NOAH Compendium

Printed from NOAH Compendium ( (c) Copyright NOAH Compendium 2024. All Rights Reserved.
Date: Wednesday, May 29, 2024 17:56

Release 2.204
FIPROtec® COMBO Spot-On Solution for Dogs
Species: Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs
Active ingredient: Fipronil, (S)-methoprene
Product:FIPROtec® COMBO for Dogs
Product index: FIPROtec® COMBO Dog
Qualitative and quantitative composition
Active ingredient
Each pipette contains:
For the full list of excipients, see below.
Pharmaceutical form
Spot-on solution. Clear yellow solution.
Clinical particulars
Target species
Indications for use
To be used against infestations with fleas, alone or in association with ticks and/or biting lice.
- The treatment of flea infestations (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 8 weeks. Prevention of the multiplication of fleas by inhibiting the development of eggs (ovicidal activity) and larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas for eight weeks after application.
- The treatment of tick infestations (Ixodes ricinus, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus). The product has persistent acaricidal efficacy for up to 4 weeks against ticks.
- The treatment of infestations with biting lice (Trichodectes canis).
In the absence of available data, the product should not be used on puppies less than 8 weeks old and/or weighing less than 2kg. Do not use on sick (e.g. systemic diseases, fever) or convalescent animals. Do not use if your dog has a hypersensitivity to fipronil or S-methoprene or the other ingredients. Do not apply on wounds or damaged skin. Do not use in cats and ferrets, as this could lead to overdosing. Do not use in rabbits, as adverse reactions with even mortality could occur. Do not use in any other non-target species.
Special warnings for each target species
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. 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. When treating infestations of parasites, all in-contact animals should be treated with an appropriate product at the same time. 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.
Special precautions to be taken by the person administering the veterinary medicinal product
Avoid contact with the animal'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 animals do not lick each other following treatment. This product can cause mucous membrane, skin and eye irritation. Therefore, contact of the product with mouth, skin and eyes should be avoided. 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 ocular exposure the eye should be rinsed carefully in clean water. If the product is accidentally swallowed, seek medical advice immediately and show the package leaflet to the physician. Wash hands after use. Do not smoke, drink or eat during application. 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 pipettes in original packaging until ready to use.
Other precautions
Dogs should not be allowed to swim in watercourses for 2 days after application.
Adverse reactions
Among the very rare suspected adverse reactions, transient skin reactions on 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. In the case of licking the administration site, a brief period of excessive salivation may be observed due mainly to the nature of the carrier. Do not overdose.
Use during pregnancy and lactation
The produce can be used during pregnancy and lactation.
Interaction with other medicinal products
Do not use simultaneously with other flea products which are applied directly on to the animal.
Dosage and administration
Administer one pipette by topical application to the skin. In the absence of safety studies the minimum treatment interval is 4 weeks.
Body weight
1 x 0.67ml pipette
1 x 1.34ml pipette
1 x 2.68ml pipette
Remove the pipette from its packaging. Hold the pipette in an upright position, twist and pull the cap off. Turn the cap around and place the other end of the cap back on the pipette. Push and twist the cap to break the seal, then remove the cap from the pipette. 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 onto 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.
No adverse effects were observed in target animal safety studies in 8 week-old puppies, growing dogs and dogs weighing about 2kg treated once at five times the recommended dose. The risk of experiencing adverse effects may however increase when overdosing, so animals should always be treated with the correct pipette size according to body weight.
Pharmacological particulars
Pharmacotherapeutic group: Ectoparasiticides for topical use, insecticides. ATC vet code: QP53AX65
Pharmacodynamic properties
Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. It acts by interacting with ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre and post-synaptic transfer of chloride ions across cell membranes. This results in uncontrolled activity of the central nervous system and death of insects or acarines. Fipronil kills fleas within 24 hours and ticks (Dermacentor reticulatus, Dermacentor variabilis, Rhipicephalus sanguineus, and Ixodes ricinus) and lice within 48 hours post-exposure. S-methoprene is an insect growth regulator (IGR) of the class of compounds known as juvenile hormone analogues that inhibit the development of immature stages of insects. This compound mimics the action of juvenile hormone and causes impaired development and death of the developing stages of fleas. The on-animal ovicidal activity of S-methoprene results from either direct penetration of the eggshell of newly laid eggs or from absorption through the cuticle of the adult fleas. S-methoprene is also effective in preventing flea larvae and pupae from developing, which prevents contamination of the environment of the treated animals with the immature stages of fleas.
Pharmaceutical particulars
List of excipients
Butylhydroxyanisole (E320), Butylhydroxytoluene (E321), Povidone (K25), Polysorbate 80, Ethanol 96%, Diethylene glycol monoethyl ether.
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
Store below 30°C. Store in the original package in order to protect from light and moisture.
Nature and composition of immediate packaging
White polypropylene single-dose pipette packaged in aluminium foil sachets. Cardboard box containing 1, 3 or 6 pipettes. Not all pack sizes may be marketed.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product 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 container.
Marketing Authorisation Holder (if different from distributor)
KRKA, d.d., Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Marketing Authorisation Number
Vm 01656/4119, 20, 21, 23
Significant changes
Date of the first authorisation or date of renewal
12 October 2015
Date of revision of the text
May 2018
Any other information
Legal category
Legal category: AVM-GSL
GTIN description:Small Dog, 1 pipette pack
GTIN description:Small Dog, 3 pipette pack
GTIN description:Medium Dog, 1 pipette pack
GTIN description:Medium Dog, 3 pipette pack
GTIN description:Large Dog, 1 pipette pack
GTIN description:Large Dog, 3 pipette pack