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EPAR summary for the public
This document is a summary of the European Public Assessment Report. Its purpose is to explain how
the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis
of the documentation provided, led to the recommendations on the conditions of use.
This document cannot replace a face-to-face discussion with your veterinarian. If you need more
information about your animal’s medical condition or treatment, contact your veterinarian. If you want
more information on the basis of the CVMP recommendations, read the scientific discussion (also part
of the EPAR).
What is Prac-tic?
Prac-tic is a spot-on solution that contains pyriprole as active substance.
It is given to dogs with pre-filled spot-on pipettes, i.e. small plastic containers which are already filled
with the correct amount of Prac-tic needed to treat one dog (Pract-tic is available in 4 different sizes
for different dog sizes). For large dogs a combination of pipettes might be needed to achieve the
correct dose. The content of the pipette is squeezed onto the skin after parting the fur in one up to
three spots between the shoulder blades and down the backline of the dog.
What is Prac-tic used for?
Prac-tic is an “ectoparasiticide”, which means that it will kill parasites that live on the skin or in the fur
of animals, such as fleas and ticks.
Prac-tic is used to treat and to prevent tick and flea infestations in dogs. Once applied, it remains
active for at least 4 weeks.
How does Prac-tic work?
Pyriprole, interacts with a receptor involved in transmitting neural impulses (GABA receptor). This
interferes with the nervous system of fleas or ticks and leads to the death of these parasites. Adult
fleas are killed before they lay eggs; since Prac-tic completely eliminates egg production, it breaks the
flea life cycle.
How has Prac-tic been studied?
Data were provided on the pharmaceutical quality, the tolerance of the product in dogs and the safety
in humans (people in contact with the product) and the environment.
The effectiveness of pyriprole against flea and tick infestations in dogs was investigated in laboratory
studies and in field trials.
Two field studies were conducted in dogs at veterinary practices in several European countries and
different geographic regions. Dogs from various breeds, age groups and weight that were infested with
fleas or ticks were either treated with Prac-tic or with other products authorised in the EU for this
indication. The effectiveness was measured looking at the number of live ticks or number of fleas at
various times up to 3 months after application.
What benefit has Prac-tic shown during the studies?
The results of the field trials showed that Prac-tic is effective in the treatment and prevention of flea
and tick infestations in dogs. The medicine killed fleas within 24 hours and ticks within 48 hours after
treatment and its effectiveness lasted for at least 4 weeks.
What is the risk associated with Prac-tic?
The most common side effects in dogs are local reactions at the place where the product has been
applied: change in the fur colour, hair loss and itchiness, as well as change in appearance of the fur
(greasy appearance and clumpiness). If a dog licks the application area, the dog might salivate a lot
for a short period.
Prac-tic should not be used in dogs less than 8 weeks old or less than 2 kg bodyweight since it has not
sufficiently been studied in these animals. As other products of this group, Prac-tic should not be used
in sick animals or dogs that have just recovered from illness. This product is specifically developed for
dogs and should not be used in any other animal species.
Prac-tic should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
What are the precautions for the person who gives the medicine or comes
into contact with the animal?
As a precautionary measure, direct contact with the treated dog should be avoided and children should
not be allowed to play with a treated animal until the application site is dry. 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 Prac-tic.
Skin contact with the pipette content should be avoided. Skin should be washed and eyes should be
rinsed with water, if accidental exposure occurred. When administering Prac-tic, the user should not
smoke, eat or drink.
Why has Prac-tic been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Prac-tic
exceed the risks for the approved indications and recommended that Prac-tic be given a marketing
authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Other information about Prac-tic:
The European Commission granted a marketing authorisation valid throughout the European Union, for
Prac-tic to on 18 December 2006. Information on the prescription status of this product may be found
on the label/outer package.
This summary was last updated in December 2012.
B. PACKAGE LEAFLET
Prac-tic spot-on solution for dogs
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Manufacturer for the batch release:
Elanco France S.A.S.
26, Rue de la Chapelle
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prac-tic 56.25 mg spot-on solution for very small dogs
Prac-tic 137.5 mg spot-on solution for small dogs
Prac-tic 275 mg spot-on solution for medium dogs
Prac-tic 625 mg spot-on solution for large dogs
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
One ml contains 125 mg pyriprole as a colourless to yellow, clear solution for external application to
One pipette delivers:
Prac-tic for very small dogs
Prac-tic for small dogs
Prac-tic for medium dogs
Prac-tic for large dogs
The solution also contains 0.1 % Butylhydroxytoluene (E321)
Treatment and prevention of flea infestation (
canis and C. felis
Treatment and prevention of tick infestation (
Ixodes ricinus, Ixodes scapularis, Dermacentor
variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus, Amblyomma americanum
Treatment and prevention of flea infestation: Prac-tic is effective against new infestations with fleas
for a minimum duration of 4 weeks.
Treatment and prevention of tick infestation: Prac-tic is effective against ticks for 4 weeks.
Do not use in dogs less than 8 weeks of age or weighing less than 2 kg.
Do not use in case of known hypersensitivity to phenylpyrazole class compounds or to any of the
Do not use on sick animals or on animals recovering from disease.
The veterinary medicinal product is specifically developed for dogs.
Do not use in cats, as this could lead to overdosing.
Do not use in rabbits.
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
- neurological reactions: ataxia (lack of coordination) and convulsions.
- systemic reactions: lethargy (drowsiness).
- digestive tract reactions: emesis (vomiting) and diarrhoea.
Those 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).
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.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
For spot-on use for external application to the dog’s skin.
The recommended minimum dose is 12.5 mg pyriprole per kg bodyweight, equivalent to 0.1 ml spot-
on solution per kg bodyweight.
Weight range of
Pipette size to be used
One pipette of 12.5%
(w/v) solution contains
(mg / kg bw)
2 – 4.5 kg
Very small dog
12.5 – 28.1
4.5 – 11 kg
12.5 – 30.6
11 – 22 kg
12.5 – 25.0
22 – 50 kg
12.5 – 28.4
Use the appropriate combination of pipettes to achieve the correct dose
Within each weight range the entire contents of the correct size pipette should be deposited on the
Flea treatment and prevention
Pyriprole kills fleas within 24 hours after contact. One treatment prevents future flea infestation for 4
Tick treatment and prevention
Pyriprole kills ticks within 48 hours after application. One treatment is effective against ticks for 4
ADVICE ON CORRECT ADMINISTRATION
For application on the skin only.
Remove one pipette from the package. Hold the pipette 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 so as to prevent run-off.
The dogs should be accurately weighed before the treatment to ensure the correct pipette size is used.
SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Do not use after the expiry date stated on the pipette after “EXP”.
Keep the pipettes in the original blister package until ready to use, in order to protect from light.
Do not store above 25
Special precautions to be taken by the person administering the veterinary medicinal product to
People with known allergies to the phenylpyrazole class of compounds or any of the excipients should
avoid contact with the product.
Avoid the contents coming into contact with your fingers. Wash your hands after use and wash off any
product in contact with your skin with soap and water. If the product accidentally gets in your eyes,
rinse them carefully with water. If eye irritation persists seek medical advice and show the package
leaflet or the label to the doctor
If you come into contact with the product, it may happen that your skin and mucosa become numb and
irritated but these conditions usually disappear spontaneously.
If you or anybody else accidentally swallows this product, seek medical advice immediately and show
this leaflet or the label to your doctor.
Do not smoke, eat or drink while handling the product.
As a precautionary measure, direct contact with the treated dogs should be avoided and children
should not be allowed to play with treated dogs until the application site is dry. It is therefore
recommended to treat dogs in the evening. Recently treated dogs should not be allowed to sleep in the
same bed as their owners, especially children.
This veterinary medicinal product is for the treatment of ticks and adult fleas. All dogs in a household
should be treated at the same time.
Special precautions for use in animals
Following treatment, ticks will drop off from the dog within 24 to 48 hours after coming into contact
with the animal; however, single ticks might remain on the animal. For this reason, a transmission of
infectious diseases by ticks cannot be completely excluded.
In cases of heavy infestation prior to treatment, the dog’s surrounding should be vacuumed and treated
with a suitable insecticide.
Apply only to the skin surface and on intact skin.
The product is for skin application on dogs only; do not put in your dog’s mouth. Take care to avoid
the veterinary medicinal product coming into contact with your dog’s eyes.
Consult a veterinary surgeon if it is intended to use the product on dogs with other products or
Do not give the product by mouth as this can lead to an overdose, or any other route.
The safety of the product has not been established in breeding dogs, including pregnant or lactating
dogs. If you suspect your dog may be pregnant or if your bitch is nursing puppies or if you want to
treat a breeding dog, contact your veterinarian for advice before use.
Overdose (symptoms, emergency, procedures, antidotes):
Mild neurological signs such as slight incoordination and unsteadiness were observed in some animals
treated once a month. Those signs disappeared within 3 hours following administration.
In one out of 8 dogs the following transient adverse effects were observed: tremors (shaking), ataxia
(lack of coordination), panting and convulsions. These signs disappeared within 18 hours following
Following an overdose 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 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
Apply the dose to an area where your dog cannot lick it off and do not allow your dog or other
animals lick each other following treatment.
Dogs should not be bathed or shampooed from 48 hours before treatment. Immersion of your dog in
water or shampooing within 24 hours after treatment may reduce the efficacy of the product. If you
want to wash your dog, leave at least one day between treatment and shampooing.
When administering the product, try to avoid wetting the fur as this will lead to a sticky and tangled
appearance. However, should this happen it will disappear within 24 hours.
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.
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 the local requirements.
Prac-tic should not enter water courses, as this may be dangerous for fish and other aquatic organisms.
Medicines should not be disposed of via wastewater or household waste.
These measures should help to protect the environment.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/
Adult fleas are killed before they lay eggs for a minimum of 4 weeks after treatment. Since Prac-tic
completely eliminates egg production, it breaks the flea life cycle.
Cardboard carton containing 1, 2 or 10 blisters of 3 pipettes.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the marketing