Fipronil EU Pharmaceuticals Spot on Solution Cat 50 mg

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Fipronil

Tilgængelig fra:

EU Pharmaceuticals Ltd

ATC-kode:

QP53AX15

INN (International Name):

Fipronil

Lægemiddelform:

Spot-on solution

Recept type:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Terapeutisk gruppe:

Cats

Terapeutisk område:

Ectoparasiticide

Autorisation status:

Expired

Autorisation dato:

2018-10-09

Produktets egenskaber

Unlimited renewal: May 2023
AN: 00150/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fipronil EU Pharmaceuticals Spot-on Solution Cat 50 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 0.5 ml pipette contains:
ACTIVE SUBSTANCE:
Fipronil
50 mg
EXCIPIENTS:
Butylhydroxyanisole E320
0.1 mg
Butylhydroxytoluene E321
0.05 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear, pale amber solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE
Treatment of flea (_Ctenocephalides_ spp.) infestations.The product
has a persistent
insecticidal efficacy for up to 5 weeks against fleas
(_Ctenocephalides_ spp.).
Although no immediate killing effect against ticks has been
demonstrated, the
product has shown an acaricidal efficacy against
_Dermacentorreticulatus_. If ticks of
this species are present when the product is applied, all the ticks
may not be killed
within the first 48 hours but they will be killed within a week.
4.3
CONTRAINDICATIONS
In the absence of available data, the product should not be used on
kittens less than
8 weeks old and/or weighing less than 1 kg.
Do not use on sick (systemic diseases, fever…) or convalescent
animals.
Do not use in rabbits, as adverse drug reactions and even death could
occur.
Do not use on animals with known hypersensitivity to the active
substance or to any
of excipients.
Unlimited renewal: May 2023
AN: 00150/2023
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Fleas from pets often infest the animal's basket, bedding and regular
resting areas
such as carpets and soft furnishings which should be treated, in case
of massive
infestation and at the beginning of the control measures, with a
suitable insecticide
and vacuumed regularly.
The product does not prevent ticks from attaching to the animals. Once
dead, ticks
will often drop off the animal, but any remaining ticks may be removed
with a gentle
pull.
Avoid frequent swimming or shampooing the animal bec