Frontline Combo 134.00 mg / 120.60 mg spot-on solution for dog M: Dogs (weighing 10 to 20 kg bw).

Frontline Combo 268.00 mg / 241.20 mg spot-on solution for dog L: Dogs (weighing 20 to 40 kg bw).

Frontline Combo 402.00 mg / 361.80 spot-on solution for dog XL: Dogs (weighing over 40 kg bw).

To be used against infestations with fleas, alone or in association with ticks and/or biting lice.

In the absence of available data, the veterinary medicinal product should not be used on puppies less than 8 weeks old.

Do not use in rabbits, as adverse reactions with even mortality could occur. In absence of studies, the use of the veterinary medicinal product is not recommended in non-target species.

Do not use on sick (e.g. systemic diseases, fever) or convalescent animals.

This veterinary medicinal product is specifically developed for dogs. Do not use in cats and ferrets, as this could lead to overdosing.

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of based on its epidemiological features, for each individual animal.

Bathing/immersion in water within 2 days after application of the veterinary medicinal product and more frequent bathing than once a week should be avoided, as no study has been performed to investigate how this affects the efficacy of the veterinary medicinal product. Emollient shampoos can be used prior to treatment, but reduce the duration of protection against fleas to approximately 5 weeks when used weekly after application of the veterinary medicinal product Weekly bathing with a 2% chlorhexidine medicated shampoo did not affect efficacy against fleas during a 6 week long study.

There may be an attachment of a few 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.

Other animals living in the same household should also be treated with a suitable product.

It is important to make sure that the veterinary medicinal 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.

People with a known hypersensitivity to fipronil or (S)-methoprene, or alcohol should avoid contact with the veterinary medicinal 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 pure water.

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.

Do not smoke, drink or eat during application.

Dogs should not be allowed to swim in watercourses for 2 days after application (see section "Pharmaceutical particulars").

Dogs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Application site reactions (skin discoloration1, hair loss1, itching1, reddening1). Generalised itching or hair loss. Hypersalivation2, vomiting, respiratory signs. Increased sensitivity to stimulation3, depression3, other nervous signs3.

1 Transient.

2 If licking occurs, a brief period of hypersalivation may be observed due mainly to the nature of the carrier.

3 Reversible.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

Spot-on use.

The minimum dose is 6.7 mg/kg bw of fipronil and 6 mg/kg bw of (S)-methoprene, corresponding to one pipette of 4.02 ml (XL) per dog (weighing over 40 kg). To ensure a correct dosage, body weight should be determined as accurately as possible. Underdosing could result in ineffective use and may favour resistance development.

For infestations with fleas and/or ticks, the need for and frequency of re-treatment(s)should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle. In the absence of safety studies, the minimum treatment interval is 4 weeks.

Temporary changes to the coat (clumped/greasy hair) may be noted at the application site.

No adverse events were observed in target animal safety studies in 8 week old puppies, growing dogs and dogs weighing about 2 kg treated once at five times the recommended dose. The risk of experiencing adverse events (see section "Adverse reactions (frequency and seriousness)" above) may however increase when overdosing, so animals should always be treated with the correct pipette size according to bodyweight.