Bob Martin Fipronil 402 mg Spot-on Solution for Extra Large Dogs

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Fipronil

Tilgængelig fra:

Bob Martin (UK) Ltd

ATC-kode:

QP53AX15

INN (International Name):

Fipronil

Lægemiddelform:

Spot-on solution

Recept type:

NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person

Terapeutisk gruppe:

Dogs

Terapeutisk område:

Ectoparasiticide

Autorisation status:

Authorized

Autorisation dato:

2011-12-14

Produktets egenskaber

Revised: February 2017
AN: 00396/2016
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bob Martin Clear Spot on 402 mg spot-on solution for extra-large dogs
UK: Bob Martin Fipronil 402 mg spot-on solution for extra large dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 4.02 ml pipette contains:
ACTIVE SUBSTANCE:
Fipronil
402 mg
EXCIPIENTS:
Butylhydroxyanisole E320
0.804 mg
Butylhydroxytoluene E321
0.402 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, SPECIFYING THE TARGET SPECIES
Treatment of flea (_Ctenocephalides spp_.) and tick (_Rhipicephalus
sanguineus_ and
_Ixodes ricinus_) infestations.
Fleas will be killed within 24 h. Insecticidal efficacy against new
infestations with adult
fleas persists for 8 weeks.
The product has a persistent acaricidal efficacy for 4 weeks against
ticks
(_Rhipicephalus sanguineus_, _Ixodes ricinus_, _Dermacentor
reticulatus_).
Ticks will usually be killed within 48 h after contact with Fipronil.
However, if ticks of
some species (_Dermacentor reticulatus_) are already present when the
product is
applied, all of the ticks may not be killed within the first 48 hours.
The product can be used as part of a treatment strategy for the
control of Flea Allergy
Dermatitis (FAD), where this has been previously diagnosed by a
veterinary surgeon.
Page 1 of 6
Revised: February 2017
AN: 00396/2016
4.3
CONTRAINDICATIONS
Do not use on puppies less than 2 months old and /or weighing less
than 2kg. 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.
Do not use on animals with known hypersensitivity to the active
substance or to any
of the excipients.
4.4
SPECIAL WARNINGS
Avoid frequent swimming or