NOAH Compendium

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Date: Tuesday, July 14, 2020 16:03

Description: Virbac 2013
Release 5.69
Activyl Spot on solution for dogs VIRBAC
Species: Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs
Active ingredient: Indoxacarb
Product:Activyl Spot-on for dogs
Product index: Activyl Spot-on for dogs
Qualitative and quantitative composition
Each ml contains 195mg indoxacarb as active ingredient
Unit dose (ml)
Indoxacarb (mg)
Activyl Spot-on for very small dogs
Activyl Spot-on for small dogs
Activyl Spot-on for medium dogs
Activyl Spot-on for large dogs
Activyl Spot-on for extra large dogs
Excipients: Isopropyl alcohol 354mg/ml
Pharmaceutical form
A clear, colourless to yellow spot-on solution
Clinical particulars
Target species
Indications for use
Treatment and prevention of flea infestation (Ctenocephalides felis). Efficacy against new infestations with fleas persists for 4 weeks following a single application.
The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Developing stages of fleas in the pet’s immediate surroundings are killed following contact with Activyl treated pets.
Special warnings for each target species
The product should not be used in dogs younger than 8 weeks of age as the safety of the product has not been established in these dogs.
The product should not be used in dogs weighing less than 1.5 kg as the safety of the product has not been established in these dogs.
Special precautions for use
Special precautions for use in animals
Ensure that the dosage (pipette) corresponds to the weight of the treated dog.
Apply the product only to the skin surface and on intact skin. Apply the dose to an area where the dog cannot lick it off. Ensure that animals do not groom each other immediately following treatment. Keep treated animals separately until the application site is dry.
This product is for external topical application only. Do not administer orally or via any other route. Care should be taken to avoid the product coming into contact with the eyes of the dog.
The product remains effective following shampoo treatment, water immersion (swimming, bathing) and exposure to sunlight. However, animals should not be allowed to swim or treated with shampoo within 48 hours after treatment.
All dogs in a household should be treated with a suitable flea product.
A proper treatment of the pet´s environment by additional chemical or physical measures is recommended.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Keep pipettes in the original packaging until ready to use.
Do not eat, drink or smoke while handling the veterinary medicinal product.
The sachet is child-resistant. Keep the product in the sachet until use, in order to prevent children from getting direct access to the product. Used pipettes should be disposed of immediately.
People with known hypersensitivity to indoxacarb should avoid contact with this product.
Local and/or systemic reactions have been observed in some people after exposure. To avoid adverse reactions:
• administer the product in a well-ventilated area;
• do not handle recently treated animals until the application site is dry;
• on the day of treatment, children must not handle treated animals and the animals should not be permitted to sleep with their owners, especially children;
• wash hands immediately after use and wash off any product in contact with the skin immediately with soap and water;
• avoid contact with eyes, as the product may cause moderate eye irritation. If it occurs, the eyes should be rinsed slowly and gently with water.
If symptoms occur, seek medical advice and show the package leaflet to the physician
This product is highly flammable. Keep away from heat, sparks, open flame or other sources of ignition.
Adverse reactions
In very rare cases, a brief period of hypersalivation may occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application (see section 4.9) will minimise licking of the application site. In very rare cases, application site reactions such as transitory scratching, erythema, alopecia or dermatitis at the application site may occur. These effects will usually resolve without treatment.
The application of the veterinary medicinal product may produce a local, temporary oily appearance or hair clumping at the application site. A dry white residue may be also observed. This is normal and will generally resolve within a couple of days after administration. These changes do not affect the safety or efficacy of the veterinary product.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals )
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Do not use during pregnancy.
Do not use during lactation.
Do not use in breeding animals.
None known.
In dogs: In clinical studies, Activyl was co-administered with deltamethrin collars impregnated with up to 4% deltamethrin without evidence of associated adverse reactions.
Amounts to be administered and administration route
Dosage schedule:
Dogs: The recommended dose is 15 mg indoxacarb/kg body weight, equivalent to 0.077 ml/kg body weight. The following table defines the size of pipette to be used according to the weight of the dog:
Weight of dogs (kg)
Pipette size
Volume (ml)
Indoxacarb (mg/kg)
Less than or equal to 6.5
Activyl Spot-on for very small dogs
min 15
6.6 - 10
Activyl Spot-on for small dogs
10.1 - 20
Activyl Spot-on for medium dogs
20.1 - 40
Activyl Spot-on for large dogs
40.1 - 60
Activyl Spot-on for extra large dogs
> 60
The appropriate combination of
pipettes should be used
Method of administration:
For spot-on use only. Open one sachet and remove the pipette.
Step 1: The animal should be standing for easy application. With one hand, hold pipette in an upright position away from your face and with the other hand, snap tip open by bending it and folding it back on itself.
Step 2: Part the hair until the skin is visible and place pipette tip against the skin between the shoulder blades for dogs. Squeeze pipette firmly applying the entire contents directly to the skin
In larger dogs, the entire contents of the pipette(s) should be applied evenly to two or three or four spots, all located at different application sites along the backline from the shoulder to the base of the tail. Do not apply an excessive amount of solution at any one spot which could cause some of the solution to run off the side of the animal.
Treatment schedule: Following a single administration, the veterinary medicinal product will prevent further flea infestation for at least 4 weeks.
No adverse effects were observed in dogs aged 8 weeks or older when administered 5 times the recommended dose on 8 occasions at 4 weeks intervals or administered 5 times the recommended dose on 6 occasions at 2 weeks intervals.
Withdrawal periods
Not applicable
Pharmacological particulars
Pharmacodynamic properties
Indoxacarb is an ectoparasiticide belonging to the oxadiazine chemical family. After being converted into a metabolite, indoxacarb is active against adult, larval and egg stages of insects. In fleas, in addition to its adulticidal activity, indoxacarb activity on the developing larval stages in the immediate surroundings of the treated pet has been demonstrated.
Indoxacarb is a pro-drug that requires bioactivation by the insect enzymes to exert its pharmacodynamic effects. It enters the insect primarily through ingestion but is also absorbed, to a lesser degree, through the insect cuticle. In the mid-gut of susceptible insect species, the insect’s enzymes remove the carbomethoxy group from parent indoxacarb, and convert it into its biologically active form. The bioactivated metabolite acts as a voltage-dependent sodium channel antagonist in insects, by blocking the sodium channels that regulate the flow of sodium ions in the insect’s nervous system. This results in a rapid cessation of feeding within 0 to 4 hours after treatment followed by cessation of egg laying (oviposition), paralysis and death occurring within 4 to 48 hours.
Pharmacokinetic properties
Following a single spot-on application of the product, indoxacarb can still be detected in both skin and hair coat after 4 weeks post-treatment. Absorption through the skin also occurs, but this systemic absorption is partial and not relevant for the clinical efficacy. The absorbed indoxacarb is extensively metabolised by the liver to a variety of metabolites. The major route of excretion is in faeces.
Pharmaceutical particulars
List of excipients: Triacetin, Ethyl acetoacetate, Isopropyl alcohol
Major incompatibilities
Shelf life
As packaged for sale - 4 years
Special precautions for storage
Does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture
Immediate packaging
Cardboard box with 1, 4 or 6 sachets; each sachet contains one unit-dose pipette. One unit-dose pipette holds 0.51 ml, 0.77 ml, 1.54 ml, 3.08 ml or 4.62 ml spot-on solution. One size of unit-dose pipette only per box.The pipette consists of a blister film (polypropylene/cyclic-olefin-copolymer/polypropylene) and a foil lidstock (aluminium/polypropylene co-extruded) sealed into aluminium sachets.
Not all pack sizes may be marketed
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Activyl should not be allowed to enter surface waters as indoxacarb may have harmful effects on aquatic organisms.
Marketing Authorisation Holder (if different from distributor)
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Marketing Authorisation Number
Significant changes
Date of the first authorisation or date of renewal
Date of revision of the text
Any other information
Legal category
Legal category: NFA-VPS
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