Prac-tic - summary of medicine characteristics

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:

Pyriprole 125 mg

One pipette delivers:

Excipients:

0.1% Butylhydroxytoluene (E321)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Colourless to yellow, clear spot-on solution for external application

4. CLINICAL PARTICULARS4.1 Target species

Dog

• 4.2 Indications for use, specifying the target species

Treatment and prevention of flea infestation (Ctenocephalides canis and C. felis ) in dogs. Efficacy against new infestations with fleas persists for a minimum of 4 weeks.

Treatment and prevention of tick infestation (Ixodes ricinus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor reticulatus, Dermacentor variabilis, Amblyomma americanum ) in dogs.

Efficacy against ticks persists for 4 weeks.

4.3 Contraindications

Do not use in dogs less than 8 weeks of age or with a body weight of less than 2 kg.

Do not use in cases of known hypersensitivity to phenylpyrazole class compounds or to any of the excipients.

Do not use on sick (e.g. systemic diseases, fever) animals or animals recovering from disease.

This veterinary medicinal product is specifically developed for dogs.

Do not use in cats, as this could lead to overdosing.

Do not use in rabbits.

• 4.4 Special warnings for each target species

This veterinary medicinal product is for the treatment of ticks and adult fleas. All dogs in a household should be treated.

In cases of heavy infestation prior to treatment, the dog’s surrounding should be vacuumed and treated with a suitable insecticide.

Dogs should not be bathed or shampooed from 48 hours before treatment. Immersion of the animal in water or shampooing within 24 hours after treatment may reduce the efficacy of the veterinary medicinal product. However, weekly immersion in water did not affect efficacy against fleas and ticks.

• 4.5 Special precautions for use

Special precautions for use in animals

Apply only to the skin surface and on intact skin.

This veterinary medicinal product is for external topical application as a spot-on treatment only. Do not administer orally or via any other route.

The dogs should be accurately weighed before the treatment.

Care should be taken to avoid contact of the veterinary medicinal product with the eyes of the animal.

It is important to apply the dose to an area where the dog cannot lick it off and to make sure that animals do not lick each other following treatment.

Following treatment, ticks will detach from the host within 24 to 48 hours after infestation; however, single ticks might remain on the animal. For this reason, a transmission of infectious diseases by ticks cannot be completely excluded.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

As a precautionary measure, people should avoid contact with the treated area of the animals and children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended to treat animals in the evening. Recently treated animals should not be allowed to sleep in the same bed as their owners, especially children.

People with known hypersensitivity to the phenylpyrazole class compounds or any of the excipients should avoid contact with the veterinary medicinal product.

Avoid skin contact with the pipette content. Wash hands or other exposed body parts after use with soap and water. If accidental eye exposure occurs, the eyes should be rinsed carefully with water. If eye irritation persists seek medical advice and show the package leaflet or the label to the doctor. Do not smoke, eat or drink during application.

In case of contact with the product, numbness and irritation of skin and mucosa, which usually resolves spontaneously, may occur.

Other precautions

Care should be taken to avoid excessive wetting of the dog’s hair with the veterinary medicinal product since this may cause a sticky and tangled appearance of hair at the treatment spot. However, should this occur, it will disappear within 24 hours post application.

The solvent in Prac-tic may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

• 4.6 Adverse reactions (frequency and seriousness)

On very rare occasions the following have been reported:

• – application site and skin reactions: pruritus (itchy skin), hair change, dermatitis (inflammation of the skin), erythema (redness of skin), alopecia (loss of hair), fur discoloration and greasy appearance of hair.

• – neurological reactions: ataxia (lack of coordination) and convulsions.

• – systemic reactions: lethargy (drowsiness).

• – digestive tract reactions: emesis (vomiting) and diarrhoea.

These signs are usually transient and disappear within 24 hours of the application; if they take longer to disappear consult your veterinarian.

A brief period of hypersalivation (drooling) may occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within minutes without treatment. Correct application will minimise licking of the application site.

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).

• 4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established in pregnant or lactating bitches, nor in breeding animals, although in laboratory animal studies no indications of relevant effects on reproduction or foetal development were observed.

Do not use during pregnancy or lactation or consult a veterinary surgeon to establish the benefit/risk assessment of treatment during pregnancy or lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None known. However, dog owners are advised to consult a veterinary surgeon if they intend to use the product on dogs given other products/medication

• 4.9 Amounts to be administered and administration route

Spot-on use for external application.

Dosage Table

The recommended minimum dose is 12.5 mg pyriprole per kg bodyweight, equivalent to 0.1 ml spot-on solution per kg bodyweight.

Within each weight range the entire contents of the correct size pipette should be deposited on the dog’s skin.

Flea treatment and prevention

Pyriprole kills fleas within 24 hours after application. One application prevents flea infestation for 4 weeks.

Tick treatment and prevention

Pyriprole kills ticks within 48 hours after application. One application is effective against ticks for 4 weeks.

Method of administration

For application to the skin only.

Remove one pipette from the package. Hold it in an upright position. Tap the narrow part of the pipette to ensure the contents are in the main body of the pipette. Snap-off the top of the pipette along the scored line.

Part the coat on the back of the animal between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze it gently several times at one or two spots to empty the contents onto the skin. Ensure the product is deposited on the skin. Apply the 5 ml pipette to 2–3 spots down the backline of large dogs in order to prevent run-off.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Mild neurological signs such as slight incoordination and unsteadiness were observed in some animals treated once a month at 3 times the recommended maximum dose for six consecutive months. Those signs disappeared within 3 hours following administration.

In one out of 8 dogs repeatedly treated with 5 times the recommended dose, the following transient adverse effects were observed: tremors (shaking), ataxia (lack of coordination), panting and convulsions. These signs disappeared within 18 hours following administration.

Following an overdose of 10 times the maximum dose on a single occasion the following adverse effects were seen: vomiting, anorexia (loss of appetite), reduced body weight, muscle tremors, seizures, unsteadiness, laboured breathing. All signs resolved within 48 hours, with the exception of the loss of appetite.

An overdose of the veterinary medicinal product may cause a sticky and tangled appearance of hair at the treatment spot for up to 24 hours.

In case of an overdose contact your veterinary surgeon.

• 4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Ectoparasiticides for topical use; ATCvet code: QP53AX26

5.1 Pharmacodynamic properties

The veterinary medicinal product is an insecticidal and acaricidal solution for spot-on use, containing pyriprole as active substance.

Pyriprole is an insecticide and acaricide belonging to the phenylpyrazole class. It acts by interacting with ligand-gated chloride channels, in particular those gated by the neurotransmitter gammaaminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. This results in uncontrolled activity of the central nervous system and death of fleas and ticks. In dogs, adverse reactions are associated with neurological signs caused by metabolites of the active substance.

Parasites are killed through contact rather than by systemic exposure. Pyriprole kills fleas within 24 hours and ticks (Ixodes ricinus, Rhipicephalus sanguineus, Dermacentor reticulatus, Ixodes scapularis, Dermacentor variabilis, Amblyomma americanum ) within 48 hours post-exposure.

Adult fleas are killed before they lay eggs for a minimum of 4 weeks after treatment. Since the veterinary medicinal product completely eliminates egg production, it breaks the flea life cycle.

• 5.2 Pharmacoki­netic particulars

In dogs, after administration to the skin pyriprole is slowly absorbed by skin, leading to a systemic exposure by its two main metabolites.

Following administration to the skin pyriprole is rapidly distributed in the hair coat of dogs within one day after application. It can be found in the hair coat throughout the treatment interval.

Environmental properties

Pyriprole may be harmful to aquatic organisms.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Butylhydroxytoluene (E321)

Diethylene glycol monoethyl ether

6.2 Major incompatibilities

Not applicable.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

6.4. Special precautions for storage

Store the pipettes in the original container in order to protect from light.

Do not store above 25°C.

• 6.5 Nature and composition of immediate packaging

The spot on pipette is composed of a bright yellow polypropylene shell, with a pale yellow aluminium foil back coated with a polyethylene terephthalate film. The pipette is contained in a child resistant soft tempered aluminium foil/PVC blister.

Cardboard carton containing 1, 2 or 10 blisters each containing 3 pipettes.

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

7. MARKETING AUTHORISATION HOLDER

Elanco GmbH

Heinz-Lohmann-Str. 4

27472 Cuxhaven

Germany

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/06/066/001–012

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 18 December 2006

Date of last renewal: 16 November 2011