NexGard
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
08-04-2020
Charakterystyka produktu
(SPC)
08-04-2020
Sprawozdanie z oceny publicznego
(PAR)
10-12-2018
Składnik aktywny:
afoxolaner
Dostępny od:
Boehringer Ingelheim Vetmedica GmbH
Kod ATC:
QP53BE01
INN (International Nazwa):
afoxolaner
Grupa terapeutyczna:
Dogs
Dziedzina terapeutyczna:
Isoxazolines, Ectoparasiticides for systemic use
Wskazania:
Treatment of flea infestation in dogs (Ctenocephalides felis and C. canis) for at least 5 weeks. The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus). One treatment kills ticks for up to one month.Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. Treatment of demodicosis (caused by Demodex canis).Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).
Podsumowanie produktu:
Revision: 11
Status autoryzacji:
Authorised
Data autoryzacji:
2014-02-11
Ulotka dla pacjenta
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
NEXGARD 11 MG CHEWABLE TABLETS FOR DOGS 2–4 KG
NEXGARD 28 MG CHEWABLE TABLETS FOR DOGS >4–10 KG
NEXGARD 68 MG CHEWABLE TABLETS FOR DOGS >10–25 KG
NEXGARD 136 MG CHEWABLE TABLETS FOR DOGS >25–50 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:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release:
Boehringer Ingelheim Animal Health France SCS
4 Chemin du Calquet
31000 Toulouse
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NexGard 11 mg chewable tablets for dogs (2–4 kg)
NexGard 28 mg chewable tablets for dogs (>4–10 kg)
NexGard 68 mg chewable tablets for dogs (>10–25 kg)
NexGard 136 mg chewable tablets for dogs (>25–50 kg)
afoxolaner
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each chewable tablet contains:
NexGard
Afoxolaner (mg)
chewable tablets for dogs 2–4 kg
11.3
chewable tablets for dogs >4–10 kg
28.3
chewable tablets for dogs >10–25 kg
68
chewable tablets for dogs >25–50 kg
136
Mottled red to reddish brown, circular shaped (tablets for dogs 2–4
kg), or rectangular shaped (tablets
for dogs >4–10 kg, tablets for dogs >10–25 kg and tablets for dogs
>25–50 kg).
4.
INDICATIONS
Treatment of flea infestation in dogs (
_Ctenocephalides felis _
and
_ C. canis_
) for at least 5 weeks. The
product can be used as part of a treatment strategy for the control of
flea allergy dermatitis (FAD).
Treatment of tick infestation in dogs (
_Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, _
_Rhipicephalus sanguineus). _
One treatment kills ticks for up to one month.
Fleas and ticks must attach to the host and commence feeding in order
to be exposed to the active
substance.
Treatment of demodicosis (caused by
_Demodex canis_
).
17
Treatment of sarcoptic mange (caused by
_Sarcoptes scabiei _
var.
_canis_
).
5.
CONTRAINDICATIONS
Do not use
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NexGard 11 mg chewable tablets for dogs 2–4 kg
NexGard 28 mg chewable tablets for dogs >4–10 kg
NexGard 68 mg chewable tablets for dogs >10–25 kg
NexGard 136 mg chewable tablets for dogs >25–50 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
ACTIVE SUBSTANCE:
NexGard
Afoxolaner (mg)
chewable tablets for dogs 2–4 kg
11.3
chewable tablets for dogs >4–10 kg
28.3
chewable tablets for dogs >10–25 kg
68
chewable tablets for dogs >25–50 kg
136
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablets.
Mottled red to reddish brown, circular shaped (tablets for dogs 2–4
kg) or rectangular shaped (tablets
for dogs >4–10 kg, tablets for dogs >10–25 kg and tablets for dogs
>25–50 kg).
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea infestation in dogs (
_Ctenocephalides felis _
and
_ C. canis_
) for at least 5 weeks. The
product can be used as part of a treatment strategy for the control of
flea allergy dermatitis (FAD).
Treatment of tick infestation in dogs (
_Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, _
_Rhipicephalus sanguineus). _
One treatment kills ticks for up to one month.
Fleas and ticks must attach to the host and commence feeding in order
to be exposed to the active
substance.
Treatment of demodicosis (caused by
_Demodex canis_
).
Treatment of sarcoptic mange (caused by
_Sarcoptes scabiei _
var.
_canis_
).
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Parasites need to start feeding on the host to become exposed to
afoxolaner; therefore the risk of the
transmission of parasite borne diseases cannot be excluded.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In the absence of available data, treatment of puppies les
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