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).
Recocam is a medicine for cattle, pigs and horses that contains the active substance meloxicam. It is available as a clear yellow solution for injection (20 mg/ml).
Recocam is a ‘generic’ medicine which means that Recocam is similar to a ‘reference veterinary medicine’ already authorised in the European Union (EU; Metacam). Recocam is ‘bioequivalent’ to the reference medicine which means that it is equivalent to Metacam in the way it is absorbed and used by the body.
In cattle, it is used together with appropriate antibiotics, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder). It can be used with oral rehydration therapy for diarrhoea in calves of over one week of age and in young, non-lactating cattle. Recocam is given in cattle as a single injection of 0.5 mg per kg body weight under the skin or into a vein.
It is used in pigs to reduce the symptoms of lameness and inflammation in noninfectious locomotor disorders (diseases that affect the ability to move) and for the treatment of certain diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome), together with appropriate antibiotic therapy. It is given as a single injection of 0.4 mg per kg body weight into a muscle. A second dose may be given after 24 hours if required.
Recocamis used in horses to relieve colic (abdominal pain) and for the alleviation of inflammation and relief of pain in musculoskeletal disorders. Recocam is given as a single injection of 0.6 mg per kg body weight into a vein.
Recocam 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 the prostaglandins trigger inflammation, pain, exudation and fever, meloxicam reduces these clinical signs.
Although Recocam is a generic medicine no bioequivalence studies have been provided as the composition of the product is sufficiently similar to the reference product Metacam for the products to be considered essentially similar.
Recocam was considered to be bioequivalent with the reference medicine. Consequently, Recocam’s benefit is taken as being the same as that of the reference medicine.
In cattle and pigs, subcutaneous, intramuscular and intravenous administration is well tolerated. Only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of cattle treated in clinical studies.
In horses, a transient swelling at the injection site can occur but resolves without intervention. In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Recocam.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the doctor.
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. The withdrawal period for Recocam for meat is 15 days for cattle and five days for pigs and horses. Milk can be taken five days after administration in cattle. The medicine should not be used in horses producing milk for human consumption.
The CVMP considered that, in accordance with European Union requirements, Recoocam is bioequivalent to Metacam. Therefore the CVMP’s view was that, as for Metacam, Recocam’s benefits are greater than its risks when used for the approved indications. The Committee recommended that Recocam 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 Recocam on 13 September 2011. Information on the prescription status of this product may be found on the label / outer package.
Recocam : EPAR - Summary for the public
Product information
Recocam : EPAR - Product Information
Latest procedure affecting product information: IAIN/0011
13/06/2019
Recocam : EPAR - All Authorised presentations
Product details
- Name of medicine
- Recocam
- Active substance
- meloxicam
- International non-proprietary name (INN) or common name
- meloxicam
- Species
- Horses
- Pigs
- Cattle
- 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 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
Recocam : EPAR - Procedural steps taken and scientific information after authorisation