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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/535843/2007

EMEA/V/C/000121

EPAR summary for the public

Rheumocam

meloxicam

This document 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 document 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 Rheumocam?

Rheumocam is a veterinary medicine that contains the active substance meloxicam. It is available as granules in sachet (330 mg), oral suspension (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).

Rheumocam is a 'generic', which means that Rheumocam is similar to a 'reference veterinary medicine' already authorised in the EU (Metacam).

What is Rheumocam used for?

In cattle, Rheumocam 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 be used as supportive therapy in the treatment of acute mastitis (inflammation of the udder), in combination with antibiotics.

In pigs, Rheumocam 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)

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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, Rheumocam 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).

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

The formulation to use depends on the animal and the condition being treated.

How does Rheumocam work?

Rheumocam 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 Rheumocam been studied?

Since Rheumocam 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 benefit has Rheumocam shown during the studies?

Based on the findings of the studies, Rheumocam was considered to be bioequivalent to the reference medicine. Consequently, Rheumocam's benefit is taken as being the same as that of the reference medicine.

What is the risk associated with Rheumocam?

Side effects sometimes seen with other NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, renal (kidney) failure and apathy (lack of vitality) are occasionally seen with Rheumocam in dogs and cats. These generally occur within the first week of treatment and usually disappear once treatment has stopped. In very rare cases they may be serious or fatal.

In horses given the granules in sachet and oral suspension, slight urticaria (itchy rash) and diarrhoea were observed in clinical trials.

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

In cattle, pigs and horses in very rare cases anaphylactoid reactions (allergic) which may be serious (including fatal) may occur and should be treated symptomatically.

Rheumocam 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 to any of the other ingredients.

Rheumocam should not be used in pregnant or lactating horses and dogs, but it can be used during pregnancy and lactation for cattle and pigs.

Rheumocam must not be used in dogs or horses less than six weeks of age or in cattle less than one week of age when used in the treatment of diarrhoea. It must not be used in cats weighing less than 2 kg.

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 Rheumocam. If someone swallows or 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 before the animal can be slaughtered and the meat 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 for the 20 mg/ml solution for injection and three days for the granules in sachet and 15 mg/ml oral suspension. The product is not authorised for use in horses producing milk for human consumption.

Why has Rheumocam been approved?

The CVMP considered that, in accordance with European Union requirements, Rheumocam has been shown to be bioequivalent to Metacam. Therefore the CVMP's view was that, as for Metacam, Rheumocam's benefits are greater than its risks when used for the approved indications and the Committee recommended that Rheumocam be given a marketing authorisation.

Other information about Rheumocam:

The European Commission granted a marketing authorisation valid throughout the European Union, for Rheumocam on 10 January 2008. Information on the prescription status of this product may be found on the label of the carton.

This summary was last updated in March 2015.

Rheumocam

EMA/535843/2007

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