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Date: Wednesday, May 29, 2024 17:43

Release 2.261
FIPROtec® Spray 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs (NI)
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs, For cats
Active ingredient: Fipronil
Product:FIPROtec® Spray for Cats and Dogs (NI)
Product index: FIPROtec® Spray (NI)
Incorporating:
Qualitative and quantitative composition
Active ingredients
1ml of solution contains Fipronil 2.5mg.
Excipients
For the full list of excipients, see below.
Pharmaceutical form
Cutaneous spray solution. Clear, colourless liquid.
Clinical particulars
Target species
Cats and dogs.
Indications for use
- The treatment and prevention of fleas (Ctenocephalides spp.) Insecticidal efficacy against new infestations with adult fleas persists for up to 2 months in cats and up to 3 months in dogs, depending on environmental challenge.
- The treatment and prevention of ticks (Ixodes spp., including Ixodes ricinus) infestations in cats and dogs.The product has a persistent acaricidal efficacy for up to one month against ticks, depending on the level of environmental challenge.
- The treatment of biting lice infestations on cats (Felicola subrostratus) and (Trichodectes canis) on dogs.
Contraindications
Do not use on dogs or cats less than 2 days old, or weighing less than 166g. Do not use on animals weighing more than 10kg. Do not use on sick (systemic diseases, fever…) or convalescent animals. Do not spray directly onto areas of broken skin. Do not use in rabbits, as adverse reactions and even death could occur. Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Do not allow animals to groom each other following treatment. Allow treated animals to dry in a well-ventilated room. Do not confine animals in an enclosed space or pet carrier until the coat is totally dry. In the absence of specific tolerance and efficacy data, the product is not recommended for the treatment of species other than cats and dogs. There may be an attachment of single ticks. For this reason, the transmission of infectious diseases cannot be completely excluded if conditions are unfavourable. For optimum efficacy, it is not recommended to bathe or shampoo animals within the two-day period prior to treatment or within the two-day period following treatment. Bathing or shampooing up to four times in two months has been shown to have no significant effect on the residual efficacy of the product. Monthly treatment is recommended when more frequent shampooing is carried out. For optimal control of flea infestations in multi-pet households, all dogs and cats in the household should be treated at the same time. Fleas from pets often infest the animal’s basket, bedding and regular resting areas, such as carpets and soft furnishings. These should be treated in cases of massive infestation and upon the initiation of control measures with a suitable insecticide and vacuumed regularly. Given the volume delivered by the spray pump (0.5ml/pump) the product is very suitable for use in cats and dogs weighing between 166g and 10kg body weight, depending on the length of hair, but not adequate for medium and large dogs. For external use only.
Special precautions to be taken by the person administering the veterinary medicinal product
Keep treated animals away from fires or other sources of heat, and surfaces likely to be affected by the alcohol spray, for at least 30 minutes following spraying and until the fur is totally dry. Do not spray on a naked flame or any incandescent material. This product can cause mucous membrane and eye irritation. Therefore, contact of the product with the mouth and eyes should be avoided. People with asthma or a known hypersensitivity to insecticides or alcohol should avoid contact with the veterinary medicinal product. Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water. If irritation occurs, seek medical advice. After accidental ocular exposure, the eye should be rinsed carefully with plain water. Treated animals should not be handled until the fur is dry, and children should not be allowed to play with treated animals until the fur 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. Spray animals in the open air or a well-ventilated room. Do not breathe spray. Do not smoke, drink or eat during application. Wear PVC or nitrile gloves during the treatment of animals. It is recommended to wear a waterproof apron for the protection of clothing. If clothing becomes heavily wetted with the product, it should be removed and washed before reuse. Dispose of gloves after use and then wash hands with soap and water. Treatment of multiple animals: Good ventilation is particularly important where several animals are to be treated. Treat multiple animals outside, or reduce the build-up of vapour by removing the animals from the treatment room while the alcohol is evaporating and ensure that the treatment room is well-ventilated between individual treatments. In addition, ensure that the drying room is well-ventilated and avoid housing several recently treated animals within the same air space.
Other precautions
Fipronil may adversely affect aquatic organisms. Dogs should not be allowed to swim in watercourses for 2 days after application.
Adverse reactions
If licking occurs, a brief period of hypersalivation may be observed due mainly to the nature of the carrier. Among the extremely rare suspected adverse reactions, transient cutaneous reactions erythema, pruritus or alopecia have been reported after use. Exceptionally, hypersalivation, reversible neurological signs (hyperaesthesia, depression, nervous signs), vomiting or respiratory signs have been observed after use.
Use during pregnancy and lactation
Laboratory studies did not reveal any teratogenic effect of fipronil in the rat and rabbit. The formulation is very well tolerated by puppies following treatment of the lactating bitch. Data is not available on the treatment of pregnant or nursing queens.
Interaction with other medicinal products
Do not use simultaneously with other flea products which are applied directly onto the animal.
Dosage and administration
Depending on the length of hair, apply 3 to 6 ml per kg body weight, (7.5 to 15mg of active ingredient per kg body weight) i.e. 6 to 12 pump applications per kg body weight of the 100ml presentation.
Spray the entire body of the animal, and apply from a distance of approximately 10–20cm. Apply against the lay of the hair and make sure that the entire coat of the animal is dampened. Ruffle the coat, especially in long-haired animals, so that the product penetrates down to the skin. For treatment of the head region, and when treating young or nervous pets, application may be carried out by spraying onto a gloved hand and rubbing the product into the coat. Allow to dry naturally. Do not towel dry. It is important to dampen the coat down to the skin.
The 100ml bottle contains approximately; 3 to 6 treatments for a dog weighing 5kg, depending on hair length; Approximately 8 treatments for a short-haired cat weighing 4kg; Approximately 2 treatments for a long-haired dog weighing 8kg.
The formulation contains a coating agent. Therefore, spraying builds up a film and makes the fur glossy. In the absence of safety studies, the minimum treatment interval is 4 weeks. Puppies and kittens from 2 days of age may be safely treated, provided they weigh more than 166g.
Overdose
The risk of experiencing adverse effects may increase when overdosing, so animals should always be treated with the correct dose according to body weight. Start an appropriate symptomatic treatment in case of overdosing.
Pharmacological particulars
Pharmacotherapeutic group: Ectoparasiticides for topical use, incl. insecticides. ATC vet code: QP53AX15
Pharmacodynamic properties
Fipronil is an insecticide and acaricide from the phenylpyrazole family. It acts by inhibiting the GABA complex, binding to the chloride channel and thereby blocking pre and post-synaptic transfer of chloride ions across the membrane. This results in uncontrolled activity of the central nervous system and death in insects and acarids. Fipronil exhibits insecticidal and acaricidal activity against fleas (Ctenocephalides spp.), ticks (Ixodes spp.) and lice (Trichodectes canis and Felicola subrostratus) in dogs and cats.
Pharmacokinetic particulars
*Absorption – The amount of Fipronil absorbed by the skin in the dog, after application of the spray to the coat and skin is extremely slight to negligible.*Distribution – The persistence of fipronil on the hair is very long (on average 52.5 ± 11.5 days), given that the limit of quantification of the assay method is 0.25 µg/g. This can be explained by the fact that fipronil dissolves well in fat and concentrates in the sebaceous glands. From the sebaceous glands the amount of fipronil on the skin is constantly replenished.*Biotransformation – In all species fipronil is mainly metabolised to its sulphone derivative (RM1602), which also possesses insecticidal and acaricidal properties.The RM1602 detected on the hair after spray application in dogs may be explained by its presence in the original raw material.
Pharmaceutical particulars
List of excipients
Copovidone K28, Isopropyl alcohol, purified water.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening the immediate packaging: 1 year.
Special precautions for storage
Highly flammable. Do not store above 25°C.
Nature and composition of immediate packaging
A 100ml bottle consisting of high density polyethylene, fitted with a spray pump delivering 0.5ml per pump (dip tube consisting of low density polyethylene).
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Fipronil may adversely affect aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty containers.
Marketing Authorisation Holder (if different from distributor)
Beaphar B.V., Drostenkamp 3, 8101 BX, Raalte, Netherlands
Marketing Authorisation Number
Vm 41941/3002
Significant changes
Date of the first authorisation or date of renewal
October 2017
Date of revision of the text
July 2021
Any other information
N/A.
Legal category
Legal category: NFA-VPS
GTIN
GTIN description:Fiprotec Spray
GTIN:08711231171286