Rheumocam

meloxicam

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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 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) 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 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 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.

Name Language First published Last updated
Rheumocam : EPAR - Summary for the public BG = bălgarski 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public ES = español 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public CS = čeština 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public DA = dansk 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public DE = Deutsch 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public ET = eesti keel 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public EL = elliniká 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public EN = English 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public FR = français 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public IT = italiano 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public LV = latviešu valoda 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public LT = lietuvių kalba 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public HU = magyar 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public MT = Malti 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public NL = Nederlands 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public PL = polski 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public PT = português 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public RO = română 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public SK = slovenčina 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public SL = slovenščina 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public FI = suomi 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public SV = svenska 2009-10-19 2015-06-10
Rheumocam : EPAR - Summary for the public HR = Hrvatski 2009-10-19 2015-06-10

This EPAR was last updated on 22/09/2016 .

Authorisation details

Product details

Product details for Rheumocam
NameRheumocam
Agency product numberEMEA/V/C/000121
Active substance

meloxicam

International non-proprietary name (INN) or common name

meloxicam

Species HorsesDogsPigsCattleCats
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 Rheumocam
Marketing-authorisation holder

Chanelle Pharmaceuticals Manufacturing Limited

Revision10
Date of issue of marketing authorisation valid throughout the European Union10/01/2008

Contact address:

Chanelle Pharmaceuticals Manufacturing Limited
Loughrea
Co. Galway
Ireland

Product information

Product information

08/09/2016  Rheumocam -EMEA/V/C/000121 -WS0933-G

Name Language First published Last updated
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22
Rheumocam : EPAR - Product Information HR = Hrvatski 2009-10-12 2016-09-22

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
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10
Rheumocam : EPAR - All Authorised presentations HR = Hrvatski 2009-08-14 2015-06-10

Pharmacotherapeutic group

Anti-inflammatory and anti-rheumatic products, non-steroids, oxicams

Therapeutic indication

Dogs

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs. To reduce post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats

Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

Cattle

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs. For use in diarrhoea in combination with oral re-hydration 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 non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy. For the relief of post operative pain associated with minor soft tissue such as castration.

Horses

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses..

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
Rheumocam : EPAR - Scientific Discussion HR = Hrvatski 2009-10-19  
CVMP summary of opinion for Rheumocam HR = Hrvatski 2009-07-17  
Rheumocam : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2008-01-24  

Authorised

This medicine is approved for use in the European Union

News

More information on Rheumocam