1. Name of the veterinary medicinal product
FIPROMED for cats
50 mg, spot-on solution for cats
2. Composition
| Name |
Contents of a 0.50 ml pipette (S pipette) |
|
Active substance: Fipronil |
|
|
50 mg |
|
| Excipients: |
|
|
Butilhidroxianisol |
0,10 mg |
|
Butilhidroxitoluen |
0,05 mg |
| Other excipients (benzyl alcohol, diethylene glycol monoethylene ether) up to: |
0,50 ml |
3. Target species
Cats.
4. Indications for use
Treatment and prevention of flea (Ctenocephalides spp.) and tick (Rhipicephalus spp., Dermacentor spp., Ixodes spp.) infestations in cats.
The veterinary medicinal product is used as part of a treatment regimen for the control of flea allergy dermatitis (FAD) when diagnosed by a veterinarian.
Treatment and prevention of mange lice (Felicola subrostratus) infestations in cats.
5. Contraindications
In the absence of available data, do not use in kittens less than 8 weeks of age and/or with a body weight less than 2 kg.
Do not use in sick (systemic diseases, fever) or convalescent animals.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
It is not used in rabbits, as it can cause adverse reactions and even death.
6. Special warnings
Special warnings:
For external use only.
Avoid contact of the veterinary medicinal product with the animal's eyes.
When treating flea infestations, all cats in direct contact should be treated simultaneously with an appropriate flea treatment.
In households with multiple pets, all dogs and cats should be treated simultaneously with an appropriate insecticide.
The veterinary medicinal product prevents reinfestation with Rhipicephalus spp., Dermacentor spp. and Ixodes spp. ticks, in all their development stages, for up to one month, but the effect depends on the degree of infestation in the animal's environment.
When used as part of the treatment of flea allergy dermatitis, monthly application of the veterinary medicinal product is recommended both for allergic patients and for other cats in the household.
Special precautions for safe use in the target species:
It is important to ensure that the veterinary medicinal product is applied to an area where the animal cannot lick the product and to ensure that the animals do not lick each other after treatment.
There are no data available on the efficacy of the veterinary medicinal product after bathing or shampooing in cats. However, based on information on the efficacy of the product in dogs shampooed two days after application of the product, it is not recommended to bathe cats for two days after application of the product.
Ticks may occasionally attach. Therefore, the transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
Dead ticks usually detach from the host animal and any remaining ticks should be carefully removed, ensuring that no parts of the tick remain in the cat's skin.
Pet fleas often infest baskets, bedding and places where animals usually rest (carpets and soft furniture). Therefore, in case of massive infestations and at the beginning of control measures, these areas should be treated with an appropriate insecticide and vacuumed regularly.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
The veterinary medicinal product should not come into contact with the skin and mucous membranes!
The veterinary medicinal product may cause irritation of the mucous membranes or eyes. Therefore, avoid contact with the skin, mouth or eyes. People with known hypersensitivity to insecticides or alcohol should avoid contact with the veterinary medicinal product. Avoid contact of the contents of the pipette with the fingers. If this happens, wash your hands thoroughly with soap and water. In case of accidental contact with the eyes, rinse the eyes thoroughly with clean water. Wash hands after use.
Treated animals should not be touched and children should not be allowed to play with treated animals until the application site has dried. Therefore, it is not recommended to apply the treatment during the day, but in the early evening, and the treated animal should not be allowed to sleep with the owners, especially children.
Do not smoke or eat or drink while applying the veterinary medicinal product.
The solvent in this veterinary medicinal product may have undesirable effects on painted, varnished or other surfaces in the home.
Special precautions for the protection of the environment:
Fipronil may be harmful to aquatic organisms. Do not contaminate lakes, rivers or canals with this veterinary medicinal product or its empty container.
Pregnancy and lactation:
The safety of the veterinary medicinal product has been established in breeding females, as well as in pregnant and lactating females, which have been treated with multiple consecutive doses of up to three times the maximum recommended dose.
Can be used in pregnant and lactating females.
Interaction with other veterinary medicinal products and other forms of interaction:
None known.
Overdose:
No adverse effects were observed in safety studies conducted in cats and kittens over 8 weeks of age and weighing approximately 1 kg treated with monthly doses of 5 times the recommended dose for 6 consecutive months. However, the risk of adverse effects may increase with overdose (see section 7).
Pruritus may occur after treatment.
Overdose causes clumping of hair at the application site.
Major Incompatibilities:
None known.
7. Adverse events
If the animal licks the application site immediately after treatment, a short period of hypersalivation may occur, mainly due to the action of the excipients.
In very rare cases, after use, transient skin reactions at the application site (skin discoloration, local alopecia, pruritus, erythema) and general pruritus or alopecia have been reported. Exceptionally, after use, the following adverse effects may occur: hypersalivation, transient neurological signs such as hyperaesthesia (increased sensitivity to light or sound, agitation, behavioral disorders), depression and other neurological reactions, vomiting or respiratory signs.
Avoid overdose.
8. Dosage for each species, routes of administration and methods of administration
External application to the skin between the shoulder blades. Spot-on application.
Dosage:
1 pipette of 0.5 ml per cat.
Method of administration:
Hold the pipette upright and tap the narrow end of the pipette gently to allow the entire contents to flow into the body of the pipette. Break off the tip of the pipette. Make a path in the animal's fur, between the shoulder blades, until the skin is visible. Place the tip of the pipette on the skin and by repeated pressing empty its contents directly onto the skin, preferably at two different points, one at the base of the skull and the other 2-3 cm below.
9. Recommendations for correct administration
It is recommended to avoid excessive wetting of the hair with the product, as this will cause the hair to clump together at the application site. However, the clumping will disappear completely within 24 hours of application.
One dose provides protection against flea infestation for up to 5 weeks.
The medicine is active for 3 to 4 weeks against ticks.
For optimal control of flea and/or tick infestations, the treatment regimen should be based on the local epidemiological situation.
In the absence of safety studies, the minimum interval between treatments is 4 weeks.
10. Withdrawal periods
Not applicable.
11. Special precautions for storage
Keep out of the sight and reach of children.
Store in the original package.
This veterinary medicinal product does not require any special storage conditions.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: use immediately.
12. Special precautions for disposal
The veterinary medicinal product should not enter water courses as it may be dangerous for fish and other aquatic organisms.
Use the return systems for unused veterinary medicinal products or waste materials derived from such medicinal products, in accordance with local requirements and applicable national collection systems. These measures should help protect the environment.
Ask your veterinarian or pharmacist for information on how to dispose of medicines no longer required.
13. Classification of veterinary medicinal products
Veterinary medicinal product not available without a prescription.