML]
TIGOLANER
EMODEPSIDE
PRAZIQUANTEL
Felpreva for small cats
(1.0 - 2.5 kg)
0.37 ml
36.22 mg
7.53 mg
30.12 mg
Felpreva for medium cats
(> 2.5 – 5.0 kg)
0.74 ml
72.45 mg
15.06 mg
60.24 mg
Felpreva for large cats
(> 5.0 –8.0 kg)
1.18 ml
115.52 mg
24.01 mg
96.05 mg
EXCIPIENTS:
2.63 mg/ml butylhydroxyanisole (E320) and 1.10 mg/ml
butylhydroxytoluene (E321) as antioxidants.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear yellow to red solution.
Change in colour may occur during storage. This phenomenon does not
affect product quality.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For cats with, or at risk from, mixed parasitic
infestations/infections. The veterinary medicinal product
is exclusively indicated when ectoparasites, cestodes and nematodes
are targeted at the same time.
Ectoparasites
For the treatment of flea (_Ctenocephalides felis_) and tick (_Ixodes
ricinus, Ixodes holocyclus_)
infestations in cats providing immediate and persistent killing
activity for 13 weeks.
The veterinary medicinal product can be used as part of a treatment
strategy for the control of flea
allergy dermatitis (FAD).
For the treatment of mild to moderate cases of notoedric mange
(_Notoedres cati_).
For the treatment of ear mite infestations (_Otodectes cynotis_)
3
Gastrointestinal roundworms (nematodes)
For the treatment of infections with:
_Toxocara cati _(mature adult, immature adult, L4 and L3)
_Toxascaris leonina_ (mature adult, immature adult and L4)
_Ancylostoma tubaeforme_ (mature adult, immature adult and L4)
L
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