Melovem

meloxicam

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This is a summary of the European public assessment report (EPAR). 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 Melovem?

Melovem is a medicine that contains the active substance meloxicam. It is available as a solution for injection (5 mg/ml, 20 mg/ml and 30 mg/ml).

Melovem is a ‘generic’. This means that Melovem is similar to a ‘reference veterinary medicine’ containing the same active substance. While the reference medicine, Metacam, is available as 5-mg/ml and 20-mg/ml solutions for injection, Melovem is also available as a 30-mg/ml solution for injection.

What is Melovem used for?

Melovem is used in cattle, together with appropriate antibiotic therapy, to reduce the signs of acute respiratory infections (infection of the lung and airways). It can be used in combination with oral rehydration therapy (medicines given by mouth to restore water levels in the body) for diarrhoea in calves of over one week of age and young, non‑lactating cattle. The 20-mg/ml and 30-mg/ml solutions for injection are also used in combination with antibiotic therapy to treat acute mastitis (inflammation of the udder).

Melovem solution for injection (5 mg/ml, 20 mg/ml and 30 mg/ml) is used in pigs to reduce the symptoms of lameness (inability to walk normally) and inflammation in noninfectious locomotor disorders (diseases that affect the ability to move). The 5-mg/ml solution for injection can be used for the relief of postoperative pain associated with minor soft-tissue surgery such as castration (surgical removal of the testicles). The 20-mg/ml and 30-mg/ml solution for injection can be used together with appropriate antibiotic therapy for the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia (bacteria present in blood) and toxaemia (a toxic state) (mastitis-metritis-agalactia syndrome).

Melovem solution for injection (20 mg/ml) is used in horses to relieve colic (abdominal pain) and the inflammation and pain in musculoskeletal disorders.

How does Melovem work?

Melovem contains meloxicam, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins. As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.

How has Melovem been studied?

Studies have been carried out, both in calves and in pigs, to show that Melovem is bioequivalent to the reference medicine, Metacam.

What benefit has Melovem shown during the studies?

As Melovem is considered to be bioequivalent to the reference medicine, its benefit is taken as being the same as that of the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What is the risk associated with Melovem?

A slight temporary swelling at the injection site following injection under the skin and in the muscle was observed in cattle and pigs. In horses, a temporary swelling at the injection site can occur but resolves without intervention.

In very rare cases, potentially serious or fatal anaphylactoid reactions (similar to severe allergic reactions) may occur following injection and should be treated symptomatically.

Melovem must not be used in animals with liver, heart or kidney problems, bleeding disorders, or suffering from irritation or ulcers of the digestive tract. It must not be used in animals which are hypersensitive (allergic) to the active substance or any of the other ingredients. If used for the treatment of diarrhoea in cattle, Melovem must not be used in animals of less than one week of age. Melovem must also not be used in horses less than six weeks of age.

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

People who are hypersensitive (allergic) to NSAIDs should avoid contact with Melovem. If someone accidentally injects themselves with the medicine, the advice of a doctor should be sought immediately.

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 eggs or milk used for human consumption. It is also the time allowed after administration of the medicine before the milk can be used for human consumption.

Cattle

For meat, the withdrawal period is 15 days and for milk, it is five days.

Pigs

For meat, the withdrawal period is five days.

Horses

For meat, the withdrawal period is five days. The product is not authorised for use in horses producing milk for human consumption.

Why has Melovem been approved?

The CVMP decided that, in accordance with European Union requirements, Melovem has been shown to be bioequivalent to Metacam. Therefore, the CVMP’s view was that, as for Metacam, Melovem’s benefits are greater than its risks for the approved indications and the Committee recommended that Melovem be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Melovem:

The European Commission granted a marketing authorisation valid throughout the European Union for Melovem on 7 July 2009. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Melovem : EPAR - Summary for the public BG = bălgarski 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public ES = español 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public CS = čeština 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public DA = dansk 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public DE = Deutsch 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public ET = eesti keel 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public EL = elliniká 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public EN = English 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public FR = français 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public IT = italiano 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public LV = latviešu valoda 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public LT = lietuvių kalba 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public HU = magyar 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public MT = Malti 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public NL = Nederlands 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public PL = polski 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public PT = português 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public RO = română 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public SK = slovenčina 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public SL = slovenščina 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public FI = suomi 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public SV = svenska 2007-07-09 2013-10-10
Melovem : EPAR - Summary for the public HR = Hrvatski 2007-07-09 2013-10-10

This EPAR was last updated on 19/06/2014 .

Authorisation details

Product details

Product details for Melovem
NameMelovem
Agency product numberEMEA/V/C/000152
Active substance

meloxicam

International non-proprietary name (INN) or common name

meloxicam

Species PigsCalves
Anatomical therapeutic chemical veterinary (ATCvet) codeQM01AC06
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Melovem
Marketing-authorisation holder

Dopharma Research B.V.

Revision5
Date of issue of marketing authorisation valid throughout the European Union07/07/2009

Contact address:

Dopharma Research B.V.
Zalmweg 24
4941 VX Raamsdonksveer
The Netherlands

Product information

Product information

06/06/2014  Melovem -EMEA/V/C/000152 -R/0008

Name Language First published Last updated
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19
Melovem : EPAR - Product Information HR = Hrvatski 2007-07-09 2014-06-19

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
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10
Melovem : EPAR - All Authorised presentations HR = Hrvatski 2007-07-09 2013-10-10

Pharmacotherapeutic group

Anti-inflammatory and antirheumatic products, non-steroids (oxicams)

Therapeutic indication

Cattle

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. For use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.

Pigs

For use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation. For the relief of postoperative pain associated with minor soft-tissue surgery such as castration. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.

Horses

For use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders. For the relief of pain associated with equine colic.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
CVMP summary of opinion for Melovem HR = Hrvatski 2009-05-15  
Melovem : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2007-07-09  
Melovem : EPAR - Scientific Discussion HR = Hrvatski 2007-07-09  

Authorised

This medicine is approved for use in the European Union

News

More information on Melovem