Activyl 300 mg spot-on solution for medium dogs 4 pipettes
Treatment and prevention of flea infestation
Activyl 300 mg spot-on solution for medium dogs
2. ACTIVYL QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 195 mg indoxacarb.
Each unit dose pipette delivers:
Activyl spot-on solution: Unit dose (ml); Indoxacarb (mg)
Activyl spot-on solution for medium dogs: 1.54; 300.3
Isopropyl alcohol 354 mg/ml
For the full list of excipients, see section 6.1.
3. ACTIVYL PHARMACEUTICAL FORM
A clear, colourless to yellow solution.
4. ACTIVYL CLINICAL PARTICULARS
4.1 Target species
Dogs and cats
4.2 Indications for use, specifying the target species
Treatment and prevention of flea infestation (Ctenocephalides felis).
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.
4.4 Special warnings for each target species
The safety of Activyl has not been established in dogs and cats younger than 8 weeks of age. The safety of Activyl has not been established in dogs weighing less than 1.5 kg and in cats weighing less than 0.6 kg.
4.5 Special precautions for use
Special precautions for use in animals
Care should be taken to apply the dose to an area where the animal cannot lick it off, as described under section 4.9, and to ensure that animals do not groom each other immediately following treatment.
Care should be taken to ensure that the content of the pipette or the applied dose does not come into contact with the eyes of the recipient and/or other animals.
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.
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.
Wash hands immediately after use.
This product contains indoxacarb. People with known hypersensitivity to indoxacarb should not use 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.
Recently treated animals should not be handled until the application site is dry.
This product is highly flammable. Keep away from heat, sparks, open flame or other sources of ignition.
4.6 Adverse reactions (frequency and seriousness)
In rare cases in cats, neurological signs (e.g. incoordination, tremor, ataxia, convulsions, mydriasis and impaired vision) have been observed. Other signs observed in cats include emesis in rare cases or anorexia, lethargy, hyperactivity and vocalisation in very rare cases. All signs are generally reversible following supportive treatment.
In very rare cases in cats and dogs, 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 rare cases in cats and in very rare cases in dogs, 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).
4.7 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.
The use is not recommended during lactation.
Do not use in breeding animals.
4.8 Interaction with other medicinal products and other forms of interaction
In clinical studies, Activyl was co-administered with deltamethrin collars impregnated with up to 4% deltamethrin without evidence of associated adverse reactions.
4.9 Amounts to be administered and administration route
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 dog (kg): Pipette size to be used; Volume (ml); Indoxacarb (mg/kg)
< 6.5: Activyl spot-on solution for very small dogs; 0.51; Minimum of 15
6.6–10: Activyl spot-on solution for small dogs; 0.77; 15–23
10.1–20: Activyl spot-on solution for medium dogs; 1.54; 15–30
20.1–40: Activyl spot-on solution for large dogs; 3.08; 15–30
40.1–60: Activyl spot-on solution for extra large dogs; 4.62; 15–23
> 60: The appropriate combination of pipettes should be used
Cats: The recommended dose is 25 mg indoxacarb/kg body weight, equivalent to 0.128 ml/kg body weight. The following table defines the size of pipette to be used according to the weight of the cat:
Weight of cat (kg): Pipette size to be used; Volume (ml); Indoxacarb (mg/kg)
≤ 4: Activyl spot-on solution for small cats; 0.51; Minimum of 25
> 4: Activyl spot-on solution for large cats; 1.03; Maximum of 50
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, or at the base of the skull for cats, where the cat cannot lick it off. 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.
Following a single administration, the veterinary medicinal product will prevent further flea infestation for at least 4 weeks.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse effects were observed in dogs and cats 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.
4.11 Withdrawal period
5. ACTIVYL PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Ectoparasiticides for topical use, indoxacarb. ATCvet code: QP53AX27.
5.1 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.
5.2 Pharmacokinetic particulars
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.
See section 6.6.
6. ACTIVYL PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Triacetin Ethyl acetoacetate Isopropyl alcohol.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 4 years.
6.4. Special precautions for storage
This veterinary medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture.
6.5 Nature and composition of immediate packaging
Cardboard box of 1, 4 or 6 spot-on applicators, consisting of 0.51, 0.77, 1.03, 1.54, 3.08 and 4.62 ml pipettes. One size only per box. The pipette consists of a blister film (polypropylene/cyclic-olefincopolymer/polypropylene) and a foil lidstock (aluminium/polypropylene co-extruded) sealed into aluminium sachets.
Not all pack sizes may be marketed.
6.6 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 should not be allowed to enter surface waters as indoxacarb may have harmful effects on aquatic organisms.