Qualitative and quantitative composition
Fipronil 50.00 mg . (S )-methoprene 60.00 mg . Butylhydroxyanisole ( E320 ) 0.10 mg . Butylated hydroxytoluene ( E321 ) 0.05 mg . Excipient 1 pipette of 0.5 ml .
For a full list of excipients, see section "List of excipients " .
pharmaceutical form
Spot-on solution . Amber clear solution.
target species
Cats and ferrets.
Indications for use, specifying the target species
In cats
For use against infestations by fleas alone or mixed infestations by fleas and ticks and / or biting lice :
- Elimination of fleas (Ctenocephalides spp.) . Insecticidal efficacy against new infestations with adult fleas persists for 4 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 six weeks after application.
- Removal of ticks ( Ixodes ricinus , Dermacentor variabilis , Rhipicephalus sanguineus ) . The product acaricidal efficacy against ticks according to the experimental data continues until two weeks .
- Elimination of biting lice ( Felicola subrostratus ) .
The drug can be incorporated into a treatment program of Allergy Dermatitis of Flea ( FAD).
In ferrets : - For use against infestations by fleas alone or mixed infestations by fleas and ticks. - Elimination of fleas (Ctenocephalides spp.) . Insecticidal efficacy against new infestations with adult fleas persists for 4 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. - Removal of ticks ( Ixodes ricinus ) . The product has an efficacy against ticks which persists (as experimental data ) for 4 weeks.
Cons -indications
In the absence of available data , do not treat kittens under 8 weeks of age or weighing less than 1 kg .
Do not treat ferrets less than 6 months.
Not utilser in sick animals (eg systemic diseases, fever ) or convalescent .
Do not use in rabbits, as sometimes lethal side effects may occur .
In the absence of study, use of the product is not recommended for non-target species .
Special precautions for the person administering the veterinary medicinal product to animals
This product may cause irritation to mucous membranes and eyes. So avoid contact with the mouth and eyes.
Animals or users with a known hypersensitivity to insecticides or alcohol should avoid contact with the drug. Avoid contact of the contents with your fingers. If this occurs , wash hands with soap and water .
In case of accidental exposure with eyes, rinse with clean water carefully . Wash hands after use.
Do not handle animals treated and not allow children to play with treated animals until the application site is dry . It is therefore recommended that animals are not treated during the day but in the early evening , and that recently treated animals are not allowed to sleep with owners, especially children. Do not smoke, drink or eat during application.
Special warnings for each target species
Avoid contact with the eyes of the animal.
Special precautions for use in animals
It is important to make sure to apply the dose to an area where the animal can not lick it off and to ensure that animals do not lick them .
No data evaluating the effect of a bath or shampoo on the effectiveness of the product in cats and ferrets are available. However, on the basis of available information in dogs shampooed from 2 days after application of the product, it is not recommended to bathe the animals in the two days following the application.
Attached ticks may occasionally be observed. For this reason, the transmission of infectious diseases can not be completely excluded if conditions are unfavorable.
Fleas from pets often infest their basket , their sleeping area and regular resting areas such as carpets and sofas . In case of massive infestation and at the beginning of treatment, these areas should be treated with a suitable insecticide and vacuumed regularly .
The potential toxicity of the product in kittens under 8 weeks in contact with a cat treated has not been documented. Special precautions must be taken in this case.
Special precautions for the person administering the medicinal product to animals
This product may cause irritation of mucous membranes , skin and eyes. So avoid contact with the mouth , skin and eyes.
Animals or users with a known hypersensitivity to insecticides or alcohol should avoid contact with the drug.
Avoid contact of the contents with your fingers. If this occurs , wash hands with soap and water .
In case of accidental eye exposure , flush with clean water carefully .
Wash hands after use.
Do not handle animals treated and not allow children to play with treated animals until the application site is dry . It is therefore recommended that animals are not treated during the day but in the early evening , and that recently treated animals are not allowed to sleep with owners, especially children.
Do not smoke, drink or eat during application.
other Precautions
No .
Adverse reactions (frequency and seriousness)
Do not overdose .
Cats. Side effects rarely suspected , transient skin reactions at the application (desquamation , hair loss, itching, redness localized ) and itching or generalized hair loss site were reported. Excessive salivation , reversible neurological signs ( increased sensitivity to stimulation, depression , other nervous signs ) or vomiting have also been observed after use.
If licking , a brief period of salivation mainly due to the nature of the carrier can be observed .
Use during pregnancy, lactation or lay and
Cats. Specialty may be used during pregnancy and lactation.
For treatment during lactation , see " Precautions for use in animals " Ferrets . Laboratory studies on cats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. In ferrets , the safety of the veterinary medicinal product has not been tested during pregnancy and lactation. The use must be made after evaluation of the benefit / risk established by the veterinarian.
Drug interactions and other forms of interaction
None known.
dosage
The minimum recommended dose is 5 mg fipronil and 6 mg of (S )-methoprene per kg bodyweight, dermal application or a pipette of 0.5 ml per cat.
In the absence of safety data , the minimum treatment interval is 4 weeks .
A pipette 0.5 mL ferret , a 50 mg dose of fipronil of 60 mg of ( S ) -methoprene per ferret , by dermal application . The minimum interval of treatment is four weeks .
Method of administration
Hold the pipette upright . Tap the narrow part of the pipette to ensure the contents remain in the wide part of the pipette. Break the tip of a sharp movement towards the back of the pipette. Part the hair at the back of the animal at the base of the neck between the shoulder blades until the skin is visible . Place the tip of the pipette on the skin and squeeze the pipette several times to empty its contents onto the skin at one point.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The risk of experiencing adverse effects may increase in cases of overdose ( see " Adverse reactions (frequency and seriousness) ").
In cats
No adverse effects have been demonstrated in studies of tolerance in cats and kittens 8 weeks and weighing about 1 kg treated once a month for 6 months to 5 times the recommended dose. Some itching may occur after treatment.
An overdose of this product may cause a sticky appearance of hairs at the site of application. However , in this case , these signs disappear within 24 hours after application .
In ferrets
In ferrets 6 months or more and treated every 2 weeks for four treatments at 5 times the recommended dose , weight loss was observed in some animals.
Waiting time
Not applicable.
pharmacological properties
ATC vet code : QP53AX65 , group flees for cutaneous use QP53 .
The specialty is a miticide and insecticide solution for topical use , containing a combination of an adulticide active ingredient , fipronil , and ovicidal and larvicidal active ingredient , (S )-methoprene .
Pharmacodynamic properties
Fipronil is an insecticide acaricide belonging to the family phenylpyrazole . It is by interaction between the complexes formed with the chlorine channels and their ligands , particularly the neurotransmitter GABA ( gamma - aminobutyric acid ) , thus blocking the transfer of chloride ions across cell membranes at the pre- and postsynaptic . It thus causing uncontrolled activity of the central nervous system of insects and mites and their death. Fipronil kills fleas within 24 hours and ticks ( Dermacentor variabilis , Rhipicephalus sanguineus , Ixodes scapularis , Ixodes ricinus , Haemaphysalis longicornis , Haemaphysalis flava , Haemaphysalis campanulata ) and lice within 48 hours after application.
(S )-methoprene is a growth regulator of insects (ROI) in the class of juvenile hormone analogues ; it inhibits the development of the immature stages of insects. Mimicking the action of juvenile hormone , the compound causes impaired development and death of the immature stages of fleas. The ovicidal activity of (S )-methoprene applied to the resulting animal is its direct penetration of the eggshell chip which have been laid or its absorption through the cuticle of the adult fleas . (S )-methoprene is also effective in preventing the development of flea larvae and pupae , which prevents contamination of the habitat of animals treated with the immature stages of fleas.
pharmacokinetic characteristics
Metabolism studies have shown that Fipronil was converted mainly into its sulfone derivative .
The ( S ) -methoprene is largely degraded to carbon dioxide and acetate which are then incorporated into the endogenous substances .
The pharmacokinetics after topical application of fipronil and (S )-methoprene in combination were studied in cats compared with those of each of the active ingredients separately administered intravenously. This was used to estimate the absorption and other pharmacokinetic parameters in terms of use. After administration of the association topically with a potential oral exposure licking, fipronil has an absolute bioavailability ( 18% ) with a mean maximum plasma concentration ( Cmax ) of approximately 100 ng / ml for fipronil and 13 ng / ml for fipronil sulfone .
Plasma concentration of fipronil quickly reach a peak ( mean Tmax of about 6 h ) and decreased with time average half -life of about 25 h .
Fipronil is weakly metabolised fipronil sulfone in cats.
Plasma concentrations of ( S ) -methoprene are usually below the limit of quantitation ( 20 ng / ml ) in cats after topical administration .
Fipronil and its main metabolite and (S )-methoprene spread widely in the cat's coat in the day of application. Concentrations fipronil , fipronil sulfone , and (S ) -methoprene in the coat decreases over time , but are detectable at least 59 days after application.
Parasites are killed mainly by contact and not by systemic exposure.
No pharmacological interference between fipronil and ( S ) -methoprene was detected .
The pharmacokinetic profile of the product has not been studied in the ferret.
List of excipients
Butylhydroxyanisole ( E320 )
Butylated hydroxytoluene ( E321 )
Ethanol
Polysorbate 80 ( E433 )
povidone
Diethylene glycol monoethyl ether
incompatibilities
None known.
Shelf Life
3 years .
Special precautions for storage
Store in the original package .
Do not store above 30 ° C.
Nature and composition of immediate packaging
Barex 210- polypropylene pipette .
Special precautions for disposal of unused medicinal products or waste materials derived from the use of these drugs precautions
Empty packaging and any remaining product should be disposed of following the practices governed by regulations on waste.
Fipronil and (S) - methoprene may adversely affect aquatic organisms. Do not dispose of the product or empty containers in ponds , rivers or streams.
Réf. : 006996