NEXGARD SPECTRA 9 MG 2 MG VETERINARY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AFOXOLANER; MILBEMYCIN OXIME

Available from:

BEIT-EREZ HAVAT MILATIN LTD

Pharmaceutical form:

CHEWABLE TABLETS

Composition:

AFOXOLANER 9.375 MG; MILBEMYCIN OXIME 1.875 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

BOEHRINGER INGELHEIM VETMEDICA GMBH, GERMANY

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) 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, 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).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.Treatment of demodicosis (caused by Demodex canis).Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).

Authorization date:

2022-09-30

Patient Information leaflet

Page 1 of 6
VETERINARY PHYSICIAN’S PRESCRIBING INFORMATION
NEXGARD SPECTRA VETERINARY
1. TRADE NAME OF MEDICINAL PRODUCT
NEXGARD SPECTRA 9 MG / 2 MG VETERINARY – chewable tablets for dogs
2–3.5 kg
NEXGARD SPECTRA 19 MG / 4 MG VETERINARY – chewable tablets for dogs
>3.5–7.5 kg
NEXGARD SPECTRA 38 MG / 8 MG VETERINARY – chewable tablets for dogs
>7.5–15 kg
NEXGARD SPECTRA 75 MG / 15 MG VETERINARY – chewable tablets for dogs
>15–30 kg
NEXGARD SPECTRA 150 MG / 30 MG VETERINARY – chewable tablets for
dogs >30–60 kg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
ACTIVE SUBSTANCES:
NEXGARD SPECTRA VETERINARY
AFOXOLANER (MG)
MILBEMYCIN OXIME
(MG)
chewable tablets for dogs 2–3.5 kg
9.375 mg
1.875 mg
chewable tablets for dogs >3.5–7.5 kg
18.75 mg
3.75 mg
chewable tablets for dogs >7.5–15 kg
37.50 mg
7.50 mg
chewable tablets for dogs >15–30 kg
75.00 mg
15.00 mg
chewable tablets for dogs >30–60 kg
150.00 mg
30.00 mg
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_) 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, 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.

Summary of Product characteristics

Page 1 of 6
VETERINARY PHYSICIAN’S PRESCRIBING INFORMATION
NEXGARD SPECTRA VETERINARY
1. TRADE NAME OF MEDICINAL PRODUCT
NEXGARD SPECTRA 9 MG / 2 MG VETERINARY – chewable tablets for dogs
2–3.5 kg
NEXGARD SPECTRA 19 MG / 4 MG VETERINARY – chewable tablets for dogs
>3.5–7.5 kg
NEXGARD SPECTRA 38 MG / 8 MG VETERINARY – chewable tablets for dogs
>7.5–15 kg
NEXGARD SPECTRA 75 MG / 15 MG VETERINARY – chewable tablets for dogs
>15–30 kg
NEXGARD SPECTRA 150 MG / 30 MG VETERINARY – chewable tablets for
dogs >30–60 kg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
ACTIVE SUBSTANCES:
NEXGARD SPECTRA VETERINARY
AFOXOLANER (MG)
MILBEMYCIN OXIME
(MG)
chewable tablets for dogs 2–3.5 kg
9.375 mg
1.875 mg
chewable tablets for dogs >3.5–7.5 kg
18.75 mg
3.75 mg
chewable tablets for dogs >7.5–15 kg
37.50 mg
7.50 mg
chewable tablets for dogs >15–30 kg
75.00 mg
15.00 mg
chewable tablets for dogs >30–60 kg
150.00 mg
30.00 mg
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_) 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, 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.