Melovem
Authorised
This medicine is authorised for use in the European Union
meloxicam
MedicineVeterinaryAuthorised
Overview
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).
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.
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.
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.
Studies have been carried out, both in calves and in pigs, to show that Melovem is bioequivalent to the reference medicine, Metacam.
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.
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.
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.
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.
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.
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.
Product information
Latest procedure affecting product information: R/0008
06/06/2014
Product details
- Name of medicine
- Melovem
- Active substance
- meloxicam
- International non-proprietary name (INN) or common name
- meloxicam
- Species
- Pigs
- Calves
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QM01AC06
Pharmacotherapeutic group
OxicamsTherapeutic 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.
News on Melovem
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