Overview

Inflacam is an anti-inflammatory medicine used in cattle, pigs, horses, dogs and cats.

Inflacam contains the active substance meloxicam and is a generic medicine. This means that Inflacam contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Metacam.

Cattle
In cattle, Inflacam is used together with appropriate antibiotic therapy, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways). It can be used with oral re-hydration therapy (medicines given by mouth to restore water levels in the body) to reduce diarrhoea 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.

Pigs
In pigs, Inflacam is used to reduce lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move), for the relief of post-operative pain after 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).

Horses
In horses, Inflacam is used to reduce pain associated with colic (abdominal pain) and to lessen inflammation and relieve pain in acute and chronic musculo-skeletal disorders (disorders affecting the muscles and bones).

Dogs
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 to lessen inflammation and pain in acute and chronic musculo-skeletal disorders.

Cats
In cats, Inflacam is used to reduce post-operative pain and inflammation after ovariohysterectomy (spaying operation), orthopaedic and minor soft tissue surgery. Moreover it is used to lessen inflammation and pain in acute and chronic musculo-skeletal disorders in cats.

Inflacam is available as granules, an oral (taken by mouth) suspension , chewable tablets  and solution for injection . Injections may be into a vein, muscle or under the skin. 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 about using Inflacam, see the package leaflet or contact your veterinarian or pharmacist.

Inflacam 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.

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.

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.

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.

The withdrawal period is the time required after administration of a medicine before an 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 and 15 mg/ml oral suspension. The medicine is not authorised for use in horses producing milk for human consumption.

The European Medicines Agency concluded that, in accordance with EU requirements, Inflacam has been shown to have comparable quality and to be bioequivalent to Metacam. Therefore the Agency’s view was that, as for Metacam, the benefits of Inflacam outweigh the identified risks and it can be authorised for use in the EU.

Inflacam received  a marketing authorisation valid throughout the EU on 9 December 2011.

Inflacam : EPAR - Medicine overview

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Product information

Inflacam : EPAR - Product Information

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Latest procedure affecting product information: IB/0024

18/03/2021

Inflacam : EPAR - All Authorised presentations

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svenska (SV) (130.68 KB - PDF)

Product details

Name of medicine
Inflacam
Active substance
meloxicam
International non-proprietary name (INN) or common name
meloxicam
Species
  • Horses
  • Dogs
  • Cats
  • Cattle
  • Pigs
Anatomical therapeutic chemical veterinary (ATCvet) code
QM01AC06

Pharmacotherapeutic group

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

Therapeutic indication

Dogs: alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.

To reduce post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats: to reduce post-operative pain after ovariohysterectomy and minor soft tissue surgery.

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.

Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.

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.

For the relief of post-operative pain following dehorning in calves.

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.

For the relief of pain associated with equine colic.

Authorisation details

EMA product number
EMEA/V/C/002497

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder
Chanelle Pharmaceuticals Manufacturing Ltd

Dublin Road
Loughrea
Co. Galway
Ireland

Marketing authorisation issued
09/12/2011
Revision
12

Assessment history

Inflacam : EPAR - Procedural steps taken and scientific information after authorisation

Inflacam-V-C-2497-X-0015: EPAR - Assessment Report - Extension

CVMP post-authorisation summary of positive opinion for Inflacam (X-0015)

Inflacam -V-C-2497-X-0009: EPAR - Assessment Report - Extension

CVMP post-authorisation summary of positive opinion for Inflacam

Inflacam-V-C-2497-X-01: EPAR - Assessment Report - Extension

CVMP post-authorisation summary of positive opinion for Inflacam

Inflacam-V-C-2497-X-02 : EPAR - Assessment Report - Extension

CVMP post-authorisation summary of positive opinion for Inflacam

CVMP summary of positive opinion for Inflacam

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