Indications for use, specifying the target species
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.
Developing stages of fleas in the dog’s immediate surroundings are killed following contact with the
One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus perniciosus)
for up to 3 weeks.
Do not use in cats as adverse reactions and even death can occur (see also section 4.5 Special
precautions for use in animals).
Do not use in cases of known hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
The product provides repellent (anti-feeding) activity against sand flies, thus preventing the repelled
parasites from taking a blood meal. However, potential transmission of infectious disease by sand
flies cannot be excluded if conditions are unfavourable.
After treatment, ticks will generally be killed and fall off the host within 48 hours after infestation
without having had a blood meal but an attachment of single ticks after treatment cannot be excluded.
For this reason the transmission of infectious diseases by ticks cannot be excluded.
Special precautions for use
Special precautions for use in animals
The product should not be
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.
People with known hypersensitivity to indoxacarb and/or permethrin should avoid contact with this
Local and/or systemic reactions have been observed in some people after exposure to the product
such as: local skin reactions; nasal or throat/mouth irritation; neurological signs; respiratory signs;
gastrointestinal signs or other systemic signs.
To avoid adverse reactions:
• wear protective gloves when handling or applying the product;
• administer the product in a well-ventilated area;
• do not handle 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;
• as the veterinary medicinal product may cause moderate eye irritation, avoid contact with eyes. If
this occurs, rinse 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
Adverse reactions (frequency and seriousness)
Transitory erythema, hair loss or itching at the application site were commonly observed in clinical
studies. These effects will usually resolve without treatment.
Gastrointestinal signs (e.g. emesis, diarrhoea or anorexia), reversible neurological signs (e.g. tremor or
ataxia) or lethargy have been observed in very rare cases. 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 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).
Use during pregnancy, lactation or lay
Do not use in pregnant dogs.
Laboratory studies in rats, mice and rabbits with indoxacarb and permethrin have not produced any
evidence of 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.
Do not use in lactating dogs.
Do not use in breeding dogs.
Interaction with other medicinal products and other forms of interaction
Amounts to be administered and administration route
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
Pipette size to be used Volume
1.2 - 5 Very small dogs 0.5 Minimum of 15 Minimum of 48
5.1 - 10 Small dogs 1 15 - 30 48 - 96
10.1 - 20 Medium dogs 2 15 - 30 48 - 96
20.1 - 40 Large dogs 4 15 - 30 48 - 96
40.1 - 60 Extra large dogs 6 15 - 22.5 48 - 72
> 60 The appropriate combination of pipettes should be used
Method of administration:
Care should be taken to apply the product to intact skin.
Open one sachet and remove the pipette.
Step 1: Hold the pipette in an upright position away from your face.
Snap the 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 the pipette tip against the skin
between the shoulder blades.
Step 3: For very small and small dogs, squeeze the pipette firmly and apply 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 2 (medium dogs) or 3 (large dogs) or 4
(very large dogs) spots along the backline from the shoulder to the base of the tail.
Do not apply an excessive amount of solution at any one spot in order to prevent run-off. Should runoff occur, re-application is not necessary.
Following a single administration, the veterinary medicinal product will prevent further flea
infestation for 4 weeks and prevent tick re-infestation (through an acaricidal effect) with I. ricinus and
R. sanguineus for 5 and 3 weeks, respectively; repellent (anti-feeding) activity against sand flies will
last for 3 weeks
Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
In case of accidental exposure of cats:
Intravenous infusion of electrolytes should be provided to stabilize vital functions if clinical signs of
poisoning occur (e.g. hypersalivation, tremor, muscle cramp). Signs related to the nervous system can
be treated with e.g. atropine (salivation) and diazepam (muscle tremors/fasciculation/cramp).
Pentobarbital, phenobarbital or propofol might be indicated if repeated occasions of cramp/tremors
occur. Recovery occurs normally within 24-36 hours after treatment.
Pharmacotherapeutic group: Ectoparasiticides for topical use, incl. insecticides; permethrin,
ATCvet code: QP53AC54.
Indoxacarb is an ectoparasiticide belonging to the oxadiazine chemical family. Indoxacarb is a prodrug 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 nonvertebrates. 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.
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.
Indoxacarb and permethrin may have harmful effects on aquatic organisms.
List of excipients
Propyl gallate (E310)
Propylene glycol monomethyl ether (Dowanol PM)
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Store the pipettes in the original package in order to protect from moisture and light.
Nature and composition of immediate packaging
Cardboard box with 1, 4 or 6 sachets; each sachet contains one unit-dose pipette. One unit-dose pipette
holds 0.5 ml, 1 ml, 2 ml, 4 ml, or 6 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 child-resistant sachet.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
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 enter water courses as this may be dangerous for fish and other aquatic organisms.
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