Zolvix

monepantel

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This 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 summary 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 Zolvix?

Zolvix is a medicine that contains the active substance monepantel. Zolvix is available as an oral solution (25 mg/ml).

What is Zolvix used for?

Zolvix is used for the treatment and control of worm infections of the gut and associated diseases in sheep. Zolvix is effective against a wide range of worm species.

Zolvix is given as a single dose of 2.5 mg per kilogram bodyweight. The amount to use is calculated based on the weight of the sheep. The oral solution is given directly on the back of the tongue.

How does Zolvix work?

Monepantel, is an anthelmintic, a substance that is active against helminths. Helminths, also known as nematodes, are worm-like parasites that live in the gut of animals. Monepantel blocks part of a receptor, the nicotinic acetylcholine receptor, that is specific to the nematodes. This causes paralysis and death of the worms. Monepantel is effective against nematodes resistant to other anthelmintics.

How has Zolvix been studied?

A number of laboratory studies and field trials in various countries were performed. Two main studies were carried out, one in Europe and one in New Zealand, in sheep suffering from a range of nematode infections. The New Zealand study and some additional studies compared the effectiveness of Zolvix to other anthelmintics. In the studies, the effectiveness of Zolvix was measured by looking for parasite eggs in the sheep faeces at different time points during the trials.

What benefit has Zolvix shown during the studies?

The studies showed that Zolvix is effective against infections of all of the major gastrointestinal nematodes, including effectiveness against strains of parasites resistant to the currently available broad-spectrum anthelmintics.

What is the risk associated with Zolvix?

The effectiveness of Zolvix has not been established in sheep weighing less than 10 kg and safety has not been established in sheep weighing less than 10 kg or under two weeks of age. To help delay the development of resistance, users are advised to check the success of the treatment by examining the sheep’s clinical appearance, or by testing whether any parasite eggs can be found in the faeces.

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

Users who are administering this medicine to sheep should wear protective gloves. In case of accidental spillage onto skin or into eyes, the area should be washed immediately with water. Any contaminated clothes should be removed. In case of accidental ingestion medical advice should be sought immediately and the package leaflet or the label shown to the doctor. The user must not eat, drink or smoke whilst handling the product and hands and exposed skin should be washed after handling the product.

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 or milk used for human consumption. The withdrawal period for sheep for meat and offal is seven days. Zolvix is not authorised for use in lactating animals producing milk for human consumption.

Why has Zolvix been approved?

The CVMP concluded that the benefits of Zolvix exceed the risks for the approved indications and recommended that Zolvix be given a marketing authorisation. The benefit/risk balance may be found in the scientific discussion module of this EPAR.

Other information about Zolvix

The European Commission granted a marketing authorisation valid throughout the European Union, for Zolvix on 4 November 2009. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Zolvix : EPAR - Summary for the public BG = bălgarski 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public ES = español 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public CS = čeština 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public DA = dansk 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public DE = Deutsch 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public ET = eesti keel 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public EL = elliniká 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public EN = English 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public FR = français 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public IT = italiano 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public LV = latviešu valoda 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public LT = lietuvių kalba 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public HU = magyar 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public MT = Malti 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public NL = Nederlands 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public PL = polski 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public PT = português 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public RO = română 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public SK = slovenčina 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public SL = slovenščina 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public FI = suomi 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public SV = svenska 2009-11-09 2014-01-20
Zolvix : EPAR - Summary for the public HR = Hrvatski 2009-11-09 2014-01-20

This EPAR was last updated on 20/07/2016 .

Authorisation details

Product details

Product details for Zolvix
NameZolvix
Agency product numberEMEA/V/C/000154
Active substance

monepantel

International non-proprietary name (INN) or common name

monepantel

Species Sheep
Anatomical therapeutic chemical veterinary (ATCvet) codes QP52AX09








Publication details

Publication details for Zolvix
Marketing-authorisation holder

Elanco Europe Ltd

Revision10
Date of issue of marketing authorisation valid throughout the European Union04/11/2009

Contact address:

Elanco Europe Ltd
Lilly House
Priestley Road
Basingstoke
Hampshire
RG24 9NL
United Kingdom

Product information

Product information

15/07/2016  Zolvix -EMEA/V/C/000154 -IB/0019/G

Name Language First published Last updated
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20
Zolvix : EPAR - Product Information HR = Hrvatski 2009-11-09 2016-07-20

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
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20
Zolvix : EPAR - All Authorised presentations HR = Hrvatski 2009-11-01 2016-07-20

Pharmacotherapeutic group

Anthelmintics

Therapeutic indication

Zolvix oral solution is a broad spectrum anthelmintic for the treatment and control of gastro-intestinal nematode infections and associated diseases in sheep including lambs, hoggets, breeding rams and ewes.

Spectrum of activity includes fourth larvae and adults of:

  • Haemonchus contortus*;
  • Teladorsagia circumcincta*;
  • Teladorsagia trifurcata*;
  • Teladorsagia davtiani*;
  • Trichostrongylus axei*;
  • Trichostrongylus colubriformis;
  • Trichostrongylus vitrinus;
  • Cooperia curticei;
  • Cooperia oncophora;
  • Nematodirus battus;
  • Nematodirus filicollis;
  • Nematodirus spathiger;
  • Chabertia ovina;
  • Oesophagostomum venulosum.

* including inhibited larvae.

The veterinary medicinal product is effective against strains of these parasites resistant to (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones and H. contortus strains resistant to salicylanilides.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents