Prac-Tic Spot-on for Small Dogs 4.5 - 11kg (pack of 3)

What is the active ingredient in Prac-Tic spot-on?

The active ingredient in PRAC-TIC® is pyripole, an insecticide and acaricide. Pyripole causes uncontrolled activity of the central nervous system (CNS), and death of fleas and ticks. Parasites are killed through contact with the substance.

What does this ingredient do?

Fleas (Ctenocephalides canis and C. felis) are killed 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.

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.

What is in Prac-Tic spot-on?

Active substance:

Pyripole……………………………125mg per ml

Excipients:

Butylhydroxytoluene (E321)
Diethylene glycol monoethyl ether

How do I use Prac-Tic spot-on?

Apply only to the skin surface and on intact skin.
The dogs should be accurately weighed before treatment.

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.

Treatment schedule:
The minimum treatment interval is 4 weeks.

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.

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.

Method of Administration

1. Remove one pipette from the package.

2. 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.

3. Snap-off the top of the pipette along the scored line.

4. 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.

5. (For large dogs): Apply the 5 ml pipette to 2-3 spots down the backline of large dogs in order to prevent run-off.

It is important to make sure that the product is applied to an area where the animal cannot lick it off, and to make sure that animals do not lick each other following treatment.

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.

Special precautions for use in animals

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 case of known hypersensitivity to phenylpyrazole class compounds or 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.

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

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

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.

Special precautions to be taken by the person administering the 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

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.

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.

MARKETING AUTHORISATION HOLDER

Novartis Sanidad Animal S.L.
Calle de la Marina, 206
E-08013 Barcelona
Spain

MARKETING AUTHORISATION NUMBER(S)

EU/2/06/066/001-012