Imoxat

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

imidacloprid, moxidectin

Beschikbaar vanaf:

Chanelle Pharmaceuticals Manufacturing Ltd

ATC-code:

QP54AB52

INN (Algemene Internationale Benaming):

imidacloprid, moxidectin

Therapeutische categorie:

Cats; Dogs; Ferrets

Therapeutisch gebied:

Antiparasitic products, insecticides and repellents, macrocyclic lactones, milbemycins

therapeutische indicaties:

For cats suffering from, or at risk from, mixed parasitic infections:• the treatment and prevention of flea infestation (Ctenocephalides felis),• the treatment of ear mite infestation (Otodectes cynotis),• the treatment of notoedric mange (Notoedres cati),• the treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults),• the prevention of lungworm disease (L3/L4 larvae of Aelurostrongylus abstrusus),• the treatment of the lungworm Aelurostrongylus abstrusus (adults),• the treatment of the eye worm Thelazia callipaeda (adults),• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),• the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme).The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). For ferrets suffering from, or at risk from, mixed parasitic infections:• the treatment and prevention of flea infestation (Ctenocephalides felis),• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis). For dogs suffering from, or at risk from, mixed parasitic infections:• the treatment and prevention of flea infestation (Ctenocephalides felis),• the treatment of biting lice (Trichodectes canis),• the treatment of ear mite infestation (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes scabiei var. canis), demodicosis (caused by Demodex canis),• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),• the treatment of circulating microfilariae (Dirofilaria immitis),• the treatment of cutaneous dirofilariosis (adult stages of Dirofilaria repens)• the prevention of cutaneous dirofilariosis (L3 larvae of Dirofilaria repens),• the reduction of circulating microfilariae (Dirofilaria repens),• the prevention of angiostrongylosis (L4 larvae and immature adults of Angiostrongylus vasorum),• the treatment of Angiostrongylus vasorum and Crenosoma vulpis,• the prevention of spirocercosis (Spirocerca lupi),• the treatment of Eucoleus (syn. Capillaria) boehmi (adults),• the treatment of the eye worm Thelazia callipaeda (adults),• the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis).The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

Autorisatie-status:

Authorised

Autorisatie datum:

2021-12-07

Bijsluiter

49
B. PACKAGE LEAFLET
50
PACKAGE LEAFLET:
IMOXAT 40 MG + 4 MG SPOT-ON SOLUTION FOR SMALL CATS AND FERRETS
IMOXAT 80 MG + 8 MG SPOT-ON SOLUTION FOR LARGE CATS
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:
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea, Co. Galway,
Ireland
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Imoxat 40 mg + 4 mg spot-on solution for small cats and ferrets
Imoxat 80 mg + 8 mg spot-on solution for large cats
Imidacloprid, moxidectin
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each unit dose pipette contains:
UNIT DOSE
IMIDACLOPRID
MOXIDECTIN
Imoxat for small cats (≤ 4 kg) and ferrets
0.4 ml
40 mg
4 mg
Imoxat for large cats (> 4–8 kg)
0.8 ml
80 mg
8 mg
Excipients: benzyl alcohol, 1 mg/ml butylhydroxytoluene (E321)
_._
Colourless to yellow solution.
4.
INDICATION(S)
FOR CATS
suffering from, or at risk from, mixed parasitic infections:
•
the treatment and prevention of flea infestation (
_Ctenocephalides felis_
),
•
the treatment of ear mite infestation (
_Otodectes cynotis_
),
•
the treatment of notoedric mange (
_Notoedres cati_
),
•
the treatment of the lungworm
_Eucoleus aerophilus _
(syn.
_Capillaria aerophila_
) (adults),
•
the prevention of lungworm disease (L3/L4 larvae of
_Aelurostrongylus abstrusus_
),
•
the treatment of the lungworm
_Aelurostrongylus abstrusus _
(adults),
•
the treatment of the eye worm
_Thelazia callipaeda _
(adults),
•
the prevention of heartworm disease (L3 and L4 larvae of
_Dirofilaria immitis_
),
•
the treatment of infections with gastrointestinal nematodes (L4
larvae, immature adults
and adults of
_Toxocara cati _
and
_Ancylostoma tubaeforme_
).
The veterinary medicinal product can be used as part of a treatment
strategy for flea allergy dermatitis
(FAD).
FOR FERRETS
suffering from, or at risk from, mixed parasitic infections:
•
the tr

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Imoxat 40 mg + 4 mg spot-on solution for small cats and ferrets
Imoxat 80 mg + 8 mg spot-on solution for large cats.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Imoxat for small and large cats and ferrets contains 100 mg/ml
imidacloprid and 10 mg/ml
moxidectin.
Each unit dose (pipette) delivers:
UNIT DOSE
IMIDACLOPRID
MOXIDECTIN
Imoxat for small cats (≤ 4 kg) and ferrets
0.4 ml
40 mg
4 mg
Imoxat for large cats (> 4–8 kg)
0.8 ml
80 mg
8 mg
EXCIPIENTS:
Benzyl alcohol
Butylhydroxytoluene 1 mg/ml (E321)
_._
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Colourless to yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats, ferrets.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
FOR CATS
suffering from, or at risk from, mixed parasitic infections:
•
the treatment and prevention of flea infestation (
_Ctenocephalides felis_
),
•
the treatment of ear mite infestation (
_Otodectes cynotis_
),
•
the treatment of notoedric mange (
_Notoedres cati_
),
•
the treatment of the lungworm
_Eucoleus aerophilus _
(syn.
_Capillaria aerophila_
) (adults),
•
the prevention of lungworm disease (L3/L4 larvae of
_Aelurostrongylus abstrusus_
),
•
the treatment of the lungworm
_Aelurostrongylus abstrusus _
(adults),
•
the treatment of the eye worm
_Thelazia callipaeda _
(adults),
•
the prevention of heartworm disease (L3 and L4 larvae of
_Dirofilaria immitis_
),
•
the treatment of infections with gastrointestinal nematodes (L4
larvae, immature adults
and adults of
_Toxocara cati _
and
_Ancylostoma tubaeforme_
).
The veterinary medicinal product can be used as part of a treatment
strategy for flea allergy dermatitis
(FAD).
3
FOR FERRETS
suffering from, or at risk from, mixed parasitic infections:
•
the treatment and prevention of flea infestation (
_Ctenocephalides felis_
),
•
the prevention of heartworm disease (L3 and L4 larvae of
_Dirofilaria i