Prinocate 40 mg/4 mg spot-on solution for small cats and ferrets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Imidacloprid; Moxidectin

Available from:

Krka, d.d., Novo mesto

ATC code:

QP54AB52

INN (International Name):

Imidacloprid; Moxidectin

Dosage:

40,4 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

moxidectin, combinations

Authorization status:

Authorised

Authorization date:

2020-05-29

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prinocate 40 mg/4 mg spot-on solution for small cats and ferrets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.4 ml pipette contains:
ACTIVE SUBSTANCES:
Imidacloprid
40 mg
Moxidectin
4 mg
EXCIPIENTS:
Butylhydroxytoluene (E 321)
0.4 mg
Benzyl alcohol (E 1519)
329 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear, slightly yellow to yellow or to brownish yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Small cats (≤ 4 kg) and 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 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.
Treatment and prevention of flea infestation (
_Ctenocephalides felis_
),
Prevention of heartworm disease (L3 and L4 larvae of
_Dirofilaria immitis_
).
4.3
CONTRAINDICATIONS
Do not use in kittens under 9 weeks of age.
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
For ferrets: Do not use the veterinary medicinal product for large
cats (0.8 ml) or for dogs (any size).
For dogs, the corresponding veterinary medicinal product,