Target species
Dogs
Indications for use, specifying the target species
For the treatment of dogs weighing 2-to-10 kg bodyweight (S); 10-to-20 kg bodyweight (M); 20-to-40 kg bodyweight (L) and over 40 kg bodyweight (XL).
The treatment and prevention of flea and tick infestations and/or biting lice.
- Treatment of flea infestations (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 8 weeks. Prevention of the multiplication of fleas for 8 weeks after application by killing flea eggs (ovicidal activity) and larvae (larvicidal activity). By killing the larvae, pupae are prevented from developing.
- Treatment of tick infestations (Ixodes ricinus, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus). The veterinary medicinal product has a persistent acaricidal efficacy for up to 4 weeks against ticks.
- Treatment of infestations with biting lice (Trichodectes canis).
Contraindications
In the absence of available data, the veterinary medicinal product should not be used on puppies less than 8 weeks old and/or weighing less than 2 kg.
Do not use on sick (e.g. systemic diseases, fever) or convalescent animals.
Do not use in rabbits, as adverse events and even death could occur. In absence of studies, the use of the veterinary medicinal product is not recommended in non-target species.
This veterinary medicinal product is specifically developed for dogs. Do not use in non-target species.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Special warnings
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 single ticks. For this reason, a transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
In case of infestation, carpets and non-washable furnishings should be treated with an appropriate insecticide household spray to kill eggs and larvae already in the home. Wash all pet bedding at 60°C as fleas often infest the animal's regular resting areas. Vacuum the whole house, including under furniture.
Other pets living in the same household should also be treated with a suitable veterinary medicinal product.
Special precautions for use
Special precautions for safe use in the target species:
For external use only.
Avoid contact with the animal's eyes.
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 groom each other following treatment until the application site is dry.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Keep pipettes in original packaging until ready to use. In order to prevent children from getting access to used pipettes, dispose of used pipettes immediately.
This veterinary medicinal product can cause mucous membrane, skin and eye irritation. Therefore, contact of the veterinary medicinal product with mouth, skin and eyes should be avoided.
In the event of accidental exposure to the eye, it should be rinsed carefully with water.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
People with a known hypersensitivity (allergy) to insecticides, such as Fipronil or (S)-methoprene, or to alcohol should avoid contact with this veterinary medicinal product. Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and 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 should not be allowed to sleep with owners, especially children.
Do not smoke, drink or eat during application.
Special precautions for the protection of the environment:
Dogs should not be allowed to swim in watercourses for 2 days after application.
See section "Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products".
Other precautions
The alcohol carrier may have adverse effects on painted, varnished or other household surfaces or furnishings.
Adverse events
Dogs:
Very rare (< 1 animal / 10,000 animals treated, including isolated reports): | Application site reactions (skin discoloration1, localised 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.
Use during pregnancy, lactation or lay
The veterinary medicinal product can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
Do not use simultaneously with other flea products which are applied directly on to the animal.
Administration routes and dosage
Spot-on
Dogs should be weighed accurately prior to treatment.
FRONTLINE PLUS SPOT-ON DOG S: One pipette of 0.67 ml (S) per dog weighing over 2 and up to 10 kg, corresponding to a minimum recommended dose of 6.7 mg/kg of fipronil and 6 mg/kg of (S)-methoprene, by topical application to the skin.
FRONTLINE PLUS SPOT-ON DOG M: One pipette of 1.34 ml (M) per dog weighing over 10 and up to 20 kg, corresponding to a minimum recommended dose of 6.7 mg/kg of fipronil and 6 mg/kg of (S)-methoprene, by topical application to the skin.
FRONTLINE PLUS SPOT-ON DOG L: One pipette of 2.68 ml (L) per dog weighing over 20 and up to 40 kg, corresponding to a minimum recommended dose of 6.7 mg/kg of fipronil and 6 mg/kg of (S)-methoprene, by topical application to the skin.
FRONTLINE PLUS SPOT-ON DOG XL: One pipette of 4.02 ml (XL) per dog weighing over 40 kg, corresponding to a minimum recommended dose of 6.7 mg/kg of fipronil and 6 mg/kg of (S)-methoprene, by topical application to the skin.
In the absence of safety studies, the minimum treatment interval is 4 weeks.
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.
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.
Temporary changes to the coat (clumped/greasy hair) may be noted at the application site.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Do not overdose.
The risk of experiencing adverse effects may increase when overdosing (see section "Adverse events"), so dogs should always be treated with the correct pipette size according to bodyweight.
No adverse effects were observed in target animal safety studies in 8 week-old puppies, growing dogs and dogs weighing about 2 kg treated once at 5 times the recommended dose.
Withdrawal periods
Not applicable.