NOAH Compendium

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Date: Thursday, July 18, 2024 2:21

Release 3.397
Fipnil Plus Spot-on Solution for Cats
 
Species: Cats
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For cats
Active ingredient: Fipronil, (S)-methoprene
Product:Fipnil Plus Spot-on Solution for Cats
Product index: Fipnil Plus Spot-on Solution for Cats
Incorporating:
Presentation
Each pipette of 0.5 ml contains:
Active substances:
Fipronil 50.00 mg
(S)-methoprene 60.00 mg
Excipients:
Butylhydroxyanisole (E320) 0.10 mg
Butylhydroxytoluene (E321) 0.05 mg
Clear amber solution.
Uses
- To be used against infestations with fleas, alone or in association with ticks and/or biting lice.
- Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 4 weeks. Prevention of the multiplication of fleas by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas for six weeks after application.
- Elimination of ticks (Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus). The product has a persistent acaricidal efficacy for up to 2 weeks against ticks (based on experimental data).
- Elimination of biting lice (Felicola subrostratus).
Dosage and administration
One pipette of 0.5 ml per cat, corresponding to a minimum recommended dose of 5 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. Do not overdose.
Contra-indications, warnings, etc
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 1 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.
Do not use in known cases of hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
Avoid contact with the animal’s eyes.
Special precautions for use
Special precautions for use in animals
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.
No data on the effect of bathing/shampooing on the efficacy of the product in cats is available. However, based on information available for dogs shampooed as from 2 days after application of the product, it is not recommended to bath animals within 2 days after application of the product.
There may be an attachment of single 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.
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.
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.
Adverse reactions (frequency and seriousness)
Among the very rare suspected adverse reactions, transient skin reactions on the application site (scaling, 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) or vomiting 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, lactation or lay
The product can be used during pregnancy. For treatment during the lactating period, see special precautions for use above.
Interaction with other medicinal products and other forms of interaction
None known.
Pharmaceutical precautions
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.
Marketing Authorisation Number
Vm 39787/4018
Significant changes
GTIN
GTIN description:- -
GTIN:- -