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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/834845/2011

EMEA/V/C/002008

EPAR summary for the public

Panacur AquaSol

fenbendazole

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 Panacur AquaSol?

Panacur AquaSol is a medicine that contains the active substance fenbendazole. It is available as an oral suspension (200 mg/ml) for use in drinking water for pigs and chickens.

What is Panacur AquaSol used for?

Panacur AquaSol is used for the treatment and control of three types of roundworm infections in the gut of pigs:

•    Ascaris suum (adult and intestinal and migrating larval stages);

•    Oesophagostomum worms (adult stages);

•    Trichuris suis (adult stages).

Panacur AquaSol is also used for the treatment of two types of roundworm infections in the gut of chickens:

•    Ascaridia galli (L5 and adult stages);

•    Heterakis gallinarum (L5 and adult stages).

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For pigs, Panacur AquaSol is added to their drinking water in a quantity that aims to supply each pig 2.5 mg fenbendazole per kg bodyweight daily; this is done for two consecutive days for treatment and control of Ascaris suum and Oesophagostomum infections, and for three consecutive days to treat and control Trichuris suis. The amount added is based on the combined weight of all the pigs to be treated, with 2.5 mg added for each kg bodyweight on each treatment day (two or three consecutive days respectively).

For chickens, Panacur AquaSol is added to their drinking water in a quantity that aims to supply each chicken 1 mg fenbendazole per kg bodyweight daily; this is done for five consecutive days.

Before allowing the animals to access the medicated water the water delivery system should be drained and flushed with the medicated water.

How does Panacur AquaSol work?

The active substance in Panacur AquaSol, fenbendazole, is a well-known anthelmintic, a substance that is active against helminths (parasitic worms). It works by interfering with the formation of tube-like structures called 'microtubules' inside the cells of the worm that are needed to perform vital functions such as growth and cell division. As a result, the cells cannot divide and eventually die.

The medicine is effective against the worms and their eggs.

How has Panacur AquaSol been studied?

Panacur AquaSol was tested in three field studies involving pigs. The first study included 432 pigs infected with Ascaris suum and the second study included 102 pigs infected with Oesophagostomum species. In both studies, animals received either treatment with Panacur AquaSol or no treatment at all. In a third study, 254 pigs infected with Trichuris suis were treated either with Panacur AquaSol or received no treatment. The measure of effectiveness was the absence of eggs in the faeces of the animals.

The effectiveness of Panacur AquaSol was also investigated in a field study involving chickens bred for laying and chickens bred for meat, infected with Ascaridia galli or Heterakis gallinarum. The measure of effectiveness was the reduction of intestinal worms in a representative number of chickens.

What benefit has Panacur AquaSol shown during the studies?

After treatment with Panacur AquaSol no Ascaris suum or Oesophagostomum eggs could be detected in the faeces of the pigs. The third study in pigs showed that after treatment with Panacur AquaSol the number of Trichuris suis eggs was reduced by 90%.

Treatment with Panacur Aquasol in chickens reduced worm counts by 91% for Ascaridia galli and 98% for Heterakis gallinarum.

What is the risk associated with Panacur AquaSol?

There are currently no known side effects associated with Panacur AquaSol. Repeated use of Panacur AquaSol or a similar anthelmintic may result in resistance. The medicine should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Panacur AquaSol may be toxic if ingested by humans. The person administering Panacur AquaSol should avoid contact with his/her skin, eye and moist body surfaces (mucous membranes) as the medicine may cause reactions, including skin irritation. Protective gloves must be worn at all times whilst handling the product and cleaning the measuring device. Hands should be washed after use. In case of skin or eye contact the affected area should be rinsed immediately with water and any contaminated clothes should be removed. Pregnant women must take extra precautions when handling Panacur AquaSol as effects on the developing baby cannot be excluded.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption. It is also the time allowed after administration of the medicine before eggs can be used for human consumption.

The withdrawal period for Panacur AquaSol for pig meat and offal is four days. The withdrawal period for chicken meat and offal is six days and for eggs it is zero days.

Why has Panacur AquaSol been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Panacur AquaSol exceed its risks for the approved indications and recommended that Panacur AquaSol be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Panacur AquaSol:

The European Commission granted a marketing authorisation valid throughout the European Union, for Panacur AquaSol on 09/12/2011. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated in January 2014.

Panacur AquaSol

EMA/834845/2011

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