Fipronil 10% w/v + (s)-methoprene 9% w/v
Kills Fleas, Ticks & Lice
Prevents the Development of Flea Eggs
What does this product do? Kills fleas on your dog for 8 weeks. Prevents development of flea eggs, larvae and pupae for 8 weeks. Kills ticks on your dog for up to 4 weeks. Kills biting lice.
Statement of Active and Other Substances Clear amber solution containing: Fipronil - 268.00 mg (S)-methoprene - 241.20 mg Butylhydroxyanisole (E320) - 0.54 mg Butylhydroxytoluene (E321) - 0.27 mg Excipient(s): q.s - 2.68 ml Pharmaceutical Form Spot-on solution. Blister card of 1 x 2.68 ml pipette; Box of 1 blister card of 1 x 2.68 ml pipette; Box of 1 blister card of 3 x 2.68 ml pipettes; Box of 1 blister card of 4 x 2.68 ml pipettes; Box of 2 blister cards of 3 x 2.68 ml pipettes. Not all pack sizes may be marketed.
For animal treatment only. Keep out of the sight and reach of children. Fipronil and (S)-methoprene may adversely affect aquatic organisms. Dogs should not be allowed to swim in watercourses for 2 days after application. Contraindications: In the absence of available data, the product should not be used on puppies less than 8 weeks old. Do not use on sick (e.g. systemic diseases, fever) or convalescent animals. Do not use in rabbits, as adverse drug reactions and even mortality could occur. In absence of studies, the use of the product is not recommended in non-target species. This product is specifically developed for dogs. Do not use in cats and ferrets, as this could lead to overdosing. In the absence of safety studies, the minimum treatment interval is 4 weeks. Do not use in cases of hypersensitivity to the active substances or to any of the excipients. Undesirable Effects: Among the very rare suspected adverse reactions, transient skin reactions at the application site (skin discoloration, local hair loss, itching, redness) and general itching or hair loss have been reported after use. Excessive salivation, reversible nervous signs (increased sensitivity to stimulation, depression, other nervous signs), vomiting or respiratory symptoms have also been observed after use. If licking occurs, a brief period of excessive salivation may be observed due mainly to the nature of the carrier. Do not overdose. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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). If you notice any serious effects or other effects not mentioned here, please inform your veterinary surgeon. Overdose: 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 five times the recommended dose. The risk of experiencing adverse effects may however increase with overdosing (see Undesirable Effects) so animals should always be treated with the correct pipette size according to bodyweight. User warnings: This product can cause mucous membrane, skin and eye irritation. Therefore, contact of the product with mouth, skin and eyes should be avoided. If the product is accidentally swallowed, seek medical advice immediately and show the package leaflet to the physician. 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. People with a known hypersensitivity (allergy) to insecticides or alcohol should avoid contact with the product. Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water. After accidental 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. Other Precautions: Fipronil and (S)-methoprene may adversely affect aquatic organisms. Dogs should not be allowed to swim in watercourses for 2 days after application. The alcohol carrier may have adverse effects on painted, varnished or other household surfaces or furnishings. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Fipronil and (S)-methoprene may adversely affect aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty containers. For animal treatment only. Keep out of the sight and reach of children. SPECIAL WARNING(S): For external use only. Use during pregnancy and lactation: The product can be used during pregnancy and lactation. Precautions: Animals should be weighed accurately prior to treatment. 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 animals do not lick each other following treatment. When treating infestations of parasites, all in-contact animals should be treated with an appropriate product at the same time. Do not use simultaneously with other flea products which are applied directly on to the animal. Bathing/immersion in water within 2 days after application of the 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 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 product. Weekly bathing with a 2% chlorhexidine medicated shampoo did not affect efficacy against fleas during a 6 week long study. The duration of protection of the product is not affected by immersion in water or weekly shampooing with a 2% Chlorhexidine shampoo for up to 6 weeks when carried out 2 days after treatment. Avoid contact with the animal's eyes. 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.
Warnings:
For animal treatment only
Keep out of the sight and reach of children
Fipronil and (S)-methoprene may adversely affect aquatic organisms
Dogs should not be allowed to swim in watercourses for 2 days after application
Contraindications: In the absence of available data, the product should not be used on puppies less than 8 weeks old
Do not use on sick (e
g
systemic diseases, fever) or convalescent animals
Do not use in rabbits, as adverse drug reactions and even mortality could occur
In absence of studies, the use of the product is not recommended in non-target species
This product is specifically developed for dogs
Do not use in cats and ferrets, as this could lead to overdosing
In the absence of safety studies, the minimum treatment interval is 4 weeks
Do not use in cases of hypersensitivity to the active substances or to any of the excipients
Undesirable Effects: Among the very rare suspected adverse reactions, transient skin reactions at the application site (skin discoloration, local hair loss, itching, redness) and general itching or hair loss have been reported after use
Excessive salivation, reversible nervous signs (increased sensitivity to stimulation, depression, other nervous signs), vomiting or respiratory symptoms have also been observed after use
If licking occurs, a brief period of excessive salivation may be observed due mainly to the nature of the carrier
Do not overdose
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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)
If you notice any serious effects or other effects not mentioned here, please inform your veterinary surgeon
Overdose: 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 five times the recommended dose
The risk of experiencing adverse effects may however increase with overdosing (see Undesirable Effects) so animals should always be treated with the correct pipette size according to bodyweight
User warnings: This product can cause mucous membrane, skin and eye irritation
Therefore, contact of the product with mouth, skin and eyes should be avoided
If the product is accidentally swallowed, seek medical advice immediately and show the package leaflet to the physician
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
People with a known hypersensitivity (allergy) to insecticides or alcohol should avoid contact with the product
Avoid contents coming into contact with the fingers
If this occurs, wash hands with soap and water
After accidental 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
Other Precautions: Fipronil and (S)-methoprene may adversely affect aquatic organisms
Dogs should not be allowed to swim in watercourses for 2 days after application
The alcohol carrier may have adverse effects on painted, varnished or other household surfaces or furnishings
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements
Fipronil and (S)-methoprene may adversely affect aquatic organisms
Do not contaminate ponds, waterways or ditches with the product or empty containers
For animal treatment only
Keep out of the sight and reach of children
SPECIAL WARNING(S): For external use only
Use during pregnancy and lactation: The product can be used during pregnancy and lactation
Precautions: Animals should be weighed accurately prior to treatment
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 animals do not lick each other following treatment
When treating infestations of parasites, all in-contact animals should be treated with an appropriate product at the same time
Do not use simultaneously with other flea products which are applied directly on to the animal
Bathing/immersion in water within 2 days after application of the 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 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 product
Weekly bathing with a 2% chlorhexidine medicated shampoo did not affect efficacy against fleas during a 6 week long study
The duration of protection of the product is not affected by immersion in water or weekly shampooing with a 2% Chlorhexidine shampoo for up to 6 weeks when carried out 2 days after treatment
Avoid contact with the animal's eyes
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
Do not store above 30 °C. Store in the original package. Do not use this veterinary medicinal product after the expiry date stated on the package after exp. The expiry date refers to the last day of the month.
Marketing authorisation holder: Boehringer Ingelheim Animal Health UK Ltd, Bracknell, RG12 8YS, UK. Boehringer Ingelheim Animal Health France SCS, 4 Chemin du Calquet, 31000 Toulouse, France.
Item code: 8123964
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