Fipronil EU Pharmaceuticals Spot-on Solution Dog 268 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:

Dogs

Terapeutisk område:

Ectoparasiticide

Autorisation status:

Expired

Autorisation dato:

2018-10-09

Produktets egenskaber

Unlimited renewal: May 2023
AN: 00154/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fipronil EU Pharmaceuticals Spot-on Solution Dog 268 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 2.68 ml pipette contains:
ACTIVE SUBSTANCE:
Fipronil
268 mg
EXCIPIENTS:
Butylhydroxyanisole E320
0.536 mg
Butylhydroxytoluene E321
0.268 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
Dogs.
4.2
INDICATIONS FOR USE
Treatment of flea (_Ctenocephalides_ spp.) and tick
(_Rhipicephalussanguineus_ and
_IxodesRicinus_) infestations.
Insecticidal efficacy against new infestations with adult fleas
persists for 8 weeks.
The product has a persistent acaricidal efficacy for 4 weeks against
ticks
(_Rhipicephalussanguineus_, _Ixodesricinus_,
_Dermacentorreticulatus_).
If ticks of some species (_Dermacentorreticulatus_) are already
present when the
product is applied, all of the ticks may not be killed within the
first 48 hours.
4.3
CONTRAINDICATIONS
Do not use on puppies less than 8 weeks old and /or weighing less than
20 kg.
Do not use on sick (e.g. systemic diseases, fever…) or convalescent
animals.
Do not use in rabbits, as adverse reactions and even death could
occur.
This product is specifically developed for dogs. Do not use in cats,
as this could lead
to overdosing.
Unlimited renewal: May 2023
AN: 00154/2023
Page 2 of 6
Do not use on animals with known hypersensitivity to the active
substance or to any
of excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Avoid frequent swimming or shampooing the animal because the
maintenance of
effectiveness of the product in these cases has not been tested.
The product does not prevent ticks from attaching to the animals. If
the animal has
been treated prior to exposure to the ticks, the ticks will be killed
in the first 24-48
hours after attachment. This will usually be prior to engorgement,
minimising but not
excluding the r