FIPROSPOT SPOT ON LARGE DOG 2.68ML
Uses - Fiprospot
For the treatment of dogs against flea infestations (Ctenocephalides spp.)
Insecticidal efficacy against new infestation with fleas persists for up to 6 weeks.
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.
Although the product does not consistently show an immediate acaricidal efficacy (several ticks may be present after 48 hours), it has a persistent acaricidal efficacy for up to 4 weeks against Dermacentor variabilis and up to 3 weeks against Rhipicephalus sanguineus.
Dosage and administration - Fiprospot
Only by topical application to the skin.
- Fiprospot 67 mg spot-on solution for small dogs (2 - 10 kg): 1 pipette of 0.67 ml is sufficient for the treatment of a dog with a body weight of 2 kg up to 10 kg corresponding to a recommended minimum dose of 6.7 mg fipronil/kg body weight.
- Fiprospot 134 mg spot-on solution for medium dogs (10 - 20 kg): 1 pipette of 1.34 ml is sufficient for the treatment of a dog with a body weight of 10 kg up to 20 kg corresponding to a recommended minimum dose of 6.7 mg fipronil/kg body weight.
- Fiprospot 268 mg spot-on solution for large dogs (20 - 40 kg): 1 pipette of 2.68 ml is sufficient for the treatment of a dog with a body weight of 20 kg up to 40 kg corresponding to a recommended minimum dose of 6.7 mg fipronil/kg body weight.
- Fiprospot 402 mg spot-on solution for very large dogs (40 - 60 kg): 1 pipette of 4.02 ml is sufficient for the treatment of a dog with a body weight of 40 kg up to 60 kg corresponding to a recommended minimum dose of 6.7 mg fipronil/kg body weight.
For dogs over 60 kg: use two 2.68 ml pipettes (Fiprospot for large dogs)
The minimum interval between two treatments should be not less than 4 weeks.
Advice for the safe application:
Disconnect one of the blisters from the blister card. This helps to avoid accidental opening of the adjacent blister package in order to protect the still unopened pipettes from exposure to humidity. Open the blister with scissors. To avoid damaging of the pipette cut along the line marked with the scissors icon. Carefully peal back the foil from the cut off end and withdraw the pipette.
Hold the pipette upright. Tap lightly to ensure the entire liquid contents are within the main body of the pipette. Bend the upper border strip backwards. Then the pipette can be set aside, if necessary. To open the pipette, snap off the top of the pipette along the scored line.
Part the coat between 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 content completely and directly onto the skin in one or two spots.
Application of the solution near the base of the head minimises the possibility that the animal will lick the solution off. Care should be taken after the application that animals do not mutually lick off the solution.
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.
For the treatment and control of flea allergy it is recommended that allergic patients and all other dogs and cats in the household should be treated at monthly intervals.
Contra-indications, warnings, etc
Do not use on sick (systemic disease, fever, etc.) or convalescent animals.
Do not use on rabbits, as adverse drug reactions and even death could occur.
This veterinary medicinal product has been developed specifically for dogs. Do not use on cats as this could lead to overdosing.
Do not use on animals with hypersensitivity to the active substance or any other excipients.
Animals should be weighed accurately prior to treatment.
In the absence of available data, the veterinary medicinal product should not be used on puppies less than 2 months old and/or weighing less than 2 kg.
Fiprospot 134 mg spot-on solution for medium dogs should not be used on dogs weighing less than 10 kg.
Fiprospot 268 mg spot-on solution for large dogs should not be used on dogs weighing less than 20 kg.
Fiprospot 402 mg spot-on solution for very large dogs should not be used on dogs weighing less than 40 kg.
It is important to make sure that the product is applied to an area where the animal cannot lick it off. Do not allow recently treated animals to lick each other.
Avoid contact with the animal's eyes. Should the veterinary medicinal product come into contact with the eyes, rinse thoroughly at once with water.
Do not apply the veterinary medicinal product to wounds or skin lesions.
There may be an attachment of some ticks. For this reason transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
Specific studies investigating the safety of the product following repeated administration or at overdosage have not been conducted due to the known safety profile of the active substance and excipients.
Special warnings for each target species
The veterinary medicinal product does not prevent an infestation of the animal by ticks.
Ticks will usually die within 48 hours of infestation, however attached ticks (both live and killed) may be seen at this time. Some of these will have had a blood meal.
Death normally occurs before the ticks are fully engorged so that the risk of transmission of infectious diseases by ticks is minimised, but cannot be completely ruled out. As soon as the ticks are dead they generally fall off the animal.
For the optimal control of flea problems in households with several animals all dogs and cats should be treated with an authorised insecticide.
Fleas from pets often infest animal's baskets, 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.
Shampooing with a medicated shampoo, followed by thorough drying, 1 to 2 hours before treatment application and bathing once weekly over a period of 6 weeks, has been shown not to affect the efficacy of this veterinary medicinal product against fleas. Bathing and intensive wetting of the coat should be avoided for the first 2 days following administration of the veterinary medicinal product.
Dogs should not be allowed to swim in watercourses for 2 days after application
If licking occurs, a brief period of hypersalivation may be observed due mainly to the nature of the carrier substance.
Among the extremely rare suspected adverse reactions, transient cutaneous reactions at the application site (scaling, local alopecia, pruritus, erythema) and general pruritus or alopecia have been reported after use.
In very rare cases, hypersalivation, reversible neurological signs (hyperaesthesia, depression, nervous signs), vomiting or respiratory signs have been observed after use.
Use during pregnancy and lactation
Laboratory studies using fipronil have not shown any teratogenic or embryotoxic effect. No studies have been carried out on pregnant or lactating dogs using this veterinary medicinal product. Therefore its use during pregnancy and lactation should only be after a relevant benefit-risk analysis made by the treating veterinarian.
The toxicity of the veterinary medicinal product administered to the skin is very low. The risk of experiencing adverse effects may however increase when overdosing, so animals should always be treated with the correct pipette size according to body weight.
Special precautions to be taken by the person administering the medicinal product to animals
This veterinary medicinal product can cause mucous and eye irritation. Therefore avoid contact of the product with mouth and eyes.
Should the veterinary medicinal product come into contact with the eyes, rinse thoroughly at once with water. If the eye irritation persists, seek medical help at once and show the package insert or label.
Avoid contact with the skin. Should the product come into contact with the skin, wash with soap and water. Wash hands after use.
Do not eat, drink or smoke during application.
Animals or operators with known hypersensitivity to fipronil or one of its components should avoid contact with the veterinary medicinal 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 during the early evening. Moreover recently treated animals should not be allowed to sleep with owners, especially children.
This veterinary medicinal product does not require any special storage conditions.
Store in original package. Keep out of reach and sight of children. For animal treatment only.
Any unused product or waste materials should be disposed of in accordance with national requirements. Fipronil may be harmful to aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty container.
Packs containing 3 or 6 pipettes.
Fipronil is an insecticide and acaricide belonging to the group of phenylpyrazole. It acts by inhibiting the GABA complex, binding to the chloride channel thereby blocking pre- and post-synaptic transfer of chloride ions across the membrane. This results in uncontrolled activity of the central nervous system and hence to death in insects and acarids.
Fipronil acts as an insecticide against fleas (Ctenocephalides spp.) and as an acaricide against ticks (Rhipicephalus sanguineus and Dermacentor variabilis).
Fleas are killed within 48 hours. Most ticks are killed within 48 hours. Some ticks may still be present after 48 hours.
The veterinary medicinal product distributes itself within 48 hours over the entire skin of the animal.
The absorption of fipronil is negligible in dogs following topical application.
The concentration of fipronil on the fur decreases over time.
Marketing Authorisation Holder (if different from distributor)
IDT Biologika GmbH, Am Pharmapark , D-06861 Dessau-Rosslau, Germany
Marketing authorisation number
Fiprospot 67 mg spot-on solution for small dogs (2 - 10 kg): Vm 26750/4003.
Fiprospot 134 mg spot-on solution for medium dogs (10 - 20 kg): Vm 26750/4002.
Fiprospot 268 mg spot-on solution for large dogs (20 - 40 kg): Vm 26750/4001.
Fiprospot 402 mg spot-on solution for very large dogs (40 - 60 kg): Vm 26750/400
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