Dosage and administration
Mechanical pump spray for external use only.
The pump delivers 0.5 ml (100 ml bottle) or 1.5 ml (250 ml bottle) or 3ml (500 ml bottle) spray per pump. In order to dampen the coat down to the skin, apply 3 to 6 ml per kg bodyweight, (7.5 to 15 mg of active ingredient per kg bodyweight), depending on the length of hair.
This dosage can be achieved with 6 to 12 pump applications per kg bodyweight of the 100 ml presentation, or 2 to 4 pump applications of the 250 ml presentation or 1 to 2 pump application(s) of the 500 ml presentation.
Depending on the coat length,
the 100 ml presentation allows 4 to 8 treatments of a 4 kg cat or up to 3 treatments of a 10 kg dog,
the 250 ml presentation allows 2 to 4 treatments of a 20 kg dog,
the 500 ml presentation allows 2 to 4 treatments of a 40 kg dog.
Method of administration:
For the 250 and 500 ml bottles, adjust the pump nozzle to spray setting.
Spray the entire body of the animal, and apply from a distance of approximately 10-20 cm. 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 make sure that animals do not lick each other following treatment.
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 disappear within 24 hours post application.
There may be an attachment of single ticks. For this reason transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
The product is not suitable for direct treatment of the environment.
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.
For optimal control of flea and/or tick infestation, the treatment schedule can be based on the local epidemiological situation.
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.
Contra-indications, warnings, etc
For animal treatment only. For external use only.
Do not use on sick (systemic diseases, fever…) or convalescent animals.
Do not use in rabbits, as adverse drug reactions and even death could occur.
Do not use in cases of hypersensitivity to the active substance or to any of excipients. Avoid contact with the animal's eyes. In the case of accidental eye contact, immediately and thoroughly flush the eyes with water.
Do not exceed the recommended dosage.
Avoid contact with the animal's eyes.
Do not spray directly onto areas of broken skin.
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.
Do not allow animals to lick each other following treatment.
In the absence of specific tolerance and efficacy data, the product is not recommended for the treatment of species other than cats and dogs.
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 at the application site (squamosis, local alopecia, pruritus, erythema) and general pruritus or alopecia have been reported after use. Exceptionally, hypersalivation, reversible neurologic symptoms (hyperesthesia, depression, nervous symptoms) or vomiting have been observed after use. The risk of adverse effects may increase in cases of overdose.
Start an appropriate symptomatic treatment in case of overdosing.
This product can cause mucous membrane and eye irritation. Therefore, contact between the product and the mouth or eyes should be avoided.
Animals or operators 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 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 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 re-use.
Dispose of gloves after use and then wash hands with soap and water.
Wash splashes from skin with soap and water immediately. If irritation occurs, seek medical advice. People with known sensitivity or asthma may be particularly sensitive to the product. Do not use product if you have previously experienced a reaction to it.
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.
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. Dogs should not be allowed to swim in water courses for 2 days after application. Do not contaminate ponds, waterways or ditches with the product or empty container.
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 (Rhipicephalus spp. Ixodes spp) and lice (Trichodectes spp. and Felicola spp). in the dog and cat.
Fleas will be killed within 24 h. Ticks will usually be killed within 48 h after contact with fipronil, however if ticks of some species (Rhipicephalus sanguineus and Ixodes ricinus) are present when the product is applied, all the ticks may not be killed within the first 48 hours.
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.
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.
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.
Fipronil is mainly metabolised to its sulfone derivative (RM1602), which also possesses insecticidal and acaricidal properties. The concentrations of fipronil on the hair decrease with time.
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.
For optimum efficacy it is not recommended to bathe or shampoo the animal in the two days prior to or following treatment with the product. 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 optimum control of flea problems in a multi-pet household, all dogs and cats in the household should be treated with a suitable insecticide.
Laboratory studies did not reveal any teratogenic effect of fipronil in the rat and rabbit. Fipronil is very well tolerated by puppies following treatment of the lactating bitch. Data is not available from specific studies during pregnancy in bitches, pregnancy in queens or in nursing queens. The safety of the veterinary medicinal product has not been established, therefore, use only in accordance with the risk/benefit assessment by the veterinarian.
No known incompatibilities exist for the use of concurrently administered medicinal products.
The alcohol carrier may have adverse effects on painted, varnished or other household surfaces or furnishings.