Fypryst Combo 134 mg/120.6 mg Spot-On Solution for Medium Dogs

Summary of Product characteristics

                                AN: 00136/2013
Issued: March 2014
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fypryst Combo 134 mg/ 120.6 mg spot-on solution for medium dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1.34 ml pipette contains:
ACTIVE SUBSTANCE:
Fipronil
134 mg
S-Methoprene
120.6 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.27 mg
Butylhydroxytoluene (E321)
0.13 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs 10-20 kg
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of dogs, dosage defined by bodyweight grouping
(refer to section
4.9):
-
To be used against infestations with fleas, alone or in association
with ticks
and/or biting lice.
-
Treatment of flea infestations (_Ctenocephalides_ spp.). Insecticidal
efficacy
against new infestations with adult fleas persists for 8 weeks.
Prevention of the
multiplication of fleas by inhibiting the development of eggs
(ovicidal activity) and
larvae and pupae (larvicidal activity) originating from eggs laid by
adult fleas for eight
weeks after application.
-
Treatment of tick infestations (_Ixodes ricinus, Dermacentor
variabilis, _
_Dermacentor reticulatus, Rhipicephalus sanguineus_). The product has
persistent
acaricidal efficacy for up to 4 weeks against ticks.
-
Treatment of infestations with biting lice (_Trichodectes canis_).
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.
AN: 00136/2013
Issued: March 2014
Page 2 of 6
4.3
CONTRAINDICATIONS
In the absence of available data, the product should not be used on
puppies less
than 8 weeks old and/or weighing less than 2 kg.
Do not use on sick (e.g. systemic diseases, fever) or convalescent
animals.
DO NOT USE IN RABBITS, AS ADVERSE REACTIONS WITH EVEN MORTALITY COULD
OCCUR.
In absence of studies, the use of the product is not recommend
                                
                                Read the complete document