NOAH Compendium

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Date: Friday, January 24, 2020 13:09

Description: Chanelle_Phara_Logo_cmyk
Release 3.90
Fipnil Spot-on Solution for Dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs
Active ingredient: Fipronil
Product:Fipnil Spot on Solution Dog
Product index: Fipnil Spot on Dog
Presentation
Fipnil Spot-on Solution Dog 67 mg
Fipnil Spot-on Solution Dog 134 mg
Fipnil Spot-on Solution Dog 268 mg
Fipnil Spot-on Solution Dog 402 mg
Each 0.67 ml/1.34 ml/2.68 ml/4.02 ml pipette contains:
Fipronil 67 mg/134 mg/268 mg/402 mg
Butyhydroxyanisole E320 0.134 mg/0.268 mg/0.536 mg/0.804 mg
Butylhydroxytoluene E321 0.067 mg/0.134 mg/0.268 mg/0.402 mg
Uses
Treatment of flea (Ctenocephalides spp.) and tick (Rhipicephalus sanguineus and Ixodes Ricinus) infestations.
Insecticidal efficacy against new infestations with adult fleas persists for 8 weeks.
The product has a persistent acaricidal efficacy for 4 weeks against ticks (Rhipicephalus sanguineus, Ixodes ricinus, Dermacentor reticulatus).
If ticks of some species (Dermacentor reticulatus) are already present when the product is applied, all of the ticks may not be killed within the first 48 hours.
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.
Dosage and administration
External use only.
Administer by topical application to the skin according to the bodyweight as follows:
Bodyweight
Dose
2 - 10kg
1 pipette of Fipnil Spot-on Dog 67 mg
10 - 20kg
1 pipette of Fipnil Spot-on Dog 134 mg
20 - 40kg
1 pipette of Fipnil Spot-on Dog 268 mg
40 - 60kg
1 pipette of Fipnil Spot-on Dog 402 mg
Over 60kg
2 pipettes of Fipnil Spot-on Dog 268 mg
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 dog’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.
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. 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 4 weeks.
To ensure administration of a correct dose, body weight should be determined as accurately as possible.
Discard any opened pipettes.
Contra-indications, warnings, etc
Do not use on puppies less than 2 months old.
Fipnil Spot-on Solution Dog 67 mg: Do not use on animals weighing less than 2 kg.
Fipnil Spot-on Solution Dog 134 mg: Do not use on animals weighing less than 10 kg.
Fipnil Spot-on Solution Dog 268 mg: Do not use on animals weighing less than 20 kg.
Fipnil Spot-on Solution Dog 402 mg: Do not use on animals weighing less than 40 kg.
Do not use on sick (e.g. systemic diseases, fever...) or convalescent animals.
Do not use in rabbits, as adverse reactions and even death could occur.
This product is specifically developed for dogs. Do not use in cats, as this could lead to overdosing.
Do not use on animals with known hypersensitivity to the active substance or to any of the excipients.
Special Warnings
Avoid frequent swimming or shampooing the animal because the maintenance of effectiveness of the product in these cases has not been tested.
The product does not prevent ticks from attaching to the animals. If the animal has been treated prior to exposure to the ticks, the ticks will be killed in the first 24-48 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, but any remaining ticks may be removed with a gentle pull.
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.
When used as part of a strategy for the treatment of Flea Allergy Dermatitis, monthly applications to the allergic patient and to other dogs in the household are recommended.
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.
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.
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 effect. Studies have not been carried out with this product in pregnant and lactating bitches. 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.
Overdose: No adverse effects were observed in target animal safety studies in 2 month-old puppies, growing dogs and dogs weighing about 2 kg treated with 5 times the therapeutic dose once a month for 3 consecutive months. The risk of adverse effects may increase in cases of overdose.
User warnings
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.
For animal treatment only.
Adverse reactions
If licking occurs, a brief period of hypersalivation (excessive production of saliva) 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 (itching), erythema (redness)) and general pruritus (itching) or hair loss have been reported after use.
Exceptionally, hypersalivation, reversible neurologic symptoms (hyperesthesia (abnormal increased sensitivity to any stimulus), 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.
Environmental Warning
Fipronil may adversely affect aquatic organisms. Dogs should not be allowed to swim in watercourses for 2 days after application.
Dispose of empty packaging and any remaining product in the household refuse. Do not contaminate ponds, water ways or ditches with the product or empty container.
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.
Legal category
Legal category: NFA-VPS
Packaging quantities
Blister cards or boxes of 3 or 6 pipettes. Not all pack sizes may be marketed.
Further information
PETS travel scheme – it is necessary to consult a veterinary surgeon at least one month prior to intended travel and before using this product.
Marketing Authorisation Holder (if different from distributor)
EU Pharmaceuticals Ltd., 37 Geraldine Road, London SW18 2NR, UK.
Marketing Authorisation Number
Fipnil Spot-on 67 mg - Vm 39787/4005
Fipnil Spot-on 134 mg - Vm 39787/4004
Fipnil Spot-on 268 mg - Vm 39787/4006
Fipnil Spot-on 402 mg - Vm 39787/4007
Significant changes