Nexgard Spectra

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

afoxolaner, milbemycin oxime

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QP54AB51

INN (International Name):

afoxolaner, milbemycin oxime

Therapeutic group:

Dogs

Therapeutic area:

Endectocides, Antiparasitic products, insecticides and repellents, milbemycin oxime, combinations

Therapeutic indications:

For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease (Dirofilaria immitis larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of Angiostrongylus vasorum), thelaziosis (adult Thelazia callipaeda) and/or treatment of gastrointestinal nematode infestations is indicated.Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks. Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs for 4 weeks.Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense and Ancylostoma ceylanicum) and whipworm (Trichuris vulpis). Treatment of demodicosis (caused by Demodex canis). Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis). Prevention of heartworm disease (Dirofilaria immitis larvae) with monthly administration. Prevention of angiostrongylosis (by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum) with monthly administration.Prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection) with monthly administration.

Product summary:

Revision: 9

Authorization status:

Authorised

Authorization date:

2015-01-15

Patient Information leaflet

17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET:
NEXGARD SPECTRA 9 MG / 2 MG CHEWABLE TABLETS FOR DOGS 2–3.5 KG
NEXGARD SPECTRA 19 MG / 4 MG CHEWABLE TABLETS FOR DOGS
>
3.5–7.5 KG
NEXGARD SPECTRA 38 MG / 8 MG CHEWABLE TABLETS FOR DOGS >7.5–15 KG
NEXGARD SPECTRA 75 MG / 15 MG CHEWABLE TABLETS FOR DOGS >15–30 KG
NEXGARD SPECTRA 150 MG / 30 MG CHEWABLE TABLETS FOR DOGS >30–60 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 SPECTRA 9 mg / 2 mg chewable tablets for dogs 2–3.5 kg
NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5–7.5 kg
NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5–15 kg
NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15–30 kg
NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30–60 kg
Afoxolaner, milbemycin oxime
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each chewable tablet contains the active substances:
NEXGARD SPECTRA
Afoxolaner (mg)
Milbemycin oxime (mg)
chewable tablets for dogs 2–3.5 kg
9.375
1.875
chewable tablets for dogs >3.5–7.5 kg
18.75
3.75
chewable tablets for dogs >7.5–15 kg
37.50
7.50
chewable tablets for dogs >15–30 kg
75.00
15.00
chewable tablets for dogs >30–60 kg
150.00
30.00
Mottled red to reddish brown, circular shaped (tablets for dogs
2–3.5 kg) or rectangular shaped (tablets
for dogs >3.5–7.5 kg, tablets for dogs >7.5–15 kg, tablets for
dogs >15–30 kg and tablets for dogs
>30-60 kg).
19
4.
INDICATION(S)
For the treatment of flea and tick infestations in dogs when the
concurrent prevention of heartworm
disease (
_Dirofilaria immitis _
larvae),
_angiostrongylosis _
(reduction in level of immature adults (L5)

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2–3.5 kg
NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5–7.5 kg
NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5–15 kg
NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15–30 kg
NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30–60 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
ACTIVE SUBSTANCES:
NEXGARD SPECTRA
Afoxolaner (mg)
Milbemycin oxime (mg)
chewable tablets for dogs 2–3.5 kg
9.375
1.875
chewable tablets for dogs >3.5–7.5 kg
18.75
3.75
chewable tablets for dogs >7.5–15 kg
37.50
7.50
chewable tablets for dogs >15–30 kg
75.00
15.00
chewable tablets for dogs >30–60 kg
150.00
30.00
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
2–3.5 kg) or rectangular shaped (tablets
for dogs >3.5–7.5 kg, tablets for dogs >7.5–15 kg, tablets for
dogs >15–30 kg and tablets for dogs
>30-60 kg).
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of flea and tick infestations in dogs when the
concurrent prevention of heartworm
disease (
_Dirofilaria immitis_
larvae), angiostrongylosis (reduction in level of immature adults (L5)
and
adults of
_Angiostrongylus vasorum_
), thelaziosis (adult
_Thelazia callipaeda_
) and/or treatment of
gastrointestinal nematode infestations is indicated.
Treatment of flea infestations (
_Ctenocephalides felis _
and
_ C. canis_
) in dogs for 5 weeks.
Treatment of tick infestations (
_Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, _
_Rhipicephalus sanguineus_
) in dogs for 4 weeks.
Fleas and ticks must attach to the host and commence feeding in order
to be exposed to the active
substance.
3
Treatment of infestations with adult gastrointestinal nematodes of the
following speci