4.1. Target species
Dogs
4.2. Indications for use, specifying the target species
In dogs:
For the treatment and prevention of flea (killing effect) and/or tick (killing and
repellent effects) infestations where repellent activity is necessary against
mosquitoes, sandflies and/or biting flies.
Fleas
Treatment and prevention of Ctenocephalides felis flea infestations and prevention of
Ctenocephalides canis flea infestations. One treatment prevents new flea
infestations for 4 weeks.
The product can be used as part of a treatment strategy for flea allergy dermatitis
where this has been previously diagnosed by a veterinarian.
Ticks
Treatment and prevention of tick infestations (Dermacentor reticulatus, Ixodes
ricinus, Rhipicephalus sanguineus). One treatment kills (Dermacentor reticulatus,
Ixodes ricinus, Rhipicephalus sanguineus) and repels (Ixodes ricinus, Rhipicephalus Revised: January 2020
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sanguineus) ticks for 4 weeks after treatment, and repels Dermacentor reticulatus
from 7 days up to 4 weeks after treatment.
Mosquitoes and sandflies
Repels (anti-feeding activity) sandflies (Phlebotomus perniciosus) for 3 weeks and
mosquitoes (Culex pipiens, Aedes albopictus) for 4 weeks.
Kills sandflies (Phlebotomus perniciosus) and mosquitoes (Aedes albopictus) for 3
weeks.
Biting flies (Stable flies)
Repels (anti-feeding activity) and kills stable flies (Stomoxys calcitrans) for 5 weeks.
4.3. Contraindications
Do not use on sick or convalescent animals.
This product is for use on dogs only. Do not use in cats and rabbits, as adverse
reactions and even death could occur (see also section 4.5).
Do not use in cases of hypersensitivity to the active substances or to any of the
excipients. (see also section 4.5).
4.4. Special warnings for each target species
There may be an attachment of single ticks or bites by single mosquitoes or
sandflies. For this reason, transmission of pathogens by these arthropods cannot be
completely excluded if conditions are unfavorable. Single ticks may attach and
detach within the first 24 hours after infestation and if ticks are present when the
product is applied not all ticks may be killed within 48 hours after treatment.
The product remains effective against fleas when treated animals are immersed in
water occasionally (e.g., swimming, bathing). However, dogs should not be allowed
to swim or be shampooed within 48 hours after treatment. Avoid frequent swimming or
shampooing of treated dogs as this may adversely affect maintenance of product
effectiveness.
To reduce re-infestation from emergence of new fleas, it is recommended that all
dogs in a household be treated. Other animals living in the same household should
also be treated with a suitable product. To aid further in reducing environmental
challenge, the additional use of a suitable environmental treatment against adult
fleas and their developmental stages could be recommended.
4.5. Special precautions for use
Special precautions for use in animals
In the absence of specific studies, the use of the product is not recommended in
dogs younger than 8 weeks of age, or in dogs weighing less than 2 kg.
Care should be taken to avoid contact of the veterinary medicinal product with the
dog’s eyes.
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 other animals do not lick the
treatment sites following application.
Animals should be weighed accurately prior to treatment.
Seek veterinary advice if the product is accidentally ingested or comes into contact
with your dog’s eyes.Revised: January 2020
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Due to the unique physiology of cats which prevents them from metabolizing certain
compounds, including permethrin, the product can induce potentially fatal
convulsions in this species. In case of accidental dermal (skin) exposure, wash the
cat with shampoo or soap, and seek veterinary advice rapidly. To prevent cats from
being accidentally exposed to the product, keep treated dogs away from cats until
the application site is dry. It is important to ensure that cats do not groom the site of
application on a dog which has been treated with this product. In case of exposure
of this type seek veterinary advice immediately.
Do not use in cats and rabbits.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
This product can cause skin and eye irritation, therefore, avoid contact of the
product with skin and eyes. Do not open the pipette near or towards the face. In
case of ocular (eye) exposure or if eyes become irritated during administration,
immediately flush the eyes with plenty of water. If ocular (eye) irritation persists, seek
medical attention. In case of dermal (skin) exposure or if skin becomes irritated
during administration, immediately wash the skin with plenty of soap and water. If
skin irritation persists or recurs, seek medical attention.
People with known hypersensitivity to fipronil and/or permethrin should avoid
contact with the product.
The product is harmful if swallowed. Avoid hand-to-mouth contact. Do not smoke,
drink or eat during application. Wash hands after use. If swallowed rinse mouth
and seek medical attention if you feel unwell.
Since the excipient N-methylpyrrolidone may induce foetotoxicity (toxicity to the
foetus) and teratogenicity (embryonic or foetal malformation) after significant
exposure, pregnant women should wear gloves to avoid contact with 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 are
not allowed to sleep with owners, especially children.
Keep the stored pipettes in the original blister and once used, the empty pipette
should immediately be disposed of appropriately, preventing further access.
Other precaution
The product may adversely affect aquatic organisms. Treated dogs should not be
allowed to enter surface water for 2 days after treatment.
4.6. Adverse reactions (frequency and seriousness)
Transient skin reactions at the application site (skin discolouration, local hair loss,
itching, redness) and general itching, hair loss and erythema (redness) have been
reported very rarely after use. Reversible nervous signs (increased sensitivity to
stimulation, hyperactivity, muscle tremor, lethargy, ataxia (loss of coordination), other
nervous signs), vomiting, anorexia (not eating) and hypersalivation have also been
reported very rarely after use.Revised: January 2020
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If licking of the application site occurs, transient hypersalivation and emesis
(vomiting) may be observed.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7. Use during pregnancy, lactation or lay
Laboratory studies using fipronil or permethrin have not produced any evidence of
teratogenic (capable of causing embryonic or foetal malformation) or embryotoxic
(capable of causing toxicity to the embryo) effects. The safety of the veterinary
medicinal product has not been established during pregnancy and lactation.
N-methylpyrrolidone, an excipient in the veterinary medicinal product, has been
shown to be teratogenic (capable of causing embryonic or foetal malformation) in
laboratory animals after repeated exposure at high doses.
Consult your veterinary surgeon before using the product in pregnant or lactating
bitches.
4.8. Interaction with other medicinal products and other forms of interaction
Do not use simultaneously with other products active against fleas, ticks or flies
which are applied directly on to the animal.