Summary of medicine characteristics - Activyl Tick Plus
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Activyl Tick Plus 75 mg + 240 mg spot-on solution for very small dogs
Activyl Tick Plus 150 mg + 480 mg spot-on solution for small dogs
Activyl Tick Plus 300 mg + 960 mg spot-on solution for medium dogs
Activyl Tick Plus 600 mg + 1920 mg spot-on solution for large dogs
Activyl Tick Plus 900 mg + 2880 mg spot-on solution for extra large dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances:
One ml contains 150 mg indoxacarb and 480 mg permethrin. One unit dose pipette delivers:
| Volume of unit dose (ml) | Indoxacarb (mg) | Permethrin (mg) | |
| Very small dogs (1.2 – 5 kg) | 0.5 | 75 | 240 |
| Small dogs (5.1 – 10 kg) | 1 | 150 | 480 |
| Medium dogs (10.1 – 20 kg) | 2 | 300 | 960 |
| Large dogs (20.1 – 40 kg) | 4 | 600 | 1920 |
| Extra large dogs (40.1 – 60 kg) | 6 | 900 | 2880 |
Excipients:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Spot-on solution.
A clear, colourless to yellow or brown-coloured solution.
4. CLINICAL PARTICULARS4.1 Target species
Dogs.
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4.2 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 treated dogs.
One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus perniciosus ) for up to 3 weeks.
4.3 Contraindications
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.
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4.4 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.
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4.5 Special precautions for use
Special precautions for use in animals
The product should not be used in dogs younger than 8 weeks or dogs weighing less than 1.2 kg.
Ensure that the dosage (pipette) corresponds to the weight of the treated dog (see section 4.9).
This product is for external topical application only. Do not administer orally or via any other route. Care should be taken to avoid contact of the veterinary medicinal product with the eyes of the dog.
Apply the product only to the skin surface and on intact skin. It is important to ensure that the product is applied to an area where the dog cannot lick it off, and to ensure that other animals do not lick the treatment sites following application. Keep treated animals separately until the application site is dry.
The veterinary medicinal product remains effective when treated dogs 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.
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.
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 is extremely poisonous to cats and can induce potentially fatal convulsions in cats, due to the unique physiology of this species which is unable to metabolise certain compounds, including permethrin. Signs of poisoning are severe tremors, muscle cramp and ataxia. In case of accidental dermal exposure, 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
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. 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 product.
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 ignition.
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4.6 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.
If adverse reactions occur, bathe the animal with mild soap and rinse with large amounts of water.
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:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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4.7 Use during pregnancy, lactation or lay
Pregnancy:
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.
Lactation:
Do not use in lactating dogs.
Fertility:
Do not use in breeding dogs.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
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4.9 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) | Pipette size to be used | Volume (ml) | Indoxacarb (mg/kg) | Permethrin (mg/kg) |
| 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 shou | d be used | ||
Method of administration:
Spot-on use.
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 run-off occur, re-application is not necessary.
Treatment schedule
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.
4.10 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.
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4.11 Withdrawal period(s)
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Ectoparasiticides for topical use, incl. insecticides; permethrin, combinations. ATCvet code: QP53AC54.
5.1 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.
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5.2 Pharmacokinetic particulars
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.
Environmental properties
Indoxacarb and permethrin may have harmful effects on aquatic organisms. See section 6.6
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Propyl gallate (E310)
Propylene glycol monomethyl ether (Dowanol PM)
6.2 Major incompatibilities
None known.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
6.4 Special precautions for storage
Store the pipettes in the original package in order to protect from moisture and light.
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6.5 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.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/11/137/001–015
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 09/01/2012.
Date of latest renewal: 14/12/2016.