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Date: Sunday, May 5, 2024 15:09

Description: Beaphar_CMYK_Logo_strapline_center
Release 2.247
FIPROtec® Spot-On Solution for Cats
Species: Cats
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For cats
Active ingredient: Fipronil
Product:FIPROtec® Spot-On for Cats
Product index: FIPROtec® Spot-On Cat
Incorporating:
Qualitative and quantitative composition
Active ingredient
Each pipette contains Fipronil 50mg.
Excipients
Butylhydroxyanisole (E-320) 0.100 mg, Butylhydroxytoluene (E-321) 0.050 mg, Benzyl alcohol (E-1519) 142.500 mg. For the full list of excipients, see below.
Pharmaceutical form
Spot-on solution. Clear, colourless to slightly yellow solution.
Clinical particulars
Target species
Cats.
Indications for use
- Treatment and prevention of flea infestations (Ctenocephalides felis). The duration of protection against flea infestation is 5 weeks.
- Treatment of tick infestations (Ixodes ricinus). Ticks (Ixodes ricinus) on the animal at time of treatment will be killed within 48 hours. Treatment does not protect against new tick infestations.
Contraindications
In the absence of available data, the product should not be used on kittens less than 8 weeks old and/or weighing less than 1kg. Do not use on sick (systemic diseases, fever...) or convalescent animals. Do not use in rabbits, as adverse reactions and even death could occur. Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special warnings for target species
For external use only. Animals should be weighed accurately prior to treatment. 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. There may be an attachment of ticks. For this reason transmission of infectious diseases cannot be excluded. Do not apply the product on wounds or damaged skin. 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. Avoid frequent swimming or shampooing of the animal because the maintenance of effectiveness of the product has not been tested in these cases. 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. Do not use in rabbits, as adverse reactions and even death could occur. Do not use in non-target animals.
Special precautions to be taken by the person administering the veterinary medicinal product
Keep pipettes in original packaging until ready for use. This product can cause mucous membrane and eye irritation. After accidental ocular exposure the eye should be rinsed carefully with plain water. Therefore, contact of the product with mouth and eyes should be avoided. Persons with known hypersensitivity to fipronil or any of the excipients should avoid contact with the product. Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water. Do not smoke, drink or eat during application. Wash hands after use. Ingestion of the product is harmful. Prevent children getting access to the pipettes and discard the used pipettes immediately after applying 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.
Other precautions
The product may have adverse effects on painted, varnished or other household surfaces or furnishings.
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 at the application site (skin discolouration, local alopecia, pruritus, erythema) and general 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. Do not overdose.
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 the product in pregnant and lactating queens. The potential toxicity of the product for kittens of less than 8 weeks of age in contact with a treated queen is not documented. Special care should be taken in this case. Use in pregnancy and lactation only in accordance with professional veterinary advice and a benefit/risk assessment.
Interaction with other medicinal products
Do not use simultaneously with other flea products which are applied directly onto the animal.
Dosage and administration
1 x 0.5ml pipette per cat. Hold upright. Tap the narrow part of the pipette to ensure the contents are within the main body of the pipette. Cut off the top of the pipette with scissors. Part the coat between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze gently to empty its contents onto the skin, preferably at two spots, one at the base of the skull and a second 2–3 cm further back. 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. In the absence of safety studies, the minimum treatment interval is 4 weeks. For optimal control of flea infestation the treatment schedule can be based on the local epidemiological situation.
Overdose
Overdose application of the product will cause a sticky appearance of hairs at the treatment spot. However, should this occur, it will disappear within 24 hours post application.
Pharmacological particulars
Pharmacotherapeutic group: Ectoparasiticides for topical use, incl. insecticides. ATC vet code: QP53AX1
Pharmacodynamic properties
Fipronil is an insecticide/acaricide in 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.
Pharmacokinetic particulars
*Absorption – After local application of the product in the cat, absorption of fipronil through the skin is negligible. *Distribution – After application, a concentration gradient of fipronil is set up on the fur of the animal extending from the point of application to the peripheral areas (lumbar zones, flanks,…). *Biotransformation – In ‘in vitro’ studies with subcellular liver fractions, the principal metabolite is the sulfone derivative of fipronil. However, this may be of limited relevance ‘in vivo’ as fipronil is poorly absorbed in the cat. *Elimination – The concentrations of fipronil on the hair decrease with time to attain a level of approximately 1 μg.g‑1 two months after treatment.
Pharmaceutical particulars
List of excipients
Butylhydroxyanisole (E-320), Butylhydroxytoluene (E-321), Benzyl alcohol (E-1519), Diethylene glycol monoethyl ether.
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: 2 years. Shelf-life after first opening the immediate packaging: use immediately.
Special precautions for storage
Do not store above 25°C. Keep pipette within box until ready for use, in order to protect from light.
Nature and composition of immediate packaging
A blue pipette is composed of a heat-formed shell (polypropylene/cyclic olefin copolymer/ethylene-vinyl alcohol copolymer/polypropylene) and a film (polyethylene terephthalate/aluminium/polypropylene). The blue pipette is enclosed in an aluminium blister polyethylene/polyamide/aluminium/polyamide/polyethylene and polyamide/aluminium/polyethylene). 1, 2, 3, 4, 6 pipettes are packed in a cardboard box. Not all pack sizes may be marketed.
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, The Netherlands
Marketing Authorisation Number
Vm 41941/4000
Significant changes
Date of the first authorisation or date of renewal
08 August 2014
Date of revision of the text
March 2018
Any other information
N/A.
Legal category
Legal category: AVM-GSL
GTIN
GTIN description:1 pipette pack
GTIN:08711231155187
GTIN description:4 pipette pack
GTIN:08711231155873
GTIN description:6 pipette pack
GTIN:8711231156795