Profender

emodepside / praziquantel

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This is a summary of the European public assessment report (EPAR) for Profender. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical use on how to use Profender.

For practical information about using Profender, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Profender?

Profender is an antiparasitic medicine that contains two active substances, emodepside and praziquantel. Profender is available as a solution for use on cats, and as modified release tablets for dogs.

Profender solution is packed as spot-on pipettes, which are already filled with the correct amount of Profender needed to treat one cat (3 sizes of pipette for different cat weights) and as a multidose bottle for use only in a veterinary surgery, where the vet will measure the exact volume of Profender needed for each cat before application.

Profender tablets are available in three different strengths to cover a range of dog weights (small, medium or large dogs).

What is Profender and what is it used for?

Profender is a medicine used to treat cats and dogs that have, or are at risk of catching, “mixed” (caused by more than one parasite) parasitic infections. Profender works for infections caused by certain types of roundworms, tapeworms, as well as lungworms in cats.

How is Profender used?

Profender solution is packed as spot-on pipettes, which are already filled with the correct amount of Profender needed to treat one cat (3 sizes of pipette for different cat weights) and as a multidose bottle for use only in a veterinary surgery, where the vet will measure the exact volume of Profender needed for each cat before application.

Profender tablets are available in three different strengths to cover a range of dog weights (small, medium or large dogs). Profender can only be obtained with a prescription.

Cats are treated using the Profender spot-on solution range. The appropriate quantity of Profender (either the contents of one full pipette or the volume measured by the vet) is applied onto the cat’s skin, after parting the fur on the back of its neck at the base of its head.

Dogs are treated using Profender modified-release tablets, which are given by mouth when the dog is fasting. The correct number of tablets or half tablets to use is calculated based on the dog’s weight.

Profender is given as a single treatment for roundworms and tapeworms. For lungworms two treatments are needed two weeks apart.

How does Profender work?

The two active substances in Profender interact with different parts of the parasites systems. Emodepside interferes with certain specific receptors in the nervous systems of roundworms, which results in their subsequent paralysis and death. Praziquantel damages the skin-like outer layer of tapeworms, leading to their paralysis and death.

What benefits of Profender have been shown in studies?

The effectiveness of each of the products against the specified roundworms and tapeworms was investigated in both laboratory studies and in large field studies (one for the spot-on for cats and another for the tablets for dogs) carried out at several different places across Europe. In each of the field studies, animals of various breeds, age groups and different weights that were naturally infected with roundworms or tapeworms in their guts, were treated either with Profender or another approved worming medicine (selamectin in cats, and milbemycin oxime and praziquantel in dogs). The effectiveness was measured by looking at the number of worm eggs or parts of tapeworms passed out in the animal’s faeces after treatment. The results from the laboratory studies and from the field studies, in both cats and dogs, showed that Profender was as effective as the comparator medicine. Over 90% of cats and 99% of dogs had no roundworm or tapeworm infection after treatment with Profender.

For lungworms in cats a laboratory study together with a field study showed Profender to reduce the number of larvae passed in the animal’s faeces by more than 99%. The laboratory study showed Profender to reduce the worm count in the lungs by more than 99%.

What is the risk associated with Profender?

In cats, in very rare cases, the cat might salivate or vomit after treatment. Mild and short-lived signs relating to the nervous system such as ataxia (inability to co-ordinate muscle movements) or tremor (shaking) may occur in very rare cases. These effects are thought to occur as a result of the cat licking the application site straight after treatment. In very rare cases there might also be some temporary itchiness, inflammation or hair loss at the place where the product has been applied to the cat’s skin. These signs disappear without further treatment.

No side effects have been reported in dogs.

Profender should not be used in young animals (cats under 8 weeks of age or weighing less than 0.5 kg, or puppies under 12 weeks of age or weighing less than 1 kg).

As with other products of this type, Profender should be used on sick or ill cats or dogs only after a risk-benefit assessment by the vet. Profender should not be used for any other animal species.

Profender 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?

When giving Profender spot-on solution, skin contact with the pipette contents should be avoided and animals should not be stroked, groomed or allow to groom each other, until the application site is dry. The person giving the dose should not smoke, eat or drink, and should wash their hands thoroughly after use. If accidental exposure occurs, the eyes should be rinsed with water or the skin washed with soap and water.

The solvent in Profender spot-on solution may stain certain materials including leather, fabrics, plastics and finished surfaces, so contact between the product and such surfaces should be avoided.

Users should also wash their hands after giving Profender as tablets to a dog.

Why has Profender been approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Profender’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Profender

The European Commission granted a marketing authorisation valid throughout the EU for Profender on 27 July 2005.

For more information about treatment with Profender, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Profender : EPAR - Summary for the public BG = bălgarski 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public ES = español 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public CS = čeština 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public DA = dansk 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public DE = Deutsch 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public ET = eesti keel 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public EL = elliniká 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public EN = English 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public FR = français 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public IT = italiano 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public LV = latviešu valoda 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public LT = lietuvių kalba 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public HU = magyar 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public MT = Malti 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public NL = Nederlands 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public PL = polski 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public PT = português 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public RO = română 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public SK = slovenčina 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public SL = slovenščina 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public FI = suomi 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public SV = svenska 2008-11-23 2016-06-06
Profender : EPAR - Summary for the public HR = Hrvatski 2008-11-23 2016-06-06

This EPAR was last updated on 18/10/2017 .

Authorisation details

Product details

Product details for Profender
NameProfender
Agency product numberEMEA/V/C/000097
Active substance

emodepside / praziquantel

International non-proprietary name (INN) or common name

emodepside / praziquantel

Species DogsCats
Anatomical therapeutic chemical veterinary (ATCvet) codes QP52AA51








Publication details

Publication details for Profender
Marketing-authorisation holder

Bayer Animal Health GmbH

Revision15
Date of issue of marketing authorisation valid throughout the European Union27/07/2005

Contact address:

Bayer Animal Health GmbH
D-51368 Leverkusen
Germany

Product information

Product information

12/10/2017  Profender -EMEA/V/C/000097 -IAIN/0041

Name Language First published Last updated
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18
Profender : EPAR - Product Information HR = Hrvatski 2008-11-22 2017-10-18

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  
Profender : EPAR - All Authorised presentations HR = Hrvatski 2008-09-23  

Pharmacotherapeutic group

Therapeutic antiparasitic agent

Therapeutic indication

Cats

For cats suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:

Roundworms (Nematodes)

  • Toxocara cati (mature adult, immature adult, L4 and L3);
  • Toxocara cati (L3 larvae) – treatment of queens during late pregnancy to prevent lactogenic transmission to the offspring;
  • Toxascaris leonina (mature adult, immature adult and L4);
  • Ancylostoma tubaeforme (mature adult, immature adult and L4).

Tapeworms (Cestodes)

  • Dipylidium caninum (mature adult and immature adult);
  • Taenia taeniaeformis (adult);
  • Echinococcus multilocularis (adult).

Lungworms

  • Aelurostrongylus abstrusus (adult).

Dogs

For dogs suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:

Roundworms (nematodes):

  • Toxocara canis (mature adult, immature adult, L4 and L3);
  • Toxascaris leonina (mature adult, immature adult and L4);
  • Ancylostoma caninum (mature adult and immature adult);
  • Uncinaria stenocephala (mature adult and immature adult);
  • Trichuris vulpis (mature adult, immature adult and L4);

Tapeworms (Cestodes):

  • Dipylidium caninum;
  • Taenia spp.;
  • Echinococcus multilocularis (mature adult and immature);
  • Echinococcus granulosus (mature adult and immature).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Profender : EPAR - Scientific Discussion HR = Hrvatski 2008-12-14  
Profender : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-11-21