Composition
| Name | Contents of a 0.67 ml pipette (S pipette) |
Contents of a 1.34 ml pipette (M pipette) |
Contents of a 2.68 ml pipette (L pipette) |
Contents of a 4.02 ml pipette (XL pipette) |
| Active substance: Fipronil |
67 mg | 134 mg | 268 mg | 402 mg |
| Excipients: Butylhydroxyanisole E320 |
0.134 mg | 0.268 mg | 0.536 mg | 0.804 mg |
| Butylhydroxytoluene E321 | 0.067 mg | 0.134 mg | 0.268 mg | 0.402 mg |
| Other excipients (benzyl alcohol, diethylene glycol monoethylene ether) up to: | 0.67 ml | 1.34 ml | 2.68 ml | 4.02 ml |
Target species
Dogs.
Indications for use
Treatment and prevention of infestations with fleas (Ctenocephalides spp.), ticks (Rhipicephalus sanguineus, Ixodes ricinus, Dermacentor reticulatus) and mange lice (Trichodectes canis).
The insecticidal activity of the veterinary medicinal product against fleas (Ctenocephalides spp.) lasts up to 8 weeks.
The acaricidal activity of the veterinary medicinal product against ticks (Rhipicephalus sanguineus, Ixodes ricinus, Dermacentor reticulatus) lasts up to 4 weeks.
If certain species of ticks (Rhipicephalus sanguineus, Ixodes ricinus) are already present on the animal at the time of application of the product, they may not die within the first 48 hours, but they will die within 7 days.
The veterinary medicinal product is effective in the treatment and control of flea allergy dermatitis (FAD).
Contraindications
In the absence of available data, do not use in puppies less than 8 weeks of age and/or weighing 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.
Do not use in rabbits, as it may cause adverse reactions and even death.
The veterinary medicinal product is specifically designed for dogs, do not use in cats, as it may cause overdose.
Special warnings
Special warnings:
For external use only.
Animals should be weighed accurately before treatment. Do not exceed the recommended dose.
Avoid contact of the veterinary medicinal product with the animal's eyes.
Special precautions for safe use in target species:
It is important to ensure that the veterinary medicinal product is applied to an area where the animal cannot lick the medicinal product and to ensure that the animals do not lick each other after treatment.
Bathing or shampooing the animal one hour before treatment does not affect the efficacy of the veterinary medicinal product.
Bathing or immersion in water during the first two days after application of the product and bathing more frequently than once a week should be avoided as there are no studies evaluating their effect on the efficacy of the product. Emollient shampoos can be used before treatment, but their use once a week after application of the veterinary medicinal product will reduce the duration of flea protection to approximately 5 weeks. A 6-week study showed that weekly bathing with a shampoo containing 2% chlorhexidine did not affect the efficacy against fleas.
Dogs should not be allowed to swim in watercourses for two days after application (see section “Environmental properties”).
The veterinary medicinal product is effective against flea infestations for approximately 2 months and against tick infestations for up to 1 month. In the event of re-infestation with fleas, they are killed within 24 hours of contact with the treated animal.
When used as part of the treatment of flea allergy dermatitis, monthly application of the veterinary medicinal product and treatment of all dogs in the household is recommended.
At the same time, fleas on animals infest the environment and their habitat (baskets, bedding and places where animals usually rest, such as carpets and soft furniture), therefore, in case of massive infestations and at the beginning of the application of control measures, these places should be treated with an appropriate insecticide and vacuumed regularly.
The veterinary medicinal product does not prevent ticks from attaching to animals, but they die within the first 24-48 hours after attachment, before the tick reaches satiety, minimizing the risk of disease transmission. However, some isolated ticks may remain on the animal. For this reason, the transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
Dead ticks usually detach from the animal the host, and the remaining ticks should be carefully removed, ensuring that no parts of the tick remain in the animal's skin.
For optimal control of flea and tick infestations, in households with multiple pets, all dogs and cats should be treated simultaneously with an appropriate insecticide.
When treating flea infestations, all dogs in direct contact should be treated simultaneously with an appropriate insecticide.
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 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. It is therefore recommended that treatment is not applied during the day but in the early evening and that the treated animal is not 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 packaging. Do not allow dogs to swim in lakes or streams for two days after application.
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Fertility:
Can be used in bitches during the breeding season.
Interaction with other veterinary medicinal products and other forms of interaction:
None known.
Overdose:
No adverse effects were observed in safety studies conducted in 8-week-old puppies, growing dogs and dogs weighing around 2 kg, which were treated once with doses up to 5 times the recommended dose. However, the risk of adverse effects may increase with overdose, therefore use the pipette with the dose corresponding to the animal's weight.
Major incompatibilities:
None known.
Adverse events
If the animal licks the application site immediately after treatment, a short period of hypersalivation may occur, mainly due to the nature of the solvent.
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 events 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.
Dosage for each species, routes of administration and methods of administration
For external use only, by topical application to the skin.
Dosage:
- 1 pipette of 0.67 ml per dog weighing 2 kg - 10 kg
- 1 pipette of 1.34 ml per dog weighing 10 kg - 20 kg
- 1 pipette of 2.68 ml per dog weighing 20 kg - 40 kg
- 1 pipette of 4.02 ml per dog weighing 40 kg - 60 kg
- For dogs weighing more than 60 kg, use 2 pipettes of 2.68 ml.
The minimum recommended dose is 6.7 mg fipronil/kg body weight.
Hold the pipette upright and tap the narrow end of the pipette gently so that the entire content drops into the body of the pipette. Break off the pre-cut tip of the pipette along the marked line. On the animal's back, at the base of the neck, above the shoulder blades, make a path through the fur until the skin is visible. Place the tip
pipette on the skin and by repeated pressing empty its contents, in one or preferably two different points (one at the base of the skull and the other 2-3 cm below). Use pipettes with doses corresponding to the dog's body weight and administer in the two application points.
Recommendations for correct administration
Make sure to apply the contents of the pipette directly to the skin, avoiding contact with the fur, as it may appear sticky in the first 24 hours after application.
In the absence of safety studies, the minimum interval between treatments is 4 weeks.
Waiting periods
Not applicable.
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.
Special precautions for disposal
The veterinary medicinal product should not enter watercourses as it may be harmful to fish and other aquatic organisms.
Use the return system for unused veterinary medicinal products or waste materials derived from such veterinary medicinal products, in accordance with local requirements and applicable national collection systems. These measures should help protect the environment.
Ask your veterinarian or pharmacist how to dispose of medicines no longer required.
Classification of veterinary medicinal products
Veterinary medicinal product not available without a prescription.
Registration certificate numbers and packaging sizes
FIPROMED for dogs 2-10 kg - 250079
FIPROMED for dogs 10-20 kg - 250080
FIPROMED for dogs 20-40 kg - 250081
FIPROMED for dogs 40-60 kg - 250082
Primary packaging: Polypropylene pipette with spot on solution, individually packed in a bag of laminated aluminum foil.
Secondary packaging: Foldable cardboard box with 3 pipettes.