Activyl Tick Plus - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Activyl Tick Plus spot-on solution for dogs

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF

THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder :

Intervet International BV

Wim de Korverstraat 35

5831 AN Boxmeer

The Netherlands

Manufacturer responsible for batch release :

Intervet Productions SA

Rue de Lyons

27460 Igoville

France

• 2. 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

Indoxacarb + permethrin

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Active substances:

One ml contains 150 mg indoxacarb and 480 mg permethrin.

One pipette delivers:

	Volume (ml)	Indoxacarb (mg)	Permethrin (mg)
For very small dogs (1.2 – 5 kg)	0.5	75	240
For small dogs (5.1 – 10 kg)	1	150	480
For medium dogs (10.1 – 20 kg)	2	300	960
For large dogs (20.1 – 40 kg)	4	600	1920
For extra large dogs (40.1 – 60 kg)	6	900	2880

A clear, colourless to yellow or brown-coloured solution.

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.

• 5. CONTRAINDI­CATIONS

Do not use on dogs in case of known hypersensitivity to the active substances or any of the excipients.

DANGER – Do not use in cats as adverse reactions and even death can occur (see also section Special precautions for use in animals).

• 6. ADVERSE REACTIONS

Transitory erythema (redness of skin), hair loss or itching at the application site were commonly (13 of 359 dogs) observed in clinical studies. These effects will usually resolve without treatment.

Gastrointestinal signs (e.g. emesis (vomiting), diarrhoea or anorexia (loss of appetite), reversible neurological signs (e.g. tremor (shakiness) or ataxia (unsteady movement)) or lethargy (drowsiness) 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 also be 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 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).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Dogs.

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Spot-on use. For application to the dog’s skin only.

The recommended dose for dogs is 15 mg indoxacarb and 48 mg permethrin per kg bodyweight, equivalent to 0.1 ml/kg bodyweight. The following table defines the pipette to be used according to the weight of the dog:

Weight of dog (kg)	Pipette size to be used
1.2 – 5	Activyl Tick Plus for very small dogs
5.1 – 10	Activyl Tick Plus for small dogs
10.1 – 20	Activyl Tick Plus for medium dogs
20.1 – 40	Activyl Tick Plus for large dogs
40.1 – 60	Activyl Tick Plus for extra large dogs
> 60	The appropriate combination of pipettes should be used

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.

ADVICE ON CORRECT 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 run-off occur, re-application is not necessary.

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Stored pipettes must be kept in the child-resistant sachet.

Store the pipettes in the original package in order to protect from moisture and light.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton, foil and pipette after “EXP”. The expiry date refers to the last day of that month.

• 12. SPECIAL WARNING(S)

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 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 8).

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.

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 maternotoxic 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.

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.

In case of accidental exposure of cats :

If clinical signs of poisoning occur, seek veterinary advice immediately and show this package leaflet to your veterinarian.

Advice for the veterinarian : 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 23

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.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

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.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED