Ectoline Duo 268 mg/80 mg Spot-on Solution for Large Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Fipronil, Pyriproxyfen

Available from:

Alfamed

ATC code:

QP53AX65

INN (International Name):

Fipronil, Pyriproxyfen

Pharmaceutical form:

Spot-on solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Ectoparasiticide; Insect Growth Regulator

Authorization status:

Expired

Authorization date:

2015-07-15

Summary of Product characteristics

Revised: June 2017
AN: 00181/2017
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ectoline duo 268 mg/80 mg spot-on solution for large dogs
Fiprovet duo 268 mg/80 mg spot-on solution for large dogs (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 2.68 ml pipette contains:
ACTIVE SUBSTANCES
2.68 ML
PIPETTE
Fipronil
268.00 mg
Pyriproxyfen
80.4 mg
EXCIPIENTS
Butylhydroxyanisole
0.536 mg
Butylhydroxytoluene
0.268 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear, colourless to yellowish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs (20-40 kg)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To be used against infestations with fleas alone or in association
with ticks.
Against fleas:
Treatment and prevention of infestations by fleas _(Ctenocephalides
felis). _One treatment
prevents further infestations for 7 weeks.
Prevention of the multiplication of fleas by preventing flea eggs
developing into adult fleas
for 12 weeks after application.
Against ticks:
Treatment of infestations by ticks (_Ixodes ricinus). _
One treatment provides persistent acaricidal efficacy for 2 weeks
against
_Ixodes ricinus_,
and for 4 weeks against _Dermacentor reticulatus_
and
_Rhipicephalus sanguineus_.
If ticks of some species (_Dermacentor reticulatus_, _Rhipicephalus
sanguineus_) are present
at the time of application, not all ticks may be killed within 48
hours.
Revised: June 2017
AN: 00181/2017
Page 2 of 7
4.3
CONTRAINDICATIONS
Do not use in rabbits, as adverse reactions and even death could
occur.
Do not use in cases of known hypersensitivity to the active substances
or to any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Shampooing or immersion of the animal in water directly after
treatment may reduce the
duration of activity. The product remains effective against fleas for
5 weeks when the dog
is shampooed at monthly intervals after treatment. If the dog requires
shampooing, it is
better to do so before