Imoxicate 80 mg/8 mg spot-on solution for large cats

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Imidacloprid; Moxidectin

Saadav alates:

Krka, d.d., Novo mesto

ATC kood:

QP54AB52

INN (Rahvusvaheline Nimetus):

Imidacloprid; Moxidectin

Annus:

80,8 mg/pipette

Ravimvorm:

Spot-on solution

Retsepti tüüp:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutiline ala:

moxidectin, combinations

Volitamisolek:

Authorised

Loa andmise kuupäev:

2020-03-13

Toote omadused

CONFIDENTIAL
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Imoxicate 80 mg/8 mg spot-on solution for large cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.8 ml pipette contains:
ACTIVE SUBSTANCES:
Imidacloprid
80 mg
Moxidectin
8 mg
EXCIPIENTS:
Butylhydroxytoluene (E 321)
0.8 mg
Benzyl alcohol (E 1519)
658 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
Large cats (>4-8 kg).
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).
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.
Do not use the veterinary medicinal product for large cats (0.8 ml) or
for dogs (any size) for ferrets.
For dogs, the corresponding veterinary medicinal product, which
contains 100 mg/ml imidacloprid and
25 mg/ml moxidectin, must be used.
2
CONFIDENTIAL
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Please refer to section 4.5.
Brief contact of the animal with water on one or two occasions betw