MiPet Easecto
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
15-05-2019
Karatteristiċi tal-prodott
(SPC)
15-05-2019
Rapport ta 'Valutazzjoni Pubblika
(PAR)
23-02-2018
Ingredjent attiv:
sarolaner
Disponibbli minn:
Zoetis Belgium SA
Kodiċi ATC:
QP53BE03
INN (Isem Internazzjonali):
sarolaner
Grupp terapewtiku:
Dogs
Żona terapewtika:
Ectoparasiticides for systemic use
Indikazzjonijiet terapewtiċi:
For the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus,Ixodes ricinus and Rhipicephalus sanguineus). The veterinary medicinal product has immediate and persistent tick killing activity for at least 5 weeks. For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis). The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for at least 5 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 sarcoptic mange (Sarcoptes scabiei). For the treatment of ear mite infestations (Otodectes cynotis). For the treatment of demodicosis (Demodex canis). Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.,
Sommarju tal-prodott:
Revision: 1
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2018-01-31
Fuljett ta 'informazzjoni
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
MIPET EASECTO CHEWABLE TABLETS 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 and manufacturer responsible for batch
release:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
MiPet Easecto 5 mg chewable tablets for dogs 1.3–2.5 kg
MiPet Easecto 10 mg chewable tablets for dogs >2.5–5 kg
MiPet Easecto 20 mg chewable tablets for dogs >5–10 kg
MiPet Easecto 40 mg chewable tablets for dogs >10–20 kg
MiPet Easecto 80 mg chewable tablets for dogs >20–40 kg
MiPet Easecto 120 mg chewable tablets for dogs >40–60 kg
sarolaner
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each tablet contains:
MiPet Easecto chewable tablets
sarolaner (mg)
for dogs 1.3–2.5 kg
5
for dogs >2.5–5 kg
10
for dogs >5–10 kg
20
for dogs >10–20 kg
40
for dogs >20–40 kg
80
for dogs >40–60 kg
120
Mottled brown coloured, square shaped chewable tablets with rounded
edges. The number embossed
on one side refers to the strength (mg) of the tablet: “5”,
“10”, ”20”, “40”, “80” or “120”.
4.
INDICATION(S)
For the treatment of tick infestations (
_Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus_
and
_Rhipicephalus sanguineus_
). The veterinary medicinal product has immediate and persistent tick
killing
activity for at least 5 weeks.
For the treatment of flea infestations (
_Ctenocephalides felis _
and
_ Ctenocephalides canis_
). The
veterinary medicinal product has immediate and persistent flea killing
activity against new infestations
for at least 5 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 sarcoptic mange (
_Sarcoptes scabiei_
).
For the treatment of ear mite infestations (
_Otodectes cynotis_
).
17
For the treatment of demodicosis (
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
MiPet Easecto 5 mg chewable tablets for dogs 1.3–2.5 kg
MiPet Easecto 10 mg chewable tablets for dogs >2.5–5 kg
MiPet Easecto 20 mg chewable tablets for dogs >5–10 kg
MiPet Easecto 40 mg chewable tablets for dogs >10–20 kg
MiPet Easecto 80 mg chewable tablets for dogs >20–40 kg
MiPet Easecto 120 mg chewable tablets for dogs >40–60 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
MiPet Easecto chewable tablets
sarolaner (mg)
for dogs 1.3–2.5 kg
5
for dogs >2.5–5 kg
10
for dogs >5–10 kg
20
for dogs >10–20 kg
40
for dogs >20–40 kg
80
for dogs >40–60 kg
120
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablets.
Mottled brown coloured, square shaped chewable tablets with rounded
edges.
The number embossed on one side refers to the strength (mg) of the
tablets: “5”, “10”, ”20”, “40”,
“80” or “120”.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of tick infestations (
_Dermacentor reticulatus, Ixodes hexagonus,_
_ _
_Ixodes ricinus_
and
_Rhipicephalus sanguineus_
). The veterinary medicinal product has immediate and persistent tick
killing
activity for at least 5 weeks.
For the treatment of flea infestations (
_Ctenocephalides felis _
and
_ Ctenocephalides canis_
). The
veterinary medicinal product has immediate and persistent flea killing
activity against new infestations
for at least 5 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 sarcoptic mange (
_Sarcoptes scabiei_
).
For the treatment of ear mite infestations (
_Otodectes cynotis_
).
3
For the treatment of demodicosis (
_Demodex canis_
).
Fleas and ticks must attach to the host and commence feeding in order
to be exposed to the active
substance.
4.3
CONTRAINDICATI
Aqra d-dokument sħiħ
