Prac-tic

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  • Heiti vöru:
  • Prac-tic
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  • Dýr
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  • Allópatísk lyf

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Staðsetning

  • Fáanlegt í:
  • Prac-tic
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Dogs
  • Lækningarsvæði:
  • Ectoparasiticides for topical use
  • Ábendingar:
  • 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.
  • Vörulýsing:
  • Revision: 10

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/V/C/000103
  • Leyfisdagur:
  • 17-12-2006
  • EMEA númer:
  • EMEA/V/C/000103
  • Síðasta uppfærsla:
  • 28-03-2019

Opinber matsskýrsla

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8447

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.

EMA/421838/2006

EMEA/V/C/000103

EPAR summary for the public

Prac-tic

Pyripole

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

Prac-tic

EMA/421838/2006

Page 2/3

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.

Prac-tic

EMA/421838/2006

Page 3/3

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.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Prac-tic 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:

Elanco GmbH

Heinz-Lohmann-Str. 4

27472 Cuxhaven

Germany

Manufacturer for the batch release:

Elanco France S.A.S.

26, Rue de la Chapelle

68330 Huningue

France

2.

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

Pyriprole

3.

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

the skin.

One pipette delivers:

Unit dose

Pyriprole

Prac-tic for very small dogs

0.45 ml

56.25 mg

Prac-tic for small dogs

1.1 ml

137.5 mg

Prac-tic for medium dogs

2.2 ml

275 mg

Prac-tic for large dogs

5.0 ml

625 mg

The solution also contains 0.1 % Butylhydroxytoluene (E321)

4.

INDICATION(S)

Treatment and prevention of flea infestation (

Ctenocephalides

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.

5.

CONTRAINDICATIONS

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

excipients.

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.

6.

ADVERSE REACTIONS

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.

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.

7.

TARGET SPECIES

8.

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

For spot-on use for external application to the dog’s skin.

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.

Weight range of

dog (kg)

Pipette size to be used

One pipette of 12.5%

(w/v) solution contains

(ml)

Pyriprole

(mg / kg bw)

2 – 4.5 kg

Very small dog

0.45

12.5 – 28.1

4.5 – 11 kg

Small dog

12.5 – 30.6

11 – 22 kg

Medium dog

12.5 – 25.0

22 – 50 kg

Large dog

12.5 – 28.4

Greater than

50 kg

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

dog’s skin.

Flea treatment and prevention

Pyriprole kills fleas within 24 hours after contact. One treatment prevents future flea infestation for 4

weeks.

Tick treatment and prevention

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

weeks.

9.

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.

10.

WITHDRAWAL PERIOD(S)

Not applicable.

11.

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

12.

SPECIAL WARNING(S)

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

animals

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

medication

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

administration.

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.

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 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.

14.

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/

15.

OTHER INFORMATION

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

authorisation holder.