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Date: Sunday, July 14, 2024 1:27

Release 3.155
Fipnil Plus Spot-on Solution for Dogs
Species: Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs
Active ingredient: Fipronil, (S)-methoprene
Product:Fipnil Plus Spot-on Solution for Dogs
Product index: Fipnil Plus Spot-on Solution for Dogs
Each pipette of 0.67 ml contains:
Active substances:
Fipronil 67.00 mg
(S)-methoprene 60.30 mg
Butylhydroxyanisole (E320) 0.13 mg
Butylhydroxytoluene (E321) 0.07 mg
Each pipette of 1.34 ml contains:
Active substances:
Fipronil 134.00 mg
(S)-methoprene 120.60 mg
Butylhydroxyanisole (E320) 0.27 mg
Butylhydroxytoluene (E321) 0.13 mg
Each pipette of 2.68 ml contains:
Active substances:
Fipronil 268.00 mg
(S)-methoprene 241.20 mg
Butylhydroxyanisole (E320) 0.54 mg
Butylhydroxytoluene (E321) 0.27 mg
Each pipette of 4.02 ml contains:
Active substances:
Fipronil 402.00 mg
(S)-methoprene 361.80 mg
Butylhydroxyanisole (E320) 0.80 mg
Butylhydroxytoluene (E321) 0.40 mg
Clear amber solution.
For the treatment of dogs weighing 2 -to-10 kg bodyweight, 10 -to-20 kg bodyweight, 20 -to-40 kg bodyweight and over 40 kg bodyweight:
- 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 persist 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 a persistent acaricidal efficacy for up to 4 weeks against ticks.
- Treatment of infestations with biting lice (Trichodectes canis).
Dosage and administration
One pipette of 0.67 ml (S) per dog weighing over 2 and up to 10 kg, corresponding to a minimum recommended dose of 6.7 mg/kg for fipronil and 6 mg/kg for (S)-methoprene, by topical application to the skin.
One pipette of 1.34 ml (S) per dog weighing over 10 and up to 20 kg, corresponding to a minimum recommended dose of 6.7 mg/kg for fipronil and 6 mg/kg for (S)-methoprene, by topical application to the skin.
One pipette of 2.68 ml (S) per dog weighing over 20 and up to 40 kg, corresponding to a minimum recommended dose of 6.7 mg/kg for fipronil and 6 mg/kg for (S)-methoprene, by topical application to the skin.
One pipette of 4.02 ml (S) per dog weighing over 40 kg, corresponding to a minimum recommended dose of 6.7 mg/kg for fipronil and 6 mg/kg for (S)-methoprene, by topical application to the skin.
In the absence of safety studies, the minimum treatment interval is 4 weeks.
Method of administration:
Hold the pipette upright. Tap the narrow part of the pipette to ensure the contents remain within the main body of the pipette. Snap back the tip. Part the coat on the back of the animal at the base of the neck in front of 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 completely and directly onto the skin in one spot. Temporary changes to the coat (clumped/greasy hair) may be noted at the application site. Do not overdose.
Contra-indications, warnings, etc
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, due to a risk of adverse drug reactions or even death. In absence of studies, the use of the product is not recommended in non-target species.
This product is specifically developed for dogs. Do not use in cats, as this could lead to overdosing.
Do not use in known cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Bathing/immersion in water within 2 days after application of the product and more frequent bathing than once a week should be avoided, as no study has been performed to investigate how this affects the efficacy of the product. Emollient shampoos can be used prior to treatment, but reduce the duration of protection against fleas to approximately 5 weeks when used weekly after application of the product. Weekly bathing with a 2% chlorhexidine medicated shampoo did not affect efficacy against fleas during a 6 week long study.
There may be an attachment of a few ticks. For this reason a transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
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.
Special precautions for use
Special precautions for use in animals
Avoid contact with the animal's eyes.
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product can cause mucous membrane, skin and eye irritation. Therefore, contact of the product with mouth, skin and eyes should be avoided.
People with a known hypersensitivity to insecticides or alcohol should avoid contact with the product. Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water.
After accidental ocular exposure the eye should be rinsed carefully with clean water.
If the product is accidently swallowed, seek medical advice immediately and show the package leaflet 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 are not allowed to sleep with owners, especially children.
Keep stored pipettes in the original packaging until ready to use. In order to prevent children from getting access to used pipettes, dispose of used pipettes immediately.
Do not smoke, drink or eat during application.
Other precautions
Fipronil and (S)‑methoprene may adversely affect aquatic organisms. Dogs should not be allowed to swim in watercourses for 2 days after application.
Adverse reactions (frequency and seriousness)
Among the very rare suspected adverse reactions, transient skin reactions on the application site (skin discoloration, local hair loss, itching, redness) and general itching or hair loss have been reported after use. Excessive salivation, reversible nervous signs (increased sensitivity to stimulation, depression, other nervous signs), vomiting or respiratory symptoms have also been observed after use.
If licking occurs, a brief period of excessive salivation may be observed due mainly to the nature of the carrier.
Use during pregnancy and lactation
The product can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
None known.
Pharmaceutical precautions
Special precautions for storage
Do not store above 30°C. Store in the original package.
Legal category
Legal category: AVM-GSL
Packaging quantities
A white pipette composed of a heat-formed shell of composed of polypropylene/cyclic olefin copolymer/polypropylene layer and polyethylene/ethylene vinyl alcohol/polyethylene layer.
1, 2, 3, 4 or 6 pipettes in individual foil sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder (if different from distributor)
EU Pharmaceuticals Ltd., 37 Geraldine Road, London SW18 2NR
Further information
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Fipronil and (S)-methoprene should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Marketing Authorisation Number
Fipnil Plus 67 mg/60.3 mg Spot-on Solution for Small Dogs - Vm 39787/4019
Fipnil Plus 134 mg/120.6 mg Spot-on Solution for Medium Dogs - Vm 39787/4015
Fipnil Plus 268 mg/241.2 mg Spot-on Solution for Large Dogs - Vm 39787/4016
Fipnil Plus 402 mg/361.8 mg Spot-on Solution for Extra Large Dogs - Vm 39787/4017
Significant changes
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