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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/840902/2011

EMEA/V/C/0002497

EPAR summary for the public

Inflacam

meloxicam

This is a summary of the European public assessment report (EPAR) for Inflacam. 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 advice on how to use Inflacam.

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

What is Inflacam and what is it used for?

Inflacam is a medicine that contains the active substance meloxicam.

Inflacam is a 'generic medicine'. This means that Inflacam is similar to a 'reference medicine' already authorised in the EU called Metacam.

In cattle, Inflacam is used together with appropriate antibiotic therapy, to reduce clinical signs of disease in acute respiratory infection (infection of the lungs and airways). It can be used in diarrhoea in combination with oral re-hydration therapy (medicines given by mouth to restore water levels in the body) to reduce clinical signs of the disease in calves of over one week of age and young, non-lactating cattle. It can also be used as supportive therapy in the treatment of acute mastitis (inflammation of the udder), in combination with antibiotics.

In pigs, Inflacam is used in non-infectious locomotor disorders (diseases that affect the ability to move) to reduce the symptoms of lameness and inflammation, for the relief of post-operative pain associated with minor soft tissue surgery such as castration, and for supportive therapy together with appropriate antibiotic therapy in the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome). Septicaemia and toxaemia are conditions where bacteria circulate in the blood and produce harmful substances (toxins).

In horses, Inflacam is used for the relief of pain associated with colic (abdominal pain) and for the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders (disorders affecting the muscles and bones).

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In dogs, Inflacam is used to reduce post-operative pain and inflammation following orthopaedic (e.g. fracture operation) and soft tissue surgery. Moreover, it is used for the alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

In cats, Inflacam is used to reduce post-operative pain and inflammation after ovariohysterectomy (spay operation), orthopaedic and minor soft tissue surgery.

How is Inflacam used?

Inflacam is available as granules in sachets (330 mg), oral suspensions (1.5 mg/ml and 15 mg/ml), chewable tablets (1 mg and 2.5 mg) and solution for injection (5 mg/ml and 20 mg/ml). The formulation and dose to use depends on the animal and the condition being treated.

Inflacam can only be obtained with a prescription. For further information, see the package leaflet.

How does Inflacam work?

Inflacam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory 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 Inflacam been studied?

Since Inflacam is a generic medicine, studies have been conducted to determine that it is bioequivalent to the reference medicine, Metacam. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Inflacam?

Because Inflacam is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

What is the withdrawal period in food-producing animals?

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

Cattle

The withdrawal period for meat is 15 days and for milk it is five days.

Pigs

The withdrawal period for meat is five days.

Horses

The withdrawal period for meat is five days for the 20 mg/ml solution for injection and three days for the granules in sachet and 15 mg/ml oral suspension. The medicine is not authorised for use in horses producing milk for human consumption.

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

Safety information has been included in the summary of product characteristics and the package leaflet for Inflacam, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers. The precautions are the same as for the reference medicine since Inflacam is a generic medicine.

Why has Inflacam been approved?

The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Inflacam has been shown to have comparable quality and to be bioequivalent to Metacam. Therefore the CVMP's view was that, as for Metacam, the benefits outweigh the identified risks. The Committee recommended that Inflacam be approved for use in the EU.

Other information about Inflacam

The European Commission granted a marketing authorisation valid throughout the EU, for Inflacam on 09/12/2011.

The full EPAR for Inflacam can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary Medicines/European public assessment reports. For more information about treatment with Inflacam, read the package leaflet (also part of the EPAR) or contact your veterinarian or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency's website.

This summary was last updated in October 2015.

Inflacam

EMA/840902/2011

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