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Date: Sunday, April 14, 2024 7:33

Description: Virbac 2013
Release 8.96
Effipro Duo Spot on solution for Cats
 
Species: Cats
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For cats
Active ingredient: Fipronil, Pyriproxyfen
Product:Effipro Duo spot on solution for CATS
Product index: Effipro Duo spot on solution for CATS
Incorporating:
Qualitative and quantitative composition
Effipro Duo for cats
Each 0.5ml pipette contains:
Active substances: Fipronil 50 mg, Pyriproxyfen 60 mg
Effipro Duo for very large cats
Each 1ml pipette contains:
Active substances: Fipronil 100 mg, Pyriproxyfen 120 mg
Excipients: Butylhydroxyanisole E320, Butylhydroxytoluene E321
Pharmaceutical form
Clear, colourless to yellowish spot-on solution
Clinical particulars
Target species
Effipro Duo for cats: Cats.
Effipro Duo for very large cats: Cats (>6-12 kg)
Indications for use
In cats, 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 5 weeks.
Prevention of the multiplication of fleas by preventing flea eggs developing into adult fleas for 12 weeks after application.
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.
Against ticks
Treatment of infestations by ticks (Ixodes ricinus and Rhipicephalus turanicus).
One treatment provides persistent acaricidal efficacy for one week.
If ticks are present at the time of application, not all ticks may be killed within 48 hours.
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.
Special warnings for each target species
Wetting of the haircoat with water 2 hours before product application and twice during the claimed period of efficacy against fleas (at two week intervals against adult fleas or four week intervals against developing flea stages) was investigated during two laboratory studies. Wetting of the haircoat with water as described did not adversely affect product effectiveness.
The impact of shampooing on product effectiveness has not been investigated. If a cat requires shampooing it is recommended that this is done before applying the veterinary medicinal product.
At the beginning of the control measures, in the case of an infestation, the animal's basket, bedding and regular resting areas such as carpets and soft furnishings should be treated, with a suitable insecticide and vacuumed regularly.
To reduce environmental flea challenge, all animals living in the same household should also be treated with a suitable flea control product.
The product does not prevent ticks from attaching to animals. If the animal has been treated prior to exposure to the ticks, the ticks will be killed within 48 hours after attachment. This will usually be prior to engorgement, minimising but not excluding the risk of transmission of diseases.
Once dead, ticks will often drop off the animal. Any remaining ticks should be carefully removed, ensuring that their mouth parts are not left within the skin.
Special precautions for use
Special precautions for use in animals
For external use only. Do not administer orally.
Animals should be weighed accurately prior to treatment.
The safety of the product has not been established in cats younger than 10 weeks of age or in cats weighing less than 1 kg.
Avoid contact with the animal’s eyes. In the case of accidental eye contact, flush the eyes with water.
Care should be taken to apply the product correctly as described below. Do not apply the product on wounds or damaged skin. It is important to make sure that the veterinary medicinal product is applied directly onto an area of dry skin where the animal cannot lick it off and to make sure that animals do not lick each other following treatment.
The use of the product has not been studied in sick or debilitated cats. Consult your veterinary surgeon before using the product if your cat is unwell or currently receiving any other veterinary treatment.
Inform your veterinary surgeon that you are using this product if they provide your cat with any other medication.
Seek veterinary advice if the product is accidentally ingested or comes into contact with your animal’s eyes.
In the absence of additional safety studies, do not repeat the treatment at intervals of less than 4 weeks.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
The product may cause neurotoxicity.
The product may be harmful if swallowed.
Avoid ingestion including hand-to-mouth contact.
Do not smoke, drink or eat during application.
In the event of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
This product can cause eye and mucous membrane irritation.
Avoid contact with skin, eye and mouth, including hand to eye contact.
In the case of accidental skin or eye contact, immediately and thoroughly flush with water. If skin or eye irritation persists, seek medical advice and show the package leaflet or the label to the physician.
Wash hands after use.
Treated animals should not be handled until the application site is dry, and children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended that animals are not treated during the day, but should be treated during the early evening, and that recently treated animals should not be allowed to sleep with owners, especially children.
Keep the pipettes in the original packaging until ready for use and dispose of used pipettes immediately.
Other precautions
The product may have adverse effects on painted, varnished or other household surfaces or furnishings. Allow the application site to dry before permitting contact with such materials.
Adverse reactions (frequency and seriousness)
Transient cosmetic effects such as wet appearance or slight scaling can occur very rarely at the application site.
According to the accumulated experience on these active ingredients within spot on pharmaceutical forms, transient cutaneous reactions at the application site as squamosis (scaling of the skin), local alopecia (hair loss), pruritus, (itchiness) erythema, skin discolouration and general pruritus or alopecia may very rarely be observed after use. Hypersalivation, reversible neurologic symptoms such as hyperesthesia (increased sensitivity to stimuli), depression and nervous symptoms may very rarely be observed. Respiratory signs or vomiting might occur in very rare cases.
Use during pregnancy, lactation or lay
Laboratory studies using fipronil and pyriproxyfen have not shown any evidence of teratogenic or embryotoxic effect. The safety of the product has not been established in pregnant and lactating queens. Consult your veterinary surgeon before using the product in pregnant or lactating queens .
Interaction with other medicinal products and other forms of interaction
Do not use simultaneously with other flea or tick products which are applied directly on to the animal.
Amounts to be administered and administration route
Spot-on use.
Dosage
For a cat weighing 1-6 kg apply one pipette of 0.5 ml per cat corresponding to the minimum recommended dose of 8.3 mg fipronil/kg b.w. and 10 mg pyriproxyfen/kg b.w..
For a cat weighing more than 6 kg apply one pipette of 1 ml per cat corresponding to the minimum recommended dose of 8.3 mg fipronil/kg bodyweight and 10 mg pyriproxyfen/kg bodyweight. The recommended dose of 1 ml can also be achieved by applying two 0.5 ml pipettes.
Cat Weight
Pipette
Volume
Fipronil (mg)
Pyriproxyfen (mg)
1 - 6 kg
0.5 ml
50
60
6-12 kg
1 ml
100
120
Method of Administration
Remove the pipette from the overblister. Hold the pipette upright. Tap the narrow part of the pipette to ensure that the contents are within the main body of the pipette. Break the snap-off top of the spot-on pipette along the scored line.
Part the coat on the back of neck area until the skin is visible. Place the tip of the pipette on the skin and squeeze firmly several times to empty the contents evenly at one or two spots. Ensure the solution is applied to healthy skin only and avoid superficial application to the cat’s hair or run off, especially in large cats over 6kg.
Drop stop system (the product is released only by pressing the body of the pipette).
Consult your veterinary surgeon if the product fails to control the flea and tick infestation. However, in the absence of additional safety studies, do not repeat the treatment at intervals of less than 4 weeks.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No serious adverse effects were observed in a target animal safety study in 10-week old kittens treated with up to 5 times the maximum recommended dose 3 times at intervals of 4 weeks and with the maximum recommended dose 6 times at intervals of 4 weeks.
The risk of experiencing adverse reactions (see adverse events section above) may however increase with overdosing, so animals should always be treated with correct pipette size according to bodyweight.
Withdrawal period(s)
Not applicable.
Pharmacological particulars
Pharmacodynamic properties
Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. Fipronil and its metabolite fipronil sulfone act at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA) as well as desensitising (D) and non-desensitising (N) channels gated by glutamate (Glu, unique invertebrate ligand-gated chloride channels), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. This results in uncontrolled activity of the central nervous system and death of insects or acari.
Pyriproxyfen is an insect growth regulator (IGR) of the class of compounds known as juvenile hormone analogues. Pyriproxyfen sterilises adult fleas and inhibits the development of immature stages. The molecule prevents, by contact, the emergence of adult insects by blocking the development of eggs (ovicidal effect), larvae and pupae (larvicidal effect), which are subsequently eliminated. Following contact and/or ingestion by adult fleas, the molecule also acts by sterilising eggs during their maturation and before being laid. The molecule prevents contamination of the environment of treated animals with the immature stages of fleas.
Combination of fipronil and pyriproxyfen provides an insecticidal and acaricidal activity against fleas (Ctenocephalides felis), ticks (Rhipicephalus turanicus, Ixodes ricinus) in addition to preventing flea eggs developing into adult fleas.
Such combination provides an integrated flea control which can be used against infestations with fleas alone or in association with ticks.
Pharmacokinetic particulars
Following topical application of the product, under the normal conditions of use, fipronil and pyriproxyfen are well distributed in the haircoat of the cat from the first day post application. The major metabolite of fipronil is the sulfone derivative, which also possesses insecticidal and acaricidal properties.
The concentrations of fipronil and pyriproxyfen in the haircoat decrease over time but both active substances are present for at least 84 days after application (i.e. above the lower limit of quantification (LOQ) 100 ng/g for fipronil and 50 ng/g for pyriproxyfen). Concentrations of fipronil sulfone remained below the lower limit of quantification (LOQ 100 ng/ml) after product application.
The plasmatic peaks of fipronil and pyriproxyfen concentration are rapidly reached 1 day after administration. Concentrations of fipronil are quantifiable in all cats up to 3 days after application (LOQ 1 ng/ml). Concentrations of pyriproxyfen are quantifiable in all cats up to 42 days after application (LOQ 0.2 ng/ml). Concentrations of fipronil sulfone remained below the lower limit of quantification (LOQ 1 ng/ml) after product application.
Pharmaceutical particulars
List of excipients
Butylhydroxyanisole E320
Butylhydroxytoluene E321
Diethylene glycol monoethyl ether
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Do not store above 30°C.
Store in a dry place.
Keep the blister pack in the outer carton in order to protect from light.
Nature and composition of immediate packaging
Transparent multi-layer plastic single-dose pipettes containing 0.5 ml (Effipro Duo for cats) / 1.0 ml (Effipro Duo for very large cats) obtained by thermoforming a transparent bottom complex (polyacrylonitrile-methacrylate, polypropylene, cyclic olefin copolymer, polypropylene) and closed by heat sealing with a lid complex (polyacrylonitrile-methacrylate, aluminium, polyethylene-terephthalate).
The boxes contain individual pipette(s) placed in overblister(s) made from polypropylene, cyclic olefin copolymer, polypropylene and closed with lid made from polyethylene-terephthalate, aluminium, polypropylene.
Boxes of 1, 4, 24 and 60 pipettes.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Do not contaminate ponds, waterways or ditches with the veterinary medicinal product or empty container as this may be dangerous for fish and other aquatic organisms.
Marketing Authorisation Holder (if different from distributor)
Virbac Limited, Woolpit Business Park, Windmill Avenue, Woolpit, Bury St Edmunds, Suffolk, IP30 9UP
Marketing Authorisation Number
Effipro Duo for cats - Vm 11188/4026
Effipro Duo for very large cats - Vm 11188/4027
Significant changes
Date of the first authorisation or date of renewal
20 June 2019
Date of revision of the text
December 2020
Any other information
Legal category
Legal category: NFA-VPS
GTIN
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