NOAH Compendium

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Date: Thursday, July 9, 2020 17:00

Description: Virbac 2013
Release 3.26
Activyl Tick Plus Spot-on for DOGS VIRBAC
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs
Active ingredient: Indoxacarb, Permethrin
Product:Activyl Tick Plus Spot-on for DOGS
Product index: Activyl Tick Plus Spot-on for DOGS
Qualitative and quantitative composition
Pipette
variant
Volume (ml)
Indoxacarb (mg)
Permethrin (mg)
Very Small Dogs
(1.2kg - 5kg)
0.5
75
240
Small Dogs (5 - 10kg)
1.0
150
480
Medium Dogs
(10 - 20kg)
2.0
300
960
Large Dogs (20 - 40kg)
4.0
600
1920
Extra Large Dogs
(40 - 60kg)
6.0
900
2880
Pharmaceutical form
A clear, colourless to yellow or brown-coloured spot-on solution
Clinical particulars
Target species
Dogs
Indications for use
Treatment of flea infestations (Ctenocephalides felis); the product has persistent insecticidal efficacy for up to 4 weeks against Ctenocephalides felis.
The product has persistent acaricidal efficacy for up to 5 weeks against Ixodes ricinus and up to 3 weeks against Rhipicephalus sanguineus. If ticks of these species are present when the product is applied, all the ticks may not be killed within the first 48 hours but they may be killed within a week.
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 Tick Plus treated pets.
Contra-indications
DO NOT USE IN CATS
Do not use in case of known hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
None
Special precautions for use
Special precautions for use in animals
The safety of Activyl Tick Plus has not been established in dogs younger than 8 weeks of age.
The safety of Activyl Tick Plus has not been established in dogs weighing less than 1.2 kg.
Care should be taken to avoid contact of the veterinary medicinal product with the eyes of the dog.
Avoid contact with treated areas (application sites) until dry.
The veterinary medicinal product remains effective when treated animals are exposed to sunlight or immersed in water (e.g. swimming, bathing). However, dogs should not be allowed to swim or be shampooed within 48 hours after treatment. In case of frequent shampooing, the duration of activity may be reduced.
Ticks already attached on the dog may not be killed within two days after treatment and may remain attached and visible. Therefore the removal of ticks already on the dog at the time of treatment is recommended, in order to prevent them from attaching and having a blood meal.
The veterinary medicinal product can induce convulsions in cats that could be fatal, due to the unique physiology of this species which is unable to metabolise certain compounds, including permethrin. In case of accidental exposure, if undesirable effects occur, wash the cat with shampoo or soap, and seek veterinary advice rapidly. To prevent cats from being accidentally exposed to the product, keep treated dogs away from cats until the application site is dry. It is important to ensure that cats do not groom the site of application on a dog, which has been treated with this product. In case of exposure of this type seek veterinary advice immediately.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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. Keep the used pipette out of sight and reach of children. Used pipettes should be disposed of immediately.
Wash hands immediately after use.
This product contains indoxacarb and permethrin. People with known hypersensitivity to indoxacarb and/or permethrin should avoid contact with this product.
As the veterinary medicinal product may cause moderate eye irritation, avoid contact with eyes. If this occurs, rinse slowly and gently with water.
This product is highly flammable. Keep away from heat, sparks, open flame or other sources of ignition.
Adverse reactions
Transitory scratching, erythema or hair loss at the application site may occur. These effects will usually resolve without treatment.
In very rare cases, gastrointestinal signs (e.g. emesis, diarrhoea or anorexia), reversible neurological signs (e.g. tremor or ataxia) or lethargy have been observed. These signs are usually transient and generally resolve within 24-48 hours.
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 medicinal product.
The frequency of adverse reactions is defined using the following convention:
− very common (more than 1 in 10 animals displaying adverse reactions 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
Laboratory animal studies (rats, mice and rabbits) with indoxacarb and permethrin have not produced any evidence of a teratogenic, foetotoxic or materno toxic effects. However, a reproductive toxicity study conducted in the dog at three times the recommended therapeutic dose did reveal a significant reduction in the live pup ratio; the clinical significance of this latter finding is unknown as no studies were carried out in dogs using the recommended therapeutic dose.
Pregnancy:
Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Lactation:
Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Fertility:
Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Interactions
None known
Amounts to be administered and administration route
Dosage schedule:
The recommended minimum dose is 15 mg indoxacarb/kg bodyweight, and 48 mg/kg permethrin equivalent to 0.1 ml spot-on solution per kg bodyweight.
The following table defines the size of pipette to be used according to the weight of the dog:
Weight of dog (kg)
Name
Volume (ml)
Indoxacarb (mg)/kg)
Permethrin (mg/kg)
1.2 - 5 kg
Activyl Tick Plus spot-on for very small dogs
0.5
Min 15
Min 48
5.1 - 10 kg
Activyl Tick Plus spot-on for small dogs
1.0
15-30
48-96
10.1 - 20 kg
Activyl Tick Plus spot-on for medium dogs
2.0
15-30
48-96
20.1 - 40 kg
Activyl Tick Plus spot-on for large dogs
4.0
15-30
48-96
40.1 - 60 kg
Activyl Tick Plus spot-on for extra large dogs
6.0
15-22.5
48-72
> 60 kg
The appropriate combination of pipettes should be used
Method of administration:
For spot-on use.
Care should be taken to apply the product to intact skin.
Open one sachet and remove the pipette.
Step 1: With one hand, hold pipette in an upright position away from your face and snap tip open by bending it and folding it back on itself.
Step 2: The dog should be standing for easy application. Part the hair until the skin is visible and place pipette tip against the skin between the shoulder blades.
Step 3: Gently squeeze the pipette hence applying the solution on the skin. In order to avoid the product running onto the coat of the animal (especially in larger dogs) do not apply an excessive amount of solution to any one spot. Should this occur, re-application is not necessary; however, contact with treated areas (application sites) should be avoided until dry.
For very small and small dogs, squeeze pipette firmly applying the entire contents directly to the skin in one spot, between the shoulder blades.
For larger dogs, apply the contents of the pipette evenly to two (medium dogs) or three (large dogs) or four (very large dogs) spots, all located at different application sites along the backline from the shoulder to the base of the tail.
Overdose
No adverse reactions were observed in dogs aged 8 weeks and older, treated 8 times at 4 week intervals or 6 times at 2 week intervals, with 5 times the recommended dose
Withdrawal periods
Not applicable
Pharmacological particulars
Pharmacodynamic properties
Indoxacarb is an ectoparasiticide belonging to the oxadiazine chemical family. Indoxacarb is a pro-drug that requires bioactivation by enzymes in susceptible insects 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. In addition to its adulticidal activity against fleas, indoxacarb has activity against the developing stages of fleas in the immediate surroundings of the treated dog.
Permethrin belongs to the Type I class of pyrethroids, which are acaricides and insecticides with repellent activity. Pyrethroids affect the voltage-gated sodium channels in vertebrates and non-vertebrates. Pyrethroids are so-called “open channel blockers” affecting the sodium channel by slowing both the activation and the inactivation properties, thus leading to hyper-excitability and death of the parasite.
The product provides repellent (anti-feeding) activity against ticks and various insect species, preventing the repelled parasite from taking a blood meal and thus reducing the risk of disease transmission.
Pharmacokinetic properties
Following a single spot-on application of the product, indoxacarb and permethrin 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 and permethrin are extensively metabolised by the liver to a variety of metabolites. The major route of excretion is in faeces for indoxacarb and both in urine and faeces for permethrin.
Pharmaceutical particulars
Excipients
Propyl gallate (E310)
Propylene glycol monomethyl ether (Dowanol PM)
Major incompatibilities
None known
Shelf life
As packaged : 3 years
Special precautions for storage
Store the pipettes in the original package in order to protect from moisture and light
Immediate packaging
Cardboard box of 1, 4 or 6 spot-on pipettes consisting of 0.5 ml, 1 ml 2 ml, 4 ml, and 6 ml pipettes. One size 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 child-resistant sachet.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Activyl Tick Plus should not be allowed to enter surface waters as indoxacarb and permethrin may have harmful effects on aquatic organisms.
Marketing Authorisation Holder (if different from distributor)
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
Marketing Authorisation Number
EU/2/11/137/001-015
Significant changes
Date of the first authorisation or date of renewal
09/12/2012
Date of revision of the text
Any other information
Nil
Legal category
Legal category: POM-V
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