NOAH Compendium

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Date: Wednesday, October 20, 2021 20:00

Description: Chanelle_Phara_Logo_cmyk
Release 2.144
Fipnil Spot-on Solution for Cats
Species: Cats
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For cats
Active ingredient: Fipronil
Product:Fipnil Spot-on Cat 50mg
Product index: Fipnil Spot-on Cat
Each pipette contains:
Fipronil 50 mg
Butylhydroxyanisole E320 0.1 mg
Butylhydroxytoluene E321 0.05 mg
Treatment of flea (Ctenocephalides spp.) infestations. The product has a persistent insecticidal efficacy for up to 5 weeks against fleas (Ctenocephalides spp.).
Although no immediate killing effect against ticks has been demonstrated, the product has shown an acaricidal efficacy against Dermacentor reticulatus. If ticks of this species are present when the product is applied, all the ticks may not be killed within the first 48 hours but they will be killed within a week.
The product can be used as part of a treatment strategy for Flea Allergic Dermatitis, where this has been previously diagnosed by a veterinary surgeon.
Dosage and administration
Route of administration and dosage
External use only. Administer by topical application to the skin as follows:
1 pipette of 0.5 ml per cat.
Method of administration
Remove the pipette from the blister packaging. Hold the pipette upright. Tap the narrow part of the pipette to ensure the contents are within the main body of the pipette. Twist and pull the snap-off top of the pipette to enable the contents to be expelled.
Part the pet’s coat until the skin is visible. Place the tip of the pipette directly against the bared skin and squeeze gently to empty its contents at two points along the cat’s back, preferably at the base of the head and between the shoulder blades, emptying approximately half the volume at each site. Squeeze the pipette several times to ensure dosing is complete.
Advice on correct administration
Application of the solution as directed minimises the possibility that the animal will lick the solution off.
Care should be taken to avoid excessive wetting of the hair with the product since this will cause a sticky appearance of hairs at the treatment spot. However, should this occur, it will usually disappear within 24-48 hours post application. There is little evidence available from studies with this product in cats; however from studies in dogs, crystals may be seen on the hair and slight scaling may occur within 24-48 hours after application.
Treatment schedule:
For optimal control of flea and/or tick infestation the treatment schedule can be based on the local epidemiological situation. The minimum interval between two treatments is four weeks.
Discard any opened pipettes.
Contra-indications, warnings, etc
Do not use on kittens less than 8 weeks old and /or weighing less than 1 kg in the absence of available data.
Do not use on sick (e.g. systemic diseases, fever...) or convalescent animals. Do not use in rabbits, as adverse drug reactions and even death could occur.
Do not use on animals with known hypersensitivity to the active substance or to any of the excipients.
Adverse reactions
If licking occurs, a brief period of hypersalivation (a lot of saliva in the cat’s mouth) may be observed due mainly to the nature of the ingredients.
Among the extremely rare suspected adverse reactions, temporary skin reactions on the application site (skin discoloration, local hair loss, pruritus (hives, rash), erythema (redness)) and general pruritus (hives, rash) or hair loss have been reported after use. Exceptionally, hypersalivation, reversible neurologic symptoms (hyperesthesia (oversensitivity), depression, nervous symptoms), vomiting or respiratory symptoms have been observed after use.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Special warnings
The product does not prevent ticks from attaching to the animals. Once dead, ticks will often drop off the animal, but any remaining ticks may be removed with a gentle pull. The product prevents re-infestation with all stages of ticks (Dermacentor Reticulatus) for four weeks, depending on the level of environmental challenge.
Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings which should be treated, in case of massive infestation and at the beginning of the control measures, with a suitable insecticide and vacuumed regularly. The product prevents re-infestation with all stages of ticks (Dermacentor Reticulatus) for four weeks, depending on the level of environmental challenge.
For optimal control of flea infestation in a multi-pet household, all dogs and cats in the household should be treated with a suitable insecticide.
When used as part of a strategy for the treatment of Flea Allergy Dermatitis, monthly applications to the allergic patient and to other cats in the household are recommended.
Special precautions for use in animals
Animals should be weighed accurately prior to treatment.
Avoid contact with the animal’s eyes. In the case of accidental eye contact, immediately and thoroughly flush the eyes with water.
It is important to make sure that the product is applied to an area where the animal cannot lick it off and to make sure that animals do not lick each other following treatment.
Avoid frequent swimming or shampooing the animal because the maintenance of effectiveness of the product in these cases has not been tested.
Do not apply the product on wounds or damaged skin.
Use during pregnancy and lactation: Laboratory studies using fipronil have not shown any evidence of teratogenic or embryotoxic effects. Studies have not been carried out with this product in pregnant and lactating queens. Use in pregnancy and lactation only in accordance with professional veterinary advice and a benefit/risk assessment.
Interaction with other medicinal products and other forms of interaction: None known.
The toxicity of the veterinary medicinal product when administered to the skin is very low. The risk of experiencing adverse effects may increase in cases of overdose, so animals should always be treated with the correct product according to species and body weight.
User warnings
Keep pipettes in original packaging until ready to use.This product can cause mucous membrane and eye irritation. Therefore, contact between the product and the mouth or eyes should be avoided.
In the case of accidental eye contact, immediately and thoroughly flush the eyes with water. If eye irritation persists seek medical advice and show the package leaflet or the label to the physician.
Do not smoke, drink or eat during application.
Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water. Wash hands after use.
Animals or people with a known hypersensitivity to fipronil or any of the other ingredients should avoid contact with the product.
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.
Other precautions
The product may have adverse effects on painted, varnished or other household surfaces or furnishings.
Pharmaceutical precautions
Do not use after expiry date stated on the label. Do not store above 25°C. Store in a dry place in the original package.
Keep out of the reach and sight of children.
Dispose of empty packaging and any remaining product in the household refuse. Fipronil may adversely affect aquatic organisms. Do not contaminate ponds, water ways or ditches with the product or empty container.
Legal category
Legal category: NFA-VPS
Packaging quantities
Blister cards or boxes of 3 or 6 pipettes. Not all pack sizes may be marketed.
Marketing Authorisation Holder (if different from distributor)
EU Pharmaceuticals Ltd., 37 Geraldine Road, London SW18 2NR, UK.
Marketing Authorisation Number
Vm 39787/4009
Significant changes